bioihbjkbjnl/mcl2 huggingface dataset:
Pregabalin as Treatment for Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Pregabalin
Intervention description: pregabalin up to 600 mg/day
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label pilot study
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: alcohol use disorder; alcohol abuse; treatment; lyrica

Summary:

      The proposed protocol is an 8 week open label outpatient pilot trial of the safety and
      efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary
      objective of the study is to determine the efficacy of pregabalin in promoting alcohol
      abstinence among individuals with an alcohol use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-5 criteria for current alcohol use disorder

          -  Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women
             at least 4 days per week over the past 28 days

          -  Between the ages of 18 and 65

          -  Able to provide informed consent and comply with study procedures

        Exclusion Criteria:

          -  Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD,
             that in the investigator's judgment might require intervention over the course of the
             study.

          -  Subjects receiving psychotropic medication treatment

          -  Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13)

          -  History of alcohol withdrawal seizures or alcohol withdrawal delirium

          -  History of allergic reaction to candidate medication (pregabalin)

          -  Pregnancy, lactation, or failure in females patients to use adequate contraceptive
             methods

          -  Unstable physical disorders which might make participation hazardous

          -  Subjects who have a current DSM-5 diagnosis of moderate or severe substance use
             disorder, with the exception of alcohol, nicotine and caffeine use disorders. A
             diagnosis of a mild substance use disorder will not be exclusionary, as long as the
             current primary substance use disorder is alcohol.

          -  Are legally mandated to participate in alcohol use disorder treatment program

          -  Cognitively impaired
A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Diarrhea (IBS-D)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea; Abdominal Pain
Intervention: MD-7246; Placebo
Intervention description: Oral tablet; Matching oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 515.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abdominal pain; Diarrhea; Irritable Bowel Syndrome

Summary:

      To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose
      response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel
      syndrome (IBS-D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets the Rome IV criteria for diagnosis of IBS-D

          -  Patient maintains a minimum level of compliance with daily diary

          -  Female patients of childbearing potential must agree to use one of the following
             methods of birth control:

               1. Hormonal contraception

               2. Double-barrier method

               3. Maintenance of a monogamous relationship with a male partner who has been
                  surgically sterilized by vasectomy

        Exclusion Criteria:

          -  Patient has clinically significant findings on a physical examination and/or clinical
             laboratory tests

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments

        NOTE: Additional inclusion/exclusion criteria may apply
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: Differing doses and frequencies of iv administration
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will determine the appropriate dose and frequency of administration of iv Mircera
      maintenance therapy in hemodialysis patients with chronic renal anemia who were previously
      receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target
      sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  on hemodialysis therapy for at least 3 months;

          -  receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding or using unreliable birth control methods;

          -  use of any investigational drug within 30 days of the run-in phase, or during the
             run-in or study treatment period.
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Condition: Stage V Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized
      recipients of deceased donor kidney transplants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants ≥18 years old.

          2. Participants with Stage V chronic kidney disease who received a kidney transplant from
             a deceased donor to whom they were sensitized.

          3. History of prior exposure to HLA (human leukocyte antigen):

               -  Prior solid organ or tissue allograft

               -  Pregnancy

               -  Blood transfusion

               -  Prior exposure to specific donor's HLA

        Exclusion Criteria:

          1. Has received treatment with eculizumab at any time prior to enrolling in this study.

          2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased
             donor.

          3. History of severe cardiac disease.

          4. Prior splenectomy.
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Condition: Hodgkin Disease
MeSH terms: Hodgkin Disease
Intervention: Nivolumab; Doxorubicin; Vinblastine; Dacarbazine
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Doxorubicin; Nivolumab; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously
      treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Must have received prior high-dose conditioning chemotherapy followed by autologous
             stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C -
             enrollment closed)

          -  Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab
             vedotin treatment (cohort A, B & C - enrollment closed)

          -  Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)

        Exclusion Criteria:

          -  Known central nervous system lymphoma

          -  Participants with nodular lymphocyte-predominant Hodgkin Lymphoma

          -  Prior allogeneic stem cell transplantation (SCT)

          -  Chest radiation ≤ 24 weeks prior to first dose

          -  Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: LY573636-sodium
Intervention description: A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to estimate the time to progressive disease for patients who receive
      LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for
      metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study
      drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose
      and then after every other treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic non-small-cell lung cancer

          -  At least 18 years of age

          -  Have received 2 previous treatment regimens for metastatic non-small-cell lung cancer

        Exclusion Criteria:

          -  Serious pre-existing medical conditions

          -  Previous cancer (except skin cancer, excluding melanoma)

          -  Have received 3 or more previous treatment regimens for metastatic non- small-cell
             lung cancer

          -  Active treatment with Coumadin
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Capecitabine
Intervention description: Sequential Therapy: Docetaxel will be given at 100 mg/m^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.
Concurrent Therapy: Docetaxel will be given at 50 mg/m^2 IV Day 1.; Sequential Therapy: administration of capecitabine 1000 mg/m^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
Intervention MeSH terms: Docetaxel; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      The purpose of this study is to find out if the combination of docetaxel and capecitabine can
      shrink the size of breast tumors and preserve the breast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed breast carcinoma.

          -  Early stage breast cancer (stage 1, 2, 3).

          -  No evidence of disease outside the breast or chest wall, except ipsilateral axillary
             lymph nodes.

          -  18 years of age or older.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.

        Exclusion Criteria:

          -  Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast
             cancer.

          -  Major surgery within 28 days of study entry.

          -  Evidence of central nervous system (CNS) metastases.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.
A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; placebo; sildenafil
Intervention description: tablet form, 1 mg, single dose (Day 1); tablet form, 2 mg, single dose (Day 1); tablet form, 4 mg, single dose (Day 1); tablet form, 10 mg, single dose (Day 1); tablet form, 20 mg, single dose (Day 1); tablet form, single dose (Day 1); tablet form, 20 mg, single dose (Day 1)
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PAH pulmonary hypertension pulmonary arterial hypertension

Summary:

      Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic or familial pulmonary arterial hypertension (PAH)

          -  Mean PAP at least 25 mm Hg, PCWP < 15 mm Hg at rest

          -  For females of child-bearing potential negative pregnancy test at screening and use of
             contraception during the study and 4 weeks after its completion

          -  Signed and dated informed consent

          -  Willingness to comply with the study plan and procedures

        Exclusion Criteria:

          -  pulmonary arterial hypertension (PAH)other than idiopathic or familial

          -  For females, pregnancy or lactation

          -  Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha
             blockers or arginine 30 days prior tio randomization and during the study

          -  Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium
             channel blockers, digoxin, diuretics 30 days prior tio randomization and during the
             study

          -  Large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to
             baseline visit and/or during the study visit

          -  Subjects with intracardiac shunts and/or serious heart, lung or other health
             conditions

          -  HIV positive subjects

          -  Subjects participating in another clinical trial with an investigational drug or
             device

          -  Subjects with degenerative retinal disorders, history of non-arteritic anterior
             ischemic optic neuropathy or untreated proliferative diabetic retinopathy

          -  Allergies and previous intolerance of PDE5 inhibitors

          -  Alcohol or drug abuse

          -  Blood donation during the study, or 1 month before or after the study
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD

Summary:

      This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when
      administered using a jet nebulizer for 7 days in a cross-over design to patients with
      moderate to severe chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have a negative pregnancy test, and must be prepared to use effective
             contraception if of child-bearing potential

          -  Subject is capable of performing reproducible spirometry maneuvers

          -  Subject has post-bronchodilator FEV1/FVC (forced expiratory volume in 1 second/forced
             vital capacity) ratio <0.7

          -  Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global
             Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)

          -  Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80%
             of predicted normal

          -  Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of
             pre-ipratropium FEV1 response

          -  Subject has a current or past smoking history of at least 10 pack-years.

        Exclusion Criteria:

          -  Subject has a significant respiratory disease or disorder other than COPD that would
             affect the interpretation of data from this study

          -  Subject has a history of reactions or hypersensitivity to inhaled anticholinergic or
             beta-agonist agents

          -  Subject suffers from any medical condition that would preclude the use of inhaled
             anticholinergic agents

          -  Subject has been hospitalized for COPD or pneumonia within 12 weeks.

          -  Subject requires long-term oxygen therapy (>15 hours a day)
Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia
Intervention: Deferasirox; Cholecalciferol; Azacitidine
Intervention description: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO; Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO; Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Intervention MeSH terms: Vitamin D; Cholecalciferol; Azacitidine; Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 65 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Azacitidine; Vidaza; Deferasirox; Exjade; Cholecalciferol; Vitamin D

Summary:

      The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia
      will go into complete remission (meaning the leukemia is completely gone), and to find out
      how long it stays away. The drugs used in this project are FDA approved and commercially
      available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  65 or older (must have reached 65th birthday)

          -  Morphologically confirmed diagnosis of AML, excluding AML-M3

          -  Must have a Zubrod performance status of 0-3

        Exclusion Criteria:

          -  Patients with known HIV infection are excluded. If HIV infection is suspected based on
             clinical condition, testing may be performed at the discretion of treatment team, but
             is not mandated prior to enrollment.

          -  Patients with central nervous system involvement by AML are excluded

          -  Patients with history of an active cancer (except basal cell and squamous cell cancers
             of the skin) within the previous 2 years are excluded
Fetal Tracheal Balloon Study in Diaphragmatic Hernia
Condition: Diaphragmatic Hernia; Lung Disease
MeSH terms: Lung Diseases; Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Intervention: Fetal tracheal obstruction with detachable balloon (device)
Intervention description: Fetal tracheal obstruction with detachable balloon (device): Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.
- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diaphragm; Trachea; Lung development; Lung growth; Tracheal occlusion; ECMO; Neonatal death

Summary:

      The purpose of this phase 2 limited study is to examine whether prenatal intervention correct
      the lung underdevelopment associated with severe diaphragmatic hernia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Singleton pregnancies

          -  Isolated congenital diaphragmatic hernia

          -  Normal karyotype (amniocentesis)

          -  Initial diagnosis before 26 weeks gestation

          -  Competent cervix

          -  Severity of CDH: lung-to-head ratio (LHR) ≤0.8 at 22-26 weeks gestation

          -  Liver herniation in the chest

          -  Informed consent

        Exclusion Criteria:

          -  Preterm labor, premature rupture of membranes or amniotic leak

          -  Significant maternal morbidity

          -  Minor (<18 years)