bioihbjkbjnl/mcl2 huggingface dataset:
Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Condition: Anovulation
MeSH terms: Polycystic Ovary Syndrome; Anovulation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Visceral fat area and other criteria
      assessed during initial screening could predict the response to ovulation induction with
      clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).
    

Detailed description: 
      The study was carried out on 150 patients with PCOS. Initial CC doses were 50 mg daily for 5
      days starting on cycle day 3. In the case of an absent response, doses were increased to 100
      and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end
      point.Statistical methods Distribution of characteristics in patients is presented as the
      mean ± SD. We used the Mann-Whitney U test for exploratory comparison of initial parameters
      between responders and nonresponders. The univariate and multivariate relation with response
      to CC was assessed using logistic regression analysis. Backward stepwise elimination was used
      for the multivariate logistic analysis of prediction of patients being CRA, and P < 0.10 was
      used as a cut-off level for elimination of non-significant predictors from the prognostic
      model. The area under the receiver operating characteristics (ROC) curve (AUC) was used to
      assess the discriminative ability of the logistic models. SPSS with statistical package
      version 17 (SPSS Inc., Chicago, IL) and MedCalc Software version 12.4, (Ostend, Belgium) were
      employed for data analysis.
    

Intervention name(s): clomiphen citrate
Intervention type(s): Drug
Intervention description(s): The study was carried out on 150 patients with PCOS. Initial clomiphen citrate (CC) doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.
Other intervention name(s): clomid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: PCOS; clomiphene citrate; AMH; visceral fat area; HOMA-IR
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
Condition: HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of
      oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and
      grazoprevir [GZR] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric
      hepatitis C virus (HCV)-infected participants who are 3 to <18 years of age. Within each age
      cohort (Cohort 1: 12 to <18 years of age; Cohort 2: 7 to <12 years of age; and Cohort 3: 3 to
      <7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest
      cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to
      administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric
      granules instead of a tablet.
    


Intervention name(s): EBR/GZR FDC Tablet; Placebo; Grazoprevir Oral Granules; Elbasvir Oral Granules
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants who are 12 to <18 years of age will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily by mouth.; Placebo tablet matched to EBR/GZR FDC tablet.; Participants 3 to <12 years of age take grazoprevir granules 0.5 mg by mouth in a soft food vehicle at a dose not to exceed 50 mg.; Participants 3 to <12 years of age take elbasvir oral granules 1 mg by mouth in a soft food vehicle at a dose not to exceed 100 mg.
Other intervention name(s): MK-5172A; ZEPATIER®; MK-5172; MK-8742
Intervention MeSH terms: Grazoprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Memory Reconsolidation Blockade for Treating Drug Addiction
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The treatment involves administering propranolol, a medication indicated for treating high
      blood pressure. Propranolol is hypothesized to reduce the strength of drug or alcohol
      cravings (an integral factor involved in relapse), specifically when memories of substance
      use are recalled. In this study, propranolol or a placebo will be administered to patients
      participating in a drug or alcohol rehabilitation facility once a week over three or six
      weeks. After receiving propranolol or placebo, strong memories associated with substance
      craving are recalled by asking participants to read aloud a summary of a substance use
      experience. The investigators hypothesize that participants who receive propranolol will
      report fewer and less intense drug or alcohol cravings than participants who receive the
      placebo or treatment-as-usual.
    

Detailed description: 
      Trial Objectives: To test the feasibility of reconsolidation blockade as an adjunct treatment
      for reducing drug or alcohol cravings in individuals diagnosed with a substance dependence or
      substance abuse disorder and participating in a drug rehabilitation program.

      Study Design and Duration: This study will be a 3 to 6 week, randomized, double-blind trial
      involving participants with a DSM-IV-TR diagnosis of substance dependence or abuse. Consented
      participants meeting enrolment criteria will receive a dose of propranolol (1mg/kg) or
      placebo ninety minutes before undergoing a brief memory reactivation procedure twice a week
      for a three-week period (or once a week for a six week period, depending on the participants
      availability) as an adjunct to their usual drug rehabilitation treatment. Participants will
      be randomized to one of two treatment arms (i.e. placebo group + treatment as usual, or
      propranolol group + treatment as usual) and remain in that arm for the duration of the study.
      Participants from the placebo arm will be offered the opportunity to continue receive
      open-label propranolol treatment for another 3-6 weeks following the double-blind phase of
      the study. A four-month follow-up assessment will also be conducted.
    

