bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
Condition: Pruritus; Prurigo Nodularis; Atopic Dermatitis; Psoriasis
MeSH terms: Psoriasis; Dermatitis; Pruritus; Prurigo
Intervention: 5 mg Serlopitant Tablets
Intervention description: Serlopitant Tablets
Intervention MeSH terms: Serlopitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the long term safety of serlopitant for the treatment of pruritus in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18 years or older at consent.

          -  Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.

          -  Female subjects of childbearing potential must be willing to practice highly effective
             contraception until 5 weeks after last dose of study drug.

          -  Willing and able to comply with study visits and study related requirements including
             providing written informed consent.

        Exclusion Criteria:

          -  Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous
             malignancies).

          -  Any known major psychiatric diagnosis, such as major depressive disorder, bipolar
             disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol
             use disorder, which may confound the assessment of serlopitant safety or efficacy, or
             interfere with the subject's ability to comply with protocol-mandated activities,
             within 3 years prior to enrollment.

          -  Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease,
             or history of thyroid malignancy; or the prescense of any medical condition or
             disability, that could interfere with the assessment of safety in this study or
             compromise the safety of the subject.

          -  Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever
             is longer) or expected participation in another clinical study involving an
             investigational product or device during the subject's participation in this study.

          -  Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant,
             fosaprepitant, rolapitant) within 4 weeks.

          -  Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.

          -  Currently pregnant or breastfeeding or planning to become pregnant during the study.
Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan/amlodipine 80/5 mg; Valsartan 80 mg; Valsartan 160 mg
Intervention description: 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily; 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily; 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Intervention MeSH terms: Amlodipine; Valsartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1134.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hypertension, valsartan, amlodipine, high blood pressure

Summary:

      This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine
      in adult patients with mild to moderate hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients >= 18 years and < 86 years

          -  Patients with essential diastolic hypertension

          -  At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and
             < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting
             diastolic blood pressure < 100 mmHg

          -  At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg
             and < 100 mmHg

          -  At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg
             and < 110 mmHg

        Exclusion Criteria:

          -  Severe hypertension >= 180/110 mmHg

          -  Known or suspected contraindications, including a history of allergy or
             hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical
             structures

          -  Inability to discontinue all prior antihypertensive medications safely for a maximum
             period of up to 28 days prior to Visit 2

          -  History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic
             attack, myocardial infarction or other types of revascularization

          -  Malignant hypertension

          -  All patients with Type I diabetes and those patients with Type 2 diabetes who are not
             well controlled based on the investigator's clinical judgment

          -  Pregnant or nursing women

          -  History of heart failure

          -  Angina pectoris

          -  Second or third degree heart block

          -  Life threatening or symptomatic arrhythmias

          -  Clinically significant valvular heart disease

          -  Evidence of a secondary form of hypertension

          -  Known or moderate malignant retinopathy

          -  Evidence of hepatic disease

          -  Evidence of renal impairment

        Other protocol-defined exclusion criteria may apply.
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Intervention: OPC-34712; Escitalopram; Fluoxetine; Paroxetine CR; Sertraline; Duloxetine; Venlafaxine XR
Intervention description: Tablet; Tablet; Capsule; Controlled-release tablets; Tablets; Delayed-release capsules; Extended-release capsules
Intervention MeSH terms: Duloxetine Hydrochloride; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2944.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment

Summary:

      To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in
      addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major
      Depressive Disorder (MDD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female outpatients 18-65 years of age

        Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:

          -  Subjects who completed participation in the Double-blind Randomization Phase (i.e.
             Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or

          -  Subjects who met criteria for a response, but did not meet criteria for remission at
             Week 14 of either trial

        Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:

        • Subjects who completed the last scheduled visit of the prior Double-blind Randomized
        Phase 3 trial.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving OPC-34712.

          -  Subjects with a major protocol violation during the course of their participation in
             the Double-blind Randomization Phase
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide once weekly suspension; Sitagliptin; Placebo
Intervention description: Placebo oral capsule once daily
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes, Type 2, exenatide, Sitagliptin

Summary:

      To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once
      weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in
      subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  Diagnosed with type 2 diabetes mellitus

          -  HbA1c of 7.1% to 11.0%, inclusive, at screening

          -  Has stable body weight, i.e., not varying by >3% for at least 3 months prior to
             screening

          -  Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening

          -  Body mass index of <45 kg/m2 at screening

          -  Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2
             months prior to Visit 1 (Screening)

        Exclusion Criteria:

          -  History of pancreatitis or triglycerides >=500 mg/dL

          -  Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of
             either

          -  History of renal transplantation, or is currently receiving renal dialysis, or has an
             estimated creatinine clearance <50 mL/min

          -  Active cardiovascular disease

          -  Presence or history of severe congestive heart failure

          -  Central nervous system disease, including epilepsy

          -  Liver disease

          -  History of severe gastrointestinal diseases

          -  Clinically significant malignant disease

          -  Repeated severe hypoglycemia within the last 6 months

          -  Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog

          -  Any DPP-4 inhibitor within 3 months prior screening
Enhancement of Corticosteroid Efficacy in COPD
Condition: COPD
Intervention: Theophylline; Roflumilast
Intervention description: Oral; Oral
Intervention MeSH terms: Theophylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This is a pilot study designed to evaluate the effects of theophylline and roflumilast on
      circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator
      effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive
      to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by
      measurement of circulating HDAC and the acute effect of oral prednisone on the bronchodilator
      response to inhaled beta agonist. Roflumilast tablets will be added to the theophylline for a
      further week and the studies repeated. The study will provide preliminary data on the effects
      of theophylline and roflumilast on circulating HDAC levels and the effects of corticosteroids
      on the beta agonist bronchodilator response in COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of COPD with FEV1 <60% predicted

          -  FEV1/FVC <70% and <+15% FEV1 response to bronchodilator.

          -  Patients of both genders will be included.

          -  IRB approved written informed consent will be obtained from each subject.

        Exclusion Criteria:

          1. Recent (<1 month) exacerbation of COPD,

          2. Known hypersensitivity to beta agonists, theophylline, steroids, or roflumilast.

          3. Current or recent (<2 weeks) treatment with oral steroids, theophylline or other
             methylxanthines, or roflumlast.

          4. Diagnosis or history of asthma, uncontrolled hypertension, or congestive heart
             failure.

          5. History of Cardiac arrhythmia

          6. History of seizures.

          7. History of Liver disease

          8. Gastrointestinal disease, including history of peptic ulcer disease.

          9. Current infection or antibiotic treatment.

         10. History of depression or psychiatric disease.
Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
Condition: Anxiety Disorders; Somatoform Disorders
MeSH terms: Anxiety Disorders; Body Dysmorphic Disorders; Somatoform Disorders
Intervention: Escitalopram; Placebo
Intervention description: At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.; At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Intervention MeSH terms: Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Body Dysmorphic Disorder; Escitalopram; Lexapro; BDD; Body Image

Summary:

      This study's primary aim is to compare time to relapse and relapse rates in responders to
      acute escitalopram who are then randomized to placebo versus continuation treatment with
      escitalopram.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient men and women age 18 and older

          -  Diagnosis of BDD within 6 months of study start date based on the Diagnostic and
             Statistical Manual of Mental Disorders (DSM-IV)

          -  Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale

          -  Lives within driving distance of Boston, MA or Providence, RI

        Exclusion Criteria:

          -  Suicidal or homicidal tendencies

          -  Alcohol/drug abuse or dependence within 3 months of study entry
Long-term Safety Extension to Study TRCA-301
Condition: Metabolic Acidosis
MeSH terms: Acidosis
Intervention: TRC101; Placebo
Intervention description: Oral suspension; Oral suspension
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: blood bicarbonate, kidney disease

Summary:

      This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301
      (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301
      have the option to participate in this extension study evaluating the long-term safety and
      durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease
      and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily
      (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive
      the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed the 12-week treatment period and attended the Week 12 Visit in the parent
             study TRCA-301.

          -  Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study
             TRCA-301.

        Key Exclusion Criteria:

          -  Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the
             Investigator, requires emergency intervention or evaluation for an acute acidotic
             process.

          -  Required dialysis for acute kidney injury or worsening CKD during the parent study
             TRCA-301.

          -  Planned initiation of renal replacement therapy within 6 months following study entry.

          -  History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing
             disorders, severe gastrointestinal disorders, inflammatory bowel disease, major
             gastrointestinal surgery, or active gastric/duodenal ulcers.

          -  Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa carbidopa intestinal gel (LCIG); Placebo gel; Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets; Placebo (PBO) oral capsules; CADD-Legacy® 1400 ambulatory infusion pump; PEG tube; J-tube
Intervention description: infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa per/hour); percutaneous endoscopic gastrostomy tube; jejunal tube
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: carbidopa; levodopa-carbidopa; levodopa; levodopa/carbidopa suspension; dyskinesia; Duodopa; levodopa-carbidopa intestinal gel; Severe Motor Fluctuations; DUOPA

Summary:

      The primary objective of this study was to demonstrate the superiority of levodopa -
      carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease
             Society (UKPDS) Brain Bank Criteria

          -  Levodopa-responsive participants who demonstrate some identifiable 'on response,'
             established by Investigator observation

          -  Demonstrate severe motor fluctuations in spite of individually optimized treatment and
             where therapy options are indicated

        Exclusion Criteria:

          -  Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as
             secondary parkinsonism

          -  Undergone surgery for the treatment of PD

          -  Contraindications to levodopa

          -  Subjects with any neurological deficit that may interfere with the study assessments
Nifedipine for Acute Tocolysis of Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Intervention: Nifedipine; Placebo; Usual care
Intervention description: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.; Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.; Usual evaluation, monitoring and care for women with preterm labor.
Intervention MeSH terms: Nifedipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 88.0
Sex: Female
Minimum age: 16 Years
Maximum age: 44 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if nifedipine treatment of women in preterm labor
      receiving corticosteroids results in postponement of delivery when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 16 and 44 years of age inclusive

          -  Singleton pregnancy

          -  Intact membranes

          -  Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive

          -  Reported or documented uterine activity

          -  Cervical dilation between 2 cm and 4 cm inclusive

        Exclusion Criteria:

          -  Multifetal gestation

          -  Less than 28 weeks' gestation

          -  34 or more weeks' gestation

          -  Ruptured membranes

          -  More than 4 cm dilated

          -  Previously received a course of corticosteroids for fetal lung maturation

          -  Oligohydramnios

          -  Fetal growth restriction

          -  Chorioamnionitis or temperature of at least 38.0 degrees Celsius

          -  Fetal death

          -  Preeclampsia

          -  Suspected placental abruption or placenta previa

          -  Lethal fetal malformation or amniotic fluid index at least 35

          -  Systolic BP < 90 mmHg or diastolic BP < 50 mmHg

          -  Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)

          -  Chronic hypertension treated with antihypertensives in pregnancy

          -  Seizure disorder or HIV

          -  Maternal allergy to nifedipine

          -  Known maternal cardiac disease

          -  Women who have received progesterone therapy in the second or third trimester for
             prevention of preterm birth