bioihbjkbjnl/mcl2 huggingface dataset:
CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes
Condition: Acquired Immunodeficiency Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase
      inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2
      nucleoside reverse transcriptase inhibitors (NRTI) as first-line treatment regimes of HIV-1
      infection. Recent clinical studies suggest potential advantages of NNRTI- over PI-based
      regimes in therapy initiation due to lower rates of virologic failure and less metabolic
      side-effects. In contrast, PI regimes were claimed to cause greater increases in CD4 cell
      count than NNRTI regimes, which has been attributed to intrinsic antiapoptotic effects of the
      PI. However, it is still unclear whether the immunological response to a PI-containing regime
      is greater than to an NNRTI-containing regime, whether there is a difference in the extent of
      reduction of apoptosis between PI and NNRTI regimes and whether a difference in apoptosis is
      associated with a difference in CD4 cell recovery.

      We conducted a controlled, long-term, random matched pair design study in HIV-1 infected
      individuals under sustained virologic suppression to evaluate in head-to-head comparison the
      clinical effects of a constant PI-based or NNRTI-based regime on CD4 cell recovery and the
      underlying molecular, biochemical and functional mechanisms.
    


Intervention name(s): Lopinavir/Ritonavir plus Lamivudine/Zidovudine; Efavirenz plus Lamivudine/Zidovudine
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg lopinavir and 100 mg ritonavir (Kaletra capsules, Abbott Laboratories) twice daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over 476 weeks; 600 mg efavirenz (Sustiva tablets, Bristol-Myers Squibb) once daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over 476 weeks
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine; Zidovudine; Lamivudine, zidovudine drug combination; Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: treatment naive
Trial of PED-1 in Male Patients With Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the
      treatment of premature ejaculation.
    

Detailed description: 
      This study is to evaluate whether PED-1 is effective than Placebo in the treatment of
      premature ejaculation. The patients will be randomized and allocated to two treatment groups
      into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for
      enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis
      premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The
      patients undergone drug free baseline period will take test drugs for 12 weeks.
    

Intervention name(s): Clomipramine
Intervention type(s): Drug
Intervention description(s): Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
Other intervention name(s): PED-1
Intervention MeSH terms: Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PE; IELT; DCIT
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
Condition: Dyslipidemia; Cardiovascular Disease; Hypercholesterolemia
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      There will be no significant differences in the efficacy and tolerability between the test
      and reference formulations of atorvastatin 20 mg in these Korean adults with primary
      hypercholesterolemia.
    


Intervention name(s): Atorvastatin (Lipinon); Atorvastatin (Lipitor)
Intervention type(s): Drug; Drug
Intervention description(s): treatment of dyslipidemia administration : PO, qod; treatment of dyslipidemia administration : PO, qod
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: statins; cholesterol; hypercholesterolemia; atorvastatin; Dyslipidemia in cardiovascular disease (KoLipinon)
Factors Affecting Caloric Regulation in Human Feeding
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study will test the hypothesis that reducing the energy density of the diet by
      incorporating more water-rich foods will result in: 1) greater weight loss and weight
      maintenance; 2) greater diet satisfaction and satiety; and 3) more healthful dietary patterns
      than reducing dietary fat alone.
    

Detailed description: 
      Energy density refers to the amount of calories (energy) in a given weight of food. For the
      same amount of energy, a larger volume (weight) of food can be consumed if the food or diet
      is low in energy density than if the food or diet is high in energy density. The two
      nutrients that have the largest impact on energy density are fat and water. Foods high in fat
      and low in water content are typically high in energy density, whereas foods low in fat and
      high in water content, such as fruits and vegetables, are low in energy density. This study
      will examine whether there are increased benefits for weight loss and weight maintenance when
      the ad libitum consumption of water-rich foods is added to a reduced-fat diet, thus making it
      even lower in energy density.

      Comparisons: Reduced-energy-dense diet and Reduced-fat diet
    

Intervention name(s): Reduced-energy-density diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: reduced-energy-density diet; fat-restricted diet; fruit; vegetables; ad libitum intake; weight loss; obesity
Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult
      workplace environment (AWE) setting
    

Detailed description: 
      This study has both an optimization and double-blind period
    

Intervention name(s): LDX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting; Placebo administered once-daily for one week during the adult workplace environment setting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
Condition: Obesity; Chronic Inflammation; Type 2 Diabetes
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Obesity and type 2 diabetes, dyslipidemia and related metabolic disease has become a threat
      to our national life and health which is showing a trend. Bariatric Surgery had been
      confirmed definite therapeutic effect to obesity and type 2 diabetes. However, laparoscopic
      gastric bypass and laparoscopic sleeve gastrectomy have the similar outcome to type 2
      diabetes, but the two surgical methods and principles are completely different, which
      mechanisms are not yet clear. Lots of literature report adipose tissue releases adipokines
      and inflammatory cytokines induced chronic inflammation and obesity-related complications
      (insulin resistance and Type 2 diabetes).It is not clear whether to change these
      gastrointestinal hormones, adipokines and secretion of inflammatory cytokines with the
      operation, which play a therapeutic effect of obesity-related complications and diabetes. In
      addition, the investigators are wonder whether gut hormones, adipokines and inflammatory
      cytokines have some correlation in different severity obese patients,. It is worth to explore
      that could intestinal hormones, adipokines and inflammatory factors levels guide us to choice
      the different surgical approach to different severity obese patients. The investigators tried
      to investigate different surgical methods to alleviate diabetes and other metabolic diseases
      mechanisms though hormones and inflammatory factors and adipose tissue inflammation level and
      compare the impact of intestinal hormones and inflammatory adipokines of the two surgical
      approaches.
    


Intervention name(s): laparoscopic Roux-en-Y gastric bypass; laparoscopic sleeve gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Roux-en-Y gastric bypass was one of the interventions pre-specified to be administered to participants. The patients undergo Roux-en-Y gastric bypass (RYGB group) following a comprehensive evaluation for the surgical indication; Laparoscopic sleeve gastrectomy was the other intervention pre-specified to be administered to participants. The patients undergo sleeve gastrectomy (SG group) following a comprehensive evaluation for the surgical indication
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: obesity; bariatric surgery; gut hormones; inflammatory adipokine
miRNA in Fetal Overgrowth
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine whether placental and umbilical cord blood miRNA
      expression is altered in women with obesity with macrosomic neonates to when compared to
      miRNA expression from control patients.
    

Detailed description: 
      MicroRNA's are a class of non-coding RNA's that function as translational repressors and are
      thought to modulate tissue development, proliferation, differentiation and function.
      Differential expression of certain placental miRNA's has been associated with preeclampsia.

      The fetal origins of adult disease hypothesis suggests that risk factors from intrauterine
      environmental exposures affect the fetus' development during sensitive periods, and increases
      the risk of specific diseases in adult life. Our aim is to understand factors that predispose
      fetuses to fetal overgrowth in utero, especially in women with obesity. The objective of the
      study is to identify miRNA which are differentially expressed in the placenta and cord blood
      of pregnancies that are affected by fetal macrosomia to determine factors that may predispose
      fetuses to fetal overgrowth.
    

Intervention name(s): Neonatal exposure to maternal obesity
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients delivering in the labor and delivery unit at the Hospital of the University of
        Pennsylvania.
      
Biospecimen description: 
      A small placental sample will be obtained after delivery in addition to cord blood
      collection.
    
Keywords: Maternal obesity; Macrosomic; miRNA; Fetal overgrowth
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
Condition: Cerebral Palsy; Spastic Paraplegia and Hemiparesis; Equine and Equinovarus Foot Deformation
MeSH terms: Muscle Spasticity; Clubfoot; Talipes; Equinus Deformity; Cerebral Palsy; Paresis; Paraplegia
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children
           with spastic equine and equinovarus foot deformation in pediatric cerebral palsy

        2. To assess the safety of Xeomin® use as compared to Botox® in this patient population
    


Intervention name(s): Xeomin; Botox®
Intervention type(s): Drug; Drug
Intervention description(s): Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.; Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Other intervention name(s): IncobotulinumtoxinA; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; OnabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to estimate the effect of moderate or mild hepatic
      impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in
      participants with hepatic impairment relative to healthy matched control participants with
      normal hepatic function.
    


Intervention name(s): Vorasidenib
Intervention type(s): Drug
Intervention description(s): Administered orally as tablets.
Other intervention name(s): S095032; AG-881
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vorasidenib
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, multicenter, placebo-controlled, double-blind study will evaluate the
      efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing
      motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the
      clinic.
    


Intervention name(s): CVT-301; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Levodopa Inhalation Powder
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; Off episodes
The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs
      repaglinide and bupropion as a means of predicting drug-drug interactions.
    


Intervention name(s): repaglinide; BI 187004 tablet; bupropion extended release tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose on day 1 of visits 2 and 3; multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3; single dose on day 3 of visits 2 and 3
Intervention MeSH terms: Repaglinide; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1B, randomized, participant- and investigator-blinded, placebo-controlled,
      multi-center clinical trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamics
      (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1
      Pulmonary Arterial Hypertension (PAH).
    

