bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Muscle Afferent Feedback During Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Recently, direct evidences point to the contributing role of peripheral muscle fatigue in
      exercise tolerance among patients with COPD. However, the physiological mechanisms by which
      peripheral muscle fatigue impairs exercise tolerance are still unknown, as factors regulating
      peripheral muscle fatigue in COPD may be complex. One possible link between limb muscle
      fatigue and exercise intolerance could be enhanced afferent signals from the active limb
      muscles to the central command, thereby limiting central motor output and eventually leading
      to exercise termination.

      A direct method to investigate the regulation of peripheral muscle fatigue during exercise in
      patients with COPD is the blockade of peripheral neural afferents via lumbar anesthesia.
      Consequently, investigating the interplay between the peripheral muscular component and the
      central motor command during self-paced exercise could shed light on the regulation of
      peripheral muscle fatigue in COPD and its implication in exercise intolerance.
    

Detailed description: 
      The aim of the study is to characterize the role of peripheral muscle afferents on the
      development of muscle fatigue, cardiorespiratory response and exercise tolerance to
      constant-workrate endurance cycling exercise in patients with COPD.

      In a double-blind randomized design, patients with GOLD stage II-III COPD will be recruited
      and will complete a constant-workrate cycling test following either the injection of a
      placebo [NaCl, interspinous L2-L3] or an opioid [Fentanyl 25 µg, intrathecal L2-L3]
      inhibiting central feedback of peripheral muscles sensory afferents. Quadriceps force (TwQ)
      will be measured by magnetic stimulation of the femoral nerve and central chemoreceptors
      response will be assessed by CO2 rebreathing, both performed before and after the injection.
      Finally, TwQ will also be measured after the endurance cycling test to assess the magnitude
      of quadriceps fatigue induced by symptom-limited exercise.
    

Intervention name(s): Fentanyl; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours; placebo [NaCl]
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Chronic pulmonary obstructive disease; Muscle dysfunction; Exercise intolerance; Muscle afferents; Ventilation
Lidocaine for Pain After Urodynamic Testing
Condition: Voiding Disorders; Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      Urodynamic testing can be associated with mild discomfort, particularly at the time of
      insertion, repositioning, and removal of the bladder catheter (a tube inserted into the
      bladder via the urethra). Few studies have investigated ways to improve patient comfort
      during this procedure. In this study, the investigators want to see if applying external
      lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.
    

Detailed description: 
      Urodynamic testing can be associated with mild discomfort, particularly at the time of
      insertion, repositioning, and removal of the bladder catheter (a tube inserted into the
      bladder via the urethra). Few studies have investigated ways to improve patient comfort
      during this procedure. In this study, the investigators want to see if applying lidocaine (a
      numbing gel) prior to the procedure can help to minimize patient discomfort.

      Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2
      phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours
      after testing). Additionally, the investigators will record any adverse effects (such as an
      allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after
      testing.

      Participants will be randomly assigned to receive either lidocaine gel or placebo gel for
      their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it
      contains no active drug. The assigned study regimen will be chosen by chance, like flipping a
      coin. Participants will have an equal (50/50) chance of being given either study regimen.
      Neither the participant nor the study doctor or nurse practitioner will know which study
      regimen the participant is getting. Additionally, a member of the study team will ask
      participants about their pain level before and after the testing. The rest of the urodynamic
      testing procedure will take place exactly as it would if the participant was not in this
      research study.
    

Intervention name(s): Lidocaine gel 2%; Standard lubricant gel
Intervention type(s): Drug; Other
Intervention description(s): If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.; If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Ovarian Reserve in Female Cancer Survivors
Condition: Breast Cancer Survivor; Pediatric Cancer Survivor
Study type: Observational

Summary: 
      Chemotherapy can damage the ovaries and cause premature menopause. In women treated before
      the age of 40 years, menopause does not usually occur. We have very little information about
      the impact of chemotherapy on ovarian function in this particular group of women. In this
      study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the
      reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and
      childhood cancer. We will do the same tests in our comparison group. We can use these results
      to estimate the reduction in fertility in young cancer survivors.
    

Detailed description: 
      As women across North America and Europe increasingly delay childbirth, fertility
      preservation is emerging as an important issue among young breast cancer patients. The
      dramatic increase in survival for the major pediatric cancers in the last 50 years has
      resulted in an expanding population of childhood cancer survivors. The information currently
      available to counsel these patients about the impact of treatment on their fertility is
      inadequate. A significant degree of subfertility can exist prior to the onset of frank
      ovarian failure, and current studies do not address this.

      This study will adopt new technologies that have revolutionized the evaluation of female
      fertility to assess ovarian function in young breast cancer survivors. The results will
      provide new, more accurate and clinically useful information to patients and physicians about
      the impact of cancer therapy on fertility. The results have the potential to influence
      clinical decisions regarding cancer treatment, and the use of assisted reproductive
      technologies for contemporary patients and survivors. Further, insofar as treatment advances
      are designed to improve disease control while reducing toxicity, these results may serve as
      the basis for better understanding the toxicity of modern therapy and provide opportunities
      for improvement.
    

Intervention name(s): Blood Draw and Ultrasound
Intervention type(s): Procedure
Intervention description(s): Patients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are selected from their primary care clinic.
Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
Condition: Depression - Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of
      DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

      To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after
      administration of 50 mg SR formulation of DVS.
    


Intervention name(s): desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two tablets of 25 mg, single administration, under fed condition; One tablet of 50 mg, single administration, under fed condition; Two tablets of 25 mg, single administration, under fast condition; One tablet of 50 mg, single administration, under fast condition
Other intervention name(s): DVS-233 SR, Pristiq; DVS-233 SR, Pristiq; DVS-233 SR, Pristiq; DVS-233 SR, Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DVS SR; healthy; Bioequivalence study
Measuring the Glycemic Index of Pulse Based Breads
Condition: Carbohydrate Intolerance
Study type: Interventional

Summary: 
      The objective of this study is to determine the glycemic index of 4 pulse-based breads in at
      least 10 normal healthy human volunteers. Participants will be studied in the morning on 6
      separate days after overnight fasts. On the first and last days they will consume a test meal
      consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they
      will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch
      obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over
      2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area
      under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after
      white bread.
    


Intervention name(s): Bread
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
Condition: Tetanus; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus
      acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4
      and 5 months of age.
    


Intervention name(s): diphtheria, tetanus, pertussis & Hib vaccine
Intervention type(s): Biological
Other intervention name(s): diphtheria; tetanus; pertussis & Hib vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the present study is to compare plasma volume determination by 99mTc-labeled
      albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that
      plasma volume determined by the different methods are the same.
    

Detailed description: 
      For many years, radioiodinated albumin has been "the golden standard" for measurement of
      plasma volume. There are a number of clinical situations in which a nuclide with a shorter
      half-life would be preferred. Furthermore, due to periodic lapses in the availability in the
      delivery of 125I-labeled albumin, there is a need to evaluate another nuclide as a tracer for
      plasma volume determination.

      99mTc-labeled albumin is easily prepared by a simple and reproducible method with a high
      labeling efficiency and short half-life.

      In this study, we want to compare plasma volume determined by 99mTc-labeled albumin with
      plasma volume determined by 125I-albumin (golden standard). In both procedures, plasma volume
      is estimated from multiple postinjection samples for accurate zero-time extrapolation in
      order to correct for leakage of labeled albumin from the vascular compartment.
    

Intervention name(s): Plasma volume determination (99mTc-albumin); Plasma volume determination (125I-albumin)
Intervention type(s): Radiation; Radiation
Intervention description(s): The test is performed using 5MBq technetium-labeled albumin (99mTc-albumin-Vasculosis) with several postinjection samples for accurate zero-time extrapolation.; The test is performed using 0.2MBq 125iodine-labeled albumin (125I-albumin) with several postinjection samples for accurate zero-time extrapolation.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: plasma volume; technetium-labeled albumin; radioiodine-labeled albumin; Healthy volunteers
Integrated Neuromuscular Inhibition, Muscle Energy and Strain Counter Strain Techniques in Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain; Sprains and Strains
Study type: Interventional

Summary: 
      1. To determine effects of Neuromuscular Inhibition, Muscle energy and strain counter
           strain techniques on Pain, disability, pain pressure threshold, range of motion, and
           health-related quality of life in mechanical neck pain.

        2. To compare the effects of Integrated Neuromuscular inhibition, Muscle energy and strain
           counter strain techniques in the Management of mechanical neck pain.
    


Intervention name(s): Strain Counter Strain Technique; Muscle Energy Technique,; Integrated Neuromuscular Inhibition Technique
Intervention type(s): Other; Other; Other
Intervention description(s): When general or local pain began to diminish, upper trapezius , levator scapulae and SCM was placed in a position of ease and was held for approximately 20 to 30 seconds.
2. Moderate digital pressure was applied to the identified MTrP as participants rated their level of pain on a scale ranging from 1 to 10.
3. Ease was defined as the point at which a reduction in pain of at least 70% was achieved.
4. Once the position of ease was identified, it was held for 20 to 30 seconds.; After the ease position was maintained for 20 to 30sec an isometric contraction focused on the muscle fibers around the MTrP was performed.
2. Each isometric contraction was held for 7 to 10 sec and was followed by a soft-tissue stretch for 15 seconds and then relax for 30 seconds. Each stretch was held for 30 seconds, and it was repeated 3 times during the treatment session.
3. Treatment was performed on the 3 most painful areas between the upper border of the upper trapezius muscle, the SCM, the levator scapulae, and the SC muscle.; Group c will receive Combination of exercise (strain counter strain , muscle energy & ischemic compression. In ischemic compression patient will receive compression,
After MTrPs identification,
Ischemic compression was applied in an intermittent manner for up to 2 minutes for each MTrP.
The pincer grasp (for the trapezius muscle and SCM) or direct digital pressure (for the levator scapulae and SC muscle) was used with the patients in either the supine position or sitting upright
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mechanical Neck Pain; Chronic Neck Pain; Muscle Energy Technique; Strain counter Strain; INIT
Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Observational

Summary: 
      Numerous human cardiac stem cell studies have been published, including relatively small
      number of patients. Meta-analysis of randomized trials have reported safety and a 3-6%
      increase in global left ventricular performance after intracoronary stem cell therapy in
      patients with acute myocardial infarction. Since most of the studies used different type of
      stem cells, delivery modes, and patient population, the results are heterogenous, therefore
      the comparison of the results is biased regarding generalizable conclusions about the effect
      of treatment. The present comparative meta-analysis is based on individual patient data, and
      gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the
      cardiac stem cell therapy.
    

Detailed description: 
      -  Background: Many clinical trials and meta-analyses presented moderate but significant
           improvement of the left ventricular ejection fraction (LVEF) after intracoronary
           autologous bone-marrow (BM) or peripheral blood origin stem cells transfer. However, it
           remains controversial, whether this beneficial effects is comparable with the
           intramyocardial delivery of the stem cells, or could be maintained during moderate and
           long term follow-up. The BOOST trial suggested that cardiac stem cell therapy did not
           improve LVEF at 5-year follow-up. By contrast, BALANCE study showed a long sustained
           benefit of BM-stem cells treatment. Due to these divergent outcomes of the presented
           trials, the aim of the present meta-analysis is to compare the safety and effectiveness
           of the cardiac stem cell therapy in different patient population, delivery mode and cell
           type, to find out, which patients with which therapy mode can have the greatest benefit
           from cardiac stem cell therapy.

        -  Study design: individual patient data meta-analysis

        -  Data sources: European Centre performing human cardiac stem cell therapy have been
           contacted calling for participation.

        -  Methods: Individual data gathering and entering into the database for a pooled analysis.
           The meta-analysis will be done in line with recommendation from the Cochrane
           Collaboration and the Quality of Reporting of Meta-analyses guidelines with Review
           Manager 5.0. Fixed-effect model will be used.
    

Intervention name(s): cell therapy
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with cell-based cardiac therapy at one of the participating centers
      
Keywords: meta-analysis; stem cell; cardiac; remodeling; ACCRUE
Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults
Condition: QT Intervals Changes; QTc Intervals Changes
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effect of a single therapeutic (50 mg)
      oral dose of omecamtiv mecarbil (OM) on the QT interval / QT interval corrected for heart
      rate (QTc), relative to placebo, in healthy adults.

      The QT interval is the section on an electrocardiogram (ECG) that represents the time it
      takes for the electrical system to fire an impulse through the ventricles and then recharge,
      or the time it takes for the heart muscle to contract and then recover.
    

Detailed description: 
      The study consists of 2 parts: Part A and Part B. Participants are enrolled in Part A to
      determine eligibility for Part B.

      In Part A participants receive a single oral dose of 25 mg omecamtiv mecarbil; participants
      with a resulting maximum observed OM plasma concentration (Cmax) ≤ 350 ng/mL are eligible to
      enter Part B.

      Part B is a 3-period cross-over study in which participants are randomized to receive 3
      treatments in 1 of 6 sequences, each separated by a washout of at least 7 days.

      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
    

Intervention name(s): Omecamtiv Mecarbil (OM); Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral solution; Placebo oral solution; 400 mg moxifloxacin oral tablet
Other intervention name(s): AMG 423
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thorough QT; QTc study
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
Condition: Cancer, Pancreas
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality
      of life have seriously deteriorated. There have been a few studies that showed an effect for
      pain control by hyperthermia (heating the patient's body). However, there are several
      limitations in conventional hyperthermia. In this study, the investigators tried to show the
      effect of "Oncothermia" which is more selective to malignant tissue than conventional
      hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.
    


Intervention name(s): Oncothermia
Intervention type(s): Other
Intervention description(s): Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Quality of life; Pain