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742 | 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. | All volunteer subjects must be between 21 and 75 years of age, in good health, and must
have provided informed, written consent for participation in this study.
No subjects with a history or evidence of present or past hypertension (blood pressure
greater than 145/95 mmHg), hypercholesterolemia (LDL cholesterol greater than 130 mg/dL),
diabetes mellitus (fasting blood glucose greater than 120 mg/dL), smoking within 2 years,
cardiac disease, peripheral vascular disease, coagulopathy, or any other disease
predisposing to vasculitis or Raynaud's phenomenon.
No volunteer subject will be allowed to take any medication (oral contraceptive agents are
allowed) or vitamin supplements for at least one month prior to study and will not be
allowed to take aspirin for one week prior to study.
Pregnancy testing will be required of all women of reproductive age to exclude current
pregnancy.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Vascular Effects of Endothelium-Derived Versus Hemoglobin-Transported Nitric Oxide in Healthy Subjects | NCT00001963 | Contradiction |
7,002 | 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:
1. Age 50-85 years (including 50 and 85 years old), male or female;
2. Diagnose probable AD in accordance with the National Institute Aging and Alzheimer's
Association (NIA-AA) (2011);
3. Mild-to-moderate AD patients, MMSE 11-26 (including 11 and 26, primary school
education subjects from 11 to 22);
4. Hachinski Incheinic Score (HIS) less than 4 points;
5. Hamilton depression scale /17 Version (HAMD) score less than 10 points;
6. Memory decline at least 12 months, and the decline is progressive;
7. Brain MRI examination was done within 6 months before screening;
8. Neurological examination had no obvious signs (except due to AD disease or peripheral
injury);
9. Females were postmenopausal (menopause beyond 24 weeks), or accepted the surgical
sterilization, or women of childbearing age agreed to take effective contraceptive
measures during the study. Women of childbearing age or menopausal time shorter than
24 weeks must do the urine pregnancy test and results to be negative during the
screening period;
10. Subjects should have stable and reliable caregivers, or have frequent contact with
caregivers (at least 4 days per week, at least 2 hours per day), caregivers will help
patients to participate in the study. Caregivers must accompany the subjects in the
study visit to provide valuable information for the NPI, ADCS-ADL and CIBIC-plus
scales assessments;
11. Subjects have at least primary school education level, and have the ability to
complete the determination of cognitive ability assessments and other tests;
12. The participants and legal guardian must sign informed consent.
Exclusion Criteria:
1. Brain MRI examination showed significant focal lesions, moderate-to-severe white
matter lesions, and key parts lacunar infarction such as the thalamus, hippocampus,
entorhinal cortex, cortical and subcortical gray matter nuclei;
2. Other type of dementia except AD;
3. Suffered from nervous system diseases (including stroke, optic myelopathy, Parkinson's
disease, epilepsy, etc);
4. Psychotic patients, according to the DSM-5 criteria, include schizophrenia or other
psychiatry disorders, bipolar disorder, major depression disorder, or delirium;
5. Abnormal laboratory test results: HBsAg and HBeAg and/or HbcAb positive and active
stage of hepatitis B, liver function (ALT, AST) more than 1.2 times of the upper limit
of the normal range, Cr exceeds the upper limit of normal, white blood cell count less
than 4 x 109/L or platelet less than 100 x 109/L, hemoglobin less than 100g/L, blood
glucose concentration of diabetic subjects (random) is more than 13.9mmol/L;
6. Systolic pressure was more than 160mmHg or less than 90mmHg, diastolic blood pressure
was more than 100mmHg or less than 60mmHg;
7. With unstable or serious heart, lung, liver, kidney and hematopoietic system diseases
(including unstable angina, myocardial infarction, uncontrolled asthma, gastric
cancer, et al), or resting heart rate after 10 minutes of rest was less than 60 BPM,
or QTc (QTc B (Bazett's correction value) or QTc F (Fridericia's correction value))
was equal or greater than 450msec, or with bundle branch block, the QTc B or QTc F was
equal or greater than 480msec, or the researchers estimate there were abnormal EKG
results which cannot be randomized to the study;
8. There was uncorrected of visual and auditory disturbances, and neuropsychological
tests and scale assessments cannot be completed by the subject;
9. Subject was currently using Alzheimer's disease drugs and cannot be terminate the
treatment;
10. Subjects that cannot take the test drug according to the prescription should be
excluded;
11. Alcohol abuse or drug abuse;
12. Pregnant or lactating women;
13. Participated in other clinical pharmacological tests within 30 days before screening
visit;
14. The researchers believe that the subject was impossible to complete the study;
15. Participants were employees of the study and immediate family members, employees of
CRO company or sponsor and their immediate family members.
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.
Subject must be at most 85 Years | Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease | NCT03283059 | Entailment |
5,969 | 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 aged > 18 years, undergoing surgery for the treatment of GERD, of massive
incarcerated hiatus hernia ± GERD, in which a laparotomic, laparoscopic or
thoracotomic approach is preoperatively indicated.
Exclusion Criteria:
- association of GERD with epiphrenic esophageal diverticulum, collagen diseases,
undetermined esophageal motility disorders;
- redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and
stomach, on the diaphragm.
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.
| Foreshortened Esophagus and Its Surgical Therapy | NCT00507377 | Contradiction |
3,368 | 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:
- 21-35 years of age
- right-handed
Exclusion Criteria:
- left-handedness or ambidexterity
- fMRI safety reasons (ferromagnetic material in their bodies, epilepsy, claustrophobia
- history of middle ear/tympanic membrane surgery (tympanostomy tubes)
- abnormal otoscopic findings and/or tympanometry on physical exam
- pregnancy
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 35 Years | Functional Manifestations of Pressure Changes in the Middle Ear System | NCT01932736 | Contradiction |
6,568 | 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 years
- Severe hemophilia A (FVIII<1%) diagnosis
- Prior treatment or ongoing treatment with on-demand or prophylaxis regimens according
to Turkish guidelines and requirements
- Previously treated patients with at least >50 exposure days
- Written informed consent signed by patient/legal representative
Exclusion Criteria:
- Currently on immune tolerance treatment
- Platelet count < 75,000/mm3
- Participation in another study
- Existence of inhibitors in the past and in the last currently available blood sample
prior to study start (Bethesda titer < 0.6 BU/ml)
- Existence of inhibitor history in family members who also are diagnosed with
hemophilia A
- Having been on primary prophylaxis as defined in the introduction
- Participation in another 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.
| Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients | NCT01817868 | Contradiction |
3,090 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Is male and 13 to 22 years old (inclusive) at the time of informed consent.
- Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).
Exclusion Criteria:
- Concomitant disease or condition that are clinically significant and would limit study
participation
- Clinically significant lab abnormalities or vital signs at the time of screening
- History of uncontrollable seizure disorder or seizure episodes within 6 months of
screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
- Unable or does not have a caregiver able to comply with study requirements.
- Enrolled in any clinical trial within the 30 days before screening.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 22 Years | A Study of OV101 in Individuals With Fragile X Syndrome | NCT03697161 | Entailment |
4,003 | 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:
- Significant joint effusion
Exclusion Criteria:
- Hemorrhagic effusion
- Traumatic effusion
- Less than 3 ml total of collected fluid (used for routine analysis and culture)
- Inability or refusal to consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 95 Years | Synovial Fluid Bank From Arthritic Patients | NCT00512343 | Entailment |
409 | 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:
Age :20-35yrs.
1. Embryo transfer at 3rd or 5th day after ovum pick up.
2. The transferred embryos are in the four cell stage ,eight cell stage, sixteen cell
stage or blastocyst stage.
Exclusion Criteria:
1. Age <20 or >35 yrs old.
2. Chronic medical disease.
3. Single embryo transfer.
4. Previous ICSI failure.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Comparison Between Effect of Enoxaparin and Clopidogrel on Improving Pregnancy Rate in ICSI | NCT02696330 | Contradiction |
906 | 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:
- experiencing hand pain and swelling
Exclusion Criteria:
- unable to give informed consent
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 | C-GLOVES: the Effectiveness of Compression Gloves in Arthritis | NCT01874067 | Entailment |
3,213 | 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:
- participants were were willing to attend an exercise class once a week for 12 weeks,
were willing to complete questionnaires at baseline and 12 weeks, allowed the
intervention staff to monitor their attendance at the YMCA for 6 months post
intervention, and allowed the exercise instructor to create an audio recording of all
of the intervention sessions.
Exclusion Criteria:
- not have any illnesses that would prevent them from exercising once a week, not be
pregnant or planning to get pregnant within the next 3 months
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| An Examination of the Efficacy of a Self-Determination Theory and Motivational Interviewing Exercise Intervention | NCT02250950 | Entailment |
2,614 | 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:
- Children 2-8 years of age
- Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or
hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont
Hospital, Royal Oak
- American Society of Anesthesiologists physical status classification 1 and 2 (patients
that have either no systemic illness, or mild systemic disease that is well
controlled, eg. mild asthma)
Exclusion Criteria:
- History of allergy to study medications
- Enrollment in concurrent research study
- Pregnant patients*
- Students/trainees/staff*
- Mentally disabled/cognitively impaired*
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 8 Years | Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery | NCT01698268 | Contradiction |
3,755 | 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:
- Female - 50 years of age or older
- Knee pain on most days of the week
- Less than 30 minutes of morning stiffness
- Bony enlargement
- Bony tenderness to palpation
- Signs of inflammation
- Able to safely climb 2 flights of stairs without aid
- Visited a family physician within the last 12 months
Exclusion Criteria:
- Any other forms of arthritis
- Osteoporosis
- History of patellofemoral symptoms
- Active non-arthritic knee disease
- Knee surgery
- Use of cane or walking aid
- Unstable heart condition
- Neurological conditions
- Skin allergy to medical tape
- Hip or ankle injuries in past 3 months
- Any injuries that would prohibit participation in yoga
- Ipsilateral hip or ankle conditions
- Currently receiving cancer treatment
- Currently pregnant
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Yoga as an Intervention for Women With Knee Osteoarthritis | NCT02146105 | Contradiction |
3,499 | 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:
- Minimum age: 50 years
- Audiometrically-confirmed hearing loss
- Availability of a communication partner to attend the program with the participant
- Be Spanish speaking and able to sign written informed consent
Exclusion Criteria:
- Cognitive impairment
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien) | NCT03255161 | Entailment |
6,751 | 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:
- You are a man or a woman between the ages of 18-60, inclusive.
- You have a body mass index (BMI) between 20 and less than 40 kg/m2. BMI is a number
calculated from your height and weight.
- You have a lipoma (a benign fatty tumor) that is 1 inch or more in diameter under the
skin of your abdomen or on another area of your body that is easily accessible to
study (such as the thigh).
- You have not gained or lost more than 11 pounds in the last 3 months.
- Your exercise routine has been stable for the last 3 months or you are sedentary.
Sedentary means you do less than 60 minutes of exercise per week.
Exclusion Criteria:
- You have a history of heart or blood vessel disease.
- Your blood pressure is above 140/90 mmHg.
- You have type 1 diabetes.
- You have a history of kidney or liver disease.
- You have thyroid disease that has not been treated.
- You are a smoker.
- You use a Beta-2 (B2) adrenergic stimulator (a type of drug used to treat asthma), a
beta adrenergic blocker (a type of drug used to treat blood pressure) or
glucocorticoid medications (a type of drug used to treat immune system disease).
- You have a problem with alcoholism or other substance abuse.
- You are pregnant or breast feeding.
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 60 Years | Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas | NCT00624416 | Entailment |
2,018 | 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 must meet all of the following inclusion criteria to be eligible for enrollment
into the study:
- Pathologically confirmed diagnosis of adenocarcinoma of stomach, GEJ or esophagus
(central confirmation is not required). Primary tumor or metastatic lesion must be
HER2+ documented as HER2 gene amplification by FISH as positive (HER2:CEP17 ratio of
≥2.0) or IHC 3+.
- Metastatic or unresectable adenocarcinoma of stomach, GEJ, or esophagus that is
evaluable or that is measurable for response as per RECIST 1.1 criteria, defined as at
least one lesion that can be accurately measured in at least one dimension (longest
diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with
spiral computed tomography (CT) scan.
- Adult subjects greater than 18 years of age
- Patients who received postoperative adjuvant therapy with a single-agent
fluoropyrimidine and radiation are eligible.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow functions defined as follows:
oAbsolute neutrophil count >1,500 cells/ul
- Platelets >100,000/ul
- Hemoglobin >9.0g/dl
- INR < or equal to 1.5 or INR < or equal to 3 if patient is on warfarin
- Serum creatinine < or equal to 1.5 times upper limit of normal (ULN) or calculated
creatinine clearance (CRCL) > or equal to 60ml/min
- Serum electrolytes within the normal range (per institution standard) during
screening.
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or equal to 3
times ULN
- Albumin > or equal to 3g/dL
- No history of another malignancy in the past 5 years, except treated non-melanoma
skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
- No coexisting medical problems of sufficient severity to limit compliance with
the study
- Ability to understand and sign a written informed consent document. Patient must
have willingness and ability to comply with scheduled visits, treatment plans,
laboratory tests and other study procedures.
- Female subjects of childbearing potential must have a negative serum pregnancy
test prior to study entry (positive urine tests are to be confirmed by serum
test).
- Female subjects of childbearing potential and males must agree to use a highly
effective method of contraception (<1% per year failure rate) for the duration of
study treatment and for six months after discontinuation of the study drug.
Highly effective birth control methods include implants, injectables, combined
oral contraceptives, some IUDs, sexual abstinence, or vasectomy for males.
Exclusion Criteria:
- Prior treatment chemotherapy or HER2-directed therapy for metastatic gastric, GEJ or
esophageal adenocarcinoma chemotherapy.
- Prior peri-operative therapy with a platinum-containing regimen.
- Angina secondary to fluoropyrimidine therapy in the adjuvant setting
- Surgery, radiotherapy, or lesion ablative procedure to the only area of
measurable/evaluable disease.
- Major surgery within 4 weeks prior to the first dose of KD019
- Left ventricular ejection fraction (EF) <50% at baseline as measured by multi-gated
acquisition (MUGA) scan or echocardiogram (ECHO).
- Treatment with chronic immunosuppressants (e.g. cyclosporine following
transplantation)
- Current known active infection with HIV, hepatitis B or C viruses
- Uncontrolled systemic disease
- Brain metastases that are:
- Untreated or
- Progressive or
- Have required any type of therapy (including radiation, surgery, steroids or
anticonvulsant therapy) to control symptoms from brain metastases within 60 days
prior to the first study treatment
- Leptomeningeal
- Hemorrhagic
- Subject has evidence of pre-existing idiopathic pulmonary fibrosis on CT scan at
baseline
- History of an invasive secondary primary malignancy diagnosed within the previous 3
years, except for appropriately treated stage I endometrial or cervical carcinoma,
prostate carcinoma treated surgically or non-melanoma skin cancer.
- No other non-protocol antineoplastic agents will be permitted during this study
- Patients may not be receiving any other investigational agents.
- Women who are pregnant or lactating.
- Subject has any of the following EKG criteria:
- Corrected QT interval (QTc) of >0.47 seconds
- Finding of a left bundle branch block or right bundle bunch block
- Bradycardia defined as a heart rate of <50 beats per minute (bpm)
- Presence of a pacemaker or implantable cardioverter defibrillator (ICD)
- History of sustained ventricular arrhythmias (subjects with a history of atrial
arrhythmias should be discussed with the sponsor before entry into the study)
- Family history of congenital long QT syndrome or unexplained sudden death.
- Moderate or severe pulmonary dysfunction
- History of clinically significant cardiac dysfunction including:
- Unstable angina
- History of myocardial infarction (MI) within 6 months prior to first study
treatment
- History of symptomatic CHF (grade >3 by NCI CTCAE or Class >II by New York Heart
Association (NYHA) criteria or serious cardiac arrhythmia requiring treatment,
with the exception of atrial fibrillation and paroxysmal supraventricular
tachycardia
- Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 and/or
diastolic blood pressure (DBP) ≥ 100 despite maximal medical therapy.
- Subject requires treatment with drugs known to be associated with torsades de pointes
or significant QT interval prolongation.
- Patients will be eligible for the study if they discontinue any medications
listed in one week prior to registration and study enrollment.
- Stable regimen of antidepressants of the SSRI class is allowed (common SSRIs
include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline and
fluoxetine)
- Use of cytochrome P450 enzyme-inducing anti-epileptic drugs (such as phenytoin,
carbamazepine or phenobarbital) is not allowed.
- Subject has a serum potassium or magnesium level outside the normal range despite
repletion.
- Has gastrointestinal tract disease resulting in an inability to take or absorb oral
medication.
- Inclusion or exclusion of patients on other medications, or severe acute/chronic
medical or psychiatric conditions or laboratory abnormality that may increase the risk
associated with study participation or study drug administration, or may interfere
with the interpretation of study results will be at the judgment of the study
investigator.
- Subject is unable or unwilling to abide by the study protocol or cooperate fully with
the investigator or designee.
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.
| KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer | NCT02205463 | Entailment |
5,202 | 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:
- Patients with T score of bone mineral densitometry lower than -2.5.
Exclusion Criteria:
- Neurological or vestibule dysfunctions which may affect balance
- Severe mental disturbances effecting communication
- Locomotor dysfunction which prevents patient to perform balance tests
- Active musculoskeletal pathology which disrupt performing exercises.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 85 Years | The Effect of Yoga Asana 'Vrksasana (Tree Pose)' on Balance in the Patients With Osteoporosis | NCT03882853 | Entailment |
1,579 | 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:
- Patients aged 16 to 25 years old
- Patients followed at Necker-Enfants Malades hospital
- Patients who have taken or taking macro-progestins treatment by oral route (Luteran,
Lutenyl, Surgestone) for at least 6 months between the age of 16 and 25 years
Exclusion Criteria:
- Patients with a pathology or treatment that can alter bone mineral density
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 25 Years | Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment | NCT04007614 | Contradiction |
6,371 | 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:
- Patients ≥ 16 years old with no upper age limit
- Patients able to read and understand English
- Patients able to give informed consent
- Patients being triaged through ED for any complaint, not necessarily COVID-19 QEUH ED
staff
Exclusion Criteria:
- Patients not meeting the inclusion criteria
- Patients who do not have capacity to consent
- Patients attending ED who are fast-tracked without triage
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| Thales Thermography Triage (3T) - Pilot Project | NCT04792450 | Entailment |
3,967 | 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:
- History of mild to moderate OA
- OA grade II
Exclusion Criteria:
- Intraarticular injections in the affected knee
- Oral application of glucosamine and chondroitin sulphate during the last 6 months
prior to the beginning of the study
- Clinically significant knee joint effusion
- Neoplasm
- Diabetes mellitus
- Osteonecrosis
- Rheumatoid arthritis or any other inflammatory arthritis diagnosed by American College
of Rheumatology criteria.
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 95 Years | Intra-articular Hyaluronic Acid in Mild to Moderate Knee Osteoarthritis | NCT01239810 | Entailment |
1,061 | 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:
- Evidence of Bifascicular block
- At least one episode of syncope during last 6 months from the enrollment
Exclusion Criteria:
- Patients with Brady-tachy syndrome that needs of pacemaker to prevent the symptomatic
bradycardia o symptomatic tachycardia arrhythmia
- Patients with vasovagal syndrome by positive TTT or carotid sinus syndrome
- Patients with Chronic Atrial Fibrillation
- Patients with Atrial Ventricular Block induces at EPS
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.
| Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block | NCT01463358 | Contradiction |
622 | 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:
- Women who are pregnant
Exclusion Criteria:
- Males
- Women who are not pregnant
- Women under 18 years of age or older than 70 years of age
- Women who are unable to provide consent for themselves, and for whom a parent, legal
guardian, or legally authorized representative does not provide consent
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | PregSource: Crowdsourcing to Understand Pregnancy | NCT02577536 | Entailment |
2,871 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- ALS patients
- 18 years old or more
- IC and nutritional assessment within 1.5 months
- delay between diagnosis and IC < 12 months
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Hypermetabolism in ALS Using Six REE Formulas | NCT03382392 | Entailment |
2,877 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- All ALS patients, over 18 years of age and with a clear diagnosis and symptomatology
of ALS since at least 6 months.
Exclusion Criteria:
- Women under 50 years of age and childbearing age.
- Tracheotomy patients.
- Patients with invasive or non-invasive ventilation with positive ventilatory pressure
- Gastrectomized patients.
- Patients with evidence of dementia.
- Patients with alcohol or drug abuse dependency.
- Patients infected with B or C hepatitis, or HIV positive
- Renal patients with creatinine levels twice as high as normal markers.
- Liver patients with liver markers (ALT, AST) elevated 3 times above normal levels.
- Patients included in other research with drugs or therapies in the experimental phase.
- Patients treated with anticoagulants or with haemostatic problems
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 | Impact of the Combined Treatment of Liposomed Polyphenols With Dutasteride on the ALS Patients | NCT04654689 | Entailment |
5,398 | 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:
1. Adult females 13-45 years of age.
2. Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, past
bleeding)
3. Menorrhagia defined as PBAC >100 in at least one of the last two menstrual cycles.
4. Regular menses, at least every 21-35 days.
5. Willingness to have blood drawn
6. No prior history of an allergic reaction or anaphylaxis to rVWF or TA.
7. Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents (NSAIDS)
during the study.
8. Willingness to comply with randomization to rVWF or TA study arms.
9. Willingness to keep a personal diary of menorrhagia bleeding frequency duration and
severity by pictorial blood assessment chart, and any drugs or hemostatic agents
taken.
10. Willingness to make 4 visits and undergo blood sampling for coagulation studies, and
accept randomization of two therapies for each of four consecutive menstrual cycles,
including an end-of-study visit.
11. Willingness to use "double-barrier" method of contraception during the study.
Exclusion Criteria:
1. Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
2. Pregnant or lactating, or use of hormones (other than progesterone-only), or combined
oral contraceptives, and contraceptive implants in past 3 months.
3. Platelet count < 100,000/ul.
4. Use of immunomodulatory or experimental drugs.
5. Surgery within the past 8 weeks.
6. Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
7. Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
containing VWF within 5 days of study.
8. Inability to comply with study requirements.
9. Hypothyroidism as defined by elevated TSH.
10. Iron deficiency as defined by low serum ferritin, unless iron replacement has been
initiated.
11. History of renal disease
Female
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 45 Years | Minimize Menorrhagia in Women With Von Willebrand Disease | NCT02606045 | Entailment |
2,025 | 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:
- single lesion of adenocarcinoma in preoperative endoscopic biopsy
- clinical stage T1N0 in the preoperative evaluation of endoscopy and computed
tomography
- tumor size: less than 3cm
- location: 3cm far from the pylorus or cardia
- aged 20 to 80
- ECOG 0 or 1
- patient who signed the agreement
- patient who is suspected to underwent laparoscopy assisted gastrectomy
Exclusion Criteria:
- absolute indication of endoscopic submucosal resection
- inoperable due to poor cardiac, pulmonary function
- pregnant
- having allergic reaction, previous upper abdominal surgery except laparoscopic
cholecystectomy, previous radiation therapy to upper abdomen
- diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and
thyroid cancer
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 | Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2) | NCT03837301 | Entailment |
3,187 | 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:
- Patients with suspected pSS underwent a standardised evaluation
Exclusion Criteria:
- Opposition of patient
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.
| Diagnostic Suspicion of Primitive Syndrome Sjögren's : Brest Cohort | NCT03681964 | Entailment |
6,134 | 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:
- Able to read and understand informed consent.
- High initial clinical suspicion by physician based on signs and symptoms (fever,
cough, myalgias, fatigue, shortness of breath) followed by RT-PCR for confirmation of
COVID-19 diagnosis
- Any gender
- Age 60 years and older
- Age 30-59 years with one or more of the following:
- abnormal lung exam
- abnormal oxygen staturation <95%
- abnormal chest x-ray or chest CT
- persistent fever >100.4 degrees Fahrenheit upon arrival to Emergency department
(ED)
- one of the following co-morbidities: hypertension, diabetes mellitus, history of
coronary artery disease, chronic kidney disease (CKD), asthma, chronic
obstructive pulmonary disease, current or former smoker, or morbid obesity (Body
Mass Index ≥35)
Exclusion Criteria:
- Pregnant or breastfeeding female
- Severe COVID-19 requiring admission for inpatient treatment
- Need for any oxygen supplementation
- Need for mechanical ventilatory support
- History of oxygen supplementation dependency
- History of cancer with ongoing chemotherapy or radiation therapy
- Concurrent antimicrobial therapy
- Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
- Already taking hydroxychloroquine or chloroquine within 1 month
- Known G6-PD deficiency
- History of retinopathy
- History of current cardiac diseases (heart failure, ventricular arrhythmias, Left
bundle branch block and/or Right bundle branch block, QTc prolongation >480ms), or
family history of sudden cardiac death
- Ongoing use of drugs that prolong the QTc interval (antipsychotics, antidepressants,
class I and III antiarrhythmics, triptans)
- Severe renal disease: glomerular filtration rate (GFR) <30ml/min
- Severe hepatic impairment (elevated total bilirubin >2 mg/dL, decreased albumin <2.8
g/dL, signs of jaundice and ascites.)
