bioihbjkbjnl/mcl2 huggingface dataset:
Role of Core Exercise in Treatment of Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      the purpose of this study is to investigate the effect of core exercises on health status,
      pain, pressure pain thresholds and functional capacity in patients with FM
    

Detailed description: 
      Fibromyalgia (FM) is a chronic non-degenerative disease of unknown etiology without effective
      medical treatment that mostly affects women. At present, the diagnostic and classification
      criteria are still under debate. As a result, the treatments for FM are also under
      investigation. No single treatment has achieved a reduction in the symptoms. Its occurrence
      increases with age. Exercise is one of the treatment approaches where effectiveness in the
      management of FM is supported by stronger evidence. Besides, recent reviews found that
      exercise has a positive effect on pain, physical function and health-related quality of life
      .with no associated adverse effects. Among the different exercise modalities available, core
      stability training has shown its effectiveness by improving static and dynamic balance,
      functionality and risk of falls, pain and quality of life. so This study will be conducted to
      investigate the effect of core exercises on health status, pain, pressure pain thresholds and
      functional capacity in patients with FM
    

Intervention name(s): core exercise; traditional therapy
Intervention type(s): Other; Other
Intervention description(s): the patients will receive seven exercises performed in crook lying and side lying position on exercise mats. Cushions were used to allow the participants to be comfortable in all positions. The exercises in the crook lying position were core activation with breathing, single-leg lift with knees bent, single-leg slides, bridging and knee drop sideways. The exercises completed in side lying included hip external rotation with knees bent and hip abduction with knees straight.; the patients will receive : an active warm-up including low intensity movements and dynamic stretching; choreographed aerobic training, progressing gradually from low to moderate intensity; and a cool-down involving low intensity movements, and dynamic and static stretching
Other intervention name(s): aerobic exercise
Intervention model: Single Group Assignment
Intervention model description: core exerscie
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia syndrome; core exercise; aerobic exercise; pressure pain threshold
IVF Outcome Following Progestogen Ovarian Stimulation
Condition: IVF; Oocyte Maturation Defect 1; Clinical Pregnancy Rate; Ovarian Hyperstimulation
Study type: Interventional
Phase: Phase 1

Summary: 
      The new strategy is by using the progestogen to block the luteinizing hormone(LH) surge
      either endogenous during luteal phase stimulation, or exogenous in the follicular phase i.e
      progestin primed ovarian stimulation (PPOS). The goal of PPOS is to develop a single dominant
      follicle. Various types of oral Progestin had been studied before including
      Medroxyprogesterone Acetate (MPA) and Utrogestan with different dosage. A different study by
      Wang et al conducted by using MPA to patients with PCOS. The use of MPA is contraindicated in
      human pregnancy whereas Dydrogesterone had been extensively used worldwide for the treatment
      of threatened miscarriage as well as luteal support in infertility setting. Previous protocol
      on PPOS showed inconclusive results. Therefore in this study, Dydrogesterone was used as the
      Progestin Primed Ovarian hyperstimulation to explore its effect on PCOS women IVF outcome.
    

Detailed description: 
      This is a prospective controlled cohort study conducted at the Department of Medical Assisted
      Conception (MAC) unit of the University Kebangsaan Malaysia Medical Centre (UKMMC). From May
      2018 through May 2019, women with Polycystic Ovarian Syndrome (PCOS) undergoing
      IVF/intracytoplasmic sperm insemination(ICSI) regimens for the treatment of infertility were
      recruited.

      Patients recruited will then be randomized accordingly using the randomizer software. Group A
      will be the interventional group and group B will be the control group.

      Oocyte retrieval will be performed 34-36 hours following the human chorionic gonadotrophin
      (hCG) trigger. Sperm was obtained on the same day. Mature oocytes will be fertilized with
      sperm via IVF or ICSI. Fertilized embryos were observed via time laps method and the progress
      and cleavage were monitored before planning for embryo transfer. Embryo transfer will be
      performed on day 3 or day 5 after oocyte retrieval.

      All results will be analyzed using Statistical Package for the Social Sciences(SPSS) version
      21 software. Descriptive analysis will be done for demographic data and presented in mean ±
      Standard deviation (SD). Demographic characteristic between the two groups will be compared
      with the use of the Mann-Whitney U test. The categorical data was analysed by using
      Chi-square test for the association of variables. A p-value of 0.05 or less was considered to
      be significant.
    

Intervention name(s): Dydrogesterone Pill
Intervention type(s): Drug
Intervention description(s): started from day 1 of menses till trigger day
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: progestogen; ovarian stimulation regime; IVF outcome
S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000
Condition: Colorectal Cancer; Precancerous Condition
MeSH terms: Precancerous Conditions
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on
      the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors
      predict a participant's response to treatment and help plan the best treatment.

      PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on
      colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the effect of selenium on colorectal adenoma (CRA) occurrence.

        -  To assess the effect of selenium on number, location, size, histologic type, and degree
           of dysplasia of CRA.

        -  To assess the effect of selenium on colorectal cancer (CRC) incidence.

      Secondary

        -  To assess the effect of vitamin E on CRA occurrence.

        -  To assess the effect of vitamin E on CRC incidence.

      Tertiary

        -  To explore the effect modification of selenium and vitamin E by aspirin on CRA
           occurrence.

        -  To explore the effect modification of selenium and vitamin E by body mass index.

      OUTLINE: This is a multicenter study.

      Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the
      presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number,
      location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed
      to exclude a diagnosis of colorectal cancer.

      Additional data, including aspirin use, height and weight, date of birth, and other
      demographic and baseline characteristics, is also obtained. Participants' medical records are
      reviewed periodically.

      Participants are followed annually.
    

Intervention name(s): Vitamin E; Selenium; Vitamin E placebo; selenium placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400 IU daily by mouth for 7 - 12 years; 200 mcg daily for 7 - 12 years; 1 pill by mouth daily for 7 - 12 years; 1 pill by mouth daily for 7 - 12 years
Other intervention name(s): alpha tocopherol; L-selenomethionine; placebo; placebo
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer; adenomatous polyp
Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors
Condition: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Cancer Survivor; Overweight; Postmenopausal; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8
MeSH terms: Breast Neoplasms; Overweight; Frailty
Study type: Interventional

Summary: 
      This trial studies how well weight bearing exercise works in preventing frailty in stage
      I-IIIA breast cancer survivors. Weight bearing exercise, including muscle-strengthening,
      aerobic, flexibility, and balance exercises, can decrease fat and increase muscle, which may
      lead to reduced frailty.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Demonstrate reproducibility of forearm muscle activation and subcutaneous fat measures in
      a healthy convenience sample/population (N= 10).

      II. Demonstrate that measures of muscle activation and signal attenuation by subcutaneous fat
      mass can be conducted in a systematic and reproducible fashion in breast cancer survivors
      prior to and following weight bearing exercise training.

      III. In a cross sectional analysis, describe the level of lean muscle mass, muscle
      activation, strength, insulin resistance, inflammatory cytokines and growth factors, and
      inter-individual variability in breast cancer survivors prior to training.

      IV. Describe the level of lean muscle mass, muscle activation, strength, insulin resistance,
      inflammatory cytokines (such as IL-6, CRP and others), and growth factors (such as myostatin,
      IGF-1, IGFBP-3 and others) in breast cancer survivors following weight bearing exercise
      training.

      V. Evaluate the influence of genetic variability on response to prescribed training in breast
      cancer survivors.

      OUTLINE:

      Participants undergo a weight bearing exercise program in a group 2 days a week and at home 5
      days a week for 8 weeks.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): Undergo weight bearing exercise program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
HER Salt Lake Initiative
Condition: Birth Control; Contraception
Study type: Observational

Summary: 
      This study aims to understand the long-term health, social, and economic impacts of
      transitioning a community to Highly Effective Reversible Contraception (HER-C).
    

Detailed description: 
      The persistently high rate of unintended pregnancy in the US suggests an inadequacy of
      current prevention models and a need for new approaches to contraceptive acceptability and
      promotion. Although popularity of Highly Effective Reversible Contraception (HER-C) in the US
      is steadily increasing, less than 10% of contracepting women use intrauterine devices (IUDs)
      or subdermal contraceptive implants, which are the most effective methods for avoiding
      unintended pregnancy.

      Poverty is an important predictor of unintended pregnancy where women with incomes below the
      Federal Poverty Level (FPL) have over a five-fold increased risk of unintended pregnancy
      relative to women with higher incomes. Because of limited public funds for family planning,
      low-income women in Salt Lake County have limited access to HER-C, which has high initiation
      cost but significant cost-saving potential over time. Additionally, contraceptive research
      has inadequately measured the social impact of HER-C.

      The first aim of the HER Salt Lake Initiative is to evaluate the increase in HER-C methods
      with three strategies: 1) Client centered contraceptive counseling; 2) Removal of financial
      barriers; and 3) Targeted media campaigns.

      The second aim of the HER Salt Lake Initiative is to assess changes in earnings and education
      among women initiating HER-C compared to other methods of contraception and model the
      projected lifetime earning potential of women based on their contraceptive method choices.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females 16-45 years of age, who desire to prevent pregnancy for at least one year and are
        seeking contraceptive counseling and long term contraception services in Salt Lake County.
      
Keywords: Birth Control; Contraception; IUD
A Phase 2b Diabetic Kidney Disease Study
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and
      Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
    

Detailed description: 
      This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to
      evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care,
      including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers
      (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects
      with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of
      25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility
      criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506
      dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will
      receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary
      objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD.
      Secondary objectives include evaluating safety, PK and the incidence of ADA during the
      treatment period.
    

Intervention name(s): MEDI3506; Placebo; Dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose 1, Dose 2, Dose 3, Dose 4; Placebo; Dapagliflozin 10 mg
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized to receive MEDI3506 or placebo as follows:
Group 1: MEDI3506 Dose 1. Group 2: MEDI3506 Dose 2. Group 3: MEDI3506 Dose 3 Group 4: MEDI3506 Dose 4 Group 5: Placebo (volume matched) All subjects will receive Dapa from Day 85 to Day 168.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Association Between Psoriasis and Intestinal Bacterial Population
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis
      Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal
      bacterial populations will be compared in order to examine whether there are differences
      between the groups.
    

Detailed description: 
      Intestinal bacterial population has a significant influence on health and sickness
      conditions. It affects the development and the function of the immune system (Th2, Th1 or
      Th17) by bacterial protein expression and by the composition of the bacterial population.

      Psoriasis is an immune related dermal disease. The trigger for this disease is currently
      unknown but, it is possible that intestinal bacteria are a factor in its development.

      Study design:

      Participants will be divided into 3 groups:

        -  Psoriasis patients treated with topical medications

        -  Psoriasis patients treated with IV or sub-cutaneous medications (e.g biological
           medications)

        -  Healthy participants (control group) Bacterial genomic DNA will be extracted from stool
           samples of participants. The intestinal bacterial populations will be compared in order
           to examine whether there are differences between the groups.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both psoriasis patients and healthy participants (as a control group) will be recruited for
        the study.
      
Biospecimen description: 
      stool
    
Keywords: psoriasis; microbiota
Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery
Condition: Wound Sepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      efficacy of adding azithromycin to cephalosporin before cesarean delivery
    

Detailed description: 
      efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious
      morbidity following cesarean delivery in high risk women
    

Intervention name(s): cephalosporin; Azithromycin Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision; 72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
Intervention MeSH terms: Azithromycin; Cephalosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Muscle Weakness After Anterior Cruciate Ligament Reconstruction
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The main aims of the study are (1) to examine the impact of contralateral strength training
      on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of
      cross-education induced by NMES versus eccentric strength training.
    


Intervention name(s): Neuromuscular electrical stimulation; eccentric training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct
      therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease.
      Mesdopetam is taken for 84 days.
    

Detailed description: 
      At the screening visit consenting patients will be screened for eligibility according to
      study specific inclusion/exclusion criteria within 8 weeks before start of Investigational
      Medicinal Product (IMP) administration. A diary concordance training will be performed and
      following the screening visit the patient will be asked to self-administer three 24-hour home
      diaries and to bring the completed diaries to the baseline visit for assessment prior
      randomization.

      At the baseline visit, patients will be randomized to receive one of three doses of
      mesdopetam (dose 1, dose 2 and dose 3) or placebo b.i.d.

      During the first week a dose run-in phase will take place, where all patients allocated to
      mesdopetam will receive a run-in dose of mesdopetam twice daily and patients allocated to
      placebo will receive placebo twice daily. At Visit 2, patients will receive mesdopetam dose
      1, dose 2 or dose 3 or placebo b.i.d., as randomized and continue the same dose for the rest
      of the treatment period until EOT. Dose reductions are restricted and the dose can only be
      reduced once. Dose reductions are permitted from visit 2 (day 9) until visit 3 (day 28),
      where after the dose should be kept stable until EOT.

      The treatment allocation will be double-blind, i.e. it will not be disclosed to the patients,
      the site staff or the Sponsor.

      During the treatment period, changes in disease state and ON phase dyskinesia will be
      assessed using the MDS-UPDRS, the modified UDysRS (i.e. parts 1, 3 and 4), and Clinician's
      Global Impression of Severity (CGI-S). Furthermore, patients will self-administer three
      24-hour home diaries prior to visit 3 (week 4), visit 4 (week 8) and visit 5 (week 12) to
      assess daily motor function.

      Blood samples for pharmacokinetic (PK) analysis will be collected at visit 4 (week 8) and
      visit 5 (week 12).

      Visit 6 (follow-up) will be performed for all patients, including any patients that
      discontinue the IMP early, 5-8 days after last administration of IMP.
    

Intervention name(s): Mesdopetam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral use; Oral use
Other intervention name(s): IRL790
Intervention MeSH terms: Mesdopetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment