bioihbjkbjnl/mcl2 huggingface dataset:
Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
Condition: Sensitivity in Esophagus
MeSH terms: Hypersensitivity
Intervention: AZD1386; Placebo to AZD1386
Intervention description: 95 mg, oral solution, single dose; Placebo, oral solution, single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD; patient; esophagus; pain

Summary:

      The purpose of the study is to compare sensitivity of visceral pain in the esophagus using
      different pain stimuli.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent form

          -  BMI 18.5-35.0, inclusive

          -  Continuous PPI treatment for GERD during the last 4 weeks

        Exclusion Criteria:

          -  Patients that have not experienced any GERD symptoms improvement at all after PPI
             treatment

          -  Unstable or clinically significant disorders including cardiovascular, respiratory,
             renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal
             disorders besides GERD

          -  Prior surgery of the upper GI tract
Study in Pediatric Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: ezogabine/retigabine
Intervention description: ezogabine dose escalation
Intervention MeSH terms: Ezogabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of
      ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled
      partial onset seizures or Lennos-Gastaut syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 12 and 18 years of age.

          -  Diagnosis of uncontrolled partial onset seizures (with or without secondarily
             generalized seizures) or Lennox-Gastaut syndrome.

          -  Taking between one and three antiepileptic drugs.

          -  Able to swallow tablets.

          -  Females must be of : (1) Non-childbearing potential or (2) Child-bearing potential and
             agrees to use acceptable contraception.

        Exclusion Criteria:

          -  Epilepsy secondary to progressive cerebral disease, tumor or any progressive
             neurodegenerative disease.

          -  History of status epilepticus in the last six months.

          -  Currently treated with felbamate or has been treated with vigabatrin within the past 6
             months.

          -  Following the ketogenic diet.

          -  Suicidal intent or history of suicide attempt in the last 2 years.

          -  Elevated liver enzymes or abnormal kidney function.

          -  Current disturbance of micturition or known urinary obstructions.

          -  History of vesicoureteric reflux.

          -  Abnormal post-void residual bladder ultrasound.

          -  Urinary retention and/or required urinary catheterization in the preceding 6 months.

          -  Abnormal urine sample at screening/.baseline.

          -  Abnormal blood sample at screening.

          -  Clinically significant arrhythmias.

          -  Abnormal ECG at screening.

          -  BMI lower than the 10th percentile for age and gender or subject weighs less than
             30kg.
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Condition: Clostridium Difficile Infection Recurrence
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Recurrence
Intervention: Full Spectrum Microbiota; Placebo
Intervention description: Orally administered donor derived microbiota; Placebo for CP101
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium Difficile Infection; CP101; Crestovo; FMT; CDI; C. difficile; C. diff; Recurrent Clostridium Difficile Infection; Recurrent C. diff; Recurrent CDI; Finch; Fecal transplant; Fecal microbiota transplant; rCDI; Finch Therapeutics

Summary:

      Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules
      one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose
      of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence
      of C. difficile.

      Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study
      drug (CP101 or placebo) may be eligible to enroll in the open-label extension study
      (CP101-CDI-E02) and will receive CP101.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent

          -  Men or women 18 years of age or older

          -  Current diagnosis of a recurrence of non-severe, non-complicated CDI

          -  Subject has a clinical response to standard-of-care CDI antibiotics for the most
             recent CDI episode

        Exclusion Criteria:

          -  Pregnant, breast-feeding, or considering becoming pregnant during the study

          -  Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's
             disease and ulcerative colitis)

          -  Any prior diagnosis of diarrhea-predominant irritable bowel syndrome

          -  Systemic chemotherapy or radiation for the treatment of cancer during the 60 days
             prior to consent or planned during the 8 weeks following Randomization

          -  Prior fecal transplant for any condition, regardless of route of administration in the
             last year or plans to undergo during the study

          -  Major intra-abdominal surgery within the past 60 days prior to Screening

          -  History of total colectomy/ileostomy or bariatric surgery

          -  Admitted to, or expected to be admitted to an intensive care unit for any medical
             reason. Note: Residents of long term care facilities are eligible study entry

          -  Planned hospitalization or invasive surgery during the study

          -  Severe acute illness unrelated to CDI
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
Condition: Acute Leukemia
MeSH terms: Leukemia; Acute Disease
Intervention: Micafungin
Intervention MeSH terms: Micafungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: leukemia; induction; prophylaxis; antifungal; micafungin; phase II

Summary:

      The purpose of this study is to determine whether prophylaxis with micafungin is effective in
      the induction chemotherapy for newly diagnosed acute leukemia patients.
    

Eligibility criteria:

        Inclusion Criteria:

        A. patients belong to either A-1 or A-2 A-1. patients with newly diagnosed acute myeloid
        leukemia who approve to get induction chemotherapy with (cytarabine plus idarubicin) or
        (modified Fludarabine + cytarabine + idarubicin ) A-2. patients with newly diagnosed acute
        lymphoid leukemia who approve to get induction chemotherapy with VPDL (vincristine +
        prednisolone + daunorubicin + L-asparaginase), C-VPDL (cyclophosphamide + vincristine +
        prednisolone + daunorubicin + L-asparaginase), or (R)-hyperCVAD ((Rituximab) +
        cyclophosphamide + vincristine + Adriamycin + dexamethasone) B. Eastern Cooperative
        Oncology Group performance status score is equal to or more than 2 C. patients who
        voluntarily sign the agreement

        Exclusion Criteria:

        A. evidence of proven/probable/possible fungal infection within 30 days before induction
        chemotherapy B. hypersensitivity to echinocandin C. patients had other malignancy within 5
        years D. previous treatment history with chemotherapy, radiation therapy, or
        immunosuppressive therapy.

        E. pregnant or breast-feeding women F. immunodeficient patients including AIDS G. patients
        with uncontrolled seizure or psychiatric disorder H. clinically significant heart disorder
        (myocardial infarction within 3 months or left ventricular ejection fraction < 40%) I.
        interstitial lung disease J. previous organ transplantation history K. galactose
        intolerance L. patients who participated this study before.
Alemtuzumab and Pentostatin In T-cell Neoplasms
Condition: Lymphoma; Leukemia
MeSH terms: Neoplasms
Intervention: Pentostatin; Alemtuzumab
Intervention description: 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks; 30 mg IV three times weekly
Intervention MeSH terms: Alemtuzumab; Pentostatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T-Cell Neoplasms; Alemtuzumab; Pentostatin; Campath-1H; Deoxycoformycin; Lymphoma; Leukemia

Summary:

      The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab
      can help to control T-cell malignancy. The safety of this combination therapy will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years and older

          2. Diagnosis of T lymphoid malignancy established by peripheral blood, bone marrow or
             tissue (skin, lymph node or other) examination and using the standard criteria.

          3. Patients with untreated T-cell-prolymphocytic leukemia (T-PLL), peripheral T-cell
             lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible.

          4. Patients with relapsed/refractory T-PLL, T-lineage acute lymphoblastic leukemia
             (T-ALL), Adult T-cell leukemia/lymphoma (ATLL), peripheral T-cell lymphoma,
             hepatosplenic T-cell lymphoma and NK/T cell lymphoma and other T-lymphoid malignancies
             are eligible. Patients who have had prior therapy with either alemtuzumab or
             pentostatin as single agents are eligible.

          5. Willing to use adequate contraception for the entire duration of the study.

          6. Performance status 0-2.

          7. Creatinine less than or equal to 2.0 mg/dL and calculated creatinine clearance greater
             than 40

          8. Bilirubin less than or equal to 3.0 mg/dL, transaminases (aminotransferase (AST or
             SGOT) and alanine aminotransferase (ALT or SGPT)) less than 4 x upper limit of normal
             unless related to the disease.

          9. Left ventricular ejection fraction greater than 30%.

        Exclusion Criteria:

          1. Unable or unwilling to sign the consent form.

          2. Pregnant or lactating

          3. Known to be HIV+

          4. Active and uncontrolled infection as judged by treating physician
Post-stroke Neural Plasticity With Atomoxetine
Condition: Atomoxetine Hydrochloride; Placebos
Intervention: Atomoxetine; Placebo
Intervention description: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.; Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: motor training; motor recovery; human; neuroplasticity; transcranial magnetic stimulation

Summary:

      This proposal evaluates the safety and effectiveness of a noradrenergic drug named
      atomoxetine combined with motor training to enhance cortical plasticity and improve hand
      function after stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic stroke patients

          -  Single stroke

          -  Chronic (more than 6 months after from stroke)

          -  At least 21 years old, but there is no upper age range for this project.

          -  Participants NOT able to extend the affected metacarpophalangeal joints at least 10°
             and the wrist 20°.