- Active alcohol abuse (>5 drinks per day or >20 drinks per week.)
- Seizure disorder, currently on medications
- Known hypersensitivity to any tetracyclines.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting | NCT04370782 | Contradiction |
1,685 | 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 e-cigarette non-users
- Adult (18 years old and above)
- Non-e-cigarette user (never user or more than 6 months former e-cigarette user)
- Non-smoker or user of any kind of tobacco/nicotine product (never or ex-smoker for >6
months)
- Not being regularly exposed to cigarettes or e-cigarettes at home or other settings
For the e-cigarette user
- Adult (18 years old and above)
- Daily user of e-cigarettes (at least 2 months)
- Non-user of any other tobacco/nicotine products for at least 2 months
Exclusion Criteria:
For all participants:
- Pregnancy or breastfeeding
- Ongoing or recent illness (<4 weeks prior to the study)
- Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart
disease, arrhythmia, hypertension or other)
- Any type of medication (<2 weeks prior to the study)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
| Bystanders' Exposure to Electronic Cigarette Aerosol in Confined Settings | NCT04140617 | Entailment |
35 | 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:
- Age greater than or equal to 50 years but not older than 80 years of age;
- Serum testosterone level <13.8 nmol/l;
- Sperm concentration > 40 Million/ml;
- Willing to give written informed consent.
Exclusion Criteria:
- Testicular diseases or having had any surgical procedures applied to the testes;
- History or currently existing serious disease of any type, in particular liver, kidney
or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
- Current androgen, anabolic steroid or sex hormone treatment or any treatment with such
compounds in the previous 6 months;
- Blood donation within the 12-week period before the initial study dose.
- History of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis,
atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal
septum deviation, recurrent epistaxis) or sleep apnea;
- Elevated serum PSA levels (> 4 ng/ml for subjects >= 50 years of age);
Male
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 80 Years | Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application | NCT00705796 | Contradiction |
5,672 | 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: (Overweight Subjects)
Volunteers will qualify if they meet the following criteria:
1. Good general health. Individuals taking medication for obesity-related co-morbid
conditions will not be excluded.
2. Age greater than or equal to 18 years.
3. Body Mass Index greater than or equal to 25 kg/m(2).
4. For women with childbearing potential, a negative pregnancy test at the initial
evaluation.
5. Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorous levels (2.3 - 4.3
mg/dl).
INCLUSION CRITERIA: (Normal Weight Subjects)
Volunteers will qualify if the meet the following criteria
1. Good general health.
2. Age greater than or equal to 18 years.
3. Body Mass Index 1-24.99 kg/m(2)
4. For women with childbearing potential, a negative pregnancy test at the initial
evaluation. Since these subjects have to undergo DXA (dual Energy X-ray
Absorptiometry) scan screening in their second visit, for safety purposes, pregnant
women will be excluded from participation in the study.
5. Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorus levels (2.3-4.3
mg/dl).
EXCLUSION CRITERIA: (overweight subjects)
Volunteers will be excluded (and referred to non-experimental treatment programs as
needed) for the following reasons:
1. A presence of major illnesses: renal, hepatic (other than obesity-related
steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper-
or hypothyroidism), hematological problems or pulmonary disorders (other than
asthma not requiring continuous medication or sleep-apnea related disorders);
2. Women who are pregnant, or who are currently nursing an infant; or who are having
unprotected intercourse;
3. Individuals who have a current substance abuse or a psychiatric disorder or other
condition that in the opinion of the investigators would impede competence or
compliance or possibly hinder completion of the study;
4. Subjects who regularly use prescription medications unrelated to the
complications of obesity {e.g., calcium channel blockers, diuretics (including
thiazide diuretics), beta-blockers etc}. Oral contraceptive use will be
permitted, provided the contraceptive has been used for at least two months
before starting study medication. The use of over-the-counter medications will be
reviewed on a case-by -case basis;
5. Subjects who have a total calcium intake of more than 3.5 g/day on the screening
calcium intake questionnaire (SCQ) or more than 3 g/day of total calcium intake
on review of their 7-day food diaries;
6. Subjects who take supplement calcium in excess of 300 mg/day or vitamin D
supplements in excess of 400 IU/day;
7. Recent (3 months) use of anorexiant medications;
8. History of renal stones;
9. Intentional weight change of more than 3% of body weight in the past two months.
10. Post-menopausal women who are medically advised to take calcium supplementation.
11. Subjects with iPTH greater than 75 pg/ml (Normal range: 10-75 pg/ml) when
associated with a serum calcium level greater than 2.5 mmol/L. (normal range 2.05
to 2.55 mmol/L)
12. Subjects with a serum 25-(OH)-D level less than 10 ng/ml (Normal range: 10-68
ng/ml) when associated with a serum 1-225-(OH)(2)-D level of less than 22 pg/ml
(Normal Range: 22-67 pg/ml.
13. Subjects with a consistently (2 weeks apart) elevated systolic blood pressure of
greater than 160 mm Hg and/or a diastolic blood pressure greater than 95 mm Hg.
EXCLUSION CRITERIA: (Normal Weight Subjects)
Volunteers will be excluded (and referred to non-experimental treatment programs as
needed) for the following reasons:
1. Presence of major illnesses: renal (serum creatinine greater than 1.6), hepatic
(AST/ALT greater than 3 times upper limit of normal range used in Clinical Center
assays), gastrointestinal, most endocrinologic (e.g. Cushing syndrome, hyper- or
hyothyroidism), hematological problems or pulmonary disorders (other than asthma
not requiring continuous medication or sleep-apnea related disorders);
2. Women who are pregnant, or who are currently nursing an infant;
3. Individuals who have current substance abuse of a psychiatric disorder or other
condition that in the opinion of the investigators would impede competence or
compliance or possibly hinder completion of the study;
4. Subjects who regularly use prescription medications. Oral contraceptive use will
be permitted, provided the contraceptive has been used for at least two months
before starting study medication. Individuals taking medications for most
conditions will be excluded, but medication use will be considered on a
case-by-case basis.
5. Subjects who take supplemental calcium in excess of 300 mg/day or vitamin D
supplements in excess of 400 IU/day.
6. Recent (3 months) use of anorexiant medications;
7. Intentional weight change of more than 3% of body weight
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.
| Supplemental Calcium in Overweight People | NCT00030238 | Contradiction |
2,722 | 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:
- Patients with painless uncomplicated primary bilateral inguinal hernias
Exclusion Criteria:
- Immune compromised patients
- Coagulopathy
- Chronic liver or renal disease
- High-risk patients unfit for major surgery (ASA III or IV),
- Massive scrotal hernias, Recurrent or Complicated hernias
- Groin pain due to any other pathology
- Previous infra-umbilical surgery
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 | Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia | NCT04437784 | Entailment |
671 | 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:
- Men, at least 18 years old
- hereditary hemochromatosis C282Y homozygous diagnosed and followed in the service of
Liver Diseases, University Hospital of Rennes
- Maintenance therapy with phlebotomy for at least 1 year with stable iron stock on the
basis of at least four previous plasma ferritin < 50μg / L,
- Written, free and informed consent
Exclusion Criteria:
- Intercurrent illness unrelated to hemochromatosis causing cytolysis or inflammatory
reaction.
- Person with a measure of legal protection (guardianship)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| HEPFER-Evaluation of a New Phenotypic Biological Marker in Genetic Type 1 Hemochromatosis | NCT01784939 | Contradiction |
5,867 | 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 ≥ 18 years, < 85 years, life expectancy > 3yrs.
- Documented history of GERD symptoms such as heartburn and/or regurgitation.
- On daily PPI treatment for at least 3-months.
- Responsive to PPI treatment.
- GERD symptoms, in absence of PPI therapy (minimum 10 days).
- Ambulatory Esophageal pH < 4 for ≥ 5% time or pH < 4 for ≥ 3% time in supine position.
- Patient is a surgical candidate.
- Patient is willing and able to cooperate with follow-up examinations.
- Patient has been informed of the study procedures and the treatment and has signed an
informed consent form and provided authorization to use and disclose information for
research purposes (HIPAA).
Exclusion Criteria:
- The procedure is an emergency procedure.
- Patient is currently being treated with another investigational drug or
investigational device.
- Patient has had prior gastric or esophageal surgery.
- Patient has had any previous endoscopic intervention for GERD
- Patient has suspected or confirmed esophageal or gastric cancer.
- Patient has any size paraesophageal hiatal hernia or sliding hiatal hernia ≥3cm.
(Investigator to identify and record type of hiatal hernia at the time of assessment
(i.e. para-esophageal, sliding)).
- Patient's esophageal motility is less than 35 mmHg peristaltic amplitude on wet
swallows or > 30% failed (non-propulsive) peristaltic sequences.
- Patient has esophagitis - Grade B, C, D (LA Classification).
- Patient has Barretts Esophagus.
- Patient has BMI > 35.
- Patient has symptoms of dysphagia or indications of dysphagia from barium esophagram.
- Patient has Scleroderma and/or Achalasia.
- Patient has an esophageal stricture or gross esophageal anatomic abnormalities
(obstructive lesions, etc.).
- Patient has an electrical implant or metallic, abdominal implant(s).
- Patient cannot understand trial requirements or is unable to comply with follow-up
schedule.
- Patient is pregnant or nursing, or plans to become pregnant.
- Patient has a psychiatric disorder.
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 | An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter | NCT01058070 | Contradiction |
5,323 | 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 with no desire to preserve their fertility who have heavy menstrual bleeding
without organic pathology (DUB) of more than six months duration
- Premenopausal follicular follicle stimulating hormone (FSH) level of less than 40
IU/L.
- Associated functional disability (negative impact on life quality).
- Lack of response to medical treatment.
- Prepared to undergo surgical treatment without general anaesthesia
Exclusion Criteria:
- Women under 25 years
- Suspected genital tract infection
- Uterine pathology including endometrial pathology on endometrial biopsy (e.g.
endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine
malformations, adhesions, polyps, submucous fibroids or extracavity fibroids > 3cm in
diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
- Uterine cavity length >11cm
- Adnexal pathology
- Previous open myomectomy or endometrial ablation / resection and classical caesarian
section
- patients considered vulnerable (e.g. current mental illness, emotionally labile,
learning difficulties, immaturity)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
| A Study to Compare the Effectiveness of Two Different Outpatient Endometrial Ablation Techniques Used for Heavy Periods | NCT01124357 | Contradiction |
3,668 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Back pain for less than 3 months
- Positive unilateral Straight Leg Raise test which includes reports of back and leg
pain or paraesthesia below 45-degree hip flexion
- At least one additional neurological sign should be present including- (a) Diminished
Achillis/Hamstring tendon reflex, tested in the supine position or (b) Hyposthesia in
any of the L4-S2 dermatome, or (c) Muscle weakness in any of the L4-S2 myotome.
- MRI evidence of L-4-L5 or L5-S1 disc prolapse or both.
Exclusion Criteria:
- Malignancy, Tuberculosis, Osteoporosis, Osteomyelitis of the vertebral column
- Cord compression, Pregnancy, Hypertension, Cardiovascular disease, Joint hyper
mobility
- Subjects who could not tolerate the traction force secondary to being in an acute
stage of back pain.
- Subjects who have taken previous physiotherapy treatment in the last three months for
back pain.
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 | Effects of Lumbar Traction on the Straight Leg Raise Test and Pain | NCT04728685 | Contradiction |
628 | 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:
- Established diagnosis of atransferrinemia, defined as serum levels of transferrin
below 40 mg/dl
- Informed consent
Exclusion Criteria:
- Known with allergic reactions against human plasma or plasma products
- Having detectable anti-immunoglobulin A antibodies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Apotransferrin in Atransferrinemia | NCT01797055 | Contradiction |
4,965 | 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:
- Men and women, between 18 and 80 years.
- Patients who underwent the MRgFUS procedure.
- Patients who are able and willing to give consent and able to attend all study visits
and Radiologic follow-up examination by MRI.
- A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination
preformed by a movement disorders neurologist.
- ET patients: tremor severity score of greater than or equal to 2 in the treated
hand/arm as measured by postural or action item on the Clinical Rating Scale for
Tremor (CRST).
- PD patients: tremor severity score of equal or greater than 3 on either item 20 or
item 21 of motor part in the Unified PD Rating Scale (UPDRS).
- Substantial disability in the performance of at least two daily activities from the
disability subsection of the scales UPDRS for PD patients or CRST for ET patients.
- The patient must have a history of an unsatisfactory response to medical management.
All patients will need to have tried and failed at least one drug. Alternatively, a
patient may also qualify if tremor-suppressing medications are contraindicated due to
a coexisting medical condition or drug allergy.
- Stable doses of all medications for 30 days prior to study entry.
Exclusion Criteria:
- Patients which have not completed the MRgFUS procedure.
- Patients which were diagnosed during the trial with additional diagnoses that can
affect motor function, quality of life and symptoms of tremor.
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 | The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease | NCT03300193 | Entailment |
858 | 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:
- 50-75 years of age (for women, post-menopausal)
- Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees
- knee pain on most days for ≥ 6 months
- self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling,
ascending or descending stairs, or performing daily activities
- willing and able to avoid all prescription and non-prescription, non-opiate pain
medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks
prior to testing
- meets research diagnostic criteria for sleep maintenance insomnia
Exclusion Criteria:
- health conditions with immunological components or undergoing or taking
immunosuppressive therapies
- conditions contraindicated for or potentially limiting ability to conduct NFR and/or
cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory
conditions; leg/hip nerve damage; BMI ≥ 32)
- sleep disorders other than insomnia
- dementia or cognitive impairment
- history of schizophrenia or bipolar I disorder; current or recent history (within 3
months) of major psychiatric disorders
- current depressive symptomatology or current suicidality
- active substance dependence
- untreated hypertension
- use of antidepressants (stable use for 3 months okay), antipsychotics, mood
stabilizers, sedative-hypnotics, opiate analgesics
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.
Subject must be at most 75 Years | Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis | NCT01683799 | Entailment |
6,281 | 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:
- Adults (18 years and over) admitted to hospital who are COVID-19 positive (PCR positive
on a swab, through routine clinical laboratory testing)
Exclusion Criteria:
- No exclusion criteria
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.
| COVID-19 Hyperinflammation Syndrome (COV-HI): Protocol for a Rapidly Executed Cohort Study | NCT04385069 | Entailment |
5,368 | 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:
- Patients ≥13 years of age and ≤21 years of age with Mild Hemophilia A (MHA), with a
historical baseline FVIII:C level of ≥5% to ≤40% followed at either the Hospital for
Sick Children or St. Michael's Hospital (Toronto).
- Patients ≥13 years of age and ≤21 years of age with genetically confirmed Mild
Hemophilia A (MHA), with FVIII:C level of ≥5% to ≤50% followed at either the Hospital
for Sick Children or St. Michael's Hospital (Toronto).
Exclusion Criteria:
- A currently circulating or history of a previous inhibitor ( ≥0.5 BU) within the past
5 years. As inhibitor development in MHA is rare, it is not expected that any patient
will be excluded for this reason.
- Any FVIII infusion or DDAVP use in the preceding week. This is to avoid an residual
FVIII still being present in a patient who has taken an extended half-life FVIII.
- Co-existence of a congenital bleeding disorder other than MHA (e.g. VWD).
- Prior history of coronary artery disease or pulmonary disease, severe arthropathy
interfering with ability to exercise.
- Patients on beta-blockers, anti-platelet agents or regular non-steroidal
anti-inflammatory medications (e.g. Celebrex).
- Patients with an active infectious or inflammatory condition. This includes HIV,
active hepatitis B or C as reflected in elevated AST, ALT, RNA positivity for
hepatitis B or C.
- Patients who are active (defined as smoking daily) smokers (cigarettes, marijuana).
This exclusion is put into place as we do not know if daily smoking will impact on the
hemostatic response to either exercise or DDAVP.
- Patients with limited exercise tolerance for any reason.
- Patients with a history of a recent bleed (in preceding 2 weeks) in any location, or a
joint/muscle bleed in the lower limbs in the preceding 4 weeks.
- Patients who for medical reasons should not receive DDAVP [those with renal or CNS
disease (e.g. brain tumor)] or have previously experienced adverse events with DDAVP
(e.g. hypotensive event; seizure).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 21 Years | DDAVP vs. Exercise in Patients With Mild Hemophilia A | NCT03136003 | Contradiction |
2,751 | 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:
- all referred patients with inguinal hernias
Exclusion Criteria:
- workers Compensation cases
- previous extraperitoneal intervention
- unfit for a general anaesthetic
- strangulated hernias
- present of or previous ventral hernia repair extending 5 cm below umbilicus
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 86 Years | A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair | NCT01660048 | Entailment |
3,997 | 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:
- Primary OA of the knee according to ACR with synovitis criteria (warmth, swelling or
effusion);
- OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
- Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing
knee X-ray;
- VAS of pain while walking ≥40 mm.
Exclusion Criteria:
- Known allergy to chondroitin sulphate;
- Progressive or serious pathologies (cancer, AIDS,...);
- Other bone and articular diseases (antecedents and/or current signs) such as
chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout,
septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease,
osteochondromatosis;
- Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or
chondroitin sulphate during the 12 weeks preceding inclusion;
- Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion;
- Radioactive synovectomy during the 12 weeks preceding inclusion;
- If the patient is receiving NSAID at baseline (D0), it should be maintained at a
stable dosage as much as possible from D0 to D180. In the open phase of the study
(D180 to D360), NSAID will also be allowed as rescue medication along with
acetaminophen.
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.
| Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee | NCT00604539 | Entailment |
950 | 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:
- Female or Male, Age ≥ 45 years
- Chronic knee discomfort based on affirmative response to the question "During the past
12 months, have you had any pain, aching, or stiffness in or around your knee(s) on
most days for at least one month?"
- Baseline (Month 0) Pain score >2 on at least one of the WOMAC weight-bearing pain
questions; and total weight-bearing pain score <8
- Tibiofemoral or patellofemoral OA on posterior-anterior weight-bearing semi-flexed or
lateral knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or
3
- Evidence of synovitis on ultrasound at screening
- Clinical examination confirming knee pain or discomfort referable to the knee joint
- Prepared to discontinue NSAID(s)/analgesic(s) for 2 days prior to each assessment
Exclusion Criteria:
- Prior septic (study) knee joint
- Prior reconstructive surgery in the study knee
- Prior osteonecrosis (avascular necrosis of bone)
- Chronic use of oral corticosteroids; knee intra-articular corticosteroid injection
within 3 months of Month 0 (baseline) visit
- Ongoing use of doxycycline, indomethacin, glucosamine and/or chondroitin; or use of
these within 2 months of Screening visit
- Evidence of other inflammatory joint disease (e.g., gout, CPPD)
- Serious medical conditions or impairments that, in the view of the investigator, would
obstruct their participation in the trial such as uncontrolled diabetes, uncontrolled
hypertension, opiate dependency
- Plan to permanently relocate from the region, or take an extended vacation for greater
than 3 months during the trial period
- Planned arthroscopy and/or arthroplasty in the study knee.
- Any contra-indication to having an MRI
- Inability to speak or comprehend English
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Effect of Steroid Injections in a Knee With Osteoarthritis | NCT01230424 | Entailment |
4,349 | 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:
- 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 |
6,538 | 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:
- Severe hemophilia A ((FVIII:C <= 1%)
- Male subjects >= 12 years of age
- Previously treated with FVIII concentrate, at least 50 EDs
- Immunocompetent (CD4+ count > 200/ul)
- Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000
copies/mL
Exclusion Criteria:
- Other coagulation disorder than hemophilia A
- Present of past FVIII inhibitor activity (.= 0.6 BU)
- Severe liver and kidney disease
- Receiving of scheduled to receive immuno-modulating drugs
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A | NCT01125813 | Contradiction |
4,036 | 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. Ambulatory male and non-pregnant females 35 years and older diagnosed with
osteoarthritis according to the American College of Rheumatology Criteria (ACR) in one
knee. Target knee is the one with higher level of pain.
ACR Criteria includes: Knee Pain and at least 3 of the following: age ≥ 50, stiffness
lasting < 30 mins, bony tenderness, crepitus, bony enlargement, and no palpable
warmth.
2. Symptom onset of > 6 Months prior to Screening for the target knee.
3. If female and of child-bearing potential, prepare to abstain from sexual intercourse
or use a reliable method of contraception during the study (e.g., IUD, oral,
transdermal, injected, implanted hormonal contraceptives or condom + spermicide).
4. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc.) that
required the use of oral or topical treatments (e.g., NSAIDs or acetaminophen).
5. Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease
based upon the Kellgren-Lawrence disease severity scale.
6. After a minimum of 7-day wash out of all pain medication has Baseline pain on movement
score of ≥ 50mm on a 0-100-mm Visual Analogue Scale for the target knee.
7. After a minimum of 7-day wash out of all pain medication has Baseline WOMAC Pain sub
scale of ≥ 9 on a 5 question, 5 point (0 to 4) Likert scale for the target knee.
8. Willing and able to use only acetaminophen as rescue medication.
9. Willing and able to comply with the study requirements.
Exclusion Criteria:
1. Females who are pregnant, breast feeding, or planning a pregnancy.
2. Radiograph of the target knee within the previous year with a Grade 4 score on the
Kellgren-Lawrence disease severity scale.
3. History of osteoarthritis in the contralateral knee requiring medication (OTC or
prescription) within 12 months of screening.
4. After a minimum of 7-day wash out of all pain medication has Baseline pain on movement
score of ≥ 20mm on a 0-100-mm Visual Analogue Scale for the contralateral knee
immediately prior to randomization.
5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty
arthritis) of the knee or rheumatoid arthritis.
6. Known history of other chronic inflammatory diseases, (e.g., colitis) or fibromyalgia
during last 5 years. Patients whose disease was diagnosed at least 5 (five) years
prior to screening visit and have had no known disease activity (i.e., no disease
related complaints nor disease treatment prescribed) since then may enter into the
study.
7. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke,
congestive heart failure, impaired renal function or liver disease. Patients who have
had high blood pressure measured at least 2 (two) years prior to screening visit and
have had no disease activity (i.e., no record of hypertension or anti-hypertensive
treatment prescribed) for at least 2 (two) years prior to screening visit may enter
into the study.
8. History of coronary artery bypass graft within 6 months of screening.
9. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac
prophylaxis (max. 162 mg daily) taken for at least 3 months prior to enrollment and
maintained throughout the duration of the study.
10. Use of warfarin or other anticoagulant therapy within 30 days of screening.
11. Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30
days of screening or during the study.
12. Known history of gastrointestinal bleeding or peptic ulcer disease.
13. Abnormal screening clinical laboratory evaluations which the Investigator deems
clinically significant.
14. Known allergy to aspirin or NSAIDs.
15. Skin lesions or wounds in the affected area.
16. Significant (requiring surgery) injury or major knee surgery to either knee within six
months prior to screening.
17. Transaminase levels that are more than two times the upper limit of the normal range
at screening.
18. Any other acute or chronic illness that in the opinion of the investigator could
compromise the integrity of study data or place the Patient at risk by participating
in the study.
19. Concomitant use of corticosteroids (any formulation) or use within 30 days of study
randomization.
20. Receipt of any drug as part of a research study within 30 days prior to screening.
21. Previous randomization into this study.
22. Known allergy (hypersensitivity) to acetaminophen.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
| Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1% | NCT02913521 | Entailment |
4,340 | 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:
1. Subject is informed and has been given ample time and opportunity to think about
his/her participation and has given his/her written informed consent
2. Subject is ≥18 years of age
3. Subject's health status: individual is considered to be healthy (hypertension and
hypotension is permissible. Other stable diseases at the time of testing are also
permissible)
4. Subject is capable of undergoing controlled hypoxaemia to the levels called for the in
the protocol with minimal medical risk (unless only participating in the blood
pressure study).
Exclusion Criteria:
1. Subject cannot expose their face fully for a reading to be taken
2. Subject is unable to give informed consent
3. Subject is outside of the specified age range
4. Subject has already taken part in the study (all 4 sub studies)
5. Subject with significant irregular heart rhythm or any disease that might affect the
results of the study
6. Subject is not capable of undergoing controlled hypoxia and would be placed at undue
medical risk if this occurred
7. Subject has any contraindications identified that would deem them unsuitable to take
part
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application | NCT03998098 | Entailment |
1,966 | 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 with gastric lesions which were detected by conventional screening endoscopy
and suspected of early malignancy.
Exclusion Criteria:
- advanced gastric cancer or any other malignancy;
- patients under unsuitable conditions for examination or treatment, such as acute upper
gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
- inability to provide informed consent;
- inability to provide histology of resected specimens after endoscopic treatment or
surgery.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions | NCT01508520 | Entailment |
3,973 | 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. Female
2. Age 40-70 years
3. Knee symptoms (pain, aching, or stiffness) on most of the last 30 days (categorically
defined)
4. Body Mass Index (BMI) 30-45kg/m2
Exclusion Criteria:
1. Resistance training at any time in the last 3 months prior to the study
2. Bilateral knee replacement
3. Lower limb amputation
4. Lower limb surgery in the last 6 months that affects walking ability or ability to
exercise
5. Back or hip problems that affect walking ability or ability to exercise
6. Unable to walk without a cane or walker
7. Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or
polymyalgia rheumatica
8. Multiple sclerosis or other neurodegenerative disorder
9. Known neuropathy
10. Currently being treated with insulin for diabetes
11. Currently being treated for cancer or having untreated cancer
12. Terminal illness (cannot be cured or adequately treated and there is a reasonable
expectation of death in the near future)
13. Peripheral Vascular Disease
14. History of myocardial infarction or stroke in the last year
15. Chest pain during exercise or at rest
16. Use of supplemental oxygen
17. Inability to follow protocol (e.g. lack of ability to attend visits or understand
instructions)
18. Staff concern for participant health (such as history of dizziness/faintness or
current restrictions on activity)
19. Unable to attend more than 2 days within any 1 week or unable to attend 4 or more
sessions during the study
20. Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or
other implanted electrical device.
21. Dermatitis or skin sensitivity to tape used in the study.
22. Pregnancy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 39 Years old.
Subject must be at most 70 Years | Combined Application of Electrical Stimulated Antagonist Contraction During Walking (Walking Study) | NCT02730598 | Entailment |
4,260 | 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:
- Infertile males , Azoospermia undergoing TESE as a preliminary step for ICSI .
- Age: 20-50 year
Exclusion Criteria:
- males <20 years and >50years
- Cryptorchidism .
- Testicular Agenesis and testicular atrophy .
Male
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Seminal Level of Clusterin Before Testicular Sperm Extraction | NCT03857828 | Entailment |
1,338 | 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:
- Men and women 18 years or older
- Biological or adoptive parent
- At least one child of participants has a medical problem or problems that have
remained undiagnosed for > 2 years
- The child with an undiagnosed medical problem must reside with the parent
- Read and write in English
EXCLUSION CRITERIA:
-One parent/household may participate
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 | The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition | NCT00955370 | Contradiction |
1,554 | 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:
1. Signed written Institution approved Informed Consent Form (ICF)
2. Male and Females over the age of 18 years
3. Patients in intensive care or cardiology units who are under continuous oversight of
existing Invasive (A-Line) Gold Standard monitors.
4. Only subjects who are fitted with an invasive Arterial Line (A LINE)
5. To the extent possible, individuals who have not been using medication 5 (five) hours
prior to the test shall be classified as non-medicated subjects.
Exclusion Criteria:
1. Subject who are unable to provide consent
2. Where it would be impractical or inconvenient or otherwise unfeasible to place to
place a wristband and generate a signal.
3. Subjects who are not fitted with, or not planned to be fitted with an A-Line during
their stay in the hospital.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| 'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals | NCT03409861 | Contradiction |
2,881 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- All subjects must be at least 18 years old and able to provide informed consent
- All subjects have no health conditions that limit their ability to safely exert
maximal force using the muscles in their arms and legs.
- Subjects with a diagnosis of laboratory supported probable, probable or definite ALS
according to the World Federation of Neurology El Escorial, as determined by their
referring neurologist at MGH.
- All subjects must be able to speak and understand English.
Exclusion Criteria:
- Presence of significant arthritis, orthopedic conditions, or cardio-pulmonary
conditions or other medical conditions that may limit the ability to maximally exert
force safely.
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.
| Validation of a New Device to Measure Neuromuscular Disease Progression | NCT00606918 | Entailment |
5,251 | 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 woman, less than 85 years old.
- BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture
(within 5 years).
- Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
- Laboratory tests within the normal range, including serum calcium, Vitamin D,
parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.
Exclusion Criteria:
- BMD T-score ≤-5.0 at the lumbar spine or hip.
- History of bone disorders (for example, Paget's disease) other than postmenopausal
osteoporosis.
- Significantly impaired renal function.
- History of any cancer.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 85 Years | Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis | NCT01674621 | Entailment |
857 | 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 40 ~ 75 years of age
- VAS (Visual Analogue Scale) over 30mm
- Kellgren & Lawrence Grade I~II by X-ray
- Subject who agrees to participate in this clinical trial by themselves and signs the
Informed Consent Form (ICF)
Exclusion Criteria:
- Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia,
systemic lupus erythematosus, septic arthritis, gout)
- Joint space under 2 mm by X-ray
- Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular
surfaces, or subchondral bone cyst by X-ray
- Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases,
tumor diseases
- Subjects having gastrointestinal diseases
- Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
- Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)
- Patients with TSH <= 0.1 uIU/mL or >= 10 uIU/mL
- Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of
the normal values)
- Subjects have attended abnormal values at creatinine (2 times excess at upper limit of
the normal values)
- Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
- Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to
screening
- Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
- History of osteoarthritis treatment therapy within 2 weeks prior to screening
- Have participated in another clinical trial within the 3 months prior to screening
- Subjects who have hypersensitivity history about investigational product
- Have difficulty to be participated in this clinical trial by investigator's decision
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Efficacy and Safety of Tabetri on Osteoarthritis | NCT03757611 | Entailment |
6,427 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Main Inclusion Criteria:
1. Male or female subjects age 18 years or older;
2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and
pustules) of rosacea on the face;
3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored
3 or 4 according to Clinician's Erythema Assessment [CEA]);
4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to
the Investigator's Global Assessment [IGA]);
5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
6. Female subjects of childbearing potential must practice a highly effective method of
contraception during the study;
7. Females subjects of non-childbearing potential;
Main Exclusion Criteria:
1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that
may be confounded with rosacea;
2. Subjects with more than 2 nodules of rosacea on the face;
3. Subjects with any uncontrolled chronic or serious disease or medical condition that
may either interfere with the interpretation of the clinical trial results, or with
optimal participation in the study or would present a significant risk to the subject;
4. Subjects with known or suspected allergies or sensitivities to any component of the
investigational and non-investigational products, including the active ingredients
brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
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.
| MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. | NCT02616250 | Entailment |
1,651 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study v1.0 | NCT02524470 | Entailment |
271 | 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:
- good general health
- older than the age of legal consent (i.e. >18 years old)
- requesting medical abortion and eligible for abortion
- on Day 1 of the study (day of letrozole and mifepristone administration) the duration
of pregnancy not more than 63 days as confirmed by pelvic ultrasound examination
- intrauterine pregnancy (intrauterine amniotic sac seen in US)
- willing to use other than hormonal or intra-uterine contraception until the first
menses after termination of pregnancy
- if treatment should fail agrees to termination of pregnancy with the surgical method
- willing and able to participate after the study has been explained
- haemoglobin higher than 10g/L, normal liver and renal function
Exclusion Criteria:
- a history or evidence of adrenal pathology, steroid-dependent cancer, porphyria,
diastolic pressure over 95mm Hg, bronchial asthma, arterial hypotension
- a history or evidence of thrombo-embolism, severe or recurrent liver disease or
pruritus of pregnancy
- the regular use of prescription drugs before admission to the study
- the presence of an IUCD in utero
- breast-feeding
- multiple pregnancies
- heavy smoker of more than 20 cigarettes per day
- any abnormal values in pre-treatment blood tests
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy | NCT01475318 | Contradiction |
3,873 | 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:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory
drugs (NSAIDs)
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 34 Years old.
Subject must be at most 74 Years | A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee | NCT02183116 | Entailment |
3,695 | 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:
- Diagnosis of osteoarthritis of the knee (fulfilling ACR criteria) for at least 6
months duration
- At least moderate pain in the knee for most days in the last month
- Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
- Documented radiographic changes of osteoarthritis (Kellgren-Lawrence grade>2) at the
time of rheumatological screening
- Signed informed consent
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.
| Acupuncture Safety/Efficacy in Knee Osteoarthritis | NCT00010946 | Contradiction |
6,261 | 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:
- Signed informed consent form by any patient capable of giving consent, or, when the
patient is not capable of giving consent, by his or her legal/authorized
representatives prior to initiation of any study procedures.
- Men and women, ≥18 years of age at time of enrollment.
- Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or other
health authority-approved commercial assay or other validated public health assay in
any specimen within 72 hours prior to randomization (point-of-care viral infection
test allowable if RT-PCR test result not available at the time of screening).
- Less than or equal to 12 days from COVID-19 symptom onset to starting treatment.
- Symptoms are defined as one or more of the following: cough, fever, shortness of
breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches,
weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny
nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as
determined by the Investigator.
- Hospitalized for no more than 4 days duration, and:
- requiring supplemental oxygen by mask or tongs, or ii) non-invasive ventilation
or iii) high-flow oxygen (WHO category 4 or 5)
- Female patients participating in this study must agree to avoid becoming pregnant and
have a negative pregnancy test prior to randomization. Male patients must agree to use
appropriate contraceptive methods to prevent pregnancy with their partner(s), during
the study and up to post 30 days after the last dose of study drug. Female patients
must be:
- unable to have children (e.g., post-menopausal*, bilateral tubal ligation,
hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g.,
vasectomy) OR
- willing to remain abstinent (not engage in sexual intercourse for the duration of
the screening period and throughout the study, and for 30 days after the last
dose) OR
- willing to use two effective barrier methods of birth control (partner using
condom and female using IUD, hormonal or nonhormonal contraceptive, diaphragm
plus spermicide, or contraceptive sponge)
Exclusion Criteria:
- 1. Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or any
excipient(s) of Novaferon, including pre-existing allergy or hypersensitivity to
ampicillin.
- Currently undergoing invasive mechanical ventilation (including venous ECMO).
- Inability to use a nebulizer with a mouthpiece.
- ALT/AST > 5 times the upper limit of normal or a history of decompensated cirrhosis.
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/
1.73m2).
- In the opinion of the Investigator, progression to death is imminent and inevitable
within the next 48 - 72 hours, irrespective of the provision of treatment.
- In the opinion of the Investigator, progression to mechanical ventilation is imminent
and inevitable within the next 24 hours, irrespective of the provision of treatment.
- Possibility of the patient being discharged from hospital within 24 hours.
- Participation in other anti-COVID-19 therapeutic or interventional trials. Patients
may, at the discretion of the Investigator, participate in other non-interventional
COVID-19 studies.
- Current use of other antiviral therapy (e.g. remdesivir, etc.) or other experimental
therapy, including anti-inflammatory agents, convalescent plasma, or
hydroxychloroquine
- Has received, or has a plan to receive within the 28 day treatment period, a
SARS-CoV-2 vaccine.
- Use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of
chronic oral corticosteroids for a non-COVID-19-related condition at a dose higher
than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks.
- Other known active infections or other clinical conditions (e.g. chronic obstructive
pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is
allowed.
- Patients with current or prior psychiatric illness, seizure disorders, retinal
autoimmune disorders, pre-existing severe cardiovascular disease and patients with
prior transplants.
- Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- Positive for hepatitis B, hepatitis C or uncontrolled HIV
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 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 | NCT04669015 | Contradiction |
2,447 | 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:
- Diagnosis of Sarcoidosis
- Access to a computer with Internet
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.
| Worldwide Sarcoidosis Research Study | NCT01610843 | Entailment |
3,283 | 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:
- Females
- 16-45 years of age
- Seeking contraceptive counseling and services at four participating Planned Parenthood
clinics in Salt Lake County
- Desire to prevent pregnancy for at least one year
- Fluent in English or Spanish
- Their current preferred phone number must be functioning at the time of study entry
and will be tested prior to enrollment
Exclusion Criteria:
- Currently pregnant and planning to continue the pregnancy, or trying to get pregnant
- Relying on female or male sterilization as contraceptive method
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 45 Years | HER Salt Lake Initiative | NCT02734199 | Entailment |
1,214 | 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:
- Every patient referred to the endoscopy unit for medical thoracoscopy
Exclusion Criteria:
- Pregnancy
- Known allergy to the fluorescein
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.
| Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis | NCT04731129 | Entailment |
1,352 | 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:
- Achondroplasia, first lengthening period
Exclusion Criteria:
- Previous lengthening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients | NCT01328418 | Entailment |
3,145 | 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:
1. Subjects must have dry mouth symptoms (xerostomia) or a reasonable clinical
suspicion of having Sj(SqrRoot)(Delta)gren s syndrome or other salivary gland
disease
2. Ability to provide informed consent.
EXCLUSION CRITERIA:
a. Age less than 12 years.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Evaluation of Salivary Gland Dysfunction | NCT00001196 | Contradiction |
5,373 | 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:
- BMI of 20-29.9 kg/m2,
- regular menstrual cycle
- length 28-30 day
- cycle bleed from 3 to 7 days,
Exclusion Criteria:
- contraindication to stretching exercise
- taking any hormonal medications:
- smoker
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 23 Years | Stretching Exercises on Symptoms of Primary Dysmenorrhea | NCT04475874 | Entailment |
6,942 | 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:
- Age: 20+ years
- Have a score of 7≤ MoCA ≤ 25
- Being diagnosed with either mild cognitive impairment (MCI) or mild/moderate stage of
Alzheimer's.
- Except the MCI/Alzheimer's diagnosis, have no known or diagnosis of major depression,
bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, Huntington
disease, ALS, MS, and/or any other neurological disorder.
- Reading/writing fluency in English
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 95 Years | Brain Fitness APP for Cognitive Enhancement | NCT03587012 | Entailment |
3,004 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- For hub-user group (experimental group): 12 - 24 year- old hub users who receive
community-based mental wellness youth hub services for young people.
- For non-hub user group (active control group): 12 -24 year- old youths who do not
receive the community-based mental wellness youth hub services but other generic youth
services in the community.
- For non-hub user group (passive control group): 12 -24 year- old community youth who
do not receive any youth services in the community.
Exclusion Criteria:
- Youths with known diagnosis of psychiatric disorders (including Depression,
Generalized Anxiety Disorder, Panic Disorder, Phobia, Obsessive Compulsive Disorder,
Bipolar Disorder, Eating Disorder, Personality Disorder, Post-Traumatic Stress
Disorder and Psychotic Disorder)
- Youths who receive psychiatric medication (including antidepressants, antipsychotics
and antiepileptic drugs)
- Youths who have limited comprehension due to epilepsy or mental retardation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 24 Years | The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub | NCT04840303 | Contradiction |
4,341 | 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 for clinics: Clinics must be a clinic that offers Primary Care (Family
Medicine Clinics, Pediatrics Clinics, General Practice Clinics, Internal Medicine clinics
that are not limited to a subspecialty focus, and multi-specialty clinics that include
primary care providers as part of a comprehensive care team.) Clinics must have implemented
their EHR by 1/1/2014.
Inclusion criteria for patients: EHR Patients must be established patients within a health
care system: at least one ambulatory visit to an included clinic in 2015 and at least 1
visit to a primary care clinic within the same health system prior to that visit.
Inclusion criteria for patients for Medicaid based Outcomes: Patient must have been
continuously covered by Medicaid in 2015 and have had at least 1 visit billed as an office
visit in 2015 with a provider identified as a primary care provider and at least 1 prior
claim billed to the same provider. Patients must meet the age/condition criteria for the
assessment of at least 1 secondary outcome.
Exclusion Criteria:
Exclusion criteria for patients: Patients with no geocoded address on file will be excluded
from the analysis.
Exclusion criteria for patients for Medicaid based Outcomes: Patient with Medicaid coverage
gaps of >45 days will be excluded from theses analyses. Exclusion criteria for providers:
Providers with <20 patients in any Quality metric denominator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Impact of Patient Complexity on Healthcare Utilization | NCT03327896 | Entailment |
4,556 | 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:
- Patients who underwent endometriosis or adenomyosis-related surgery in the
investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up
medication.
Exclusion Criteria:
- None
Female
No healthy subjects accepted to join the trial.
| Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis | NCT03778359 | Contradiction |
752 | 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:
-
1.Clinical diagnosis of knee osteoarthritis, Diagnostic criteria is based on the Chinese
medical association's 2007 diagnosis and treatment guidelines for osteoarthritis:
1. Repeated knee joint pain within 1 month;
2. X-ray(weight-bearing or not)shows narrowed joint space,sclerosis and (or) cystic
degeneration of subchondral bone, osteophytes of the joints;
3. The joint fluid (at least twice) is clear and viscous, WBC<2000个/ml;
4. Age of patients ≥40 yrs;
5. Morning stiffness≤3 min;
6. Bone friction in the activity; Note：Combine clinical feature, laboratory and X-ray
examination,when the patients meet(1)+(2) or (1)+(3)+(5)+(6) or (1)+(4)+(5)+(6)，they
can be diagnosis as knee osteoarthritis.
2.VAS≥4分; 3.No surgical treatment is planned within 6 months;
Exclusion Criteria:
1. Other types of arthritis, such us RA(rheumatoid arthritis)
2. Severe deformity of knee joint;
3. Over obesity patients（BMI>35）;
4. Other comorbidities that would severely affect somatic function, such as: cerebral
infarction, lumbar disease that meets surgical indications, lower extremity
angiopathy;
5. Decompensated cardiac dysfunction;
6. Severe cardiovascular and cerebrovascular diseases, or the patient is too weak for any
kinds of exercise;
7. Lack of compliance;
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.
| The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis | NCT03363490 | Contradiction |
954 | 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:
- Women aged between 40 and 80 years.
- Patients diagnosed with osteoarthritis (OA) hand according to the American College of
Rheumatology classification criteria.
- Pain symptom in proximal interphalangeal (PIP's) or distal interphalangeal (DIP's)
dominant hand in II and III or fingers.
- Provide greater pain symptom of II and III or fingers between each other.
- Complains of pain symptom measured by a visual analog scale (VAS) pain between 3 to 8
cm in the II and III or fingers of the dominant hand reported to perform joint
movement (activity).
- Thumb abduction with the II and III fingers without changing the pincer movement
pulp-pulp.
Exclusion Criteria:
- Other rheumatic diseases, neurological and skeletal muscle that can affect the upper
limb.
- Fibromyalgia uncontrolled.
- Pregnancy.
- Geographical inaccessibility and transport.
- Cognitive impairment that prevents the understanding of assessment tools.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand | NCT02789852 | Entailment |
166 | 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:
- Hypogonadal males with a qualifying general medical health who have Completed the
MTE08 trial up to and including Day 120/121 in a compliant manner
- Were able to communicate with the trial staff, understand the Trial Information Sheet
and sign the Written Informed Consent Forms; were willing to follow the Protocol
requirements and comply with Protocol restrictions and procedures
Exclusion Criteria:
- Any clinically significant chronic illness or finding and/or laboratory testing that
would interfere with the trial objectives or safety of the subject
- Any man in whom testosterone therapy was contraindicated, which included those with:
- Known or suspected carcinoma (or history of carcinoma) of the prostate or
clinically significant symptoms of benign prostatic hyperplasia and/or clinically
significant symptoms of lower urinary obstructions and with a International
Prostate Symptoms Score (IPSS) score of greater than or equal to 19
- Known or suspected carcinoma (or history of carcinoma) of the breast
- Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver
function tests >2 times the upper limit of the normal range values
- Active deep vein thrombosis, thromboembolic disorders or a documented history of
these conditions
- Current significant cerebrovascular or coronary artery disease
- Untreated sleep apnoea
- Haematocrit of >54%
- Untreated moderate to severe depression
- Men with clinically significant prostate exam or clinically significant elevated serum
Prostate Specific Antigen (PSA) level (> 4 ng/mL) or age adjusted reference range of
PSA values
- Men taking concomitant medications (prescribed, over-the-counter or complementary)
that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations
(excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as
warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha
reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for
physiological replacement doses), estradiol
- Men with uncontrolled diabetes (Hemoglobin A1c [HbA1c] greater than or equal to 10%)
- Subjects intending to have any surgical procedure during the course of the trial
- Subjects with a partner of child bearing potential who are not willing to use adequate
contraception for the duration of the trial
- Subjects whose partners are pregnant
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations | NCT00857454 | Entailment |
859 | 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:
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael
Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10
degrees flexion contracture
- Body mass index less ≤ 40 kg/m2
Exclusion Criteria:
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower
extremity that is not undergoing the TKA
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.
Subject must be at most 85 Years | Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function | NCT00710840 | Entailment |
4,972 | 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:
- Diagnosis of Parkinson's Disease (PD), Essential Tremor (ET) or Multiple Sclerosis
(MS)
- Scheduled to undergo Deep Brain Stimulation (DBS) electrode implant or implanted pulse
generator (IPG) replacement surgery
- Neurologically stable
- Able to understand the study and consent form
Exclusion Criteria:
- Inability to execute the motor tasks during the study
- Inability to tolerate withholding anti-parkinsonian and/or anti-tremor medications
- Clinically ineffective DBS
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Effects of Stimulation Patterns of Deep Brain Stimulation | NCT02553525 | Entailment |
4,491 | 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:
- Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
- Regular cycling (28 days +/- 2)
- Non-hormonal contraception methods used
- German-speaking
- Written informed consent to participate in the study
Exclusion Criteria:
- Any health-related issues that may affect menstrual cycle
- Any consumption of medication or other substances that may affect the menstrual cycle
or any of the physiological parameters investigated
- Frequent travel between time zones
- Sleeping disorders
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Physiological Data in the Menstrual Cycle | NCT03128983 | Contradiction |
6,240 | 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 pneumonia; Covid-19 test negative; hospitalized subjects; both sexes;
given informed consent
Exclusion Criteria:
- age lower than 18 years; pregnancy; breast-feeding
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 | Determinants of COVID-19 Pneumonia (MC-19) | NCT04387799 | Contradiction |
3,734 | 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:
- Men and women of at least 18 years of age
- Clinical or radiological diagnosis of knee OA according to the criteria of the
American College of Rheumatology
- Knee pain lasting for six months or longer
- Radiographic evidence of at least one osteophyte at the tibiofemoral joint
(Kellgren-Lawrence grade ≥ 2) or one or more of the following signs and symptoms in
the knee; restricted range of motion, pain in motion, crepitations, morning stiffness
- Written informed consent
Exclusion Criteria
- Patients diagnosed with rheumatoid arthritis or other musculoskeletal diseases
affecting lower extremities
- Relevant effusion in the index knee
- Known current or remittent cancer
- Carry cardiac pacemaker or defibrillator in situ
- Knee surgery in previous 6 months
- Received treatment with arthrocentesis
- Intra-articular injection of steroids in previous 3 months
- Inability to understand instructions or to give informed consent
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.
| Effect of Transcutaneous Electrostimulation (TENS) on Pain and Physical Function in Patients With Knee Osteoarthritis | NCT01875042 | Contradiction |
6,729 | 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
- Moderate or Severe Congenital Hemophilia A or B (FVIII or FIX clotting activity less
than or equal to 5% of normal).
- Able to give informed consent (by patient or parent/authorized guardian).
- Previously treated with plasma-derived or recombinant clotting factor replacement
products with at least 50 exposure days (as assessed either from direct clinical
records in children under age 5, or by clinical history of dosing in older patients).
For Arm B being enrolled retrospectively, this previous treatment must be prior to
product switch under study.
- Planning to switch, or recently switched within the previous 50 weeks, to a new brand
or type of replacement factor VIII or IX, FDA approved after January 1, 2013.
- Arm B only: Negative inhibitor screen within the last 6 months prior to switching.
Note: History of prior transient inhibitor or inhibitor eradicated by immune tolerance
induction (ITI) are eligible.
Exclusion Criteria
- Presence of any known bleeding disorder other than hemophilia A or B (i.e., patients
with concurrent hemophilia and a second hemostatic defect are NOT eligible). Low Von
Willebrand Factor (VWF) without VWF diagnosis are not excluded.
- Presence of an active inhibitor >0.6 BU for factor VIII, > 0.4 BU for factor IX at the
time of eligibility assessment. Detection of such an inhibitor at the baseline visit
prior to dosing with the new product (Arm A), or after dosing with new factor dosing
(Arm B), would result in early termination without other study assessments.
- Currently undergoing ITI.
- Immunosuppressive therapy (cyclophosphamide, mycophenolate, IVIG) within 90 days and
Rituximab within 6 months; topical steroid treatments and short course steroids for
asthma or allergy allowed.
- Previous participation in Phase I, II or III interventional trials of the factor
product being switched to.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| ATHN 2: Factor Switching Study | NCT02546622 | Contradiction |
5,640 | 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:
- Female participants
- Aged 25 to 70
- Those who have intentionally lost more than or equal to 5% of initial body weight in
the previous 6 months will be recruited
- Objective evidence that volunteers were overweight or obese and have lost weight will
be obtained from doctors records
Exclusion Criteria:
- Presence of major illness including cancers
- Established cardiovascular disease or stroke
- Diabetes
- Gestational diabetes
- Renal disease
- Malabsorption disorders
- Thyroid disorders
- Major psychiatric disorders
- Taking weight loss medication or medications known to cause weight gain
- Planning a pregnancy in the next 2 years
- Those who do not intend to be in the area for the next 2 years
Female
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 70 Years | The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management | NCT00128336 | Contradiction |
6,214 | 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
- Healthy healthcare professionals of any age
Exclusion Criteria
- Previous PCR/Antibody positive test for COVID-19
- Not working in high-risk COVID-19 area (ICU, A&E, COVID positive wards)
- Involved in COVID-19 Vaccine Trial
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers) | NCT04363489 | Contradiction |
5,386 | 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:
The participant will not be considered eligible for the study without meeting all of the
criteria below.
Participants who have completed Study 071301 or Study 071102 (or participants who have
completed the surgery in Study 071102 and want to continue to receive on-demand (OD)
treatment) and are willing to immediately transition into this study, must meet the
following 2 criteria to be eligible for this study:
1. If female of childbearing potential, has a negative blood/urine pregnancy test at
screening and agrees to employ highly effective birth control measures for the
duration of the study.
2. Participant and/or legally authorized representative is willing and able to comply
with the requirements of the protocol.
New participants (Cohort 4) who meet the above 2 and ALL the following additional
criteria are eligible for this study:
3. Participant has a documented diagnosis of severe von Willebrand disease (VWD)
(baseline von Willebrand factor: Ristocetin cofactor (VWF:RCo) <20 IU/dL) with a
history of requiring substitution therapy with von Willebrand factor (vWF) concentrate
to control bleeding:
1. Type 1 (VWF:RCo <20 IU/dL) or,
2. Type 2A (as verified by multimer pattern), Type 2B (as diagnosed by genotype),
Type 2M or,
3. Type 3 (Von Willebrand factor antigen (VWF:Ag) ≤3 IU/dL). Diagnosis is confirmed
by genetic testing and multimer analysis, documented in patient history or at
screening.
4. Participant has been receiving OD therapy with VWF products for at least 12 months,
and prophylactic treatment is recommended by the investigator.
5. Participant has ≥3 documented spontaneous bleeds (not including menorrhagia) requiring
VWF treatment during the past 12 months.
6. Participant has available records that reliably evaluate type, frequency, and
treatment of bleeding episodes for at least 12 months preceding enrollment; up to 24
months of retrospective data should be collected if available.
7. Participant is ≥12 years old at the time of screening and has a body mass index ≥15
but <40 kg/m^2.
Exclusion Criteria:
The participant will be excluded from the study if any of the following exclusion criteria
are met.
1. The participant has been diagnosed with Type 2N VWD, pseudo VWD, or another hereditary
or acquired coagulation disorder other than VWD (eg, qualitative and quantitative
platelet disorders or elevated prothrombin time (PT)/international normalized ratio
[INR] >1.4).
2. The participant has a history or presence of a VWF inhibitor at screening.
3. The participant has a history or presence of a Factor VIII (FVIII) inhibitor with a
titer ≥0.4 Bethesda units (BU) (by Nijmegen modified Bethesda assay) or ≥0.6 BU (by
Bethesda assay).
4. The participant has a known hypersensitivity to any of the components of the study
drugs, such as mouse or hamster proteins.
5. The participant has a medical history of immunological disorders, excluding seasonal
allergic rhinitis/conjunctivitis, mild asthma, food allergies, or animal allergies.
6. The participant has a medical history of a thromboembolic event.
7. The participant is human immunodeficiency virus (HIV) positive with an absolute Helper
T cell (CD4) count <200/mm^3.
8. The participant has been diagnosed with significant liver disease per investigator's
medical assessment of the participant's current condition or medical history or as
evidenced by, but not limited to any of the following: serum alanine aminotransferase
(ALT) greater than 5 times the upper limit of normal; hypoalbuminemia; portal vein
hypertension (eg, presence of otherwise unexplained splenomegaly, history of
esophageal varices) or liver cirrhosis classified as Child-Pugh class B or C.
9. The participant has been diagnosed with renal disease, with a serum creatinine (CR)
level ≥2.5 mg/dL.
10. The participant has a platelet count <100,000/mL at screening.
11. The participant has been treated with an immunomodulatory drug, excluding topical
treatment (eg, ointments, nasal sprays), within 30 days prior to signing the informed
consent (or assent, if appropriate).
12. The participant is pregnant or lactating at the time of enrollment.
13. The participant has cervical or uterine conditions causing menorrhagia or metrorrhagia
(including infection, dysplasia).
14. The participant has participated in another clinical study involving another
investigational product (IP) or investigational device within 30 days prior to
enrollment or is scheduled to participate in another clinical study involving an IP or
investigational device during the course of this study.
15. The participant has a progressive fatal disease and/or life expectancy of less than 15
months.
16. For new OD subjects, the participant is scheduled for a surgical intervention.
17. The participant is identified by the investigator as being unable or unwilling to
cooperate with study procedures.
18. The participant has a mental condition rendering him/her unable to understand the
nature, scope and possible consequences of the study and/or evidence of an
uncooperative attitude.
19. The participant is member of the study team or in a dependent relationship with one of
the study team members which includes close relatives (i.e., children, partner/spouse,
siblings and parents) as well as employees.
Delay criteria Only for Cohort 4, if the participant presents with an acute bleeding
episodes or acute illness (eg, influenza, flu-like syndrome, allergic
rhinitis/conjunctivitis, and non-seasonal asthma) the screening visit will be postponed
until the participant has recovered. For all other participants, end of study (EOS) visit
for 071102 or 071301 will be completed per protocol and the completed EOS in Study 071102
or 071301 will also serve as the screening visit for this continuation study (SHP677-304).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| rVWF Pediatric and Adult Study | NCT03879135 | Entailment |
2,070 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | No eligibility criteria
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 90 Years | Linkage Study in Familial Pulmonary Fibrosis | NCT00016627 | Entailment |
3,918 | 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. Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
2. Has a medical history of OA symptoms confirmed at least 3 months prior to the
screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to
resume during study
Exclusion Criteria:
1. Clinically significant apparent large effusion of the target knee;
2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal
instability as assessed by the Investigator;
3. Any musculoskeletal condition affecting the target knee that would impair assessment
of the effectiveness in the target knee such as Paget's disease
4. Medical history of anaphylactic reactions
5. History of septic arthritis in any joint
6. Females who are pregnant or breast-feeding
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.
| Hymovis™ Versus Placebo in Knee Osteoarthritis | NCT01372475 | Entailment |
5,549 | 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:
- Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk)
Exclusion Criteria:
- None of the parents wants to participate
- Diagnosed somatic course of overweight
- Parents or children do not speak danish
- Sever physical handicap
- Psychiatric illness or mental retardation in children or parents
- Severe child abuse
- Siblings participation in the trail.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 15 Years | GRIB Forsoeget-2004 | NCT00554645 | Contradiction |
2,750 | 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:
- Written informed consent from the patient or his/her legal representative
- Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair.
Exclusion Criteria:
- No written informed consent
- Recurrent groin hernia
- Open hernia repair
- Bilateral hernias
- Concomitant repair of another abdominal hernia eg umbilical hernia
- Hernia repair combined with another surgical procedure
- Emergency operations, like incarcerated hernias
- Patients under the age of 18 years and over 80 years
- Pregnant women
- ASA score 4 or more
- Patients unable to perform the QoL assessment, because of language barrier or
intellectual incapacity
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.
| Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™ | NCT01936584 | Entailment |
5,289 | 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
- not severely obese (BMI < 40 kg/m2);
- healthy (determined by a screening questionnaire, complete metabolic panel);
- willing to include dried plums in their daily diet;
- not taking any natural dietary supplement containing phenolics, blueberries or apples
for at least 2 months prior to study entry; can stop for 2 months to meet entry
criteria
- non-smoking; ambulatory;
- low BMD as measured by dual energy X-ray absorptiometry (DXA). Eligible BMD values
(T-scores) for DXA measures of the lumbar spine, total hip and/or femoral neck will
correspond to T-scores between 0 and -3.0.
Exclusion Criteria:
- Women who regularly consume dried plums, dried apples, prune juice, or heavy consumers
of blueberries (1 cup or more/day). Potential volunteers who will refrain from
consumption of the afore mentioned foods for the duration of the study will become
eligible after a 2 month washout period;
- vitamin D deficiency (<20 ng/mL);
- history of vertebral fracture or fragility fracture of the wrist, humerus, hip or
pelvis after age 50 yr);
- untreated hyper- or hypothyroidism;
- current hyper- or hypoparathyroidism;
- significantly impaired renal function; high potassium
- current hypo- or hypercalcemia;
- history of spinal stenosis;
- history of heart attack, stroke, thromboembolism, kidney disease, malabsorption
syndrome, seizure disorders;
- positive for HIV, Hep-C or Hep-B surface antigen and malignancy.
- Use of the following agents affecting bone metabolism:
- intravenous bisphosphonates at any time;
- fluoride (for osteoporosis) within the past 24 months;
- denosumab at any time;
- bisphosphonates, parathyroid hormone or strontium within the past 12 months;
- calcitonin or selective estrogen receptor modulators within the past 12 months;
- systemic oral or transdermal estrogen within the past 3 months;
- systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than
10 days); or
- tibolone within the past 3 months.
- Participants who will not consume study therapy or will not stop taking natural
product supplements of their own selection.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 75 Years | Dried Plums and Bone Health in Postmenopausal Women | NCT02822378 | Entailment |
331 | 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:
- have had vaginal penetrative intercourse within the last 12 months
- have a regular menstrual cycle (between 24-35 days) and be able to record the day of
onset of menses in a menstrual diary
- able to ambulate for 20 consecutive minutes after vaginal self-insertion of gel using
an applicator
- willing to use a condom when engaging in sexual intercourse within 4 days before a
study visit
- willing to avoid using any mechanical sex toy within 1 day before a study visit
- willing to use one of the following contraception methods if engaging in sexual
intercourse during the length of participation in the study (hormonal contraceptive,
tubal ligation, non-surgical procedure such as permanent transcervical sterilization,
Fallopian tubes removed, partner vasectomy)
- able to provide informed consent
Exclusion Criteria:
- pregnant, potentially pregnant, nursing, or trying to conceive
- allergic to latex, fluorescein, hydroxyethylcellulose, ascorbic acid, sodium citrate,
citric acid
- using an intrauterine device (IUD)
- using depo-provera
- douching during the course of participation in the study
- had medical or cosmetic surgery involving the reproductive organs or genitals within
the past 6 months
- have a gynecological infection or other condition requiring treatment, such as
candidiasis, chlamydia trachomatis, trichomoniasis, HIV, herpes simplex virus (HSV),
neisseria gonorrhea, symptomatic bacterial vaginosis, or syphilis
- currently enrolled in any other research studies involving the application of vaginal
formulations
- employed or supervised by the study investigators
- have any other condition that, in the opinion of the study physician, would
contraindicate participation in the study
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Optical Imaging and User Perception Study of Vaginal Gel | NCT01716000 | Contradiction |
4,344 | 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:
- Adult male and female in-patients with vital signs considered 'stable' by clinical
caregivers.
Exclusion Criteria:
- Pediatric patients
- Female patients who are pregnant
- Patients with internal or external defibrillators
- Patients who have undergone surgery and still have a fresh incision on the chest.
- Patients with skin damage on the chest such as burns, irritation, infections, wounds,
etc.
- Patients in the Critical Care Unit (CCU)
- Patients who otherwise satisfy any of the contraindications associated with the VSP
system.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Vital Signs Patch Early Feasibility and Usability Study v1.0 | NCT02524470 | Entailment |
3,486 | 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. | Hearing impaired
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 Diagnosis of Steroid-Responsive & No-Responsive Hearing Loss | NCT00013468 | Entailment |
4,472 | 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. Patients were selected for inclusion if two or more of the following criteria were
noted on the physical examination form: pain over the lateral aspect of the elbow;
pain on palpation over the lateral epicondyle or the associated myotendinous junction
of the common extensor tendon; pain on hand gripping; and pain with either resisted
static contraction or stretching of the wrist extensor muscles.
2. symptoms have persisted for at least 2 months
3. symptoms are unilateral
Exclusion Criteria:
1. signs and symptoms suggesting a cause other than overuse (e.g., cervical
radiculopathy)
2. osteoarthritis of the elbow joints
3. pathologic, neurologic, and/or vascular findings in the arms
4. arthritis (local/generalized polyarthritis)
5. radiohumeral bursitis
6. ligamentous sprain
7. bilateral tennis elbow
8. painful shoulder
9. surgery or dislocation of the elbow
10. coagulopathy
11. pregnancy
12. infection
13. malignancy
14. Patients who had been treated with other therapies or drugs for lateral epicondylitis
in the 2 weeks before the start of the trial, those who had received corticosteroid
injections in the previous 6 months, and those who had received acupuncture and fire
needle therapy for lateral epicondylitis were also excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Acupuncture Plus Fire Needle and Acupuncture on Lateral Epicondylitis | NCT03820856 | Entailment |
1,967 | 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:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging
Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2
lymphadenectomy
- no severe organ dysfunction
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I or II
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal
dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of predicted values
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 | Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy | NCT03016026 | Entailment |
6,522 | 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 18 years or older with established severe Haemophilia A (endogenous FVIII level
≤1 IU/dL) as evidenced by their medical history.
2. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure
days (EDs)
3. Greater than or equal to 12 bleeding episodes for patients on on-demand FVIII
replacement therapy over the previous 12 months. Does not apply to patients on
prophylaxis
4. No history of inhibitor, and results from a modified Nijmegen Bethesda assay of less
than 0.6 Bethesda Units (BU) 2 consecutive occasions at least one week apart within
the past 12 months
5. Sexually active patients must be willing to use an acceptable method of contraception.
Exclusion Criteria:
1. Detectable pre-existing immunity to the AAV5 capsid as measured by AAV5 transduction
inhibition or AAV5 total antibodies
2. Any evidence of immunosuppressive disorder or active chronic infection including
hepatis B, hepatitis C, HIV
3. Significant liver dysfunction as defined by abnormal elevation ofliver function tests,
or for patients who have undergone liver imaging or biopsy and found to have evidence
of grade 3 or higher fibrosis
4. Evidence of any bleeding disorder not related to haemophilia A
5. 12. Treatment with any investigational product within 30 days prior to the end of the
screening period, or any previous exposure to any gene transfer therapy
6. Any disease or condition that per the physician's discretion would prevent the patient
from fully complying with the requirements of the study including possible
corticosteroid treatment outlined in the protocol. The physician may exclude patients
unwilling or unable to agree on not using alcohol for the 16-week period following the
viral infusion.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Gene Therapy Study in Severe Haemophilia A Patients (270-201) | NCT02576795 | Contradiction |
1,031 | 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:
- Patients with moderate knee osteoarthritis determined by a combination of clinical and
radiographic findings and documented by Kellgren-Lawrence radiographic classification
(Grade 2 or 3)
- Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes,
possible narrowing of joint space
- Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple
osteophytes, definite narrowing of joints space, some sclerosis and possible deformity
of bone contour.
- Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have
bilateral symptoms may have their more symptomatic knee injected. If equivalent
symptoms are reported by the patient, then the patient will choose which knee is to be
injected. The contralateral knee can be treated with local standard of care such as
steroid injection, cold therapy or soft brace.
- Age 18 and older
- BMI less than 40
- 7 day average pain score of 4 or greater for the involved knee on a numeric pain scale
from 1 to 10.
- Female patients must be actively practicing a contraception method, abstinence, be
surgically sterilized, or be postmenopausal
Exclusion Criteria:
- Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15
days before injection (may take acetaminophen)
- Receiving pain medication other than acetaminophen for conditions unrelated to
osteoarthritis of the index knee
- Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of
antiplatelet medications are not a reason for exclusion
- History of substance abuse.
- Failure to agree NOT to take additional knee symptom modifying drugs, other than
acetaminophen, during the course of the study without reporting to the study team
- Pregnancy or desire to become pregnant during study duration
- Positive pregnancy test on premenopausal subject
- Morbid obesity (defined as BMI 40 or greater)
- Symptoms of locking, intermittent block to range of motion or loose body sensation
which could indicate meniscal displacement or an intraarticular loose body
- Corticosteroid injection into the index knee within 3 months
- Viscosupplement injection into the index knee within 3 months
- Knee surgery of involved index knee within 12 months
- Knee surgery contralateral knee 6 months
- Worker compensation
- Acute index knee injury (injury within 3 months)
- History of Diabetes mellitus
- History of solid organ or hematologic transplantation
- History of rheumatoid arthritis or other autoimmune disorder
- Diagnosis of a non-basal cell malignancy within the preceding 5 years
- Infection requiring antibiotic treatment within the preceding 3 months
- Current therapy with any immunosuppressive medication, including corticosteroids at a
dose > 5 mg per day
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis | NCT02318511 | Entailment |
779 | 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:
1. Male or female patients aged between 40 and 70;
2. Medial or lateral arthrosis (grade 2-3 according to Kellgren-Lawrence score);
3. Failure after at least 6 months of conservative treatment (patients not responding to
drug therapy with NSAIDs and painkillers, no benefit from rehabilitation cycle in
water or gym, no benefit after hyaluronic acid or platelet-rich plasma (PRP)
infiltrations, or after at least one infiltration of corticosteroids);
4. Ability and consent of patients to participate actively in the rehabilitation and
clinical and radiological follow-up protocol;
5. Signing of informed consent.
Exclusion Criteria:
1. Patients who are incapable of understanding and will;
2. Trauma patients within 6 months prior to surgery;
3. Patients with malignancies;
4. Patients with rheumatic diseases;
5. Patients with diabetes;
6. Patients with metabolic thyroid disorders;
7. Patients abusing alcoholic beverages, drugs or drugs;
8. Patients with lower limb impairment above 10°
9. Body Mass Index <18 or > 35;
10. Patients undergoing knee surgery during the 12 months prior to surgery;
11. Patients with pathology ascribable to patellofemoral pathology;
12. Untreated knee instability.
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 | Knee Osteoarthritis Treatment With Percutaneous Injections of Autologous Bone Marrow Concentrate | NCT04310852 | Entailment |
4,000 | 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:
- Man or Women, aged from 45 to 80
- Presenting a symptomatic femoro-tibial knee osteoarthritis responding to clinical and
radiologic ACR (American College of Rheumatology) criteria,
- Symptomatic since at least 6 months
- Mean global knee pain determined on Visual Analog Scale for the last 24 hours over 40
mm (without any NSAIDs or analgesics for more than 48 hours).
- Kellgren and Lawrence (K&L) radiological stage must have been II or III on pictures
lasted less than 12 months
- Requiring a treatment with hyaluronic acid after failure or intolerance to first line
analgesics or NSAIDs
- Having signed an informed consent after receiving comprehensive information
- Capable to follow the study instructions
- Benefiting from health insurance.
Exclusion Criteria:
Related to the osteoarthritis pathology:
- Significant clinical knee effusion
- Radiographical Kellgren and Lawrence grade I or IV
- Osteoarthritis secondary to a microcrystalline arthropathy: chondrocalcinosis
previously known or defined by a calcium border on at least one tibiofemoral spacing,
gout ...
- Isolated femoropatellar osteoarthritis
- Presence of another joint (other than the evaluated knee) affected by osteoarthritis
(known and symptomatic): collateral knee, hip, hand, shoulder, ankle or foot
- Chondromatosis or villonodular synovitis of the knee
- Paget disease
- Recent trauma (< 1 month) of the evaluated knee
- Pathologies interfering with the evaluation of osteoarthritis (microcrystalline
inflammatory arthropathy, rheumatoid arthritis, radiculalgia in the lower limbs,
arteritis. etc)
- Acute inflammatory osteoarthritis (Kofus ≥ 7)
Related to previous and concomitant treatments
- Corticosteroids injection in the last month before injection regardless the concerned
joint
- Hyaluronan injection in the last 6 months before injection regardless the concerned
joint
- Analgesics and NSAIDs intake during the last 48 hours before inclusion visit
- Change in the dosage of slow-acting drugs against arthrosis i.e. chondroitin,
glucosamine, diacerein or avocado-soybean unsaponifiables in the last 3 months before
inclusion or planned during study
- Arthroscopy or surgery in the target knee in the last 3 months before inclusion
- Oral corticotherapy
Related to associated pathologies
- Severe diseases (severe hepatic failure, renal failure, uncontrolled cardiovascular
diseases….)
- Dermatological infection at the site of injection
- Anticoagulant treatment
- Risk of hemorrhage according to the evaluator or injector assessment
Related to the patients
- Known allergy to hyaluronan
- Known allergy to acetaminophen
- Known allergy to mannitol
- Pregnant or breastfeeding women
- Premenopausal women without contraception
- Patient unable to read, and to write
- Patient having participated in a clinical research investigation in the last 3 months
- Patient under guardianship or judicial protection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Pilot, Prospective, Comparative Multicentric Study Evaluating the Effects on the Arthrosis Biomarkers, the Clinical Effectiveness, the Tolerance of an Intra-articular Injection of Hyaluronic Acid KARTILAGE CROSS Versus Placebo in Patients Suffering From Knee Osteoarthritis | NCT02951585 | Entailment |
6,476 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Key Inclusion Criteria:
1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
and at Baseline/Day 1 (prior to the study drug application).
4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
at Baseline/Day 1 (prior to the study drug application).
Key Exclusion Criteria:
1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
telangiectasia.
2. Presence of three (3) or more facial inflammatory lesions of rosacea.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac
glycosides, beta blockers or other antihypertensive agents.
5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
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 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea | NCT01355471 | Entailment |
6,186 | 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:
- Healthy on the basis of physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities,
they must be consistent with the underlying illness in the study population. This
determination must be recorded in the participant's source documents
- Healthy on the basis of clinical laboratory tests performed at screening. If the
results of the serum chemistry panel including liver enzymes, other specific tests,
hematology, urinalysis or breathing alcohol test are outside the normal reference
ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant. This
determination must be recorded in the participant's source documents and initialed by
the investigator
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140
millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg
diastolic
- Have no history of psychiatric disorder within the 5 years prior to the screening
- Have no history of gastrointestinal resection that may affect drug absorption
Exclusion Criteria:
- Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at
screening as deemed appropriate by the investigator
- Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
- History of malignancy within 5 years before screening (exceptions are squamous and
basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,
which is considered cured with minimal risk of recurrence)
- Taken any disallowed therapies as noted in local prescribing information, concomitant
therapy before the planned first dose of study drug
- Use of any prescription or nonprescription medication (including oriental medicines)
within 30 days before the first dose of the study drug is scheduled
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
| A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants | NCT04214691 | Contradiction |
6,144 | 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. | Study inclusion criteria;
- Written informed consent
- Healthcare workers at nursing homes with resident contact
- Willingness to adhere to study protocol
Additional inclusion criteria for primary objective 2 (reinfection after vaccination)
- SARS-CoV-2 vaccination
List the study exclusion criteria:
- Unwillingness to adhere to study protocol
- HCW exclusively working with patients with aerosol-generating procedures during the
entire study period
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 65 Years | Clinical Efficiency of Surgical Masks and Filtering Face-piece 2 Masks | NCT04823351 | Contradiction |
Subsets and Splits