bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate
Condition: Protein Malabsorption
MeSH terms: Malabsorption Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to examine the pattern of plasma amino acid appearance after a
      two-week daily regimen of milk protein concentrate supplementation with and without the
      addition of Bacillus coagulans GBI-30, 6086 among older women.
    

Detailed description: 
      Once determined eligible and providing consent, participants will be assigned in a
      randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk
      protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans
      GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart
      rate, blood pressure, body mass, height, and body composition measured. Upon ingestion of
      their final assigned supplementation dose, standard multiple sample phlebotomy approaches
      will be used to collect approximately 10mL of venous blood from a forearm vein at specific
      time intervals up to four hours after ingestion of their final assigned supplementation dose
      for that period in the study protocol.
    

Intervention name(s): Bacillus Coagulans GBI-30, 6086
Intervention type(s): Dietary Supplement
Intervention description(s): In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, crossover study design
Masking: Double (Participant, Investigator)
Primary purpose: Other
Intraocular Pressure (IOP) and Isometric Exercise
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      The purpose of this study is to investigate changes in intraocular pressure measured
      continuously during isometric exercise.
    


Intervention name(s): isometric exercise
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Isometric exercise; intraocular pressure; Physiological changes in intraocular pressure during isometric exercise
Warm Water and Unsedated Colonoscopy
Condition: Gastrointestinal Diseases; Digestive System Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no
      incidence of drug-related side effects. May be slightly painful or discomforting for the
      patient. Based on numerous recent reports, the investigators designed this randomized
      controlled trial hypothesizing that the use of warm water irrigation versus air insufflation
      during the insertion phase of colonoscopy might increase the global tolerability of the
      examination and the proportion of patients undergoing complete colonoscopy without sedation
      or with a low dose of sedatives.
    


Intervention name(s): air insufflation; warm water irrigation
Intervention type(s): Other; Other
Intervention description(s): air insufflation during insertion phase colonoscopy; warm water irrigation during insertion phase colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: colonoscopy; warm water method; hydrocolonoscopy; unsedated colonoscopy
Sirolimus in Graves' Orbitopathy
Condition: Graves Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Study type: Observational

Summary: 
      Graves' Orbitopathy (GO) is a disabling and disfiguring condition associated with Graves'
      Disease, due to autoimmunity against antigens expressed by the thyroid and orbital tissues,
      and resulting in orbital fibroblast proliferation and release of glycosaminoglycans. The
      current treatments available, especially glucocorticoids, are not effective in all patients.
      Two cases of patients with GO treated with Sirolimus have been reported with an excellent
      response to the drug.

      The rationale for the use of Sirolimus lies in its mechanisms of action. Sirolimus is able to
      inhibit T-cell activation as well as fibroblast proliferation. In addition, acts indirectly
      on the Insulin-Like Growth Factor-1 (IGF-1) pathway, and recent clinical trials have shown
      that a monoclonal antibody against the IGF-1 receptor (Teprotumumab) is effective in patients
      with GO. Thus, Sirolimus could be used in GO as monotherapy in patients with GO.

      The aim of the present drug vs standard treatment, observational study is to evaluate the
      efficacy of Sirolimus as a second-line treatment in patients with moderately severe, active
      GO.
    

Detailed description: 
      Study Design: observational

      Thirty consecutive patients with moderate-to-severe and active GO treated with sirolimus (15
      patients) or methylprednisolone (15 patients) observance 18 consecutive months will be
      compared.

      Study Timeline

      Baseline visit - (Time 0) Treatment period (week 1-week 12): daily administration of the
      trial agent (Sirolimus) or weekly administration of the standard treatment
      (methylprednisolone) Outcome visit (week 24)
    

Intervention name(s): Sirolimus; Methylprednisolone
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg orally on the first day followed by 0.5 mg per day for 12 weeks; 500 mg/weekly (6 weeks) intravenously, 250 mg/weekly (6 weeks) (cumulative dose 4.5 g).
Intervention MeSH terms: Sirolimus; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with moderate-to-severe, active Graves' orbitopathy treated with
        either sirolimus of methyprednisolone as a second-line treatment after a previous course of
        methyprednisolone, over 18 consecutive months
A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      A single-blind (investigator-blinded), randomized, parallel group, single center study to
      evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac
      Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.
    

Detailed description: 
      This is a single-blind (investigator-blinded), randomized, parallel group, single center
      study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac
      Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately
      40 male and female subjects will be enrolled (20 per study group).

      Subjects will participate in the study for 12 weeks; visits will be scheduled at baseline and
      at weeks 1, 2, 4, 8, and 12 (total of 6 visits). Eligible subjects will be randomized at
      baseline to 1 of the 2 study groups in a 1:1 ratio (Duac Gel/Tazorac Cream to Acanya
      Gel/Tazorac Cream). Subjects will apply either Duac Gel or Acanya Gel to the face each
      morning and apply Tazorac Cream to the face each evening.

      Tolerability will be evaluated through subject assessments of burning/stinging, itching, and
      oiliness and through investigator assessments of peeling, erythema, and dryness. In addition,
      subjects will evaluate their overall skin comfort and record the usage of moisturizer and
      sunscreen, if needed. Efficacy will be assessed through lesion counts (total, inflammatory
      and noninflammatory) and ISGA. Safety will be assessed by evaluating adverse events (AEs),
      concomitant medication use, and withdrawals from the study.

      This is an investigator-blinded study; therefore, subjects and study-center staff will not be
      blinded to study treatment allocation. Subjects (and parents or legal guardians) and
      study-center staff will be instructed not to reveal study product allocation to the
      investigator.
    

Intervention name(s): Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene; clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Intervention type(s): Drug; Drug
Intervention description(s): Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene; clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Intervention MeSH terms: Nicotinic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of the study is to test whether adalimumab can induce clinical remission in subjects
      with active Crohn's disease when compared to placebo (an inactive substance)
    


Intervention name(s): Adalimumab (D2E7)
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Introduction There is a strong relationship between eating habits and diseases of the
      cardiovascular system. It is known that walnut consumption has positive effects on
      cardiovascular system diseases. However, its effect on small dense LDL (sdLDL) is discussed.
      Therefore in this study, you participated the effects of walnut consumption on the serum
      lipids values, especially sdLDL values of healthy volunteers.

      Methods Volunteers participating in this study were offered 30 grams of walnuts per day for
      21 days. Walnuts were consumed on empty stomach or with breakfast every morning for 21 days.
      The blood values of subjects were measured at the beginning and the end of the study. The
      serum was obtained from the taken blood and blood lipid/hemoglobin parameters were measured
      on routine blood work. Food consumption records and surveys were taken from individuals.
    


Intervention name(s): The Investigation of effect on Blood Lipid parameters with walnut addition of Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Participants were asked to consume 30 g of walnuts daily for 21 days. Individuals have consumed walnuts on an empty stomach in the morning or with breakfast.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cholesterol; walnut consumption; small dense LDL; blood lipids; dietary fiber
A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy
Condition: Hypercholesterolemia; Cardiovascular Disease; CRP
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      This study is being conducted to test the hypothesis that daily consumption of a baked food
      product containing whole soy for 6 weeks will significantly reduce plasma Low Density
      Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall
      goals of this study are to determine whether daily consumption of muffins made from whole soy
      flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect
      is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and
      physical characterization of certified defatted whole soy flour that will be incorporated
      into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a
      control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy
      muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical
      trial. All participants will be randomized into one of three groups and asked to eat two
      muffins daily for 6 weeks in the following combination: high dose soy; control group or low
      dose soy. Before, after, and mid-way during the feeding period, blood samples will be
      obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals.
      The effect of soy consumption on waist circumference, body mass index (BMI) and blood
      pressure will also be examined.
    


Intervention name(s): Standardized soy containing muffin
Intervention type(s): Other
Intervention description(s): Standardized muffin containing two levels of soy
Other intervention name(s): Soy containing muffins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cholesterol; Cardiovascular disease; Soy; Dose-response
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the performance of the modified AutoSet device
      is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the
      treatment and the subjective comfort.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper
      airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure
      (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive
      pressure to the upper airway via a tube and mask. The modified device to be assessed in this
      study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved
      algorithm which should maintain or enhance the effectiveness of the treatment.
    

Intervention name(s): Nexus Flow Generator; VPAP Flow Generator 25
Intervention type(s): Device; Device
Intervention description(s): The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.; Exiting VPAP Auto 25 Flow Generator with A10 Algorithm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of co-administration with erythromycin
      on the time course of PH-797804 concentration in the blood following dosing by oral immediate
      release tablet formulation.
    


Intervention name(s): PH-797804; PH-797804 + erythromycin
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, 6mg, single; PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Safety and Efficacy of RIC on Adult Moyamoya Disease
Condition: Moyamoya Disease
MeSH terms: Moyamoya Disease
Study type: Interventional

Summary: 
      There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic
      stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays,
      revascularization is the only effective way for ischemic MMD and there is no effective
      conservative treatment for MMD. This study was to explore the safety and efficacy of remote
      ischemic conditioning(RIC ) on adult MMD patients.
    

Detailed description: 
      There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic
      stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the
      only effective way for ischemic MMD while controversial for hemorrhagic MMD patients.
      Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding
      often occurred postoperatively. There is no effective conservative treatment for MMD up to
      now.

      Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and
      easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia
      reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy
      of remote ischemic conditioning on adult MMD patients.
    

Intervention name(s): RIC; Aspirin
Intervention type(s): Device; Drug
Intervention description(s): Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.; patients will accept medication guided by neurologists
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: moyamoya disease; remote ischemic conditioning; cerebral blood flow
Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone
      mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C.

      MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and
      accumulates within mitochondria in organs such as liver, brain, heart, skeletal muscle. There
      is strong evidence for increased oxidative stress and mitochondrial damage leading to
      apoptosis via caspase activation. Several studies have shown that MitoQ protects cells from
      apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in
      liver disease.

      It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with
      chronic Hepatitis C compared with placebo. Approximately 36 patients who have been
      unresponsive or not suitable for interferon-based therapy will be enrolled at one centre.
      Treatment duration will be 28 days with 28 days post-treatment follow-up.
    

Detailed description: 
      Hepatitis C is a viral liver infection that contributes significantly to the burden of
      chronic liver disease. It is currently estimated that over 170 million individuals (3% of the
      world's population)are infected. In New Zealand, an estimated 25,000 people are living with
      hepatitis C virus (HCV) infection and prevalence is predicted to increase by 50% over the
      next 10 years. HCV is primarily spread by blood-to-blood contact. The single most important
      risk factor for acquiring HCV is the use of injected recreational drugs, accounting for
      approximately 80% of infections.

      Unlike hepatitis B, no hepatitis C vaccine is currently available. In the absence of an
      effective vaccine the current treatment of choice is interferon and ribavirin. However,
      treatment of chronic HCV infection with interferon-alpha monotherapy does not achieve
      sustained virologic response. Therefore, it is important to develop alternative treatment
      strategies for patients who are unresponsive or intolerant to current antiviral therapy.

      The aim of this protocol is to compare two doses of a mitochondrial antioxidant treatment
      (MitoQ) and placebo for the treatment of patients with raised liver enzymes due to HCV
      infection. Approximately 36 eligible patients with chronic HCV infection will be randomised
      to receive one of two doses of MitoQ or placebo in a 1:1:1 ratio. Treatment duration will be
      28 days with 28 days post-treatment follow-up.
    

Intervention name(s): Mitoquinone mesylate (MitoQ)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; antioxidant; liver enzymes; ALT
Exploration the Effect of Walking Program in Patients With Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The aims of this four-year study are to

        1. explore the relationships between fatigue and muscle strength (i.e., upper limbs and
           lower legs)

        2. comparison with the effects of 8-week, 12-week moderate intensity of walking program on
           muscle strength and fatigue.

        3. develop a clinical guidelines of home-based walking program for patients with colorectal
           cancer receiving active treatment and survivors in Taiwan.

        4. explore the relationships among the self-report fatigue intensity and metabolism.
    


Intervention name(s): muscular strength
Intervention type(s): Behavioral
Intervention description(s): 12-week moderate intensity walking program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer,fatigue,6-minute walking test
Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      It consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract
      of Sclerocarya birrea). It is a clinical trial, during which certain parameters of the
      glucidic metabolism will be measured analytically. Other secondary variables such as lipid
      profile, inflammatory markers, blood pressure, endothelial function and body composition will
      also be determined.
    


Intervention name(s): Dietary Supplement: nutraceutical; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will consume two capsules at breakfast and dinner for ten weeks.; Subjects will consume two capsules at breakfast and dinner for ten weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment