bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, open-label, noncomparative study evaluates two oral formulations of
      raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other
      antiretroviral agents for safety, tolerability, and antiretroviral activity in
      treatment-naive or treatment-experienced Russian children and adolescents infected with human
      immunodeficiency virus-1 (HIV-1).

      As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the
      treatment of HIV-1 infection in pediatric patients in the United States (US), this study is
      designed to gain local treatment experience on the use

      of raltegravir in the pediatric HIV-infected population in Russia.
    


Intervention name(s): Raltegravir Film-coated Tablet; Raltegravir Chewable Tablet; Other Anti-Retroviral Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
Other intervention name(s): ISENTRESS®; MK-0518; ISENTRESS®; MK-0518
Intervention MeSH terms: Raltegravir Potassium; Anti-Retroviral Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nonalcoholic Fatty Liver Disease in Taiwanese Children
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Observational

Summary: 
      Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan.
      However, the prevalence and clinical characteristics have not been studied well. The purpose
      of this study is to resolve the aforementioned problem.
    

Detailed description: 
      [Study Subjects] Obesity was defined as the BMI value > 95 percentile by different age- and
      gender groups according to the standards of the Department of Health in Taiwan.

      [Data Collection] The following data were obtained for each subject: age, gender, BMI, waist
      and hip circumference. BMI was calculated as body weight (kg)/ height (m2).

      In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase,
      aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total
      cholesterol,high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.

      [Liver Ultrasonography] All participants underwent an ultrasonographic study of the liver
      performed by one operator.

      NAFLD was defined as the presence of an ultrasonographic pattern consistent with the
      following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility
      of diaphragm, and obscure hepatic vessel structures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obese children will be enrolled from elementary school and high school in Taiwan
      
Biospecimen description: 
      Serum, WBC DNA
Further Studies of Attention Deficit Disorder - Residual Type (RT)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The first phase was a double-blind crossover design of methylphenidate in the treatment of
      adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in
      adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo
      in treating ADHD symptoms during the first phase. It was also hypothesized that
      methylphenidate responders from the double-blind trial would continue to benefit from
      treatment in the second phase. Improvement would include both ADHD symptoms and social
      adjustment.
    

Detailed description: 
      All patients received a single-blind week on placebo, followed by a double-blind random
      assignment crossover trial of methylphenidate and placebo, with each double-blind phase
      lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate
      would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured
      monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale
      (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of
      Functioning (GAF). Social functioning was assessed by the clinician administered version of
      the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement,
      symptom improvement and AEs.
    

Intervention name(s): methylphenidate; methylphenidate; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosing was flexible and dependent on clinical judgement, AEs and treatment response.; Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day; Dosing is identical to the MPH arm except that the pills will contain no active medication.
Other intervention name(s): ritalin; ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Adult; crossover; randomized; Long-term; Open-label; methylphenidate; Social adjustment
Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 multicenter trial to evaluate safety and immune response of three
      consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be
      given to healthy subjects who do not have a smallpox scar.

      Approximately 1110 subjects will be randomly enrolled into one of three groups:

      Group 1 will include 370 subjects, who will receive two separate injections (shot) with a
      short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 1).

      Group 2 will include 370 subjects, who will receive two separate injections (shot) with a
      short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 2).

      Group 3 will include 370 subjects, who will receive two separate injections (shot) with a
      short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 3).

      The primary objective of the trial is to show that the immune response elicited (produced) by
      three consecutively produced MVA-BN lots are statistically (numerically) comparable.
    


Intervention name(s): FD MVA-BN
Intervention type(s): Biological
Intervention description(s): Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
China-Administration of Nicorandil Group（CHANGE）
Condition: Myocardial Infarction; Percutaneous Coronary Intervention; Nicorandil
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients
      undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and
      after the reperfusion with those standard therapy treated by PCI
    

Detailed description: 
      The aim of this study was to evaluate the efficacy and safety of nicorandil in improving
      myocardial infarct size in patients with acute myocardial infarction through a multi-center,
      prospective, randomized, double-blind and parallel-controlled clinical study, providing
      evidence-based support for the optimization of PCI treatment strategies. The primary
      objective of the study was to compare whether the effect of nicorandil in combination with
      PCI was significantly better at reducing the myocardial infarct size than that of PCI alone
      in AMI patients.
    

Intervention name(s): Nicorandil; Placebo
Intervention type(s): Drug; Other
Intervention description(s): After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h; After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h
Intervention MeSH terms: Nicorandil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac magnetic resonance; Infarct Size
Preoperative Nutritional Intervention in Head and Neck Cancer
Condition: Head and Neck Cancer; Malnutrition
MeSH terms: Head and Neck Neoplasms; Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of preoperative nutritional supplements
      on head and neck surgery patients.
    


Intervention name(s): Nutritional Supplement; Preoperative Dietitian Consult; Education
Intervention type(s): Dietary Supplement; Behavioral; Behavioral
Intervention description(s): Oral nutritional supplementation; Nutritional assessment; Informational materials about nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Surgery; Malnutrition; Preoperative; Nutrition
Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions
Condition: Regional Blood Flow; Ocular Physiology
Study type: Interventional
Phase: Phase 2

Summary: 
      There is evidence from a variety of animal studies that choroidal blood flow is under neural
      control. By contrast, only little information is available from human studies. Recent results
      indicate that a light/dark transition is associated with a short lasting reduction in
      choroidal blood flow. We have shown that during unilateral dark/light transition both eyes
      react with choroidal vasoconstriction strongly indicating a neural mechanism.

      The present studies investigate this possibility by using pharmacological interventions. The
      pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor
      agonist (as a control substance for the blood pressure increasing nitric oxide synthase
      inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were
      chosen on the basis of previous animal experiments, as the systems, which are specifically
      influenced by these substances, are likely involved in neural control of choroidal blood
      flow.
    


Intervention name(s): Phenylephrine; NG-Monomethyl-L-Arginine; Propanolol; Atropine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Atropine; Propranolol; Phenylephrine; Oxymetazoline; omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Choroidal blood flow; NO-synthase; light/dark transition
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single intravenous and subcutaneous doses of CFZ533 in healthy subjects
      and intravenous doses in rheumatoid arthritis patients.
    

Detailed description: 
      This was a Healthy Volunteer only study originally, but after an amendment to protocol,
      rheumatoid arthritis patients will be starting 7-Mar-2014 and thus, the protocol is now
      registered.
    

Intervention name(s): CFZ533; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Single dose at varying dosage levels depending on treatment assignment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis, RA, first-in-human, single ascending dose, safety, tolerability
Arthroscopic Resection Arthroplasty of Carpometacarpal and/or Pantrapezial Osteoarthritis
Condition: Thumb Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT
    

Detailed description: 
      The purposes of this study were to report 1) long-term outcomes on a large series of patients
      that underwent arthroscopic resection arthroplasty (ARA) for thumb basal joint arthritis
      (BJA) and 2) to compare outcomes of ARA for isolated carpometacarpal osteoarthritis versus
      those undergoing simultaneous ARA of CMC plus the scaphotrapeziotrapezoid joint for
      pantrapezial disease.

      Please note, all patients treated by Dr. Cobb for CMC and/or STT OA received the same
      treatment regardless of whether or not they chose to participate in the study. Patients who
      chose to enroll in the study received the same treatment as those who did not only their data
      was analyzed. Data collection is the same for those who do not participate, only their data
      is not analyzed.
    

Intervention name(s): Arthroscopic Resection Arthroplasty
Intervention type(s): Procedure
Intervention description(s): Surgical removal of the arthritic joint(s) using a minimally invasive technique.
Other intervention name(s): Arthroscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting with basal joint arthritis who were scheduled to undergo arthroscopic
        resection arthroplasty of the CMC and/or STT joints.
The Effectiveness of Commercial Weight Loss Programmes
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The objective is to compare the effectiveness of 4 different commercial weight-loss diets
      available to adults in the UK.

      This is achieved with a 6 month multi-centre randomised unblinded controlled trial of

        -  Dr Atkins' New Diet Revolution,

        -  The slimFast Plan,

        -  The weight Watchers Pure Points Programme,

        -  Rosemary Conley's "Eat Yourself Slim" Diet & Fitness Plan.

        -  No diet (control)

      Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and
      obese adults.

      Main outcome measures are weight and body fat change over 6 months.
    


Intervention name(s): calorie controlled diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Phase I/II Study of Escalating Doses of Idarubicin Orally Given With Oral Cyclophosphamide, Etoposide, Prednisolone and Intravenous Rituximab in Elderly Patient With Disseminated High Grade Non Hodgkin Lymphoma
Condition: High Grade Lymphomas CD20 Positive
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      R-CHOP with doxorubicin is the standard first line treatment of high grade non-Hodgkin's
      lymphoma. In order to avoid central venous system insertion and reduce hospitalization time
      in elderly patients, we developed an oral chemotherapy treatment: " OROCIEP"trial.

      Nineteen patients were enrolled and 127 chemotherapy cycles were available for toxicities.
      The estimated two-years overall survival was 74%. The main haematological toxicity was
      neutropenia.

      This study is still ongoing to confirm recommended dose of oral anthracycline.
    


Intervention name(s): idarubicin
Intervention type(s): Drug
Intervention MeSH terms: Idarubicin
Intervention model: Single Group Assignment
Primary purpose: Treatment
The Effect of Auricular Point Stimulation on Obese Women
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to examine whether the ear acupoint stimulation is effective on obese
      women.
    

Detailed description: 
      % change body weight, BMI, lipid profile, glucose and obese hormone.
    

Intervention name(s): ear-acupuncture A; stimulation B; stimulation C
Intervention type(s): Other; Other; Other
Intervention description(s): with needle stimulation; with bread stimulation on ear acupuncture point; without needle stimulation
Other intervention name(s): ear acupuncture needle; ear acupuncture bread; placebo needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ear acupuncture; obese; obese women; women
CVD Risk and Health in Postmenopausal Phytoestrogen Users
Condition: Bone Diseases; Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Ischemia; Osteoporosis; Postmenopause
MeSH terms: Osteoporosis; Bone Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the acceptability and benefits of use of a dietary supplement of the
      phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and
      psychosocial outcomes in postmenopausal women.
    

Detailed description: 
      BACKGROUND:

      Estrogen replacement therapy is beneficial for heart disease risk factors as well as for bone
      density. However, a large proportion of postmenopausal women are not compliant with
      therapeutic regimens. Phytoestrogens are naturally occurring compounds found in plants and
      soy products that have estrogenic effects, and may represent an alternative treatment for the
      prevention of heart disease and osteoporosis in postmenopausal women. However, few
      intervention trials have examined the extent to which it is possible to improve heart disease
      risk factors, bone density, and quality of life in postmenopausal women through use of a
      dietary supplement of phytoestrogen.

      DESIGN NARRATIVE:

      Randomized, double-blind, placebo-controlled study. A total of 210 women were enrolled in the
      study to be followed for one to two years. The women were randomized to phytoestrogen
      treatment or to placebo. Data are collected at baseline visits, at one and three month
      follow-up telephone calls, and at 6, 12, and 24 month follow-up clinic visits. Measures of
      high density lipoprotein and other heart disease risk factors, hip and spine bone density,
      and depression, life satisfaction, and quality of well-being are obtained. Cross-sectional
      and longitudinal comparisons of treatment and placebo groups are performed before and after
      adjustment and stratification for potentially confounding covariates.

      The study was renewed in March 2002 to assess whether the women treated with phytoestrogens
      had lowered homocysteine, interleukin-6, C-reactive protein, E-selectin, and decreased
      obesity and fat mass over two years.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): dietary supplements; genistein; diet, soy proteins
Intervention type(s): Behavioral; Drug; Behavioral
Intervention MeSH terms: Genistein
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Hepatoprotective Effect of Remote vs Local Preconditioning of Liver
Condition: Liver Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury
      of remote ischemic preconditioning of the liver against local ischemic preconditioning of the
      liver during human liver resections.
    

Detailed description: 
      In this randomized control study, a total of 60 patients were randomized into 3 groups:
      remote ischemic precondition group - RIPC (3 intervals of 5 minute right upper limb ischemia
      with 3 intervals of 5 minute reperfusion), local ischemic precondition group - LIPC (15
      minutes of inflow liver occlusion followed by 10 minutes of reperfusion before liver
      transection), control group - CG (group without ischemic preconditioning before liver
      transection). Patients were also stratified according to the extent of the hepatectomy.
      Hepatoprotective effect was evaluated by comparing serum transaminase levels, bilirubin
      levels, albumin, and protein levels, coagulograms and pathohistological exams. We also
      measured flow rate by Doppler ultrasound of hepatic artery and portal vein before and after
      preconditioning.
    

Intervention name(s): Preconditioning
Intervention type(s): Procedure
Intervention description(s): Local ischemic preconditioning (LIPC) is process during which a short period of ischemia is followed by a period of reperfusion prior to the prolonged ischemia which seems to render organs more tolerant to the IR(ischemic-reperfusion) injury.
Remote ischemic preconditioning (RIPC) involves the protection of an organ from prolonged ischemia by brief periods of ischemia and reperfusion to a remote organ.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preconditioning, resection
The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin
      concentration and glucose infusion rate.
    

Detailed description: 
      The investigators hypothesize that RAI absorption and action measured by time to reach
      maximum insulin concentration and glucose infusion rate during the clamp study will be
      significantly faster when insulin bolus is delivered using the "Quick Bolus" feature as
      compared to the "Standard Bolus".

      Outcomes were updated at time of results entry.
    

Intervention name(s): Quick Bolus; Standard Bolus
Intervention type(s): Device; Device
Intervention description(s): Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "quick bolus" of 15 units per minute during a euglycemic clamp.; Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via "standard bolus" of 1.5 units per minute during a euglycemic clamp.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
Masking: Single (Participant)
Primary purpose: Basic Science