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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Preeclampsia Ability to read and understand informed consent Unique pregnancies > 24 weeks and <41 weeks Suspected preeclampsia: 1. 140/90 or worsening of chronic hypertension 2. Onset of proteinuria (Labstick + or proteinuria> 300mg / 24 hours) or worsening of it 3. Preeclampsia prodromal clinic such as epigastric, headache, photopsia, tinnitus and increased edema in the face hands or legs or weight gain (> 1 kg per week in the third trimester) 4. Analytical alterations: decrease in platelets <100,000. Increased transaminases. 5. Ultrasound alterations: Small fetus for gestational age or restriction of interatrial growth, increased resistance of the uterine arteries Pre-eclampsia (ACOG Practice Bulletin 2013) Multiple pregnancies <24 weeks of gestation Fetal chromosomal or congenital abnormalities Conditions that require immediate delivery (eclampsia, pulmonary edema, uncontrolled hypertension, severe visual disturbances, severe headache, fetal demise, non-reassuring fetal status….)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-35.0, Polycystic Ovary Syndrome Infertility more than 2 years. 2. Age between 20-35 years. 3. clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic. 4. No contraindications for laparoscopy. 5. Normal Hysterosalpingography Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect…. 2. Women's age less than 20 years or more than 35 years. 3. Previous Laparoscopic surgery. 4. Previous ovarian surgery. 5. Women with Antimullerian hormone level less than 4 ng/ml. 6. Tubal factor infertility as diagnosed by Hysterosalpingography
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Documented evidence of active acromegaly Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy Biochemically controlled Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label Pituitary surgery within six months Conventional or stereotactic pituitary radiotherapy any time in the past Patients who previously participated in CH-ACM-01 or OOC-ACM-302 Any clinically significant uncontrolled concomitant disease Symptomatic cholelithiasis Pegvisomant, within 24 weeks Dopamine agonists, within 12 weeks Pasireotide, within 24 weeks
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 15.0-60.0, Thyroid Nodule Adult male or female patient with cystic thyroid nodule 2. Presence of pressure symptoms or cosmetic problems 3. Benign lesions confirmed by histopathological examination by FNAC. 4. Serum levels of thyroid hormone thyrotropin, within normal limits Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US 2. solid thyroid nodule 3. mixed thyroid nodule(cystic with solid component)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Thumb Osteoarthritis Pain Physical Disorder Women over 18 diagnosis of CMC joint OA in their dominan hand State 1-2 according to the American College of Rheumatology Pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS) Ability to read or understand the patient information sheets Ability to sign a consent form will be included in the study Neurologic disorder affecting the upper limb Previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb Had fractures or a significant hand injury or previous surgery to the wrist, thumb or hand Finger tenosynovitis Dupuytren disease Psychological treatment
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Csf Leakage male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Pituitary Adenoma adult patients undergoing transsphenoidal surgery diagnosis of pituitary adenoma on pre-operative MRI able to provide consent patients less than 18 years of age patients undergoing transcranial surgery diagnosis other than that of pituitary adenoma on pre-operative MRI e.g., meningioma unable to provide consent e.g., mental illness or later withdrawing consent
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.083-26.0, Acute Lymphoblastic Leukemia Leukemia, Acute Myeloid (AML), Child Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Primary Immune Deficiency Disorder Osteopetrosis Cytopenia Hemoglobinopathy in Children Anemia, Aplastic Age > 1 month and < 26 years 2. Life expectancy > 10 weeks 3. Subjects deemed eligible for allogeneic stem cell transplantation. 4. Subjects with life-threatening hematological malignancies (high-risk ALL in 1st CR, ALL in 2nd or subsequent CR, AML in 1st CR, AML in 2nd or subsequent CR, myelodysplastic syndromes, non-Hodgkin lymphomas in 2nd or subsequent CR, other hematologic malignancies eligible for stem cell transplantation per institutional standard); 5. Non-malignant disorders amenable to cure by an allograft: 1. primary immune deficiencies, 2. severe aplastic anemia not responding to immune suppressive therapy, 3. osteopetrosis, 4. hemoglobinopathies, (thalassemias, and sickle cell anemia, and Diamond-Blackfan anemia among others) 5. congenital/hereditary cytopenia, including Fanconi Anemia before any clonal malignant evolution (MDS, AML) Note: Subjects will be eligible if they meet either item 4 OR item 5. 6. Lack of suitable conventional donor (HLA identical sibling or HLA phenotypically identical relative or 10/10 unrelated donor evaluated using high resolution molecular typing) or presence of rapidly progressive disease not permitting time to identify an unrelated donor 7. A minimum genotypic identical match of 5/ 10 is required. 8. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA- DRB1 and HLA-DQB1. 9. Lansky/Karnofsky score > 50 10. Signed written informed consent Greater than Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at the time of 2. Subject receiving an immunosuppressive treatment for GVHD treatment due to a previous allograft at the time of 3. Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance < 30 mL / min) 4. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction < 40%) 5. Current active infectious disease (including positive HIV serology or viral RNA) 6. Serious concurrent uncontrolled medical disorder 7. Pregnant or breastfeeding subject 8. For subjects who have received more than 1 x 10E5 alpha/beta T cells/kg with the graft infusion the clinical trial site must contact the sponsor for approval to be eligible to receive BPX-501 infusion
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, Menstrual Cycle Abnormal PCOS Overweight Obesity Aged 18-45 years At least 2y post-menarche BMI >18.5kg/m2 Good visibility of the ovaries on ultrasound Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>35 days); or Previous diagnosis of PCOS from a primary care provider Weight >300lbs Currently pregnant or breast feeding History of ovarian surgery Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months Evidence of reproductive aging as assessed by the principal of STRAW+10 stages
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-35.0, Polycystic Ovary Syndrome Women diagnosed with PCOS Women 20-35 years old BMI ≤30 kg/m without previous ovulation induction Partners with normal semen parameters Parameter World Health Organization (WHO) 2010 Volume1.5 ml Concentration 15 million/ml Progressive motility 32% Normal forms 4% Women with evidence of hyper-or hypothyroidism, hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia or androgen-secreting tumors Women with factors of infertility other than PCOS Women with incomplete data
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Neoplasms, Malignant Breast Neoplasm Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanoma Skin Neoplasm Head and Neck Neoplasms Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject. 2. Subject has an eligible tumor that is within 5 mm of the surface (either skin or mucosa) or has had a tumor removed with a tumor bed that is within 5 mm of the surface. 1. Eligible tumors types Intraoral tumors: squamous cell carcinoma (SCC), melanoma Primary cutaneous tumors (including, but not limited to): SCC, basal cell carcinoma (BCC,) melanoma Breast malignancies post surgery Other tumors: any tumor within 5 mm of the surface and with planned radiation therapy Previous adverse reaction to a charcoal product e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal 2. Previous adverse reaction to the suspending agent 3. Subject has a pacemaker that is not known to be MRI compatible 4. Subject has a non-removable implant or device with metal that is not known to be MRI compatible 5. Subject is pregnant or has a likelihood for becoming pregnant during the basic study timeframe. Note: There is no known harm to the woman or her fetus from participating; this is precautionary only
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, PCOS Written consent for participation in the clinical trial 2. Age 18 to 45 years Irregular menstruation (> 35 days) or secondary amenorrhea> 3 months 4. Hyperandrogenism (hirsutism and / or acne) and / or hyperandrogenemia (total serum testosterone> 0.5 ng / mL) 5. BMI > 25 Ovarian cancer, adrenal gland tumor, endometrial cancer, cervical cancer, breast cancer 2. Congenital adrenal hyperplasia (17-OH-progesterone> 2.5 ng / mL) 3. Clinically diagnosed Cushing's disease, acromegaly, gigantism 4. Type I or II diabetes 5. Unexplained bleeding from the genital tract 6. Hormone treatment within the last 2 months
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-35.0, Polycystic Ovary Syndrome Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam and underwent laparoscopic ovarian drilling from more than two years. Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam and didn't undergo laparoscopic ovarian drilling Age <19 or > 35 years. 2. BMI <19 or > 35 3. patients refusing to participate in the study. 4. previous ovarian cystectomy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-35.0, Infertility Polycystic Ovarian Syndrome PCOS women subjected to COS through fixed gonadotropin releasing hormone (GnRH) antagonist protocol with final triggering of oocyte maturation by GnRH agonist (GnRHa) Elevated serum AMH level (≥ 7 ng/ml) Age < 18 years or > 35 years Body mass index (BMI) < 19 kg/m2 or > 35 kg/m2 Use of cabergoline therapy or coasting to minimize the risk of OHSS
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Orthodontic Appliance Complication ANB angle between 0º 2. Systemically and periodontally healthy subjects not taking any medications. 3. Maxillary and/or mandibular irregularity index (canine-to-canine) between mild to moderate 4. A non-extraction treatment approach. 5. Permanent dentition with second molars erupted or in a functional eruptive phase Systemically and periodontally compromise subjects and taking any medications. (2 ) subjects who did not want participate in the investigation
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-39.0, Emergency Contraception Contraception Healthy women of reproductive age (18-39 years old) with BMI 18-30 kg/m2 Regular menses for the last 3 months Cycle duration 24 to 35 days Women using copper IUD, sterilization, or barrier methods as current or preferred birth control method, and women reporting exclusive sex with women English or Spanish-speaking Any contraindications to progesterone contraception per teh CDC Medical (Category 3 or 4) On medications that can alter, or be altered by, progesterone contraceptive steroid hormone (e.g., aminoglutethimide or other anti-steroid medication) Use of any hormonal contraceptive pill, patch, or vaginal ring in the month prior to recruitment Use of depot-medroxyprogesterone acetate in teh 10 months prior to recruitment Currently pregnant and/or breastfeeding History of allergic reaction to depot medroxyprogesterone acetate (rash, urticaria, anaphylaxis)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-30.0, Polycystic Ovary Syndrome PCOS group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and/or laboratory evidence of hyperandrogenism (hirsutism and/or elevated serum [calculated] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and/or ovulatory dysfunction Control group: post-pubertal (> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum [calculated] free testosterone concentration) General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism) Capable of and willing to provide informed consent Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period Inability/incapacity to provide informed consent Males will be excluded (hyperandrogenism is unique to females) Age < 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children) Age > 30 years (since ovarian reserve may decrease beyond age 30) Obesity resulting from a well-defined endocrinopathy or genetic syndrome Positive pregnancy test or current lactation Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and/or anovulation Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly) Total testosterone > 150 ng/dl, which suggests the possibility of virilizing ovarian or adrenal tumor DHEA-S greater than upper reference range limit for controls; and DHEA-S elevation > 1.5 times the upper reference range limit for PCOS. Mild elevations may be seen in PCOS, and will be accepted in this group
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-999.0, Tooth Overcrowding Patients requiring maxillary and mandible orthodontic treatment (both arches) Adult patients with completed growth based on the cervical vertebral maturation method as described by Baccetti et al. (Baccetti et al. 2002) Minimal to moderate maxillary and mandibular anterior crowding at baseline (irregularity index <6;(Little 1975)) American Society of Anesthesiology I or II (I = nor mal healthy patient; II = patient with mild systemic disease) Adequate dento-oral health (i.e., the absence of periodontal diseases, periapical infection, or untreated caries) controlled periodontitis with a loss of alveolar support >10% gingival recession >2 mm smokers altered bone metabolism (e.g., due to antiresorptive drug, steroid, or immunosuppressant use) mental or motor disabilities; and 6) pregnancy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-80.0, Aphasia Stroke Stroke, Ischemic Aphasia, Broca Aphasia, Global Aphasia, Mixed Aphasia, Jargon Aphasia, Expressive Aphasia, Conduction Aphasia, Fluent Aphasia, Anomic Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke Primarily English speaker for the past 20 years Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic) History of a right hemisphere stroke (Bilateral stroke) Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Cardiotoxicity HER2/Neu Positive Metastatic Malignant Neoplasm in the Brain Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 STEP 1 Patients must have metastatic breast cancer and be initiating within 7 days of step 1 registration or continuing trastuzumab?based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting; patients may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy Trastuzumab Trastuzumab + chemotherapy or hormonal therapy Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab) Ado-trastuzumab (Kadcyla) NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted Patients must be at increased risk for cardiotoxicity defined by at least one of the following Previous anthracycline exposure, OR or more of the following risk factors for heart disease
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Scoliosis Patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated, radiographed with the EOS system None
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-44.0, Plasma Volume Micronutrients Menstrual Cycle Female to 44 years of age General good health (does not have a known, ongoing health condition/medical issue that requires regular monitoring by a doctor or regular visits to the hospital) BMI 18.5-24.9 kg/m2 Regular menstrual cycle (26-35 days) Non-smoker Non-pregnant If pregnant before, ≥12 months since last pregnancy Known allergy to shellfish or iodine Blood pressure on the day of measurements is low or high (systolic blood pressure (SBP) <90 or ≥130 mmHg and/or diastolic blood pressure (DBP) <60 or ≥80 mmHg) Currently has low or high blood pressure (SBP <90 or ≥130 mmHg and/or DBP <60 or ≥80 mmHg), self-reported Current hypertension or previous hypertensive disorder in pregnancy (gestational hypertension or preeclampsia) Taking regular medication(s) (physician's prescribed medications for a health condition) Currently trying to conceive Currently breastfeeding Currently using hormonal birth control or used within last 3 months Used depot medroxyprogesterone acetate (DMPA) in the past 12 months Diagnosis of polycystic ovary syndrome
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Growth Hormone Treatment Sleep Apnea Cardiovascular Diseases Bone Diseases Recently diagnosed with acromegaly Age above 18 Written consent Pregnancy
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 17.0-42.0, PCOS Age group: 18-40 Females Diagnosed a case of polycystic ovary syndrome • Female patients with other acute or chronic illness Cardiovascular disease Neoplasms Current smoking, diabetes mellitus Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Acne Vulgaris Ability to provide written informed e-consent. 2. Males and Females ages 18-40. 3. Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B [Section 12.2], IGA and Lesion Count Acne Grading). 4. Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol). 5. Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose). 6. Females with non-cyclical acne. 7. Females of childbearing potential willing to use adequate contraception (e.g., total abstinence, intrauterine device (IUD), barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera®, Norplant®, or NuvaRing® for the duration of the Screening Period and during study participation. All oral contraceptive and hormonal implants will need to have been initiated and on a stable dose for at least 3 months prior to the screening period. Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal; postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. 8. Male participants willing to use an acceptable method of contraception (e.g., total abstinence, barrier methods with spermicide, surgical sterilization or surgically sterilized partner) during study participation Active bacterial, viral, or fungal skin infections. 2. Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection. 3. Comorbid skin conditions in the area of application. 4. Active periodontal disease or ongoing procedures (e.g., gum grafting). 5. History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts. 6. History of sarcoidosis. 7. History septic joints/endocarditis. 8. Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier. 9. Sensitivity to or difficulty tolerating glycerin, polyethylene glycol. 10. History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment. 11. Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period. 12. Current major systemic comorbid conditions. 13. Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug. 14. Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware. 15. Participants with close contact (e.g., spouses, children, or members in the same household) with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware. 16. Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections. 17. History of malignancy (with the exception of non-melanoma skin cancer). 18. Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome [AIDS], neutropenia). 19. Major surgical procedure, open biopsy, or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed), or anticipation of the need for major surgery during the study. 20. The presence of a medical or psychiatric condition, history of drug or alcohol abuse that, in the opinion of the PI, makes the subject inappropriate for study inclusion. 21. Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised. 22. Inability or unwillingness of participant to comply with study protocol procedures. 23. Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation. 24. Imprisonment or under legal guardianship
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Acne Patient with acne Patient (or parents/guardians for minors) who are not opposed to participating in the cohort Subjects affiliated to an appropriate health insurance Dermatosis of the face other than acne Refusal to participate by the minor or parent/guardian Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Obstetric Complication Postpartum Hemorrhage Postpartum Endometritis Female Able to give consent Gestational age > 24 weeks Postpartum Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours Primary obstetrician amenable to proceeding with either method of management during the study period Age < 18 years old IBT removed within 2 hours of placement Chorioamnionitis Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Nipple Disorder Nursing mothers aged 18 years or older 2. Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales 3. Having given birth to a healthy, full-term child 4. Performing exclusive breastfeeding 5. Newborn with no oral, palatal or maxillofacial abnormalities 6. Newborn weighing between 2500 and 4000 grams History of psychological disorder 2. Presence of mastitis 3. Bacterial or fungal infection in breasts 4. Use of breast pump or plastic nipple
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-75.0, Dermatomyositis, Adult Type Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent Must be 18 years at time of signing the informed consent form Willing to participate in all required evaluations and procedures in the study including the ability to swallow pills without difficulty Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer[6] and/or a skin biopsy consistent with DM Patients must be candidate for systemic therapy for their DM skin disease defined by inadequate response to aggressive sun protection along with the use of potent topical corticosteroids and/or immunomodulators Patients with a diagnosis of dermatomyositis on steroid-sparing agent and/or systemic steroids (maximum dose of prednisone 1mg/Kg) and still having cutaneous disease activity of at least 5 on the CDASI scale If on immunosuppressive treatments and/or steroids, patients must be on stable doses for at least 4 weeks (28 days) Patients must undergo age appropriate cancer screening Females of childbearing potential (FCBP) must have a negative pregnancy test at screening (day 0 of the study and every month throughout the study). While on investigational product and for at least 28 days after taking the last dose of investigational product Increasing or changing dose of topical therapy within 14 days of study day 0 (including but not limited to topical corticosteroids, tacrolimus, pimecrolimus) Increasing or changing systemic steroids dosing within 28 days of study day 0 Increasing or changing dosing for concurrent therapy agents within 28 days or 5 half-lives of the biologic agent, whichever is longer, before study day 0: methotrexate, azathioprine, mycophenolate mofetil, hydroxychloroquine, dapsone, leflunomide, cyclosporine, biologic agents (anti-TNFs), IVIG, rituximab History of any clinically significant (as determined by the investigators) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant or breastfeeding Untreated Latent Mycobacterium tuberculosis infection or active tuberculosis infection as indicated by a positive Purified Protein Derivative (PPD) skin test or T-spot Any condition, including the presence of laboratory abnormalities that places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with acute dermatomyositis onset and rapid progression of muscle disease or significant systemic involvement including pulmonary diseases associated with DM Prior major surgery or major life-threatening medical illness within 2 weeks
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acute Pain Headache Musculoskeletal Pain Patient Participants Age 18 years or older; ii) index outpatient encounter with International Classification of Disease (ICD)-10 code for acute neck, back, or other musculoskeletal and headache diagnosis ("acute" defined as no similar diagnosis in past 3 months) Cancer diagnosis (other than non-melanoma skin cancer) Receipt of opioid prescription within 12 months of index outpatient encounter 2. Providers Primary care provider (MD, Doctor of Osteopathy (DO), Physician Assistant (PA), Nurse Practitioner (NP)) at participating practice None
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Polycystic Ovary Syndrome (PCOS) Menstrual Irregularity Overweight and Obesity Aged >18 years At least 2y post-menarche BMI >18.5kg/m2 Good visibility of the ovaries on ultrasound Pelvic exam with normal results within the last 2 years Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>36 days); or Previous diagnosis of PCOS from a primary care provider Use of medication(s) known or suspected to interfere with reproductive function, metabolism, and/or appetite (e.g., oral contraceptives) within the past 3 months Use of fertility medications in the past 2 months (e.g., Clomid) Current use of a non-copper intrauterine device for contraception (e.g., Mirena) Diagnosis of premature ovarian failure, endometriosis, or another disease/disorder (other than PCOS) known or suspected to interfere with reproductive function History of ovarian surgery Missing uterus or an ovary Pregnant or breastfeeding Diagnosis of a bleeding disorder Regular use of blood thinners/anticoagulants Skin allergy/condition that might be aggravated by alcohol application
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-40.0, Caffeine Cellulitis Patients with mild to moderate cellulite diagnosis will be included, according to the validated Photonumeric scale of cellulite severity Body mass index less than 30 (kg / m2) Individuals who have a deregulated menstrual cycle who are pregnant Breastfeeding or using some hormone Antibiotic medication including steroids over 1 month of treatment of skin diseases; •Sensitivity or hypersensitivity of the skin Use of the same or similar cosmetics or remedies on the glutes within 1 month Surgical procedure (liposuction and skin treatments) in the region to be treated or planning some procedure within the study period Chronic debilitating diseases such as asthma, diabetes or hypertension Atopic dermatitis
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Thumb Osteoarthritis Adult men and women (>18 years of age) No prior traumatic thumb injuries (fractures, dislocation) No concurrent thumb procedures scheduled Eaton/Littler stage 2-4 osteoarthritis9 Minimal CMC joint subluxation on x-ray Traumatic thumb injury (fracture, dislocation) Prior thumb surgery proximal to the interphalangeal joint. Non-fluent English Speaking Planned concurrent procedures on the thumb eg ganglion removal, trigger thumb release
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Cracked Nipple During Lactation Normal spontaneous delivery Pregnancy weeks between 37-42 Single birth Initiated breastfeeding Presence of crack in the nipple Medication applied to the nipple The maternal health condition that may interfere with breastfeeding The infant with congenital abnormalities that would impair breastfeeding The infant attained low birth weight or other to intensive care unit
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, NASH - Nonalcoholic Steatohepatitis Women 18-45 years of age at Baseline Visit. 2. Documentation of NASH diagnosis confirmed on baseline liver biopsy (performed as clinical care) prior to study enrollment. 3. Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data 3. Uncontrolled diabetes (HbA1c 9.5% or higher within 60 days prior to enrollment) 4. Routine alcohol consumption >7 drinks per week during the preceding 3 months prior to baseline liver biopsy. 5. Other forms of chronic liver disease including hepatitis B virus infection (hepatitis B surface antigen positive), chronic hepatitis C virus (HCV) infection (HCV Ab and HCV ribonucleic acid positive), autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology 6. Any prior or upcoming weight reduction surgery (e.g., Roux-en-Y or gastric bypass) 7. HIV infection 8. Receipt of drugs associated with NAFLD (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or between baseline and follow-up biopsies 9. Perimenopausal status (defined as within 3 years of self-reported menopause) due to unstable hormonal levels during that time 10. Renal impairment defined as glomerular filtration rate <45 ml/min/1.73m or potassium levels > 5.0 mmol/L due to the diuretic effect of spironolactone 11. Participation in another clinical trial of an investigational drug or device 12. History of medication non adherence as noted upon chart review or patient report of difficulty with medication adherence 13. Androgen receptor antagonist use (i.e. flutamine, spironolactone or flutamide) for more than 3 months within one year prior to baseline biopsy 14. Eplerenone use as this is a diuretic that also blocks the aldosterone receptor and could compound side effects 15. Cirrhosis on baseline biopsy as this condition leads to altered sex hormone metabolism 16. Unstable dosing (i.e. dose increase, intermittent use, or initiation) of Vitamin E anytime during the 3 months prior to baseline biopsy 17. Significant weight loss (at least 10% decrease in body weight) over preceding 3 months prior to baseline biopsy 18. Contraindication to MRI scanning (e.g. presence of permanent pacemakers, implanted cardiac devices, etc.)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-36.0, Menstrual Disorders Polycystic Ovary Syndrome Female aged 18-36years Females diagnosed with Polycystic ovarian syndrome according to Rotterdam criteria Participants willing to adopt a healthy life style and regularly practice yoga (at least 30 minutes for 5 days a week) Diabetes mellitus, Cushing's disease, hyper-prolactinemia Untreated hypo or hyperthyroidism Adrenal hyperplasia and adrenal tumour Ovarian tumour hyperthecosis History of intake of drugs aldactone/metformin or history of oral contraceptive pills (OCP) use or intake of drugs known to interfere with carbohydrate metabolism 4 weeks prior to enrolment pregnancy, breast feeding cases with any systemic disease
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Leukemia Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease Female with uneligible MRI exam conditions
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Hypercorticism Subject, male or female over 18 Subject presenting a hypercortisolism in remission or controlled by a drug treatment for more than one year Subject with a good understanding of the French language Non-institutionalized subject Subject whose informed consent could be obtained Minor subject or over 80 years Subject presenting hypercortisolism in remission for more than 20 years Major cognitive impairment that does not allow answering a questionnaire Genetic syndrome responsible for hypercortisolism Mixed adenoma whose corticotropic share is responsible for hypercortisolism Pituitary carcinoma Subject refusing to participate in the study Subject having no close Subject whose relative refuses to answer the questionnaires
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 65.0-90.0, Vitamin D Deficiency Cognitive Decline for this study are: 1) Age 65-90; 2) Low Vitamin D status, defined by a serum 25-OHD <20 ng/ml, as measured by competitive immunoassay at the Screening visit; 3) Fluent in either English or Spanish; 4) Willingness to be randomized to high-dose vs. standard dose vitamin D; 5) Education adjusted scores between 12-30 on the Montreal Cognitive Assessment (MOCA) at baseline; 6) A consensus clinical diagnosis of No Cognitive Impairment, Mild Cognitive Impairment, or mild AD dementia In order to be included in the No Cognitive Impairment (NC) subgroup, an individual must show no significant cognitive impairment on the baseline neuropsychological tests. Diagnoses are made by a comprehensive case conference review, including investigators from both sites, resulting in a consensus diagnosis made according to current research criteria. We will also require a minimum MOCA score of 23 or above for those with education >12 y, or MOCA >20 (uncorrected score) for those with education <12 years. These subjects are expected to mostly have CDR global scores of 0, but we will not CDR=0.5, as long as Peterson (Petersen, Journal of Internal Medicine 2004) for MCI (amnestic or non-amnestic) are not met and the CDR-Sum of Boxes is <1.0. Similarly, we will not elderly with subjective memory complaints from the NC group In order to be included in the Mild Cognitive Impairment (MCI) subgroup, a participant will need to meet research for amnestic MCI, either single-domain or multiple-domain (McKhann et al, Neurology 1984). Thus, participants with amnestic MCI will have standardized memory scores >1.5 SDs below average, and if cognitive scores in other cognitive domains are also >1.5 SDs below average they will be classified as multiple-domain amnestic MCI. All MCI participants will be required to have a global CDR=0.5. In addition, we will require a minimum MOCA score of >20 for those with education >12 y, or MOCA >17 (uncorrected score) for those with education <12 years In order to be included in the Mild AD dementia subgroup, a participant will need to meet research for probable or possible AD (McKhann et al, Neurology 1984). A global CDR score of 1 will be required (mild dementia). In addition, we will require a minimum MOCA score of >15 at entry for those with education >12 y, or MOCA >12 (uncorrected score) for those with education <12 y. AD therapies will be allowed (e.g. donepezil, memantine) as long as doses have been stable for >6 weeks, and no changes in doses or CNS active medications are planned while participating in this trial (for all participants) are: 1) Lacks adequate vision, hearing, or literacy to complete the required psychometric tests (e.g. severe bilateral deafness despite use of hearing aids, or visual acuity poorer than 20/100 in both eyes); 2) Hepatic insufficiency, defined by either albumin <3.3 g/dL or by a value >2X the upper limit of normal (ULN) in either alanine aminotransaminase (ALT/SGPT) or bilirubin, or >3X the ULN for aspartate aminotransaminase (AST/SGOT); 3) Renal insufficiency, defined by either serum creatinine >1.7 mg/dL or glomerular filtration rate <40 mL/min/1.73 m2; (calculated per CKD-EPI formula). 4) Hypercalcemia, defined by serum calcium level >2 standard deviations above the mean. Corrected Calcium mg/dL = [0.8*(4.0g/dL Patients Albumin g/dL)] + Serum Calcium mg/dL (X of 8.6-10.5 is in normal range; formula accurate only if Albumin is in 3.2-4.6 range). 5) Current serious or unstable medical illnesses including cardiovascular (e.g. unstable ischemic cardiovascular disease), hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the participant being able to safely take high-dose vitamin D for the 3.5 year study duration; or has a life expectancy of <4 years; 6) History of recurrent renal stones; 7) Unable to undergo MRI scanning (e.g. pacemaker, metallic implants, severe claustrophobia); 8) Subjects with a history of osteoporosis will be excluded if the Screening serum 25-OHD level is < 12 ng/ml. 9) History of chronic psychiatric illness (e.g. schizophrenia, bipolar disorder), any episode of major depression within last 2 years, or current GDS > 6, any recent suicide attempts or suicidal ideation; 10) history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis), or head trauma resulting in protracted loss of consciousness (>10 minutes) or any persistent cognitive deficit; 11) History of chronic alcohol or drug abuse/dependence as defined by DSM-IV, within the past 5 years; 12) History within the last 5 years of a primary or recurrent malignant disease with the exceptions of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or non-metastatic prostate cancer with a normal prostate-specific antigen post-treatment; 13) Does not have good venous access, such that multiple blood draws would be precluded; 14) Regular use of any of these CNS active medications: benzodiazepines, antipsychotics, narcotics, cholinesterase inhibitors, memantine or anti-epileptic drugs. Stable doses of SSRIs or SNRI anti-depressants will be allowed, and included persons will be discouraged to change the doses of any potentially CNS active medication throughout the 3.5-year study. 15) Those who plan to change their dosage of any vitamin supplement during the duration of the study may be discontinued from the clinical trial. Changes in vitamin supplement dosing (e.g. vitamin B12) will only be allowed if a specific deficiency has been found. If participants are taking vitamin D supplementation (e.g. in a daily multi-vitamin) at the time of screening, they should continue on this same dose of vitamin supplementation throughout the duration of the randomized clinical trial. 16) Current participation in any clinical trial involving experimental AD therapies (anti-amyloid, anti-tau, etc.). 17) Female subjects who are pregnant or plan to become pregnant during participation in this trial. 18) Inability to swallow oral capsules We will not subjects with stable coronary artery disease or vascular risk factors such as diabetes or hypertension, who otherwise meet our inclusion/exclusion criteria. We will allow of participants with prior TIA or prior history of one stroke, but will those with past history of multiple strokes. We will allow participants with up to two incidental infarcts on structural MRI, because the presence of cerebrovascular disease is very common in any representative sample of U.S. elderly persons, and may be an important contributor to dementia and age-associated cognitive decline. We will not those with severe white matter (WM) hyperintensities, for similar reasons
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-94.0, Acromegaly Age >=18 years-old and <95 years-old Patient self-reported acromegaly diagnosis which will be further confirmed by a knowledge screening based on current medications and doses Currently on injectable Somatostatin analogues (SSA), Sandostatin® LAR or Somatuline® Depot, for >=12 months Have not had a change in dosage of their acromegaly treatment at the time of or since their last office visit Have seen their treating acromegaly physician within the past 12 +/-2 months NOTE: This timeframe allows two additional months for scheduling an appointment with their physician, since most patients should see their acromegaly physician at least once every 12 months Ability to read and understand English Live and receive acromegaly treatments in the US Willing to provide signed informed consent Previous or current participant in Mycapssa® (octreotide capsules) trial Use of Pegvisomant (Somavert®) monotherapy Use of Pasireotide (Signifor®)
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Carcinoma, Squamous Cell of Head and Neck Written informed consent including participation in translational research and any locally required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years at time of study entry 3. Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) or nasal sinus not amenable to local therapies 4. Availability of tumor tissue from biopsy for determination of PD-L1 and HPV status according to the following priority ranking: i) recent biopsy (≤3 months old) without intervening therapy; ii) any recent biopsy (≤3 months old); iii) any archival tumor tissue (> 3 months old) [Biopsy should be excisional, incisional or core biopsy. Fine needle aspiration is not allowed.] 5. Progression or recurrence during or after platinum-based palliative chemotherapy for relapsed or metastatic disease OR Progression within 6 months after completion of definitive platinum-containing radiochemotherapy for locally advanced disease 6. At least 1 measurable lesion according to 1.1 7. ECOG performance status 0-1 8. Completion of local therapy for brain metastases with discontinuation of steroids prior to start of study treatment 9. Adequate blood count, liver enzymes, and renal function neutrophil count > 1.5 x 10^6/mL platelet count ≥ 100 x 10^9/L (>100,000 per mm³) hemoglobin ≥ 9 g/dL INR ≤ 1.5 and PTT ≤ 1.5 x lower limit during the last 7 days before therapy AST (SGOT)/ALT (SGPT) < 3 x institutional upper limit of normal (5 x lower limit in case of liver metastases) bilirubin < 1.5 x ULN serum creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 40 mL/min 10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. 11. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. [WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of nivolumab.] Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) do not require contraception. 12. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. [Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of up to 7 months after the last dose of IMP.] Men who are not of childbearing potential (ie, surgically sterile or azoospermic ) do not require contraception 13. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up Nasopharynx carcinoma or carcinoma of salivary glands 2. Life expectancy less than 3 months 3. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: 1. Minor surgery ≤ 24 hours prior first dose of nivolumab monotherapy 2. Anticancer treatment during the last 30 days prior to start of nivolumab monotherapy, including systemic therapy, or major surgery [palliative radiotherapy has to be completed at least 2 weeks prior to start of nivolumab monotherapy] 3. Known active HBV, HCV or HIV infection 4. Active tuberculosis 5. Any other active infection requiring systemic therapy 6. History of allogeneic tissue/solid organ transplant (including hematopoietic stem cell transplantation) 7. Diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy or randomization. 8. Has an active autoimmune disease requiring systemic treatment within the past 3 months before enrolment or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. Psoriasis not requiring treatment is not excluded from the study. 9. Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy or during study treatment. 10. Other active malignancy requiring treatment 11. Clinically significant or symptomatic cardiovascular/cerebrovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrollment 12. History or clinical evidence of CNS metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following are asymptomatic and have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases 4. Medication that is known to interfere with any of the agents applied in the trial. 5. Has known hypersensitivity to nivolumab or ipilimumab or docetaxel or any of the constituents of the products. 6. Any other efficacious cancer treatment except protocol specified treatment at study start. 7. Patient has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. [Subjects with ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.] 8. Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. 9. Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand,a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) 10. Participation in another clinical study with an investigational product during the last 30 days before or 7 half-lifes of previously used trial medication, whichever is longer 11. Previous treatment in the present study (does not screening failure) [Criterion is not applicable during re-assessment of for randomization]. 12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG. 13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG]
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Patients Requiring Mandible Orthodontic Treatment Patients requiring at least mandible orthodontic treatment (both arches) Patient presenting alveolar bone thickness < XX mm Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002) Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975) American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease) Adequate dento-oral health (i.e., the absence of periodontal diseases, peri-apical infection, or untreated caries) were as follows Controlled periodontitis with a loss of alveolar support > 10% Gingival recession > 2 mm Smokers Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use) Mental or motor disabilities Pregnancy
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-64.0, Acromegaly Muscle Dysfunction Physical Activity Exercise Patients with acromegaly, of both sexes, older than 18 and younger than 65 years, either with active or controlled disease Patients who present clinical stability and who are eligible for the treatment protocol (patients with hormone deficiency will continue on replacement therapy - SILVA et al., 2013) Signature of the Informed Consent Term (TCLE) Patients with inability to perform the 6MWT, according to ATS criteria Patients who have cognitive impairment by mini mental state examination (MEEN) Abandonment of treatment during the application of the protocol Uncontrolled hypertension (> 180/100 mmHg with medication use) Use of psychotropic drugs Any significant limitations due to osteoarthropathy History of surgery in the previous year with exercise restriction. Não Untreated hypothyroidism or hypocortisolism (HUBBLE et al., 2014) IPAQ with very active classification
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Anal Squamous Intraepithelial Neoplasia HIV infection as confirmed by ELISA and western blot Unable to provide informed consent
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Parkinson Disease Dexterity Rehabilitation diagnosis of Parkinson's Disease other neurological disease psychosis auditive or visual deficit
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-35.0, Polycystic Ovary Syndrome Infertility Women age ≤35 years; 2. AMH level ≥5.6ng/ml; 3. Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria; 4. Written informed consent Women who diagnosed as uterus abnormality, adenomyosis, submucous myoma, intrauterine adhesion Women who diagnosed as untreated hydrosalpinx Women who had underwent unilateral ovariectomy Women with medical condition that represent contraindication to assisted reproductive technology or pregnancy Women or their partner with abnormal chromosome karyotype Male partner with oligoasthenozoospermia or obstructive azoospermia Male partner whose sperm is collected by surgery Subjects are found breach the or in accordance with during the test, excluded Patients request withdrawal and exit the trial because adverse events occur during the trial
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Acromegaly Male and female subjects 18 to 70 years of age 2. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. Willing to provide signed informed consent Treatment naïve acromegaly subjects 2. Prior treatment with paltusotine 3. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions. 4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result 7. History of alcohol or substance abuse in the past 12 months 8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities 10. Subjects with symptomatic cholelithiasis 11. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study 12. Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg 13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Acromegaly Male and female subjects 18 to 70 years of age 2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot 3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. Willing to provide signed informed consent Treatment naïve acromegaly subjects 2. Prior treatment with paltusotine 3. Pituitary surgery within 6 months prior to Screening or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible. 4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years. 5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result 7. History of alcohol or substance abuse in the past 12 months 8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities. 10. Subjects with symptomatic cholelithiasis 11. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study 12. Subjects who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months) 13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg 14. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Breech Presentation; Before Labor Pregnant nulliparous women Breech presentation of fetus, eligible for external version Unwilling to participate Unable to understand written and oral Swedish in the absence of interpreter Contraindications to spinal anaesthesia
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-999.0, Pituitary Adenoma Confirmed pituitary adenoma for whom pituitary imaging is indicated as part of standard clinical management Pregnancy, breastfeeding and any contraindications to MRI or intravenous contrast administration
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-35.0, Polycystic Ovary Syndrome To be included in this study, participants must be: 1. Female, within 16-35 years of age 2. Diagnosed with Polycystic Ovary Syndrome based on the 2003 Rotterdam (must meet 2 out of 3 criteria): 1. evidence of either biochemical or clinical hyperandrogenism (elevated free and or total testosterone level above the normal reference range for assay, and/or an modified Ferriman-Gallwey hirsutism score >8) 2. Oligo or anovulation 3. Polycystic ovary morphology on ultrasound 3. Adolescents should be at least 2 years out from menarche (first menstrual period). 4. Participants must not be on an oral contraceptive pill (OCP) at the start of the study and or Spironolactone therapy (an anti-androgen medication), but recommended by their physician to start OCP therapy Females with Polycystic Ovary Syndrome (PCOS) who do not have either biochemical (elevated total or free testosterone levels) or clinical (modified Ferriman-Gallwey hirsutism score <8) findings of hyperandrogenism will not be included in the study as this is one of the primary outcome measures. 2. Females with PCOS who are already on and currently using a form of contraceptive (oral, IUD, vaginal ring, or patch) 3. Females that are concurrently using or plan to use an anti-androgenic medication such as Spironolactone in the next 6 months. 4. Females currently or are planning to obtain permanent hair removal (ex. laser hair removal, electrolysis) in the concurrent 6 months of starting oral contraceptive (OCP) therapy will also be excluded from the study 5. Women who are pregnant or have contraindications for starting an OCP, including active smokers, history of clotting disorders, history of deep vein thrombosis or blood clots, neoplasia, vascular disease, migraines, hypertension, or have renal/hepatic disease will be excluded from the study as OCP therapy would not be indicated or approved in this population. 6. Females with elevated potassium levels above the normal reference range for age
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 15.0-50.0, Hypertension, Pregnancy-Induced Hypertension, Essential Hypertension Hypertension; Pre-Eclampsia Hypertension in Pregnancy High risk pregnancy At 12-16 weeks of gestation Aged between 15 to 50 years Living in Matlab bangladesh Have congenital malformation/anomaly in current pregnancy Current pregnancy have chromosomal abnormality e.g. Down syndrome Have chronic debilitating illness Mother is a known case of psychosis Who do not have electricity at their house Do not have smart phone at their house
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, PCOS PCOS patients in the age range 18 years old Diagnosis of PCOS is based on the 2003 ESHRE/ASRM diagnostic according to which patients who had at least two of the following conditions are accepted as having PCOS: 1. Oligo or anovulation, defined by the presence of oligomenorrhea or amenorrhea, confirmed by luteal progesterone and normal serum follicle stimulating hormone (FSH) levels (1.0-10.0 IU/L). 2. Clinical hyperandrogenism signs which was defined as the presence of at least one of the following three features: hirsutism, acne, and androgenic alopecia. Biochemical hyperandrogenism was defined as a serum testosterone (T) level >60 ng/dL (>2.08 nmol/L). 3. PCOS manifestation was defined as the presence of >12 unilateral follicles 2-9 mm in size on the ovary or having the least unilateral ovary volume of 10 cm3 by ultrasonography (the measurement was performed when there was no follicle >10 mm). Ovarian volume was calculated by the formula [0.5× ovarian length × thickness × width]. In the case of transabdominal ultrasonography, the presence of at least 10 unilateral antral follicles was required Patients (age <18 or > 40years) Other endocrinology diseases as diabetes mellitus or thyroid disorders, Brain disorders as pituitary adenoma or tumour or brain tumours or masses Chronic diseases such as cardiovascular, hepatic, hematologic, chronic renal failure, hypertension, and cancer Use of oral contraceptives, antiandrogenics, glucocorticoids, antihypertensives, antidiabetics and anti-obesity drugs as well as the cigarettes, alcohol, and patients unwilling to participate in the study
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-38.0, Polycystic Ovary Syndrome Ovarian Hyperstimulation Syndrome Infertile women with polycystic ovary syndrome based on Rotterdam criterion 2. 20<Age<38 3. BMI<30 4. Non recurrent miscarriage 5. Non endocrine, hematologic and autoimmune disorders 6. Non chromosomal and genetic abnormalities 7. Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydrosalpinx, uterine fibroids 8. Non azoospermia Patient's tendency for withdrawal
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-999.0, Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Anatomic Stage IV Breast Cancer AJCC v8 Anemia Ann Arbor Stage III Hodgkin Lymphoma Ann Arbor Stage III Non-Hodgkin Lymphoma Ann Arbor Stage IIIA Hodgkin Lymphoma Ann Arbor Stage IIIB Hodgkin Lymphoma Ann Arbor Stage IV Hodgkin Lymphoma Ann Arbor Stage IV Non-Hodgkin Lymphoma Ann Arbor Stage IVA Hodgkin Lymphoma Ann Arbor Stage IVB Hodgkin Lymphoma Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Castration-Resistant Prostate Carcinoma Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Hematopoietic and Lymphoid Cell Neoplasm Locally Advanced Pancreatic Adenocarcinoma Metastatic Breast Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Pancreatic Adenocarcinoma Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Primary Myelofibrosis Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive Recurrent Hematologic Malignancy Recurrent Hodgkin Lymphoma Recurrent Myelodysplastic Syndrome Recurrent Myelodysplastic/Myeloproliferative Neoplasm Recurrent Myeloproliferative Neoplasm Recurrent Non-Hodgkin Lymphoma Recurrent Plasma Cell Myeloma Recurrent Small Lymphocytic Lymphoma Refractory Acute Lymphoblastic Leukemia Refractory Acute Myeloid Leukemia Refractory Chronic Lymphocytic Leukemia Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive Refractory Chronic Myelomonocytic Leukemia Refractory Hematologic Malignancy Refractory Hodgkin Lymphoma Refractory Malignant Solid Neoplasm Refractory Myelodysplastic Syndrome Refractory Myelodysplastic/Myeloproliferative Neoplasm Refractory Non-Hodgkin Lymphoma Refractory Plasma Cell Myeloma Refractory Primary Myelofibrosis Refractory Small Lymphocytic Lymphoma Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Unresectable Pancreatic Adenocarcinoma Key Ability to understand and the willingness to sign a written informed consent document Participants, both men and women, must agree to use an adequate method of contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration Patients must have a histologically or cytologically-confirmed metastatic solid tumor or hematological malignancy that has progressed as follows Patients with a solid tumor must have metastatic disease and have progressed on at least 1 line of established therapy that is known to provide clinical benefit, or for whom no standard curative therapy exists. Participants with newly diagnosed, unresectable, locally-advanced or metastatic pancreatic adenocarcinoma and are beginning first-line treatment with a course of chemotherapy are eligible OR Participants must have a hematological malignancy that is advanced, relapsed, or refractory to at least 1 line of established therapy that is known to provide clinical for the treatment of their disease. Hematological disease included in this study are as follows Acute myelogenous leukemia (AML), or Myelodysplastic syndrome (MDS), or MDS/myeloproliferative neoplasms (MDS/MPN), or Participants with metastases to the central nervous system that are considered uncontrolled and/or were diagnosed within the past 4 weeks of screening for this study Participants cannot have an active malignancy of another cancer. Those with a history of prior malignancy will be considered on a case-by-case basis. Guiding examples for those who can be enrolled individuals who have been disease free for > 5 years; individuals who are considered to have a high likelihood of being cured (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated localized non-melanomatous skin cancer Participants cannot be on other forms of anti-cancer therapy at the same time, except as described within this protocol. There must be at least a washout period that accounts for 5 half-lives (or >= 21 days, whichever is longer) of last therapy Participants with prostate cancer (PCa) will continue treatment with androgen deprivation therapy, either by prior castration or treatment with luteinizing hormone-releasing hormone (LHRH) antagonists or agonists, as is standard practice Participants with breast cancer (BCa) who are HER2 positive may continue to receive anti-HER2 therapy per standard practice guidelines, while participants who are hormone receptor positive may continue to receive hormone therapy per standard practice guidelines Participants with a hematological malignancy may continue to receive hydroxyurea or other hypomethylating agent for two cycles of therapy, as described in this protocol Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD Participants with uncontrolled infection will not be enrolled until infection is treated Participant is seropositive with human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Acne Vulgaris adult female patients with acne vulgaris between 18-40 years old any disease affecting sexual function will be excluded like female genital mutilation females with other major medical, endocrine and genital comorbidities or receiving medications that affect sexual function females with frank psychological disturbances
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Deep Vein Thrombosis Thromboses, Venous Thrombosis Embolism Postthrombotic Syndrome Pulmonary Embolism case of venous thrombosis of a limb or pulmonary embolus
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-35.0, Gender Role Woman's Role Couples Literacy Family Size Women ages 18-35 years who live with their husbands or partners within the pre-selected study clusters Consent from husband/partner as well as eligible woman Women in polygynous unions, if the wife co-resides with her husband Either woman or partner does not give consent
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Nipple Sparing Mastectomy Female between ages 18-80 BMI ≤ 29 Candidate for an NSM procedure At increased risk for breast cancer and is seeking prophylactic NSM surgery Breast ptosis ≤ Grade 2 Cup size ≤ C No presence of occult cancer as confirmed by physical exam and by preoperative imaging per institution's guidelines Current or prior history of ipsilateral in-situ or invasive breast carcinoma Previous breast surgery of the ipsilateral breast Current history of smoking or has smoked within 1 year of screening Skin conditions Uncontrolled diabetes mellitus Previous chemotherapy or radiation High risk for anesthesia or significant medical comorbidities Contraindicated for general anesthesia or surgery Known bleeding or clotting disorder Pregnant or suspected to be pregnant or is lactating
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acne Scars All gender patients Age older than 18 years Fitzpatrick skin types I-III Facial acne scarring of grades III-IV Both sides of the face should have similar amount and severity of acne scarring History of keloidal scarring Localized or active infection in the treatment region Immunodeficiency disorders Porphyria or light sensitivity Connective tissue disorders Pregnant or nursing Recent isotretinoin use within the past 6 months Renal Disease Allergies to lidocaine, tetracaine, valacyclovir
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.083-18.0, Kawasaki Disease Appendicitis Patients with Kawasaki disease Acute abdomen requiring surgery Patients with chronic gastrointestinal disease Incomplete data on the charts
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-49.0, Polycystic Ovary Syndrome Women with PCOS aged 20-30 years and 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea (average menstrual cycle length >45 days or fewer than 9 menses/year) or irregular menstruation (substantially inconsistent menstrual cycle length). Note: For subjects aged 40-49 years, they will be allowed to participate if they have fewer than 10 menses/year (average menstrual cycle length >35 days) as long as they have a compelling past history of oligomenorrhea or irregular menstruation Screening safety labs within normal reference ranges although mild abnormalities that are common in obesity and/or hyperandrogenism will not be grounds for (see Subjects must be willing and able to provide written informed consent Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study Willingness and ability to comply with scheduled visits and study procedures Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone [FSH] level) Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5 ng/mL. As an alternative, cycle day 3 FSH > 9 IU/L (with concomitant estradiol level >80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH >9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3 History of hysterectomy and/or bilateral oophorectomy BMI ≥ 40 kg/m2 Inability to comprehend what will be done during the study or why it will be done Being a study of older women with PCOS, children and men will be excluded Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy test will be informed of the result by the screening physician
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-0.038, Osteopathic Medicine Breast Feeding term infants > 37 weeks gestation Level I newborn receiving lactation support identified by lactation as having a newborn component to feeding dysfunction, -must be available for at least two inpatient treatment sessions parent has provided informed assent infants <37 weeks gestation Level II or III nursery status wards of the state receiving speech or physical therapy currently receiving OMT, bottlefed infants infants breastfeeding with maternal factors contributing to feeding dysfunction (e.g. nipple problem)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Snoring Obstructive Sleep Apnea Asthma Airway Disease Inflammatory Disease Concomitant Disease • Severe snorers that seek help based on their personal health and/or social limitations due to their snoring Patients with known OSA Patients with nasal polyps Other inflammatory diseases of the upper airways (i.e. cystic fibrosis, primary ciliary dyskinesis) or immune deficiencies, sarcoidosis or systemic vasculitis Infections in the upper airway during the past two weeks Smokers Treatment with antidepressant or sedative drugs Age below 18 Patients unable to give an informed consent Patients that do not speak or read Danish
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 35.0-45.0, Infertility, Female A. Women aged 35-45, married, without contraception, after 12 months of normal sexual life, did not take any contraceptive measures, and did not successfully conceive women. B. Blood tests for serum anti-Mullerian hormone ( AMH) less than 1.2, female hormones FSH, LH, E2 blood test is normal. C. Women who are not planning for IUI or IVF in the next three months. D. Menstrual cycle rules 21-35 days. E. Willing to sign a written consent form A. Women with contraceptive. B. Vegetarians or have been taking Traditional Chinese medicine allergies. C. The following diseases have occurred in the past six months: cancer, high blood pressure, diabetes, heart disease, stroke, myocardial infarction, hyperthyroidism or hypothyroidism, chronic hepatitis, gastric ulcer, stomach bleeding, chronic constipation or diarrhea, major trauma and surgery, severe uterine and pelvic infections. D. Because of the need for disease, it is currently necessary to take western medicine for more than three months. E. Women with abnormal liver function (GOT, GPT greater than 2 times the upper limit of normal). F. Women with abnormal renal function (serum creatinine > 1.5 mg/dl). G. Poor compliance with medication. H. In the past month, take a Traditional Chinese medicine to treat infertility. I. Take DHEA for the past month
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, Congenital Diaphragmatic Hernia Patient is a pregnant woman between 18 and 45 years of age Singleton pregnancy The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age Confirmed diagnosis of severe left or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0/7 and 31+6/7 weeks' gestation.) Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome Normal fetal karyotype or microarray The mother must be healthy enough to have surgery Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure Patient willing to remain in Houston for the duration following balloon placement until delivery Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia Allergy to latex Allergy or previous adverse reaction to a study medication specified in this protocol Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI Maternal BMI >40 High risk for fetal hemophilia
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-40.0, Polycystic Ovary Syndrome We will women in one PCOS subtype, those having these two symptoms Hyperandrogenism (a) If not on current birth control: hyperandrogenism defined as current elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism (b) if on current birth control: history from the past 10 years of hyperandrogenism defined as past elevated total testosterone >= 50 ng/dL or free androgen index > 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism oligomenorrhea-anovulation defined as spontaneous intermenstrual periods of ≥ 45 days or a total of ≤ 8 menses per year. Participants must also be overweight or obese (BMI 25-50) be 21-40 years old have regular access to the internet be able to engage in light physical activity willing and able to follow the assigned intervention a non-English speaker inability to complete baseline measurements a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy) pregnant or planning to get pregnant in the next 6 months type 1 or type 2 diabetes baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal baseline renal disease defined as BUN > 30 mg/dL or serum creatinine >1.4 mg/dL baseline uncorrected thyroid disease (TSH <0.45 mIU/ML or >4.5 mIU/ML) breastfeeding or less than 6 months post-partum planned or history of weight loss surgery
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Colorectal Cancer Patients with age more than 18 years Presenting to fast track colorectal clinic 1. With bowel symptoms 2. Presenting with anaemia 3. Rectal bleeding Any patient presenting through routine colorectal clinics 1. With bowel symptoms 2. Presenting with anaemia 3. Rectal bleeding Aged less than 18 years
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-89.0, Propionibacterium Acnes Male subjects Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center Subjects between ages 18-89 Subjects who self-report very sensitive skin Subjects who are sensitive to benzoyl peroxide Subjects who are allergic to chlorhexidine Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery) Subjects who had recent use of acne treatment Subjects who are not fluent in English
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Lung Cancer Non Small Cell Lung Cancer Adenocarcinoma of Lung Participants are eligible to be included in the study only if all of the following apply Male and female participants who are at least 18 years of age on the day of signing the informed consent will be enrolled in the study Subjects must have histologically confirmed diagnosis of non-squamous non-small cell lung cancer not amenable to potentially curative treatments (surgical resection, definitive radiation therapy or a combined modality approach) or targeted agents to actionable EGFR mutations or ALK or ROS1 gene rearrangement and excluding neuroendocrine tumors. Activating KRAS mutations are allowed. The diagnosis must be confirmed by the Laboratory of Pathology, CCR, NCI. Mutation confirmation may be done by referring institutions or by one of the assays in the Protocol Have provided archival tumor tissue sample or newly obtained fresh core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue Histologically confirmed 25% of tumor cells expressing mesothelin as determined by NCI Laboratory of Pathology. Determination can be made using archival tumor tissue or fresh biopsy Have measurable disease based on 1.1. Lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions Subjects must have received prior standard of care treatments for locally advanced or metastatic NSCLC Patients must be more than 3 weeks out of systemic treatments, such as chemotherapy All acute toxic effects of any prior radiotherapy, chemotherapy, immunotherapy, or surgical procedure must have resolved to Grade less than or equal to 1, except alopecia (any grade) and Grade 2 peripheral neuropathy Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-999.0, Hypnotic Dependence Among Those With Insomnia be currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia management; 2. have been using one or more such agents at least 5 nights/week for at least the past 12 months; 3. express interest in discontinuing hypnotic use and learning to manage their insomnia without medications; 4. report one or more failed attempts to discontinue hypnotic use in the past; 5. provide written consent to participate. 6. have an insomnia severity index score > 10 indicating at least mild insomnia symptoms without sleep medication an untreated, or unstable psychiatric disorder as suggested by current active symptoms or a medication regimen that has been changed within the past 2 months; 2. a lifetime diagnosis of any psychotic or bipolar disorder 3. an imminent risk for suicide 4. evidence of alcohol or drug abuse (other than hypnotics) within the past year, since such abuse patterns suggest specialized substance abuse treatment may be indicated 5. unstable or terminal physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia) or sleep disruptive medical condition 6. current use of medications known to cause insomnia (e.g., corticosteroids) 7. screening evidence of circadian rhythm sleep disorder (e.g., delayed sleep phase syndrome) or other sleep disorder (e.g. narcolepsy, idiopathic hypersomnolence, Rapid Eye Movement (REM) behavior disorder) for which CBTI would not represent optimal therapy 8. habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM; 9. consuming > 2 alcoholic beverages/day or any cannabis products at least 5 times/week 10. pregnant women or mothers with care-taking responsibilities for infants due to the sleep-disruption caused by such circumstances 11. clinical or polysomnographic evidence of undiagnosed and untreated restless legs syndrome (RLS), sleep apnea or periodic limb movements (PLMS) that require alternative therapies and would limit participants' responses to CBTI
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Chronic Pain Pelvic Pain Functional Abdominal Pain Syndrome Low Back Pain Migraine Age greater than or equal to 18 years old Diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back pain, or migraine with or without aura of at least 3 months duration English speaking Ability and willingness to complete questionnaires and in-person assessments Current average daily pain score of greater than or equal to 4 on the Numeric Rating Scale of Pain (0-10 scale) For patients with migraine diagnosis they must report at least 2 headaches in the baseline headache diary in the 30 days preceding randomization Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status) Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression Any suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9 assessing suicidal thoughts Any current illicit drug or alcohol abuse Any history of recurrent or unprovoked seizures Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days Pregnancy, breast-feeding or lack of reliable contraception Changes in pain medications in the previous 4 weeks Implanted electrical stimulation device Skin infection over stimulation sites
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Male or female patients, ≥18 years at screening Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening IGF-1 levels ≤1xULN at screening Adequate liver, pancreatic, renal and bone marrow functions Normal ECG GH ≥2.5 μg/L at screening (cycle) Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer] Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening Patients who have undergone pituitary surgery within 6 months prior to screening Patients who have received prior pituitary irradiation Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Grown-up Congenital Heart Disease (GUCH) GUCH, stable medication for at least 4 weeks instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 12.0-999.0, Teeth; Anomaly, Position Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII). 2. Full set of lower permanent dentition excluding the third molars. 3. No history of trauma or root resorption in the lower incisors Previous orthodontic treatment. 2. Less than 3mm of lower incisor crowding (LII) or with spaced incisors. 3. Severe crowding in the lower arch (greater than 7mm) which requires extraction. 4. Blocked-out teeth that cannot be engaged with the aligning archwire. 5. Patients with periodontally compromised teeth
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-70.0, Abdominal Pain Should be able to give informed consent for the study Has Enterra GES device in place for at least 2 months Continue to have moderate to severe abdominal pain on at least one pain questionnaire or >5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months Abdominal pain should be either persistent; for example, daily for at least >1 hour, be chronic for >2 months, and refractory to original Enterra GES settings Unable to provide informed consent Pregnancy Any other active health problems that would render patient unable to complete the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 25.0-50.0, Stress Physiology Stress, Psychological female gender to 50 years old current or past neurological, psychiatric, and cardiac disorders cognitive impairment substance or alcohol abuse or dependence recent (last 12 months) traumatic events such as a death in the family, serious accident, job firing or divorce caregiving (last 12 months) a family member with serious pathology or disability current psychotropic or contraceptive drug use
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Abdominal Pain Abdominal Myofascial Pain Syndrome (AMPS) Abdominal Plane Blocks (APB) All patients aged over 18 years. 2. Chronic abdominal pain for above 6 months 3. Moderate to severe pain in the abdomen: Baseline NRS >4 (worst pain the last 24 hours) Lack of consent, including from those patients who lack mental capacity to give informed consent. 2. Patients with known history of drug allergy to depomedrone 3. Patients with infection at injection site at on day of treatment
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 15.0-35.0, Atrophic Scars Minimum age 15years Maximum age 35 years Both males and females with mild, moderate and severe post-acne atrophic scars on face Hypertension Cardiovascular disorders Pregnancy Lactation Hypersensitivity to lidocaine
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Congenital Heart Disease Arrhythmia All patients with congenital heart disease referred for catheter ablation Absence of patient's consent Patient under guardianship or curatorship Pregnant woman
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 16.0-35.0, PCOS It will be based on the Rotterdam of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group Hyperprolactinemia Cushing's disease Hypothyroidism/ Hyperthyroidism Pregnancy and nursing Established type 1 or type 2 diabetes mellitus Any history of drug intake e.g. anti-diabetic or estrogen and progesterone History of treatment for the same complaint taken in the last 3 months Unable to come for regular follow-ups Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology Known allergic to these drugs
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Colorectal Adenoma Colorectal Cancer Endoscopic Surgery Eicosapentaenoic Acid Gastrointestinal Microbiome Participants must meet the following on screening examination to be eligible to participate in the study Underwent screening or surveillance colonoscopy with removal of at least one adenoma Age 18-80 years This study will only adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of AMR101 over the age of 80 have not yet been well-characterized ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately Subjects must be able and willing to follow study procedures and instructions Ability to understand and the willingness to sign a written informed consent document Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study Currently using or have used any fish oil supplement at any dose more than once per week within the last month Regularly consuming more than three servings of fish per week History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to omega-3 fatty acid Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome) Any adenoma that was not completely removed during previous colonoscopy Known bleeding tendency/condition (e.g. von Willebrand disease) or history of peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy Current use of anticoagulant therapies, including Heparin, Warfarin, Dalteparin sodium,Bivalirudin, Argatroban, Lepirudin, Heparin Sodium, Heparin/Dextrose, and an unwillingness or inability to discontinue anticoagulants
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-3.0, Atopic Dermatitis children 1-3 age without rash, without atopic dermatitis children 1-3 age with recurrent atopic dermatitis children 1-3 age with non-specific rush children age 1-2 with atopic dermatitis without rush during previous year
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Pregnancy Prevention Healthy sexually active women who have ever used an FC and using condoms (male or female) as their current method of contraception. 2. Be 18 to 40 years at enrolment (inclusive). 3. Have a negative urine pregnancy test at enrolment visit. 4. Is HIV negative 5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using hormonal contraception. 6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation. 7. Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation. 8. Be willing to accept a risk of pregnancy. 9. Reporting to have at least four acts of heterosexual vaginal intercourse per month for a period of 6 months. 10. Be willing to only use the study product (Cupid or FC2 female condom) as the primary method of contraception over the course of the study. 11. Be capable of using the study product properly and agree to observe all study directions and requirements. 12. Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and details of condom use and any condom failures. 13. Be willing to state that, to her best knowledge, her sexual partner Has not had a vasectomy or been previously diagnosed as infertile Is HIV negative Has no known history of allergy or sensitivity to natural rubber latex, water-based or silicone lubricants Does not want her to become pregnant in the next 7 months 14. Agree to have fingerprint identity check 15. Be willing to give written informed consent to participate in the trial. 16. Intend to stay in the area for the next 6-7 months 17. Be willing to be randomized Have a history of allergy or sensitivity to rubber latex or water-based /silicone lubricants 2. Have evidence of sexually transmitted infections on syndromic assessment and / or vaginal examination 3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study. 4. Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy. 5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy. 6. Be in a monogamous relationship of less than 4 months with their partner. 7. Have any contraindications to pregnancy (medical condition) or regularly use medications that are unsafe to use in pregnancy 8. Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use. 9. HIV positive. 10. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within 3 months prior to screening or have clinical evidence of HSV on exam. 11. Be lactating or breastfeeding. 12. Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening. 13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening. 14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment. 15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or Nur-Isterate in the last 4 months prior to enrolment 16. Have a past (within 12 months) or current history of alcohol or drug [recreational, prescription or over-the-counter (OTC)] abuse. 17. Have taken an investigational drug or used an investigational device within the past 30 days. 18. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-50.0, Cervicogenic Headache Neck Pain For Cervicogenic headache group Unilateral headache, starting from the upper neck/occipital region and spreading to the oculofrontotemporal area on the symptomatic side Pain triggered by neck movements and/or continuous awkward positions Decreased joint range of motion in the cervical vertebra For Cervicogenic headache group Previously diagnosed to have any other syndromes of headache (Migraine, Tension headache, etc.) Presence of bilateral headache; For the neck pain group Presence of 2 or more neurological symptoms (decreased upper extremity muscle strength, decreased reflexes and hypoesthesia compatible with the dermatome regions) Suggesting nerve root compression (radiculopathy, plexopathy); for both groups Presence of any signs suspicious of central nervous system involvement (hyperreflexia, nystagmus, decreased vision, etc) Reluctance to participate in the study
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Head and Neck Cancer Head and Neck Neoplasms Patients must have histologically or cytologically confirmed, previously untreated intermediate/high risk, p16-negative (if oropharyngeal primary tumor), squamous cell carcinoma of the head and neck (T1-T4, N0-N3, M0 stage II, III or IV) Male or female; Age greater than or equal to 18 years ECOG performance status less than or equal to 1 Prothombin time (PT) and partial thromboplastin time (PTT) within normal institutional limits. Patients with prolonged PTT determined to be due to lupus anticoagulant will not be excluded Patients must have adequate organ and marrow function as defined below Absolute neutrophil count greater than or equal to 1000/mcL Platelets greater than or equal to 100,000/mcL Hemoglobin greater than or equal to 10.0 g/dL Total bilirubin within normal institutiona l limits; in patients with Gilbert s, less than or equal to 3.0 mg/dL AST (AGOT)/ALT (AGPT) less than or equal to 3X upper limit of normal Patients who are immunocompromised as follows Human immunodeficiency virus (HIV) positive patients not on or not compliant with appropriate anti-retroviral therapy, patients with newly diagnosed (i.e. < 6 months) HIV, patients with an HIV viral load exceeding 400 copies/mL, HIV+ patients with a CD4 count < 150 cells/ L, and HIV+ patients on antiretroviral therapy < 1 month are excluded. HIV-positive patients will also be excluded if the PI determines that there is a clinically significant drug-drug interaction Chronic administration (defined as daily or every other day for continued use >14 days) of systemic corticosteroids or other immune suppressive drugs, within 14 days before treatment on study. Physiologic daily dosing of steroids is allowed. Nasal, or inhaled steroid, topical steroid creams and eye drops for small body areas are allowed Patients who have undergone allogeneic peripheral stem cell transplantation, or solid organ transplantation requiring immunosuppression Pregnant women are excluded from this study because M7824 is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824 breastfeeding should be discontinued if the mother is treated with M7824. These potential risks may also apply to other agents used in this study Patients with active systemic autoimmune disease, except patients with type 1 diabetes mellitus, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring current immunosuppression, or with other endocrine disorders on replacement hormones, are not excluded if the condition is well controlled History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents to be used in the cohort the subject will be enrolled into Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin). Patients enrolling on the M7824 only arm will be exempt from this exclusion Patients with a history of bleeding diathesis or recent clinically significant bleeding events considered by the Investigator as high risk for investigational drug treatment are excluded
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 35.0-50.0, Ovarian Carcinoma Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm) At least one intact ovary and fallopian tube Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required Premenopausal; defined as < 12 months of amenorrhea. However, for those patients with >= 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable Concurrently planned or prior hysterectomy is permitted as long as at least one fallopian tube and one ovary had been retained Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Patient must have negative urine pregnancy test within 14 days prior to registration based on local institutional policies Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma Patients medically unfit for the planned surgical procedure Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary) An abnormal CA-125 is defined as a level > 50 U/ml in this study population of premenopausal women if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal women who are current users of oral contraceptives Women who are currently pregnant or plan to become pregnant in the future
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 19.0-999.0, Abdominal Pain Patient presenting to the MGH Emergency Department with abdominal pain English-speaking Known to be pregnant Patients with altered mental status Patients who are critically ill or unstable
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-99.0, Breast Cancer Peripheral Neuropathy Chemotherapy-induced Peripheral Neuropathy Patients ≥18 years of age with a diagnosis of breast cancer Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks) Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Ability to complete questionnaires by themselves or with assistance Ability to give signed informed consent History of prior sensory/motor peripheral neuropathy from any cause History of prior Raynaud's phenomenon History of cryoglobulinemia Active peripheral vascular disease Cold intolerance Prior exposure to neurotoxic chemotherapy Hand-foot syndrome Tumor metastasis in bone, soft tissue, or skin of the hands or feet Absence of one or more fingers or toes Prior exposure to taxane chemotherapy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-5.0, Congenital Heart Disease children complained of congenital heart disease with left to right shunt pressure or volume load cyanotic heart disease
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Cavernous Sinus Invasion by Pituitary Adenoma Patients undergoing preoperative brain MR for pituitary adenoma Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential Poor MRI image quality due to artifacts
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Hypogonadism Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism Decreased sexual desire or libido Decreased spontaneous erections (e.g. morning erections) Decreased energy or fatigue/feeling tired Low mood or depressed mood Loss of body (axillary and pubic) hair or reduced shaving Hot flashes AND Confirmed by 2 serum testosterone levels < 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time Blood pressure >100/60 mmHg and <140/90 mmHg Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease Prostate or breast cancer Any active malignancy Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Migraine Disorders Headache Acute Pain age 18 years or older migraine with or without aura according to International Classification of Headache Disorders-3 (ICHD-3) diagnostic confirmed by one-to-one physical exam in the ED no declaration and sign of pregnancy, or pregnancy not diagnosed during the ED evaluation before randomization did not receive any IV fluid of 100 cc or more at any facility in the last 12 hours intramuscular diclofenac potassium 75 mg, the standard treatment protocol, is ordered by the physician (no history of known allergic reaction to diclofenac potassium) severe dehydration not present as determined by the researcher (hypotension, dry mouth, tongue and eyeballs, decreased urine output) no other indication for fluid infusion no contraindication to fluid administration (heart failure patients with diuretic use, renal failure patients with fluid restriction, hemodynamic instability) do not have accompanying symptoms and signs related to headaches secondary to other obvious pathologies rather than migraine consent to be included in the study no patients will be excluded from the study after randomization. All patients will be evaluated for the primary outcome with an intent-to-treat approach
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, Hirsutism Female patients aged between 18 and 45, who presented to the dermatology outpatient clinics for any reason Not being in pregnancy and lactation period Not applying permanent epilation Not using temporary hair reduction methods in the last 4 weeks Not using oral contraceptive, corticosteroid, cyclosporin or spironolactone in the last 3 months Female patients below the age of 18, above 45 and men in any age group Pregnant women and women in lactation period Patients who had permanent epilation Patients who had temporary hair reduction methods in the last 4 weeks Patients taking oral contraceptive, corticosteroid, cyclosporin or spironolactone in the last 3 months
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Age ≥ 18 AHI ≤ 20 per hour of sleep Complaints of socially disturbing snoring by the partner of the patient Capable of giving informed consent Craniofacial deformities Acute nasal trauma, fracture (during the past 3 months) Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis Cerebrospinal fluid leaks History of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia< 100/µl), lower respiratory tract disorders Pregnancy or willing to become pregnant Excessive alcohol or drug use (> 20 alcohol units/week or any use of hard drugs) History of sleep medication use
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Alkylating Agents Antimetabolites, Antineoplastic Antiviral Agents Analgesics, Non-narcotic Anti-infective Agents Analgesics Peripheral Nervous System Agents Hematologic Diseases Hematologic Neoplasms Leukemia in Remission Treatment Screening Patient Patients must satisfy the following to be enrolled in the study Patient has eligible disease status: Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response (Dohner, 2017) Patient with prior central nervous system involvement by malignancy are eligible provided that it has been treated and cerebral spinal fluid is clear for at least 2 weeks prior to start of Lymphodepletion Regimen Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment assessment. o For the purposes of this study, MRD positivity is defined as greater than or equal to 0.1% blasts detected by MFC on BMA by the Sponsor-selected Central MRD analysis laboratory, where assay sensitivity allows for a Lower Limit of Detection (LOD) of 1 x 10-4 (0.01%) or lower Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF) Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted Patient is willing and able to adhere to the study schedule and other protocol requirements Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2 Ability to be off immunosuppressive drugs for at least 3 days prior to the CYNK-001 infusion. Steroids at the equivalent of no more than 7.5 mg prednisone per day are permissible Female of childbearing potential (FCBP)* must not be pregnant and agree to not becoming pregnant for at least 28 days following the CYNK-001. FCBP must agree to use an adequate method of contraception during the treatment period The presence of any of the following will the Patient from enrollment Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the Patient from participating in the study Patient has any condition including the presence of laboratory abnormalities which places the Patient at unacceptable risk if he or she were to participate in the study Patient has any condition that confounds the ability to interpret data from the study Patient has bi-phenotypic acute leukemia Patient has acute promyelocytic leukemia (APL) Patient has inadequate organ function as defined below at time of Treatment Period: 1. Patient has aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase ≥ 2.5 x the upper limit of normal (ULN). 2. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease Study equation (Levey, 2006) or history of an abnormal eGFR < 60 and a decline of > 15 mL/min/1.73 m2 below normal in the past year. 3. Patient has a bilirubin level > 2 mg/dL (unless Patient has known Gilbert's disease) Patient has had prior treatment with biologic antineoplastic agents less than 7 days before first CYNK-001 infusion and at least 5 half-lives. (Exception will be granted for monoclonal antibodies that are known to have long half-lives, in which case a minimum of 2 weeks from last dose will be required). For agents that have known AEs occurring beyond these specified days after administration, this period must be extended beyond the time during which acute AEs are known to occur. Treating physicians are encouraged to discuss cases with the Medical Monitor Patient is pregnant or breastfeeding Patient has new or progressive pulmonary infiltrates or pleural effusion large enough to be detected by chest x-ray or CT scan within 2 weeks of first CYNK-001 infusion
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Pelvic Organ Prolapse Stage II-IV pelvic organ prolapse Bothersome bulge symptoms At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form English-speaking Undergoing treatment of prolapse Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data) Able and willing to follow up at 3 months for in-office exam Enrollment in another research study of pelvic organ prolapse Concomitant non-urogynecologic surgery Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively
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0
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