bioihbjkbjnl/mcl2 huggingface dataset:
Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
Condition: Relapsed or Refractory Hodgkin Lymphoma; Relapsed or Refractory Anaplastic Large-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and pharmacokinetics, and determine the
      pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.
    

Detailed description: 
      The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is
      being tested to treat children who have relapsed or refractory (r/r) anaplastic large-cell
      lymphoma (sALCL) or Hodgkin lymphoma (HL). This study will look at the maximum tolerated dose
      and/or recommended phase 2 dose, safety and pharmacokinetics of brentuximab vedotin along
      with overall response of people who took brentuximab vedotin.

      The study enrolled 36 patients. In the phase 1 portion of the study, 12 participants were
      enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, 30-minute IV infusion, Day 1 of every
      21-day cycle, until there was evidence of disease progression or unacceptable toxicity.

      Once the maximum tolerated dose and/or recommended phase 2 dose and pharmacokinetics of
      brentuximab vedotin was reached, participants were enrolled by diagnosis into two phase 2
      study arms: relapsed or refractory sALCL or relapsed or refractory HL and received
      brentuximab vedotin 1.8 mg/kg as 30-minute IV on Day 1 of every 21-day cycle for up to 16
      cycles. One participant received a maximum of 20 cycles at the joint discretion of the
      sponsor and the investigator for continued clinical benefit.

      This multicenter trial is being conducted worldwide. The overall time to participate in this
      study is approximately 5 years. Participants made multiple visits to the clinic, and were
      contacted by telephone every 12 weeks for 12 months after the end of treatment (EOT) for
      progression free survival and then every 6 months until death, study closure, or 2 years
      after enrollment of the last participant for overall survival.
    

Intervention name(s): Brentuximab vedotin
Intervention type(s): Drug
Intervention description(s): Brentuximab vedotin IV infusion
Other intervention name(s): SGN-35; ADCETRIS
Intervention MeSH terms: Brentuximab Vedotin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Lymphoma; Hodgkin; Anaplastic Large-cell; Relapsed; Refractory; Drug therapy
Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the study volunteer breathes. The accuracy of a
      noninvasive pulse oximeter sensor under motion conditions will be assessed by comparison to
      the oxygen saturation measurements from a laboratory blood gas analyzer.
    


Intervention name(s): RD Disposable Sensors
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without
      dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)
      has been shown to be safe and effective in randomized controlled clinical trials with strict
      inclusion and exclusion criteria under well-controlled conditions. This observational study
      was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to
      local label, under real world conditions in Canada in a clinical practice patient population.
    

Detailed description: 
      This was a prospective, multi-center observational study in participants receiving the
      interferon-free ABBVIE REGIMEN ± RBV in Canada. The prescription of a treatment regimen was
      at the discretion of the physician in accordance with local clinical practice and label, was
      made independently from this observational study and preceded the decision to offer the
      participant the opportunity to participate in this study. Adults chronically infected with
      HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to
      participate in this study during a routine clinical visit at the participating sites.
      Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine
      clinical practice. Data were collected at the following time windows: baseline, early
      on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24
      weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of
      treatment (representing sustained virologic response 12 weeks after the end of treatment
      [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
    

Intervention name(s): Ombitasvir/paritaprevir/ritonavir; Dasabuvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Co-formulated tablet; Tablet; Tablet
Other intervention name(s): Ombitasvir also known as ABT-267; Paritaprevir also known as ABT-450; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving
        combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.
      
Keywords: Chronic Hepatitis C; Effectiveness; Influence of adherence; Patient reported outcomes; Ombitasvir/paritaprevir/ritonavir ± dasabuvir; Chronic Hepatitis C genotype 1; Chronic Hepatitis C genotype 4
The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
Condition: Obesity; Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at the effect of exenatide, a drug which has been approved for the
      treatment of type 2 diabetes, on body weight, appetite and energy expenditure among
      moderately obese women without diabetes.

      The study is 35 weeks long and includes 19 outpatient visits. Participants will receive
      exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither
      participants nor investigators will know whether exenatide or placebo is being administered.
      Participants will be started randomly on either exenatide or placebo.

      Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss
      and may lead to changes in energy expenditure.
    

Detailed description: 
      This study will examine the effect of exenatide on body weight, energy expenditure, satiety,
      sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will
      look at 2 populations of women, one with normal glucose metabolism and one with impaired
      glucose homeostasis (IGH)--either impaired fasting glucose (IFG, fasting glucose 101-125
      mg/dL) or impaired glucose tolerance (IGT, glucose 140-199 mg/dL 2h after a 75g oral glucose
      load). This is a randomized, double blind, crossover study with two 16-week treatment periods
      separated by a 3-week washout period. There are 19 study visits over 35 weeks.

      The goals of this study are 1) to examine the effect of exenatide on body weight and
      dysglycemia in populations in which this medication has not been studied, namely obese women
      with and without IGH and 2) to investigate possible mechanisms of weight loss through
      measurements of energy expenditure, hunger, satiety, nausea, and sleep.

      The primary outcome of this study is weight loss. We will calculate absolute and relative
      change in body weight from baseline to week 16 (the first treatment period) and from week 19
      to week 35 (the second treatment period). Body weight will be measured at every study visit
      which will also allow us to assess the absolute and relative change from baseline throughout
      the entire study.
    

Intervention name(s): exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks; Twice daily injection of placebo
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; double blind; placebo controlled; weight loss; appetite; energy expenditure
Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers Turkish Version, Validity and Reliability Study
Condition: Healthy
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      Today, there is a relationship between the increase in the use of electronic devices such as
      smartphones or tablets and musculoskeletal disorders. Different usage styles of various
      electronic devices such as laptops, smartphones and tablets affect the risk factors that may
      be related to musculoskeletal disorders in office workers. In addition to the use of
      electronic devices, the posture of the office worker's head, waist and hands while sitting
      are among the risk factors. Parameters such as the features of the chair he is sitting on,
      the height and distance of the table affect the person's posture. Evaluation of these factors
      is important in preventing musculoskeletal disorders.

      The Ergonomic Risk Assessment for Musculoskeletal Disorders in Office Workers was developed
      by Kluay-On et al. in 2022 and its validity and reliability were established. The aim of our
      study is to culturally adapt the Ergonomic Risk Assessment for Musculoskeletal Disorders in
      Office Workers into Turkish and to examine its validity and reliability.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Office workers at Tokat Gaziosmanpaşa University
The Presence of Friends Increases Food Intake in Youth
Condition: Total Caloric Intake; Nutrient Dense Caloric Intake; Energy Dense Caloric Intake
Study type: Observational

Summary: 
      Participants will be matched with either their friend or an unfamiliar peer who is the same
      gender and about the same age. Participants will have 45 minutes of free-play in an
      experimental room where they will have free access to energy-dense and nutrient-dense foods
      and an assortment of games and puzzles.

      The investigators predict that participants eating with a friend will eat significantly more
      than participants eating with an unfamiliar peer. The investigators also predict that
      overweight participants eating with an overweight partner will eat significantly more than
      participants eating with a non overweight participant.
    


Sampling method: Probability Sample
Study population: 
        Boys and girls between the ages of 9-15.
      
Keywords: social influence; friends; eating behavior; childhood overweight
NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the preservation or promotion of health in
      students during the college years.
    

Detailed description: 
      Freshman college students at Northwestern University will be cluster randomized to two groups
      based on their dorm. The intervention for one group will target smoking, physical activity,
      BMI and consumption of fruits and vegetables. The intervention in the second group will
      target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline
      health and lifestyle measures will be assessed for each participant prior to intervention.
      Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon
      monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and
      tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will
      be repeated during the fall of the students' sophomore and junior years.

      Participants will be given a mobile application and encouraged to track some behaviors. In
      addition, participants will be asked to answer weekly questions regarding health behaviors.
    

Intervention name(s): Mobile Health Application; Environmental Cues; Social Support; Educational Materials
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): An application on a smart phone that is designed to help individuals self-monitor health behaviors.; Text messages, informational posts and reminders supporting healthy behaviors.; Participants may interact with each other through a private Facebook group.; Educational materials regarding healthy behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mobile Health; Smartphone; Cardiovascular health; College students; Smoking; Physical activity; Diet; BMI; Blood pressure; Cholesterol; Glucose; Text; Facebook; Instagram; Push Notifications; Ecological Momentary Assessment
Investigation of Thenar Muscles Morphometric Parameters in Patients With TMC OA
Condition: Thumb Osteoarthritis; Muscle Atrophy or Weakness
MeSH terms: Osteoarthritis; Muscular Atrophy
Study type: Observational

Summary: 
      In this study, investigators aimed to investigate the morphometric parameters tenar muscles
      and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA)
      osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level
      and hand dexterity.
    

Detailed description: 
      Patients diagnosed with trapeziometacarpal osteoarthritis and healthy subjects will be
      included in the study. Thickness and cross-sectional area measurements of the thenar muscles
      of the patient and healthy volunteers will be performed by using Shimadzu SDU 1200-Pro
      ultrasound system with an 8-10 MHz linear probe. To improve the image quality and to avoid
      muscle compression, water immersion ultrasonography will be preferred and the hands will be
      positioned in a water-filled plastic container. The thenar muscles will be imaged in hands of
      each subject.

      In this study, poster-anterior radiographic imaging will be performed. The osteoarthritis
      stage will be determined on the radiographic image. Three different measurements will be
      performed on radiography: radial subluxation of the first metacarpal base (RS), articular
      width (AW) of the first metacarpal, and the distance between the ulnar articular facet of the
      trapezium and the ulnar edge of the metacarpal (U). RS / AW ratio will be calculated.

      Because TMC OA caused pain and affect performance, especially during grip activities in the
      osteoarthritis and control groups will be tested.

      Grip strength will also be measured.
    

Intervention name(s): Muscle-Skeleton Ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): postero-anterior radiography
Other intervention name(s): Radiography
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years and who
        had the intellectual capacity to give informed consent for the treatment were included in
        the study.
      
Keywords: thumb; trapeziometacarpal osteoarthritis; muscle thickness; muscle cross sectional area; hand function; hand dexterity; pain; pinch strength
Comparative Bioavailability of Risperidone.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative
      Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).
    

Detailed description: 
      This was an open-label, 1-sequence study in patients who are were stable oral risperidone
      treatment. The study consisted of a screening visit, 1 treatment period with inpatient and
      outpatient visits, and a Follow-up visit.

      Patients who were receiving existing oral risperidone treatment (4 mg) continued the oral
      regimen for 1 week to achieve steady-state concentrations of risperidone (Treatment A).
      Following the oral risperidone treatment, a single IM dose of 100 mg Risperidone ISM® was
      administered deeply into the gluteal muscle. A total of 4 IM doses were given, each dose
      separated by 4 weeks (Treatment B).

      Safety assessments and PK sampling were performed once each dosing day and each outpatient
      visit. A final Follow-up visit was conducted to assess each patient for safety and to obtain
      PK samples.

      Approximately 80 (with no screening failure) patients were planned for enrolment, with the
      intent to complete 48 patients with the assumption of an approximate drop-out/not valuable PK
      rate of 40%.

      The primary objective of this study was to evaluate the steady-state comparative
      bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4
      mg oral risperidone in patients with schizophrenia stabilized on oral risperidone treatment.

      The secondary objective of this study was to evaluate the safety and tolerability of 100 mg
      Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg oral risperidone in
      patients with schizophrenia stabilized on oral risperidone treatment.
    

Intervention name(s): Risperidone ISM® 100 mg; Risperdal 4mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg of risperidone ISM® administered every 4 weeks; 4 mg oral risperidone once daily for 7 days
Intervention MeSH terms: Risperidone
Intervention model: Sequential Assignment
Intervention model description: This is an open-label, 1-sequence study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany) in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: risperidone; schizophrenia; long-acting injectable
Correlation of Endothelial Function and Early Coronary Artery Disease in Humans
Condition: Endothelial Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Qualifying patients who are scheduled for angiogram with endothelial function testing are
      approached to participate in this protocol (consent form reviewed with patient). Those who
      are willing to participate will have additional measurements taken during their angiogram as
      part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of
      a clinically indicated angiogram will be eligible to participate in a 6 month medication
      trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely
      during the 6 month trial via phone calls and blood testing for assessment. At the end of the
      6 months they return to Mayo for a repeat angiogram to assess endothelial function for any
      changes or improvements.
    

Detailed description: 
      Aim I: To determine the activity of the endogenous endothelin system in the coronary
      circulation in humans with coronary endothelial dysfunction and atherosclerosis risk factors.
      Aim II: To assess the potential of chronic endothelin receptor antagonists to improve
      preexisting coronary endothelial dysfunction and myocardial perfusion in humans and Aim III:
      To assess the effect of chronic endothelin receptor antagonism on the endogenous nitric oxide
      system in association with oxidative stress in humans with early coronary disease risk
      factors.
    

Intervention name(s): Atrasentan; Atrasentan; atrasentan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 10mg capsule to be taken daily for 6 month study period.; 1 10mg capsule per day for the 6 month study period.; One 10 mg capsule per day for 6 month study period
Other intervention name(s): Xinlay; Xinlay; Xinlay
Intervention MeSH terms: Atrasentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Effect of LY3556050 on Metformin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how much Metformin gets into the bloodstream
      and how long the body takes to get rid of it when it is administered orally in combination
      with LY3556050 in healthy participants. Iohexol will be administered to evaluate kidney
      function. Each enrolled participant will remain in the study for up to 7 weeks including the
      screening period.
    


Intervention name(s): LY3556050; Metformin; Iohexol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered IV.
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science