bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals
Condition: Microbiota
Study type: Interventional

Summary: 
      MicrSoy-20 (MS-20), a fermented soymilk product, has been approved as an Over the counter
      (OTC) drug in 2011. The therapeutic effect of MS-20 is to ameliorate symptoms such as fatigue
      and loss of appetite caused by cancer chemotherapy. Animal study revealed orally
      administration of MS-20 daily for 4 weeks altered the gut microbiota composition in mice. In
      addition, MS-20 could activate dendritic cell and improve immunotherapy response rate. Thus,
      it was hypothesis that MS-20 improves host immune activity thus ameliorate fatigue and
      increase weight is through alteration the gut microbiota composition.

      In this study, the ability of MS-20 in modulating gut microbiota and the subset of microbiome
      to be altered by MS-20 was investigated.
    

Detailed description: 
      This is a double-blind, placebo-controlled, investigator-initiated randomized trial to
      evaluate the impact of MS-20 on gut microbiota composition and abundance in healthy people.
      Approximately 100 subjects who meet the criteria of this study are planned to be enrolled.
      Eligible subjects will be randomized to receive placebo or MS-20 in a 1:1 ratio with 50
      subjects in each arm.

      The study comprises of a 7 days screening period, a 8-week treatment period and a 8-week
      follow-up period. Eligible subjects will receive MS-20 or placebo every day during the
      treatment period. Participants should not use any probiotics and prebiotics during the trial.
      In addition, All medications (especially antibiotics) should be recorded and documented,
      however, fluoroquinolones and vancomycin will be banned during the trial.

      The fecal gut microbiota, serum, and urea were collect at indicated time. The gut microbiota
      composition, gut microbiota metabolite, and serum biochemical items will be analysed.
    

Intervention name(s): MS-20; Placebo
Intervention type(s): Drug; Other
Intervention description(s): fermented soymilk product; No active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Molecular and Clinical Response to a Single Bout of Aerobic Exercise in a Multimorbid Population: a Study From the Consortium on Precision EXercise in Aging
Condition: Multimorbidity - End-stage Kidney Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The combination of data from different origins (biological, health, patient-related) has the
      potential to improve care for the elderly. Precision approaches that are emerging in health
      are based on the premise that a better understanding of the biological responses to
      interventions will make it possible to optimize the treatments. In the field of exercise,
      this type of approach is emerging. This pilot study aims to collect preliminary data to
      demonstrate that a patient-centric vision with data from multiple sources is mandatory to
      personalize exercise intervention and improve health care. Older adults with end-stage
      chronic disease treated by hemodialysis represent a population of choice that requires
      personalized care since they are multimorbid and exhibit a complex health profile.

      On the other hand, the beneficial effects of exercise are still little understood and the
      avoidance of adverse effects in response to exercise such as hypotension during dialysis
      remains uninvestigated.Objective: Demonstrate the feasibility of an integrative approach by
      combining "omics", clinical data, patient-related outcomes (PRO) as well as exercise
      variables (e.g., intensity, duration) Methods: A total of 10 people aged 60 and over will be
      recruited to randomly perform 2 experimental conditions: hemodialysis alone (CONT) or
      hemodialysis + aerobic exercise (EX), which will be carried out over 2 visits one week apart.
      These visits will take place at the scheduled time of the hemodialysis treatment. The
      variables of interest are: blood pressure response to a single bout of exercise exercise
      (during and post-exercise), symptoms (with visual analogue scales within 36 hours of the
      visit + Dialysis symptom index for the 7 days after the experimental visit), dialysis
      efficiency (Kt/V) and biological response (proteomics and metabolomics). Health-related
      quality of life (KDQOL questionnaire), medical data (electronic medical record), and level of
      physical activity (PASE questionnaire and smart watch; Apple Watch) will be evaluated.
    


Intervention name(s): Aerobic exercise; Control
Intervention type(s): Other; Other
Intervention description(s): EX: 30 min of aerobic exercise (3/10 Borg scale) during hemodialysis treatment (between 30 min and 3h of treatment).; CONT: participants will receive hemodialysis treatment only (usual care)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
Condition: Type 2 Diabetes (T2DM); Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is designed to investigate the effect of a structured resistance training program
      on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type
      2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator
      will compare the experimental group receiving resistance training to a control group made of
      patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise
      modalities during their sessions, which is the current standard of care.
    


Intervention name(s): Resistance Training; Standard of Care
Intervention type(s): Other; Other
Intervention description(s): 7 muscle-strengthening exercises using body weight resistance and elastic resistance bands; 3 exercises that do not include these 7 muscle-strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901
      following escalating single and multiple oral doses of RTA 901 in healthy adult subjects.

      This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD)
      and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be
      conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of
      up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or
      placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4
      will be assessed in each group prior to dose escalation.

      Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3
      groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to
      receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and
      available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose
      escalation.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): RTA 901 Capsules, 10 or 40 mg; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RTA 901; RTA 901 capsules
The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder; Healthy
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD)
      receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary
      intervention. Cognitive control functions are measured with functional Magnetic Resonance
      Imaging (MRI) before and after the intervention. Behavioural change is monitored with
      behavioural scales.
    


Intervention name(s): Eicosapentaenoic acid / Docosahexaenoic acid; Placebo dietary intervention (MUFA) in ADHD group; Eicosapentaenoic acid / Docosahexaenoic acid; Placebo dietary intervention (MUFA) in healthy control group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 650 mg EPA + 650 mg DHA daily; Placebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value; 650 mg EPA and 650 mg DHA daily; Placebo contains MUFA in stead of PUFA, same energy value
Other intervention name(s): EPA; DHA; Mono Unsaturated Fatty Acid; Poly Unsaturated Fatty Acid; EPA; DHA; Mono Unsaturated Fatty Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Attention; Cognitive control; ADHD; Healthy; EPA; Eicosapentaenoic acid; DHA; Docosahexaenoic acid; PUFA; Omega-3
Effect of Incentive Spirometery on Asthmatic Pregnant Women
Condition: Asthmatic; Pregnant With Complication
MeSH terms: Asthma; Pregnancy Complications
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of the incentive spirometer on asthma
      during pregnancy.
    

Detailed description: 
      This study will provide an evidence basis for obstetricians and physical therapist for
      women's health about the effect of spirometry on asthma during pregnancy.
    

Intervention name(s): pulmicort inhaler; Incentive spirometer treatment
Intervention type(s): Drug; Device
Intervention description(s): Each woman in both groups (A&B) will receive pulmicort inhaler on needs.; Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MOM Program 8-Year Follow-up
Condition: Child Development
Study type: Interventional
Phase: Phase 3

Summary: 
      Study measures will evaluate cognitive, academic, and behavioral outcomes for the children,
      school services received, and caregiver stress and depression. The main study outcome
      measures include cognitive status, school functioning, and behavior. Long-term outcomes will
      be studied in attempt to verify the 33 and 60 month significant differences found in school
      participation and behavior between the intervention and control groups.
    

Detailed description: 
      This study examines 8-year follow-up results from The MOM Program, a randomized controlled
      trial (RCT) of a mixed professional home visiting program to promote positive developmental
      outcomes among children in poverty. The earlier study found significant differences in both
      school participation and behavior among the intervention group at ages 33 and 60 months of
      age. Families from the original MOM Program RCT that provide informed consent will be
      eligible for the study when the children are 8 years of age.
    

Intervention name(s): MOM Program home visiting; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Mixed professional home visiting program.; Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Evaluate developmental outcomes; Evaluate child cognitive, academic, and behavioral outcomes
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
Condition: Breast Cancer; Metastasis, Neoplasm
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy and tolerability of
      sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.
    

Detailed description: 
      The administration of vinorelbine and capecitabine had been implied to be quite useful in
      metastatic breast cancer. This study was designed to explore whether sequential and
      simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the
      sequential way has better tolerability.
    

Intervention name(s): Vinorelbine and Capecitabine; Vinorelbine and Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w; Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
Intervention MeSH terms: Capecitabine; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastasis; chemotherapy; breast cancer; Vinorelbine; Capecitabine; sequential chemotherapy; TTF
Inpatient Obesity Intervention With Phone Follow-up
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this study we sought to determine whether inpatient weight loss counseling with post
      discharge phone follow-up would result in weight loss at six months. Secondary endpoints
      included weight change from baseline, changes in waist-to-hip ratios, assessment of weight
      perceptions and changes in patient reported health outcome measures. To our knowledge, this
      is the first randomized trial designed to evaluate the effects of an obesity intervention
      with post-discharge follow-up in an inpatient general medicine population.
    


