bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and effectiveness of risperidone (an
      antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.
    

Detailed description: 
      Although the safety and effectiveness of antipsychotic medications is well-established in
      adults with schizophrenia, these drugs have not been examined rigorously in adolescents with
      this disorder. Preliminary experience suggests that risperidone may hold promise for the
      treatment of these younger subjects. This is an open-label, multicenter trial of risperidone,
      formulated as an oral solution and tablets, in the treatment of adolescents with
      schizophrenia. It is an open-label, 6-month extension of two previous double-blind studies
      that assessed the safety and effectiveness of risperidone in the treatment of schizophrenia
      in an adolescent population. Patients may also enroll directly in this open-label trial.
      During the first week of the study, patients will receive increasing doses of risperidone to
      reach an optimal daily dose (2 to 6 mg/day), which will be maintained throughout the 6 months
      of the study. Assessments of effectiveness include the Positive and Negative Syndrome Scale
      for Schizophrenia (PANSS), a scale measuring the symptoms of schizophrenia, the Clinical
      Global Impression-Severity of Illness subscale (CGI-Severity), a scale measuring the severity
      of illness, the Clinical Global Impression-Improvement subscale (CGI-Improvement), a scale
      measuring clinical improvement, and the Children's Global Assessment Scale. Safety
      evaluations include the incidence of adverse events throughout the study, clinical laboratory
      tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and
      temperature), weight, and electrocardiogram (ECG) recordings at specified intervals. The
      study hypothesis is that risperidone with be effective in the treatment of adolescents with
      schizophrenia, and well tolerated. Risperidone, oral solution (1 mg/ml) once daily; dose
      increasing from 0.01 mg/kg body weight (Day 1) to a range from 2 to 6 mg/day for 6 months.
      Oral tablets (0.5, 1, 2, 3, and 4 mg) once daily; dose increasing from 0.5 mg (Day 1) to a
      range of 2 to 6 mg/day for 6 months.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; antipsychotic agents; risperidone; adolescents
Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is intended to evaluate the effectiveness, tolerability, compliance, and
      feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L
      Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of
      colonoscopy, vs the standard 4L split PEG solution.
    

Detailed description: 
      Eligible patients will be informed about the aims, procedures, benefits and possible risks of
      the study prior to sign the informed consent form from day -30 to day-3. They will provide
      medical history and undergo a physical examination. Patients will be evaluated by a Physician
      other than the blind Endoscopist. The same responsible person will instruct the patients
      about administration procedures in both oral and written form. The patients will be assigned
      to receive one of the dosing schedule bowel preparation according to a computer generated
      block-randomisation list. Patients will take the study treatment at home according to the
      given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will
      be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation
      taken by the patient. Completed colonoscopic exam will be performed with time recorded
      (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about
      safety, tolerability, overall acceptance and compliance.
    

Intervention name(s): Bisacodyl plus PEG-CS; PEG 4 litres split
Intervention type(s): Drug; Drug
Intervention description(s): the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime
the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam; the day before colonoscopy: 2 litres of PEG
the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination
Other intervention name(s): LOVOLdyl plus LOVOLesse; SELG 1000
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Investigating the Clinical Effects of Supporting Neutral Pelvic Position in Sitting
Condition: Low Back Pain; Strain; Postural
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      The aim of this study is to examine the clinical effects of supporting the human pelvis in a
      neutral sitting position in subjects with Low Back Pain over a 3-week period. The neutral
      sitting posture will be supported by a portable and adjustable "pelvic support device" or
      "pelvic support assembly" per US Patent number US 8,857,906 B2 that is used in the seat of
      the user's desk chair.
    

Detailed description: 
      This study is a randomized control trial with repeated measures. It will include 34 subjects
      with low back pain who sit 25 hours a week or more at a desk / computer.

      There will be 2 groups: control and experimental, each with 17 subjects. All subjects will be
      measured on the same 2 dates (3 weeks apart - pre and post intervention) with the same
      measures.

      The experimental group will use a pelvic support device, that aids in supporting the user's
      pelvis in a neutral position, in their desk chairs at home or work as tolerated during this 3
      weeks.

      The control group will continue in their current sitting arrangement during the same 3 weeks.

      For control of conflict of interest, the Sponsor-Investigator will not perform any of the
      measures and data will be coded for subject group assignment until all data analysis is
      finalized.

      Multiple sessions of 3-week intervals of data collection may be performed as needed to
      achieve desired subject number in the study.
    

Intervention name(s): "Pelvis Support Assembly"
Intervention type(s): Device
Intervention description(s): Use of a portable and adjustable "Pelvis Support Assembly" in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The objective of this study is to compare healthcare utilization and costs in asthma patients
      who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or
      inhaled corticosteriods in typical clinical practice using a retrospective observational
      cohort study design of large managed care database.
    


Intervention name(s): Fluticasone propionate/salmeterol combination; Inhaled corticosteroids
Intervention type(s): Drug; Drug
Intervention description(s): Asthma subjects newly prescribed fluticasone propionate/salmeterol combination; asthma subjects newly prescribed inhaled corticosteroids in clinical practice
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study intends to identify subjects with asthma treated with inhaled corticosteroids
      
Keywords: fluticasone propionate/salmeterol combination; Asthma; inhaled corticosteroids; outcomes
High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Condition: Peptic Ulcers; Upper Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Peptic Ulcer; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in
      bleeding peptic ulcers successfully treated by endoscopic therapy
    

Detailed description: 
      The recent Canadian consensus conference on the management of patients with non-variceal
      upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of
      80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg
      twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However,
      by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus
      regular doses as intermittent bolus, rebleeding, surgery, and mortality were not
      significantly different. As the previous conclusion became apparent in a meta-analytical
      evaluation of only 2 randomized clinical trials, more studies are needed on this topic.
    

Intervention name(s): omeprazole; pantoprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Omeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PPIs,; endoscopic therapy,; peptic ulcers,; upper gastrointestinal bleeding,; non-variceal upper gastrointestinal bleeding
Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      The goal of this study is to further evaluate the effect of magnesium on the symptoms of
      menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an
      elevated risk of breast cancer.
    

Detailed description: 
      Hot flashes are one of the most common symptoms that are experienced in women during
      perimenopause, menopause, and as a result of treatment of cancer such as breast cancer. Hot
      flashes, also known as vasomotor symptoms (VMS) may decrease a woman's quality of life due to
      discomfort, disruption of daily life, interruption of sleep, and worsening of depression.
      Previously, estrogen-based therapy was the primary treatment choice for VMS. However, in
      recent years, this has been considered less favorable due to the increased risk of breast
      cancer associated with estrogen-based therapy.

      While medications such as certain antidepressants, gabapentin and clonidine are available as
      non-hormonal treatment options, they appear to be less effective in comparison to estrogen
      therapy with reported adverse effects.

      Magnesium supplementation has been found to have very promising results in alleviating VMS in
      patients with a history of breast cancer. The goal of this study is to further investigate
      the effects of administering magnesium supplementation in reducing the effects of hot flashes
      in this targeted population. Our aim is to create a controlled trial using different dosages
      of magnesium glycinate in the management of hot flashes. Participants will be asked to
      complete surveys for data collection and analysis.
    

Intervention name(s): 400mg Magnesium Glycinate BID; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 400mg Magnesium Glycinate BID for 8 weeks.; Placebo BID for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Placebo Controlled, Single Blinded
Masking: Single (Participant)
Primary purpose: Treatment
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Condition: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week
      regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in
      HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,
      including those on hemodialysis or peritoneal dialysis.
    


Intervention name(s): ombitasvir/paritaprevir/ritonavir; dasabuvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet; tablet; tablet
Other intervention name(s): ABT-450/r/ABT-267; Viekira Pak; paritaprevir also known as ABT-450; ombitasvir also known as ABT-267; dasabuvir also known as ABT-333; ABT-333; RBV
Intervention MeSH terms: Ritonavir; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Hepatitis C; End-stage renal disease; Hepatitis C Genotype 1; Severe Renal Impairment; renal disease; Compensated Cirrhosis; Renal impairment; dialysis; Hepatitis C Virus; cirrhosis
A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes
      mellitus. Successive cohorts of patients will be randomized to receive either active drug, at
      escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the
      target sample size is <100 individuals.
    


Intervention name(s): RO4998452; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating oral doses; Oral doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
50% Body Weight Reverses Stature, Lumbar Disc Expansion and Vertebral Compliance by Hyper-Buoyancy Floatation.
Condition: Intervertebral Disc Compression; Muscle Atrophy; Spine Injury
MeSH terms: Muscular Atrophy; Body Weight; Spinal Injuries
Study type: Observational

Summary: 
      Study with the aim to see the effect on a space ground analogue , Hyper-Buoyancy Floatation
      (HBF) on lumbar column and the effect of a supplementary 50% of an axial load.
    

Detailed description: 
      the aim of this study was to determine the effect of 15min of 1g reloading following 4h HBF
      unloading with, and without 30s of seated static 50% BW axial loading upon stature, lumbar
      Intervertebral Disc height (via ultrasound), vertebral compliance changes, and back pain.
    

