bioihbjkbjnl/mcl2 huggingface dataset:
The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus
Condition: Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was the evaluation of cardiovascular benefits of Zingiber officinale
      Roscoe in patients with type 2 diabetes mellitus before and after 6 weeks of add-on therapy.
    

Detailed description: 
      the investigators performed a non-randomized single-arm clinical trial with a before and
      after design, carried out from December 2016 and May 2017.

      Intervention consisted of the administration of powdered ginger extracts in the form of
      capsules at a dose of 2g/day, for a period of 6 weeks. Before and after intervention, the
      following were done by the participants: bioelectrical impedance analysis (BIA), blood
      pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests,
      kidney function tests and full blood counts. These were followed by morphological workup
      including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood
      Pressure Measurements (ABPM), also done before and after intervention.

      Clinical evaluation with fasting blood sugar control and blood pressure controls were done at
      day 21 for safety purposes.
    

Intervention name(s): GINOFF1
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention lasted for six weeks and consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Diastolic function; Blood pressure; Zingiber officinale
Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of oral topical application of
      Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis
    

Detailed description: 
      This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two
      doses of ACCS will be used. It will be given topically intra-orally daily Monday through
      Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random
      chance. If there are no safety issues, cohort two will include a higher dose of ACCS
      randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing
      will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative
      microbial analysis will be performed for common oral bacteria. There will also be an analysis
      of inflammatory cytokines in crevicular fluid at the beginning and end of the study.
      Comparisons of adverse events and outcomes will be made between the subjects receiving low
      dose ACCS, high dose ACCS, and saline.
    

Intervention name(s): 1X ACCS (Amnion-derived Cellular Cytokine Solution); Normal saline; 0.3X ACCS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks; Saline will be applied to the gingival margin daily 5 days per week for 2 weeks; 0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
Other intervention name(s): ACCS; saline placebo; Diluted ACCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis; Periodontitis; ACCS
S-BLR Versus C-BLR for CI-IXT in Children
Condition: Convergence Insufficiency Intermittent Exotropia (CI-IXT)
MeSH terms: Exotropia; Ocular Motility Disorders
Study type: Interventional

Summary: 
      This is a multi-center, randomized single-blind controlled trial to compare the effectiveness
      of S-BLR with C-BLR for the treatment of CI-IXT in children.

      Specific Aim 1 (Primary): To compare the surgical successful rate of S-BLR with C-BLR for the
      treatment of CI-IXT in children.

      Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between S-BLR and C-BLR
      for the treatment of CI-IXT in children.
    

Detailed description: 
      Using conventional surgical procedures, higher postoperative near undercorrection and/or
      distant overcorrection rates were observed in CI-IXT. To achieve better outcome, S-BLR was
      introduced. Previous studies showed its efficacy in reducing near exodeviation, distant
      exodeviation, and NDD. So far, only limited studies have directly evaluated the surgical
      outcomes between S-BLR and C-BLR. The pilot study done by Snir et al included 12 patients
      with S-BLR and 6 patients with C-BLR and the success rates of S-BLR vs C-BLR were 92% vs 0 at
      one-year follow-up. The retrospective study done by Song et al included 17 patients
      undergoing S-BLR and 14 patients undergoing C-BLR. With stricter successful criteria, the
      success rates of S-BLR vs C-BLR were 35% vs 7% at six-month follow-up. A large randomized
      trial is needed to compare the surgical successful rate and suboptimal surgical outcomes of
      S-BLR with C-BLR in children with CI-IXT.

      The proposed trial will be conducted in 6 different study sites working in the field of
      pediatric ophthalmology and strabismus.Each site will have one certified surgeon to do all
      surgeries. Under general anesthesia, the LR recession is performed using an inferior-temporal
      fornix incision. For S-BLR, the lower horn of the LR is recessed based on near exodeviation
      and the upper horn is recessed based on distant exodeviation. For C-BLR, the LR is recessed
      based on distant exodeviation. Surgical dose is according to the largest preoperative
      exodeviation at distance (6 meters) or near (1/3 meter) by the prism and alternate cover
      test(PACT). The extent of the recession is based on Parks' surgical dosage schedule.
    

Intervention name(s): S-BLR; C-BLR
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgery of slanted bilateral LR recession for CI-IXT patients; Surgery of conventional bilateral lateral rectus recession for CI-IXT patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Superior Silybin Bioavailability in Healthy Volunteers
Condition: Liver Diseases; Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Twenty-four healthy volunteers of both genders, aged 18 to 44 years old and body mass indexes
      between 18 to 27 kg/m2,were selected to participate in a two-way, balanced, prospective,
      blind, single-dose crossover study with a one-week wash-out period. It was assessed that
      volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological,
      gastrointestinal and hematological diseases. The volunteers clinical evaluation were
      determined by clinical examination, ECG, and the following laboratory tests: blood glucose,
      urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric
      acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis.
      All subjects were negative for HIV, HBV, and HCV.
    

Detailed description: 
      In healthy volunteers single-dose crossover study with a one week, It was assessed that
      volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological,
      gastrointestinal and hematological diseases. The volunteers clinical evaluation were
      determined by clinical examination
    

Intervention name(s): Sylimarin and Sylibin
Intervention type(s): Other
Intervention description(s): We compared the plasma levels of Silibinin after a dosage of Silibinin-phosphatidylcholine complex, equivalent to 45 mg Silybin oily-medium soft-gel capsules after the conventional 70-mg Silymarin tablets, in 23 healthy volunteers
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All healthy volunteers
      
Keywords: liver fibrosis; Hepatoprotective; Sylimarin
Effect of Collagenase on Healing and Scarring
Condition: Scarring; Impaired Wound Healing
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6
      and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment
      versus vehicle alone.
    


Intervention name(s): Collagenase Santyl; Collagenase Santyl Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Dermatome-induced skin wounds treated with drug active.
Each subject serves as his own control receiving both treatments in parallel.; Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: wound healing; scarring; collagenase; Santyl
Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study
Condition: Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The main aim of the study is to determine if an oral supplementation of the LCS has a
      beneficial effect by itself or even enhances the beneficial effects of a moderate life-style
      intervention on the progression of NAFLD in humans.
    


Intervention name(s): Nutritional Counseling; Lactobacillus casei shirota (LCS); Nutritional Counseling and LCS
Intervention type(s): Behavioral; Dietary Supplement; Other
Intervention description(s): Nutritional counseling by a trained nutritionist for 12 weeks.; The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.; Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.
Other intervention name(s): Yakult plus; Nutritional Counseling and Yakult plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Histologically confirmed NASH; Hepatocyte Injury determined by M30 antigen
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BI
      1819479 in healthy male Japanese subjects receiving single rising doses (SRD) in order to
      provide the basis for a clinical development of BI 1819479 in Japan.
    


Intervention name(s): BI 1819479; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1819479; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Trial of Music During Labor and Delivery
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The use of music is widely supported in various areas of medicine: first of all in the
      psychiatric field as in the treatment of autism in children, obtaining surprising results
      even on Alzheimer's patients, or the unparalleled effect of music on those suffering from
      depression. To strengthen the thesis of the usefulness of music in medicine there is what is
      called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of
      mutual interactions between mental activity, behavior, nervous system, endocrine system and
      immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the
      body, but using the principles of the empirical epistemology of the scientific method strives
      to clarify those connections that make the nervous system, mind, immunity and hormonal
      regulation a unique and complex homeostatic control system of the individual, whose synergism
      would be able to modify certain biological behaviors, such as the transition from a distress
      to an eustress. This passage would seem to be of particular obstetric interest going to
      significantly change the course of labor in terms of pain, anxiety and well-being of women.
      In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during
      labor.

      A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor,
      confirming its role in this sense. However, he concluded that the quality of available
      evidence varied from low to very low, thus highlighting the need for further studies in this
      area.

      Thus, the present study arises with the rational to satisfy this need for further
      investigation into the positive effects of music on pain in women in labor.
    


Intervention name(s): music
Intervention type(s): Other
Intervention description(s): music during labor and delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Impact of Fructose Restriction in Obese Children
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The sugar fructose has been implicated not just as a cause of obesity, but as a cause of the
      metabolic diseases that go along with obesity, termed "metabolic syndrome". Obese children
      with metabolic disease will be studied before and after 10 days of a fructose restricted
      diet. The question is whether their co-morbidities will improve, even if weight remains
      constant.
    

Detailed description: 
      Recent studies suggest that specific types of macronutrients in the diet may have selective
      effects on nutrient absorption, insulin sensitivity, and lipid metabolism. Elucidation of the
      metabolic impact of specific dietary components may well result in improved efficacy of
      lifestyle approaches to reduce obesity and metabolic diseases. Despite similar fructose
      consumption, the phenotype of co-morbidities is different between African Americans and
      Latinos. Latino and Caucasian children manifest worsened dyslipidemia and non-alcoholic fatty
      liver disease (NAFLD), while African American children manifest worsened insulin resistance
      and hypertension. We have also documented in adults that a reduction in de novo lipogenesis
      (DNL; production of new lipids) in the liver and liver fat content, and improvement in
      hepatic insulin sensitivity were achieved by substitution of complex carbohydrate for
      fructose; but these changes appeared less dramatic in African American compared to Latino or
      Caucasian subjects. These divergent findings suggest ethnic and race-specific differences of
      fructose metabolism and disposition.

      To determine whether fructose is a contributor to metabolic co-morbidity in children, we will
      conduct a convenience cohort within-subject intervention with repeated measures, stratified
      by racial/ethnic group (Latinos vs. African Americans vs. Caucasians). The intervention will
      consist of restricting fructose ingestion only to naturally-occurring fructose in fruits and
      vegetables (approximately 15 gm/day for 10 days), by substituting complex carbohydrate for
      excess dietary fructose, while maintaining neutral energy balance. We anticipate fructose
      restriction to differentially improve co-morbidities in different racial/ethnic groups.
    

Intervention name(s): fructose restriction diet
Intervention type(s): Other
Intervention description(s): fruits and vegetables only
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; metabolic syndrome; insulin resistance; intrahepatic fat; hypertension
Topical Tranexamic Acid (TXA) in Hip Fractures
Condition: Hip Fracture; Anemia
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical
      benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication
      with low complication risk. Its use in the hip fracture population is unproven. The purpose
      of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction
      of peri-operative blood loss in hip fracture surgery.
    

Detailed description: 
      The results of this study may dramatically alter the manner in which surgeons manage hip
      fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture
      patients has the potential to reduce perioperative blood loss and consequently reduce
      exposure to allogeneic blood transfusion. This will positively influence post-operative
      morbidity and mortality, while at the same time substantially reduce hospital length of stay
      and overall health care costs. The proposed study is felt to have minimal risk, and is a
      relatively inexpensive study.

      Update: An interim analysis was completed in January 2018. The Data Safety Monitoring
      Committee reviewed the results and recommend the trial continue as planned.

      The final data analysis is in process. The abstract will be uploaded upon completion.
    

Intervention name(s): Tranexamic Acid; Saline Wash
Intervention type(s): Drug; Other
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect
      of renal impairment on the PK of setmelanotide. A total of approximately 32 subjects
      (approximately 8 subjects in each renal impairment group and 8 healthy subjects with normal
      renal function) are planned to be enrolled across 4 centers in the United States. At
      screening, subjects will be assigned to a study group according to eGFR.

      Cohort A - Mild Renal Impairment

      Cohort B - Moderate Renal Impairment

      Cohort C - Severe Renal Impairment

      Cohort D - Normal Renal Function (control)
    


Intervention name(s): Setmelanotide
Intervention type(s): Drug
Intervention description(s): Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Adrenal Suppression and Adrenal Recovery Induced by Megestrol Acetate
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional

Summary: 
      Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth
      control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain
      in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis,
      AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown.

      Although only approved to combat weight loss associated with AIDS and cancer, MA is
      frequently prescribed for long periods of time to prevent or reverse weight loss in nursing
      home residents and in elderly patients with serious illnesses in the community. Little data
      is available to support this practice. Among its many properties, MA acts as a partial
      glucocorticoid agonist, and long term and short term use of MA may results in adrenal
      suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course
      of resumption of normal adrenal function after discontinuation of MA is completely unknown.
      As a consequence, it is unclear whether MA can be given safely for short periods of time or
      whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The
      increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a
      substantial risk of adrenal crisis after an illness, requires a clear understanding of these
      issues. To address these concerns, we will evaluate adrenal function before, during, and
      after MA administration in healthy volunteers between the ages of 60 and 85 years.
    


Intervention name(s): megestrol acetate
Intervention type(s): Drug
Intervention description(s): 600 mg by mouth daily
Intervention MeSH terms: Megestrol; Megestrol Acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: megestrol acetate; adrenal insufficiency; adrenal suppression