Intervention name(s): Propranolol and memory reactivation; Placebo and memory reactivation
Intervention type(s): Drug; Drug
Intervention description(s): Propranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation.; Placebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in
      healthy adult subjects.
    


Intervention name(s): VAL-506440; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Escalating dose levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: VAL-506440; H10N8 antigen mRNA; Influenza vaccine
Pharmacogenetics of Bupropion Metabolism
Condition: Metabolism; Pharmacokinetics
Study type: Observational

Summary: 
      The aim of the investigators research is to see if variants in a particular gene (named
      CYP2B6) affect how the body metabolizes (breaks down) certain medications, including the drug
      bupropion. Bupropion is widely used in the treatment of depression and for helping people
      quit smoking. Genes are portions of DNA that code for particular proteins in the body. The
      investigators are studying the gene that codes for a protein called CYP2B6. Differences in
      the structure of the gene are called variants and may mean that a person metabolizes a drug
      faster or slower than a person with a different variant.
    

Detailed description: 
      Bupropion is widely used in the treatment of depression and for smoking cessation. It's most
      abundant metabolite, hydroxybupropion, may be responsible for most of the therapeutic effect
      of bupropion under conditions of long term dosing. Because the primary enzyme involved in
      metabolism of bupropion to hydroxybupropion is the liver enzyme CYP2B6, we propose to study
      the effect of different CYP2B6 genotypes on the metabolism of bupropion. These data will
      guide the use of genotypes as a surrogate for measuring drug blood levels in studying genetic
      determinants of outcomes for bupropion treatment.

      A minimum of Forty-four subjects with 4 different CYP2B6 genotypes will participate in a
      7-day study in which they take bupropion as outpatients for 6 days (to achieve steady state
      drug levels) and then come to the San Francisco General Hospital (SFGH) Clinical Research
      Center for a 1-day admission during which multiple blood and urine samples will be collected
      for pharmacokinetic analysis.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects with selected CYP2B6 genotypes.
      
Keywords: bupropion; smoking; pharmacokinetics; Pharmacokinetics of bupropion
Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study investigates whether slow-frequency repetitive transcranial magnetic stimulation
      targeting frontal pole can acutely modulate brain circuits which show abnormal functioning
      during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a
      behavioral task.
    


Intervention name(s): rTMS; sham rTMS
Intervention type(s): Device; Device
Intervention description(s): 1-Hz rTMS targeting frontal pole; sham rTMS targeting frontal pole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose
      pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability
    


Intervention name(s): Tamsulosin; Paroxetine
Intervention type(s): Drug; Drug
Other intervention name(s): Alna®; Tagonis®
Intervention MeSH terms: Paroxetine; Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected
      subjects.
    


Intervention name(s): ABT-267; Placebo; Blood Sample Collection; Cytochrome P450 inhibitor
Intervention type(s): Drug; Drug; Procedure; Drug
Intervention description(s): See arm description; See arms description; See arm description; See arm description
Intervention MeSH terms: Cytochrome P-450 Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of VSL#3 on Metabolic, Endocrine, Lipidomic and Inflammatory Parameters of Pediatric Patients With BMI>90°
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity in children has become a significant social problem considering that nowadays 4 to 5
      % of all children are obese in the industrialized countries with increased incidence in
      Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome
      in 30% of the children and is considered as a state of chronic inflammation inducing the
      production of pro-inflammatory cytokines which determine metabolic and endocrine alterations
      on the organism. It has been observed that obesity is also linked to a change in the
      intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of
      Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the
      metabolites may provide us with a characterization of the existing phenotypes and variations
      in relation to the changes of the physiological state, in particular when supplemented or not
      with a probiotic preparation.
    


Intervention name(s): VSL#3 active probiotic; VSL#3 placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): VSL#3; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: probiotic, obesity, BMI, metabolic profile, metabolomics
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      A prospective study comparing the use of mini-autogenous skin grafts and skin homograft
      versus autogenous skin grafts for covering post burn wounds in children.
    

Detailed description: 
      A prospective study comparing the use of mini-autogenous skin grafts and skin homograft
      versus autogenous skin grafts for covering post burn wounds in children so that the patient
      can continue on his/her normal life early with less deformities
    

Intervention name(s): Mini autogenous skin graft
Intervention type(s): Procedure
Intervention description(s): mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic
      cleavage, especially against dipeptidyl peptidase-4 (DPP-IV).

      ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human
      (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ZYD1 in normal healthy adult volunteers.
    


Intervention name(s): ZYD1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Plan I - Tablet ZYD1 - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
Plan II - Tablet ZYD1 - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
Plan III - Tablet ZYD1 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.; Plan I - Tablet Placebo - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
Plan II - Tablet Placebo - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
Plan III - Tablet Placebo 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I.
Other intervention name(s): Selective GLP-1 agonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Selective GLP-1 agonist
Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain
      control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived
      quality of life and use of pain medications, in people with chronic knee pain.
    

Detailed description: 
      Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in
      some chronic painful conditions, in spite of methodological weaknesses. The
      hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the
      mechanisms appear to explain how acupuncture works in part. These systems have been shown to
      be important mediators of stress, pain and other stimuli. The Osteoarthritis Research
      International suggest that osteoarthritis (OA) treatment should be multidisciplinary and
      recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA.

      This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128
      out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain.
      Participants will be randomly allocated into two groups: placebo/sham acupuncture, non
      insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese
      Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions
      weekly), three months (1session monthly), six months (1 session every 45 days) and again one
      year later (1 session every 2 months), at the end of the study.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Device
Intervention description(s): Electro acupuncture is a relatively new method of treatment in Chinese Medicine. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation. The device allows the practitioner to adjust the frequency and intensity of the electric stimulation in a consistent manner which is not operator dependant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: acupuncture; knee pain
Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
Condition: Early Interventions; Preterm Infants; Parent-Child Relations
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This randomized controlled trial will use a longitudinal repeated-measures design to examine
      the effects of two interventions, behavioral support interventions and a parent-infant
      transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions,
      and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional
      regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.
    

Detailed description: 
      The proposed study has five specific aims:

        1. to develop behavioral-support interventions for preterm infants who receive painful,
           stressful procedures in the NICU,

        2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with
           preterm infants in the NICU,

        3. to determine the short-term effects of the behavioral-support interventions and PITP on
           infant stress (salivary cortisol levels) and sleep patterns,

        4. to determine the short-term effects of the PITP on parental stress, depression, social
           support, and sleep quality during postpartum, and

        5. to determine the long-term effects of the behavioral-support interventions and PITP on
           parent-infant interactions and infants' long-term emotional regulation and
           neurobehavioral outcomes.
    

Intervention name(s): BS; Routine care; PITP; BS+PITP
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): NNS, FT, positional support, and oral sucrose feeding; Routine NICU care; Parents will learn to regulate infant responses while implementing caregiving activities.; Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Behavioral and Transaction Interventions; Parents' Biopsychosocial Well-being; Preterm Infants; Sleep; Salivary cortisol
The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication
Condition: HBV Infection
MeSH terms: Hepatitis B
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine whether the general anesthesia immunosuppressive
      could effect hepatitis B Virus replication
    

Detailed description: 
      The change of immune state can influence HBV replication or elimination, it has been reported
      that a certain degree of immunosuppression occured after general anesthesia. In this study we
      detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA
      content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate
      the influence of general anesthesia immunosuppressive on HBV replication. If the results show
      that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune
      enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence
      HBV replication.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with HBV infection receive surgery under general anesthesia
      
Biospecimen description: 
      serum
    
Keywords: Need general anesthesia
Substance Use and Fitness
Condition: Substance Abuse; Exercise
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this pilot study is to estimate the effect size of a contingency management
      procedure that reinforces walking at rates consistent with the American College of Sports
      Medicine recommendations of 10,000 or more steps per day in older adults. We expect that
      participants randomized to the contingency management intervention will increase walking to a
      greater degree than those assigned to a standard care condition.
    


Intervention name(s): contingency management
Intervention type(s): Behavioral
Intervention description(s): Participants assigned to the experimental group will earn chances to win prizes if they have walked the recommended number of steps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment