bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Proprioception
Condition: Proprioceptive Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      The osteoarthritis (OA) is a chronic and degenerative disease which brings articular
      cartilage degeneration. As a consequence, balance and proprioception could be dangerously
      reduced after total knee arthroplasty.

      Several studies demonstrated the correlation between OA, proprioception reduction and
      increased risk of falling. The aim of this study is to evaluate the proprioception
      improvement in patients with total knee arthroplasty.
    


Intervention name(s): Reconditioning Proprioception
Intervention type(s): Other
Intervention description(s): Proprioceptive training using Delos Postural Proprioceptive System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: total knee arthroplasty; Proprioception; osteoarthritis
Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus
Condition: Heart Failure, Diastolic; Diabetes Mellitus, Type 2
MeSH terms: Heart Failure; Heart Failure, Diastolic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients enrolled into the study will be randomly allocated either to Empagliflozin group or
      control group. In the Empagliflozin group patients will be receiving standard care +
      Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care
      without sodium glucose contransporter 2 (SGLT2) inhibitors.
    


Intervention name(s): Empagliflozin; Standard care
Intervention type(s): Drug; Other
Intervention description(s): 10 mg tablet; Standard care with no SGLT-2 inhibitors
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HF; HFpEF; DM; Empagliflozin; Jardiance
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study aims to evaluate safety and immunogenicity of two doses, administered three
      weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms
      or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine
      containing 15 micrograms of H5N1 influenza antigen, in adults
    


Intervention name(s): MF59 adjuvanted H5N1 influenza vaccine
Intervention type(s): Biological
Intervention description(s): MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
non-adjuvanted influenza vaccine containing 15 ug of H5N1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: influenza; pandemic influenza; influenza vaccine; adjuvanted influenza vaccine; H5N1 influenza antigen; MF59; Pandemic influenza disease
Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer
Condition: Enhanced Recovery After Surgery; Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      At present, there are more and more reports about enhanced recovery after surgery（ERAS）in
      China, but there is no ERAS treatment standard for gastrointestinal cancer, and there are
      many factors limiting the development of ERAS. In recent years, due to the development of
      minimally invasive technology, the establishment of evidence-based medicine model and the
      development of MDT, it makes a good solid foundation for the clinical application of ERAS.
      The implementation of ERAS requires the cooperation of surgeons, anesthesia management,
      nursing, rehabilitation and other teams. As an individualized treatment mode, ERAS focuses on
      the optimization of treatment for different individuals in order to acquire the best benefit
      of patients. Therefore, the concept of ERAS is still in the process of continuous improvement
      and development in China, hoping to explore the Chinese ERAS clinical pathway for
      gastrointestinal cancer. The purpose of this study is to optimize the clinical pathway of
      ERAS in the perioperative period of gastrointestinal cancer, and to evaluate the
      effectiveness and safety of ERAS in gastrointestinal cancer.
    


Intervention name(s): Enhanced Recovery After Surgery （ERAS）
Intervention type(s): Procedure
Intervention description(s): Preoperative education，Preoperative nutritional support，Preoperative bowel preparation，Preventative applying of antibiotics，Intraoperative warming，Goal-directed fluid therapy，Postoperative analgesia，Postoperative diet, drainage and activity management，Prevention of deep vein thrombosis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3857210 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the presence of study drug LY3857210 in the
      brain measured by positron emission tomography (PET) with the radioligand [18F]-LY3818850 in
      healthy participants. The safety and tolerability of LY3857210 will also be evaluated. The
      study will last up to approximately 6 weeks for each participant and may include up to four
      visits to the study center.
    


Intervention name(s): LY3857210
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efavirenz in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with
      metastatic prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the effect of efavirenz on the PSA non-progression rate at 3 months in
           patients with castration-refractory metastatic prostate cancer.

      Secondary

        -  To assess the effect of efavirenz on the PSA non-progression rate at 6 months.

        -  To assess the effect of efavirenz on overall survival.

        -  To assess the effect of efavirenz on PSA progression-free survival..

        -  To assess the tolerability and safety profile of efavirenz.

      OUTLINE: This is a multicenter study.

      Patients receive oral efavirenz once daily in the absence of disease progression or
      unacceptable toxicity.
    

Intervention name(s): efavirenz
Intervention type(s): Drug
Intervention MeSH terms: Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent prostate cancer; stage IV prostate cancer
Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The objective of this project is to determine the effects of gait-retraining on articular
      cartilage composition, gait mechanics, pain and function in persons with mild to moderate
      knee osteoarthritis (OA).
    

Detailed description: 
      Variables of gait mechanics during walking have been linked to the onset and progression of
      knee osteoarthritis (OA). The knee adduction moment is one key variable that has been
      identified as an important indicator of medial compartment loads across the knee joint. Use
      of gait-retraining strategies to alter gait movement patterns and lower the knee adduction
      movement in persons with knee OA is a new and promising direction for the potential
      intervention in a population in which few strategies have worked successfully.

      Factors that affect cartilage composition are crucial to understanding the disease mechanisms
      in knee OA. A multi-scale approach towards understanding the knee OA disease process by
      evaluating tissue compositional changes, joint contact mechanics, whole-body neuromuscular
      dynamics, and functional performance. The results will be the first to show the association
      between cartilage composition and daily function (performance and patterns) which are
      implicated in OA development and progression. With the addition of comprehensive muscle
      testing (cross sectional area/volume assessment using MR, strength testing, muscle activation
      and co-contraction patterns during daily activities), it will be possible to study the
      interaction between all major tissues around the knee.
    

Intervention name(s): Gait Retraining
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: knee OA
Androgen Replacement Therapy in Women With Hypopituitarism
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Study type: Interventional

Summary: 
      This is a study to determine whether testosterone replacement with TheraDerm can improve bone
      density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women
      with hypopituitarism.
    

Detailed description: 
      Patients will be randomized into 2 groups to receive testosterone replacement therapy or
      placebo. Group 1 will receive 2 testosterone patches and estrogen pills for 12 months. Group
      2 will receive 2 placebo patches and estrogen pills for 12 months. Changes in bone density,
      bone metabolism markers, body composition, libido, and quality of life will be compared in
      the women receiving testosterone replacement therapy with that of the women receiving
      placebo.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): TheraDerm
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Topiramate and Severe Obesity
Condition: Obese Children and Adolescents
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body
      Mass Index compared to placebo at 9 months.
    

Detailed description: 
      Childhood obesity remains through adulthood in main cases, and is associated with an early
      increase of cardiovascular risk and an excess mortality in young adults due to stroke and
      cancer.

      Bariatric surgery is very rare in France for children and can cause severe complications.
      Long term effects are still unknown.

      Topiramate is already use in thousands of children in neurology, its effects are already well
      known, and no lethal complication is reported.

      The hypothesis is that Topiramate associated with standard treatment of obesity is more
      effective than standard treatment alone.

      This will be a 4.5-years, randomized, double-blind, placebo-controlled, clinical trial of
      topiramate (9 months) vs placebo (9months) for Body Mass Index reduction in 160 adolescents
      (ages 9-17 years old) with severe obesity.

      The main objective is to evaluate the efficacy of Topiramate on the decrease of Body Mass
      Index compared to placebo at 9 months.

      The secondary objectives are to evaluate:

        -  the decrease of Body Mass Index Z-score

        -  the tolerance of Topiramate

        -  the effectiveness of Topiramate on weight decrease and decrease of Body Mass Index and
           Body Mass Index Z-score at 1, 3 ,4 and 6 months

        -  the effectiveness of Topiramate on eating behaviour, physical activity, calculated with
           validated questionnaires and scales at 6 and 9 months

        -  the pharmacokinetic of Topiramate in obese children and adolescents
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topiramate for 9 months treatment, and then 27 months of follow-up Dose regimen will be determined according to theoretical weight (taken orally), escalated every 15 days. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose.; Placebo will be taken orally following to the same dose regimen according to theoretical weight
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Topiramate; Obesity; Children; Adolescents
Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of the standard rehabilitation offered
      by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in
      Levanger, compared to an interval treadmill training program. The subjects participating in
      the study are patients with myocardial infarction. The maximal oxygen consumption of the
      subjects will be tested before and after the training period.
    

Detailed description: 
      The purpose of this study is to investigate the effect of the standard rehabilitation offered
      by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in
      Levanger, compared to an interval treadmill training program. The subjects participating in
      the study are patients with myocardial infarction. The maximal oxygen consumption of the
      subjects will be tested before and after the training period.

      Primary outcome: Maximal oxygen consumption Secondary outcomes: Blood values (for endothelial
      function, blood lipids, etc), flow mediated dilatation, quality of life (SF 36 and MacNew),
      weight, BMI, heart rate fall 1 minute after stopping the maximal treadmill test.
    

Intervention name(s): Exercise training; Exercise training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard exercise training at the hospital, two times per week for twelve weeks; Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxygen Consumption; Exercise; Rehabilitation
Influence of Peer Mentoring on Adolescent Contraceptive Decision Making
Condition: Peer Counseling; LARC Desire
Study type: Interventional

Summary: 
      This is a prospective, randomized-controlled trial in which subjects will be randomized to
      receive either routine contraceptive counseling or peer mentoring plus routine contraceptive
      counseling.
    

Detailed description: 
      Unintended adolescent pregnancy continues to be a significant public health problem in the
      United States. While the use of highly effective forms of birth control, such as the
      long-acting, reversible contraceptives (LARC) have been found to be more effective in
      decreasing pregnancy rates than non-LARC methods of birth control, knowledge and use of LARC
      has been shown to be low in this vulnerable population. We are interested in better
      understanding the influence peers may have on contraceptive decision making among
      adolescents. The purpose of this study is to evaluate the impact of a peer mentoring
      intervention on adolescent contraceptive decision making, specifically with regard to
      increasing long-acting, reversible contraceptive uptake. The main study intervention will
      consist of randomization to usual contraceptive counseling versus peer-mentoring plus usual
      contraceptive counseling. Pre- and post-intervention questionnaires will be used to better
      understand peer influence on contraceptive decision making, and to assess the peer
      mentor-teen intervention interaction.
    

Intervention name(s): Peer Mentor Counseling
Intervention type(s): Behavioral
Intervention description(s): Peer mentoring will entail the peer mentor describing her positive experience with her LARC method. The participant will then have a chance to ask any experience related questions to the mentor. Any clinical inquiries or questions the mentor does not feel comfortable answering, she will defer to the contraceptive counselor/ physician who will be subsequently providing the routine counseling. The entire peer mentor encounter should not last more than 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Unintended pregnancy in adolescence; LARC; contraception
Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori
Condition: H. Pylori Eradication Failure
MeSH terms: Infections; Sprains and Strains
Study type: Observational

Summary: 
      The purpose of this study is to determine whether mixed H. pylori strain infection is the
      reason for eradication failure during treatment of H. pylori infection. The investigators
      present the results got from extensive sampling of biopsy samples taken from individuals
      diagnosed with H. pylori connected disease. The investigators were looking for individuals
      that were not able to eradicate H. pylori although they had susceptibility testing tailored
      antibiotic therapy. On their control visit after 2 months they presented again with H. pylori
      although at their first visit they had H. pylori isolated from biopsy sample sensitive to all
      antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence
      type of H. pylori and E test was used to determine susceptibility of H. pylori to
      antibiotics.
    


Intervention name(s): Antibiotics to which H. pylori can not develope resistance
Intervention type(s): Drug
Intervention description(s): Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.
Intervention MeSH terms: Anti-Bacterial Agents
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators invited people who were not able to eradicate H. pylori although at their
        first visit they had H. pylori sensitive to all antibiotics tested. At first visit all
        patients had stomach biopsy sample taken and H. pylori isolated and therapy prescribed. If
        they did not eradicate bacteria after 2 months they were again invited to control visit to
        define the problem and appropriate therapy prescribed. They were again invitation to
        control visit at the end of June 2010 to see the outcome of therapy.
      
Biospecimen description: 
      Isolated PBMC cell from patients, isolated H. pylori
Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Clopidogrel administration is considered standard of care in patients with stable coronary
      artery disease post PCI. However , a significant proportion of patients is considered
      clopidogrel resistant and this is shown to be accompanied by future adverse events. The
      hypothesis of the study is to define among consecutive outpatient clinics individuals with
      stable coronary artery disease being on chronic clopidogrel treatment, those that are
      clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel
      resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or
      clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment
      crossover will be performed without a washout period. At Day 28 platelet reactivity will be
      assessed as well.
    


Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10mg per day; Clopidogrel 150mg per day
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary angioplasty; clopidogrel resistance; prasugrel
Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      The aim of the present study was to evaluate the association between ferritin levels and
      clinical parameters in patients with fibromyalgia syndrome.
    

Detailed description: 
      This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients
      with non anemic non FMS diagnosis whose ferritin levels were measured within the last four
      weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck
      Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index
      (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin
      level of <30 ng/mL was considered iron deficiency.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This sectional study included 100 female patients older than 18 years of age who presented
        to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.
      
Keywords: Fibromyalgia Syndrome, Ferritin, Sleep