bioihbjkbjnl/mcl2 huggingface dataset:
High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
Condition: COPD
Study type: Interventional

Summary: 
      Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with
      chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of
      patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and
      tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs.
      10x1min in patients with moderate to severe COPD.
    

Detailed description: 
      12 patients with severe to moderate COPD will be included in the study, where two different
      HIIT interventions will be compared with regards to fidelity and tolerability. Baseline
      measurements will be performed to assess fitness and cardiopulmonary health status for the
      included patients. The baseline measurements include a medical health interview and
      examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test,
      lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity),
      and an assessment of body composition. The following two visits consist of two different HIIT
      protocols.

      Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as
      time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at
      least a 3-day wash-out period.
    

Intervention name(s): High intensity interval training
Intervention type(s): Other
Intervention description(s): Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIIT; COPD
Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study will be to evaluate the the effect of Thera Togs soft orthotic
      undergarment on modulation of the spinal geometry and mobility in sagittal plan in children
      with spastic diplegic cerebral palsy.
    

Detailed description: 
      Forty children with spastic diplegic CP will be assigned and randomly distributed into two
      equall groups (A& B). Control group (A) will receive conventional rehabilitation program for
      postural correction 2 hours/3 sessions' weekly/3 successive months. Study group (B) will
      receive conventional rehabilitation protocol as in group (A) plus wearing TheraTogs soft
      orthotic undergarment. Children evaluation will be carried out before and after the
      intervention programs to assess postural deviations using the Formetric system.
    

Intervention name(s): TheraTogs Orthotic Undergarment
Intervention type(s): Other
Intervention description(s): Strapping undergarment made from a lightweight, breathable fabric that is velcro sensitive. It consists of sleeveless vest (tank-Top), two shorts (Hipster) each with two thigh cuffs and limb cuffs
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Condition: Skin Manifestations; Skin Wrinkling
MeSH terms: Skin Manifestations
Study type: Interventional

Summary: 
      Comparison of a randomized, double-blind, and control-group study for the effect of oral
      ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat
      reduction in participants
    

Detailed description: 
      The aim is to investigate the effect of oral ingestion of collagen tripeptides derived from
      fish on dermal moistures and wrinkles body fat reduction in participants by a randomized,
      double-blind, and control-group study.
    

Intervention name(s): CTP; placebo (starch)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1,000 mg of CTP was orally administered per day for 12 weeks.; placebo (starch)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Hemodynamics for Equi-MAC Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      The aim of this study is to compare the peripheral perfusion index values produced by
      equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation
      anesthesia.
    

Detailed description: 
      Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on
      vascular tissue and both are vasodilators. However, there has been no direct comparison of
      vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral
      perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor
      tone. Therefore, the purpose of this study is to compare the peripheral perfusion index
      values produced by sevoflurane and desflurane at equipotent concentration in patients
      undergoing single-agent inhalation anesthesia.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): End-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.; End-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
Other intervention name(s): Sevorane; Suprane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the decline of virus in the blood and liver in
      patients treated with telaprevir, pegylated interferon and ribavirin.

      Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance
      the understanding of how the virus decays in the liver in response to treatment with
      anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA
      is an alternative procedure to core needle biopsy in its ability to repeatedly sample the
      liver with significantly reduced morbidity.
    


Intervention name(s): Telaprevir; Peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).; Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).; Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg).
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; FNA; intrahepatic
A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and
      long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R
      injury and maintaining renal function during renal transplant surgery is therefore very
      important in order to improve post-operative outcome. This purpose of this study is to
      investigate whether propofol anesthesia done in both kidney donors and recipients during
      deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury
      via its antioxidant and antiinflammatory properties and improve post-transplant outcome
      compared to desflurane anesthesia.
    


Intervention name(s): Desflurane balanced anesthesia; Propofol total intravenous anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation; Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion
Intervention MeSH terms: Anesthetics; Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Propofol, renal protection, kidney transplantation
Comparing the Effects of Different Types of Exercise on Glucose Handling
Condition: Glycemic Control; Insulin Sensitivity; Sex Differences
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of the proposed study is to compare the acute effects of different types of
      exercise modalities on glucose handling in young, healthy males and females. The exercise
      modalities that will be compared include: a high intensity interval exercise (HIIE) protocol,
      a moderate intensity continuous exercise (MICE) protocol and a low-load, high-repetition
      (LL-HR) resistance exercise protocol.
    

Detailed description: 
      The purpose of this study is to compare the effects of different exercise modalities (High
      intensity interval exercise, Moderate intensity continuous exercise, and Low-load-high
      repetition resistance exercise) on blood sugar control in young healthy, males and females.
      To test this theory, a sugar challenge (oral glucose tolerance test - OGTT) will be performed
      during the pre-testing visit to determine the baseline blood sugar response. An OGTT will
      also be performed 2 hours after each single exercise session to determine how each type of
      exercise affects the blood sugar response. Investigators will take multiple blood samples
      throughout the trial to allow us to measure blood sugar, insulin and concentrations and
      oxidative stress. Muscle biopsies will be taken before and after each exercise bout so that
      investigators can examine the underlying mechanisms that contribute to the effectiveness of
      the different types of exercise on blood sugar control. Investigators will also use an
      ultrasound to measure factors related to of cardiovascular health such as artery stress and
      vascular conductance during the exercise bouts. Direct benefits of this study include
      characterizing sex differences of blood sugar handling after single exercise sessions. This
      study could have direct benefits on deterring the effectiveness of different forms of
      exercise on blood sugar levels.
    

Intervention name(s): Control Oral Glucose Tolerance Test; Mixed Exercise
Intervention type(s): Other; Other
Intervention description(s): control oral glucose tolerance test; exercise performed in randomized order
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia
      and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these
      children represent a relatively small and unique patient population, they account for the
      largest proportion of deaths of all pediatric diseases. The long-term goal of this project is
      to improve outcomes among these patients. Recently, the intratracheal administration of
      calfactant has resulted in decreased mortality among children with ALI including promising
      results among children with cancer and following HSCT. Consequently, the primary specific aim
      of this study is to assess the effect of calfactant on intensive care (PICU) survival among
      pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment
      of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU
      stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung
      injury in the overall pediatric population by improving oxygenation and decreasing mortality.
      These findings, in conjunction with recent subgroup analysis in which calfactant therapy
      appeared to improve outcomes in immunocompromised children provide the rationale for
      assessing calfactant therapy in this patient population.

      Funding Source - FDA Office of Orphan Products Development (OOPD)
    


Intervention name(s): Calfactant; Air placebo
Intervention type(s): Drug; Other
Intervention description(s): Endotracheal calfactant, up to 3 doses if subject qualifies; Endotracheal air administration
Intervention MeSH terms: Calfactant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Lung Injury; Cancer; Pediatrics
A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to evaluate the residual effects of TS-142 on driving performance in healthy
      and elderly subjects.
    


Intervention name(s): TS-142; Zopiclone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TS-142; Zopiclone; Placebo
Intervention MeSH terms: Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment
      of subjects with diabetic foot ulcers (DFUs).
    

Detailed description: 
      This is a phase II, randomized, controlled, two-center pilot study designed to assess the
      safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry
      criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either
      MEBO or SOC.
    

Intervention name(s): MEBO Wound Ointment; Standard of Care (sterile saline moistened gauze)
Intervention type(s): Drug; Procedure
Intervention description(s): Topical application twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcers (DFUs)
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)
Condition: Anemia; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected
      subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to
      assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained
      with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.
    

Detailed description: 
      This was a Phase IV, open-label, non-randomized, multi-center study conducted in community
      based practices, physicians networks, or academic institutions in the US. This study included
      anemic (Hb < 12 g/dL) HIV-infected subjects and HIV/hepatitis C (HCV) co-infected subjects
      not receiving HCV treatment on a stable anti-retroviral therapy (ART) regimen for at least 4
      weeks prior to enrollment.

      Quality of life assessments, laboratory results, and transfusion information were obtained
      during the study. Laboratory tests, vital signs (blood pressure), and incidence and severity
      of adverse events were collected and assessed.

      The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa)
      dosing can maintain quality of life in anemic HIV-infected patients. The primary hypothesis
      of interest was that the mean quality of life score (as measured by MOS-HIV General Health
      Perception score) at the end of the every other week (Q2W) maintenance phase was not lower
      than that at the beginning of the maintenance phase by more than 7 points.

      It was anticipated that less frequent dosing, every other week, was more convenient for
      patients and will improve patient compliance. The starting dose (Baseline/Study Day 1) of
      PROCRIT (Epoetin alfa) for all eligible subjects was 40,000 U given subcutaneously QW. The
      maximum duration was 24 weeks. Subjects who achieved target Hb levels >= 13 g/dL were
      converted to a maintenance dose of PROCRIT (Epoetin alfa) sc Q2W.
    

Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia; erythropoetin; Epoetin alfa; erythropoetin recombinant; HIV, AIDS
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia
    


Intervention name(s): Z-338
Intervention type(s): Drug
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
Condition: Anemia; Hemodialysis; Renal Impairment
MeSH terms: Renal Insufficiency; Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal
      anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these
      patients.
    


Intervention name(s): roxadustat
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): ASP1517
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: FG-4592; ASP1517; Safety and tolerability; Plasma concentration; Pharmacokinetics
IV Cocaine Abuse: A Laboratory Model - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine
      taking and on the physiological and subjective effects of cocaine, including cocaine craving.
    


Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Primary purpose: Treatment
Keywords: intravenous abuse
Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this study is the multimodal exploration via eyetracking, MRI and EEG data of
      ocular movements and the corresponding brain activation during ecologic visual stimulation in
      the healthy population.
    

Detailed description: 
      Cerebral activation following visual stimulation is explored using two neuroimaging
      techniques EEG and MRI while eye movements are recorded. Three experiments are performed: in
      MR scanner 1) functional localisation of specific areas: LOC, FFA, MT/V5, V1 and V2 and 2) a
      saccadic choice experiment; with EEG, replication of the experiments performed in the MR
      scanner and 3) an additional experiment of movement detection during the ocular saccades.

      Thirty young volunteers (18-40 y old) are involved.
    

Intervention name(s): Neuroimaging
Intervention type(s): Other
Intervention description(s): MR, EEG recordings
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Children's WEAR Trial(Phase 1&2)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Phase I: Focus groups on different designs of adjustable glasses and standard glasses
      (August-September 2012) Phase II: Two-month randomized trial comparing four groups:
      (September 2012 - August 2013)
    

Detailed description: 
      Phase I: Focus groups on different designs of adjustable glasses and standard glasses
      (August-September 2012) Phase II: Two-month randomized trial comparing four groups:
      self-refraction with adjustable glasses, receiving custom standard glasses; subjective
      refraction by an expert refractionist after cycloplegic automated refraction and receiving
      custom standard glasses; subjective refraction by a rural refractionist after cycloplegic
      automated refraction, receiving custom standard glasses; and subjective refraction by an
      expert refractionist after cycloplegic automated refraction receiving ready made glasses
      (September 2012 - August 2013)
    

Intervention name(s): group1; group2; group3; group4
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Non-cycloplegic self-refraction +conventional glasses; Cycloplegic subjective refraction by experienced optometrist +conventional glasses; Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses; Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Myopia; Focus groups; refraction; Glasses; spectacles