bioihbjkbjnl/mcl2 huggingface dataset:
Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is
      considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the
      forearm, especially extensor carpi radialis brevi.

      The aim of this study is to The compare the short-term effects of different physiotherapy
      approaches on pain, function and grip strength in the rehabilitation of patients with lateral
      epicondylitis.
    

Detailed description: 
      Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is
      considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the
      forearm, especially extensor carpi radialis brevi. Different treatment approaches are
      described in the literature. The primary aim of the treatment approaches are decrease the
      pain and improve the functional level in patients with lateral epicondylitis. Thus,
      decreasing pain and regaining the functional performance in the daily living activity is
      essential in early diagnosed patients.

      The aim of this study is to compare the short-term effects of different treatment approaches
      on pain, function and grip strength in the rehabilitation of patients with lateral
      epicondylitis.
    

Intervention name(s): first physiotherapy; second physiotherapy; third physiotherapy
Intervention type(s): Other; Other; Other
Intervention description(s): physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions; physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy; physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session.
Other intervention name(s): physiotherapy; kinesiotaping; Extracorporeal shockwave therapy (ESWT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tennis elbow; pain; shock wave; kinesio taping
Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether arhalofenate is effective in preventing
      flares and reducing serum uric acid in gout patients.
    


Intervention name(s): Arhalofenate 600 mg; Allopurinol 300 mg; Colchicine 0.6 mg; Placebo; Arhalofenate 800 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Arhalofenate 600 mg tablets once daily for 12 weeks; Allopurinol 300 mg tablets once daily for 12 weeks; Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks; Placebo tablets once daily for 12 weeks; Arhalofenate 800 mg tablets once daily for 12 weeks
Intervention MeSH terms: Colchicine; Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Weight Loss Following Gastric Bypass or Sleeve Surgery
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The overall aim is to study the multiple factors determining the variation of weight loss
      after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.

      The specific aims are to evaluate:

      a) what explains the large individual differences in weight loss seen after RYGB and Sleeve
      surgery, b) if it is possible pre-operatively to identify which patients will not obtain
      beneficial effects of bariatric surgery in relation to weight loss and quality of life and c)
      if patients in need of improved care can be identified pre- and/or early post-operatively.
    


Intervention name(s): Roux-en-Y gastric bypass surgery or sleeve surgery
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Bariatric surgery
A Study Evaluating the Perception of Insertion Pain With Accu-Chek FlexLink and FlexLink Plus Insulin Pump Devices Under Real Life Conditions in Diabetic Patients.
Condition: Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      German Multi-centered, randomized, crossover study in diabetic patients evaluating two
      infusion sets under real life conditions at home. Subjects will be randomized to use one of
      the infusion set devices during the first period of 4 weeks, and be switched to the other
      infusion set for the second period of 4 weeks.
    


Intervention name(s): Accu-Chek FlexLink; Accu-Chek FlexLink Plus
Intervention type(s): Device; Device
Intervention description(s): Insulin pump device used for 4-weeks under real life conditions; Insulin pump device used for 4-weeks under real life conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of
      people throughout the tropics and subtropics. This study will evaluate the safety,
      tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180)
      in healthy adults who previously received a live-attenuated tetravalent dengue vaccine (TV003
      or TV005).
    

Detailed description: 
      Dengue fever is caused by any one of four viral serotypes (DENV1, DENV2, DENV3, and DENV4)
      and infection by any serotype creates life-long immunity against that serotype. V180 is an
      experimental tetravalent recombinant subunit dengue vaccine that would protect against all
      four serotypes (DENV1, DENV2, DENV3, and DENV4). The purpose of this study is to evaluate the
      safety, tolerability, and immunogenicity of adjuvanted (with Alhydrogel™) and nonadjuvanted
      formulations of V180 in healthy adults who have previously received the live-attenuated
      tetravalent dengue vaccine TV003 or TV005.

      Participants will be randomly assigned to receive one intramuscular injection of either
      adjuvanted V180, nonadjuvanted V180, or placebo at study entry (Day 1). Participants will
      record their temperature and any adverse events for 14 days after receiving the vaccination.
      Additional study visits will occur on Days 15, 28 and 180. Visits will include a physical
      examination and blood and urine collection. Study staff will contact participants by
      telephone at Days 7 and 90 (and at other occasional time points between Days 90 and 180) for
      health and safety follow-up monitoring.
    

Intervention name(s): V180; Alhydrogel™; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Tetravalent recombinant subunit dengue vaccine; V180 will contain 10 µg, 10 µg, 10 µg, and 20 µg of the DENV1, DENV2, DENV3, and DENV4 antigens, respectively.; Aluminum hydroxide gel adjuvant
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Vaccine
The Impact of Maternal Microbes on Infant Health Programming
Condition: Healthy
Study type: Observational

Summary: 
      MAMI aims to characterize maternal microbes to be transferred to neonates and determine their
      function in infant health programming.
    

Detailed description: 
      Recent reports suggest that early microbial colonization has an important role for in
      promoting health. This may contribute to reduce the risk of chronic diseases such as obesity,
      allergies and inflammatory conditions. Advances in understanding host-microbe interactions
      imply that maternal microbiota plays a crucial role on health programming. This process
      begins in utero and it is modulated by mode of delivery and diet. The investigator's previous
      data has shown that i) specific shifts in milk microbial composition are associated with
      lactation time and mode of delivery, ii) milk microbes drive the infant microbiota
      composition; iii) maternal microbiota dysbiosis may be transferred to the infant. However,
      factors defining maternal microbiota and its biological role upon infant's health are not yet
      fully understood. Hence, this project aims to characterize maternal microbes to be
      transferred to neonates and determine their function in infant health programming. The
      specific aims are:(1) understanding how the maternal microbiome is influenced by host and
      environmental factors;(2) characterizing the microbial core and bioactive compounds
      transmitted to the offspring mainly via breastfeeding and their key roles in the microbial
      modulation and host response;(3) understanding the interactions among breast milk bioactive
      compounds and their role in infant health;(4) shedding light on how maternal microbes
      influence the infant immune system.

      Results obtained will demonstrate the interaction between infant nutrition, microbes and host
      response in early life and its key role in health programming, enabling new applications in
      the field of personalized nutrition & medicine.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Families located on the Mediterranean area
      
Keywords: microbiota; breast milk; diet
Effect of Quetiapine on Marijuana Withdrawal and Relapse
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate the interaction between marijuana and
      quetiapine, with the goal of using this information to improve marijuana treatment outcome.
    

Detailed description: 
      The purpose of this study is to determine if quetiapine decreases marijuana relapse in a
      controlled lab setting. For the purposes of this model, relapse is defined as a return to
      marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient,
      counter-balanced design, with each participant maintained on placebo and quetiapine (200
      mg/day) for 18 days. Participants will begin taking capsules as outpatients so that the dose
      can be incremented prior to the inpatient phase. While inpatient, participants will have the
      opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day,
      depending on the study day. Our laboratory model, which has distinguished the effects of a
      range of medications on marijuana withdrawal and relapse, will provide important information
      on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate
      abstinence in the initial stages of marijuana treatment.
    

Intervention name(s): Marijuana; Quetiapine; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0,6.2% THC; 200 mg/day
Other intervention name(s): cannabis; seroquel; Riboflavin
Intervention MeSH terms: Riboflavin; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: quetiapine; smoked marijuana; marijuana use
Miltefosine and GM-CSF in Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 3

Summary: 
      Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony
      (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been
      described in up to 50% of patients, and the long period of 60 to 90 days required for healing
      of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives
      include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited
      either by toxicity or because, as with Sbv, the parenteral route hinders adherence and
      regularity of treatment in the rural area. Recent studies by our group indicate that oral
      miltefosine is the most effective drug for the treatment of patients with CL caused by L.
      (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75%
      respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue
      damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L.
      (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the
      use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis
      in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.
    


Intervention name(s): Sbv; Miltefosine plus placebo; Miltefosine plus GM-CSF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard treatment for CL, parenteral drug used during 20 days.; Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. Placebo gel cream will be used topically.; Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. GM-CSF gel cream will be used topically.
Other intervention name(s): Glucantime; Impavido plus placebo; Impavido plus GM-CSF
Intervention MeSH terms: Miltefosine; Meglumine Antimoniate; Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cutaneous leishmaniasis; miltefosine; cytokines; treatment
Analysis of Peripheral Blood ILC2s and Th2 Cells in Response to ANB020
Condition: Asthma
Study type: Observational

Summary: 
      This exploratory laboratory only study will assess alterations in immune cells in blood
      samples that may be responsive to an inflammatory mediator in asthma called IL-33 (Innate
      lymphoid type 2 cells, basophils and Th2 cells) in response to treatment with ANB020/placebo
      (a drug that targets IL-33, in the linked clinical trial ANB020-004). The study will involve
      additional 10ml blood draws on scheduled study visits in the ANB020-004 clinical trial at
      baseline, 1 week, 5 weeks, 18 weeks (4 visits total). Total number of subjects is 24 at the
      same 3 participating UK sites as the main linked clinical trial ANB020-004.

      Blood samples will be sent on the same day to a flow cytometry laboratory at the NIHR
      Leicester Biomedical Research Centre (BRC) - Respiratory. A dedicated post doctoral, trained
      laboratory scientist will analyse the blood samples for the required cell types using a
      technique called flow cytometry - this technique identifies cell surface and intercellular
      markers, that together provide a unique cell identity. The experiments will be supervised by
      a senior research scientist and flow cytometrist Professor Dave Cousins, at the University of
      Leicester and results of the experiments will be fed back to AnaptysBio (the linked clinical
      trial Sponsor). Professor Salman Siddiqui at the University of Leicester will oversee the
      clinical conduct of this laboratory study and act as the Chief Investigator. Professor
      Siddiqui is also the local site lead Principal Investigator at Leicester for the linked
      ANB020-004 clinical trial described below.

      The linked study (ANB020-004) is a Double-blind Placebo-Controlled Proof of Concept Study to
      Investigate ANB020 (a drug that targets an inflammatory mediator called IL-33) Activity in
      Adult Patients with Severe Eosinophilic Asthma. The expected duration of the study is up to
      141 days. Screening period of 7-14 days and treatment and follow-up period of 127 days.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthma patients taking part in the link study ANB202-004 (EudraCT 2017-000647-40) will be
        asked to take part in this observational study, in parallel with the main study.
Effect of Hippotherapy in Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Purpose: The aim of this study was to determine the effect of hippotherapy on balance,
      functional mobility, and functional independence in children with Down syndrome (DS).

      Methods: Thirty-four children with DS were randomly assigned to the experimental
      (hippotherapy) and control groups after initial assessment. Both groups received
      physiotherapy including balance exercises, and the experimental group also received
      hippotherapy. Pediatric Balance Scale (PBS), Timed Up and Go Test (TUG), and Functional
      Independence Measure for Children (WeeFIM) were used before and after the intervention.
    

Detailed description: 
      Purpose: The aim of this study was to determine the effect of hippotherapy on balance,
      functional mobility, and functional independence in children with Down syndrome (DS).

      Methods: Thirty-four children with DS were randomly assigned to the experimental
      (hippotherapy) and control groups after initial assessment. Both groups received
      physiotherapy including balance exercises, and the experimental group also received
      hippotherapy. Pediatric Balance Scale (PBS), Timed Up and Go Test (TUG), and Functional
      Independence Measure for Children (WeeFIM) were used before and after the intervention.
    

Intervention name(s): Hippotherapy; Home exrecises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The hippotherapy program consisted of 6 weekly sessions that varied in duration between 20 and 30 minutes depending on the weekly program and the participant's condition. Each session started with brief greetings and contact with the horse.; The home exercise program consisted of the following balance training exercises: one leg standing on foam with eyes open and closed, double leg standing on foam with eyes open and closed, walking in tandem with eyes open and closed, balance exercises on an inclined surface, balance exercises in squat, and jumping over an obstacle on the ground. All participants performed the exercises under parental supervision, 3 times per week for 6 weeks. The physiotherapist made video calls to the children and parents to ensure their adherence to the home exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Hippotherapy; Functional Mobility; Balance; Down Syndrome
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast sodium tablets 10mg of Dr. Reddy's
      Laboratories Limited, India comparing with that of SINGULAIR® (containing Montelukast sodium)
      tablets 10mg of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fasting
      conditions.
    

Intervention name(s): Montelukast sodium
Intervention type(s): Drug
Intervention description(s): Montelukast sodium tablets 10mg
Other intervention name(s): SINGULAIR
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Montelukast Sodium; crossover
Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
MeSH terms: Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary and secondary objectives of this study are:

      Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving
      SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells
      circulating in peripheral blood.

      Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic
      neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined
      multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total
      neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory
      testing (QST)
    

Detailed description: 
      SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a
      researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around
      the injection site and causes these cells to make a protein. This protein causes your cells
      to increase production of another protein called vascular endothelial growth factor (VEGF),
      which may improve the structure and function of nerves. In addition, there are changes in the
      levels of 28 additional proteins in your cells. These proteins function to promote the growth
      of cells, are structures in cells, help synthesize products, and affect immune cells, and
      some have unknown functions. This increase in your own VEGF proteins may protect and repair
      the damaged nerves caused by diabetic neuropathy.

      This study is intended to further evaluate the mechanism of SB-509 action.
    

Intervention name(s): SB-509; SB-509; Placebo; SB-509
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active drug; Active drug; Placebo; Active drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy; Stem Cells