bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Dexmedetomidine for Cesarean Section
Condition: Breast Feeding; Analgesia Obstetrical; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Normal Saline; Dexmedetomidine 0.03ug/kg/h; Dexmedetomidine 0.05ug/kg/h; Dexmedetomidine 0.08ug/kg/h
Intervention description: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: Female
Minimum age: 24 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexmedetomidine; Butorphanol tartrate; Analgesia; Breastfeeding; Relative infant dose

Summary:

      Nervous, anxiety, fear and other psychological reactions always appears in parturients during
      cesarean section. This study intends to investigate the effectiveness and safety of
      dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and
      breastfeeding after caesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Parturients who had successfully breastfed a prior infant and planned to breastfeed
             after this delivery were screened for eligibility.

          2. Parturients undergoing elective caesarean delivery under epidural anaesthesia

          3. ASA I and II parturients aged 18-45 years, with singleton gestation.

          4. Parturients with verbal and written mandarin

          5. Parturients who want to use PCA intravenous analgesia and can use the pump correctly

          6. written informed consent.

        Exclusion Criteria

          1. Multiple gestation.

          2. A history of allergy to dexmedetomidine or other study drugs

          3. Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)

          4. Opioid drugs abuse.

          5. BMI more than 35 kg/m2

          6. Conditions that preclude spinal anesthesia.

          7. Preeclampsia or epilepsy.

          8. A history of neuromuscular disease.

          9. Epidural anaesthesia was unsuccessful.

         10. The parturients, whose surgery ended after 11 a.m.
Endophenotype for Alcohol Misuse in Healthy Minority Populations
Condition: Healthy
Intervention: Naltrexone; placebo; alcohol; Sham alcohol
Intervention description: 50 mg/day for two days prior to the alcohol challenge session; placebo pills; 190 proof alcohol prepared to 11% volume mixed with fruit juice.; non-alcoholic placebo alcohol
Intervention MeSH terms: Ethanol; Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Naltrexone; Alcohol

Summary:

      The purpose of the study is to understand the relationship between what an individual
      inherited from their family (genetics), how they respond and feel after drinking alcohol, and
      how they respond to pre-treatment with naltrexone, a medication that blocks some of the
      effects of alcohol and is approved for the treatment of alcoholism. The investigators are
      conducting this study on those of African descent because there is almost no research focused
      on this group and the association with genetics. The investigators seek to enroll 40 people
      in the study. Participation will consist of 4 different alcohol challenge sessions in a cross
      over design. Each session will be separated by at least 10 days. In total, there will be four
      challenge sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and 21 years of age or older

          -  Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per
             week

          -  Of African descent by self report

        Exclusion Criteria:

          -  Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine

          -  Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana,
             or amphetamine at the screening visit

          -  Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder,
             schizophrenia, or any psychotic disorder

          -  The presence of unstable or serious medical illness; including history of stroke,
             seizure disorder, severe liver disease (AST or ALT > 5X normal at the time of
             randomization), or unstable cardiac disease

          -  Needs treatment with any psychotropic medication (antidepressant, antipsychotic,
             benzodiazepine, or mood stabilizing medication)

          -  Pre-menopausal female subjects who are pregnant, nursing, or not using a reliable
             method of contraception

          -  Insulin-dependent diabetes

          -  Any medical or psychological condition that could jeopardize the subject's safe
             participation in the trial as determined by the PI.
Brief Intervention to Reduce Fear of Public Speaking
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: propranolol; Placebo
Intervention description: active treatment; inactive pill
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: propranolol; public speaking anxiety

Summary:

      The study will test the efficacy of propranolol or placebo, administered after retrieval of a
      previously acquired public speaking fear, in reducing fear and avoidance of public speaking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-60 years of age at the time of consent

          -  Principal Diagnosis of Social Anxiety Disorder, Performance only type

          -  Has clinically significant fear of public speaking

          -  Physically healthy

          -  If female, non-pregnant and not nursing

          -  Off all psychotropic drug for at least 4 weeks

          -  A level of understanding sufficient to provide written informed consent to all
             required study tests and procedures.

        Exclusion Criteria:

          -  History of other serious psychiatric disorder

          -  Current Major Depressive Disorder

          -  Presence of developmental disorder or intellectual disability

          -  SAD patients with SAD not of the performance only type

          -  Women who are pregnant or nursing

          -  Current use of psychiatric medication

          -  Current substance use disorder

          -  Persons planning to start another treatment during the study period.

          -  Any significant medical condition that might increase the risk or participation (e.g.,
             seizure disorder, respiratory disorders [e.g., bronchial asthma], cardiovascular
             disease [e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and
             greater than first degree block ], low blood pressure [ < 90/60], diabetes, liver or
             kidney disorders)

          -  Use of medications that might negatively interact with propranolol (e.g., ACE
             inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel
             blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel;
             phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Intervention: Rikkunshito; Rikkunshito placebo
Intervention description: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks; - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rikkunshito; Double blind; Functional dyspepsia (FD)

Summary:

      The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to
      placebo in Japanese subjects with Functional Dyspepsia (FD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  -Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled
             for the last 3 months with symptom onset at least 6 months prior to obtaining informed
             consent ii) Have not received upper endoscopy within the last 6 months prior to
             enrollment and do not have evidence of structural/organic disease iii) Must have one
             or more of the following symptoms:

               1. Bothersome postprandial fullness

               2. Early satiation

               3. Epigastric pain

               4. Epigastric burning

          -  At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale
             (bothersome postprandial fullness, early satiation, epigastric pain, epigastric
             burning) is ≥4, whereas heartburn is ≤3.

          -  Total score of depression-related symptoms on Hospital Anxiety and Depression Score
             (HAD) is ≤10.

          -  Type of visit: Outpatient

          -  Provides voluntary informed consent after receiving adequate explanation and
             demonstrates thorough understanding of the nature of the study.

        Exclusion Criteria:

          -  Confirmed ulcer (excluding scars) or malignant tumor in the upper GI

          -  Suspected organic lesions in the hepato-biliary-pancreatic regions such as
             cholelithiasis, hepatitis, pancreatitis

          -  History of upper GI resection

          -  Serious complications (liver, kidney, heart, or blood disease or metabolic disease)

          -  Less than a year since testing positive for H. pylori or have undergone a successful
             eradication therapy

          -  Use of prohibited medications

          -  Neuropsychiatric disorders

          -  Use of or planned use of any investigational drugs

          -  Unable to take drugs orally

          -  History of allergic reactions to Kampo medicines

          -  Pregnant or lactating women or those who are planning to conceive during the study
             period

          -  Deemed ineligible by principal investigator or sub-investigator
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
Condition: ECG; Pharmacokinetics; Safety
Intervention: Gemtuzumab Ozogamicin
Intervention description: Three doses of GO 3 mg/m2 (up to one vial) as a 2 hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the criteria
Intervention MeSH terms: Gemtuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single arm, open-label, interventional
Masking: None (Open Label)
Masking description: open-label
Enrollment: 51.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: gemtuzumab ozogamicin; Mylotarg; QT interval prolongation; Pharmacokinetics; Safety; Veno-occlusive disease; Anti-drug antibody

Summary:

      This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc,
      pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and
      pediatric patients with relapsed or refractory CD33-positive AML.
    

Eligibility criteria:

        Inclusion Criteria

          -  Refractory or relapsed (ie, bone marrow blasts >5%) CD33-positive AML.

          -  Age >=12 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.

          -  Initial peripheral white blood cells (WBC) counts >=30,000/mL; patients with a higher
             WBC count should undergo cytoreduction.

          -  Adequate renal/hepatic functions

        Exclusion Criteria

          -  Patients with prior treatment with gemtuzumab ozogamicin (GO).

          -  Patients with prior history of VOD/SOS.

          -  Prior HSCT is not allowed, if it was conducted within 2 months prior to study
             enrollment.

          -  Patients with known active central nervous system (CNS) leukemia.

          -  Uncontrolled or active infectious status.

          -  Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2, uncontrolled atrial
             fibrillation of any grade.

          -  Sero-positivity to human immunodeficieny virus (HIV).

          -  Active hepatitis B or hepatitis C infection

          -  Chemotherapy, radiotherapy, or other anti-cancer therapy (except hydroxyurea as
             cytoreduction) within 2 weeks prior to enrollment in the study.

          -  Major surgery within 4 weeks prior to enrollment.

          -  QTc interval >470 milliseconds (msec) using the Fridericia (QTcF), family or personal
             history of long or short QT syndrome, Brugada syndrome or known history of QTc
             prolongation, or Torsade de Pointes (TdP).

          -  The use of medications known to predispose to Torsades de Pointes within 2 weeks prior
             to enrollment

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to gemtuzumab ozogamicin (GO).
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Condition: Catheter; Infection (Indwelling Catheter); Catheter Infection; Catheter-Related Infections; Catheter Bacteraemia; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Bacteremia; Catheter-Related Infections
Intervention: Povidone-iodine irrigation
Intervention description: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm parallel study with 1 to 1 randomization
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Catheter associated UTI; Povidine iodine; Bladder Irrigation

Summary:

      Over the last decade, there has been great emphasis on reducing the incidence of
      hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will
      evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled
      into the bladder immediately prior to indwelling catheter removal to decrease the risk of
      subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent and the willingness and ability to comply with all
             aspects of study requirements

          2. Male

          3. Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days
             with a plan for removal

        Exclusion Criteria:

          1. Patients planned for discharge with an indwelling catheter in place

          2. Patients unable to report urinary symptoms accurately

          3. Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or
             other related compounds

          4. Clinical signs or symptoms of urinary tract infection at the time of consent

          5. Patients currently being treated for UTI

          6. Patients currently taking any antibiotic medication, other than vancomycin, linezolid,
             daptomycin, clindamycin, or metronidazole.

          7. Patients already taking medications known to potentially irritate the bladder, such
             as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic
             agents

          8. Patients with history of bladder cancer, pelvic radiation or interstitial cystitis

          9. Patients unable to comply with study requirements

         10. Any other condition which, per investigators' judgment, may increase patient risk
             and/or impede the reliability of study data
Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo; Exenatide; Dapagliflozin; Exenatide and Dapagliflozin
Intervention description: Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period; Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period; Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period; Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
Intervention MeSH terms: Dapagliflozin; Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Participants will be randomized to one of four groups (20 per group): i) placebo; (ii) exenatide 5 ug subcutaneously; (iii) dapagliflozin (10 mg); and (iv) dapagliflozin 10 mg plus exenatide 5 ug
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Research Design/Plan: After screening, each subject will receive 1 measurements of Endogenous
      Glucose Production [EGP] with prime-continuous Infusion of 3-3H-glucose. After completing the
      EGP measurement each subject will receive a Double Tracer Oral Glucose Tolerance Test [OGTT].

      Methods: Visit 1: Screening. Medical history will be obtained, physical exam performed, and
      pregnancy test performed.

      Visit 2: Endogenous Glucose Production Measurement: The rate of EGP will be measured with
      3-3H-glucose.

      Visit 3: Double Tracer OGTT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in
             good general health as determined by physical exam, medical history, blood
             chemistry-CBC, TSH, T4, EKG and urinalysis)

          -  BMI: 21-45kg/m

          -  HbA1C>7.0% and <10.5%

          -  Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more
             than 3 months)

        Exclusion Criteria:

          -  Health Status: Type 1 Diabetics

          -  Proliferative diabetic retinopathy

          -  Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males,
             or 24 hour urine albumin excretion greater than 300mg/dL

          -  Medication: Subjects taking drugs known to affect glucose metabolism (other than
             metformin and sulfonylurea)
Acthar Gel in Participants With Pulmonary Sarcoidosis
Condition: Sarcoidosis, Pulmonary
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Intervention: Acthar Gel; Placebo
Intervention description: Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL); Placebo gel for SC injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if Acthar Gel is safe and effective to treat
      pulmonary sarcoidosis.

      Participants will be randomly assigned (like flipping a coin) to receive a shot under their
      skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their
      assigned shot twice a week for 24 weeks.

      All participants who complete the 24-week treatment period will be eligible to receive Acthar
      Gel for 24 more weeks, even if they were originally in the placebo group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year
             at screening (Visit 1)

          -  Has protocol-defined symptomatic pulmonary disease

          -  Has been receiving a stable prednisone dose between 5 mg and 40 mg (or equivalent) for
             pulmonary sarcoidosis, for at least 4 weeks before screening, or a stable dose of
             another disease-modifying anti-sarcoidosis drug for at least 3 months before screening

          -  Has lung function within protocol-defined parameters

        Exclusion Criteria:

          -  Has at least a 10% change in forced vital capacity (FVC) on spirometry between Visits
             1 and 2

          -  Has pulmonary arterial hypertension requiring treatment

          -  Has been treated with antitumor necrosis factor-α antibody within the past 3 months

          -  Has any pulmonary condition that requires treatment, therefore impeding corticosteroid
             tapering