bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Intervention: Placebo; Chlorogenic acid
Intervention description: Placebo: 1200 mg per day for three months; Chologenic acid: 1200 mg per day for three months
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Chlorogenic acid; Control glucose; Insulin Secretion; Insulin Sensitivity

Summary:

      Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control,
      obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show
      that Chlorogenic acid has an excellent potential for the control of glucose as well as
      insulin secretion and insulin sensitivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI: 30.0-34.99 kg / m2.

          -  Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl.

          -  Written informed consent.

          -  Body weight stable over the last 3 months.

          -  Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the
             time of laboratory tests.

          -  Women who are not contemplated get pregnant within the next 6 months.

        Exclusion Criteria:

          -  Women pregnant or breastfeeding.

          -  Physical or mental disability that makes it impossible to perform the intervention.

          -  Diagnosis of Hypertension or heart failure.

          -  Smokers.

          -  Untreated thyroid disease.

          -  Consumption of oral agents or other medications or supplements with proven properties
             that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin,
             lipid-lowering).

          -  Diagnosis of liver disease or elevation twice of the upper normal value of liver
             enzymes.

          -  Diagnosis of renal disease or creatinine > 1.5 mg / dl.

          -  Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or OGTT
             ≥ 200 mg / dL and/or A1C ≥ 6.5%.

          -  Total Cholesterol ≥ 280 mg/dL.

          -  Triglycerids ≥ 300 mg/dL.

          -  Known allergy to calcined magnesia or Chorogenic acid.
Topiramate for the Treatment of Methamphetamine Dependence - 1
Condition: Methamphetamine
Intervention: Topiramate; Placebo Oral Tablet
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: methamphetamine addiction

Summary:

      The purpose of this study is to assess the efficacy and safety of topiramate as compared to
      placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment seeking individuals as the time of the study

          -  Must be able to proved written informed consent

          -  Must have a body mass index greater than 18 kg/m(2)

          -  Must meet DSM-IV criteria for methamphetamine dependence

          -  Must currently be using methamphetamine as confirmed by a positive urine test over the
             past 14 days

          -  If female of child bearing potential, must agree to use birth control

        Exclusion Criteria:

          -  Please contact the site for more information
Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Retigabine; Placebo
Intervention description: 150mg/day up to 900mg/day; daily
Intervention MeSH terms: Ezogabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Postherpetic Neuralgia, PHN, Shingles,

Summary:

      The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing
      pain associated with post-herpetic neuralgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide informed consent

          -  Male or female subjects

          -  18-85 years of age

          -  PHN for more than 6 months after the healing of herpes zoster skin rash

          -  Has a pain score at screening and randomization that qualifies

        Exclusion Criteria:

          -  Other significant pain that may potentially confound PHN pain assessment

          -  Previous neurolytic or neurosurgical therapy for PHN

          -  Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS
             lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy

          -  Significant psychiatric or neuropsychiatric disorders including but not limited to
             severe depression, bipolar disorder or schizophrenia spectrum disorder, history of
             suicide attempt, or recent history of suicidal ideation

          -  Has clinically significant abnormalities on physical examination, vital signs, ECG, or
             laboratory tests at the screening visit
Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; Bevacizumab; Docetaxel
Intervention description: administered every three weeks on day 1, every 21 days. The dose given will be 6 mg/kg. The initial loading dose is 8mg/kg and is administered as a 90-minute infusion. Thereafter, the maintenance dose is 6mg/kg every three weeks administered as a 30 minute infusion (unless the treating physician indicates a longer infusion duration is warranted). Trastuzumab is given prior to bevacizumab. Trastuzumab is to be continued until disease progression or unacceptable toxicity.; administered every three weeks on day 1, every 21 days. The dose given will be 15 mg/kg. The initial dose is administered over 90 minutes. If the first infusion is well tolerated, the second dose is given over 60 minutes, and if that is well tolerated, then subsequent doses may be given over 30 minutes. Avastin is given after trastuzumab and prior to docetaxel.; administered every three weeks on day 1, every 21 days. The dose given will be 75 mg/M². All doses of docetaxel are administered over 60 minutes. Docetaxel is given after trastuzumab and bevacizumab.
Intervention MeSH terms: Bevacizumab; Trastuzumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic; Breast Cancer; MBC

Summary:

      The primary objectives are to determine the progression-free survival (PFS) and to evaluate
      safety of the trastuzumab, bevacizumab and docetaxel regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed breast cancer with evidence of metastatic disease

          -  HER2 3+ or FISH (fluorescent in situ hybridization)+

          -  Age ≥ 18 years

          -  No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.

          -  No prior chemotherapy in the metastatic setting.

        Exclusion Criteria:

          -  CNS (central nervous system) metastases

          -  Prior radiation therapy within the last 4 weeks

          -  Pregnant (positive pregnancy test) or lactating women

          -  Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic
             injury within 28 days prior to starting study or anticipation of need for major
             surgical procedure during the study

          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to start of study.
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: CDI-31244; SOF/VEL
Intervention description: investigational drug; sofosbuvir and velpatasvir fixed dose combination
Intervention MeSH terms: Sofosbuvir-velpatasvir drug combination
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
Healthy volunteers: No
Keywords: HCV; GT1

Summary:

      Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir
      followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic
      hepatitis C (HCV) genotype 1 (GT1) infection
    

Eligibility criteria:

        Key Inclusion Criteria:

        Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence
        of advanced fibrosis or cirrhosis

        Key Exclusion Criteria:

        Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV)
        infection; History of use of any HCV direct-acting antiviral therapy
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
Condition: Circadian Rhythm Sleep Disorders
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Intervention: VEC-162
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety and efficacy of VEC-162 compared to
      matching placebo on circadian phase shift and sleep parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No medical, psychiatric, or sleep disorders

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Lifetime history of night shift work

          -  Evidence of any sleep disorder

          -  Psychiatric or neurological disorders
Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin
Condition: Physical Activity
MeSH terms: Prediabetic State
Intervention: Metformin; Placebo; Carbohydrate Beverage; Protein Beverage
Intervention description: Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program.; Daily administration of matching placebo during a 12 week exercise training program.; Supervised aerobic exercise 3 days per week followed by a carbohydrate drink; Supervised aerobic exercise 3 days per week followed by a protein drink
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were assigned to either Metformin-Protein, Metformin-Carbohydrate, Placebo-Protein, and Placebo-Carbohydrate.
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators propose that post-exercise milk protein feeding will enhance the
      mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In
      addition, the investigators propose that this stimulatory effect of protein feeding will
      overcome the potential blunting effect of metformin on exercise responses. The investigators
      will investigate these outcomes over a 12-week exercise-training program in older adults with
      pre-diabetes with or without metformin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  55 years or older

          -  Individuals with Prediabetes defined as impaired fasting glucose (100 to 126 mg/dl),
             HbA1c (5.7-6.4%), and/or impaired glucose tolerance defined as 2 hour postprandial
             blood glucose of 140 to 200 mg/dl.

        Exclusion Criteria:

          -  Medications contraindicated with Metformin (Dofetilide, Lamotrigine, Pegvisomant,
             Somatropin, Trimethoprim, Trospium, Gatifloxacin, Cephalexin, Cimetidine,
             Dalfampridine)

          -  Recent (less than 6 weeks) or planned imaging that requires IV contrast,

          -  Renal dysfunction creatinine ≥ 1.3 mg/dL in men or ≥ 1.2 mg/dL in women

          -  Alanine Aminotransferase (ALT) levels exceed 52 IU/L

          -  Heart, Kidney or Liver Disease

          -  Type I or Type II Diabetes

          -  Anti-coagulant therapy (warfarin/heparin)

          -  Lung/respiratory dysfunction

          -  Medications affecting primary outcomes

          -  Lactose Intolerant

          -  Tobacco Use

          -  Heavy Alcohol Use

          -  Cancer

          -  Lidocaine Allergy
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Condition: Advanced or Inoperable Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Pamiparib; Placebo
Intervention description: 60 mg orally twice daily; 60 mg orally twice daily
Intervention MeSH terms: Pamiparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BGB-290; PARP inhibitor; Phase 2; maintenance therapy; gastric cancer; oral treatment; PARALLEL 303; PARALLEL; BGB290303; BGB-290-303

Summary:

      This study enrolled participants with previously-treated advanced or inoperable gastric
      cancer who have responded to first line platinum therapy into two treatment arms. In Arm A
      participants received BGB-290; in Arm B participants received placebo. The purpose of this
      study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free
      survival (PFS) in participants with advanced or inoperable gastric cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age ≥ 18 years.

          2. Signed informed consent.

          3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of
             the stomach or gastroesophageal junction.

          4. Received platinum based first line chemotherapy for ≤ 28 weeks.

          5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

          6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

          7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

          8. Adequate hematologic, renal and hepatic function.

          9. Must be able to provide archival tumor tissue for central biomarker assessment.

         10. Females of childbearing potential and non-sterile males must agree to use highly
             effective methods of birth control throughout the course of study and at least up to 6
             months after last dosing.

        Key Exclusion Criteria:

          1. Unresolved acute effects of prior therapy ≥ Grade 2.

          2. Prior treatment with PARP inhibitor.

          3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days
             prior to randomization.

          4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

          5. Diagnosis of myelodysplastic syndrome (MDS)

          6. Other diagnoses of significant malignancy

          7. Leptomeningeal disease or brain metastasis

          8. Inability to swallow capsules or disease affecting gastrointestinal function.

          9. Active infections requiring systemic treatment.

         10. Clinically significant cardiovascular disease

         11. Pregnant or nursing females.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
Condition: COVID-19; Coronavirus; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Convalescent Plasma; Saline solution
Intervention description: SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate; Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 941.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of
      anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms
      requiring oxygen supplementation.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients ≥18 years of age

          2. Hospitalized with laboratory confirmed COVID-19

          3. One or more of the following respiratory signs or symptoms: cough, chest pain,
             shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)

          4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness

          5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen

          6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19
             and patients who meet eligibility criteria will not be excluded on this basis.

        Exclusion Criteria

          1. Receipt of pooled immunoglobulin in past 30 days

          2. Contraindication to transfusion or history of prior reactions to transfusion blood
             products

          3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

          4. Volume overload secondary to congestive heart failure or renal failure

          5. Unlikely to survive past 72 hours from screening based on the assessment of the
             investigator

          6. Unlikely to be able to assess and follow outcome due to poor functional status
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
Condition: Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Intervention: Infusion of autologous cord blood; Placebo
Intervention description: Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.; Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Maximum age: 6 Hours
Healthy volunteers: No
Keywords: Hypoxic-ischemic encephalopathy; autologous cord blood cells; newborn infants

Summary:

      This study will test the safety and efficacy of an infusion of a baby's own (autologous)
      umbilical cord blood as compared with placebo in babies born with history and signs of
      hypoxic-ischemic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria

          2. Mothers must have consented or given verbal assent for cord blood collection at
             delivery, and cord blood must be available for volume and red blood cell reduction
             before 45 hours of age

          3. The infant must be able to receive at least one dose of autologous cord blood before
             48 hours of age

          4. All infants must have signs of encephalopathy within 6 hours of age

        Exclusion Criteria:

          1. Major congenital or chromosomal abnormalities

          2. Severe growth restriction (birth weight <1800 g)

          3. Opinion by attending neonatologist that the study may interfere with treatment or
             safety of subject

          4. Moribund neonates for whom no further treatment is planned

          5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have
             active syphilis or CMV infection in pregnancy

          6. Infants suspected of overwhelming sepsis

          7. ECMO initiated or likely in the first 48 hours of life