bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Condition: Parkinson Disease; Cognitive Dysfunction
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Intervention: SAGE-718
Intervention description: Oral tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study had two parts: Part A and Part B with unique participants for each study part. Part B was started after Part A was completed.
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Cognitive Dysfunction; SAGE-718

Summary:

      The primary purpose of this two-part study was to evaluate the safety and tolerability of
      SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants
      with Parkinson's disease mild cognitive impairment (PD-MCI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic PD
             according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet
             MDS Task Force Criteria for MCI in PD.

          2. Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at
             Screening.

          3. Meet criteria for Hoehn & Yahr Stage I to III (mild to moderate motor severity) at
             Screening.

          4. Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of
             the investigator.

        Exclusion Criteria:

          1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia
             associated with PD (probable or possible), Dementia with Lewy Bodies, Alzheimer's
             Dementia, and Vascular Dementia.

          2. Have any indication of parkinsonism other than idiopathic PD.

          3. In the opinion of the investigator, be experiencing unpredictable fluctuations in
             motor and/or nonmotor symptoms associated with PD.

          4. Have an ongoing central nervous system condition other than idiopathic PD, including
             active neurologic and/or nonremitted psychiatric disorders, in the opinion of the
             investigator.

          5. Have a history of brain surgery, deep brain stimulation, a significant head injury
             causing loss of consciousness greater than 30 minutes, or hospitalization due to a
             brain injury.

          6. Have experienced significant psychotic symptoms within the past 3 months, including
             those associated with PD medications, as determined by the investigator.
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Obese; Overweight
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Intervention: Gastric Emptying test; Mixed Oral Glucose Tolerance test; Conjugated bile acids sodium; Placebo
Intervention description: participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.; Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.; 500 mg tablets taken orally twice daily for 28 (+/- 4) days; Placebo tablets taken orally twice daily for 28 (+/- 4) days
Intervention MeSH terms: Bile Acids and Salts
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity,
      postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum
      FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on
      therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in
      combination with metformin.
    

Eligibility criteria:

        Inclusion criteria:

          1. Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking
             DPP4 inhibitors alone or in combination with metformin.

          2. Women of childbearing potential will have a negative pregnancy test before initiation
             of medication and within 48 hours of receiving radioisotope.

        Exclusion criteria:

          1. Structural of metabolic diseases/conditions that affect the gastrointestinal system,
             or functional gastrointestinal disorders.

          2. Irritable bowel syndrome

          3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.

          4. Subjects with other treatment for type 2 diabetes mellitus.

          5. Subjects with HbA1c > 8%

          6. Females who are pregnant or breastfeeding

          7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or
             lorcaserin.

          8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal,
             hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes
             mellitus), and unstable psychiatric disease.

          9. Subjects who have donated blood or plasma in the past 8 weeks.

         10. Subjects who have participated in another study within the past 30 days.
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Condition: Breast Cancer; Metastatic Breast Cancer; MBC; HER2 Positive; HER2; Estrogen Receptor Positive; ER; Triple Negative
MeSH terms: Breast Neoplasms
Intervention: Lucitanib
Intervention description: Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Metastatic breast cancer; MBC; HER2 positive; HER2+; Estrogen receptor positive; ER+; Triple negative; FGFR1; 11q; FGF aberrant; Biomarker negative; FGF non-aberrant

Summary:

      The purpose of this study is to determine whether lucitanib is safe and effective in the
      treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment
      of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic breast cancer relapsed or
             refractory to approved standard available treatment

          -  Prior treatment with standard first line therapy in the metastatic setting

          -  Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q
             amplification status

          -  Demonstrated progression of disease by radiological or clinical assessment (Measurable
             disease according to RECIST Version 1.1 is NOT required for enrollment)

          -  Estimated life expectancy >6 months

        Exclusion Criteria:

          -  Current or recent treatment with biologic anticancer therapies

          -  Ongoing AEs from prior anticancer therapies

          -  Active central nervous system (CNS) metastases

          -  Clinically significant or uncontrolled hypertension or cardiac disease

          -  Females who are pregnant or breastfeeding
Association Between Body Size and Response to Hydromorphone in ED
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone
Intervention description: a fixed dose (1 mg) of hydromorphone will be given to the study subjects
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hydromorphone; acute pain; emergency department

Summary:

      Pain is the most common complaint for patients presenting to the emergency department (ED).
      Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and
      responses to intravenous opioids vary widely and are influenced by multiple factors. The
      objective of the current study is to examine the association between total body weight, BMI
      (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking

          -  Age 18 - 65 years old

          -  Acute pain (less than 7 days in duration)

          -  Pain with sufficient severity to warrant use of intravenous opioids in the judgment of
             ED attending physician

        Exclusion Criteria:

          -  Allergy to hydromorphone

          -  Systolic blood pressure < 90 mm Hg

          -  Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental
             oxygen

          -  Alcohol or other drug intoxication as judged by the attending physician

          -  Suspicion of drug seeking by ED physician

          -  Use of opioids within the past 24 hours

          -  Use of a monoamine oxidase inhibitor

          -  Concurrent use of benzodiazepines

          -  Presence of a chronic pain syndrome (such as sickle cell disease, peripheral
             neuropathy, diabetic neuropathy, or fibromyalgia)

          -  History of COPD, sleep apnea, renal failure, liver disease

          -  Pregnancy or breast feeding

          -  Prior entry of patient in the study

          -  Inability or unwillingness to provide informed consent
Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
Condition: Long QT Syndrome
MeSH terms: Long QT Syndrome
Intervention: Placebo; Ranolazine
Intervention description: Matching Placebo will be given for first month.; Patients will receive ranolazine 1000mg bid for subsequent 5 months.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will receive placebo for 1 month and subsequently ranolazine 1000mg twice a day for 5 months.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Matching placebo and ranolazine pills were used. Patients were blinded regarding administration of medication. ECG Core Lab reading ECGs was blinded regarding drug assignment.
Enrollment: 25.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: ranolazine; clinical trial

Summary:

      The purpose of this study is to determine whether late sodium channel blockade might be
      effective in shortening the QTc interval in various LQT3 mutations and be considered as a
      safe therapeutic option for LQT3 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotyped positive for LQT3 (SCN5A) mutation

          -  Age 21 years or older

          -  Not currently taking an antiarrhythmic drug (beta blockers are allowed)

          -  Enrolled in LQTS Registry

        Exclusion Criteria:

          -  Age less than 21 years

          -  Not confirmed to have an LQT3 mutation

          -  Significant co-morbidity that would preclude subject's safe participation in this
             study

          -  Females who are pregnant or nursing

          -  Females of childbearing age who are not using acceptable method of birth control

          -  Evidence of prior sensitivity to ranolazine

          -  Hepatic or renal disease that might adversely affect ranolazine excretion

          -  Currently taking strong CYP3A inhibitors

          -  Currently taking P-gp inhibitors

          -  Currently taking CYP3A inducers

          -  In vitro studies of specific mutation show no effect of ranolazine on late sodium
             current kinetics or show repolarization prolongation
PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: PF-06651600; Placebo
Intervention description: 50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD; tablet, dosed as 4 tablets QD or 1 tablet QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: alopecia totalis; alopecia universalis; hair loss; alopecia; JAK; ritlecitinib; PF-06651600; double-blind; placebo-controlled; phase 2a

Summary:

      This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the
      safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp
      hair loss due to Alopecia Areata (AA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.

          -  At least 25% hair loss due to alopecia areata

          -  Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)

          -  Must have a normal neurological exam; can have a stable unilateral median neuropathy
             or ulnar neuropathy

          -  Signed informed consent

          -  Stable regimen for other medications before and during the study

        Exclusion Criteria:

          -  Other significant medical conditions

          -  Occupational or recreational noise exposure

          -  History of peripheral neuropathy or first degree relative with a hereditary peripheral
             neuropathy

          -  HbA1c > or = 7.5% at Screening

          -  Recurrent or disseminated Herpes Zoster

          -  Active or chronic infection; or infection requiring hospitalization or IV
             antimicrobials within 6 months

          -  Active or latent (insufficiently treated) Hepatitis

          -  Active or latent (insufficiently treated) TB

          -  Concomitant medications associated with peripheral neurologic or hearing loss

          -  Protocol specific laboratory abnormalities
Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Brolucizumab 3 mg/50 μL; Brolucizumab 6 mg/50 μL
Intervention description: Administered as an intravitreal injection; Administered as an intravitreal injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; nAMD; wetAMD; Age-Related Macular Degeneration

Summary:

      The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2
      different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when
      administered at 4-week intervals for a total of 3 intravitreal injections in subjects with
      neovascular age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent;

          -  Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the
             central subfield in the study eye;

          -  Best Corrected Visual Acuity (BCVA) > 23 letters in the study eye at Baseline;

          -  50 years of age or older at the time of Screening.

        Exclusion Criteria:

          -  Any active ocular infection or inflammation;

          -  Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®),
             brolucizumab, or an investigational drug for neovascular AMD prior to enrollment in
             the study, as specified in protocol;

          -  Ocular surgery in the study eye, as specified in protocol;

          -  Uncontrolled glaucoma in the study eye, as specified in protocol;

          -  Use of steroids in the study eye, as specified in protocol;

          -  Medical conditions that may prevent study completion;

          -  Pregnant or nursing (lactating) women;

          -  Women of child-bearing potential unless using contraception;

          -  Uncontrolled blood pressure, as specified in protocol;

          -  Other protocol-specified exclusion criteria may apply.
Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Genistein; Placebo
Intervention description: Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.; A placebo pill will be taken orally for 12 weeks.
Intervention MeSH terms: Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Genistein is a natural supplement that comes from soy. The purpose of this study is to see if
      genistein has any effect on preventing or reducing heart disease and diabetes risk in men
      receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional
      measures, blood markers and imaging tools will assess body composition, lipid levels and
      insulin resistance. Information from this pilot study will increase understanding of
      interventions which may prevent or reduce health risks during prostate cancer treatment. This
      project involves 24 men who will receive androgen deprivation therapy for prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical indication for androgen deprivation therapy (ADT) via luteinizing
             hormone-releasing hormone (LHRH) analog ± oral anti-androgen

          -  Diagnosis of prostate cancer

          -  ECOG performance status ≤ 2

          -  Life expectancy > 6 months

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Transmural myocardial infarction, unstable angina, or congestive heart failure
             requiring hospitalization within the last 6 months

          -  Acute coronary event within the past month

          -  Use of intravenous antibiotics within the last 6 months

          -  Chronic liver disease

          -  Current use of cytotoxic or immunosuppressive drugs

          -  Chronic glucocorticoid or acute glucocorticoid or other synthetic steroid intake
             within the last month

          -  Chronic diarrhea or malabsorptive diseases (e.g., Crohn's disease)

          -  Stage 5 chronic kidney disease or need for hemodialysis

          -  Supplemental oxygen dependency

          -  Brain metastasis

          -  Severe cognitive dysfunction impairing ability to provide informed consent or consume
             study drug

          -  Dysphagia or requirement for artificial feeding

          -  Surgery or hospitalization within the last month

          -  Chemotherapy or radiation therapy within the last 60 days

          -  Insulin dependent diabetes

          -  HIV/AIDS

          -  History of organ transplant

          -  ECOG performance status > 2
Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: Oral furosemide; Placebo Oral Tablet
Intervention description: Furosemide (Lasix), 20 milligram, PO, PO, daily; Placebo, PO, daily
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, randomized, placebo control design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study medication (furosemide) and placebo will be stored at room temperature at the University of Pennsylvania research pharmacy. Pharmacy will be responsible for labeling and randomizing the medications.
Enrollment: 384.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Furosemide; Postpartum; Hypertension

Summary:

      A randomized, double-blind, placebo-controlled single center investigation of furosemide's
      effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders
      of pregnancy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum

          -  Gestational hypertension

          -  Pre-eclampsia with or without severe features

          -  Superimposed pre-eclampsia with or without severe features

          -  New diagnosis of HDP within 24 hours from delivery

          -  Postpartum, delivery ≥ 20 weeks estimated gestational age

          -  Age ≥18 years old

        Exclusion Criteria:

          -  History of allergic reaction to furosemide

          -  High risk comorbidities for which treatment may be indicated or contraindicated: class
             C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2,
             cardiac disorders including cardiomyopathy, congenital heart disease, angina or
             coronary heart disease, rheumatic disease (lupus), sickle cell disease

          -  Baseline labs with K <3

          -  Use of furosemide or other diuretics antepartum or intrapartum

          -  Use of ototoxic agents including aminoglycosides (ie, Gentamicin for >1 dose),
             cephalosporins (ie Ancef >1 dose),

          -  Patient unstable for protocol per investigator's judgement