Intervention name(s): Hyper-buoyancy Floatation (HBF); Axial Load after 4h of HBF
Intervention type(s): Device; Device
Intervention description(s): Participants remained on a waterbed encased within a wooden frame partially (≈50%) filled with water super-saturated with magnesium sulphate at a temperature between 34-36°C regulated by an ultra-thin underbed heater. Participants remained supine and motionless when lay on the HBF except for temporary passive re-orientation to/and back from the prone position for vertebral compliance assessment; Participants from observational sat upright in a chair without back support for 15 min before post testing (1G), whilst experimental group participants performed a 30s seated squat with 50% of their body weight (BW) before returning to the upright seated position.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        NASA astronaut criteria (1.57-1.90m, 50-95kg)
Adipose Tissue Cellular Response to Exercise in Healthy Humans
Condition: Metabolic Disease; Adipose Tissue
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effects of a single session of exercise on
      changes in the cellular composition of the body fat of humans.
    

Detailed description: 
      Fat tissue is far more than just a place where humans store body fat. Fat tissue contains
      many different types of cells, such as immune cells, endothelial cells, and fat precursor
      cells. Differences or changes in the number of immune cells, endothelial cells, and fat
      precursor cells in fat tissue can have a great impact on metabolic health. The abundance of
      all immune cells, endothelial cells, and fat precursor cell types are known to change when a
      person loses or gains weight. For example, the abundance of inflammatory cells is often found
      to decrease markedly with weight loss - and this change has been linked to the profound
      improvements in metabolic health that occur with weight loss. In contrast, the effects of
      exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not
      known. Determining the effects of exercise on changes in the cellular composition within fat
      tissue will provide important information for optimizing lifestyle interventions aimed at
      improving metabolic health.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Subjects will exercise on a treadmill for 1 hour at a moderate intensity (approximately 70% of their predicted VO2peak).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise
A Study to Investigate the Safety, Tolerability, PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of MG1113 in the single
      ascending dose study (IV injection or SC injection) in healthy subjects and hemophiia
      patients.
    

Detailed description: 
      This is a single-dose study that explore the safety, tolerability, PK, and PD of the study
      drug by sequentially increasing the study drug in 4 dose levels. The route of administration
      is either subcutaneous (SC) injection or intravenous (IV) injection.

      For healthy subjects, 6 subjects will be assigned to the study group and 2 subjects will be
      assigned to the placebo group to explore the safety and tolerability, and PK/PD of the study
      drug in comparison with placebo. Hemophilia patients will be assigned only to the study group
      with 3 and 6 subjects in each cohort, respectively.

      The investigator and subjects will know which cohort the healthy subjects have been assigned
      to, but they will be double-blinded as to whether the subjects are assigned to the study
      group (study drug) or the placebo group (placebo) within each cohort.

      The doses planned in healthy subjects are 0.5 mg/kg, 1.7 mg/kg, and 3.3 mg/kg by SC
      injection; 3.3 mg/kg by IV injection. In hemophilia patients, 1.7 mg/kg and 3.3 mg/kg will be
      administered by SC injection. The planned dose will be administered after checking the safety
      and tolerability at the previous dose to the extent not exceeding the criteria for
      discontinuation of dose escalation. The dose escalation will be decided by the Data
      Monitoring Committee(DMC) and Data and Safety Monitoring Boards (DSMB) in the blinded
      evaluation of the safety and tolerability data obtained from each previous cohort for 7 days
      after administration. Before deciding dose escalation and proceeding to the next step, the
      safety, tolerability, PK, and PD data obtained from all healty subjects and hemophilia
      patients up to cohort 6 will be evaluated by the Data and Safety Monitoring Boards (DSMB) in
      an unblinded manner. In addition, if necessary, the analysis result of cohort that has
      completed all the scheduled visits can be reviewed in an unblinded manner.
    

Intervention name(s): MG1113; Placebo of MG1113
Intervention type(s): Biological; Other
Intervention description(s): MG1113; Placebo of MG1113
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential dose escalation model
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: MG1113; Hemophilia
Team-based Ergonomics Educational Model for Workplace WELLNESS Improvement: A Pilot Study
Condition: MSDs; Muscle Pain
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      This research is being done to explore the potential benefit of a physical therapist-guided
      stretching program on musculoskeletal pain and well-being.
    


Intervention name(s): stretching exercises
Intervention type(s): Behavioral
Intervention description(s): Head/neck stretches
Head tilt side to side
Cross-chest stretch Torso stretches
Side stretch
Mid-back stretch Lower limb
Standing quadriceps stretch
Standing hamstring stretch
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment