bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Vascular Calcification
Study type: Interventional

Summary: 
      study the effect of omega 3fatty acids on the vascular calcification biomarkers Fetuin -A and
      Osteoprotegerin (OPG) in dialysis patients.
    

Detailed description: 
      2-All Participants agreed to take part in this clinical research and provide informed
      consent.

      3-Patients undergo both undergo hemodialysis (HD) will be enrolled from dialysis unit in al
      Moussa Hospital Alexandria.

      4-Serum samples will be collected for measuring the biomarkers. 5-Our design is randomized,
      controlled, open-intervention study. 6- All enrolled patients will be divided into 2 groups,
      Group 1 will be 40 patients that will take omega 3fatty acids and Group 2 will be 20 patients
      will not take omega 3 fatty acids.

      7-All patients will be followed up during 6 months' period. 8-Statsicial tests appropriate to
      the study design will be conducted to evaluate the significance of the results.

      9-Measuring outcome: the primary outcome is the increase of the serum levels of the vascular
      calcification biomarkers after 6months.

      10-Results, conclusions, discussion and recommendations will be given.

      Inclusion criteria:

        -  60 hemodialysis patients, (20-80) years old.

        -  Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at
           least 6months).

      Exclusion Criteria:

      People with active infections (fever or any evidence of infections), known malignancy,
      connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current
      use of warfarin ,history of fish oil/omega 3 allergies were excluded.

      Methodology:

        -  Feutin-A and Osteoprotegrin (OPG) will be determined by ELISA.

        -  Serum lipid levels, phosphorus, calcium, Parathormone (i-PTH), alkaline phosphatase,
           albumin and creatine levels.

        -  BMI
    

Intervention name(s): Omega 3 fatty acids (fish oil) 1000 mg/day oral
Intervention type(s): Dietary Supplement
Intervention description(s): Omega 3 fatty acids (fish oil) 1000 mg/day oral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: enrolled patients will be divided into 2 groups, Group 1 will be 40 patients that will take omega 3fatty acids and Group 2 will be 20 patients served as control will not take omega 3 fatty acids.
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of an Early Rehabilitation Program During Hospitalization in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen
      consumption, reduce effort-induced lactic acid production, and increase skeletal muscle
      oxidative capacity, as well as psychological aspects such as increased self-esteem and
      improvement of the quality of life.

      In the literature there is only one study involving rehabilitation in hospitalized pediatric
      patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is
      required in adult cystic fibrosis patients.

      The present study aims to evaluate the effects of an early rehabilitation program, based on
      aerobic training and muscle strength training, in adolescent and adult patients with cystic
      fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung
      disease.
    

Detailed description: 
      After completing the study inclusion criteria, the individual will be invited to participate
      and will receive the consent form for signature.

      The patient will be submitted to the following evaluations: quality of life questionnaire for
      cystic fibrosis, spirometry, Shwachman-Kulczycki score, modified dyspnea questionnaire
      (Modified Medical Research Council), maximum repetition test, six minute walk test and blood
      sample for the determination of inflammatory markers. These evaluations should be performed
      within the first 48 hours of hospitalization, and will be repeated on the last day of
      hospitalization.

      In the period up to 48 hours after hospital admission, patients will be randomized to either
      the intervention group or the control group.
    

Intervention name(s): Exercise; Control
Intervention type(s): Other; Other
Intervention description(s): Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive an early rehabilitation program, which will begin within the first 48 hours after admission. The patient will perform physical training (aerobic and anaerobic) 5 times a week during the hospitalization period, with sessions about an hour. The professional who supervises the training will be blinded to the results of the measurements.; Patients randomized to the control group will continue to receive the physiotherapeutic follow-up performed by the physiotherapist of the Program for Adults with CF during the hospitalization period. Supervision includes respiratory physiotherapy involving inhalation therapy and techniques for removal of secretions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect
      feasibility, usability, and engagement data, for patients receiving medications for opioid
      use disorder (mOUD).
    


Intervention name(s): MORE-VR
Intervention type(s): Other
Intervention description(s): Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      The purposes of this study are to prospectively determine the effect of a very low
      carbohydrate diet on quality of life and gastrointestinal symptoms in patients with
      diarrhea-predominant irritable bowel syndrome (IBS-D); and to determine possible
      physiological correlates of symptom improvement, as related to post-prandial
      5-hydroxytryptamine (5-HT) release, weight loss and fiber content.
    

Detailed description: 
      Approximately 10-15% of individuals in the United States have symptoms consistent with
      irritable bowel syndrome (IBS) which is a costly disorder and negatively impacts patient
      quality of life. The pathogenesis of this heterogeneous disorder is still not well
      understood. Patients frequently identify worsening of symptoms after meals and often cite
      particular foods as triggers of their IBS symptoms. Unfortunately, there is insufficient
      randomized clinical trial data to allow for specific dietary recommendations. Previous
      research has suggested a role for carbohydrate ingestion in IBS. There is also evidence for
      the role of the post-prandial release of 5-hydroxytryptamine (5-HT) and its turnover (as
      represented by the ratio of its metabolite, 5-hydroxyindoleacetic acid (5-HIAA), to 5-HT in
      response to a carbohydrate-rich meal, especially in those with IBS-D. As the prevalence of
      overweight (body mass index [BMI] > 25 kg/m2) and obesity (BMI > 30 kg/m2) has risen in
      recent years, very low carbohydrate diets have become popular for those attempting to lose
      weight. Patients with IBS, especially IBS-D, anecdotally report improvement in their
      gastrointestinal symptoms after initiating a very low carbohydrate diet. However, no study
      has investigated the effect of a very low carbohydrate diet on symptoms and quality of life
      in patients with IBS-D.
    

Intervention name(s): Very low carbohydrate diet
Intervention type(s): Other
Intervention description(s): 4 weeks on strictly controlled low carbohydrate diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: D-IBS (diarrhea predominant irritable bowel syndrome)
Intraoperative Bleeding During Endoscopic Sinus Surgery
Condition: Blood Loss
MeSH terms: Blood Loss, Surgical
Study type: Interventional

Summary: 
      The purpose of this study is to compare the blood loss during sinus surgery looking at two
      different types of anesthesia: either intravenous anesthesia with propofol or inhalational
      anesthesia with sevoflurane.
    


Intervention name(s): propofol; sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): 100-200mcg/kg/min by infusion; 1-3% of sevoflurane (expired)
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
      (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and
      ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who
      have not responded to previous treatment. The primary efficacy objective is to estimate
      efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of
      participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks
      after completion of all study therapy (Sustained Viral Response 24 [SVR24]).
    


Intervention name(s): Vaniprevir; peg-IFN; ribavirin
Intervention type(s): Drug; Biological; Drug
Intervention description(s): Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 24 weeks; Open-label peg-IFN alfa-2b at 1.5 μg/kg once per week, administered subcutaneously (SC) for 24 weeks; Capsules containing 200 mg RBV, orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 weeks
Other intervention name(s): MK-7009; PegIntron; REBETOL®
Intervention MeSH terms: Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will
      be treated for 48 weeks with lacquer application to at least one affected great toenail. All
      subjects will receive treatment with EcoNail™ lacquer.
    

Detailed description: 
      This study will use a multi-center, open-label study design in subjects with onychomycosis of
      at least one great toenail to assess the safety, local tolerability, and efficacy of chronic
      daily ungual application of EcoNail™. Forty (40) evaluable subjects will apply study drug
      daily to at least one affected great toenail for 48 weeks. The subjects must comply with all
      inclusion and exclusion criteria.
    

Intervention name(s): EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)
Intervention type(s): Drug
Intervention description(s): nail lacquer applied daily for 48 weeks
Other intervention name(s): econazole; SEPA
Intervention MeSH terms: Econazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: toenail; fungus; onychomycosis; antifungal; anti-fungal; nail
Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus
Condition: Diabetic Foot Infections
MeSH terms: Diabetic Foot; Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or
      II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS
      score of 0 to 3 and DFI wound score of 1 to 3.
    

Detailed description: 
      The study is designed to run the cohorts in series with the completion of the first cohort
      before initiating the next dosing level. At all study visits the ulcer will be visually
      examined for any changes and photographed using the Aranz Medical Silhouette™ system that
      will calculate area and depth of the ulcer.

      In Arm 1, eligible subjects will be treated with a single application of Nu-3 or placebo in 4
      to 1 ratio to judge the initial safety of Nu-3 over a brief one (1) hour interval and 24-hr
      interval post application. Bisphosphocin Nu-3 will be applied topically to the chronic
      infected ulcer, covered with a non-abrasive bandage following the initial observation period.
      The subject will be released with verbal instructions to leave the bandage on the wound and
      return for a follow up visit within 24h ± 2h. At the follow up visit, the bandage will be
      removed, the ulcer visually examined and the subject cleared for the MAD Arm 2 based on the
      recommendation of the PI and absence of any SAEs.

      In Arm 2, eligible subjects which are those who have been approved by the PI after the Visit
      2 examination will be instructed in the proper application of bisphosphocin Nu-3. The
      subjects will be observed applying the first dose in the clinic to ensure compliance.
      Subjects will then be given a 7 day supply and sent home to continue treatment. Visit 4 or
      earlier in the case of any adverse events, subjects will return to the clinic for an
      examination, including visual examination of the ulcer, vital signs, adverse events, photo
      documentation, collection of a sample for microbiology and concomitant medication use. A
      final follow up visit will be scheduled +7 days after last dose of study medication (Day 15)
      for a complete examination as described above.
    

Intervention name(s): Bisphosphocin Nu-3; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Nu-3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to
      form blood clots is missing or not present in sufficient levels. In a person with haemophilia
      A, the clotting process is slowed and the person experiences bleeds that can result in
      serious problems and potential disability.

      The current standard treatment for severe haemophilia A is regularly scheduled infusion of
      FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII,
      prophylaxis may require treatment as often as every other day.

      In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is
      evaluated in subjects with severe Hemophilia A.

      120-140 patients will receive open label treatment with long-acting rFVIII either on-demand
      to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension
      to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic
      treatment will receive study drug at dosing intervals between once and twice a week depending
      on their observed bleeding. Patients will attend the treatment centre for routine blood
      samples and be required to keep an electronic diary.

      Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at
      least 50 exposure days may be eligible for this study.
    

Detailed description: 
      Subjects in prophylactic treatment arms will undergo clinical evaluation at 10 weeks. Those
      with adequate control of bleeding will undergo randomization to every 5 or 7 day infusion.
      Those with continued bleeding will remain in treatment arm and have an increase in dose.

      Part B-major surgery - optional sub study included to collect information on efficacy of
      BAY94-9027 in major surgical setting. Due to rarity of surgery in this population, enrollment
      to this sub-study may be independent of participation in main study.
    

Intervention name(s): BAY94-9027
Intervention type(s): Biological
Intervention description(s): Intravenous infusion of BAY94-9027
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A, factor VIII, prophylaxis
Prevention of Hamstring Injuries in Football Players.
Condition: Hamstring Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Introduction: The prevalence of hamstring injuries in football is high, causing an increase
      in the number of casualties and a high socio-economic cost. Currently there are different
      treatment protocols for this muscle group, but there are often no comparisons of different
      types of passive, active and combined therapies, and their potential efficacy, in
      professional football players.

      Objectives: To compare the efficacy of three different interventions; passive manual therapy,
      active therapy based on therapeutic exercise and combined therapy, in relation to hamstring
      injuries in professional football players.

      Methodology: A simple Randomised Clinical Trial (RCT) was conducted (NCT04935398). After
      applying the selection criteria, a sample of 66 professional football players was obtained.
      They were divided into 3 intervention groups (A, B and C) with 22 participants in each group
      and were given passive manual therapy, active therapy (exercise) and combined therapy (sum of
      the above). The corresponding tests and questionnaires were evaluated to obtain data on
      hamstring flexibility and hip range of movement at three time periods: pre, post and post2.
    


Intervention name(s): Passive Neurodynamics and Passive axial hip mobilisation/distraction; Active therapy; 2.5.3. Combined therapy
Intervention type(s): Other; Other; Other
Intervention description(s): The physiotherapist performs passive techniques on the hamstring muscles and the nerve that innervates the hamstring muscles.; Active lumbopelvic CORE control exercises and active stretching of the ischiopelvic nerves; The physiotherapist performs passive techniques on the hamstring muscles and the nerve that innervates the hamstring muscles and active lumbopelvic CORE control exercises and active stretching of the ischiopelvic nerves.
Other intervention name(s): Active Neurodynamics and Therapeutic exercise; Passive and Active therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: physiotherapies techniques; Range of Motion; Hamstring Muscles; Prevention and Control; Muscuoeskeletal Manipulations.
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover,
      comparative bioequivalence study.
    

Detailed description: 
      The study was an open label, randomised, two-treatment,two-period, two-sequence, single-dose,
      crossover,comparative bioequivalence study of Naproxen Sodium 550 mg tablets (containing
      naproxen 500 mg) manufactured by Dr. Reddy's Laboratories, ltd, Generics, India compared with
      ANAPROX® DS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche
      Laboratories Inc. 340 Kingsland Street, New Jersey; in healthy,adult, human subjects under
      fed conditions with a wash out period of 10 days between two periods.
    

Intervention name(s): Naproxen Sodium
Intervention type(s): Drug
Intervention description(s): Naproxen Sodium Tablets 550 mg
Other intervention name(s): Anaprox DS 550 mg
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Naproxen; crossover
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate
Condition: Clomiphene Citrate; Resistant Ovary Syndrome; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Primary Ovarian Insufficiency; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of
      polycystic ovary.
    

Detailed description: 
      Clomiphene, PTX and ALA each used in treatment of pco but they do so by different mechanisms.

      Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It
      works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and
      subsequently gonadotropin from the anterior pituitary.

      PTX and ALA are used in treatment of pco due its anti-oxidant effect.
    

Intervention name(s): Alpha lipoic acid (ALA); Pentoxifylline (PTX); Clomiphene Citrate
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.; Pentoxifylline is a methylxanthine derivative which acts as a vasodilator by increasing blood flow to tissues, inhibits inflammatory responses, and reduces blood viscosity by impeding platelet aggregation; is a medication used to treat infertility in women who do not ovulate
Other intervention name(s): thiotacid; trental; clomid
Intervention MeSH terms: Thioctic Acid; Pentoxifylline; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled open label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pentoxifylline; alpha lipoic acid; polycystic ovary; clomiphene