bioihbjkbjnl/mcl2 huggingface dataset:
Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)
Condition: Scoliosis; Bone Diseases, Metabolic
MeSH terms: Scoliosis; Bone Diseases; Bone Diseases, Metabolic; Metabolic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective randomized controlled trial investigating the effect of vibration
      therapy on bone mineral density (BMD) and bone quality in AIS subjects suffering from
      osteopenia (low bone mass).
    

Detailed description: 
      Scoliosis is a three-dimensional spinal deformity and AIS is the commonest with a high
      prevalence of 2-4 % in the general population. As many as 30% of AIS subjects also suffer
      from osteopenia which can persist and result in serious health problems later in life
      including vertebral collapse, fragility fractures, decreased quality of life and even
      mortality. In spite of this, a safe, effective and evidence-based treatment protocol for
      AIS-related osteopenia is not available. It remains uncertain how effective dietary advices,
      physical activity, Calcium and Vitamin D supplements are in this regard. On the other hand,
      low-magnitude high-frequency vibration therapy was shown to be effective in increasing bone
      mass both in animal models and in clinical trials involving elderly subjects. AIS-related
      osteopenia may have a different clinical behaviour. In addition, the in-vivo effect on bone
      quality has never been studied. We plan to carry out a scientific clinical study on the
      effect of vibration therapy on skeletally mature female AIS subjects with osteopenia. They
      are randomly allocated to either the treatment or the control group. BMD, bone
      micro-architectures are assessed to delineate whether vibration therapy has any therapeutic
      effect on improving low bone mass in osteopenic AIS subjects.
    

Intervention name(s): Vibration Platform
Intervention type(s): Device
Intervention description(s): The patients receive treatment by standing on the Vibration Platform 20 minutes a day, five days a week. The platform will deliver a vibration of 0.3g with a vertical displacement of 0.085mm at 35 Hz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent Idiopathic Scoliosis; AIS; Vibration Therapy; Low bone mass; osteopenia
A Research Study, Looking at the Characterization of Treatment Intensified (Add on to Metformin) Real-world Adult Population With Type 2 Diabetes Mellitus in India, Pakistan and Thailand.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study aims to describe demographics, clinical, treatment and healthcare resource
      utilization characteristics with a particular focus on those relating to cardiovascular
      disease in selected treatment intensified patients with type 2 diabetes in the real-world
      settings in India, Pakistan, and Thailand.

      The study will be based on data already recorded in participants medical record and no new
      tests or procedures are required as part of the study.

      The study will last for about 6 months and it does not affect participants current treatment.
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): The study will be based on data already recorded in the medical record
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of patients with T2DM fulfilling the inclusion criteria
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose
      schedule (3-dose primary series followed by a toddler dose) of V114 compared with
      Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is
      non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the
      response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique
      V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following
      dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13
      based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG)
      geometric mean concentrations (GMCs) at 30 days following dose 3.
    


Intervention name(s): V114; PCV13
Intervention type(s): Biological; Biological
Intervention description(s): 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.; 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine; Prevnar 13™
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effect of Rye Bread Breakfasts on Eight Hour Satiety Ratings
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of the present study was to investigate subjective appetite during 8 hours after
      intake of iso-caloric rye bread breakfasts varying in dietary fiber composition and content.
    

Detailed description: 
      Energy-dense foods that require little effort to consume and that are rapidly digested may
      cause passive over-consumption by failure to provide a feeling of fullness corresponding to
      the energy content. A diet that is predominantly based on such foods may lead to overweight.
      It is therefore important to identify properties of foods that facilitate energy balance by
      creating a high satiety per calorie. A number of studies have confirmed that foods naturally
      rich in dietary fiber promote the feeling of fullness and reduce hunger in the short term.
    

Intervention name(s): Rye bread breakfast; wheat bread based breakfast
Intervention type(s): Other; Other
Intervention description(s): A randomised, within-subject comparison design was used. Appetite (hunger, satiety and desire to eat) was rated regularly from just before breakfast at 08:00 until 16:00. Amount, type and timing of food and drink intake during the study period were standardised.; Reference wheat bread breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Rye bread satiety breakfast
Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
Condition: Rhino Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      This study is a prospective comparison between absorbable hemostatic agents as a group and
      the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral
      sinus surgery with or without septoplasty.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in
      comparison with physiologic hemostasis after endoscopic sinus surgery. The investigators aim
      to determine the relative efficacy of hemostatic agents to halt epistaxis and compare this
      with the degree of epistaxis observed without therapy and evaluate objective healing
      parameters.
    

Intervention name(s): Arista; Nexfoam; Nasopore
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: After sinus surgery, the surgeon will randomize the patient to one of six hemostatic agents and place that product in one sinus cavity, while leaving the other sinus cavity without packing. The treatment group will be compared to control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bilateral chronic rhino sinusitis
A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may
      receive duloxetine or placebo during the course of the trial. All subjects will, in fact,
      receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day
      of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after
      placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).

      Study Hypothesis:

      In subjects who continue to have activity-limiting osteoarthritis pain after treatment with
      acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10
      weeks will provide significant additional pain relief over that achieved with placebo(> 30%
      reduction after Duloxetine treatment).
    


Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): Weeks 0-2 placebo Weeks 2-3 30mg duloxetine Weeks 3-4 60mg duloxetine Weeks 4-12 60-90mg duloxetine Week 13 30 mg duloxetine Week 14 stop
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis pain; activity limitation; antidepressant; depression; single-blind
Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective unblinded, randomized trial for the use of Fecal Microbiota
      Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or
      without antibiotic pretreatment.
    

Detailed description: 
      This is a prospective open-label, randomized trial for the use of Fecal Microbiota
      Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or
      without antibiotic pretreatment.

      This trial involves 11 study visits at UCSF in San Francisco, CA.

      The routes of administration will be via colonoscopy for all subjects with maintenance
      therapy administered orally (i.e. using encapsulated FMT) for half of the subjects and per
      rectum by enema in the other half of the subjects. Additionally, the utility of pretreatment
      antibiotics will be assessed.
    

Intervention name(s): Fecal Microbiota Transplantation (FMT), OpenBiome; pretreatment antibiotics
Intervention type(s): Biological; Other
Intervention description(s): Delivered by colonoscopy, enema or orally (as capsules); 5 day course (vancomycin PO 500mg bid, metronidazole PO 500mg bid, and neomycin PO 500mg bid) starting 6 days prior FMT
Other intervention name(s): vancomycin, metronidazole, neomycin
Intervention MeSH terms: Anti-Bacterial Agents; Metronidazole; Vancomycin; Neomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative colitis; FMT; fecal transplant
Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer
Condition: Infertility
MeSH terms: Infertility; Vitamin D Deficiency
Study type: Observational

Summary: 
      Vitamin D receptors are present and differently expressed in murine endometrium and ovary
      throughout the estrous cycle , whereas knock-out experiments have shown that vitamin D
      receptor null mice experience uterine hypoplasia and impaired folliculogenesis.

      Only few retrospective studies examining the role of vitamin D levels in infertile patients
      have been published up to date, whereas results are strongly contradictory, with some
      supporting that maternal vitamin D deficiency is associated with lower pregnancy rates and
      others demonstrating that vitamin D deficiency does not affect final reproductive outcome.

      Finally, a recent retrospective study postulated that vitamin D deficiency may negatively
      affect pregnancy rates with an effect mediated through the endometrium, given that vitamin D
      deficiency was not correlated with ovarian stimulation characteristics or with markers of
      embryo quality in this study.

      In order to examine a potential negative effect of vitamin D deficiency on pregnancy rates,
      mediated through the endometrium, the aim of the current study was to examine the impact of
      vitamin D levels on pregnancy rates only in an infertile population undergoing embryo
      transfer of frozen-thawed embryos.
    


Intervention name(s): Frozen embryo transfer
Intervention type(s): Procedure
Intervention description(s): Embryo transfer of frozen/thawed embryos after IVF/ICSI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile women undergoing a frozen ET with 1 or 2 Day 5 (blastocyst stage) embryo
      
Keywords: Infertility
A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree
      AIT administered once daily in order to define a dose-range that would be suitable for
      at-home administration.
    


Intervention name(s): ALK tree AIT 0.5 DU; ALK tree AIT 1 DU; ALK tree AIT 2 DU; ALK tree AIT 4 DU; ALK tree AIT 7 DU; ALK tree AIT 12 DU; ALK tree AIT Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Drink Composition on the Appearance of Ingested Water in Body Fluids
Condition: Rate of Water Appearance/Delivery in the Blood; Water Balance
Study type: Interventional

Summary: 
      To determine the effects of amino acids on the rate of water absorption and availability as a
      precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in
      three experimental trials. In each trial, volunteers will be given one of two commercially
      available sports drinks or a commercially available sport drink with added amino acids in a
      double-blinded, randomised, crossover design. Each drink will be a single 550 mL bolus. All
      beverages will be labelled with deuterium (D2O). Trials will be compared for temporal
      accumulation of deuterium in plasma over the course of 60 minutes and in urine (60 min).
      Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume
      changes calculated. It is hypothesised that the amino acid trial will increase the rate of
      fluid absorption.
    


Intervention name(s): Composition of Sports Drink
Intervention type(s): Other
Intervention description(s): The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, randomised, crossover design
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Virtual Reality and Cervical Mobilization
Condition: Neck Pain; Virtual Reality
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of virtual reality and cervical mobilization
      on proprioception, balance parameters, pain, disability level, quality of life and overall
      felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively
      evaluate the virtual reality perspectives of individuals with chronic neck pain.
    


Intervention name(s): virtual reality; cervical mobilization; exercise
Intervention type(s): Other; Other; Other
Intervention description(s): The individuals participating in the study will experience virtual reality.; The individuals participating in the study will be applied cervical mobilization techniques.; The individuals participating in the study will performed neck-specific exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Neural Changes in the Aging Auditory System
Condition: Progesterone; Estrogens; Hearing; Psychoacoustics; Auditory Perceptual Disorders
MeSH terms: Hearing Loss; Auditory Perceptual Disorders; Perceptual Disorders
Study type: Observational

Summary: 
      The purpose of this study was to determine the effects of hormone replacement therapy (HRT)
      on hearing in post-menopausal women.
    

Detailed description: 
      Background: Female hormone influences on the development and aging of the auditory system are
      not completely understood. The present study retrospectively analyzed and compared hearing
      abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with
      estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group,
      matched for age, who did not receive any HRT.

      Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and
      health status participated. All had relatively healthy medical histories, absence of
      significant noise exposure, middle ear problems, major surgeries or current/heavy smoking.
      Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product
      otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and
      hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise:
      the major complaint of hearing-impaired persons.

      .
    

Intervention name(s): Hormone Replacement Therapy - HRT
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Observational model: Case-Control
Time perspective: Other
Keywords: Hearing Loss, Central; Presbycusis; Hearing Loss, Sensorineural; Hearing Loss, Cochlear; Hearing Loss, Bilateral; Sex Steroid Hormones; Estradiol
A 47 Hour Occlusive Cutaneous Skin Patch Test on Adult Subjects With Dry/Atopic Skin
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, non-comparative investigation to determine the tolerance of Eczema
      Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin.

      The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will
      be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.
    

Detailed description: 
      At immediate, 1, 24, 48, and 72 hours post-test patch removal (date & time of each assessment
      will be recorded), each test site will be scored for erythema and oedema by the trained
      investigator using the ISO 10993 scoring system.

      Primary Endpoint The irritation of the test product according to the Cutaneous Irritancy
      Index value. The test product should be graded as 'non-irritant' and confirmed by the study
      dermatologist.
    

Intervention name(s): Eczema Repair Emollient
Intervention type(s): Device
Intervention description(s): An Emollient
Intervention MeSH terms: Emollients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Leiomyosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It
      is not yet known whether giving gemcitabine together with docetaxel is more effective than
      giving gemcitabine alone as second-line therapy in treating uterine or soft tissue
      leiomyosarcoma.

      PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well
      they work compared to gemcitabine alone as second-line therapy in treating patients with
      metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the anti-tumor activity, in terms of objective response rate, in patients with
           metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma treated with
           gemcitabine with vs without docetaxel as second-line therapy.

      Secondary

        -  Compare the progression-free survival of patients treated with these regimens.

        -  Compare the response duration and overall survival of patients treated with these
           regimens.

        -  Compare the tolerability and dose intensity of these regimens in these patients.

        -  Determine biological markers with a predictive value for response to these regimens in
           these patients.

      OUTLINE: This is a randomized study. Patients are stratified according to location of
      leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4
           weeks for 2-8 courses.

        -  Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment
           repeats every 3 weeks for 2-8 courses.

      PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be
      accrued for this study.
    

Intervention name(s): docetaxel; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uterine leiomyosarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; adult leiomyosarcoma