Detailed description: 
      The primary objective for this trial is to evaluate the safety and tolerability of GB002. The
      secondary objective for this trial is to evaluate the PK parameters of GB002. Exploratory
      objectives are to evaluate the PD readouts, change in WHO Group I functional class, and
      change in quality of life associated with GB002 treatment.

      In this Phase 1B study, two dose levels of GB002 will be tested in adult participants with
      PAH. Four participants in cohort 1 will be randomized to receive up to two daily doses of
      either active drug or placebo, with 3 subjects receiving GB002 and 1 subject receiving
      placebo. An additional 4 participants (3 active and 1 placebo) may be added to cohort 1 at
      the discretion of the Data Review Committee (DRC). The dose and dosing interval (i.e., once
      daily or twice daily) for the second cohort will be determined by review of the safety,
      tolerability, and drug levels in the blood from cohort 1. Cohort 2 participants will also be
      randomized such that 6 subjects receive GB002 and 2 subjects receive placebo.

      Eligible subjects who have completed the 2 week treatment period have the option to
      participate in a 24 week open label extension.
    

Intervention name(s): GB002; Placebo; Generic Dry Powder Inhaler
Intervention type(s): Drug; Drug; Device
Intervention description(s): GB002 low dose or high dose for inhalation; Placebo for inhalation; Generic dry powder inhaler for GB002 or Placebo delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Ultrasound-guided Rectus Sheath Block In Children
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Inguinal hernia repair is one of the common day-case surgery in children. The aim of this
      study is to compare the effects of ultrasound guided rectus sheath block and intravenous
      tramadol on peroperative anesthetic requirement and postoperative analgesia.
    

Detailed description: 
      After approval the faculty ethical committee and informed consent from the parents (legal
      guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in
      this prospective, randomized study. The patients were divided into two groups. After
      induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R
      with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T
      before closure of the fascia. Intraoperative and postoperative hemodynamic parametres,
      postoperative pain by means of the FLACC were evaluated.

      Primary end point was pain score using FLACC scale.
    

Intervention name(s): rectus sheath block; Tramadol
Intervention type(s): Procedure; Drug
Intervention description(s): ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine; tramadol 1 mg/kg iv
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound, rectus sheath block, children, inguinal hernia
Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to examine whether ovulation is suppressed after use
      of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD)
      for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones
      produced by your body) will be measured and transvaginal ultrasound examinations will be
      conducted at regular intervals. In addition, the concentrations of the administered hormones
      EE and GSD in blood will be determined in regular intervals.

      With regard to the tolerability of the hormone patches subjects will be asked regularly how
      they feel and blood pressure, pulse and body weight will be determined. In addition, blood
      and urine safety examinations will be conducted at defined timepoints.
    


Intervention name(s): Gestodene/EE Patch (BAY86-5016); Gestodene/EE Patch (BAY86-5016); Gestodene/EE Patch (BAY86-5016)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days; 0.35 mg ethinyl estradiol (EE) + 0.67 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days; 0.275 mg ethiny estradiol (EE) + 1.05 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Intervention MeSH terms: Gestodene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Administration; Cutaneous
Comparison of Longitudinal Blood Pressure and Arterial Stiffness in Preeclamptic Women After Delivery
Condition: Preeclampsia and Eclampsia; Stiffness, Aortic; Blood Pressure
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      The investigator measured the arterial stiffness using cardio-ankle vascular index (CAVI)
      test in patient with preeclampsia and normal pregnant women to evaluate the longitudinal
      change of CAVI and their predictors.
    

Detailed description: 
      This study was a case control study and included 37 women with preeclampsia (PE group) and 36
      normotensive women (control group) who gave birth to child at Seoul National University
      Bundang Hospital.

      Cario-ankle vasuclar index (CAVI) was measured at one day, six months and one year after
      delivery in both group.

      The investigator also checked the body weight, blood pressure, lipid profile, serum
      creatinine, aspartate transaminase (AST) and alanine transaminase (ALT) simultaneously with
      CAVI.

      The relationship between the presence of preelampsia and longitudinal changes of CAVI, blood
      pressure and metabolic indices were evaluated using generalized estimating equation (GEE)
      method.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study included 37 women with preeclampsia (PE group) and 36 normotensive women
        (control group) who gave birth to child at Seoul National University Bundang Hospital from
        March 2013 to May 2016.
      
Keywords: Preelampsia; Cardio-ankle vascular index (CAVI); Aortic stiffness; Blood pressure; LDL-cholesterol