bioihbjkbjnl/mcl2 huggingface dataset:
Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: N-acetylcysteine capsule
Intervention description: N-acetylcysteine capsule
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as
      therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All participants must be 18 years or older

          2. All enrollees must understand and cooperate with requirements of the study in the
             opinion of the investigators and must be able to provide written informed consent

          3. Individuals with medically stable Parkinson's disease (in the opinion of the
             investigator)

          4. All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10,
             vitamin C, or vitamin E for 3 weeks prior to the study

          5. Absence of dementia in all subjects

        Exclusion Criteria:

          1. Inability to undergo MRI scanning without sedation and other MRI counterindications,
             such as metal in the body (see section 7.3)

          2. Medically unstable conditions as determined by the investigators

          3. Pregnant or lactating or those women of child-bearing age that are not using
             acceptable forms of contraception

          4. Diagnosis of asthma that is presently being treated with any medication, or past
             history of asthma/bronchospasm resulting in an emergency room visit, hospitalization
             or treatment

          5. Unable to adhere to study protocol for whatever reason
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Irinotecan associated to fluorouracil and leucovorin
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 70 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Chemotherapy; gastric cancer; geriatric evaluation; efficacy; safety

Summary:

      The number of patients over 70 years old with cancer is increasing in France. This population
      is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a
      lot between subjects of the same age. Physicians hesitate to treat them with optimal doses
      because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty
      eight percent of gastric cancers are diagnosed in patients over the age of 70 in France.
      FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising
      treatment for digestive cancer. It increases the level of response and survival without major
      toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their
      conditions.

      The principal objectives are to demonstrate the efficacy of treatment, safety, survival and
      to find out if geriatric assessment data can help to better predict chemotherapy toxicity.
      The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic
      gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day
      1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of
      cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up
      and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and
      Lachs-Balducci screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  70 years of age or older

          -  Gastric cancer, locally advanced or metastatic

          -  No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6
             months

          -  One measurable lesion

          -  ECOG < 3

          -  Biology and biochemistry within normal limits

          -  Life expectancy > 12 weeks

        Exclusion Criteria:

          -  Other palliative chemotherapy for this cancer

          -  Other cancer in the last 5 years

          -  Previous treatment with irinotecan

          -  Atropine treatment not possible

          -  Concomitant cancer therapy except bone radiotherapy

          -  Metastases to brain or meninges with symptoms

          -  Other severe pathology uncontrolled

          -  Problem of compliance
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)
Condition: Graves' Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Intervention: RVT-1401
Intervention description: RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label study
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMVT-1401; Graves' Orbitopathy; Thyroid Eye Disease

Summary:

      The purpose of this study was to evaluate safety, tolerability, and pharmacodynamic
      parameters of RVT-1401 in graves' ophthalmopathy (GO) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 years of age.

          2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active,
             moderate to severe GO with a Clinical Activity Score (CAS) ≥ 4 for the most severely
             affected eye at Screening (on the 7-item scale) and Baseline (on the 10-item scale).

          3. Onset of active GO within 9 months of screening.

          4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on
             daily life), usually associated with one or more of the following: lid retraction ≥ 2
             mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race
             and gender, and/or inconstant or constant diplopia.

          5. Other, more specific inclusion criteria are defined in the protocol

        Exclusion Criteria:

          1. Use of any steroid (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1
             g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.

          2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within
             the past 9 months prior to Baseline.

          3. Total IgG level < 6g/L at Screening.

          4. Absolute neutrophil count <1500 cells/mm3 at Screening.

          5. Participants with decreased best corrected visual acuity due to optic neuropathy as
             defined by a decrease in vision of 2 lines on the Snellen chart, new visual field
             defect, or color defect secondary to optic nerve involvement within the last 6 months
             at Screening.

          6. Previous orbital irradiation or surgery for GO.

          7. Other, more specific exclusion criteria are defined in the protocol
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3209590; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3209590 is safe and effective in
      participants with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have type 2 diabetes mellitus according to the World Health
             Organization (WHO) criteria treated with a stable dose of metformin in combination
             with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a
             Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to
             screening

          -  Participants must have a HbA1c value of 7.0% to 9.5%, inclusive

          -  Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter
             squared (kg/m²), inclusive

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus or latent autoimmune diabetes

          -  Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to screening

          -  Have any of the following cardiovascular (CV) conditions: acute myocardial infarction,
             New York Heart Association Class III or IV heart failure, or cerebrovascular accident
             (stroke)

          -  Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other
             liver disease

          -  Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²

          -  Have active or untreated cancer

          -  Are receiving chronic (>14 days) systemic glucocorticoid therapy
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Recurrence
Intervention: Fecal Microbiota Transplant (FMT)
Intervention description: Fecal Microbiota Transplant (FMT)
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention; Recurrence; Fecal Microbiota Therapy

Summary:

      The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the
      risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection.
      The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical
      symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team
      hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after
      surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is
      also hypothesized that FMT will be safe and well-tolerated in these patients.
    

Eligibility criteria:

        Inclusion Criteria (Patients):

          -  Adults (age > 18)

          -  Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging
             (confirmed by Study PI for each site)

          -  Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to
             enrollment

          -  Resection margins & anastomosis free of active inflammation based on histology and
             surgical description (confirmed by Study PI for each site)

          -  No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for
             anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior
             to enrollment.

        Exclusion Criteria (Patients):

          -  Diagnosis of indeterminate colitis

          -  Women who are pregnant or nursing

          -  Patients who are unable to give informed consent

          -  Patients who are unable or unwilling to undergo colonoscopy with moderate sedation
             (>ASA class II)

          -  Patients who have previously undergone FMT

          -  Patients who have a confirmed malignancy or cancer

          -  Participation in a clinical trial in the preceding 30 days or simultaneously during
             this trial

          -  Probiotic use within 30 days of start date

          -  Decompensated cirrhosis

          -  Congenital or acquired immunodeficiencies

          -  Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44

          -  History of rheumatic heart disease, endocarditis, or valvular disease due to risk of
             bacteremia from colonoscopy
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: Belinostat
Intervention MeSH terms: Belinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Belinostat; Peripheral T-cell lymphoma; PXD101; PTCL; HDAC inhibitor; Histone deacetylase inhibitor

Summary:

      The purpose of this study is to assess efficacy and safety of belinostat in participants with
      relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior
      systemic therapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  A histologically confirmed diagnosis of PTCL

          -  Participants must have relapsed or refractory disease after at least one prior
             systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or
             immunotherapy administered systemically.

          -  Participants must have at least one site of disease measurable in two dimensions by
             computed tomography (CT).

          -  Age ≥ 18 years.

          -  Adequate bone marrow, liver, and renal functions.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Negative pregnancy test for women of childbearing potential.

        Exclusion criteria:

          -  Relapse within 100 days of autologous or allogeneic bone marrow transplant.

          -  Prior histone deacetylase (HDAC) inhibitor therapy.

          -  Co-existing active infection or any medical condition likely to interfere with trial
             procedures.

          -  Severe cardiovascular disease.

          -  Clinically significant central nervous system disorders with altered mental status or
             psychiatric disorders precluding understanding of the informed consent process and/or
             completion of the necessary studies.

          -  Active concurrent malignancy (except adequately treated non-melanoma skin cancer or
             carcinoma in situ of the cervix).

          -  Symptomatic or untreated central nervous system (CNS) metastases.

          -  Pregnant or breast-feeding women.

          -  Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Condition: Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Intervention: PF-06882961; Placebo
Intervention description: PF-68882961 will be provided as tablets twice a day (BID); Placebo comparator will be provided as tablets twice daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID)
      administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who
      are treated with metformin and in non-diabetic adults with obesity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1
             (screening).

        Exclusion Criteria:

          -  Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             New York Heart Association Functional Class II IV heart failure, or transient ischemic
             attack within 6 months of screening (Visit 1).

          -  Participants with a known medical history of active liver disease (other than non
             alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary
             biliary cirrhosis.

          -  History of major depressive disorder or history of other severe psychiatric disorders
             (eg, schizophrenia or bipolar disorder) within the last 2 years.

          -  Any lifetime history of a suicide attempt.
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine
Intervention description: Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 61 Years
Healthy volunteers: No

Summary:

      This is an outpatient study to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed the double-blind treatment period of the lead-in study
             RGH-MD-16 (NCT 00694707)

          -  Patients who have responded to double-blind treatment in the lead-in study as defined
             as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative
             Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S)
             score of ≤ 3.

          -  Patients eligible to continue as outpatients based on the opinion of the Principal
             Investigator.

          -  Patients must have a caregiver to ensure treatment compliance.

        Exclusion Criteria:

          -  Patients with clinically significant abnormalities on physical examination,
             laboratory, vital signs, and/or electrocardiogram (ECG).
TXA127 for the Treatment of Severe COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: TXA127; Placebo
Intervention description: 0.5 mg/kg per day; 0.5 mg/kg per day
Intervention MeSH terms: Angiotensin I (1-7)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded, placebo-control, randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; multi-organ failure; acute kidney injury

Summary:

      The purpose of this study is to determine if administration of angiotensin-(1-7) (TXA127)
      prevents acute kidney injury and deterioration into multi-organ failure in patients with
      severe COVID-19. Participants will undergo a 10-day treatment with either placebo or study
      drug. The drug will be administered intravenously for 3 hours once each day for 10 days
      consecutively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe COVID-19: Adult patients admitted to the hospital through the Emergency
             Department (ED) requiring oxygen therapy (any level) to maintain oxygen saturation
             (SaO2) > 90%

          -  COVID positive by polymerase chain reaction (PCR) on hospital admission

          -  Hospitalized patients aged 18 years or greater

        Exclusion Criteria:

          -  Pre-existing chronic kidney disease

          -  New use of or change in dose of ACE-inhibitors or angiotensin receptor blocker (ARB)
             within the last 6 months

          -  Acute kidney injury at the time of enrollment defined as either increase pf serum
             creatinine by more than 50% or 0.3 mg/dL above baseline or estimated creatinine
             clearance (by MDRD) of less than 60 ml/min (if no baseline serum creatinine available)

          -  Pregnant and breastfeeding women

          -  Contraindicated medications: new use or change of medications from start of trial
             (start of an ACE inhibitor or ARB within 6 months of trial).
ET-01 in Subjects With Lateral Canthal Lines, LCL-207
Condition: Lateral Canthal Lines; Crow's Feet
Intervention: Vehicle; botulinum toxin, Type A; botulinum toxin, Type A
Intervention description: Vehicle Formulation; botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline; botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel dose groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: different doses are packaged in identical containers
Enrollment: 79.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet wrinkles on contraction

          -  willingness to refrain from any product affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child