bioihbjkbjnl/mcl2 huggingface dataset:
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic
      spinal manipulation in addition to shoulder mobilization and exercise for improving range of
      motion, pain, physical function and fear avoidance beliefs in patients with subacromial
      shoulder impingement.

      Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition
      to shoulder mobilization and exercise will achieve greater improvements in range of motion,
      pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4
      weeks following treatment conclusion, and at discharge when compared to the subjects who did
      not receive the spinal manipulation.
    


Intervention name(s): thoracic mobilization & shoulder mobilization & exercise; shoulder mobilization & exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This single centre study will be used to investigate the efficacy of an experimental stannous
      fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term
      use compared with a standard fluoride dentifrice.
    

Detailed description: 
      This will be a single centre, three day, randomised, examiner blind, two treatment arm,
      parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected
      test teeth), controlled study, in participants with at least two sensitive teeth that meet
      all the criteria at the screening and baseline (pre-treatment) visits. DH will be assessed at
      baseline (pre-treatment), post-treatment and after 3 days twice daily use.
    

Intervention name(s): Stannous fluoride; Sodium monofluorophosphate
Intervention type(s): Other; Other
Intervention description(s): 0.454% weight by weight (w/w) stannous fluoride containing 1100 parts per million (ppm) fluoride; 0.76% w/w sodium monofluorophosphate containing 1000 ppm fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
Condition: Osteoarthritis; Rheumatoid Arthritis; Other Inflammatory Arthritis; Post-Traumatic Arthritis; Juvenile Rheumatoid Arthritis; Avascular Necrosis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile; Necrosis
Study type: Interventional

Summary: 
      The study will evaluate the clinical performance of the rotating platform and fixed bearing
      implants through patient questionnaires, outcomes scoring and radiographic assessment.
    

Detailed description: 
      The study will evaluate the clinical performance of rotating platform and fixed bearing
      cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will
      receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or
      P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
    

Intervention name(s): Total Knee Arthroplasty; Total knee replacement
Intervention type(s): Device; Device
Intervention description(s): Rotating Platform (RP) Cruciate Substituting Knee System; Fixed Cruciate Substituting Knee System
Other intervention name(s): P.F.C.® Sigma™ RP Cruciate Substituting Knee System; P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Replacement; Knee Prosthesis
Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to
      severe active rheumatoid arthritis.
    


Intervention name(s): SHR0302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of a Plant-based Ingredient on Glucose Response
Condition: Healthy
Study type: Interventional

Summary: 
      The study is designed to determine the extent to which a plant-based ingredient is able to
      modulate blood glucose response when administered with a meal.
    


Intervention name(s): Plant-based ingredient; No Plant-based ingredient
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: subjects
Citrus Beverages and Gastrointestinal Function
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of daily intake of orange pomace on
      gastrointestinal function as measured by stool frequency. Additional outcomes will include
      aspects of digestive health, diet quality, and fasting blood glucose and lipid
      concentrations. Possible explanations for the mechanism of the pomace will be explored in
      microbial ecology analyses.
    

Detailed description: 
      In this randomized, double-blind, controlled trial, healthy adults will be asked to consume
      daily servings of orange juice containing either 0 g (n=120; control) or 180 g (i.e. 10 g
      fiber; n=120) of orange pomace for 3 weeks to assess the effect of the pomace on stool
      frequency. Blood samples will be obtained to assess the effect of the pomace on metabolic
      markers. Stool samples will be collected for analyses of the effect of the pomace on fecal
      bacteria known to be associated with health benefits (e.g., bifidobacteria). For exploratory
      analyses, additional groups will be asked to consume orange juice containing 90 g of pomace
      (i.e. 5 g fiber; n=40) or orange-flavored, calorie-matched water (n=40); outcomes from the
      water group will be compared to those of the 0 g pomace juice group to assess any effects of
      the juice alone, and outcomes from the 90 g pomace group will be compared to those of the 180
      g and 0 g groups in microbiota analyses.
    

