bioihbjkbjnl/mcl2 huggingface dataset:
Obesity-related Inflammation in Patients Prior to and After Bariatric Surgery
Condition: Obesity; Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid; Inflammation
Study type: Observational

Summary: 
      This study investigates the chronic long-term health condition of obesity and its effect on
      neutrophil function and the inflammatory response
    

Detailed description: 
      Inflammation is a central component of the immune response. In its acute form it aids the
      transition from disease to health via the activation of numerous immune cells, enabling them
      to reach the site of infection/injury and orchestrate themselves to combat pathogens,
      facilitating resolution and repair to restore the host to health. However, chronic
      inflammation is deleterious to the host and differs from the "classical" acute inflammatory
      process in that the inflammation is not necessarily so readily obvious and is not
      self-limiting; rather, the immune system is in a constant state of low-grade activation and
      when challenged by pathogenic or sterile injury the response is heightened, resulting in
      prolonged tissue damage and a failure of efficient resolution mechanisms.

      Neutrophils are important mediators of acquired innate immune responses but may also
      contribute to the pathogenesis of chronic inflammatory diseases. Neutrophils are heavily
      involved in antimicrobial defence; their primary role is the localisation and elimination of
      pathogenic microorganisms. This, combined with their relatively short lifespan, has resulted
      in a traditional view of them as limited "kamikaze" cells. However, as detailed here,
      neutrophils have been shown to act with complexity and sophistication, orchestrating the
      immune/inflammatory response but also inadvertently contributing to tissue damage in
      different disease states. This study investigates the chronic long-term health condition of
      obesity and its effect on neutrophil function and the inflammatory response
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Two study populations: Healthy control defined as systemically healthy and not taking
        medication or supplements with a BMI less than 27; Bariatric participants who fit the
        inclusion and exclusion criteria, but may also present with co-morbidities associated with
        obesity.
      
Keywords: gastric bypass; Obesity; Morbid obesity; Matched Healthy Controls
Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ascending single oral doses of SAM-315, an
      investigational drug, in healthy adult subjects. To obtain a preliminary pharmacokinetic (PK)
      and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect
      of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult
      subjects.
    


Intervention name(s): SAM-315
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the percentage of participants with perianal fistula
      healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram
      (mg) in participants with fistulizing Crohn's disease (CD).
    

Detailed description: 
      The drug being tested in this study is called vedolizumab IV. Vedolizumab IV is being tested
      to treat people who have fistulizing CD. This study will look at fistula healing in people
      who take vedolizumab IV.

      The study is planned to enroll approximately 100 patients. Participants will be randomly
      assigned (by chance, like flipping a coin) to one of the two treatment groups-which will
      remain undisclosed to the patient and study doctor during the study (unless there is an
      urgent medical need):

        -  Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion
           at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug
           but has no active ingredient).

        -  Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study from screening to 18 weeks after the last dose is 44 weeks. Participants will make
      multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of
      study drug for a follow-up assessment.
    

Intervention name(s): Vedolizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vedolizumab 300 mg IV infusion; 0.9% sodium chloride IV infusion
Other intervention name(s): Entyvio; MLN0002; Kynteles
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy; Fistulizing Crohn´s disease; Perianal Fistula
High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in
      multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each
      method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level,
      the durability of the response, the practicality and the possible toxicity.
    

Detailed description: 
      Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D
      insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals
      with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D
      supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune
      disease in animals that is used as a model of MS.

      Recently, emerging data from epidemiologic studies suggest that vitamin D may play an
      important role in the progression of the development of MS. A longitudinal study in pediatric
      MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A
      similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher
      vitamin D levels have also been shown to be associated with less subsequent inflammatory MS
      activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that
      patients have lower vitamin D levels during MS relapses.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Registry of Sustained Immunity to COVID-19 Among ESKD Patients
Condition: SARS-CoV-2 Infection; Anti-SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Study type: Observational

Summary: 
      This is a multi-center, prospective registry study of subjects undergoing hemodialysis for
      treatment of end-stage renal disease in a DaVita center.

      The objective of this study is to understand whether and to what degree anti-SARS-CoV-2
      antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the
      ESKD population.
    

Detailed description: 
      This is a multi-center, prospective registry study of subjects undergoing hemodialysis for
      treatment of end-stage renal disease in a DaVita center.

      The objective of this study is to understand whether and to what degree anti-SARS-CoV-2
      antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the
      ESKD population.

      Following informed consent, participants will undergo baseline serologic characterization for
      anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19.
      Enrollment will continue until the total sample size of 2500 is reached or until the study
      sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be
      actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The
      relationship between baseline serologic status and subsequent infection/disease will be
      determined.

      This study will have 2 distinct phases.

      Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at
      different times at the active sites. Participants will be consented and enrolled and blood
      will be collected for anti-SARS-CoV-2 antibodies.

      Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study
      location may be triggered to start at separate times. Study participants will be followed
      prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor
      trigger and will occur once monthly for 4 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Between ≥18 and 80 years of age, inclusive.

          2. Ability to provide informed consent.

          3. Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita
             dialysis center.
      
Biospecimen description: 
      Baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG
    
Keywords: Immunoglobulin G; Immunoglobulin M
Mechanisms of Dyspnea Relief During Exercise in COPD Patients Following Treatment With Tiotropium (Spiriva)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Dyspnea; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To explore the mechanisms of dyspnea relief during exercise in patients with COPD following
      treatment with tiotropium bromide (Spiriva)
    

Detailed description: 
      This was a single-centre, randomised, double-blind, placebo-controlled, cross-over study. The
      duration of subject participation was 9 weeks. There was an initial screening period of up to
      2 weeks. The first screening visit consisted of medical history, clinical assessment, chronic
      dyspnea evaluation, complete pulmonary function testing, and a symptom-limited maximal
      incremental cycle exercise test. A second visit during the screening period was intended as a
      training of the subject to the procedures to be performed in the study, with specific focus
      on familiarisation with the constant work rate exercise test. The screening period was
      followed by 2 x 7 day treatment periods (1 x tiotropium and 1 x placebo), separated by a 4
      week washout period. On the last day of each treatment period, the subject visited the clinic
      to complete a series of trial related procedures, including lung function measurements and a
      constant work rate exercise test at 75% Wcap to symptom limitation. Testing consisted of
      pulmonary function testing, dyspnea evaluation, and symptom-limited constant-load cycle
      exercise tests with measurements of cardiopulmonary parameters, symptom intensity and
      pulmonary mechanics. \

      Study Hypothesis:

      Dynamic hyperinflation restricts volume expansion during exercise and is suspected as a
      primary mechanism of dyspnea. The dissociation between drive or muscular effort to breathe
      and the mechanical response to increased volume (as reflected by an increased Pes/PImax:
      VT/predicted VC ratio) correlates well with the intensity of inspiratory difficulty during
      exercise in COPD. It was hypothesised that reduced Borg ratings at a standardized exercise
      level after tiotropium would correlate strongly with reduced restricted volume expansion
      during exercise (i.e., increased VT/IC and EILV/TLC ratios, and decreased IC and IRV). In
      other words, dyspnea and its predominant qualitative dimensions (i.e., inspiratory
      difficulty) result from patients being forced by DH to breathe at a high lung volume, at or
      above predicted TLC.

      Comparison(s):

      tiotropium bromide (Spiriva) vs. placebo
    

Intervention name(s): tiotropium bromide
Intervention type(s): Drug
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting
      conditions.
    


Intervention name(s): Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC; Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC; GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb; GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study was to evaluate the efficacy, safety and tolerability of a single
      peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid
      in 2 episodes of moderate tension headache.
    


Intervention name(s): Metamizol; Acetylsalicylic acid (ASA); Metamizol placebo; ASA placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Dipyrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Women With Cancer: An Exercise Study to Promote Health
Condition: Bone Loss; Cancer
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program
      compared to a home based physical activity program on bone mass, body composition, metabolic
      risk factors and cardiovascular fitness in women with cancer who have completed therapy.
    

Detailed description: 
      The proposed study will evaluate an endurance-resistive exercise intervention to attenuate
      the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean
      muscle mass, weight gain, decreased physical activity) in an at-risk population of female
      cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma
      who have completed primary and/or adjuvant therapy within the past three years and who are
      perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be
      recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise
      intervention (N=75) versus a health promotion control group (N=75). The specific aims of the
      study are to: (1) examine the effects of an exercise intervention on bone mass (serum
      biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist
      circumference), (2) examine the effect of an exercise intervention on metabolic risk factors
      (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood
      pressure), and (3) examine the effects of an exercise intervention on functional status and
      cardiovascular fitness (exercise stress test).
    

Intervention name(s): aerobic resistance exercise; home based health promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): three times per week aerobic resistance exercise for 12 months; education and support to adapt national guidelines for 30 minutes physical activity most days of the week
Other intervention name(s): physical activity; health promotion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; physical activity; intervention; cancer survivor
Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Condition: Upper Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for
      the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50
      years.
    

Detailed description: 
      This is a randomized double-blinded placebo controlled trial to assess the efficacy of
      treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of
      viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects
      complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during
      each day of the study. Phlebotomy is performed once for the determination of cytokine
      genotyping and allergy skin testing is performed once for the assessment of atopy.
    

Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cold; Upper Respiratory Infection
Motivation Makes the Move!
Condition: Obesity; Cardiovascular Diseases; Physical Conditioning
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study evaluates the effect and usability of mobile and cloud technology -based
      intervention on lifestyle modification in 18-40 year obese and overweight subjects.

      The study has a dose-response design with three randomized subjects groups from Mode 1 to
      Mode 3 with increasing intensity of intervention (guidance, exercise program, diet, support).
      The special focus of this study is on motivation and use of music and mobile health devices
      as motivational tools to support individualized exercise training, healthy diet and overall
      healthy life style.
    

Detailed description: 
      Obesity negatively impacts health in many ways. It is associated with metabolic diseases and
      mood disorders and in women pregnancy outcome as well as the health of the offspring.

      The modern evolution of societies steers populations towards a profound sedentary lifestyle.
      Physical activity brings about health benefits, however, the risk reduction for chronic
      diseases remains significantly greater for fitness than physical activity per se. The recent
      knowledge suggest Individualized approach rather than general guidelines for exercise in
      prevention-oriented strategies.

      In this study we compare three different intensities of lifestyle intervention: 1) general
      guidelines for healthy exercise and diet, 2) individual program,and 3) highly individual
      program. Individual programs will be based on pre-examinations including interview and
      clinical exercise test. Mobile and cloud technologies will be used to collect data and steer
      the subjects´ lifestyles and daily activities and together with music to motivate them. The
      duration of the active intervention is 3 months and it will continue on a self-governing
      basis up to 1 year. The primary outcome is maximal oxygen consumption (VO2max), and secondary
      outcomes are physical activity, cardio-respiratory and cardiovascular parameters, blood
      volume, total hemoglobin mass, metabolic health along with chronic low-grade inflammation and
      well-being.
    

Intervention name(s): Lifestyle
Intervention type(s): Behavioral
Intervention description(s): As part of the intervention Mode 2 and 3 subjects will use various mobile health applications including heart rate monitor, global positioning system, diet diary, and weight, sleep and mood monitors. They will also be offered music streaming service for e.g. motivation and relaxation.
Other intervention name(s): Exercise; Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients
Condition: Lower Back Pain; Musculoskeletal Diseases or Conditions
MeSH terms: Musculoskeletal Diseases; Back Pain; Disease; Low Back Pain
Study type: Interventional

Summary: 
      Lower back pain has been one of the most frequently occurring musculoskeletal disorder among
      the females. This act as a global burden and is highly prevalent in our society. This pain
      can result in life long disability, loss of function and mobility among individuals. The
      female of the society suffers from lower back pain the most because of the under lying
      causes, prolong standing and stooping as well as because of hormonal changes in their bodies
    

Detailed description: 
      After studying the prevalence of the lower back pain among the females of Pakistan, the
      investogator find the need to assess the type of their pain and find out the best way to ease
      their pains. The motive was to develop a treatment protocol whose effects last longer and is
      inexpensive for the management of lower back pain.

      Moreover, the investigator decided to study that which treatment protocol is better when
      compared to another and what is the role of sham treatment when given to the patients.
    

Intervention name(s): Therapy; Taping technique; Therapy with taping; SHAM
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Only Myofascial Release will be provided; Only Kinesiotaping will be provided; Myofascial release will be provided followed by Kinesiotaping; Placebo Treatment will be given
Other intervention name(s): Myofascial Release; Taping; Therapy followed by taping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a parallel group, four arm superiority trial with 1:1 allocation ratio and balanced randomization
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lower back pain; Non specific lower back pain