bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
Condition: Exercise Addiction
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The main purpose of the present study is to determine the effects of acute and short-term (14
      days) ginseng combined with branch chained amino acids supplementation on endurance exercise
      performance and the ability of anti-fatigue. In addition, this study also measured the
      performance of continuous attention during recovery period to examine the effect of
      supplementation on central fatigue.
    

Detailed description: 
      Muscle fatigue was a common problem after exercise. When fatigue occured, body functions were
      affected and changed. Changbai Mountain ginseng had higher anti-fatigue substances than
      general commercial ginseng. And recent studies had showed that the supplementation of
      branched chain amino acids (BCAA), including leucine, isoleucine and valine, can increase
      attention and reduce fatigue. However, its effect on Changbai Mountain ginseng combined with
      BCAA was still unclear. Subjects were allocated to Gojinsen® drinks and placebo group (1:1
      ratio) for 14 days, and then examined by maximal oxygen consumption, time to exhaustion,
      rating of perceived exertion (RPE), oxygen saturation (SPO2) , blood lactate concentration,
      and continuous attention performance test (CPT II). The Gojinsen® group significant increased
      maximal oxygen consumption, time to exhaustion, and attention compared to placebo group.
      Moreover, the Gojinsen® group significant decreased lactate concentration and fatigue
      compared to placebo group. By this study, Gojinsen® drinks did not showed absolute
      anti-fatigue effect but provided the objective evidence of fatigue-related measurement and
      the therapeutic potential for people suffering from exercise fatigue.
    

Intervention name(s): Placebo; Gojinsen® drinks
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 1 sachet per day for 14 day; consume 1 sachet per day for 14 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
"Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
Condition: Kidney Donation/Transplantation
Study type: Interventional

Summary: 
      To compare the renal protective properties of two currently used anaesthetic techniques - a
      sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil
      combination for anaesthesia in patients undergoing living donor kidney
      donation/transplantation.
    


Intervention name(s): procedure:sevoflurane-remifentanil/sufentanil; volatile agent only during reperfusion; propofol-remifentanil/sufentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Comparator; Active Comparator; Active Comparator
Intervention MeSH terms: Sufentanil; Remifentanil; Dsuvia; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: renal; transplantation; Volatile; anesthetic
Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome
Condition: Cardiovascular Diseases; Metabolic Syndrome X; Atherosclerosis
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Microvascular Angina; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test higher versus lower doses of aspirin on markers of
      atherosclerosis in patients at risk of a first heart attack.
    

Detailed description: 
      Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in
      patients who have survived a prior event as well as during an acute heart attack. Aspirin
      also prevents a first heart attack.

      Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or
      stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

      Our research is designed to explore whether higher doses of aspirin provide additional
      benefits on markers of atherosclerosis.
    

Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): Dosage
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Primary prevention; Cardiovascular diseases; Aspirin; Metabolic Syndrome X; Atherosclerosis
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength
Condition: Muscle Strength; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but
      also high standard equipment, such as isokinetic dynamometers. These, however, are expensive,
      and require extensive training. Over the years, manual dynamometers were produced, portable
      equipment that simplify its use. Among them, a national equipment was developed, but its
      reliability and validation are yet to be confirmed, compared to equipment already used, such
      as the Lafayette®. OBJECTIVE: Assess the reliability of a new manual dynamometer - Medeor®
      device (SP Tech model) -, in relation to the gold standard, Lafayette® device (model 01165),
      already validated, in the evaluation of muscle strength of the knee and hip groups. METHODS:
      A total of 26 recruits of both sexes were selected. Muscle strength was measured by
      Lafayette® and Medeor® dynamometers in the following groups: knee flexors and extensors;
      flexors, extensors, abductors, adductors, hips internal and external rotators. Each data was
      collected 3 times, and then the average was calculated.
    

Detailed description: 
      Keywords: Muscle Strength; Muscle Strength Dynamometer; Lower Extremity.
    

Intervention name(s): Assessment of muscle strength by manual dynamometry
Intervention type(s): Diagnostic Test
Intervention description(s): The reliability and validation of a new manual dynamometer was verified, compared to one already used, in the muscle groups: knee extensors and flexors; hip extensors, flexors, abductors, adductors, internal and external rotators.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Partial Enteral Nutrition With a Unique Diet vs. Exclusive Enteral Nutrition for the Treatment of Pediatric Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy and tolerability of a novel dietary
      intervention for early CD based on partial enteral nutrition, and to compare it to the gold
      standard but difficult to implement dietary intervention- Exclusive enteral nutrition with
      Modulen .
    

Detailed description: 
      Background: Crohn's disease is clearly on the rise in countries exposed to industrialization
      and western diet. Several factors may implicate diet in the pathogenesis of CD or in disease
      activity. The strongest argument for an effect of diet is the effect of exclusive enteral
      nutrition (EEN) on disease activity in CD. 40-80% of children , fed an exclusive liquid diet,
      irrespective of which diet, will enter complete remission, often with normalization of
      inflammatory markers. The effect of formula has been shown to be independent of fat or
      protein composition in pediatric studies, but to be dependent on exclusion of normal
      diet.Thus, rather than the composition of EEN being associated with remission of disease it
      may be the exclusion of certain components of the Western diet may be responsible for
      improvement.

      Methods:This is a prospective randomized controlled trial, in patients with a recent
      diagnosis of CD (up to two years),aged 4-18, comparing two arms over 12 weeks of therapy.

      Group 1:will receive 50% of their dietary needs from a polymeric formula ( Modulen, Nestle)
      and a limited whole food diet for 6 weeks/ Group 2: will receive EEN with Modulen for 6
      weeks. At the end of 6 weeks, all patients entering remission (irrespective of randomization)
      will enter the second 6 week phase, continuing 25 % of calories as Modulen in both groups.
      Patients in remission from group 2 will continue to consume 25% of calories as Modulen and be
      allowed free diet , patients in Group 1 will continue 25% of calories from Modulen but
      continue restricted diet.

      Patients will be seen at onset (week 0), weeks 3 and 6, 12 and 24 weeks.

      We hypothesize that by withdrawing the offending dietary agents we can achieve an equal
      remission rate with improved tolerability. This study will evaluate response, remission and
      tolerability in both groups, as well as the effects of nutrition on bone health.
    

Intervention name(s): Unique Diet+Partial Enteral Nutrition; Exclusive Enteral Nutrition (Modulen)
Intervention type(s): Other; Other
Intervention description(s): Modulen - liquid dietary formula
Other intervention name(s): Modulen, Nestle; Modulen, Nestle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Crohn's disease; Mild to moderate Crohn's Disease; Diet; Enteral Nutrition
Laparoscopic Myomectomy Using Barbed or Conventional Sutures
Condition: Fibroid
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare operative data and early postoperative outcomes of
      laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using
      conventional sutures .
    

Detailed description: 
      • Till now , there is only one small randomized controllrd study (n=22 in each arm) which
      compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The
      myoma bed was closed with either conventional polyglactin suture or unidirectional barbed
      suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7
      ± 18.6 min) but this difference failed to reach statistical significance because of small
      sample size . However, the time required to suture the myoma beds was significantly lower in
      the barbed suture group .
    

Intervention name(s): myomectomy using barbed sutures; myomectomy using conventional sutures
Intervention type(s): Procedure; Procedure
Intervention description(s): A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . The myometrial edges will be reapproximated in one or two layers (according to the depth of the uterine wound) by using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).; A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . Myometrial edges will be re-approximated using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myomectomy ,Laparoscopy , Barbed sutures
Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the persistence of benefit of LibiGel
      (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of
      Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.
    


Intervention name(s): transdermal testosterone gel 1%; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): 300 mcg once daily transdermal testosterone gel 1%; once daily transdermal placebo gel
Other intervention name(s): LibiGel transdermal testosterone gel 1%; transdermal placebo gel
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: testosterone; hypoactive sexual desire disorder; menopause
Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Aggressive Periodontitis
Study type: Observational

Summary: 
      The current study was performed to study levels of Il-17 and Il-18 in aggressive
      periodontitis patients before and after non surgical periodontal therapy
    

Detailed description: 
      Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the
      current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus
      periodontally healthy controls.

      Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with
      chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing
      depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were
      recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by
      enzyme-linked immunosorbent assay (ELISA).
    

Intervention name(s): non surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): Scaling and root planing
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic periodontitis patients
      
Biospecimen description: 
      GCF samples collected by periopaper strips
Thyroid Hormone for Remyelination in Multiple Sclerosis (MS): A Safety and Dose Finding Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study evaluating the safety and maximum tolerated dose of Liothyronine (T3)
      in subjects with multiple sclerosis
    

Detailed description: 
      This is a pilot, phase I, placebo controlled clinical trial of short-term high-dose thyroid
      hormone to promote remyelination in MS. Permanent clinical disability in MS is likely caused
      by the neuronal damage and degeneration that follows recurrent demyelination with progressive
      failure of remyelination. Thyroid hormone (TH) is required for central nervous system (CNS)
      myelination during development, and CNS remyelination in animal models of MS, a process
      similar to developmental myelination, has also been found to be promoted by TH. This study
      will ascertain the safety, tolerability and maximum tolerated dose of TH in people with MS,
      explore reliability for a potential signal of treatment efficacy and mechanism, and optimize
      procedures for a full scale clinical trial to evaluate the efficacy of pulsed TH for
      promotion of remyelination in MS.

      The safety and tolerability of this treatment will be assessed using subjects' self-report of
      symptoms, the validated Hyperthyroid Symptom Scale (HSS), and blood pressure measurements. a
    

Intervention name(s): Liothyronine sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.; Patient will receive a matching placebo to take twice daily for one week.
Other intervention name(s): Cytomel
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation with monitoring for safety and tolerability, as well as reliability of VEP testing.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroid hormone; Remyelination
An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)
Condition: Schizophrenia, Acute Episode
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial
      of MK-8189 compared with placebo, using Risperidone as an active control. The participants
      will be adult subjects experiencing an acute episode of schizophrenia, according to the
      criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.
      (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each
      participant. The study will consist of a Screening/tapering period (up to one week long), a
      4-week treatment period, and a 14-day follow-up period. The primary objective will be to
      assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during
      treatment and post-treatment follow-up. The secondary objective will be to assess the
      severity of schizophrenia at 4 weeks. The primary hypothesis is that MK-8189 is superior to
      placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from
      baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of
      treatment.
    


Intervention name(s): MK-8189; Risperidone; Placebo matching MK-8189; Placebo matching risperidone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral CR tablets (4 mg) administered QD at the following dose strengths: 4 mg (1 tablet); 8 mg (2 tablets); 12 mg (3 tablets); Oral capsules (2 mg) administered QD at the following dose strengths: 2 mg (1 capsule); 4 mg (2 capsules); 6 mg (3 capsules); Oral placebo tablet(s) matching the MK-8189 tablet, administered QD.; Oral placebo capsule(s) matching the risperidone capsule, administered QD.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of three groups in parallel for the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia, acute episode; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders
Effectiveness of Pharmacotherapy Follow-up Care in Outpatients With Type 2 Diabetes Mellitus
Condition: Pharmaceutical Services
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Hypothesis: Pharmacotherapy follow-up can improve clinical outcomes of outpatients with type
      2 diabetes mellitus.

      Methods: In this single blind, placebo-controlled trial, the participants with type 2
      diabetes mellitus are randomized into two groups:

        1. pharmaceutical care intervention (n=30, attended by the protocol of follow-up) and

        2. control (n=30, attended by the usual procedure of dispensing).

      Primary outcomes evaluated are: hospitalization (percentage of participants hospitalized),
      severe evolving complication - ischemic or proliferative retinopathy, severe renal
      insufficiency, severe hypoglycemia, coronaropathy or evolving foot lesion (presence or
      absence).

      Other parameter checked: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure (BP),
      total cholesterol (TC), waist circumference (WC), body mass index (BMI) and mortality. The
      investigators follow up all patients for up to 12 months.
    

Detailed description: 
      Background. Few Brazilian randomized controlled trials have established the benefits of
      pharmacotherapy follow-up in care of outpatients with type 2 diabetes mellitus in low-middle
      income country. This study evaluate the effectiveness of pharmacotherapy follow-up care to
      get better outcomes in outpatients with type 2 diabetes mellitus attended in the public
      health service in Brazil.

      Method: In this single blind, placebo-controlled trial, the investigators random patients
      with type 2 diabetes mellitus into two groups: 1) pharmaceutical care intervention (n=30,
      attended by the protocol of follow-up) and 2) control (n=30, attended by the usual procedure
      of dispensing).

      Primary outcomes checked are: percentage of hospitalization, severe evolving complication
      (ischemic or proliferative retinopathy, severe renal insufficiency, severe hypoglycemia,
      coronaropathy and evolving foot lesion).

      The investigators also check: A1c hemoglobin (HbA1c), blood glucose (BG), blood pressure
      (BP), total cholesterol (TC), HbA1c/BP, HbA1c/TC, waist circumference (WC), body mass index
      (BMI) and mortality. The participants are followed up to 12 months.
    

Intervention name(s): Pharmacotherapy follow-up care
Intervention type(s): Other
Intervention description(s): The pharmacotherapy follow-up care consists of five pharmaceutical consultations (every up to 2-3 months) aimed to identify, prevent and solve the drug related problems regarding the indication, effectiveness and safety of the use of medicines.
Other intervention name(s): Pharmacotherapy Workup
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pharmacotherapeutic follow-up care known as Pharmacotherapy Workup.
Masking: Single (Participant)
Primary purpose: Health Services Research