bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Condition: Arterial Dysfunction; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Cholecalciferol; Calcitriol
Intervention MeSH terms: Cholecalciferol; Vitamin D; Calcitriol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: chronic kidney disease; vitamin D deficiency

Summary:

      The purpose of this study is to determine whether nutritional (cholecalciferol) or active
      vitamin D (calcitriol) supplementation improves vascular endothelial function in patients
      with stage IIIB and IV chronic kidney disease with vitamin D insufficiency or deficiency. The
      investigators hypothesize that the use of calcitriol supplementation will result in improved
      vascular endothelial function as compared to cholecalciferol supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases
             Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)

          -  Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL

          -  Corrected serum calcium < 10.2 mg/dL

          -  Serum phosphate < 4.6 mg/dL

          -  Serum albumin > 3.0 g/dL

          -  Body mass index < 40 kg/m2

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Significant co-morbid conditions that lead the investigator to conclude that life
             expectancy is less than 1 year

          -  Expected to undergo living related kidney transplant in next 6 months

          -  Pregnant, breastfeeding, or unwilling to use adequate birth control

          -  History of severe liver disease

          -  Nephrotic range proteinuria (> 3.5 gm/day)

          -  Use of active vitamin D analogs within 30 days of randomization
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Daridorexant 10 mg; Daridorexant 25 mg; Daridorexant 50 mg; Placebo
Intervention description: Daridorexant 10 mg film-coated tablets; Daridorexant 25 mg film-coated tablets; Daridorexant 50 mg film-coated tablets; Matching placebo film-coated tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 804.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to assess the long term safety and tolerability of daridorexant in adult and elderly
      subjects suffering from difficulties to sleep
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure (Visit 1).

          -  Having completed the DB study treatment and the run-out period of ID-078A301
             (NCT03545191) or ID-078A302 (NCT03575104).

          -  For woman of childbearing potential, the following is required:

               -  Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)

               -  Agreement to use the contraception scheme as required by the protocol from Visit
                  1 up to at least 30 days after EODBT.

        Exclusion Criteria:

          -  Unstable medical condition, significant medical disorder or acute illness, C-SSRS©,
             ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in
             the opinion of the investigator could affect the subject's safety or interfere with
             the study assessments (Visit 1).

          -  For female subjects: lactating or planning to become pregnant during the duration of
             the study (Visit 1).

          -  Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates,
             amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by
             breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or
             Visit 1 if within 7 days after EOT).
Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-120 Gel; IDP-120 Vehicle Gel
Intervention description: IDP-120 Gel, once-daily application; IDP-120 Vehicle Gel, once-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Enrollment: 585.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120
      Vehicle Gel
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity Score (EGSS) assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Condition: Symptomatic Neurogenic Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension
Intervention: ampreloxetine
Intervention description: Oral tablet, QD
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Symptomatic Neurogenic Orthostatic Hypotension; sympomatic nOH; multiple symptom atrophy; MSA; Parkinson's disease; PD; pure autonomic failure; PAF; orthostatic hypotension; OH; ampreloxetine; 171; low blood pressure; dizziness; fainting; blacking out; lightheadedness; norepinephrine; hypotension; OAK

Summary:

      A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of
      ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic
      nOH over 182 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of Study 0170 and, in the opinion of the Investigator, would benefit from
             long-term treatment with ampreloxetine.

          -  The subject must be able to understand the nature of the study and must provide
             written informed consent prior to the conduct of any study procedures (including any
             changes occurring in the subject's current therapeutic regimen).

          -  The subject must be willing to continue on treatment and must continue to meet all the
             inclusion criteria for the preceding study (Study 0170) except, a score of >4 in
             OHSA#1.

        Exclusion Criteria:

          -  Subjects may not be enrolled in another clinical trial.

          -  Psychiatric, neurological, or behavioral disorders that may interfere with the ability
             of subjects to give informed consent, or interfere with the conduct of the study.

          -  Medical, laboratory, or surgical issues deemed by the Investigator to be clinically
             significant.

          -  Hypersensitivity to ampreloxetine or the formulation excipients.
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
Condition: Infertility
MeSH terms: Infertility
Intervention: Low dose hCG plus FSH co-trigger; Standard dose of hCG
Intervention description: Low dose hCG (1,500 IU) plus FSH (450 IU) co-trigger; Standard dose of hCG (10,000 or 5,000 IU) trigger
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 105.0
Sex: Female
Minimum age: 18 Years
Maximum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infertility; In vitro fertilization; IVF

Summary:

      This is a randomized, double-blind, single center clinical trial study to compare oocyte
      competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard
      dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus
      concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro
      fertilization (IVF).
    

Eligibility criteria:

        Inclusion Criteria: The target population includes couples undergoing IVF. All eligible
        couples will be asked to join the study. Study participants will be recruited from the
        Reproductive Endocrinology Clinic at University of California at San Francisco Center for
        Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be
        offered participation in the study.

        Exclusion Criteria:

          -  Age >41 years old

          -  Antral Follicle Count (AFC; 2-10 mm) < 8

          -  Body Mass Index > 30 kg/m2

          -  History of ≥ 2 prior canceled IVF cycles secondary to poor response

          -  Diagnosis of cancer

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow-up, or interpretation of study results

          -  Undergoing embryo co-culture

          -  Use of any of the following medications: Growth Hormone, Sildenafil, or Aspirin
             (except if being used for hypercoagulable state)

          -  Severe male factor infertility diagnosis. Male factor infertility diagnosis should be
             cleared for eligibility by the PI based on previous patient history of fertilization
             outcomes and/or expected fertilization outcomes of the cause of male factor
             infertility based on known scientific data.

          -  Ovulation trigger less than or greater than 36 hours to oocyte retrieval

          -  Serum estradiol level >5,000 pg/ml on the day of expected trigger due to high risk of
             OHSS
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
Condition: Migraine Disorder
MeSH terms: Migraine Disorders
Intervention: ALD403 (Eptinezumab)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 65 years of age, inclusive, who were diagnosed with
             migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months
             before screening.

        Exclusion Criteria:

          -  Receipt of any monoclonal antibody treatment (within or outside a clinical trial)
             within 6 months before screening.

          -  Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low
             back pain, complex regional pain syndrome).

          -  Psychiatric conditions that are uncontrolled and/or untreated, including conditions
             that are not controlled for a minimum of 6 months prior to screening. Patients with a
             lifetime history of psychosis, mania, or dementia are excluded.

          -  History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, or sporadic and familial hemiplegic migraine.
Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Radiation Therapy; Conventional radiation
Intervention description: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks; Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; Stages II or III non-small cell lung cancer

Summary:

      The study is designed to determine whether an accelerated course of hypofractionated
      radiation therapy with daily image guidance and motion assessment/control will allow more
      effective treatment of poor performance status patients with stage II-III NSCLC, who would
      benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per
      fraction).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must be willing and capable to provide informed consent to participate in
             the protocol.

          -  Patients must have appropriate staging studies identifying them as AJCC stage II or
             III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix
             III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will
             be required by biopsy or cytology within 6 months of study entry.

          -  Patients must have the potential for benefit from local therapy (at the discretion of
             the investigator).

          -  The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod
             performance status 0-1 and weight loss >10% are considered eligible. In addition,
             patients determined to be medically unfit or refusing combined modality therapy are
             eligible.

          -  Age ≥ 18.

          -  Patients must have measurable or evaluable disease.

          -  Women of childbearing potential and male participants must agree to use an effective
             method of contraception.

          -  Patients must sign study specific informed consent prior to study entry.

          -  Patients must not have plans for concurrent chemoradiation therapy.

          -  Patients must complete all required pretreatment evaluations

        Exclusion Criteria:

          -  Total (aggregate) gross tumor volume > 500 cm3 (500 cc's or 0.5 Liters)

          -  Prior radiotherapy to the region of the study cancer that would result in direct
             overlap of radiation therapy fields.

          -  Chemotherapy given within one week of study registration.

          -  Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
             or fetus.
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected subcutaneously twice daily.; Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of relamorelin compared to placebo in
      participants with diabetic gastroparesis. Participants will report daily severity scores of
      their diabetic gastroparesis symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 or Type 2 diabetes mellitus

          -  Meet the per protocol criteria of diabetic gastroparesis

          -  Compliance with diary

          -  Compliance with the per protocol study treatment dosing instructions

        Exclusion Criteria:

          -  Currently receiving nutrition intravenously, by nasogastric tube, or other feeding
             tube

          -  Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating
             disorder at the time of Screening (Visit 1)

          -  Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

          -  History of gastrointestinal disorders that may be similar to gastroparesis

          -  Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin 10 mg; Matching Placebo for Dapagliflozin
Intervention description: Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy; Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to determine whether dapagliflozin can improve
      (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal
      impairment.This study will be conducted at approximately 100 centres from countries across
      North America and European regions. It is planned to randomize a total of 302 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male aged ≥18 years and <75 years.

          -  History of T2DM for more than 12 months.

          -  Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%

          -  Stable anti-diabetic treatment regimen

          -  Renal impairment: CKD 3A

        Exclusion Criteria:

          -  Women of childbearing potential who are unwilling or unable to use an acceptable
             method to avoid pregnancy for the entire study period.

          -  History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

          -  Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood
             Pressure (DBP) ≥110 mmHg

          -  Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to
             signing the consent at visit 1:

        Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina,
        Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient
        ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously
        undiagnosed arrhythmia.

          -  History of any biopsy or imaging verifying intercurrent kidney disease (such as
             glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy
             or diabetic nephropathy with nephrosclerosis.

          -  Significant hepatic disease, including, but not limited to, chronic active hepatitis
             and/or severe hepatic insufficiency.

          -  Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting
             insulins at screening.

          -  Participation in another clinical study with an Investigational Product (IP) during
             the last 30 days prior to signing the consent at visit 1.