bioihbjkbjnl/mcl2 huggingface dataset:
Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence
Condition: Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colonic Neoplasms; Colonic Cancer; Rectal Neoplasms; Rectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Recurrence
Study type: Interventional

Summary: 
      This 12-week, exercise study will assess the feasibility of a home-based high-intensity
      interval training (HIIT) program among colorectal cancer survivors and explore the impact of
      home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic
      exercise program on physical outcomes linked with survival from colorectal cancer and
      surrogate blood markers of colorectal cancer recurrence.

      HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous
      exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10
      minutes). Participants in this study will be randomly assigned into a personalized home based
      exercise program - either high-intensity interval training (HIIT) or moderate-intensity
      continuous aerobic exercise (MICE).

      This pilot study will provide us with preliminary evidence for a larger trial aimed to
      compare the effectiveness of these two different types of home-based exercise programs on
      physical outcomes linked with survival, quality of life, and surrogate blood markers of
      colorectal cancer recurrence.
    


Intervention name(s): Home-based high-intensity interval training; Home-based moderate-intensity continuous exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be instructed to complete four, high-intensity interval training workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout.; Participants will be instructed to complete five, moderate-intensity continuous exercise workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Stem Cells in Umbilical Blood Infusion for CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety of single dose intravenous infusion of cord blood
      cells which were cryopreserved after the birth of a brother or sister to a child with
      cerebral palsy.
    

Detailed description: 
      Cerebral palsy (CP) is the most common physical disability of childhood, affecting 2 per 1000
      live births across the world. CP describes permanent non-progressive motor disorders arising
      from damage to the developing brain.

      Preclinical studies of different types of stem cells in models of acute brain injury similar
      to CP have shown significant functional improvement. The variety of stem cells available in
      umbilical cord blood (UCB), an ethically uncomplicated source of stem cells, has led to a
      focus on UCB stem cell therapy as a quick-to-clinic option. Previous studies indicate that
      autologous or unrelated donor UCBC infusion is safe and feasible for children with CP, and
      may lead to improved motor functioning, but there is no information about the safety and
      effects of matched sibling cord blood. Therefore, this trial will study the safety of
      infusing matched sibling cord blood cells to children with cerebral palsy.
    

Intervention name(s): Matched sibling donor cord blood cell infusion
Intervention type(s): Biological
Intervention description(s): Single dose intravenous infusion of 12/12 HLA matched sibling donor cord blood cells (>1x10^7 cells/kg)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a
      superior reduction compared to those taking the placebo.
    

Detailed description: 
      This study has two arms, Euiiyin-tang and placebo group. Inclusion of 80 patient each arm.
      They will be screened at first visit. At the baseline, that is the second visit, they will be
      evaluated each outcomes including weight, waist circumference, lipid profile (total
      cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat
      area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and
      eating attitudes, etc. The Euiiyin-tang will provide to the patients from the baseline, it
      contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be
      repeated except lipid profile, CRP, abdominal CT. Another Euiiyin-tang of 4 weeks will be
      given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be
      repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated
      including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous
      fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes,
      etc.
    

Intervention name(s): Euiiyin-tang; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Korean medicinal herbal drug; Placebo drug, same odor and formula as Euiiyin-tang
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Herbal product; Korean Medicine
Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's
      disease 12 months after curative, resective ileal or ileocolonic surgery in patients
      receiving post-operative infliximab or placebo
    


Intervention name(s): infliximab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6; placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
Condition: Exercise; Muscle; Gene Expression; Myokine
Study type: Interventional

Summary: 
      Rationale: Proteins released from muscle during and shortly after exercise, often referred to
      as myokines, may be central to our understanding of the cross-talk during and after exercise
      between skeletal muscles and other organs, in particular the liver. So far only a few
      myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of
      these several known myokines in developing insulin resistance, revealing new putative
      myokines might provide valuable information and a direction for future research on the
      pathogenesis and treatment of type 2 diabetes mellitus.

      Objective: The objective of the present study is to identify novel myokines, expression of
      which is altered in skeletal muscle after a single bout of exercise.

      Study design: experimental study. Study population: Ten healthy, male subjects between 40 and
      60 years of age and BMI < 30 kg/m2, will participate in this study.

      Intervention: A single exercise bout that consists of one hour one-legged cycling on a
      adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as
      control for the exercising leg.

      Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle
      after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels
      of selected proteins after exercise.
    


Intervention name(s): Single legged exercise
Intervention type(s): Other
Intervention description(s): A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the time course of PF-04764793 concentration in
      the blood following dosing by oral inhalation from dry powder inhalers.
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled, 300/150, single dose; Inhaled, 300/150, single dose; Inhaled, 300/150, single dose + oral activated charcoal block; Inhaled, 300/150, single dose + oral activated charcoal block
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Drug Interaction Study of MGL-3196 With Atorvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether MGL-3196 alters the pharmacokinetics of
      atorvastatin in healthy male subjects and female subjects not of child-bearing potential.
    


Intervention name(s): Atorvastatin; MGL-3196
Intervention type(s): Drug; Drug
Other intervention name(s): Lipitor; VIA-3196
Intervention MeSH terms: Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the safety, efficacy and tolerability of the combination
      of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary
      objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in
      pediatric subjects with chronic hepatitis C.
    

Detailed description: 
      This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and
      tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3
      through 17 years, with chronic hepatitis C.
    

Intervention name(s): peginterferon alfa-2b (PEG2b) (SCH 54031); ribavirin (SCH 18908)
Intervention type(s): Biological; Drug
Intervention description(s): PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks.; 15 mg/kg/day for up to 48 weeks
Other intervention name(s): PEG-Intron (SCH 54031); REBETOL (SCH 18908)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-pharmacological Analgesic Effects on Term Newborns
Condition: Pain; Breast Feeding
Study type: Interventional

Summary: 
      The purpose of this study is to compare the analgesic effects of four non-pharmacological
      interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in
      newborns receiving a heel lance procedure.
    

Detailed description: 
      This is an randomized control clinical study. study population is healthy term
      newborns.Patients were identified by chart review and consent was received by nurse
      researcher. Newborns were randomized into either the control group who received no pain
      intervention or the intervention group who received one of four non-pharmacological pain
      interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.

      A heel lance for newborn screen blood sampling was selected as a study procedure and
      performed by a hospital technician following standard protocol. Pain scoring was assessed by
      two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation
      and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.

      The average pain score from two research nurses were used for statistical analysis.
    

Intervention name(s): breastfeeding; oral sucrose; Skin-to-Skin contact; Non-nutritive sucking
Intervention type(s): Behavioral; Dietary Supplement; Behavioral; Behavioral
Intervention description(s): Newborns were breastfed during the procedure; Newborns were given oral sucrose during the procedure; Newborns were placed in direct contact with their mothers during the procedure; newborns were given a pacifier to suck on during the procedure
Other intervention name(s): Pacifier
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonates; Non-pharmacological
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was run to determine the safety, tolerance, and efficacy of multiple doses of
      larazotide acetate in subjects with celiac disease following a gluten challenge.
    

Detailed description: 
      CLIN1001-004 was a randomized, double-blind, placebo controlled, dose-ranging, 7-arm,
      multicenter study with a gluten challenge. The objects were multiple dose safety and
      tolerance; efficacy (intestinal permeability [change in urinary LAMA ratio] and disease signs
      and symptoms) following gluten challenge.

      Following a 21-day screening period, subjects were randomized to one of seven treatments
      groups: four groups received larazotide acetate (0.25 mg, 1 mg, 4 mg or 8 mg TID) along with
      an 800 mg gluten challenge, one group received placebo with an 800 mg gluten challenge, a
      safety control arm received the highest dose of larazotide acetate (8 mg TID) and gluten
      placebo and the last group received drug placebo and gluten placebo. The gluten challenge was
      administered as capsules (800 mg TID) with each main meal for a total of 2.4 g daily. Drug or
      drug placebo was administered TID 15 minutes prior to each main meal. Subjects received their
      assigned treatments for two weeks (Day 0 through Day 14) and came to clinic for a follow-up
      visit one week later (Day 21). Subjects remained on their gluten-free diet for the duration
      of the study.
    

Intervention name(s): larazotide acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule; capsule
Other intervention name(s): AT-1001; INN-202
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo controlled, dose ranging, multicenter
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: larazotide acetate
Cryoballoon Ablation as First Line Treatment of Atrial Flutter
Condition: Atrial Flutter Typical
MeSH terms: Atrial Flutter
Study type: Interventional

Summary: 
      Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as
      treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that
      recurrences of flutter and incidence of post-ablation atrial fibrillation are common.

      In this study, the investigators assess the hypothesis that the use of cryoballoon Pulmonary
      Vein Isolation ('novel' treatment) to achieve the electrical disconnection between the
      pulmonary veins and the heart will lead to higher rates of freedom from abnormal heart
      rhythms (atrial flutter, atrial fibrillation, or atrial tachycardia) and more improved
      quality of life than treatment using heat energy (radiofrequency ablation) directed at the
      cavotricuspid isthmus ('conventional treatment').
    

Detailed description: 
      Atrial flutter and atrial fibrillation are believed to share the same initiating triggers in
      the form of pulmonary vein ectopy. Cavo-tricuspid isthmus-dependent atrial flutter almost
      always results from short bursts of antecedent atrial fibrillation. Radiofrequency (RF)
      ablation of the cavo-tricuspid isthmus (CTI) is the current accepted first-line treatment for
      atrial flutter, although post-ablation atrial fibrillation commonly occurs, even in the
      absence of pre-existing atrial fibrillation.

      Cryoballoon Pulmonary Vein Isolation (PVI) has become an established treatment for atrial
      fibrillation. In patients with both atrial flutter and fibrillation, PVI alone has been shown
      to control both types of atrial arrhythmia, with no benefit derived from supplemental RF CTI
      ablation.

      This study aims to demonstrate that standalone cryoballoon PVI for typical atrial flutter
      without RF CTI ablation will lead to a significant difference in preventing recurrence of
      atrial arrhythmia compared to radiofrequency ablation of the CTI, and should be offered as
      first-line therapy.
    

Intervention name(s): Radiofrequency ablation of CTI; Cryoballoon PVI
Intervention type(s): Procedure; Procedure
Intervention description(s): Delivery of radiofrequency energy to the cavotricuspid isthmus (region of right atrial tissue between the tricuspid annulus and the inferior vena cava) until bidirectional block is achieved; Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
Other intervention name(s): CTI ablation; Cryoablation Pulmonary Vein Isolation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised 1:1 into two groups to receive either of the two treatments.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radiofrequency ablation; Cavo-tricuspid isthmus; Pulmonary Vein Isolation; Cryoballoon ablation
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
Condition: Pharmacokinetics; Bioavailability; HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg
      dose of TMC278 is absorbed into the body when administered as a solution, suspension,
      granules, or a tablet. In addition, the effect of each formulation of TMC278 will be
      evaluated in patients in the fasted and fed states and the palatability (how the drug tastes)
      of each formulation will be assessed. Finally, the safety and tolerability of each
      formulation of TMC278 will be assessed throughout the study.
    

Detailed description: 
      This is an open-label (both investigator and volunteer knows the name of the assigned study
      medication), randomized (study medication will be assigned by chance) cross-over study in
      healthy adults to compare the rate and the extent of absorption of TMC278 when administered
      as a single 25 mg dose of the 3 concept pediatric formulations (solution [10 mg/mL],
      suspension [5 mg/mL], granules [2.5 mg/g]), under fed and fasted conditions, to that when
      administered as the 25 mg TMC278 Phase III tablet formulation, under fed conditions, in
      healthy adults and to assess the effect of food on the bioavailability of TMC278 after a
      single 25 mg dose of the concept pediatric TMC278 formulations in healthy adults. The
      palatability of the 3 concept formulations will be assessed in a fasted state by use of a
      questionnaire and a visual analog scale. The short-term safety and tolerability of TMC278
      following administration of 3 single oral doses of 25 mg, formulated as one of the concept
      pediatric formulations (under fed and fasted conditions) and as the Phase III tablet (under
      fed conditions), in healthy adults will be evaluated. TMC278 25 mg formulated as a solution,
      suspension, granules, or tablet will be administered orally (by mouth). Each volunteer will
      receive on the first day of one treatment session one TMC278 25 mg tablet. On the first day
      of the other sessions they receive a single dose of TMC278 25 mg formulated as a the
      solution, a suspension or granules.
    

Intervention name(s): TMC278
Intervention type(s): Drug
Intervention MeSH terms: Rilpivirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC278; TMC278-C145; TMC278-TiDP38-C145; concept pediatric formulations of TMC278; HIV Infections
Reduction of Cancer Related Fatigue in Patients During TKI Therapy
Condition: All Tumor Entities Treated With TKI Therapy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine the effects of a 12-week resistance training
      program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor
      (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can
      be reduced by exercise training in this population which leads to an improved treatment
      completion rate.
    


Intervention name(s): Progressive strength training
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of supervised progressive strength training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; exercise; training; fatigue; cancer; TKI; tyrosine kinase inhibitor
Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks
Condition: Infant, Premature; Ductus Arteriosus, Patent; Natriuretic Peptide Brain
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      The aim of the study was to evaluate BNP in preterm infants < 28 weeks on the second day of
      life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or
      not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the
      need of PDA intervention in the further course.
    

Detailed description: 
      From the study infants blood samples (0.1ml) were collected in K-EDTA microtubes within 24 to
      48 hours of age through umbilical artery catheter aspiration or routine venous puncture. The
      samples were spun at 7000 rpm for 3 minutes. Platelet-free plasma was stored at -20°C until
      BNP analysis of all collected samples was carried out. The BNP assay was performed using a
      fully automated immunoassay system ADVIA method for the Centaur System (Bayer Diagnostic
      Division).

      In preterm infants who were treated with indomethacin or surgical ligation we collected
      additional blood samples 2-4 hours before intervention and 24 hours after the completion of
      the ductus treatment.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: preterm infants < 28 weeks; B-type natriuretic peptide; prediction; ductus intervention