id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
6,014 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients with symptoms of erosive or ulcerative gastroesophageal reflux disease (GERD)
during at least a period of 3 months prior to study initiation and symptoms of GERD
for at least 3 days per week within the 2 weeks prior to study initiation. The
symptoms of erosive or ulcerative gastroesophageal reflux disease includes the
following: heartburn, aching behind the breastbone, a need for antacids, and
difficulty in swallowing. Patients with evidence by endoscopy of erosive or ulcerative
gastroesophageal reflux disease with no Barret-type tissue transformation.
Exclusion Criteria:
- No narrowing or inflammation of the esophagus
- no known gastro-duodenal ulcer
- no infections (other than H. Pylori), inflammations or hemorrhage of the stomach,
small or large intestine
- no prior surgery of the stomach or intestine
- no known history of primary kinetic disorders of the esophagus, other than GERD
- no history of enlarged veins of the esophagus or stomach
- no pregnant or nursing females, or those lacking adequate contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD) | NCT00216489 | Entailment |
1,084 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- 50 years old
- syncope (defined in 2017 ACC/AHA/HRS guidelines[16]) in the prior 12 months
- diagnosis unclear after history, physical exam andelectrocardiogram
- no apparent risk of death due to the cause of syncope.
Exclusion Criteria:
- inability to give informed consent
- unable to attend routine follow up in device clinic
- positive carotid sinus massage.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Syncope Trial to Understand Tilt Testing Early or Recorders Study | NCT03974412 | Contradiction |
5,736 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in
combination with clinical appearance will be used for diagnosis
- Previous routine treatment modalities has been attempted including steroids and
immunomodulatory or antioxidant agents. i.e patients who had resistant lesions to
routine treatment .removal of possible triggering drugs was also considered.
- Patients of both sexes between 40 to 70 year's old
- Patients who have symptoms such as burning sensation, pain
- Patients who have localized precancerous lesions such as atrophic-erosive/plaque like
lichen planus with diameter lesser than 2 cm
- Patients who agree to this treatment
- Patients who are willing for evaluation in first week after surgery and every two
month for 1 years
- Patients who agree to final punch biopsy for histopathologic evaluation
Exclusion criteria:
- Patients who unable to undergo oral surgery
- Patients suffering from any localized or systemic disease
- Pregnant patients
- Smokers
- Patients who can not continue the study for private or social reasons
- Patients with generalized oral lichen planus
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Free Soft Tissue Graft in Treatment of Oral Lichen Planus | NCT00737854 | Contradiction |
6,035 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Male or female subjects at least 18 years of age.
- Subjects willing to undergo multiple nasogastric intubations.
- Patients with functional heartburn will need to meet ROME II criteria.
- Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort
characterized by bloating, postprandial fullness and early satiety)
Exclusion Criteria:
- Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant
IBS.
- Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring,
or previous or current history of ulcer disease.
- Subjects with Diffuse Esophageal Spasm or Achalasia.
Other protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia. | NCT00171457 | Entailment |
1,558 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- no participation in a similar study 2-weeks prior
- may be post-menopausal or have had a hysterectomy
- if sexually active, and of child bearing potential, subjects is using adequate
non-barrier method of birth control
- free from any vaginal disorders
- sexually active and in a monogamous, heterosexual relationship, and whose male partner
is willing and able to give informed consent and agrees to engage in sexual
intercourse at least twice each week during the two-week study or is not sexually
active
- personal lubricant user and agrees to replace her usual personal lubricant with the
investigational product
- can start regardless of where they are in their cycles
- agrees to use the provided investigational product at least four time weekly over the
two week study period
- exhibits no clinically significant evidence of vulvar or vaginal irritation, as
determined by a study doctor, and no reports of sensory irritation at the baseline
exam
- willing to refrain from introducing any new vaginal products, or using vaginal
medications or local contraceptives during study
- agrees to refrain from douching or using any medications, powder, lotions or personal
care products in the vulvar or perianal area
- willing to use a urine pregnancy test provided to them at baseline and on third visit
- standard medical history form on file
- signed informed consent
- completed HIPAA
- dependable and able to follow directions as outlined
- receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation
(burning, stinging, itching and dryness) during the first examination.
Exclusion Criteria:
- pregnant, nursing or planning a pregnancy
- currently using or has used within two weeks prior to the study initiation, any
systemic or topical corticosteroids, vasoconstrictors, antibiotics,
anti-inflammatories or antihistamines
- known allergies to vaginal or any cosmetic products
- reports history of recurrent bladder, vaginal infections or incontinence
- exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days
prior to study initiation
- uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with
spermicide as a means of contraception
- participated in a study involving the vaginal area or in an investigational systemic
drug study within two weeks of study initiation
- receives a score higher than 0/5 for erythema, edema or >0 for burning, stinging, or
itching, during first examination or shows any other sign of mucosal irregularities
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects | NCT02737592 | Contradiction |
2,027 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Biopsy specimen from the primary lesion shows adenocarcinoma
2. Diagnosed as Stage IA early gastric cancer according to the preoperative
esophagogastroduodenoscopy and computer tomography
3. Endoscopic submucosal dissection is not indicated
4. Tumor was located within lower two thirds of stomach
5. Not having duodenal invasion
6. Eastern clinical oncology group performance status is 0 or 1
7. Body mass index is lower than 30
8. No prior laparotomy
9. No prior chemotherapy or radiation including those for other cancers
10. Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT <
100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl
Exclusion Criteria:
1. Having other active cancers
2. Possibly pregnant, or breast feeding woman
3. with psychiatric disorder
4. Receiving steroids
5. With Acute myocardial infarction in 6 months or with unstable angina
6. With uncontrolled hypertension
7. With uncontrolled diabetes mellitus
8. With pulmonary disease which require continuous oxygen therapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Phase II Study for Robot Assisted Distal Gastrectomy | NCT01504997 | Entailment |
2,728 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- BMI (Body mass index) < 30
- Non severe liver, renal or cardiac disease
- No allergy or contraindications to any of the study drugs
- American Hernia Society Score type I-II-IV-V hernia
- No pain or chronic analgesic administration in the preoperative period
- No previous surgery of the inguinal region
- Normal coagulation parameters and platelet count (> 100.000).
- Dicumarol and aspirin suspension for > 7 days
- Correctly administrated premedication
- No systemic infections
- No contraindications to subarachnoid anesthesia
Exclusion Criteria:
- BMI (Body mass index) > 30
- Severe liver, renal or cardiac disease
- Allergy or contraindications to any of the study drugs
- American Hernia Society Score type III-VI-VII-0 hernia
- Pain or chronic analgesic administration in the preoperative period
- Previous surgery of the inguinal region
- Anormal coagulation parameters and platelet count (< 100.000).
- No dicumarol and aspirin suspension for > 7 days
- Incorrectly administrated premedication
- Systemic infections
- Contraindications to subarachnoid anesthesia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery | NCT01521481 | Entailment |
2,462 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Hilar/mediastinal lymph nodes with a short axis more than 1 cm on thoracic CT scan
and/or PET-CT suspicious for malignancy with or without known lung malignancy.
- Hilar and/or mediastinal lymph nodes positive on PET/CT scan without regarding the
diameter suspicious for malignancy.
- Recurrence or restaging of NSCLC after chemotherapy or radiation.
- Diagnosis of lung cancer when there is no endobronchial lesion.
- Diagnosis of both benign (especially tuberculosis and sarcoidosis) and malignant
mediastinal lesions (eg. thymoma).
Exclusion Criteria:
- Cardiovascular instability.
- Lack of patient cooperation, e.g. intractable cough, inability to remain motionless or
altered consciousness.
- Bleeding diathesis (activated partial thromboplastin time (APTT) ratio or
international normalized ratio (INR) <1.3 or platelet count of <50000 per mm3).
- Respiratory failure and patient on mechanical ventilation.
- Severe chronic obstructive pulmonary disease (COPD) (FEV1<1 liter or <35% predicted).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Value of Rapid on Site Evaluation During EBUS-guided TBNA in the Diagnosis of Mediastinal Lesions | NCT02690610 | Entailment |
2,216 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Hyperuricemic or gout patients
- Serum urate level:
>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension,
diabetes or metabolic syndrome, or >= 9.0mg/dL
Exclusion Criteria:
- Gouty arthritis within two weeks before start of study treatment
- Secondary hyperuricemia
- HbA1c: >= 8.4%
- Uric acid-overproduction type in the classification of hyperuricemia
- History of, clinically significant cardiac, hematologic and hepatic disease
- Kidney calculi or clinically significant urinary calculi
- eGFR: < 60mL/min/1.73m^2
- Systolic blood pressure: >= 180 mmHg
- Diastolic blood pressure: >= 110 mmHg
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 64 Years | Study of FYU-981 in Hyperuricemia With or Without Gout | NCT02344862 | Contradiction |
6,254 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Diagnosis of chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenstrom
disease according to the criteria of the WHO 2016 with a proven or probable infection
by COVID-19 according to the following criteria:
- Proven infection: PCR positive regardless of the radio-clinical picture (Other tests
made available later and having good diagnostic performance will be accepted)
- Probable infection: the diagnosis of probable infection is retained in case of
negative PCR or not made if presence of at least 2 major criteria or of a major
criterion associated with at least 2 minor criteria among the following, in the
absence other documented cause.
- Major criteria:
- Fever
- Loss of smell / taste
- At least one respiratory sign among cough, dyspnea, chest pain
- Radiological signs suggestive of the scanner (areas or diffuse appearance of
frosted glass, condensations including pseudonodular condensations, association
of frosted glass and condensation within the same lesion, nodules and
micronodules, thickening of the interlobular septa) or on an X-ray of the thorax
( interstitial, alveolo-interstitial or alveolar syndrome, unilateral or
bilateral)
- Notion of storytelling with a person whose SARS-CoV-2 infection has been formally
documented
- Minor criteria
- Aches
- Sore throat
- Rhinorrhea
- Headache
- Diarrhea
- Abdominal pain
- Frank asthenia
- Conjunctivitis
Exclusion Criteria:
- Patient opposition
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19 | NCT04391946 | Contradiction |
1,466 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Hypertension patients who are taking an anti-hypertensive agent, including Fimasartan
at least 12 weeks or more.
- Dyslipidemia patients who are taking dyslipidemia drug, including Rosuvastatin at
least 12 weeks or more
- Patients who has blood pressure and lipid levels (Total cholesterol, LDL-C, HDL-C,
non-HDL-C, * TG) checks 2 weeks before registration
Exclusion Criteria:
- Patients being hospitalized
- Patients who stop taking Fimasartan or Rosuvastatin within 12 weeks 14 or more
consecutive days
- Patients who have more than 400mg/dl triglyceride(TG) at the registration time
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Fimasartan and Rosuvastatin for Hypertension and Dyslipidemia Control | NCT02913794 | Entailment |
4,438 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
1. Male or female between 18 and 65 years of age
2. Clinical diagnosis of unilateral lateral epicondylosis defined as:
1. Pain reproducible on palpation of the lateral epicondyle / common extensor
origin; and
2. Pain reproducible during resisted wrist extension
3. Subject is symptomatic for at least 6 weeks
4. Subject has pain in the index lateral epicondyle after grip strength testing that
measures ≥ 40 mm on a 100 mm VAS
5. Subject must be willing to abstain from other pharmacological and surgical treatments
of the index elbow for the duration of the study
6. Subject is willing to discontinue all systemic and/or topical analgesics including
NSAIDs, (except the rescue medication oral acetaminophen/paracetamol), for the
treatment of lateral epicondylosis at least seven days before the initial treatment
injection and through the completion of the study
7. If pain medication is needed during the study, subject is willing to use only
acetaminophen/paracetamol (up to a maximum of 3.0 grams per day per the package
insert) for the treatment of elbow pain for the duration of the study
8. At least twenty four hours prior to the Baseline Visit and each follow-up visit, the
subject must discontinue use of acetaminophen/paracetamol, if used
9. Subject is able to understand and comply with the requirements of the study and
voluntarily provides consent
Exclusion Criteria:
1. Subjects with a history of hypersensitivity to any of the ingredients in the
hyaluronan or an inability to tolerate acetaminophen/paracetamol
2. Subjects in which the investigator believes the anatomical landmarks for injection are
unable to be adequately identified
3. Subjects who have a history of surgery to the intra-articular joint of the index elbow
and/or history of index elbow dislocation
4. Any diagnosed pathology or trauma that causes pain or symptoms in the index elbow
other than lateral epicondylosis (e.g. intra-articular pathology, ligament injury,
cervical radiculopathy, radial tunnel syndrome, osteochondral radiocapitellar lesion
or posterolateral elbow plica, pain starting after a motor vehicle accident)
5. Hyaluronic acid injections in the index elbow within the last 6 months
6. Steroid injections in the index elbow within the last 3 months
7. Infections or skin diseases in the area of the injection site or elbow joint
8. Known inflammatory or autoimmune disorders, or other pre-existing medical conditions
that, in the opinion of the investigator, could impact healing or affect the ability
of the subject to complete the study and comply with the study requirements
9. Subject is taking medications at the time of consent which could interfere with the
treatment procedure, healing and/or assessments. This includes but is not limited to
oral or injectable anticoagulant treatments, anti-aggregant platelet treatment and
opioid analgesics. Low dose aspirin (81 mg) used for cardiovascular protection is
allowed if a stable regimen is maintained for the duration of the study.
10. Subject is receiving or in litigation for worker's compensation
11. Subject is a woman who is pregnant or breastfeeding at the screening visit or a woman
of child bearing potential who refuses to use effective contraception during the
course of the study
12. Subject was involved in any other research study involving an investigational product,
or a new application of an approved product, within 60 days of signing the Informed
Consent Form (ICF)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow) | NCT02861183 | Contradiction |
6,604 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Patient population with acquired hemophilia A:
Adult patients with a diagnosis of acquired hemophilia A and with a social security
system. Obtaining oral non-opposition from the patient to participate in the study
following the submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
2. Population of Patients with constitutional hemophilia A:
Adult patients over 50 years of age with severe or moderate constitutional hemophilia
A, with no history of autoimmune disease, and with a social security system.
Obtaining oral non-opposition from the patient to participate in the study following
the submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
3. Population of control subjects:
Adult patients, over the age of 60, without a coagulation abnormality, with no history
of autoimmune disease, and with a social security system.
Obtaining oral non-opposition from the patient to participate in the study following
the submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
4. Patient population with inflammatory pathology:
Adult patients over the age of 50 with an inflammatory pathology likely to be associated
with acquired hemophilia A, and with a social security system.
Obtaining oral non-opposition from the patient to participate in the study following the
submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
Exclusion Criteria:
For the 4 groups:
- Minor patient, under guardianship or curatorship.
- Pregnant and lactating women.
- Blood transfusion less than 7 days old.
- Treatment with corticosteroids in the 7 days preceding inclusion or any other
immunomodulatory or immunosuppressive treatment in the 4 weeks preceding inclusion.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells | NCT04805021 | Contradiction |
1,686 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- healthy adults (age18 years and above)
- nonsmokers
Exclusion Criteria:
- previous smoker
- asthma/other respiratory illness
- acute viral upper respiratory tract infection (common cold) in previous 4 weeks
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effect of Electronic Cigarette Use on Cough Reflex Sensitivity | NCT02203162 | Entailment |
2,188 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Subject is able to understand the study procedures, the risks involved and willing to
provide written informed consent before the first study related activity.
- Subject is willing to adhere to the visit/protocol schedules.
- Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has been taking allopurinol at a dose of at least 300 mg daily for at least 12
weeks prior to Day 1, as the sole uratelowering therapy.
Exclusion Criteria:
- Subject who is pregnant or breastfeeding.
- Subject with any other medical or psychological condition, which in the opinion of the
Investigator and/or Medical Monitor, might create undue risk to the subject or
interfere with the subject's ability to comply with the protocol requirements
(including dual energy computed tomography imaging), or to complete the study.
- Subject who has received an investigational therapy or has participated in any
clinical trial or research study within 30 days of Day 1.
- Subject who has taken pegloticase (KRYSTEXXA®) or is expected to take pegloticase
during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | DECT Study in Allopurinol-Treated Gout Patients | NCT02393560 | Contradiction |
6,097 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Down syndrome childrens
- Age between 0 and 3 years
Exclusion Criteria:
- Other physical or functional impairment that limits the performance of evaluation
No condition on gender to be admitted to the trial.
Subject must be at most 3 Years | Assessment of Skills and Behaviors in Children With Down Syndrome | NCT04754178 | Entailment |
3,706 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Subject (female or male)
- 40-85 years of age
- Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for
diagnosis of osteoarthritis(OA)
- Radiographic evidence of OA in the study knee
- WOMAC pain score of 7-17 in the study knee
- WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)
- Subject normally active
- Subject has attempted but not responded adequately to previous non-pharmacological
therapy(ies)and to simple analgetics
- Subject cooperative and able to communicate effectively with the investigators
- Body mass index ≤ 35 kg/m2;
- Signed informed consent obtained
Exclusion Criteria:
- Knee effusion
- Contralateral knee OA
- Clinically significant joint pain from joints other than the knee
- Previous intra-articular steroid injection into the study knee within the last 6
months
- Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the
last 9 months
- Previous allergic type reaction to a HA product
- Treatment with analgesics other than paracetamol (acetaminophen) (including topical
agents for the knee) within 5 half lives of the drug prior to the baseline visit
- Use of analgesics 48 hours preceding the baseline visit
- Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3
months
- Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
- Change in physical therapy for the knee within the last three months
- Arthroscopy or other surgical procedure in the study knee within the past 12 months
- Serious injuries to the study knee in the past
- Any planned arthroscopy or other surgical procedure during the study period
- Previous history or presence of active septic arthritis
- Active skin disease or infection in the area of the injection site
- Systemic active inflammatory condition or infection
- Bleeding diathesis or use of anticoagulants
- History of drug or alcohol abuse within 6 months
- Any medical condition that in the opinion of the investigator makes the subject
unsuitable for inclusion
- Pregnant or breastfeeding woman or woman of childbearing potential not practicing
adequate contraception
- Involvement in other clinical trials
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | Different Volumes of Durolane in Knee OA | NCT01265459 | Contradiction |
5,743 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Signed written informed consent
- Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum
of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent
erythema with or without telangiectasia
- Free of any clinically significant disease which could interfere with the study
- Willingness to follow all study procedures
- Male or female patient at least 18 years of age
Exclusion Criteria:
- Subjects known to be non-responders to azelaic acid
- Presence of dermatoses that might interfere with the rosacea diagnosis or the
evaluation of treatment results
- Ocular rosacea, phymatous rosacea
- Any condition or therapy that in the opinion of the investigator may pose a risk to
the patient of interfere with any evaluation in the study
- Facial laser surgery in the 6 weeks prior to the study
- Topical or systemic use of prescription or non-prescription medications to treat
rosacea
- Use of any agent other than the investigational drugs to treat rosacea during the
study
- Expected use or change in dose in the 90 days prior to the study of beta-blockers,
vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
- Known hypersensitivity to any ingredients of the investigational product formulation
- Alcohol or drug abuse
- Incapability of giving fully informed consent
- Subject is dependent person, i.e., a relative/family member of the investigator and/or
is a member of the investigator's staff
- Participation in another clinical research study within the last 4 weeks before
randomization in this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea | NCT01025635 | Contradiction |
4,779 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Diagnosis of unilateral Meniere Disease (MD) per the Committee on Hearing and
Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
- Glomerular filtration rate (GFR) > 90 mls/min/1.73 m2
- Creatinine (Cr) level serum < 1.6 mg/dl
Exclusion Criteria:
- Age < 18 years
- Diagnosis of bilateral MD
- History of prior temporal bone surgery
- History of cochlear implant placement
- Pacemaker, cardiac implantable electronic device, shrapnel, aneurysm clips or other
metal objects that are prohibited in the MR suite
- GFR < 90 mls/min/1.73m2
- Cr level > 1.6 mg/d
- Lack of IV access
- Contrast allergy to gadolinium agent
- Pregnancy
- Claustrophobia necessitating parenteral anxiolytics
- Patients who are unable to provide informed consent for themselves
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis? | NCT02371798 | Entailment |
4,368 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Marfan syndrome according to Ghent criteria.
- For minors, signed informed consent of at least one of the holders of the parental
authority. For majors, signed informed consent.
- Patient affiliated to a social security scheme or equivalent.
Exclusion Criteria:
- Cardiac contraindications to Personal Training Program: O Severe aorta dilatation (aortic
diameter> 45 mm) O and / or left ventricular failure (left ventricular ejection fraction
<45%) O and / or severe mitral leakage ≥ grade 3
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 25 Years | Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome. | NCT03236571 | Entailment |
117 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
- Subjects must have been treated with a topical testosterone replacement therapy
(typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more
than 2 years.
Exclusion Criteria:
- A history of idiopathic infertility due to primary hypogonadism, testicular failure,
Kallmann's syndrome or any other infertility condition.
- Subjects demonstrating any clinically significant medical condition rendering the
subjects infertile or marginally fertile other than AIHH.
- Men with a history of, known, or suspected prostate disease not ruled out by a
prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of
current prostate disease.
- Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 60 Years | To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone | NCT00706719 | Contradiction |
4,953 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- For PD: Idiopathic PD patients (according to the UK PD Society brain bank clinical
diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no
atypical features or secondary cause).
- For ET: bilateral, largely symmetrical postural or kinetic tremor involving hand and
forearms that is visible and persistent. Additional or isolated tremor of the head may
occur but in the absence of abnormal posturing.
- For Parkinson plus syndrome: multiple system atrophy (MSA), progressive supranuclear
palsy (PSP), corticobasal degeneration (CBD) and dementia with Lewy bodies (DLB).
- For NPH: patients exhibiting some or all components of the clinical triad consisting
of gait disturbance, urinary control disturbance and cognitive impairment as well as
proof of enlarged ventricular system or hydrocephalus by cranial CT or MRI scans.
- For Dystonia: patients exhibiting a movement disorder syndrome in which sustained or
repetitive muscle contractions result in twisting and repetitive movements or abnormal
fixed postures. The movements may resemble a tremor. Patients included will be those
with either idiopathic, toxic or hereditary mechanism.
- For Cerebellar ataxia: patients exhibiting impairment of coordination and balance as
part of an ataxic cerebellar syndrome which is caused by degeneration of the
cerebellum and its afferent and efferent connections due to various etiologies, such
as genetic or sporadic neurodegenerative processes or others.
Exclusion Criteria:
- In the investigator's opinion, any unstable or clinically significant condition that
would impair the participants' ability to comply with study requirements.
- Patients with significant psychiatric symptoms or history or treatment with
neuroleptics.
- MMSE <10
- Currently with lice or open wounds on scalp.
- Significant sensory deficits, e.g., deafness or blindness
- Current drug abuse or alcoholism.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Brain Network Activation in Patients With Movement Disorders | NCT03269201 | Entailment |
5,356 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women in good overall health with no chronic medical conditions that result in
periodic exacerbations that require significant medical care
- Women between 18 and 35 years inclusive at the screening visit
- BMI< 32 kg/m²
- Regular menstrual cycles between 21 and 35 days when not using hormonal contraception.
- Subjects postpartum or post-abortal must have one normal menstrual cycle (2
menses) prior to enrollment.
- Subjects previously using Intra-Uterine Device (IUD) or taking hormonal
contraception (or any other hormonal treatment, except an injectable treatment)
need to have at least one menstrual cycle (2 menses) without the treatment before
screening.
- Subject previously using an injectable (DMPA), must have had their last injection
at least 9 months before screening.
- Women not at risk of pregnancy: not sexually active, or willing to protect all acts of
intercourse with condoms, or have a sterile partner or have undergone previous tubal
ligation (including validated Essure), or be in a same sex relationship.
- Women able to give informed consent form to participate in the study and in the
opinion of the investigator able to follow all study requirements, use the study
medication and record the requested information appropriately
- Intact uterus and both ovaries
- At least one progesterone concentration > 3 ng/mL (>10 nmol/L) during the luteal phase
of the screening period
Exclusion Criteria:
- Pregnant as confirmed by positive high-sensitivity urine pregnancy test at enrollment
visit
- Trying to conceive or desire to conceive in the next 3 months
- Currently breastfeeding, or within the last 2 months
- Known Polycystic Ovarian Syndrome (PCOS)
- Cancer (or past history of any carcinoma or sarcoma)
- Known abnormal thyroid status, if in clinical judgment of the investigator it cannot
be controlled during the study
- Known hypersensitivity to the ingredients of the test active substances or its
excipients
- Current acute liver disease and/or benign liver tumors
- Have vaginal or cervical infection including clinical evidence of bacterial vaginosis
- Evidence of abnormal cervical lesion
- History of excisional or ablative treatment procedure on cervix (ie. Loop
Electrosurgical Excision Procedure (LEEP), Cryotherapy, Cold Knife Cone)
- Undiagnosed abnormal uterine bleeding
- Prior malabsorptive-type bariatric surgery
- Known or suspected alcoholism or illicit drug abuse
- Use of any hormonal contraception or IUD other than the study medication during the
study (including ulipristal acetate for emergency contraception in the past 5 days)
- Use of any medications that can interfere with the metabolism of progestin-based
contraceptives (e.g CYP3A4 enzymes inducers or inhibitors, etc)
- Unstable diabetes mellitus
- Current participation in any other trial of an investigational medicine or
participation in the past two months (or within 5 elimination half-lives for chemical
entities or 2 elimination half-lives for antibodies, whichever is the longer) before
screening
- Abnormalities in laboratory results or TVUS performed at screening visit recognized as
clinically significant by the investigator
- Conditions not suitable for frequent TVUS examinations, (e.g. virgo intacta)
- In custody or submitted to an institution due to a judicial order
- Relative or household member of the investigator's or sponsor's staff
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill | NCT03585712 | Contradiction |
981 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male or female adult
- Age 50-75 years
- Self-reported history (>3 months) of joint discomfort in the knees. NOTE: the severity
of knee discomfort will be determined through a questionnaire called the WOMAC, and
should be at least 2 points (indicating mild knee discomfort or greater).
- No history of regular use of non-steroidal anti-inflammatory drugs (NSAIDs) use (e.g.,
ibuprofen, aspirin) during the previous two weeks, and willingness to avoid the use of
NSAIDs during the 12-week study.
- Not on other medications (e.g., analgesic gels, arthritis medications, other
anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin)
for joint discomfort during the previous two weeks, and a willingness to avoid use of
these during the 12-week study.
- No serious medical problems (current cancer case, severe rheumatoid arthritis, recent
heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or
other disease that would interfere with study participation).
- No psychiatric disorder or other condition that might interfere with self-assessment
ability.
- Willingness to follow all study procedures including randomization to one of two
groups, and to stay weight stable during the study.
Exclusion Criteria:
- Inability to comply with study requirements including avoidance of NSAIDs, other
anti-inflammatory medications, or discomfort supplements.
- Current diagnosis of cardiovascular disease, cancer (except for non-melanoma skin
cancer), severe rheumatoid arthritis, ulcers, kidney disease, psychiatric disorder.
- For female subjects: Pregnant or nursing, or planning to be pregnant or nursing during
the study.
- On a weight loss program during the study.
- Vegetarian or vegan.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Influence of Instaflex Advanced Supplement on Joint Function | NCT03041077 | Entailment |
4,989 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Patient gives an informed consent.
- Patient is over 21 years of age.
- Patient is diagnosed with a postural-intention (essential) tremor for at least 3
years, meets diagnostic criteria for ET, has been evaluated and examined by a movement
disorders fellowship trained neurologist, and is being treated with traditional VIM
DBS therapy.
- Patient has no evidence of non-ET central nervous system disease or injury and has had
a significantly disabling, upper extremity tremor despite ongoing VIM DBS therapy for
at least three (3) months prior to DBS revision surgery.
- Patient has a postural or kinetic tremor severity score of at least 2 out of 4 in the
extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for
Tremor (TRS) despite ongoing VIM DBS therapy.
- Patient has a TRS score of 2 or above in any one of the items 16-23 from the
Disability subsection of the TRS: speaking, feeding other than liquids, bringing
liquids to mouth, hygiene, dressing, writing, working and social activities despite
ongoing VIM DBS therapy.
- Patient's tremor is refractory to adequate trials of at least two medications, one of
which should be either propranolol or primidone. Proof of this is not required for
patients with a current device that is being removed and replaced with a new device.
An adequate medication trial is defined as a therapeutic dose of each medication or
the development of side effects as the medication dose is titrated.
- Patient is available for appropriate follow-up times for the length of the study.
Exclusion Criteria:
- Any previous neurosurgical intervention other than VIM DBS, including ablative brain
lesions for tremor suppression.
- Medication related movement disorders.
- Any suspicion of Parkinson's disease, including presence of Parkinsonian features such
as bradykinesia, rigidity, or postural instability.
- Any behaviors consistent with alcohol or substance abuse as defined by the criteria
outlined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).
- Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney
disease, continuous neurological disease, hematological disease, or frailty that
impact tolerability of the surgery as judged by the screening physicians.
- Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating
lesions, or infectious lesions. Also excluded will be subjects with severe brain
atrophy.
- Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache,
nausea, vomiting, lethargy, papilledema).
- A history of seizures within the past year.
- A dementia rating scale score (DRS) <130 signifying significant cognitive dysfunction
and a potential for inability to cooperate with tasks involved in the study.
- Any attempt or intent of suicide during the previous six months.
- Presence or history of psychosis.
- Any person known to have abnormal coagulation or any medications which interfere with
coagulation
- Significant untreated or unstable mood disorders including depression. This will be
determined by the Neuropsychological team during FastTrack and by the Neurologist
- In addition, patients who are pregnant or plan to become pregnant will be excluded
from this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 99 Years | Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor | NCT04212780 | Entailment |
5,207 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal
osteoporosis
- Subjects who are 50 to 65 years old with BMD T score ≤ -2.5 and > -5.0 at the lumbar
spine or hip (femoral neck or total hip) by DXA and meet one of the following: 1)
radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic
vertebral fractures or 2) history of fragility fracture to the forearm, humerus,
sacrum, pelvis, hip, femur, or tibia within the past 5 years.
- Subjects older than 65 years with BMD T score ≤ -2.0 and > -5.0 who meet the fracture
criteria may be enrolled
- Subjects older than 65 years with BMD T score ≤ -3.0 and > -5.0 at the lumbar spine or
hip (femoral neck or total hip) by DXA
- Body mass index of 18.5 to 33 kg/m^2, inclusive
- serum calcium (albumin-corrected), PTH(1-84), serum phosphorus, alkaline phosphatase,
and thyroid stimulating hormone within the normal reference range
- Serum 25-hydroxyvitamin D values must be ≥ 20 ng/mL
Exclusion Criteria:
- History of more than 4 mild or moderate spine fractures or any severe fracture
- Abnormality of the spine or hip that would prohibit assessment of BMD
- History of bone disorders other than postmenopausal osteoporosis or a diagnosis of
cancer within the last 5 years
- History of Cushing's disease, thyroid, parathyroid, or malabsorptive syndromes or any
chronic or recurrent diseases or disturbances that would interfere with the
interpretation of study data or compromise the safety of the patient
- Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived
drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or
parathyroid hormone (1-84)
- Prior treatment with bisphosphonates within the past 3 years; fluoride or strontium
within the past 5 years; treatment with corticosteroids within the past 12 months; or
selective estrogen receptor modulators within the past 6 months (except hormone
replacement therapy)
- Prior treatment with an investigational drug or device within the past 90 days or 5
half-lives of the investigational drug, whichever is longer
- History of nephrolithiasis or urolithiasis within the past 5 years or hereditary
disorders predisposing to osteosarcoma
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis | NCT04064411 | Entailment |
5,358 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy females who want oral contraception
- No cervical or vaginal abnormalities on gynecological examination
- Negative Chlamydia test
- Pap smear without evidence of moderate or severe dysplasia or any malignancy within
the preceding 12 months
- Negative urine pregnancy test conducted during Visit 1
- One normal menstrual period in 35 days prior to Visit 1
- Regular menstrual cycles (every 26-35 days)
- Last term pregnancy at least 42 days prior to Visit 1, and have had at least one
normal menstrual period (typical in duration and amount of flow for the subject) since
her last pregnancy
- Post-menarcheal and pre-menopausal
- At least one normal menstrual period (typical in duration and amount of flow for the
subject) since having undergone uterines urgery or removal of an IUD, Norplant,
DepoProvera or other hormonal injectables or implants.
Exclusion Criteria:
- History or presence of disorders commonly accepted as contraindications to steroid
hormonal therapy
- Previously discontinued ORTHO TRI-CYCLEN LO or YAZ due to breakthrough bleeding
- Pregnant or lactating
- Body mass index (BMI) of >40kg/m2
- Clinical evidence of carcinoma or other malignancy (history of basal cell carcinoma of
the skin is not exclusionary)
- History of alcohol or drug abuse in the investigator's judgment based on history and
physical examination (within 12 months prior to Visit 1)
- Significant depression or psychiatric disease in the investigator's judgment based on
history and physical examination which would result in an unreliable patient
- Patient deemed by the investigator to have questionable reliability in her ability to
comply with the protocol and provide accurate information
- Have any medical condition or planned surgical procedure which, in the opinion of the
investigator, may be exacerbated by treatment with study medication or a patient
receiving any concurrent therapy that could be affected by treatment with study
medication
- Disallowed therapies: currently taking therapeutic anticoagulants (e.g,. Coumadin,
Heparin) or have a bleeding disorder (e.g. von Willebrand's Disease), DepoProvera or
other hormonal injectables in the six months before Visit 1, currently have Norplant
or other hormonal implants in place, or have had removal of Norplant within 60 days
prior to Visit 1, used a steroid-containing IUD within 3 months prior to Visit 1
- Or current use of an IUD
- Consistently elevated blood pressure defined as sitting systolic BP>140 mmHg or
diastolic BP>90 mmHg
- Have an untreated thyroid disorder in the investigator's judgment based on history and
physical examination
- unable to swallow solid, oral dosage forms whole with the aid of water (participants
may not chew, divide, dissolve, or crush the study drug)
- Patients who in the opinion of the investigator should not be enrolled in the study
based on the product labeling for ORTHO TRI-CYCLEN LO and YAZ including potential
drug-drug interactions
- Have received an experimental drug or used an experimental medical device within 30
days before the planned start of treatment
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females | NCT00745901 | Contradiction |
4,391 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
Spherical equivalent on distance subjective refraction between -0.50D and -2.50D.
- Astigmatism ≤ 0.75D
- Stable myopia. Maximum change in refraction of 0.50D in the last 2 years.
- Best corrected visual acuity of at least 0.00 logMAR (ETDRS chart).
- Thinnest pachymetry reading ≥ 440 μm.
- No previous ocular surgery.
- No cognitive insufficiency interfering with the informed consent.
Exclusion Criteria:
- History of or current condition, disease, surgery or medication with ocular effects
that could affect the outcomes of the treatment.
- Allergy to any substance or device used in the study.
- Cognitive insufficiency interfering with the informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Photorefractive Intrastromal Corneal Crosslinking as a Treatment for Low Grade Myopia | NCT03987880 | Entailment |
4,402 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Subjects with elbow pain for at least 3 months
- those between 20 and 40 years of age
- who did not have cold allergies
Exclusion Criteria:
- With a different elbow problem or multiple elbow problems,
- having cervical or other upper extremity problems,
- elbow joint operation,
- tendon rupture,
- limited range of motion due to humerus, radius or ulna fracture
- individuals with a history of osteoporosis, malignancy, hemophilia, neurological
effect, and cognitive dysfunction
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Cold Application in Lateral Epicondylitis | NCT04536948 | Contradiction |
2,655 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Males of 41 to 80 years old who are going for elective inguinal hernia repair
(laparoscopic or open) under general anesthesia.
Exclusion Criteria:
Patient whom has any of the following will be excluded:
- Contraindication to tamsulosin : known allergy, known orthostatic hypotension,
significant cardiac co-morbidities ( New york heart association functional
classification >2) or heart failure
- End stage renal failure
- More than two anti-hypertensive use/long term alpha blockers/beta
blockers/anticholinergic (eg : buscopan)
- Previous urological or pelvic surgery
- Known benign prostatic hyperplasia on medications
- Long term indwelling catheters
- Concurrent neurologic disease such as stroke, poliomyelitis, cerebral palsy, multiple
sclerosis, spinal lesions, diabetic and alcoholic neuropathy
Male
Accepts Healthy Volunteers
Subject must be at least 41 Years old.
Subject must be at most 80 Years | Prophylactic Alpha-blockers in the Prevention of Urinary Retention Post Inguinal Hernia Repair | NCT03314259 | Entailment |
1,090 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Suspected or certain neurally-mediated syncope, based on the Guidelines recently
published by the Task Force on Syncope of the European Society of Cardiology 2,3
(Appendix 1);
- More than 3 syncope episodes in the last 2 years;
- Clinical presentation of syncope of sufficient severity requiring treatment initiation
in the physician's and patient's judgement.
- Age > 40 years.
- Negative carotid sinus massage.
- Patients accept to have an ILR implantation.
Exclusion criteria:
- Carotid sinus hypersensitivity
- Suspected or certain heart disease and high likelihood of cardiac syncope:
- Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement;
- Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic,
drop-attack, TIA, intoxication, cataplexy);
- Subclavian steal syndrome;
- Psychologically or physically (due to any other illness) or cognitively unfit for
participation in the study according to the opinion of the investigator;
- Patient compliance doubtful;
- Patient geographically or otherwise inaccessible for follow-up;
- Patient unwilling or unable to give informed consent;
- Life expectancy <1 year.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| ISSUE3: International Study on Syncope of Uncertain Etiology 3 | NCT00359203 | Contradiction |
3,188 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | INCLUSION CRITERIA:
We will review medical records of patients enrolled in NHLBI protocol who are 18 years of
age or older.
EXCLUSION CRITERIA:
This study excludes any subjects younger than 18 years old.
Female subjects recruited for this study would ideally have no prior history of male
childbearing or abortion.
Female
No healthy subjects accepted to join the trial.
| Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells | NCT00023491 | Entailment |
4,877 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | - INCLUSION CRITERIA:
Patients with the following characteristics may be included in the protocol:
Age 18-75 years.
Evidence of Cushing syndrome. Evidence to suggest overactivity of the
hypothalamic-pituitary-adrenal axis, such as increased urinary excretion of glucocorticoids
or lack of suppressibility with low doses of dexamethasone in conjunction with clinical
features, will be sought prior to admission.
EXCLUSION CRITERIA:
Patients will be excluded from entry to the protocol if:
A clear-cut pituitary tumor is present on T1-weighted conventional pituitary MR scan.
There is any contraindication to catheterization. Patients with known reaction to contrast
material will be excluded from this elective study if they have a strong history of
previous contrast media reaction and cannot be studied safely by giving medical prophylaxis
before the procedure.
The patient is pregnant.
Combined blood withdrawal during the six weeks preceding the study exceeds 450 ml, or if
hematocrit at entry is less than 33%.
Because of the increased risk of morbidity caused by contrast dyes in patients with a renal
dysfunction, patients with a creatinine greater than 1.3 mg/dl will be excluded.
Patients with a diastolic blood pressure persistently greater than 100 mm Hg (with or
without medication) will be excluded from sampling procedures.
They have had radiation exposure during the previous year that represents a significant
additive risk in combination with the expected doses in this protocol. Patients and their
doctors will be questioned about their exposure to radiation before they are accepted into
the protocol.
For the questionnaire only, patients who do not speak and read English will be excluded.
This instrument has not been validated in non-English speakers.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Jugular Vein Sampling for Hormone Levels for the Diagnosis of Cushing Syndrome | NCT00001453 | Entailment |
5,554 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Group1: Children with GH deficiency diagnosed by 2 provocative tests with peak GH less
than 10 ng/ml.
- Group 2:Children with height less than the 3rd centile without any etiology
- Group 3:children with failure to thrive until the age of 3 years.
- Group 4: children with obesity defined by BMI above the 90th centile for age and sex.
- Group 5: children with no endocrine diseases and without obesity or short stature.
Exclusion Criteria:
- Children with known pediatric or endocrine diseases.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Study of the Molecular Basis in the Pathophysiology of Food Intake and Growth in Children | NCT00830141 | Contradiction |
5,367 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Diagnosis of severe von Willebrand disease (VWD) (defined as von Willebrand factor:
ristocetin cofactor [VWF:RCo] less than [<] 20 percent [%]):
1. Type 1 (VWF:RCo < 20 International Units per deciliter [IU/dL]); or
2. Type 2A (VWF:RCo < 20 IU/dL), Type 2B (as diagnosed by genotype), Type 2N (Factor
VIII coagulation activity [FVIII:C] < 10 % and historically documented genetics),
Type 2M; or
3. Type 3 (VWF:Ag less than or equal to [=<] 3 IU/dL).
- Age 0 to < 18 years at the time of Screening.
- The participant has provided assent (if appropriate) and legally authorized
representative(s) has provided informed consent.
- If female of childbearing potential, participant presents with a negative serum
pregnancy test.
- If applicable, participant agrees to employ adequate birth control measures for the
duration of the study.
- The participant and/or the legally authorized representative are willing and able to
comply with the requirements of the protocol, which should also be confirmed based on
a pre-screening evaluation held between the Investigator and the Sponsor, to ensure no
eminent risk is present that could challenge the participants compliance with the
study requirements.
Additional inclusion criteria for previously treated participants and participants
undergoing surgery are as follows:
- Unable to tolerate or are inadequately responsive to deamino-delta-D-arginine
vasopressin.
- The participant has had a minimum of 1 documented bleed requiring VWF coagulation
factor replacement therapy (i.e. treatment with a VWF product) during the previous 12
months prior to enrollment and overall historically 3 or more exposure days (EDs) to
plasma-derived von Willebrand disease (pdVWF).
Additional inclusion criterion for previously untreated participants are as follows:
- The participant has not received prior VWF coagulation factor replacement therapy.
- Pediatric participants in the continuation study (SHP677-304 [NCT03879135]) that
require elective or emergency surgical/invasive treatment during their participation
in the continuation study may be considered for enrollment in this study's surgery arm
to receive treatment with the study drug (rVWF) for peri-operative management of
surgery related bleeds/bleeding tendency, if they continue meeting all other
eligibility criteria for the surgery arm in this Pediatric On-Demand and Surgery
study, 071102.
Exclusion Criteria:
- Diagnosis of pseudo-VWD or another hereditary or acquired coagulation disorder (eg,
qualitative and quantitative platelet disorders or elevated prothrombin time
[PT]/international normalized ratio [INR] greater than [>] 1.4).
- History or presence of a VWF inhibitor at Screening.
- History or presence of a Factor VIII (FVIII) inhibitor with a titer greater than or
equal [>=] 0.4 Bethesda units (BU) (by Nijmegen assay) or >= 0.6 BU (by Bethesda
assay).
- Documented history of a VWF: RCo half-life < 6 hours.
- Known hypersensitivity to any of the components of the study drug, such as mouse or
hamster proteins.
- Medical history of immunological disorders, excluding seasonal allergic
rhinitis/conjunctivitis/asthma, food allergies, or animal allergies.
- Medical history of a thromboembolic event.
- Human immunodeficiency virus (HIV) positive, with an absolute CD4 count < 200/ cubic
millimeter (mm^3).
- In the judgment of the Investigator, the participant has another clinically
significant concomitant disease (e.g. uncontrolled hypertension, cancer) that may pose
additional risks for the participant.
- Diagnosis of significant liver disease, as evidenced by, but not limited to, any of
the following: serum alanine aminotransferase (ALT) of 5 times the upper limit of
normal; hypoalbuminemia; portal vein hypertension (e.g. presence of otherwise
unexplained splenomegaly, history of esophageal varices) or liver cirrhosis classified
as Child B or C.
- Diagnosis of renal disease, with a serum creatinine level >= 2.5 milligram per
deciliter (mg/dL).
- Immunomodulatory drug treatment other than anti-retroviral chemotherapy (e.g.
α-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone greater
than 10 milligram per day [mg/day] (excluding topical treatment [e.g. ointments, nasal
sprays]), within 30 days prior to signing the informed consent (or assent, if
appropriate).
- If female, participant is pregnant or lactating at the time informed consent (or
assent, if appropriate) is obtained.
- Participant has participated in another clinical study involving an investigational
product (IP), other than recombinant von Willebrand Factor (rVWF) with or without
ADVATE, or investigational device within 30 days prior to enrollment or is scheduled
to participate in another clinical study involving an IP other than rVWF or
investigational device during the course of this study.
- Participant's legal representative is a family member or employee of the Investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | BAX 111 rVWF in Pediatrics | NCT02932618 | Contradiction |
668 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
Subjects will be considered eligible for entry in the study if they meet all of the
following criteria.
1. Male or female, aged > 18 years.
2. Able to comply with the study procedures and medication.
3. Written informed consent given.
4. On a stable haemodialysis regimen (at least 3x per week) for ≥12 weeks prior to
screening.
5. (a) Subject receiving phosphate binder medication(s) at screening, must have been on a
stable regimen (dose and medication) for at least 1 month prior to screening and will
remain on this regimen until entry into the washout period OR (b)Subject (i) is not
currently receiving any phosphate binding medication at screening (or medication
likely to act as a phosphate binder) and (ii) must not have done so for at least one
month and (iii) has sustained hyperphosphataemia.
6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral
aluminium- or oral iron-containing products and preparations other than the study
medication.
7. If required to take >6000 mg/day of fermagate, the subject will be willing to have at
least three meals per day.
Specifically, for randomisation and inclusion into the treatment period, the following
criterion must be fulfilled:
8. Has a serum phosphate value of ≥1.94 mmol/L (≥6.0 mg/dL) within the 2 to 4 week
washout period or above 3.0 mmol/L (9.3 mg/dL) at any time during washout.
Exclusion Criteria:
Subjects will not be considered eligible for entry in the study if they meet one or more of
the following criteria.
1. Participation in any clinical trial using an investigational product or device during
the 30 days preceding the Screening Visit.
2. Previous experience of fermagate treatment.
3. A significant history of alcohol, drug or solvent abuse in the opinion of the
investigator.
4. Any disease or condition, physical or psychological that, in the opinion of the
investigator, would compromise the safety of the subject or the likelihood of
achieving reliable results or increase the likelihood of the subject being withdrawn.
5. Laboratory findings at screening which, in the opinion of the investigator, are
clinically significant for this subject population.
6. A screen serum magnesium concentration of >1.25 mmol/L (>3.0 mg/dL).
7. A known history of haemochromatosis.
8. Subjects receiving either tetracycline or lithium treatment.
9. A serum ferritin level of ≥1000 ng/mL.
10. Non-elective hospitalisation in the 4 weeks prior to screening.
11. Female subjects who are of childbearing potential and who are neither surgically
sterilised nor using reliable contraceptive methods (hormonal, barrier methods or
intrauterine device) or who are lactating or pregnant.
12. Current hypophosphataemia at screening (last 2 consecutive phosphate values of <0.7
mmol/L [<2.2 mg/dL]).
13. Known history of colorectal malignancy, familial polyposis coli and/or strong family
history (in 2 or more first degree relatives) of these terms.
14. A QTcF interval of >560 ms at screen.
15. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens
at screen.
16. Current clinically significant intestinal motility disorder.
17. Bowel obstruction with current or previous use of sevelamer HCl.
18. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel
medication.
19. Subjects with inflammatory bowel disease that, in the investigator's opinion, is
poorly controlled.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride | NCT00844662 | Contradiction |
5,750 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Must be 18yrs to 45yr old woman, read and write in English.
- Must smoke at least 5 or more cigarettes a day
- FTND score at least 4 or higher
- A CO reading of 10 or higher during screening
- Must be in good health as verified by medical history, screening exam, screen
laboratory tests.
Exclusion Criteria:
- Excluded if using psychotropic medications, have contraindications to tolcapone use
(e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or
hyperpyrexia, confusion possibly related to medication), have other substance use
disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar
disorder, homicidal or suicidal ideation, have current (past month) substance use
disorder, other than nicotine dependence, or are unable to fulfill the scheduled
visits and procedures.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Treatment for Nicotine Addiction in Women | NCT02448654 | Contradiction |
2,605 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Age ≥ 18 years and ≤ 65 years
- Signed informed consent
- Patients submitted to unilateral, primary inguinal, open herniotomy 6-8 weeks prior to
study start.
- Open operating procedure a.m. Lichtenstein.
- Urin sample without traces of opioids (morphine, methadon, buprenorphine, codeine,
tramadol, ketobemidone, oxycodone, hydromorphine, dextromethorphan)
- ASA I-II
- Body mass index (BMI): 18 < BMI < 30
Exclusion Criteria:
- Volunteers , who do not speak or understand Danish
- Patients, who cannot cooperate with the investigation
- Patients who have had previous surgery in the groin region
- Patients with pain at rest > 3 (NRS)
- Activity-related pain in the surgical field > 5
- Allergic reaction against morphine or other opioids (including naloxone),
- Abuse of alcohol or drugs - according to investigator's evaluation
- Use of psychotropic drugs (exception of SSRI)
- Neurologic or psychiatric disease
- Chronic pain condition
- Regular use of analgesic drugs
- Skin lesions and tattoos in the assessment areas
- Nerve lesions in the assessment sites (for instance, after trauma, disc herniation,
etc.)
- Use of prescription drugs 1 week before the trial
- Use of over-the-counter drugs 48 hours before the trial
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair. | NCT01992146 | Contradiction |
2,157 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Individuals with two urate determinations >7 mg/dL in the last year and no clinical
sign, past or present, suggestive of joint inflammation (acute gout attack),
urolithiasis or uric acid nephropathy
- Over 18 years of age
- Residents of Mexico City or its metropolitan area
- Individuals with a signed informed consent form for the participation in the clinical
trial
Exclusion Criteria:
- Individuals with joint inflammation suggestive of gout during the clinical evaluation
- Patients without elemental ultrasonographic lesions (double contour sign, aggregates,
tophi) on the first metatarsophalangeal joint, knee, ankle or the tendons of the
quadriceps, patella, and calcaneus when evaluated by MSUS
- Patients taking thiazides
- Patients with history of stroke or coronary artery disease in the last year
- Patients with osteoarthritis be it by clinical presentation or imaging
- Pregnant women
- Neoplasms
- Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) , Human immunodeficiency Virus
(HIV) infection, or any other know active infections
- Autoimmune or autoinflammatory disease
- Allopurinol hypersensitivity or allergy
- Deteriorated kidney function (Glomerular Filtration Rate (GFR) <50 mL/min/1.73m^2)
- Patients taking azathioprine
- Functional New York Heart Association (NYHA) score of II or more
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effects of Allopurinol on Inflammation and Ultrasonographic Changes in People With Elevated Uric Acid But no Symptoms | NCT04012294 | Contradiction |
5,028 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
Patients will be enrolled following completion of a dose escalation trial (such as
T2000-0533)
- Confirmed essential tremor by NIH criteria
- Significant functional activity limitation due to ET
- Patients who have failed, are inadequately treated or cannot tolerate alternative
treatments for ET as well as treatment naïve patients who have considered but declined
alternative treatment
Exclusion Criteria:
- Patients adequately controlled without side effects on a current ET treatment
- Pregnant patients or patients who may become pregnant during the study
- Patients with other medical conditions that may cause tremor, such as Parkinson's
disease or active hyperthyroidism
- Patients taking medications that might produce tremor or interfere with the evaluation
of tremor such as CNS-stimulants or beta-blockers
- Patients who must take medications that alter liver metabolism as well as patients
with liver disease or coagulation disorders
- Patients with seizure disorders
- Patients with a history of allergy or hypersensitivity reaction to barbiturates or
other related medications, such as phenobarbital or phenytoin
- Patient with significant general medical or clinical laboratory abnormalities
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | T2000 in Essential Tremor - Open Label Continuation | NCT00655278 | Entailment |
1,903 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- in the esophagus: squamous cell carcinoma (well differentiated G1) or high grade
dysplasia or neoplasia on barrett esophagus with high grade dysplasia or
adenocarcinoma confirmed by two different pathologists, with only superficial tissue
(mucosal invasion (T1m) and no lymph nodes on EUS endoscopy radial and mini probe),
larger than 15 mm of diameter, with an extension of less than 10 cm high and less than
two thirds of the esophageal circumference
- in the stomach: superficial adenocarcinoma or high grade dysplasia (well
differentiated G1) with no depth invasion of the sub mucosa in EUS endoscopy and no
lymph nodes according to the recommendations of the Japanese gastric cancer
association, and with a diameter of more than 15 mm
- in the colon and the rectum: sessile serrated adenomas, adenomas or superficial
adenocarcinoma (well differentiated G1), larger than 15 mm, corresponding to non
granular Lateral spreading tumor (NG-LST) or granular (G-LST) with a focal Kudo V zone
in the lesion, with a circumferential extension of less than two thirds and with only
a superficial extension (no sub mucosal invasion and no lymph nodes in EUS endoscopy
of the rectum).
- Consent form signed
- Anesthesiology risk limited with ASA score 1 or 2
- Patients over 18 years old
- Affiliation to social safety system
Exclusion Criteria:
- other lesions of the digestive tract
- high anesthetic risk (ASA score > 2)
- previous treatment of the lesion (radiotherapy, endoscopy, surgery, chemotherapy…)
- other malignant disease locally advanced or with metastasis
- hemostasis disorders
- pregnancy or breast feeding
- participation in another clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial | NCT01913223 | Entailment |
3,337 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Patients >18 years old, who complain about blocked ear found to have ear wax which
impacts ear drum and able to sign consent.
Exclusion Criteria:
- Patients who are contraindicated to ear syringing will be excluded : otitis externa ,
otitis media , history of tympanic membrane perforation , history or ear surgery ,
unilateral deafness , in-co-operated patient (eg. Children ) , history of vertigo
after ear syringing .
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial. | NCT04094116 | Contradiction |
2,174 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Subject is able to understand the study procedures, the risks involved and willing to
provide written informed consent before the first study related activity.
- Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.
- Subject must be able to take gout flare prophylaxis with colchicine or NSAID
(including Cox-2 selective NSAID) ± PPI.
- Subject has a history (either by medical record or subject interview) of intolerance
or a contraindication to either allopurinol or febuxostat.
- Body mass index (BMI) < 45 kg/m2
Exclusion Criteria:
- Subject who is taking any other approved urate-lowering medication that is indicated
for the treatment of gout at the Screening Visit.
- Subject with a documented history or suspicion of kidney stones.
- Subject who is pregnant or breastfeeding.
- Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150
mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
- Subject with a history or suspicion of drug abuse within the past 5 years.
- Subject that requires or may require systemic immunosuppressive or immunomodulatory
treatment.
- Subject with a known or suspected human immunodeficiency virus (HIV) infection.
- Subject with a positive test for active hepatitis B or hepatitis C infection.
- Subject with a history of malignancy within the previous 5 years with the exception of
non-melanoma skin cancer that has been treated with no evidence of recurrence, treated
cervical dysplasia or treated in situ Grade 1 cervical cancer.
- Subject within the last 12 months with: unstable angina, New York Heart Association
class III or IV heart failure, myocardial infarction, stroke, or deep venous
thrombosis; or subjects currently receiving anticoagulants.
- Subject with uncontrolled hypertension.
- Subject with an estimated creatinine clearance < 30 mL/min.
- Subject with active peptic ulcer disease requiring treatment.
- Subject with active liver disease, or hepatic dysfunction.
- Subject receiving chronic treatment with more than 325 mg salicylates per day.
- Subject taking valpromide, progabide, or valproic acid.
- Subject who has received an investigational therapy within 8 weeks or 5 half-lives
(whichever is longer) prior to the Screening Visit.
- Subject with any other medical or psychological condition, which in the opinion of the
Investigator and/or Medical Monitor, might create undue risk to the subject or
interfere with the subject's ability to comply with the protocol requirements, or to
complete the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors | NCT01508702 | Contradiction |
4,798 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Patients were eligible for enrollment if they had received a clinical diagnosis of
Meniere's disease according to the 1995 AAO-HNS criteria (Committee, 1995). These
criteria can be briefly described as follows:
1. Repeated attacks of vertigo: A definitive spell is spontaneous vertigo lasting at
least 20 minutes. A mixed type of spontaneous nystagmus is observed during
attacks.
2. Fluctuating cochlear symptoms: The hearing test usually reveals a marked
fluctuation of the threshold in the low and middle tone range.
Exclusion Criteria:
- Any other neuro-otologic diseases.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Vasopressin and V2 Receptor in Meniere's Disease | NCT00599560 | Entailment |
3,263 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Signed informed consent
- Male or female patient ≥ 18 years of age
- Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et
al 2017)
- Seropositive for anti-Ro/SSA antibodies
- Stimulated whole salivary flow rate of ≥ 0.1 mL/min
Inclusion criteria specific for Cohort 1:
- ESSDAI ≥ 5 within the 8 predefined organ domains
- ESSPRI score of ≥5
Inclusion criteria specific for Cohort 2:
- ESSDAI < 5 within 8 domains scored for inclusion criterion for Cohort 1
- ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5
Exclusion Criteria:
- Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease
constitutes the principle illness
- Use of other investigational drugs
- Prior use of B cell depleting therapies, abatacept or any other immunosuppressants
unless specifically allowe be the protocol.
- Use of steroids at dose >10 mg/day.
- Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or
Meibomian gland disease (this criterion applies only to patients considered for Cohort
2)
- Active viral, bacterial or other infections requiring systemic treatment
- Receipt of live/attenuated vaccine within a 2-month period prior to randomization.
- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV).
- Evidence of active tuberculosis (TB) infection.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's Syndrome | NCT03905525 | Entailment |
4,589 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Good general health with no chronic medical conditions that result in periodic
exacerbations that require significant medical care.
2. Age between 18 and 40 years inclusive at the injection visit.
3. BMI < 40 kg/m2.
4. Intact uterus with at least one ovary.
5. Pap test within ASCCP or ACOG guidelines such that additional treatment will not be
required during the study period. If a copy of a Pap test (and indicated follow-up
testing) is not available and the subject is 21 years or older, a Pap test should be
done during the screening period.
6. Regular menstrual cycles that occur every 21-35 days:
6a. If subject is postpartum or post-second trimester abortion, she must have 3 menses (2
cycles) prior to enrollment.
6b. If subject had a first trimester abortion or pregnancy loss, she must have one
spontaneous menses prior to enrollment.
7. Have a negative urine pregnancy test at the injection visit and no unprotected
heterosexual intercourse for the previous 10 days.
8. Not at risk for pregnancy for the duration of study participation (screening through
last phone contact), defined as one of the following: 8a. heterosexually abstinent; 8b.
previous female permanent contraception procedure; 8c. in a monogamous relationship with a
vasectomized partner; 8d. consistent use of a non-hormonal barrier method with every act of
intercourse (e.g. condoms or diaphragm + spermicide).
8e. use copper IUD 9. In the opinion of the investigator, subject is willing and able to
comply with the protocol requirements.
10. Subject is willing to record requested information in the daily diary. 11. Lives within
the study site catchment area or within a reasonable distance from the site.
12. Understand and sign an IRB approved informed consent form prior to undergoing any
screening assessments (including fasting blood draw).
13. Agree not to participate in any other clinical trials during the course of this study.
Exclusion Criteria:
1. Known hypersensitivity or contraindication to progestins.
2. Abnormal Transvaginal Ultrasound (TVUS) or safety labs done during the screening
period recognized as clinically significant by the investigator (or medically
qualified designee).
3. Greater than 10% body weight change over previous year or planned significant weight
loss during the study related to bariatric surgery, dieting or other causes.
4. Known or suspected current alcohol dependence syndrome, chronic marijuana use or any
illicit drug use that may affect metabolism of the study product or study compliance.
5. Undiagnosed abnormal genital bleeding.
6. Undiagnosed vaginal discharge, lesions or abnormalities. Subjects diagnosed at
screening with BV, trichomonas, candida, Chlamydia or gonococcus infection may be
included in the trial following treatment completion. In accordance with PI/medical
designee assessment and local standards of practice, women with a history of genital
herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is
permitted.
7. Uncontrolled thyroid disorder.
8. Current use of hormonal contraception including hormonal intrauterine device.
9. Use of a long-acting injectable hormonal contraceptive (e.g., cyclofem or
depomedroxyprogesterone acetate) within the past 9 months prior to enrollment unless
the subject has had at least one spontaneous menstrual cycle (at least two menses)
since the last injection.
10. Recent use of hormonal oral, patch, intravaginal or intrauterine contraception unless
that subject has had at least one complete menstrual cycle (at least two menses) since
discontinuation before the treatment injection.
11. Women who are breastfeeding or are within 30 days of discontinuing breast feeding
unless the subject has already had a menses following discontinuation of
breastfeeding.
12. Women planning to undergo major surgery during study participation.
13. Women planning pregnancy during their anticipated months of study participation.
14. Women who smoke > 15 cigarettes per day or who use >1 ml/day of nicotine-containing
liquid for electronic cigarette must be evaluated by the PI for inclusion based on
risk factors that would increase their risk for cardiovascular disease (CVD) and
thromboembolism.
15. Current or past deep vein thrombophlebitis or thromboembolic disorders.
16. Known history of thrombophilia.
17. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis.
18. Known or suspected carcinoma of the breast, endometrium, or any other known or
suspected progestin-dependent neoplasia.
19. Current or past medically diagnosed severe depression, which, in the opinion of the
investigator, could be exacerbated by use of a hormonal contraceptive, unless she is
stable on antidepressant medication.
20. Have a current need for exogenous hormones or therapeutic anticoagulants.
21. History of any other carcinoma (excluding basal cell carcinomas) unless in remission
for more than 5 years.
22. Active liver disease or screening LFTs greater than twice the upper limit or normal.
23. Diastolic blood pressure (DBP) > 95 and Systolic blood pressure (SBP) > 145 mm Hg; (BP
will be taken three times at approximately 5-minute intervals and the mean of the last
two of the three measurements will be used to determine eligibility).
24. Clinically significant abnormal serum chemistry or hematology values according to the
Principal Investigator's judgment.
25. Participation in another clinical trial involving an investigational drug or device
within last the three months before treatment injection or planning to participate in
another clinical trial during this study.
26. Use of liver enzyme inducers within the last 90 days prior to screening or intention
to use liver enzyme inducers during the study.
27. Known HIV infection.
28. Women who use any medications on the Exclusionary Medication List OR have used any
within the past three months prior to the Injection visit.
29. Have issues or concerns (in the judgement of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
30. Have known hypersensitivity to the active substance LB or any of the excipients of the
study treatment.
31. Use any medications that can interfere with the metabolism of hormonal contraceptives,
antibiotics that can interfere with metabolism of hormonal contraceptives, or any
drugs designated by the FDA as falling in the Pregnancy and Lactation narrative
subsections (formerly Category D or X medications).
32. Have previously participated in the study.
33. Be a site staff member with delegated study responsibilities or a family member of, or
have a close relationship with, a site staff member with delegated study
responsibilities.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception | NCT04143659 | Contradiction |
367 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1- Diagnosis of Poor ovarian response (POR), according to POSSEIDON group criteria (Group
3) Young patients (<35 years) with poor ovarian reserve prestimulation parameters (AFC <5,
AMH<1.2 ng/mL).
Exclusion Criteria:
1. Premature ovarian failure diagnosis.
2. Endometriosis grade III or IV.
3. Any contraindications to ovarian stimulation treatment.
4. Uterine infertility factor.
5. Previous history of ovarian surgery.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Acupuncture for Treatment of Patients With Poor Ovarian Response | NCT04013984 | Contradiction |
4,632 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- I1. Sufficiently conversant in the English language to satisfy I3.
- I2. Able and willing to comply with all study requirements.
- I3. Able and willing to provide written informed consent to participate (including by
parent or legal guardian if under 16 years old).
Exclusion Criteria:
- There are no exclusion criteria.
No condition on gender to be admitted to the trial.
Subject must be at least 3 Years old.
| Vital Sign Comparison Between Lifelight and Standard of Care - Development | NCT04003662 | Entailment |
1,562 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- For the radiologists, they must in in active practice of community radiology
(non-university sites).
- For the cases, they must be patients who have a tube, line, or wire in their chest. A
small number of completely normal bedside chest radiographs will be included.
Exclusion Criteria:
- For radiologists: Not in active practice. Working in a university hospital.
- For cases: children. Do not meet image quality criteria.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image | NCT01655329 | Contradiction |
6,743 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Signed informed consent form from the subject, parent or guardian
- Male sex
- Diagnosis of mild congenital hemophilia A (baseline FVIII level of >5% to 30%) without
a current FVIII inhibitor or a history of FVIII inhibitor
- Any number of FVIII exposure days, including PUPs
- BMI <30
- Age ≥5 years to ≤45 years
- Medical documentation of bleeding events, outcomes and hemostatic product usage for 12
months prior to study enrollment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures, including the health-related questionnaires,
activity tracking, and bleed diaries, using systems provided during the study
- Willingness to undergo a Stimate/DDAVP challenge (only if the subject reports no
adverse event associated with prior Stimate [DDAVP/desmopressin acetate] use);
Stimate/DDAVP challenge will not be performed if the patient has a documented history
of lack of response as defined by an increase of FVIII < 2 times baseline level
- Adequate hepatic function, defined as total bilirubin ≤1.5 × age-adapted upper limit
of normal (ULN) (excluding Gilbert's syndrome) and both AST and ALT ≤3 × age-adapted
ULN at the time of screening, and no clinical signs or known laboratory/radiographic
evidence consistent with cirrhosis
- Adequate hematologic function, defined as a platelet count ≥100,000/μL and a PT≤1.5
times the ULN at the time of screening
- Adequate renal function, defined as serum creatinine ≤2.5 × age-adapted ULN and
creatinine clearance ≥30 mL/min by Cockcroft-Gault formula
Exclusion Criteria:
- Inherited or acquired bleeding disorder other than mild congenital hemophilia A
(baseline FVIII level of >5% to 30%)
- Any bleeding disorder other than or in addition to mild hemophilia A
- Current or prior inhibitor to FVIII (any titer)
- Female sex
- History of CVD, risk of CVD by the ASCVD risk estimator (defined as a subject having
>20% risk of a cardiovascular event within the next 10 years if the subject is ≥20
years of age) and/or a history of ischemic heart disease [ICD codes 120-125]
- High risk for TMA (eg, have a previous medical or family history of TMA), in the Study
Investigator's judgment
- History of illicit drug or alcohol abuse by report or in the Study Investigator's
judgment
- Previous (within the last 12 months) or current treatment for thromboembolic disease
(with the exception of previous catheter-associated thrombosis for which
anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease
- Other conditions (eg, certain autoimmune diseases) that may currently increase the
risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the Hemlibra (emicizumab) injection
- Known HIV infection with CD4 counts <200 cells/μL. HIV infection with CD4 counts ≥200
cells/μL permitted
- Use of systemic immunomodulators (eg, interferon) at enrollment or planned use during
the study, with the exception of anti-retroviral therapy
- Concomitant disease, condition, significant abnormality on screening evaluations or
laboratory tests, or treatment that could interfere with the conduct of the study, or
that would, in the opinion of the Study Investigator, pose an additional unacceptable
risk in administering study drug to the patient
- Receipt of any of the following:
- Hemlibra (emicizumab) in a prior investigational study
- An investigational drug to treat or reduce the risk of hemophilic bleeds within 5
half-lives of last drug administration
- A non-hemophilia-related investigational drug within last 30 days or 5
half-lives, whichever is shorter
- Any other investigational drug currently being administered or planned to be
administered
- Inability to comply with the study protocol in the opinion of the Study Investigator
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 45 Years | Hemlibra in Mild Hemophilia A | NCT04567511 | Contradiction |
6,990 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Care for an individual with Alzheimer's Disease or other dementia.
- Own a DVD player or have Internet access.
- Minimum age of 21 years old.
- Spend at least 8 hours/week caring for a person with dementia, which may include
assisting, watching, monitoring, or being available to help (e.g. during sleep time).
Exclusion Criteria:
- Severe psychological or physical illness.
- Inability to read and follow English instructions.
- High level of depressive symptoms.
- Unwillingness to participate in all aspects of the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| iCare Stress Management e-Training for Dementia Family Caregivers | NCT01378195 | Entailment |
5,865 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Criteria of inclusion of subjects
- desire to participate in the trial and ability to sign the informed consent;
- age above 18;
- gastroesophageal reflux disease, manifested in heartburn no less than twice a week
prior to the 1st visit;
- use for the trial period of safe contraception methods for women of fertile age;
- results of ultrasonography (US) of abdominal cavity organs (ACO) performed in the last
6 months before the enrollment.
Criteria of non-inclusion refusal to undergo the endoscopic examination;
- gastroesophageal reflux disease with severe esophagitis (grade С or D against the Los
Angeles classification);
- Barrett esophagus;
- pregnancy or lactation;
- administration of nonsteroidal antiinflammatory drugs (NSAIDs), aspirin,
bisphosphonates, nitrates, calcium antagonists, proton pump inhibitors or Н2-blockers,
prokinetics, clopidogrel;
- participation in other clinical trial;
- history of allergic reaction or intolerance of components of medicinal products;
- esophageal stricture;
- gastrectomy or gastric resection;
- malignant neoplasms in any location at present;
- alcohol abuse;
- severe cardiovascular or respiratory insufficiency;
- hepatic insufficiency;
- renal insufficiency.
Criteria of exclusion
- investigator's opinion on the necessity to exclude the patient for their own benefit;
- erroneous enrollment;
- investigator's decision to exclude the patient due to serious deviation from the trial
program;
- serious adverse events (SAEs) including death (stating the date of death);
- adverse events (AEs) requiring monitoring and drug therapy;
- acute diseases or conditions which in the investigator's opinion require the patient
to be excluded from the trial;
- administration during the trial of NSAIDs, aspirin, bisphosphonates, nitrates, calcium
antagonists, proton pump inhibitors or Н2-blockers, prokinetics, antacids (except for
the tested MP or the comparator MP) or the necessity for such treatment to be
prescribed;
- positive pregnancy test (for women);
- patient's failure to appear for the visit;
- patient's refusal to continue the trial;
- intolerance of the tested MP or the comparator MP;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate Severity | NCT02140073 | Contradiction |
1,174 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Age 18 years or older patients with single previous thoracentesis of a unilateral
pleural exudate according to Lights criteria without malignant cells.
- Lights Criteria:
Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH
ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the
Laboratorys normal Serum LDH
- Contrast enhanced CT of the Chest and abdomen performed
- Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia
- Pet-CT results or former cancer diagnosis Informed consent
Exclusion Criteria:
- bilateral pleural effusions
- known cause of pleural effusion
- likely non-malignant course of a unilateral pleura effusion such as (but not
restricted to) pneumonia, trauma, pleuritis, heart failure
- any contraindication to the study procedures
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer. | NCT04233359 | Contradiction |
1,140 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Patients referred to the center with vasovagal syncope for tilt testing.
- The patient is willing and able to cooperate with the study procedures.
- The subject or legal guardian is able to provide written informed consent
Exclusion Criteria:
- Patients under 18 years or over 90 years old.
- Women who are currently pregnant or have a positive pregnancy test.
- Patients who had a prior tilt test.
- Patients enrolled in another device or drug study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Syncope Prediction Study | NCT02140567 | Entailment |
6,212 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Confirmed SARS-CoV-2 infection
- Hospitalized primarily for the treatment of COVID-19
Exclusion Criteria:
- SARS-CoV-2 positive but hospitalized for non-COVID-19 reasons
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Michigan Medicine COVID-19 Cohort: Clinical Characteristics, Inflammatory Markers and Outcomes of Patients Hospitalized for COVID-19 | NCT04706533 | Contradiction |
4,907 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Diagnosed with essential tremor
- Currently taking medication to control tremor
Exclusion Criteria:
- Cognitive limitations that prevent comprehension or execution of study protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Continuous Tremor Assessment During Daily Activities | NCT01978080 | Contradiction |
620 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Presenting requesting medical or surgical abortion
2. Estimated to be under 13 weeks gestational age based on last menstrual period or time
of conception, or nurses best estimate.
3. Able to provide informed consent with adult supervision of a minor or with an
interpreter present
Exclusion Criteria:
1. Unable to provide informed consent
Female
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 50 Years | Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound | NCT03957200 | Entailment |
2,682 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Scheduled to undergo routine inguinal hernia repair
- Competent to give consent
- Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
- Defect size at operation is between 5mm and 35mm
- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
- Primary hernia at the operative site
- Male or female
- Life expectancy of at least 12 months
- At least 18 years of age
Exclusion Criteria:
- Signs of obvious local or systemic infection
- Any previous surgery on the hernia operative site
- Hernia is not in the inguinal area
- Hernia is not identified as indirect or direct
- Femoral hernias
- Known collagen disorder
- Presenting with unstable angina or NYHA class of IV
- Known Pregnancy
- Active drug user
- Recurrence of a repair by any method
- Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter
- e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
- Immunosuppression, prednisone>15 mg/day, active chemotherapy
- End stage renal disease
- Abdominal ascites
- Skin infection in area of surgical field
- BMI >35
- Peritoneum cannot be closed
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Freedom Inguinal Hernia Repair System Study | NCT01984996 | Entailment |
4,303 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Professional football player contracted to an SPFL club
Exclusion Criteria:
- Loss of professional status as a footballer
Male
Accepts Healthy Volunteers
| Injury Epidemiology Within Scottish Professional Football | NCT03518424 | Entailment |
3,409 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Patient aged ≥ 20 years old and < 75 years old.
- Patient who was eligible and able to participate in the study and accepts to enter the
study by signing written informed consent.
- Patient with fasting LDL-C > 100 mg/dL. The concentration of LDL-C is obtained from
laboratory examination.
- Patient with at least one of the following description (NCEP ATP III guideline).
- Female patient with child-bearing potential must take reliable contraception method(s)
during the participation of the study.
Exclusion Criteria:
- Patient who has participated in other investigational studies within 3 months.
- Patient took medication and natural health foods known to alter blood lipid profiles
within 4 weeks.
- Patient is taking any medication or food that is prohibited by the study.
- Patient taking Amiodarone will be excluded from this study (due to long half life of
this medication).
- Patient is diagnosed with type 1 DM or has been using insulin/insulin analog
medication.
- Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA
reductase inhibitors.
- Patient with TG > 400 mg/dL.
- Excessive obesity defined as BMI above 35 kg/m2.
- Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient
ischemic attack) diagnosed within 3 months.
- Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement
(cardiothoracic ratio > 0.5), significant heart block or cardiac arrhythmias within 3
months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial
fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or
implantable cardiac device were not eligible for this study.
- Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25
mg/dL).
- Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
- Patient with CK level > 5 × ULRR at any time point between Visit 1 and Visit 2.
- Patient with poorly controlled diabetes mellitus (HbA1c > 9.0%) or patient with severe
hypertension (> 180 mmHg for systolic or > 120 mmHg in diastolic blood pressure).
- Patient with hypothyroidism, hereditary muscular disorders, family history of the
above or history of drug-induced myopathy.
- Patient has significant alcohol consumption (> 65 mL pure alcohol) within 48 hours
before Visit 2.
- Any major surgery within 3 months prior to Visit 2.
- Female patient who is lactating, being pregnant or plans to become pregnant.
- Patient with conditions judged by the investigator as unsuitable for the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients | NCT01386853 | Contradiction |
6,593 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males age18 years or older
- Confirmed diagnosis of hemophilia A as evidenced by their medical history with plasma
FVIII activity levels ≤ 2% of normal
- Have received >150 exposure days (EDs) to FVIII concentrates or cryoprecipitate
- Have experienced >10 bleeding events over the previous 12 months only if receiving
on-demand therapy and having FVIII baseline level 1-2% of normal
- Have no prior history of allergic reaction to any FVIII product
- Have no measurable inhibitor against Factor VIII as assessed by the central laboratory
and have no prior history of inhibitors to FVIII protein
- Agree to use reliable barrier contraception
Exclusion Criteria:
- Evidence of active hepatitis B or C
- Currently on antiviral therapy for hepatitis B or C
- Have significant underlying liver disease
- Have serological evidence* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (* participants
who are HIV+ and stable with CD4 count >200/mm3 and undetectable viral load are
eligible to enroll)
- Have detectable antibodies reactive with AAV-Spark200 capsid
- Participated in a gene transfer trial within the last 52 weeks or in a clinical trial
with an investigational product within the last 12 weeks
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Gene Transfer Study for Hemophilia A | NCT03003533 | Contradiction |
2,172 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- First medical contact for acute attack of gout.
- ACR criteria for acute attack of gout
- Crystal proven by arthrocentesis on day of enrollment
- Primary gout
Exclusion Criteria:
- Secondary Gout
- Tophaceous Gout
- Prior steroid, colchicine, or uric acid lowering therapy in the past 6 months.
- Uncontrolled CHF
- Unstable angina
- Renal insufficiency (entry CREAT > 1.3)
- Anticoagulant therapy
- Immunosuppressive therapy or chemotherapy in the past 6 months
- Pregnancy; OR
- Known allergy to NSAID, colchicine, or allopurinol
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Initiation of Allopurinol at First Medical Contact for Acute Attacks of Gout | NCT01310673 | Contradiction |
1,622 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
Inclusion criteria for enrolment at birth
- Written informed consent obtained from the parents or guardians of the subject.
- A male or female infant born after a normal gestation period (between 36 and 42
weeks).
- Born to a mother seronegative for HBsAg.
- Free of obvious health problems as established by clinical examination before entering
into the study.
Inclusion criteria for administration of the combined vaccine regimen
- Between, and including, 6 and 8 weeks of age at the time of the first dose of the
three-dose course of vaccination.
- Free of obvious health problems as established by medical history and clinical
examination before entering into this phase of the study.
Inclusion criteria for administration of the booster dose
- Between, and including, 15 and 18 months of age at the time of the booster
vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.
- Completion of the three-dose primary vaccination course.
Exclusion Criteria:
Exclusion criteria for enrolment at birth
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- Major congenital defect(s).
Exclusion criteria for administration of the combined vaccine regimen
- Use of any investigational or non-registered drug or vaccine other than the study
vaccines within 30 days preceding the first dose of study vaccine, or planned use
during the study period.
- Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine except Bacille Calmette-Guérin
vaccine during the period starting from 30 days before each dose of vaccines and
ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae
type b disease.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or
Haemophilus influenzae type b disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.
Exclusion criteria for administration of the booster dose
- Use of any investigational or non-registered drug or vaccine other than the study
vaccines within 30 days preceding the booster dose of study vaccines, or planned use
during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months of vaccination.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B,
polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Acute disease at the time of enrolment.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the booster dose of study vaccine or planned administration during the study
period.
- Hypersensitivity reaction due to vaccine in primary course
- Encephalopathy within 7 days of previous vaccination with DTP vaccine
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Weeks old.
Subject must be at most 8 Weeks | Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine | NCT00880477 | Contradiction |
6,094 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Clinical Diagnosis of Cerebral Palsy
- Clinical Diagnosis of Down Syndrome
- Clinical Diagnosis of Spina Bifida
Exclusion Criteria:
- Uncontrolled Epilepsy
- Severe Congenital Disorders
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 3 Months old.
Subject must be at most 24 Months | Interrater Reliability of Infant Motor Profile | NCT03188107 | Entailment |
3,560 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- erythema migrans in patients > 18 years
Exclusion Criteria:
- pregnancy or lactation
- taking antibiotic with antiborrelial activity within 10 days
- erythema migrans localized on face or neck
Each patient (235 subjects) provided two skin samples (470 skin samples).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Culture Media for Borrelia Burgdorferi Sensu Lato | NCT02145754 | Entailment |
5,935 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- age more than 18 year old
- ability to provide written informed consent and undergoing an upper endoscopy
- no PPI therapy in previous 2 weeks and no esophageal tumor or stenosis or history of
esophageal surgery
- Patients with more than 3 reflux episodes/week and absence of mucosal breaks at
conventional endoscopy，The PPI test was positive
Exclusion Criteria:
- unable to provide informed consent
- erosive esophagitis or diagnosis of erosive esophagitis within the recent 6 months
- presence of columnar lined epithelium
- evidence of cancer or mass lesion in the esophagus, gastric lesions (ulcer, polyp,
cancer)
- previous gastrointestinal surgery
- esophageal strictures
- chronic use of medications known to affect esophageal motility
- presence of systemic diseases that might interfere with esophageal motility
- use of proton pump inhibitors(PPI) or histamine2-receptor antagonists in the last 4
weeks
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Diagnostic Value of Linked Color Imaging for Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and GERD | NCT03068572 | Contradiction |
53 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Age ≥ 18, ≤ 45 years old;
2. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner
score ﹤ 5;
3. Serum FSH and LH levels are low or in normal low value, testosterone was lower than
normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference
range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of
Science and Technology);
4. With or without olfactory loss/reduction;
5. Other pituitary hormone levels are normal;
6. Head MRI examination is normal;
7. Fertility is desired currently or will be desired in the future;
8. Understand and sign the informed consent form.
Exclusion Criteria:
1. Primary hypogonadism;
2. Acquired hypogonadotrophic hypogonadism;
3. A history of treatment with pulsed GnRH, hCG and FSH related hormones;
4. Receive testosterone replacement therapy for more than 6 months;
5. History of cryptorchidism or cryptorchidism;
6. The sperm density before treatment ≥1×10^6/ml;
7. Moderate or severe liver and kidney dysfunction (ALT>120IU/L, AST>80IU/L,
CR>115μmol/L);
8. The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes;
9. True hermaphroditism and pseudohermaphroditism;
10. Sex hormone abnormalities caused by adrenal lesions;
11. Hypogonadism secondary to other systemic diseases;
12. Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors);
13. There are other hormone abnormalities in the pituitary;
14. There are contraindications for the treatment with hCG or hMG.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH) | NCT03687606 | Contradiction |
4,164 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Man or woman aged between 18 to 50 years. Women can not be pregnant nor breastfeeding,
and man and woman commit to use an efficient contraceptive method along the entire
study period;
- Volunteers of Asian descent, due to differences in the pharmacokinetics of
rosuvastatin in this group of people;
- Volunteers cholecystectomy;
- Female subjects of childbearing potential must not become pregnant during the study
period, thus, should be sexually inactive through abstinence or use of contraceptive
methods the failure rate <1%. Inactivity sexual abstinence should be consistent with
the usual lifestyle of the subject. Periodic abstinence and withdrawal are not
acceptable methods of contraception. Will be accepted as methods of contraception with
failure rate less than 1%: oral contraceptives, either combined or progestogen alone,
injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring,
Percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system
(IUS ) that meets the failure rate <1%, double barrier method, partner sterilization
(vasectomy with documentation of azoospermia) prior to the female subject's entry into
the study, and this male is the sole partner for that subject;
- Body mass index ≥ 18.5 or ≤ 29.9 kg/m²;
- Volunteers with good health conditions and without significant diseases at medical
criterion, as per the Clinical History; Blood pressure, pulse and temperature are
taken, Physical examination, ECG and complementary Lab examinations;
- The volunteer is healthy as determined by a responsible and experienced physician,
based on a medical evaluation including medical history, physical examination,
laboratory tests and cardiac monitoring. A subject with a clinical abnormality or
laboratory parameters outside the reference range for the population being studied may
be included only if the Investigator and the Medical Monitor agree that the finding is
unlikely to introduce additional risk factors and will not interfere with the study;
- The volunteer must be able to understand nature and purpose of the study, including
the risks and adverse effects and must show good intention to cooperate with the
researcher and act according to the requirement of the entire trial, what is confirmed
by the signature of an Informed Consent.