        Exclusion Criteria:

          -  History of head injury with loss of consciousness

          -  History of severe alcohol or drug abuse

          -  History of psychiatric illness

          -  Unstable cardiac dysrhythmia

          -  High blood pressure (systolic pressure >160 mm Hg and/or diastolic pressure >100 mm
             Hg)

          -  History of myocardial infarction or unstable angina

          -  Pregnancy

          -  Glaucoma, history of hypersensitivity or idiosyncrasy to sympathomimetic drugs.

          -  Subjects using drugs suspected of interfering with plasticity, such as MAOI,
             alpha-adrenergic antagonists, benzodiazepines, muscarinic receptor antagonists,
             dopaminergic antagonists, or other neuroleptics within 3 months of recruitment.
Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 177Lu-PSMA-617
Intervention description: Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research.
Intervention MeSH terms: 177Lu-PSMA-617
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was an open-label, multicenter, prospective trial to assess safety and efficacy of
      177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Prostate cancer proven by histopathology

          2. Unresectable metastases

          3. Progressive disease, both docetaxel naive and docetaxel treated.

          4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior
             androgen deprivation therapy (ADT)

          5. Positive 68Ga-PSMA-11 PET/CT (positron emission computed tomography ) or diagnostic
             177Lu-PSMA-617 scintigraphy

          6. ECOG 0-2

          7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT
             (platelet) count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and
             WBC≥2.000/ μl,PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent
             cycles

          8. Signing of the Informed Consent Form

          9. Patients enrolling in this trail should have received either Enzalutamide or
             Abiraterone

        Exclusion Criteria:

          1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel,
             Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.

          2. Glomerular Filtration Rate (GFR) <40 ml/min

          3. Serum creatinine > 1.5 ULN

          4. AST and ALT>5xULN

          5. Urinary tract obstruction or marked hydronephrosis

          6. Diffuse bone marrow involvement confirmed by super-scans
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
Condition: Substance Use; Psychopathy
MeSH terms: Substance-Related Disorders; Antisocial Personality Disorder
Intervention: motivational enhancement therapy; standard care
Intervention description: Four 45-minute MET sessions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: substance use; psychopathy; motivational enhancement; criminal recidivism

Summary:

      Substance use among criminal offenders constitutes a major public health problem and is tied
      to negative consequences for offenders, their families, and their communities. One of the
      direst of these consequences is repeated incarceration; thus, interventions that reduce
      criminal recidivism are needed. Forensic populations are often viewed with considerable
      therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and
      the assessment of individual differences among offenders may provide valuable information
      that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has
      emerged as an important personality construct for the understanding of violence and criminal
      recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and
      lack of remorse may have negative implications for the efficacy of psychosocial
      interventions. A foundational premise of the present work is that understanding the
      moderating role of psychopathic traits on substance use treatment outcomes among offenders is
      essential to determining what works, and for whom. The current proposal is a Phase II
      randomized clinical trial that aims to examine the impact of psychopathic traits on the
      efficacy of a brief substance use intervention for offenders in a jail diversion program.
      Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based
      treatment will reduce substance use and related consequences relative to a Standard Care only
      condition, 2) that the reduction in substance use in the intervention group will mediate a
      reduction in later criminal recidivism relative to the Standard Care condition, and 3) that
      core psychopathic traits will moderate the efficacy of the intervention such that individuals
      with lower levels of these traits will derive greater benefits with regard to decreased
      substance use, decreased drug use consequences, and decreased criminal recidivism at a
      one-year follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In local pretrial services program; English speaking

        Exclusion Criteria:

          -  Psychosis, inability to provide informed consent
Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Intervention: pasireotide
Intervention description: Pasireotide 600 μg (batch number Y050DE) or 900 μg bid (batch number Y1270908) for subcutaneous injection. Placebo (batch number Y069HC) for subcutaneous injection.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 45.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical study will attempt to find out why in early studies in healthy volunteers,
      injections under the skin of pasireotide were associated with temporary increases in both
      fasting and post-meal glucose levels, along with possible increases in insulin and glucagon
      levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels
      are amounts of hormones that lower and raise blood sugar.

      The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and
      secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen)
      that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy.
      Insulin resistance is the condition in which higher than normal amounts of insulin are
      necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of
      insulin produced by the body and released in the blood. Glucagon is a hormone (chemical
      substance produced by the pancreas gland in the body) which increases blood glucose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lean, healthy, non-diabetic male.

        Exclusion Criteria:

          -  Family history of diabetes, BMI over 25.