bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Dry Needling of the Gluteus Medius Muscle in Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The effectiveness of dry needling of the Gluteus Medius muscle in combination with active
      exercises will be examined compared with sham needling with active exercises in low back pain
      (LBP) patients.
    

Detailed description: 
      Objectives: To examine if dry needling in combination with active physiotherapy is more
      effective in reducing pain and increase activity of daily living, range of motion and muscle
      strength in patients with chronic low back pain compared to sham dry needling in combination
      with active physiotherapy.

      Methods: the study will include individuals with non-specific LBP over 3 months.

      Subjects will be divided randomly into two research groups, both will receive physiotherapy
      including mobility, strengthening and stretching exercises. Intervention group, additionally
      to exercises, will receive dry needling to the Gluteus Medius muscle by inserting a needle to
      a trigger point until a visible involuntary twitch in the muscle appears. Sham needling will
      be applied by needling with pre-cut and smoothed needles that will not penetrate the skin.

      Both groups will receive two treatments per week and up to six treatments overall, evaluation
      will be performed before and after the series of treatments.
    

Intervention name(s): dry needling; sham dry needling
Intervention type(s): Other; Other
Intervention description(s): dry needling for Gluteus Medius muscle in combination with exercises; sham dry needling for Gluteus Medius muscle in combination with exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups. research group will receive dry needling and control group will receive sham dry needling.
Masking: Single (Participant)
Primary purpose: Treatment
Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the relative bioavailability and therefore the bioequivalence of two
      different formulations of donepezil after a single oral dose administration under fed
      conditions.
    

Detailed description: 
      Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover
      study under fed conditions.
    

Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): Donepezil Hydrochloride tablets,23 mg
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single center, randomized, placebo-controlled study with a sequential i.v. dose
      escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM
      (nangibotide) in healthy volunteers
    


Intervention name(s): nangibotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Continous i.v. infusion; Placebo
Other intervention name(s): LR12; MOTREM
Intervention MeSH terms: Nangibotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory
      defects that occur due to asthma, determine the sensitivity and specificity of MRI in
      response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due
      to asthma therapy.
    


Intervention name(s): Montelukast; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as a single daily 10 mg dose for 2 weeks; Administered orally as a single daily 20 mg dose for 2 weeks
Other intervention name(s): Singulair
Intervention MeSH terms: Prednisone; Montelukast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Self-paced High-intensity Interval Training and Moderate Intensity Continuous Training in Young Adults
Condition: Psychophysiologic Reaction
Study type: Interventional

Summary: 
      Study will be randomized clinical trial. Data will be collected from non probability
      convenient sampling technique. Total 26 participants from Pakistan Sports Board will be
      selected and randomly allocated in two different groups i.e. Group A and Group B. Group A
      will be given high intensity interval training and Group B will be on moderate intensity
      continuous training. Statistical package for the social sciences will be used to analyze the
      results by using parametric test after confirming normality of data.
    

Detailed description: 
      Recreational activities are those in which you genuinely engage with others to have fun and
      relax in your leisure time. This includes activities that require physical activity as well
      as connections and play with others. They are not activities that you can finish totally on
      your alone; while you can try to do some with your own, you will miss out on the enjoyment of
      doing that with others

      High-intensity interval training is a training that cycles between high bursts of activity
      and predetermined times of less intensive exercise or rest period. The therapy lasted 6
      weeks, and HIIT comprised of two 12-24 × 30 second high-intensity runs separated by thirty
      seconds of relaxation.

      Moderate-intensity continuous training consists of periods followed by 50 minutes of
      exercise- bicycling, running, jogging, marching, paddling, etc. - at a recorded frequency of
      70-75 percent maximal heart rate. The MICT ran continuously for 24-48 minutes. From the day
      of the six weeks intervention strategies, the mentioned assays were conducted: Yo-Yo
      Intermittent Recovery Test level 1, repeated sprint ability , sprint test, alter of way test
      which is t drill, and physical activity enjoyment scale and shuttle run. Through these
      trainings, individuals in both groups must follow the old their balanced meal.
    

Intervention name(s): High intensity interval training; Moderate intensity continuous training
Intervention type(s): Other; Other
Intervention description(s): The therapy lasted 6 weeks, and HIIT comprised of two 12-24 × 30 second high-intensity runs separated by thirty seconds of relaxation.; The MICT ran continuously for 24-48 minutes. From the day of the six weeks intervention strategies, the mentioned assays were conducted: Yo-Yo Intermittent Recovery Test level 1, repeated sprint ability , sprint test, alter of way test which is t drill, and physical activity enjoyment scale and shuttle run. Through these trainings, individuals in both groups must follow the old their balanced meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: High intensity interval training; Moderate intensity continuous training
Establishing Standards for Normal Pancreatic EUS
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Observational

Summary: 
      There is tremendous variability in regard to provider perception of findings on EUS for
      chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to
      determine the validity of minimal standard criteria.
    

Detailed description: 
      Chronic pancreatitis is a very challenging disease to diagnose as their is no gold standard
      for diagnosis. Increasingly, endoscopic ultrasound (EUS) has been used as a means of
      diagnosing chronic pancreatitis. However, there are questions about whether intra-rater
      reliability and/or validity are high enough to warrant using EUS to make the diagnosis of
      chronic pancreatitis.

      The purpose of this observational study is to determine the degree of correlation between two
      expert endosonographers in evaluating minimal standard criteria (MST) in the same patient
      during the same EUS exam. Patients both with and without chronic pancreatitis will be
      included in the study to try and determine the validity and reliability of back-to-back EUS
      examinations.
    

Intervention name(s): Endoscopic Ultrasound
Intervention type(s): Procedure
Intervention description(s): Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include patients who are scheduled for an elective EUS for
        evaluation of their pancreas. Patients will be those with and without suspected chronic
        pancreatitis.
      
Keywords: chronic pancreatitis; endoscopic ultrasound
Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
Condition: Alcohol Dependence; Schizophrenia
MeSH terms: Alcoholism; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the safety and efficacy of acamprosate for patients with
      alcohol dependence and comorbid schizophrenia spectrum disorders.

        -  1: Relative to placebo, acamprosate will significantly increase cumulative days of
           abstinence in recently detoxified alcohol dependent schizophrenia patients measured by
           Timeline Follow-Back (TLFB) method.

        -  2: Acamprosate will have no significant effect on the psychotic symptoms in
           schizophrenia patients with alcohol dependence as measured by the Positive and Negative
           Syndrome Scale (PANSS).
    

Detailed description: 
      Alcohol use disorders (AUD) are common comorbid conditions in patients with schizophrenia,
      and they cause a negative impact on the expression and course of schizophrenia. Improvements
      have been reported after attaining abstinence from alcohol, suggesting that effective
      treatments for AUD lead to clinically meaningful results. Acamprosate is a recently approved
      treatment for alcoholism, and it may be advantageous over other treatments since is not
      metabolized in the liver, and it has been used safely with other psychotropic medications.
      Therefore, acamprosate would be a promising treatment in schizophrenia patients. However,
      there are only few reports in the current literature evaluating the efficacy of medications
      available for the treatment of alcoholism in patients with schizophrenia, and the efficacy
      and safety of acamprosate have never been studied in this vulnerable group of patients.

      Research Design:

      This is a 12-week, randomized, double blind, placebo controlled trial of acamprosate (666 mg
      tid) in addition to neuroleptics in 30 recently abstinent (>5 days) schizophrenia patients
      with comorbid alcohol dependence.

      Methods:

      The study will be conducted at the West Haven, CT VA with support from Forest Laboratories.
      Patients who are between 21 and 65, with a diagnosis of schizophrenia spectrum disorder, (on
      stable psychotropic treatment > 2 weeks) and with current alcohol dependence (>1 recent
      episode of heavy drinking) will be included. Patients will be willing to undergo
      detoxification or self discontinuation >2weeks prior to the randomization. Main outcome
      variables include the TLFB method to document the degree of daily alcohol consumption, and
      PANSS, to assess the psychotic symptoms.
    

Intervention name(s): Acamprosate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acamprosate 1998 mg tid; Placebo
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Treatment; Alcohol Dependence; Schizophrenia
iCanCope With Sickle Cell Pain
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The project will test a tailored web and smartphone-based application (iCanCope with SCD) to
      improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease.
      The program will include goal setting, peer-based social support, and pain self-management
      training. The investigators will determine initial program effectiveness through a pilot
      three-site randomized controlled trial in 160 youth randomized to treatment compared to
      attention control.
    

Detailed description: 
      Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom
      reduction, improved quality of life, and decreased healthcare use. However, most people with
      SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited
      availability of professionals, and high costs. First, the investigators plan to apply a
      user-centered design approach to develop and refine the iCanCope with SCD program. Second,
      program feasibility and initial program effectiveness will be determined through a pilot
      three-site randomized controlled trial. The investigators will determine study accrual and
      dropout rates as well as levels of patient acceptability and engagement. Preliminary
      effectiveness will be determined in youth receiving treatment compared to attention control
      on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and
      6-month follow-up. Third, moderators and mediators of treatment effect will be tested by
      examining whether differences in self-efficacy and patient activation predict changes in pain
      and functioning. These results will enable a future full-scale randomized controlled trial.
    

Intervention name(s): Pain self-management; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.; Education about sickle cell disease to increase disease knowledge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase I Trial of Emulsified Isoflurane
Condition: Adverse Effect of Intravenous Anesthetics
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial, our primary goal is to investigate the safety of intravenous infusion of
      emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified
      Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of
      acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop
      severe adverse event in any dose group or any volunteer develop fatal adverse event in any
      group.
    


Intervention name(s): Emulsified Isoflurane
Intervention type(s): Drug
Intervention MeSH terms: Isoflurane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I trial; Emulsified Isoflurane; Health volunteer
5-HT3 Antagonists (Antiemetics) and Cardiac Safety
Condition: Adverse Reaction to Other Drugs and Medicines
Study type: Observational

Summary: 
      5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea
      and vomiting. However, these medications also associated with potentially severe and
      life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data
      regarding the cardiac safety and inter-individual variability in cardiac effects of
      ondansetron when used in vulnerable populations such as children and pregnant women are very
      limited. The results of this study will enable better-informed therapeutic decision-making
      regarding the use of ondansetron in children and pregnant women, with the overall goal to
      improve the safety of these commonly used antiemetic medications. Furthermore, predictive
      pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify
      patients at risk of cardiac toxicity before the drug is administered.
    

Detailed description: 
      The specific objectives are to:

        1. Determine and compare the cardiac safety profile of ondansetron in children, when used
           for prevention and management of post-operative nausea and vomiting and chemotherapy
           induced nausea and vomiting. Identify clinical factors including pre-existing cardiac
           conditions or physiological conditions that predispose to ventricular arrhythmias,
           concomitant cardiotoxic chemotherapy or concomitant volatile anaesthetic agents and
           investigate their impact on cardiac adverse effects of ondansetron.

        2. Determine and compare the cardiac safety profile of ondansetron when used in pregnant
           women or women of a reproductive age for the treatment of hyperemesis gravidarum or
           post-operative nausea and vomiting. Identify clinical factors including pre-existing
           cardiac conditions or physiological conditions, which predispose to ventricular
           arrhythmias that may support implementation of risk mitigation actions.

        3. Identify genetic variants associated with 5-HT3 antagonist-induced prolongation of QT
           interval.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): All patients will be receiving treatment with ondansetron as part of standard care.
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children, women of a reproductive age, and pregnant women receiving ondansetron for
        treatment of post-operative or chemotherapy-induced nausea and vomiting or hyperemesis
        gravidarum.
      
Biospecimen description: 
      DNA samples will be retained for genomic analyses.
    
Keywords: QT prolongation; Genomic biomarkers
Early Luteal Progesterone Profile After hCG Triggering
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This pilot-study will help characterize the serum progesterone profiles in IVF patients and
      correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous
      gonadotropins.
    

Detailed description: 
      The early luteal progesterone profile in IVF differs significantly from the progesterone
      profile of the natural cycle, in which the peak is reached around the time of implantation.
      With this non-invasive trial investigators wish to further explore the early luteal phase
      profiles of progesterone and hCG in order to optimize current luteal phase support policies
      in IVF and hopefully increase ongoing pregnancy rates.

      Stimulation, monitoring, and oocyte pick-up will be performed according to the standard
      procedure of the clinic. On the day of trigger with 5.000 IU hCG a blood sample will be drawn
      prior to triggering for subsequent analysis. Moreover, all ovarian follicles on each side
      equal to or above 11 mm will be registered. Oocyte pick-up and timing of the trigger bolus
      will be performed according to the standard procedures of the unit.

      A total 10 blood samples will be drawn during this trial - please see "blood sampling". Blood
      samples will be collected on the following days for subsequent analysis of LH, E2, hCG and
      progesterone.

      All embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer
      cycles.

      Primary endpoint Serum concentrations of progesterone, LH, E2, and hCG during early luteal
      phase.

      Secondary endpoints The correlation between follicles ≥ 11 mm and progesterone in early
      luteal phase

      Data are analyzed using SPSS version 20 software. All tests are two tailed, and P<0.05 is
      considered statistically significant. Continuous variables are presented as mean +/- SD and
      are tested by student's t-test. Categorical data are expressed as numbers and compared using
      the Chi-square test.
    

Intervention name(s): blood collection
Intervention type(s): Other
Intervention description(s): Blood samples are collected on the following days after human chorionic gonadotropin (hCG) injection: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: in-vitro fertilization; luteal phase
Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Condition: Hypoleptinemia; Generalized Lipodystrophy; Partial Lipodystrophy; Insulin Resistance
MeSH terms: Lipodystrophy, Congenital Generalized; Lipodystrophy; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Lipodystrophies represent a therapeutic challenge with regards to insulin resistance,
      hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue
      loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects
      with lipodystrophy.
    

Detailed description: 
      The mechanism by which leptin improves glucose and lipid control is not clear. We will
      examine the possible mechanisms of leptin action by studying the effects of leptin
      administration on food intake, insulin resistance, insulin secretory response, hepatic and
      intramuscular triglyceride stores in a large sample of patients with lipodystrophy.

      Hypothesis: Leptin replacement in patients with generalized and partial lipodystrophy and
      hypoleptinemia will be safe and efficacious in improving the metabolic abnormalities
      associated with insulin resistance.
    

Intervention name(s): Leptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.; Sugar pill
Other intervention name(s): Recombinant-methionyl Human Leptin.; r-metHuLeptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lipodystrophy; Insulin secretory response