Exclusion Criteria:
- The volunteer has a known hypersensitivity to the drug being studied or to any
chemically related compounds;
- History or existence of hepatic or GI diseases or any other condition that could
interfere with the absorption, distribution, excretion or metabolism of the drug;
- Use of maintenance therapy with any drug but oral contraceptives;
- History of hepatic, renal, pulmonary, GI, neurological, hematological, psychiatric,
cardiologic or allergic problem of any etiology that needs drug treatment or that the
researcher considers it is clinically relevant;
- Current or chronic history of liver disease, or know hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstone);
- ECG findings, not recommended at the researcher's criterion to participate in the
study;
- Results of complementary lab tests that are out of the values considered normal,
according to this protocol guidelines, unless the researcher considers them
non-clinically significant;
- Smoke abuse;
- Daily ingestion of more than five cups of coffee;
- History of alcohol or drug abuse;
- Use of regular medication along the two weeks that preceded the study commencement, or
use of any other medication one week before the study commencement;
- Hospitalization for any reason up to 8 weeks before the first period of study;
- Treatment along three months before the treatment commencement of the study with any
drug known because of its well-defined toxic potential to major organs;
- Participation in any pharmacokinetics study with collection of more than 300 mL of
blood or ingestion of any experimental drug along six months before the treatment
commencement of the study;
- Donation or loss of ≥ 450 mL of blood along the three months that preceded the study
or donation of more than 1500 mL along the 12 months before the treatment commencement
of the study;
- Positive result for βHCG in urine in female volunteer;
- A positive pre-study Hepatitis B surface antigen or positive Hepatites C antibody
result within 3 months os screening;
- Female subjects not using a contraceptive method that meets the failure rate <1%;
- Any condition that prevents the participation in the study, according to the
researcher's judgment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Rosuvastatin Calcium Bioequivalence Study - Fast | NCT01711749 | Contradiction |
272 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Participant is willing and able to give informed consent for participation
2. Females aged 21 to 43 years
3. Have a body mass index (BMI) above 19 and below 29
4. Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest
and longest cycle in the last 6 months
5. Minimum menstrual cycle 24 days
6. Maximum menstrual cycle 35 days
7. Normal pap smear within the last year
8. Willing to use the fertility device for at least 3 cycles
9. Willing to fill in online questionnaires
10. Willing to attend clinic up to 6 times per cycle for transvaginal ultrasound and blood
tests
11. Willing to perform LH urine tests at home twice a day from day 8 of cycle until it is
positive
12. Willing to document the last day of the previous menses and first day of the following
menses.
13. Willing to measure and record oral at the same time each morning.
14. Normal pelvic ultrasound and blood results obtained during screening tests
Exclusion Criteria:
1. Any diagnosed systemic illnesses including thyroid disease, diabetes, yeast infection,
Chlamydia, gonorrhea, trichomonas, bacterial vaginosis, inflammatory diseases, or are
in an immuncompromised state
2. Polycystic ovary disease
3. Endometriosis or other chronic pelvic pain or pelvic pathology
4. Taking steroid medication, including oral contraceptives or anti inflammatory drugs
5. Pregnant
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 43 Years | Measuring Core Body Temperature Using TempuRing | NCT02462278 | Contradiction |
3,694 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Subject is ≥40 years old.
2. Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale
grade II III) in one or both knees. Radiographs to be taken within 12 months prior to
the Screening visit.
3. Subject has OA pain in the target knee despite conservative physical treatments and/or
analgesics.
Exclusion Criteria:
1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
2. Subject has a documented history of hypersensitivity to HA.
3. Subject has a documented infection or severe inflammation of the target knee joint.
4. Subject has a skin disease in the area of the injection site.
5. Subject has a clinically apparently tense effusion of the target knee on examination
determined by either a positive bulge sign or positive ballottement of the patella
(patellar tap).
6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds
the measurement of pain in the target knee.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe | NCT04732793 | Contradiction |
726 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Compliance inform consent
- Patients with RA
- Fulfill The ACR criteria of RA
- Impairment of the hand strength with or without pain in the hands during the grip
procedure
- Chronic pain: either persistent or intermittent over a minimum period of three months
prior to recruitment
- Current pain: greater than 30/ 100 mm on a pain visual analogue scale (VAS) within the
last 24 hours despite medication
- Patients on stable dose treatment for at least 3 weeks
Exclusion Criteria:
- Under the age of 18 years
- Previously had acupuncture
- Localized skin infections
- Severe chronic or uncontrolled co-morbid disease
- The wish to get a pension.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of the Effect of Acupuncture on Hand Pain, Functional Deficits and Health Related Quality of Life in Patients With Rheumatoid Arthritis | NCT02553005 | Contradiction |
427 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Cases of infertility, older than 20 years of age and not older than 40 years.
- Body mass index (BMI): 20-29.
- Women diagnosed with endometriosis (diagnosis based on ultrasound or laparoscopy or
both)
- Recurrent implantation failure (failure to conceive following two embryo transfer
cycles, or cummulative transfer of >10 good quality embryos)
- Normal ovulatory cycles (as proven by folliculometry and/or mid luteal serum
progesterone), good ovarian reserve (as proven by early follicular FSH and AMH)
- Normal uterine cavity as assessed by ultrasonography, hysterosalpingography, or
hysteroscopy
- Normal hormonal profile (serum PRL, TSH, thyroid hormone)
- Normal semen analysis of the partner
- Infertility after one year of unprotected intercourse
- High-quality embryos were transplanted
Exclusion Criteria:
- Congenital or acquired uterine abnormalities (e.g. septate, bicornuate, fibroid
uterus, uterine polyp & Asherman Syndrome)
- Congenital or acquired tubal abnormalities (e.g. hydrosalpinx or pyosalpinx)
- Contraindication for G-CSF (renal disease, sickle cell disease, or malignancy history,
upper respiratory tract infection, pneumonia, or chronic neutropenia)
- Thrombophilia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis | NCT03549728 | Contradiction |
4,896 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Male or female aged 20 years minimum
- Patient with absolute contraindication or relative to deep brain stimulation (DBS) of
VIM.
- Patient having the Gamma Knife radiosurgery of VIM (combining clinical and
paraclinical conditions).
- Patient affiliated to a social security scheme.
- Patient having understood and signed the information notice for non opposition.
Exclusion Criteria:
- Patient having a contraindication to performing a cerebral MRI (pace-maker,
intracerebral metallic object etc.)
- Patient with a contraindication to radiosurgical treatment (previous treatment with
cerebral radiotherapy)
- Vulnerable persons: minors, protected adults (guardianship or trusteeship) and adults
unable to express their non-opposition.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Evaluation of the Predictors of Clinical and Radiological Response to Gamma-Knife Radiosurgery in the Treatment of Intermediate Ventral Nucleus of the Thalamus (VIM) Thalamotomy Tremor. | NCT03350139 | Contradiction |
6,041 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Diagnosis of GERD with symptoms for at least 6 months with at least 3 episodes a week
and one of those at nighttime
- in generally good health
- stop any previous similar (proton pump inhibitor) therapy at least 10 days before
screening
- weigh within normal weight for one's height
- able to tolerate a nasogastric tube (pH probe assembly that goes through the nose into
the stomach) for 48 hours on 2 different occasions
- esophageal acid exposure of at least 10% on a 24-hour pH monitoring study performed
within the 24 months prior to screening
- Helicobacter pylori (an infection) negative
- willing to take only TUMS antacid as rescue medicine during the washout period
Exclusion Criteria:
- History of a serious medical condition
- significant gastrointestinal illness other than GERD
- ulcer at any time in the past
- difficulty swallowing
- history of gastrointestinal disease (including bleeding)
- use of any medication that changes acid secretion or gastrointestinal movement in the
past 14 days
- use of any drugs on a list of prohibited drugs within 1 month
- chronic use of pain relieving medications (NSAIDs or COX-2 inhibitors)
- pregnant or breast-feeding
- cancer diagnosis or treatment (except for superficial skin cancers)
- abusing drugs or alcohol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn | NCT00237367 | Entailment |
2,386 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | INCLUSION CRITERIA
- Aged 5 - 9 years old
- Able to walk without assistance
- Diagnosis of DMD confirmed by one of the following:
- a) Positive X-linked family history; or
- b) Dystrophin immunofluorescence and/or immunoblot, which shows complete dystrophin
deficiency, and clinical picture consistent with DMD; or
- c) Gene deletion test positive in the central rod domain (exons 25 - 60) of
dystrophin, where reading frame can be predicted as 'out-of-frame', and clinical
picture consistent with DMD.
- Glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort
within 1 year before the study began), or has been involved in other therapeutic
research protocol within the last year
- Forced Vital Capacity (a lung function test) > 50% of predicted value
- Evidence of muscle weakness by MRC score or clinical functional evaluation
- MRC (manual muscle test) score variability no greater than 10% between screening
visits 1 and 2
EXCLUSION CRITERIA
- Failure to achieve any of the criteria listed above
- Symptomatic DMD carrier
- Symptomatic cardiomyopathy or ventricular arrhythmias
- Previous (6 months or less) or current use of glutamine or creatine (for DMD or any
other indication)
- Use of carnitine, other amino acids, coenzyme Q10, or any herbal medicines within the
last month
- History of significant concomitant illness or significant impairment of renal or
hepatic function
- Evidence of allergy to chocolate or milk solids (substances will be delivered in a
powdered hot cocoa mixture)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 9 Years | Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy | NCT00016653 | Entailment |
4,297 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria
1. Non-smoking, age greater than or equal to (>=) 20 years and less than or equal to (<=)
55 years old adult male at the time of informed consent. To be considered non-smokers,
participants must have discontinued smoking for at least 4 weeks before dosing
2. Body mass index (BMI) >=18.5 and less than (<) 25.0 kilogram per square meter (kg/m˄2)
at Screening
Exclusion Criteria:
1. Males who have not had a successful vasectomy (confirmed azoospermia) or they and
their female partners do not meet the criteria (that is, not of childbearing potential
or practicing highly effective contraception throughout the study period or for 5
times the half-life of the study drug plus 90 days after study drug discontinuation).
No sperm donation is allowed during the study period and for 5 times the half-life of
the study drug plus 90 days after study drug discontinuation
2. Clinically significant illness that requires medical treatment within 8 weeks or a
clinically significant infection that requires medical treatment within 4 weeks of
dosing
3. History of meningococcal infection or pneumococcal infection
4. Evidence of disease that may influence the outcome of the study within 4 weeks before
dosing; example- psychiatric disorders and disorders of the gastrointestinal tract,
liver, kidney, respiratory system, endocrine system, hematological system,
neurological system, or cardiovascular system, or participants who have a congenital
abnormality in metabolism
5. Any history of gastrointestinal surgery that may affect PK profiles of E8001, example-
hepatectomy, nephrectomy, and digestive organ resection at Screening
6. Any clinically abnormal symptom or organ impairment found by medical history at
Screening, and physical examinations, vital signs, ECG finding, or laboratory test
results that require medical treatment at Screening or Baseline
7. History of prolonged QT/QTc interval
8. History of left bundle branch block (LBBB)
9. History of myocardial infarction (MI) or active ischemic heart disease (IHD)
10. History of clinically significant arrhythmia or uncontrolled arrhythmia
11. Active viral hepatitis (A, B or C) and syphilis as demonstrated by positive serology
at Screening
12. History of drug or alcohol dependency or abuse, or those who have a positive drug test
at Screening or Baseline
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 55 Years | A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants | NCT04609852 | Entailment |
2,709 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- adult male primary inguinal hernia
Exclusion Criteria:
- recurrent hernia previous lower abdominal surgery [excluding appendectomy]
Male
No healthy subjects accepted to join the trial.
| Hernia Repair Four Arm Comparative Study | NCT00940433 | Entailment |
5,217 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women, diagnosed with osteoporosis
- Aged ≥ 55 and ≤ 80 years at screening
- Body weight ≥ 50 kg and ≤ 90 kg at screening
- Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar
spine as measured by DXA
- At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by
DXA
Exclusion Criteria:
- Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)
- History and/or presence of one severe or more than two moderate vertebral fractures or
hip fracture
- History and/or presence of bone metastases, bone disease or metabolic disease
- Ongoing use of any osteoporosis treatment or use of prohibited treatment
- Other bone active drugs
- History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or
hypercalcemia
Other Inclusion/exclusion criteria may apply
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 80 Years | Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis | NCT03974100 | Entailment |
1,343 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Clinical diagnosis of ACH with genetic confirmation
2. Age between 2 to 10 years old (inclusive) at Screening Visit
3. Prepubertal (Stage 1 breasts for girls or testicular volume < 4ml for boys) at
Screening Visit
4. Able to stand without assistance
5. Caregiver willing and able to administer subcutaneous injections of study drug
Exclusion Criteria:
1. Clinically significant findings at Screening that:
- are expected to require surgical intervention during participation in the trial
or
- are musculoskeletal in nature, such as Salter-Harris fractures and severe hip
pain or
- otherwise are considered by investigator or Medical Monitor/Medical Expert to
make a participant unfit to receive study drug or undergo trial related
procedures
2. Have received treatment (>3 months) of human growth hormone (hGH) or other medications
known to affect stature or body proportionality at any time
3. Have received any dose of medications intended to affect stature or body
proportionality within the previous 6 months of Screening Visit
4. Have received any study drug or device intended to affect stature or body
proportionality at any time
5. History or presence of injury or disease of the growth plate(s), other than
Achondroplasia, that affects growth potential of long bones
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 10 Years | A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia | NCT04085523 | Entailment |
412 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Women, age 18 years or greater with or without symptoms of vaginal infection.
2. Subject is ready to sign the informed consent form.
Exclusion Criteria:
1. Subject is unable or unwilling to cooperate with study procedures.
2. Subject is currently participating in another clinical study.
3. Subject suffers from vaginal bleeding or is menstruating.
4. Subject that have had sexual relations within the last 12 hours.
5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the
last 3 days.
6. Subject that applied vaginal douching within 12 hours prior to the visit at the
clinic.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Performance Proof of Product Developed to Detect Abnormal Vaginal pH | NCT01542606 | Contradiction |
1,494 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Minimum 19 years old
- Kellgren stage I ~ III by ACR criteria
- Stable osteoarthritis during 3 months
- Be able to perform WOMAC and KKS
- Written consent form voluntarily
Exclusion Criteria:
- Disease of orthopaedic surgical that could affect to evaluate the efficacy
- Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
- Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics
within four weeks
- Medical history of hypersensitivity reaction against Herbal drug
- Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose
malabsorption, etc.
- Occurrence of OA caused by the injury
- Diagnosed with psychical disorder, and taking medication
- Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel
disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure,
clinically significant ischemic heart disease, peripheral arterial disease, or
cerebrovascular diseases
- Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
- Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
- Positive in fecal occult blood test
- Gastrointestinal tract surgery except appendectomy
- Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
- Participation in another clinical trials within 4 weeks
- Not consent about using effectual contraception method during trial
- Pregnant or lactating woman
- Medical history of malignant tumor within 5 years
- Investigator's judgment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis | NCT01604239 | Entailment |
5,956 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- diagnosis of typical GERD
- well controlled on a standard clinical symptoms controlled dose of PPI treatment
- body mass index ≤32 kg/m2
Exclusion Criteria:
- exclusively atypical symptoms of GERD
- symptoms that have been shown not to be associated with GERD
- erosive oesophagitis
- hiatus hernia > 3 cm
- current diagnosis of co-existing psychiatric disease
- known clinically significant allergy or known hypersensitivity to drugs
- pregnant or breast-feeding
- has received sodium valproate or topiramate within 30 days of Screening
- has a history of a significant medical condition that may affect the safety of the
patient or preclude adequate participation in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD) | NCT00820079 | Contradiction |
874 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male or female
- ages 50-75 years
- history (>3 months) joint pain, knees, hip, ankles, shoulders, or hands
- willingness to avoid NSAIDs use during the 8-week study
- willingness to avoid other anti-inflammatory medications
- agree to stay weight stable during the 8-week study
- willing to follow all study procedures, including randomization to one of two groups
- able to walk for at least 6 min at a moderate-to-brisk pace
Exclusion Criteria:
- history of regular NSAID use during the previous two weeks
- use of other medications (e.g., analgesic gels, arthritis medications, other
anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin)
for joint pain for the previous two weeks
- serious medical problems (current cancer case, severe rheumatoid arthritis, recent
heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or
other disease that will interfere with study participation).
- psychiatric disorder or other condition that might interfere with self-assessment
ability.
- history of allergic reactions to shellfish products.
- history of allergic reactions to products containing aspirin.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Instaflex and Joint Pain in Community Adults | NCT01956500 | Entailment |
231 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Patients with history of one fresh embryo transfer failure
2. Patients with Primary infertility
3. Patients with at least one embryo with excellent quality
Exclusion Criteria:
1. Female age over 40 years old 2- Severe male factor (Azoospermia) 3- Endometriosis
diagnosis and the presence of hydrosalpinges 4- Uterine factor ( polyps, myoma and previous
myomectomy, …) 5- Patients with polycystic ovarian syndrome diagnosis 6- Cases with
pre-implantation genetic diagnosis (PGD)indication 7- Cases with difficult embryo transfer
or use of Tenaculum 8- Patients with repeated implantation failures and repeated
miscarriages. 9- Female smokers
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Frozen Embryo Transfer on Cycle Outcomes | NCT02355925 | Contradiction |
5,890 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Any patient undergoing anti-reflux surgery
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Gastroesophageal Reflux Disease Prospective Registry | NCT02479438 | Contradiction |
1,039 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Men and women
- Ages 50 years and older
- Reside within Tampa Bay Region, Florida
- Presence of symptomatic OA as determined by the AUSCAN Index. Specifically, a hand
function score of > 225 mm for the AUSCAN VA-subscale
- Presence of radiographic hand OA, as defined by grades 2, or higher, per the Kellgren
and Lawrence scale in one or more joints.
Exclusion Criteria:
- Concomitant rheumatic disease (e.g., rheumatoid arthritis, gout, lupus, fibromyalgia)
- Current hand or wrist injury (e.g., carpal tunnel syndrome, palmer tenosynovitis,
fracture, sprain)
- Use of an assistive device such as a cane or crutch
- Has hand surgery scheduled within the 48 weeks following the start of the study
- Prior hand surgery requiring joint replacement or other instrumentation in the hands
- Received any intra-articular injection (hyaluronic acid, corticosteroid, or joint
lavage) during the 3 months preceding the study
- Currently participating in another conflicting research study
- Currently using a therapeutic hand cream or practicing a hand exercise routine
- Unwilling to sign an informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Study of Effectiveness of Hand Exercises to Treat Symptoms of Hand Osteoarthritis | NCT00375947 | Entailment |
6,762 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Age 18 or older
- English literate
- A BMI ranging from 25-40 (overweight or obese), based on self-report height and weight
- Not meeting current national physical activity guidelines
- Self-report they are able to walk unassisted, without the help of a wheel chair,
walker, cane, crutches, or other walking aids
- Medically cleared to participate by completing screening form
- For women: not currently pregnant or actively trying to get pregnant for duration of
study
Exclusion Criteria:
- Younger than 18
- Not English literate
- Self-report they are unable to walk unassisted, without the help of a wheel chair,
walker, cane, crutches, or other walking aids
- A BMI outside of inclusion range (<25 or >40), based on self-report height and weight
- Meeting current national physical activity guidelines
- Not medically cleared to participate
- For women: currently pregnant or actively trying to get pregnant for duration of
study. Pregnant women or those trying to become pregnant will be excluded because
pregnancy may interfere with women's ability to go about previously normal activities,
and will influence our outcome measures (e.g., BMI).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Physical Activity and Daily Experiences Study | NCT02005042 | Entailment |
1,781 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
patients who were referred to a specialist motility center over 4 year period with:
- Unexplained gastrointestinal symptoms such as gas, bloating, belching, diarrhea, and
abdominal discomfort
- history of colectomy
- patients with no history of colectomy
- patients included who had normal: upper endoscopy, colonoscopy, computerized abdominal
tomography scan, and normal hematology, biochemical profiles, tissue transglutaminase
antibody, thyroid stimulating hormone, and normal right upper quadrant ultrasound
scan.
- patients with glucose breath test and/or duodenal aspirate
Exclusion Criteria:
- patients with upper gut or small bowel surgery
- Patients who were hospitalized or with serious cardiac or pulmonary or neurologic
comorbidities
- Patients with intestinal strictures or known intestinal motility disorders such as
scleroderma or pseudo-obstruction syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| SIBO & SIFO After Colectomy | NCT03216239 | Contradiction |
6,926 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- 18 years or older
- Healthy person without memory complaints OR person diagnosed with a neurodegenerative
disease (ie, Alzheimer's disease, Parkinson's disease, multiple sclerosis)
Exclusion Criteria:
- MR contraindication such as metal in body (ie, pacemaker, implant, shrapnel, etc.)
- Pregnant
- Claustrophobic anxieties
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Magnetic Resonance Imaging (MRI) of Brain Iron in Neurodegenerative Disease | NCT00249080 | Entailment |
5,228 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Caucasian postmenopausal women older than 40 years
- Low bone mass at lumbar spine (L2-L4) or femoral neck (BMD T-score of ≤ -2.0) or BMD
T-score of > -2.0 coexistent with low-energy fracture of vertebral, femoral neck or
forearm
- Patient's informed consent to participate
Exclusion Criteria:
- Secondary osteoporosis
- Any bone and mineral disorder other than osteoporosis, including primary or secondary
hyperparathyroidism, Paget's disease of bone, osteogenesis imperfecta, rheumatologic
diseases, paraplegia, chronic immobilization
- Severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2) or liver or
kidney transplantation
- Premature ovarian failure
- Uncontrolled thyroid disease
- Any malignancy
- Any musculoskeletal injury or surgical procedure 6 months prior to baseline
- Dental surgery or teeth removed 3 months prior to baseline or plan to
- History or concomitant medications that could affect bone metabolism, including
immunosuppressive, anticonvulsant, antiviral and anti-tuberculosis agents, addictive
drugs, corticosteroids, non-steroidal anti-inflammatory drugs, amiodarone,
thiazolidinediones, interferon, metronidazole, and tamoxifen
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass | NCT01572545 | Entailment |
6,687 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Males with hemophilia A, who have received a single intravenous administration of
SPK-8011 in any Spark sponsored SPK-8011 study
2. Individuals who understand the purpose and the risks of the study, and who provide
signed and dated informed consent before undergoing any study-specific procedures.
Exclusion Criteria:
1. Individuals who are unable or unwilling to comply with the schedule of visits and study
assessments as described in this study protocol.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Long-Term Safety and Efficacy of SPK-8011 in Males With Hemophilia A | NCT03432520 | Contradiction |
5,731 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Smokes cigarettes every day
- Smokes five or more cigarettes per day
- Has smoked cigarettes for at least 1 year before study entry
- Has a home address and phone number
- Willing to participate in phone assessments
- Willing to be assigned to either of the two study programs
Exclusion Criteria:
- Pregnant or breastfeeding
- Another household member is enrolled in the study
- Moving out of the area of residence in the 14 months after study entry
- Primary care provider is not participating in the study
- Use of other forms of tobacco products (e.g., cigars, spit, snuff) in addition to
cigarettes
- Use of a smoking cessation medication
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices | NCT00843505 | Contradiction |
1,577 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- All adults patients scheduled for hand or wrist ambulatory surgery since 2016
Exclusion criteria:
- NA
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? | NCT04306666 | Contradiction |
74 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Generally healthy, untrained men 60 years or older with low-normal testosterone levels
(200-350ng/dL)
- Must reside in the Denver metro area
Exclusion Criteria:
- Prostate/breast cancer
- Unable to exercise safely
- severe obesity (>34 body mass index [BMI])
- Polycythemia
- Diabetes
- Use of drugs that could affect T levels
- Cognitive dysfunction (MMSE less than 24)
- PSA above the age-adjusted normal level or AUA greater than 19
- Unable to pass stress test due to active CAD
Male
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
| TEAM: Testosterone Supplementation and Exercise in Elderly Men | NCT00112151 | Contradiction |
4,495 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Patients candidate for total laparoscopic hysterectomy :
- Uterine size <12 weeks.
- Having no severe endometriosis.
- Having descent of no more than 1st degree of uterus.
- Non-malignant conditions.
2. Completion of the entire procedure by laparoscopic approach up to colpotomy.
3. Benign conditions as indications for hysterectomy.
Exclusion Criteria:
- 1) Obese patients i.e., BMI > 30 k.g\m2. 2) Suspected extensive pelvic adhesions . 3)
Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid
therapy ,advanced liver diseases.
4) Inability to express adequate informed consent to participate in the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Laparoscopic Versus Transvaginal Cuff Closure | NCT03898726 | Contradiction |
1,901 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | DISEASE CHARACTERISTICS:
- Histologically proven resectable stage II or III adenocarcinoma of the stomach
- No evidence of locally inoperable or distant metastases on chest x-ray and any
combination of abdominal ultrasound, CT scan, or laparoscopy
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-1
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No clinical evidence of uncontrolled angina pectoris, cardiac failure, or significant
uncontrolled cardiac arrhythmia
Other:
- No medical contraindication to study therapy
- No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of
the cervix
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer | NCT00002615 | Entailment |
46 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Female subjects aged ≥ 42 years and ≤ 65 years, in post-menopausal period for at least
1 year and with active sexual life;
- Serum testosterone levels < 33 ng/mL;
- Follicle-stimulating hormone (FSH) levels > 22 mU/mL;
- Absence of other significant diseases which, at the physician's discretion, could
impact subject's participation in the trial, according to protocol requirements, and
study evaluations: medical history, blood pressure and heart rate measurements,
physical examination and complimentary laboratory tests;
- Ability to understand the nature and objective of the trial, including risks and
adverse events, which shall be confirmed by Informed Consent Form signature.
Exclusion Criteria:
- Screening laboratory tests results presenting clinically relevant deviations that, at
the investigator discretion, prevent the subject to participate in the trial due to
possible risks;
- Drugs addiction, including alcohol;
- Treatment with any drugs known to have a well-established toxic potential to major
organs, within 3 months before the trial, ;
- Participation in any other experimental research or administration of any experimental
drug within six months before the initiation of this trial;
- Pregnancy, labor or miscarriage in the last 12 weeks before the antecipated date of
the study treatment start;
- Any conditions, according to investigator's best judgement, that prevents the subject
to participate in the trial.
Female
Accepts Healthy Volunteers
Subject must be at least 42 Years old.
Subject must be at most 65 Years | Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1% | NCT02667561 | Contradiction |
3,452 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Patient who underwent hearing test in our otologic clinic
Exclusion Criteria:
- Age below 15 year
- Patients who cannot following command
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| The Accuracy of Automated Audiometry Application on Smart Phone to Screen Hearing Loss | NCT02840266 | Entailment |
2,654 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
1. Male patients >=20 years =<85 years old
2. Patients with Unilateral hernia
3. Patients without previous operations in lower part of abdomen
4. Patients capable to understand the explanation about purpose and method of the trial,
and write an Informed Concent Form
5. Patients capable to participate during the period of the trial
Exclusion Criteria:
1. Previous hernia repair at the same site
2. Incarcerated hernia
3. Strangulated hernia
4. Patients to whom and open surgery cannot be indicated
5. Previous urological surgery
6. Immune incompetence of patient: AIDS, vesical fibrosis, etc.
7. Patients with AIHD or patients who take immunosuppressive drugs
8. Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
9. Patients with kidney disease (creatinine>2.0mg/dL)
10. Patients on anti-coagulants
11. Patients with severe systematic disease
12. Patients with malignant tumor
13. Patients with infection or with the predicted problem of surgery site healing
14. Participation in another clinical study within the last 30 days
15. Patients whose participation is considered inappropriate according to other except
above mentioned clinical condition
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 85 Years | Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair | NCT01877122 | Entailment |
6,161 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Age ≥ 75 or age 65-74 with at least 1 of the following comorbidities: arterial
hypertension, diabetes, obesity, chronic obstructive pulmonary disease, heart disease,
chronic kidney disease
- Last 48 hours: (A)Axillary temperature ≥ 37.5oC or febrile equivalent, combined with
(a) dry cough and/or (b) breathing difficulty and/or (c) odinophagia and/or (d)
anosmia/dysgeusia and/or (e) any of the following symptoms: fatigue, anorexia,
myalgias or rhinorrhea.
- Confirmed diagnosis SARS-Cov2 by RT-PCR
- Give Informed consent
Exclusion Criteria:
- Severe respiratory disease
- Cardiac insufficiency,
- Chronic renal failure,
- Primary hypogammaglobulinemias,
- Myelodysplastic syndromes,
- Chronic linfoproliferative syndromes,
- Monoclonal gammapathies,
- Known hypersensitibility,
- Active cancer,
- HIV, HBV or HCV infection,
- Chronic administration of immunosuppressants,
- Body transplant history,
- Chronic liver disease, Chronic lung disease with oxygen requirement.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2 | NCT04479163 | Contradiction |
Subsets and Splits