bioihbjkbjnl/mcl2 huggingface dataset:
Prediction of Weight Gain by Children and Adolescents
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Gain
Study type: Observational

Summary: 
      The 'Meir children's sport and health center' runs a multi-disciplinary intervention program
      for the treatment of overweight and obese children and adolescents. The program includes
      physical activity, dietary guidelines, medical supervision and behavioral treatment. The
      participants are routinely weighed once a week, at the same day and time, in order to
      supervise their progress. According to our experience, the child can predict his weight
      change, based on his "behavior" in the previous week. To our knowledge the overweight/obese
      child's ability to predict his weekly weight change, while participating in a
      multi-disciplinary intervention program, has never been tested.
    

Detailed description: 
      The aim of this study is to examine whether a child participating in a multi-disciplinary
      intervention program for treatment of the overweight and obese in Meir medical center, can
      predict his weight change during intervention before the actual weighing.

      This study will include 1000 weight measurements of children and adolescents, boys and girls,
      ages 5-18 years. A patient might be measured several times.

      The data will be collected during 6 mounts. in this period the program participants will be
      asked, discretely, before being weighed if, in there opinion, they had lost or gained weight
      in the past week, and how mach and why.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        overweight and obese children and adolescence, boys and girls, ages 5-18
      
Keywords: overweight; obese; children; weighing; weight
Does Endometrial Injury Improve Intrauterine Insemination Outcome?
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigator suggests that local endometrial injury using pipelle catheter performed in
      the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy
      rates among patients undergoing intrauterine insemination.
    

Detailed description: 
      In a selected group of patients with repeated implantation failure, endometrial injury in the
      preceding cycle may improve ICSI outcome.

      Little is known about the efficacy of this procedure in improving intrauterine insemination
      outcome.

      Also little is known about the effect of this procedure if done in the stimulation cycle
      weather in ICSI or intrauterine insemination cycles.
    

Intervention name(s): endometrial injury.; intrauterine insemination; ovarian stimulation
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.; Placement of washed sperm in the uterus using a catheter, around the time of ovulation.; Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.
Other intervention name(s): endometrial scratch.; endometrial sample.; artificial insemination; controlled ovarian hyperstimulatiom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Observational Study of Baska Mask, a New Supraglottic Airway Device
Condition: Performance and Safety of a New Supraglottic Airway Device
Study type: Interventional
Phase: Phase 2

Summary: 
      The Baska mask is a new supraglottic airway device . The investigators would like to assess
      its performance in setting in which the current standard - LMA device - is being used.
    

Detailed description: 
      Our group has performed a number of studies on novel airway devices. In this study we would
      like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain
      parameters (time to and ease of insertion, failure rate, seal pressures, complications etc)
      as regarding the performance and safety profile of this device. This is a descriptive case
      series of patients undergoing airway management under general anaesthesia.
    

Intervention name(s): Placement and use of Baska mask
Intervention type(s): Device
Intervention description(s): use of a supraglottic airway device as a standard part of a general anaesthetic
Other intervention name(s): Baska mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Baska mask; supraglottic airway; airway management
Sedentary Screen Time Activities on Food Intake
Condition: Exogenous Obesity
Study type: Interventional

Summary: 
      The purpose is to investigate the effect of sedentary screen time activities on food intake
      and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The
      investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes
      increases subjective appetite and food intake at the next meal. Food intake will be measured
      immediately following screen-time exposure, and subjective appetite measured throughout the
      study period at 0, 15, 30, 45 and 75 minutes.
    


Intervention name(s): Television Viewing before mealtime; Video Game Playing; Computer Use; Sitting quietly
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety Study of BIIB033 in Subjects With Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic
      profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with
      MS.

      Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups
      (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of
      BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will
      review all safety data from previous groups enrolled, as well as data from another study
      where BIIB033 is being administered to healthy volunteers (215HV101).
    

Detailed description: 
      BIIB033 is a protein that acts on certain types of brain cells by blocking the function of
      another protein called LINGO-1. It is believed that LINGO-1 is one of the reasons why nerves
      in the brain of patients with MS do not repair well. It is thought BIIB033 may improve MS by
      repairing damaged nerve tissue. LINGO-1 is also present in the brain of healthy people.

      Subjects will take part in the 215MS101 study for up to 28 weeks. This includes a 4-week
      screening period, a 2 week treatment period in which 2 doses of BIIB033 are given, and a
      post-dosing safety follow up period of up to 22 weeks (depending on dose cohort).

      The study tests vary at each of the individual visits and may include:

      medical history evaluation, height and weight assessment, physical examination, neurological
      examination, vital signs assessment (pulse, respiratory rate, blood pressure, and
      temperature), MS performance score, electrocardiogram, cardiac monitoring, routine blood and
      urine tests, drug concentration testing of the blood, hepatitis and HIV tests, blood clotting
      tests, brain MRI scan, lumbar puncture, and drugs of abuse screen and pregnancy test.
    

Intervention name(s): BIIB033; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of 0.3, 1, 3, 10, 30, 60 or 100 mg/kg; IV infusion dummy drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: BIIB033; Multiple Sclerosis; anti-LINGO-1 antibody; Relapsing Remitting MS; remyelination; myelin repair; Multiple ascending dose; Secondary progessive MS
Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)
Condition: Test Meal
Study type: Interventional

Summary: 
      In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past
      fifty years, the generalization of added sugar in processed food led to a marked increase in
      fructose consumption in almost all countries, and epidemiological studies demonstrated that
      the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is
      associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.

      The objective of the study is to measure the amount of fructose that escape first-pass
      hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its
      metabolic fates with the use of tracers.
    


Intervention name(s): Test meal
Intervention type(s): Other
Intervention description(s): Liquid test meal (fructose+glucose)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fructose; Obesity; Metabolism; Post-prandial kinetics
Study of Tremelimumab in Patients With Advanced Solid Tumors
Condition: Urothelial Bladder Cancer; Triple-negative Breast Cancer; Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with
      Advanced Solid Tumors
    

Detailed description: 
      This is an open-label, multi-center study to determine the efficacy and safety of
      tremelimumab in the treatment of different cohorts of patients with selected advanced solid
      tumors. If eligible and at the discretion of the Investigator, after confirmed disease
      progression on tremelimumab monotherapy or during follow-up, patients will have the option of
      being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab
      combination therapy, for up to 12 months or until disease progression, whichever comes
      sooner.
    

Intervention name(s): Tremelimumab monotherapy; MEDI4736 monotherapy; MEDI4736 + tremelimumab combination therapy
Intervention type(s): Biological; Biological; Biological
Intervention description(s): IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after
      14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy
      Chinese subjects.
    


Intervention name(s): Paroxetine Controlled Release Tablet
Intervention type(s): Drug
Intervention description(s): Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BRL029060/Paroxetine CR; pharmacokinetics; repeat dose
Predictive Value of the "Cytocapacity Test" Patients With Lymphoproliferative Diseases and High-dose Therapy
Condition: Hodgkin's Disease; Non-Hodgkin Lymphomas; Multiple Myelomas
MeSH terms: Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This investigator initiated trial was a prospective, open, single-arm, diagnostic-prognostic
      study. Patients who received high-dose therapy with autologous stem cell transplantation for
      the treatment of their lymphoproliferative disease were included into the study.

      After completion of the high-dose therapy (day -2 with respect to the stem cell
      transplantation) the first blood sample A for the cytocapacity test with determination of
      leukocytes and neutrophils was taken in the evening of day -1. Directly thereafter the study
      medication was administered. The second blood sample B for the cytocapacity test with
      determination of leukocytes and neutrophils was taken in the morning of day 0, 12-14 hours
      after administration of the study medication. Thereafter the stem cell re-infusion was
      performed.

      The primary objective of this study was to show that the cytocapacity test with lenograstim
      is a useful predictive tool with respect to the risk of post-transplant complications and
      prolonged myelosuppression, typically occurring after high-dose chemotherapy.

      The primary variables were:

        -  the rate of patients with documented infections

        -  the time to platelet engraftment
    


Intervention name(s): lenograstim
Intervention type(s): Drug
Intervention MeSH terms: Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lymphoproliferative diseases (Hodgkin's disease, non-Hodgkin's lymphomas, multiple myelomas) and high-dose therapy
An Assessment of TLR4 and TOPK/PRPK Signaling in Sun Damaged Human Skin Acutely Exposed to Solar Simulated Light
Condition: Sun Damaged Skin
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The purpose of this project is to obtain clinical data, including skin samples, that will
      help investigators evaluate changes occurring in sun damaged human skin as a result of light
      that simulates sun exposure (Solar Simulated Light). Of specific interest are the molecular
      targets for cancer prevention. Molecular targets are the parts of the body's cells that have
      been shown to play a role in causing or preventing cancer and which scientists seek to affect
      in a way that may slow or eliminate the development of cancer.
    

Detailed description: 
      The aim of this study is to assess TLR4 and TOPK/PRPK signaling in sun damaged human skin
      acutely exposed to solar simulated light and to validate this clinical model prior to
      intervention with therapeutic skin cancer prevention approaches.

      Acute solar simulated light exposure will be evaluated in sun damaged skin to determine the
      level of activation of the targeted pathways using reverse-phase protein array (LCM-RPPA)
      analysis and immunohistochemistry (IHC).
    

Intervention name(s): Solar Simulated Light (SSL)
Intervention type(s): Other
Intervention description(s): Acute SSL will be delivered to sun damaged skin at a rate of two-times the minimal erythema dose of each individual subject. Minimal erythema dose is defined as the smallest dose of energy necessary to produce confluent erythema with four distinct borders at 22-26 hours post-exposure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Solar Simulated Light; Sun Protected Skin; Sun Damaged Skin
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the oral bioavailability of Apixaban solution
      formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment
      A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
    


Intervention name(s): Apixaban
Intervention type(s): Drug
Other intervention name(s): BMS - 562247
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of
      GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug
      development.
    

Detailed description: 
      Safety
    

Intervention name(s): Rivipansel
Intervention type(s): Drug
Intervention description(s): Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV.
Other intervention name(s): GMI-1070
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: QTc; African-American; GMI-1070; QT/QTc interval prolongation
Effect of Fibre Products on Appetite and Weight
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as
      propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to
      have direct beneficial effects on the gut, appetite, weight and fat distribution. This study
      will look into these effects by conducting a dose finding study and then a randomised
      controlled study using healthy human volunteers.
    

Detailed description: 
      This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to
      find the level of oral supplementation with propionate that increases plasma propionate
      levels to 10x the current normal plasma level and use this dose of propionate in a
      randomised, placebo controlled double bind study. This study will compare propionate with
      fermentable and non fermentable carbohydrate. The outcome measures for this study will
      include assessments of appetite with feeding studies, measurement of insulin sensitivity
      using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution
      using MRI scans and adipose tissue biopsy to determine changes in proliferation and
      differentiation of adipocytes.
    

Intervention name(s): Propionate ester; Inulin; Cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks; The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks; The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Short chain fatty acids; Appetite; Body weight; Insulin sensitivity; Propionate; Propionate ester
Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients
Condition: Sepsis; Critically Ill
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      A total of ninety patients (52men and 38women) were included in the study. Forty five
      patients developed septic complication during ICU stay (sepsis group). Forty five patients
      were critically ill without evidence of infectious organism (SIRS group). At admission,
      Patients data include clinical status; SOFA score; central venous pressure; laboratory
      analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The
      attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long
      as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.
    

Detailed description: 
      The patients staying in ICU for more than 24 hours were enrolled in the study. Patients
      received anti-inflammatory drugs or corticosteroids before admission, patients had
      immunosuppressive illness, patients had chronic organ failure; patients received massive
      blood transfusion; patients with radiation therapy and patients with previous organ
      transplantation were excluded from the study. At admission, patient's age, sex, weight and
      height were recorded. Patients data that include the clinical status; sequential organ
      failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure;
      central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen,
      blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine
      aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were
      measured. Routine cultures of suspected sites, blood and urine were obtained to determine the
      presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and
      central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood
      products and inotropic or vasopressor agents were administered. Each day the attending
      physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long
      as their stay in ICU.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of ninety patients (52men and 38women) were included in the study. Forty five
        patients developed septic complication during ICU stay (sepsis group). Forty five patients
        were critically ill without evidence of infectious organism (SIRS group). Patients were
        classified into their groups at the time of the first blood analysis for these biomarkers
        at ICU admission.
      
Keywords: TNF alpha; SOFA score