bioihbjkbjnl/mcl2 huggingface dataset:
Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: ABT-SLV187; Oral Levodopa/Carbidopa; Infusion Pump: CADD-Legacy® 1400 Pump; NJ-Tube: Silicon ED Tube; Adaptor: Hakko Adaptor
Intervention description: Tablet; contains 100 mg levodopa and 10 mg carbidopa; General infusion pump, manufactured by Smiths Medical (US); Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan); Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)
Intervention MeSH terms: Silicon; Levodopa; Carbidopa
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: 30 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Levodopa-carbidopa intestinal gel; Advanced Parkinson's disease; Severe motor fluctuations; Dyskinesia

Summary:

      To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced
      Parkinson's disease (PD) patients with severe motor complications. The complications of
      medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be
      investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS)
             Brain Bank criteria

          -  PD stage corresponds to 4 or 5 in the 'off' state according to the modified Hoehn &
             Yahr (H & Y) classification of disease severity

          -  Levodopa-responsive subjects demonstrate some identifiable 'ON response' established
             by observation by Investigator and 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
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Loss
Intervention: GI Liner
Intervention description: Medical device placed endoscopically in the duodenum, nutritional counseling
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes

Summary:

      The purpose of this study is to determine whether the GI Sleeve is safe and effective in
      treating Type II diabetes patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65

          -  BMI 40 to 60

          -  Type II Diabetes

          -  Candidates for bariatric surgery

        Exclusion Criteria:

        Patients with

          -  hepatitis B or C

          -  gastroesophageal reflux disease (GERD)

          -  HIV Positive diagnosis

          -  pancreatitis

          -  conditions of gastrointestinal tract, such as ulcers or Crohn's

          -  an infection or who are H. Pylori positive
Study of Sulfasalazine in Treating Painful Neuropathy
Condition: Painful Neuropathy
MeSH terms: Pain
Intervention: Sulfasalazine; placebo
Intervention MeSH terms: Sulfasalazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid
      arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this
      study, the investigators will evaluate whether sulfasalazine improves pain due to painful
      peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Painful neuropathy

          -  Michigan Neuropathy Screening Instrument score of 3 or greater

          -  no obvious alternative explanation for neuropathy

          -  average baseline pain > 4/10

        Exclusion Criteria:

          -  other severe pain

          -  anticipated difficulty weaning off medications

          -  past or current psychiatric disorder as determined by Mini International
             Neuropsychiatric Interview

          -  medical contraindication to sulfasalazine

          -  not proficient in English (due to heavy use of questionaires)

          -  pregnant or breast feeding women
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: nivolumab; docetaxel; enzalutamide; rucaparib; prednisone
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Prednisone; Docetaxel; Nivolumab; Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of nivolumab in combination
      with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate
      cancer that has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of adenocarcinoma of the prostate

          -  Evidence of stage IV disease on previous bone, CT, and/or MRI scan

          -  Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone
             (GnRH) analogue or bilateral orchiectomy

          -  Mandatory plasma and fresh or archival tumor tissue must be submitted

        Exclusion Criteria:

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, or carcinoma in situ of the breast

          -  Participants with active brain metastases

          -  Participants must have recovered from the effects of major surgery requiring general
             anesthesia or significant traumatic injury at least 14 days before treatment arm
             assignment

        Other protocol defined inclusion/exclusion criteria could apply
A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: TC-5214; Duloxetine; Placebo
Intervention description: Tablet, oral, twice daily for 8 weeks; Capsule, oral, once daily; Tablet, oral, twice daily for 8 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Monotherapy; Inadequate Response to Antidepressant Therapy

Summary:

      The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy
      in patients with major depressive disorder who exhibit inadequate response to
      antidepressants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  The patient must have a clinical diagnosis of major depressive disorder (MDD) with
             inadequate response to no more than one antidepressant.

          -  Women of child-bearing potential must have a negative urine pregnancy test and
             confirmed use of a highly effective form of birth control before enrollment and until
             3 months after their last dose of study drug.

          -  Outpatient status at enrollment and randomization.

        Exclusion Criteria:

          -  Patients with a lifetime history of bipolar disorder; psychotic disorder or
             post-traumatic stress disorder.

          -  Patients with a history of suicide attempts in the past year and/or seen by the
             investigator as having a significant history of risk of suicide or homicide.

          -  Patients with any significant unstable hepatic, renal, pulmonary, cardiovascular,
             ophthalmologic, neurologic, or any other medical conditions that might confound the
             study or put the patient at greater risk during study participation.

          -  History of stroke or transient ischemic attack, seizures or seizure disorder, head
             trauma including closed head injury.

          -  Pregnancy or lactation.
Development of NIC5-15 in the Treatment of Alzheimer's Disease
Condition: Alzheimer Disease; Dementia
MeSH terms: Alzheimer Disease; Dementia
Intervention: NIC5-15; Placebo
Intervention description: a natural product, found in many foods and plants with mild insulin sensitizing effects; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Healthy volunteers: No
Keywords: Alzheimer Disease; Alzheimer Type Senile Dementia; Alzheimer's Disease; clinical trial; dementia; diabetes; dietary supplements; Senile Dementia, Alzheimer Type; Therapeutics

Summary:

      The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment
      of Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NINCDS/ADRDA criteria for probable AD

          -  MMSE between 12-27

          -  Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist
             with stable dose for at least 12 weeks

          -  Home monitoring available for supervision of medications

          -  Caregiver available to accompany patient to all visits and willing to participate in
             study as informant

          -  Fluent in English or Spanish

          -  Medical stability for this study as confirmed by review of records, internist's
             physical exam, neurological exam, and laboratory tests

          -  Stable doses of non-excluded medication

          -  No evidence of hepatic insufficiency

          -  Able to swallow oral medications

          -  Ability to participate in the informed consent process

        Exclusion Criteria:

          -  History of Diabetes Mellitus (OGTT criteria) requiring treatment with an excluded
             antidiabetic medication (see below) or history of hypoglycemia

          -  Active hepatic or renal disease

          -  Cardiac disease including history of congestive heart failure or current treatment for
             CHF; history of recent myocardial infarction

          -  Use of another investigational drug within the past two months

          -  History of clinically significant stroke

          -  History of seizure or head trauma with disturbance of consciousness within the past
             two years

          -  Major mental illness including psychotic disorders, bipolar disorder, or major
             depressive episode within the past two years Medication Exclusion

          -  Current use of oral hypoglycemic agents including sulfonylureas and meglintinides

          -  Current use of a lipid-lowering agent (excluded from Study #1, see discussion below)

          -  Current or past treatment with insulin for longer than two weeks

          -  Current use of drugs with significant anticholinergic or antihistaminic properties
Convalescent Plasma for Patients With COVID-19
Condition: Coronavirus Infection; Coronavirus; COVID
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Convalescent plasma
Intervention description: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19

Summary:

      Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in
      patients with COVID-19 respiratory disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min
             Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest
             radiograph at 24 to 48 hours

        Exclusion Criteria:

          -  Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA
             ECMO
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Intervention: Seasonal Influenza Vaccine (MF59C.1)
Intervention description: 1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      This is a trial for annual registration of the updated seasonal influenza vaccine
      formulation.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects of 65 years of age or older

          -  Mentally competent

          -  Willing and able to give written informed consent prior to study entry

          -  Able to comply with all the study requirements

          -  In general good health

        Key Exclusion Criteria:

          -  Any serious chronic or acute disease disease

          -  History of any anaphylactic reaction and/or serious allergic reaction following a
             vaccination

          -  A proven hypersensitivity to any component of the study vaccine

          -  Known or suspected (or have a high risk of developing) impairment/alteration of immune
             function (excluding that normally associated with advanced age)

          -  Bleeding diathesis or conditions associated with prolonged bleeding time that in the
             investigator's opinion would interfere with the safety of the subject

          -  Within the past 12 months, participants had received more than one injection of
             influenza vaccine

          -  Within the past 6 months, participants had laboratory confirmed influenza disease or
             received influenza vaccine
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorders
MeSH terms: Body Dysmorphic Disorders
Intervention: Psilocybin
Intervention description: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Intervention MeSH terms: Psilocybin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded
      to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with
      a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will
      be conducted over a 3 month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body dysmorphic disorder of at least moderate severity, non-delusional subtype, for >6
             months

          -  History of intolerance of, or nonresponse to, a prior adequate trial of a serotonin
             reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)

          -  Currently in psychotherapy (other than cognitive behavioral therapy (CBT) for body
             dysmorphic disorder

        Exclusion Criteria:

          -  Current major depressive disorder of greater than moderate severity

          -  Other significant psychiatric or medical comorbidity or conditions that could
             interfere with safety of participation or interpretation of outcomes

          -  Use of: investigational medication within 3 months of baseline; depot antipsychotic
             within 6 months of baseline; serotonergic medication within 2 weeks of baseline (6
             weeks for fluoxetine).

          -  Females who are pregnant, breastfeeding, or sexually active and not willing to use
             adequate contraception

          -  Enrollment in any investigational drug or device study in past 30 days

          -  Prior adverse effects from psilocybin
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Condition: Neovascular (Wet) Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: aflibercept; High-dose aflibercept
Intervention description: Intravitreally (IVT) administered as a liquid formulation in a vial; Intravitreally (IVT) administered as a liquid formulation in a vial
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.
Enrollment: 106.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The primary objectives of the study are to determine the safety of high-dose aflibercept
      (hereafter referred to as HD) and to determine if HD provides greater intraocular
      pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal
      aflibercept injection (hereafter referred to as IAI).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV)
             secondary to nAMD

          -  Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS)
             letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

        Key Exclusion Criteria:

          -  Evidence of CNV due to any cause other than nAMD in either eye

          -  Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than
             1 microaneurysm) in either eye in diabetic patients

          -  Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab,
             brolucizumab, pegaptanib sodium) in the study eye

          -  Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific
             monoclonal antibodies, gene therapy)

          -  Previous use of intraocular or periocular corticosteroids within 120 days of screening
             or treatment with an IVT steroid implant at any time in the study eye

          -  History of vitreoretinal surgery (including scleral buckling) in the study eye

          -  Any other intraocular surgery within 12 weeks (84 days) before the screening visit

          -  History of corneal transplant or corneal dystrophy in study eye

        NOTE: Other protocol defined inclusion/exclusion criteria apply.
MK3207 for Treatment of Acute Migraines (3207-005)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: MK3207- 2.5 mg; MK3207- 5 mg; MK3207- 10 mg; MK3207- 20 mg; MK3207- 50 mg; MK3207- 100 mg; Comparator: placebo (unspecified)
Intervention description: Arm 1: MK3207 2.5 mg taken after migraine onset.; Arm 2: MK3207 5 mg taken after migraine onset.; Arm 3: MK3207 10 mg taken after migraine onset.; Arm 4: MK3207 20 mg taken after migraine onset.; Arm 5: MK3207 50 mg taken after migraine onset.; Arm 6: MK3207 100 mg taken after migraine onset.; Placebo taken after migraine onset.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 676.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of
      MK3207 in the treatment of acute migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women from 18 to 65 years of age

          -  1+ year history of migraine that typically last from 4 to 72 hours if untreated

          -  Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months

          -  Not pregnant or planning to become pregnant in next 6 months

        Exclusion Criteria:

          -  Pregnant or breast-feeding, or planning to become pregnant in next 6 months

          -  Cannot distinguish migraine attacks from tension type headaches

          -  Migraines are mild or resolve without medication in less than 2 hours

          -  More than 15 headache-days per month or have taken medication on more than 10 days per
             month in the last 3 months

          -  Basilar type or hemiplegic migraine headaches

          -  More than 50 years old when migraines began

          -  History of cardiovascular disorder within last 6 months