Intervention name(s): Inpatient weight loss counseling; Motivational interviewing and troubleshooting via phone
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weight loss counseling utilizing a 13 minute patient education video on weight loss and an 25 minute personalized health education session. Subjects set 3 specific behavior set three specific lifestyle goals prior to discharge including a calculated six month weight loss goal (10% of body weight) and specific dietary and fitness goals. Usual care group participants received no specific instruction regarding weight loss prior to discharge.; All subjects were asked to track their weights over the 6 month duration of the study. Weights were obtained by phone at weeks 1,2,3,4, 8, 12, 16, 20 and 24. Phone calls for the intervention group utilized motivational and troubleshooting techniques whereas calls in the usual care group were used only to obtain weight and assess for changes in medications or health condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, inpatient, intervention, weight loss
Characterisation of Occupational Allergy to Drosophila
Condition: Drosophila; Clinical Symptoms
Study type: Interventional

Summary: 
      Allergy is a very common problem and can be a handicap in everyday life, specially when
      symptoms occur at work place. Some persons working with drosophila developed respiratory
      symptoms. Investigators tried to analyze if these manifestations could be due to a specific
      allergy to drosophila.
    

Detailed description: 
      To do so, investigators invited laboratory workers who presented any symptoms in presence of
      drosophila to undergo skin prick tests in order to determine if a specific sensibilization to
      drosophila exists. Then, a blood sample is taken from these persons to research specific IgE
      directed against drosophila. By this way, investigators hope determine if a specific allergy
      to drosophila exists, its characteristics as prevalence, symptoms, populations concerned...in
      order to better protect laboratory workers and prevent allergy incidence.
    

Intervention name(s): blood test (four dry tubes 7ml) and prick tests
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion
      water.
    


Intervention name(s): Calcium tablet; Calcium ion water (250mg); Calcium ion water (125mg)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study is to compare single-dose oral bioavailability of acetaminophen 650
      mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories, USA
      (subsidiary of Ranbaxy) with Tylenol extended release geltabs (containing acetaminophen 650
      mg) of Mc Neil, Consumer & Specialty Pharmaceuticals, U.S.A in healthy, adult, male human
      subjects under fed condition.
    

Detailed description: 
      The study was conducted as open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single dose, crossover bioavailability study comparing acetaminophen 650 mg
      extended release gel tabs (containing acetaminophen 650 mg) of OHM Laboratories (subsidiary
      of Ranbaxy) with Tylenol 8 Hour 650 mg extended release gel tabs (containing acetaminophen
      650 mg) of Mc Neil, Consumer & Specialty Pharmaceuticals in healthy, adult, human, male
      subjects under fed condition.

      The treatments were assigned to the study subjects according to SAS generated randomization
      schedule. Each subject received a single oral dose either Test or Reference product in each
      period with 240ml of water at ambient temperature, 30 minutes after start of a high-fat high
      calorie breakfast during each period of the study under supervision of a trained medical
      officer.

      During the course of study, the safety parameters including vital signs, physical
      examination, medical history, clinical laboratory and safety tests (haematology, biochemical
      parameters) were assessed and clinical laboratory safety tests (hematology & biochemical
      parameters) were performed again at the end of the study.
    

Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): Extended release Gel tabs 650 mg
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Observational Program Neo-Penotran® Forte
Condition: Vaginal Candidiasis; Bacterial Vaginosis; Trichomonal Vaginitis
MeSH terms: Candidiasis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Trichomonas Vaginitis; Vaginal Diseases; Vaginitis
Study type: Observational

Summary: 
      Vaginitis is the most common gynecologic diagnosis in the primary care setting. In
      approximately 90 percent of affected women, this condition occurs secondary to bacterial
      vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.

      Neo-Penotran Forte is registered for treatment of these most common vaginal infections.
      Efficacy and safety of this product is already established, and this observational study was
      designed to learn more about practical use of Neo-Penotran® Forte in real life setting.
    


Intervention name(s): Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)
Intervention type(s): Drug
Intervention description(s): Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.
Intervention MeSH terms: Metronidazole; Miconazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in primary care setting.
      
Keywords: Vaginal candidiasis; Bacterial vaginosis (also known as non-specific, or Gardnerellosis, or anaerobic vaginosis); Trichomonal vaginitis; Vaginitis due to mixed infection
Diabetic Peripheral Neuropathic Pain (DPNP)
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared
      to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).
    

Detailed description: 
      Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
    

Intervention name(s): BMS-954561; Pregabalin; Placebo matching BMS-954561; Placebo matching Pregabalin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a
      hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated
      with keloid scarring in subjects undergoing surgical revision of keloid scars.
    


Intervention name(s): Hydrogel scaffold (MF-4181)
Intervention type(s): Device
Intervention description(s): Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
Other intervention name(s): Hydrogel scaffold
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment