bioihbjkbjnl/mcl2 huggingface dataset:
Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
Condition: Amyotrophic Lateral Sclerosis (ALS); Neuromuscular Diseases
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neuromuscular Diseases; Hypoxia
Study type: Interventional

Summary: 
      This project seeks to investigate the effects of a single acute intermittent hypoxia (AIH)
      session on respiratory and non-respiratory motor function and EMG (electromyography) activity
      on patients with ALS (amyotrophic lateral sclerosis) and healthy controls.
    

Detailed description: 
      Most ALS patients survive less than 5 years after diagnosis, and the main cause of death is
      respiratory failure. The investigators are interested in the therapeutic potential of acute
      intermittent hypoxia (AIH) for individuals with neuromuscular diseases, such as ALS. More
      than two decades of research indicates AIH elicits meaningful respiratory and non-respiratory
      motor recovery. Acute intermittent hypoxia (AIH) consists of alternating periods of breathing
      mildly hypoxic (lowered oxygen concentration) and normoxic (normal oxygen concentration) air.

      The investigators propose to study mechanisms of respiratory plasticity associated with a
      single presentation of mild AIH. The fundamental hypothesis guiding this proposal is that
      even a single AIH trial improves respiratory (and non-respiratory) motor function in ALS
      patients procedure. Participants will then be asked to breathe air with reduced oxygen for
      short periods of time, for a duration of 45 minutes. The activity of your muscles and your
      heart function will be monitored throughout the procedure.
    

Intervention name(s): Acute Intermittent Hypoxia; Sham Acute Intermittent Hypoxia
Intervention type(s): Other; Other
Intervention description(s): AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.; Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
Other intervention name(s): AIH; Sham AIH
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete both the AIH and the sham AIH visits. The order of these visits will be randomized, but all subjects will complete both visits in the course of the study.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acute intermittent hypoxia (AIH); respiratory motor function; hypoxia; normoxia; EMG (electromyography)
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants
      who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin
      (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug
      therapy will be administered during the P02538 Part 2 study. Durability of virologic response
      will be assessed for participants who attained sustained virologic response (SVR) in Part I
      of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In
      addition, this study will characterize long-term safety in all participants who received
      PEG-IFN plus RBV treatment.
    

Detailed description: 
      During the Part 2 LTFU, participants will be evaluated at Years 1, 2, 3, 4, and 5. Each
      participant's first LTFU visit will be scheduled approximately 1 year after the
      post-treatment Follow-up Week 24 visit in Part 1 of this study (NCT00104052).
    

Intervention name(s): Peginterferon alfa-2b; Ribavirin
Intervention type(s): Biological; Drug
Intervention description(s): In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).; In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).
Other intervention name(s): PEG-Intron®; REBETOL®
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tele-yoga Program in COPD and Heart Failure
Condition: Yoga; COPD; Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The combined diagnosis of chronic obstructive pulmonary disease (COPD) and heart failure (HF)
      is common but often missed because of similarities in clinical presentation, risk factors,
      and patient characteristics. The concurrent presence of both diseases worsens the limitations
      in exercise capacity and quality of life that patients experience with either disease alone.
      This pilot study will test the feasibility of a yoga program conducted in patients' homes
      using multi-point interactive videoconferencing ("Tele- Yoga") for patients with combined
      COPD/HF diagnoses. The investigators hypothesize that patients who receive a yoga program at
      home, compared to an educational control group, will experience fewer physical symptoms and
      better quality of life.
    


Intervention name(s): Yoga Program at home using internet technology
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Yoga; COPD; Congestive Heart Failure
Effects of rTMS and tDCS on Motor Function in Stroke
Condition: Stroke; Motor Function
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In this study the investigators aim to investigate the effects of two different types of
      non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation
      (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This
      is a cross-over study where subjects will receive 5 sessions of stimulation (each separated
      by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham
      tDCS and rTMS.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device; Device
Intervention description(s): Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.; Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.
Other intervention name(s): magnetic stimulation; Magstim; 1x1 low-intensity direct current stimulator; Soterix Medical
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: direct current stimulation; magnetic stimulation; transcranial stimulation
Miller Straight Blade vs Macintosh Blade
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      The purpose of this prospective open labeled randomized study was to compare the
      "laryngoscopic glottis view" as well as "ease of intubation" between the two blades in
      routine intubations in non-difficult airways.
    

Detailed description: 
      One hundred and fifty patients with predicted non difficult airway were randomly assigned
      into two groups. After induction of anaesthesia laryngoscopy was performed with respective
      blades and trachea intubated. Parameters monitored were: glottis view obtained during
      laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration
      of laryngoscopy in seconds and encountered complications.
    

Intervention name(s): Miller group; Macintosh group
Intervention type(s): Other; Other
Intervention description(s): Miller blade was used for laryngoscopy; Macintosh blade was used for laryngoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Gait Retraining to Reduce Knee Osteoarthritis Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine how well people can be trained to produce new and
      different movements through the use of haptic feedback. One particular application is
      retraining individuals to walk differently in order to reduce knee joint loads to prevent or
      treat knee osteoarthritis as an alternative to surgical treatments.
    

Detailed description: 
      During the movement retraining session, you be given different combinations of haptic,
      visual, and auditory feedback in order to inform you on desired movement changes. This will
      take place at the Human Performance Laboratory at Stanford University. Motion analysis will
      be done while you perform movement activities (such as locomotion).

      Prior to performing these movement tasks the investigators will attach reflective markers to
      your body using tape, pre-wrap and/or ace bandages. The investigators will record motion of
      your body's movements using infrared cameras which capture anatomical data from the
      reflective markers on your body.

      The investigators will provide you with feedback to inform you of desired movement
      modifications. Haptic feedback devices such as vibration motors and skin stretch devices will
      be attached to your body via velcro straps and will be used to give "touch" feedback. There
      will be a computer monitor in front of you during testing to provide visual feedback. Sounds
      will be played using speakers near the testing area to provide auditory feedback.

      The time needed for set up and performance of the above set of tests is approximately 90
      minutes. You will be performing walking and other movements for only a small part of that
      time. The rest of the time will be spent preparing you for the experiment. After the
      investigators examine your movement data, if some of the data appear inaccurate or the
      investigators are unable to process the data, the investigators may ask you to repeat the
      movement analysis at a later time.
    

Intervention name(s): Gait retraining
Intervention type(s): Behavioral
Intervention description(s): Changing the kinematics of walking
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Induced Asthma and Airway Reactivity in Athletes
Condition: Respiratory Function Tests
MeSH terms: Asthma, Exercise-Induced
Study type: Observational

Summary: 
      The overall aim is to explore pathophysiological factors related to airway
      hyperresponsiveness to direct and indirect provocation stimuli in athletes with different
      sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid
      related inflammatory response. The investigators also wish to compare indirect testing done
      as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise
      challenge.
    

Detailed description: 
      By non-invasive tools the investigators wish to characterize type of airway reaction to
      various provocative stimuli in athletes doing two different sort activities, Tennis or
      swimming. As controls are being used sedentary age-matched controls from the same region,
      exposed to the same school environment. Thus we wish to:

        -  explore the prevalence of positive mannitol reactivity among swimmers and tennis player
           and how this relates to symptoms, disease history and to a sport specific exercise
           provocation test.

        -  compare the results from sport specific testing with a standardized eucapnic
           hyperventilation test (EHV)

        -  compare the overall reactivity to mannitol or EHV among swimmers and tennis players
           compared to aged matched controls.

        -  explore the role by CC16 in airway reactivity to different provocative stimuli and to
           see whether there is a difference between different sport activities, different test
           protocols and between athletes and controls.

        -  explore evidence of eicosanoid related inflammatory reaction in athletes and controls in
           relation to different provocative stimuli

      The study population consists of 100 elite swimmers, 100 elite tennis players and 100
      non-elite, eged matched controls. In the latter group, 30 are aged matched non-atopic
      non-asthmatic controls.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        100 elite swimmers 100 elite tennis players 100 aged matched non-atletic subjects, 30
        aged-matcked healthy non-atopic controls
      
Keywords: Exercise; Mannitol
A Study on the Safety of Hakim Programmable Shunt System
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Observational

Summary: 
      This study aimed to collect safety information from subjects implanted with a shunt system
      (trade name: Hakim Shunt Programmable System) produced by Codman & Shurtleff, Inc. of the
      United States. Device safety would be assessed based on all the adverse events that occurred
      within one year after the subjects implanted the catheter.
    


Intervention name(s): Hakim Shunt Programmable System
Intervention type(s): Device
Intervention description(s): patient accept Hakim Shunt Programmable System due to HCP
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with an implanted Hakim catheter due to Hydrocephalus (HCP)
Renal Retention of Microbubbles
Condition: - Study Focus: Renal Retention of Lipid Microbubbles
Study type: Observational

Summary: 
      Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study
      is to determine whether there is retention of ultrasound contrast agents in the renal
      microcirculation, which has been described in mice.
    

Detailed description: 
      In this study patients undergoing clinically indicated contrast echocardiography will have
      renal ultrasound performed 10 minutes after completion of contrast infusion to determine the
      presence and location of renal retention of lipid microbubbles.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing contrast echocardoigraphy
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
    


Intervention name(s): Pooled mesenchymal stem cell; Standard treatment according to the Clinical protocols
Intervention type(s): Biological; Other
Intervention description(s): Pooled allogenic mesenchymal stem cell derived from olfactory mucosa; Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; mesenchymal stem cells
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
Condition: Severe Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A study to assess the long term safety and tolerability of evolocumab (AMG 145) in
      adolescents and adults with severe familial hypercholesterolemia.
    

Detailed description: 
      This phase 2/3 open-label extension study was designed to characterize the safety and
      tolerability of long-term administration of evolocumab to adults and adolescents with severe
      FH (HoFH or non-HoFH severe FH). Participants not on lipid apheresis at enrollment or within
      the prior 8 weeks initiated treatment with evolocumab 420 mg once monthly (QM). Participants
      on lipid apheresis at enrollment initiated treatment with evolocumab 420 mg once every 2
      weeks (Q2W). Dose frequency changes (420 mg QM vs 420 mg Q2W) were permitted at week 12, 24,
      or other visits with Sponsor approval. Participants with < 5% LDL-C reduction from baseline
      and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) < 100 ng/mL could
      discontinue evolocumab. If serum unbound PCSK9 was ≥ 100 ng/mL with QM dosing, the
      participant could switch to evolocumab 420 mg Q2W treatment. Participants on apheresis with ≥
      5% LDL-C reduction from baseline and serum unbound PCSK9 < 100 ng/mL with Q2W treatment could
      switch to QM dosing.

      Participants were to continue to receive open-label evolocumab for up to 5 years or until
      evolocumab became commercially available in the relevant patient population, whichever
      occurred first.
    

Intervention name(s): Evolocumab
Intervention type(s): Biological
Intervention description(s): Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; Homozygous Familial Hypercholesterolemia; PCSK9 mutations; Severe Familial Hypercholesterolemia
A Pilot Study of Romidepsin in Relapsed or Refractory Extranodal NK/T-cell Lymphoma
Condition: Histologically Proven Extranodal NKTcell Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Extranodal NK/T-cell lymphoma is a rare disease entity with aggressive clinical course and
      poor prognosis. Currently, there is no treatment option for relapsed or refractory extranodal
      NK/T-cell lymphoma. Romidepsin is a histone deacetylase inhibitor which was approved for
      cutaneous T-cell lymphoma. A recent phase II study of romidepsin for relapsed/refractory
      peripheral T-cell lymphoma reported an overall response rate of 38% (95% confidence interval
      24%-53%). The median duration of overall response was 8.9 months. Considering the median
      number of previous treatments in these patients was three (range 1-11), romidepsin has single
      agent activity against relapsed/refractory T-cell lymphoma. Thus, if the single agent
      activity of romidepsin is demonstrated, it could be a therapeutic agent for combination with
      salvage treatment.
    


Intervention name(s): Romidepsin
Intervention type(s): Drug
Intervention description(s): Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity.
Dose and administration: 4-hour infusion of 14 mg/m2
Other intervention name(s): Istodax
Intervention MeSH terms: Romidepsin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extranodal NKTcell lymphoma
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
Condition: Liver Fibrosis; Cirrhosis
MeSH terms: Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to test the safety and effectiveness of Interferon
      gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced
      liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.

      IFN-g 1b is not currently approved for the treatment of liver fibrosis.
    

Detailed description: 
      This study will evaluate the safety and tolerability of IFN-g 1b in patients with advanced
      liver fibrosis and cirrhosis due to hepatitis C. This study will also evaluate whether IFN-g
      1b is effective in reducing the amount of fibrosis in the liver.
    

Intervention name(s): interferon gamma-1b
Intervention type(s): Drug
Intervention description(s): 100 or 200 mcg, SQ, 3x per week
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatitis C; liver fibrosis; liver cirrhosis
Training at Different Intensities in Coronary Artery Disease -Effects on Myocardial Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The study investigated if aerobic endurance exercise of different intensity has different
      impact on the physical capacity and myocardial function in patients with coronary artery
      disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial
      function were measured before and after this period. Patients were randomly assigned to each
      exercise group.
    

Detailed description: 
      Peak oxygen consumption was measured by gas-analysis. Myocardial function was measured by
      echocardiography. Exercise was performed on treadmills under close supervision of an exercise
      physiologist. Patients had to complete over 70% of sessions to be included in analysis. Three
      sessions were scheduled every week. Heart rate (HR) was about 85 % of max HR in the high
      intensity group, and about 65 % in the moderate intensity group.
    

Intervention name(s): Exercise training for 10 weeks
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary artery disease; Exercise training; Intensity; Randomized; echocardiography; Aerobic Exercise
Respiration Rate Monitoring During Transitions
Condition: Focus of the Study is Measuring Respiratory Rate
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the performance of the software that calculates
      respiration rate for the study pulse oximetry monitoring system during transitions of
      ventilation type from spontaneous breathing to controlled ventilation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteer subjects from a hospital population, who are scheduled to undergo surgery
        requiring general anesthesia