Intervention name(s): 0 g pomace (control); 90 g pomace; 180 g pomace; Flavored water (control)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded); 16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).; 16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).; 16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: immune; citrus
The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels
Condition: Insulin Sensitivity; Glucose Tolerance; Sedentary Behaviour; Physical Activity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Context and Rationale: Uninterrupted sitting is associated with increased risk of diabetes,
      heart disease, and death, even among people who are physically active. These relationships
      are likely due to increases in post-meal blood sugar observed when people sit for long
      periods (e.g. > 1 hour) without interruption. In contrast to sitting, standing results in
      large reductions in post-meal blood sugar levels. Our group has recently shown that sit-stand
      desks result in large (e.g. 2.5 hour/day) reductions in occupational sitting time. Taken
      together, these findings suggest that sit-stand desks may help to reduce post-meal blood
      sugar levels. However, this has yet to be examined in the field. Theoretical Approach and
      Objectives: The objective of this randomized crossover study is to determine whether people
      have lower blood sugar when using a sit-stand desk, in comparison to a desk that can only be
      used while sitting. Methods and Procedures: Sixteen participants will be asked to wear a
      continuous glucose monitor to measure their blood sugar levels during 2 separate conditions.
      During one condition, they will be asked to use a sit-stand desk to sit and/or stand as much
      as they like during 1 workday. During the other condition, they will be asked to work at a
      seated desk for 1 workday. Participants will be provided with identical meals to eat during
      each of the two conditions. We hypothesize that participants will have lower blood sugar
      levels on the day when they use the sit-stand desk, in comparison to the day using a
      traditional seated desk. Significance and Future Use: If our results support this hypothesis,
      this would suggest that sit-stand desks may be a useful way to reduce blood sugar levels in
      people at risk for diabetes. This could also lead to larger population-based interventions
      studying the health impact of sit-stand desks.
    


Intervention name(s): Sit-stand desk; Sitting desk
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy
Condition: Sarcopenia
MeSH terms: Uterine Cervical Neoplasms; Sarcopenia
Study type: Interventional

Summary: 
      Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from
      an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by
      cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in
      cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could
      potentially maintain body weight in cancer patients undergoing intensive treatment.

      The investigators aims in this study is to evaluate the effect of omega-3 supplementation on
      body composition, functional capacity, inflammatory profile and quality of life in cervix
      cancer patients undergoing chemoradiotherapy.
    


Intervention name(s): Omega-3; Olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.; patients included in this group will take 4 capsules per day of olive oil.
Other intervention name(s): intervention group; placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: body composition; functional capacity; quality of life
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Condition: Tetanus; Diphtheria; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives:

      To provide safety data on revaccination with ADACEL® vaccine.

      To describe the immune response to tetanus, diphtheria, and pertussis antigens following
      revaccination with ADACEL® vaccine 4-5 years after first vaccination.
    


Intervention name(s): Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
Intervention type(s): Biological
Intervention description(s): 0.5mL, Intramuscular (IM)
Other intervention name(s): Adacel®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tetanus,; Diphtheria,; Pertussis
Effect on Weight Loss of Exenatide Versus Placebo
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is designed to compare the effects of twice-daily exenatide and twice-daily
      placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2
      diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus
      a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their
      current oral antidiabetes agent regimen and participate in a lifestyle modification program.
    


Intervention name(s): exenatide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg or 10mcg, twice a day; subcutaneous injection, volume equivalent to exenatide dose, twice a day
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; overweight; obesity; weight loss; exenatide; Amylin; Lilly
Drug Drug Interaction of BI 201335 and Tenofovir
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the drug-drug interaction potential between BI
      201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV
      infection and/or Hepatitis B infection. Results of this study will serve as a basis for
      guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are
      coadministered.
    


Intervention name(s): tenofovir/BI 201335
Intervention type(s): Drug
Intervention description(s): tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22
Intervention MeSH terms: Tenofovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair
Condition: Lower Eyelid Retraction
Study type: Interventional

Summary: 
      The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived,
      non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the
      correction of lower eyelid retraction, taking into consideration issues associated with the
      use of acelular dermis such as contraction and potential regression of repairs.
    

Detailed description: 
      To Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal
      implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction,
      taking into consideration issues associated with the use of acelular dermis such as
      contraction and potential regression of repairs.
    

Intervention name(s): Non Cadaveric Human Acellular Dermal Tissue
Intervention type(s): Procedure
Other intervention name(s): Bella Derm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lower eyelid; retraction
Effects of Exenatide on Motor Function and the Brain
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to investigate how the brain and motor behavior changes
      Parkinson's Disease (PD) over time in response to Exenatide. In previous clinical trials, PD
      patients have experienced symptomatic improvement on Exenatide and literature suggests it may
      help slow the progression of Parkinson's. Both will be evaluated in this study.
    

Detailed description: 
      Participants will receive baseline testing to confirm a diagnosis of Parkinson's Disease and
      to determine eligibility in the research study. All of the participants in this study will
      receive the study drug (Exenatide). The study drug will be provided at the end of the first
      visit, and participants will be administered the drug once per week for the duration of the
      study (1 year).

      During the research study the following test may occur: (1) questionnaires about quality of
      life and depression; (2) tests to measure strength and motor function; (3) tests to measure
      cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI
      scan of the brain; (6) structural MRI scan of the brain.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
Other intervention name(s): Bydureon; Glucagon-like peptide-1 receptor agonist
Intervention MeSH terms: Exenatide; Glucagon; Glucagon-Like Peptide 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exenatide
Myofunctional Therapy in Facial Palsy
Condition: Facial Paralysis
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis; Facies
Study type: Interventional

Summary: 
      Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin
      injection in patients with long standing facial unilateral palsy.
    

Detailed description: 
      Twenty-five patients with long standing facial palsy were studied; all had been previously
      treated for facial reanimation. Patients were randomly divided in two groups; Group A did the
      myofunctional therapy sessions with the speech therapist before the botulinum toxin
      injection, while the participants of Group B did the myofunctional therapy after it.
    

Intervention name(s): Botulinum Toxin Type A; myofunctional therapy
Intervention type(s): Drug; Procedure
Intervention description(s): All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.; All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.
Other intervention name(s): BOTOX (Allergan)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: facial paralysis; asymmetry; myofunctional therapy; botulinum toxin; facial evaluation
A Clinical Study of Curcuvail® in Patients With Non-alcoholic Fatty Liver Disease
Condition: Fatty Liver Without Mention of Alcohol
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease.
      It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic
      steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular
      carcinoma (HCC).
    

Detailed description: 
      Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease.
      It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic
      steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular
      carcinoma (HCC).

      Currently there are no effective medications to cure NAFLD. Current treatments for NAFLD
      include weight reduction through lifestyle modification and exercise, insulin-sensitizing
      agents, lipid-lowering agents, and hepatoprotective drugs. However, the efficacy of these
      therapies is not satisfactory, some drugs may even induce liver toxicity. Thus, it is
      necessary to develop novel therapies that are effective and safe for the treatment of NAFLD.

      Hence, K Patel Phyto Extractions Pvt. Ltd. has formulated Curcuvail®. Objective of the
      current study is to compare efficacy, safety and tolerability of test formulation Curcuvail®
      by administering the medications in the adult patients suffering from Non-alcoholic Fatty
      Liver Disease (NAFLD) and eligible to receive Curcuvail® as treatment.
    

Intervention name(s): Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids); Placebo product
Intervention type(s): Drug; Drug
Intervention description(s): Curcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days; Placebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days
Other intervention name(s): Curcuvail® 250 mg capsule; Placebo Comparator: Placebo Product
Intervention MeSH terms: Turmeric extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment