bioihbjkbjnl/mcl2 huggingface dataset:
Genistein Stimulates Insulin Sensitivity Through Gut Microbiota
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      There is evidence that genistein present in soy can improve insulin resistance in rodents and
      humans with metabolic syndrome (MetS). However, it is not known if this improvement is
      associated with changes in the gut microbiota. In the present study, the investigators show
      that the consumption of genistein for 2 months could have an effect on insulin resistance in
      subjects with MetS. This effect will be accompanied by a modification of the gut microbiota
      taxonomy. As a consequence, there will be a reduction in metabolic endotoxemia accompanied by
      an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of
      genes of fatty acid oxidation in skeletal muscle.
    

Detailed description: 
      The investigators included 45 participants who met the following inclusion criteria: adults
      between 20 and 60 years of age with a diagnosis of MetS, HOMA index greater than 2.5, BMI ≥30
      and ≤ 40 kg / m2 and who signed the consent letter. Patients who had any added pathology,
      pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent
      was accepted, the patients were assigned to the respective treatment group. These individuals
      were advised to consume the recommended diet for subjects with MetS according to the
      guidelines of the ATPIII. Participants were randomly distributed to consume a) placebo
      treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months.
      In the previsit, informed consent letters were given, and blood samples were taken to
      evaluate glucose concentration, lipid profile, lipopolysaccharide and serum insulin. Also
      determined blood pressure, body weight, height, body composition and gut microbiota. The
      presence of insulin resistance was determined by means of the HOMA-IR index and by an oral
      glucose tolerance test. After 2 months, the same variables were assessed, and an expert
      surgeon in the operating room performed a vastus lateralis muscle biopsy, then RNA extraction
      and gene expression microarray assay was performed
    

Intervention name(s): genistein; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Administered orally once every 12 hours; Administered orally once every 12 hours
Intervention MeSH terms: Genistein
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: These individuals were advised to consume the recommended diet for subjects with MetS according to the guidelines of the ATPIII. Patients were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: genistein; gut microbiota; AMPK; fatty acid oxidation
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of
      Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of
      oocytes retrieved in women for assisted reproductive treatment.
    


Intervention name(s): QL1012; Gonal-f ®
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU; Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Dialectical Behavior in Patients With Bipolar Disorder
Condition: Dialectical Behavior Therapy
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      This study aims to:

      • Determine the effect of implementing Dialectical Behavior Therapy on emotion regulation
      difficulties, distress tolerance, and social functioning among patients with bipolar
      disorder.

      RESEARCH HYPOTHESIS Patients with bipolar disorder who are exposed to Dialectical Behavior
      Therapy will exhibit lower emotion regulation difficulties, distress tolerance, and higher
      social functioning than those who are not exposed to such training.
    

Detailed description: 
      The researchers decided to work on a convenient sample of 30 adult patients with bipolar
      disorder. Dialectical behavior therapy will be applied through psychoeducation, discussion,
      rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion
      Regulation, Emotion Regulation, and Emotion Regulation.
    

Intervention name(s): Dialectical behavior therapy
Intervention type(s): Behavioral
Intervention description(s): 14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in 14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in the following sequence 1. Mindfulness , 2. Emotion Regulation , 3. Distress Tolerance and 4. Interpersonal effectiveness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics
      and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus
      Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in
      Healthy Male Subjects.
    


Intervention name(s): Fimasartan/Amlodipine/Rosuvastatin; Fimasartan/Amlodipine; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of a High-risk Diabetic Patients Program
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether case management for type 2 diabetic
      patients with target-organ damage improves quality of care compared to usual care.
    


Intervention name(s): Case manager counseling; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets.; Usual care provided by primary care physician and/or specialist according to patients' needs and professional criteria. Includes free access to educational diabetes workshops and educational brochures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2 [C18.452.394.750.149]; Case Management [N04.590.233.624.250]; Disease Management [N04.590.607]; Diabetes Complications [C19.246.099]
Long Term Effects of Raloxifene Treatment on Bone Quality
Condition: Osteoporosis, Post-Menopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of
      long-term treatment with raloxifene on histomorphometry and bone quality in patients who
      participated in the Continuing Outcomes Relevant to Evista Study.
    


Intervention name(s): Raloxifene; Raloxifene; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 60 mg QD; 120 mg QD; Placebo
Other intervention name(s): LY139481; LY139481
Intervention MeSH terms: Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic
      product efficacy after 8 weeks of application on the face (twice-daily application). At T1
      (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:

        -  The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the
           forehead

        -  The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA
           score) of the face

        -  The reduction in visible follicles

        -  The standardized numerical photographs of face and ¾ right and left profile in normal,
           parallel polarized, cross polarized and UV light

        -  The analysis of the skin lipids of the forehead

        -  The qualitative and quantitative analysis of the sebum and comedones constituents (nose
           wings)

      This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the
      face.

      Each group includes 18 subjects.
    

Detailed description: 
      This study is monocentric, comparative versus non-treated group, open-labelled, exploratory,
      conducted in adults having oily and acne prone skin.

      The study includes 4 visits for each group, including subjects' selection:

        -  V0: Subjects' selection

        -  V1: Baseline inclusion

        -  V2: 4 weeks, follow-up visit

        -  V3: 8 weeks, study end

      The maximal study duration is 61 days. The front, temporal areas and nose wings are defined
      as the study interest areas for superficial samples.

      The evaluation is at 3 times: T1 baseline, T2 at 4 weeks and T3 at 8 weeks of application of
      RV3278A formula ET0943 with comparison of each time versus baseline.

      There are twice-daily applications (morning and evening) of the test product on the face.
    

Intervention name(s): Cosmetic product
Intervention type(s): Other
Intervention description(s): It is a comparative study with two parallel groups of subjects:
Tested group: twice daily application of the cream RV3278A cosmetic product on the whole face
Comparative group: no application of study product or reference product
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects have been recruited from the panel of the centre. An investigator made a
        dermatological examination of the subjects before inscription in the panel. Data from this
        clinical examination, stored in the computer database with the consent of the subjects, can
        ensure the recruitment; computer software being questioned based on the eligibility
        criteria of the study.
      
Biospecimen description: 
      Sebum and comedones constituents
    
Keywords: Lipids; Biometrological; Microcomedomes; Sebum; Fatty acids; Phytotherapy
Single-sex Female Controlled Human Schistosomiasis Mansoni Infection
Condition: Schistosomiasis; Schistosomiasis Mansoni
MeSH terms: Schistosomiasis; Schistosomiasis mansoni
Study type: Interventional

Summary: 
      Groups of 3 or 7 volunteers will be exposed to a predetermined number of female Schistosoma
      mansoni cercariae until 10 volunteers are found infected.
    


Intervention name(s): female Schistosoma mansoni cercariae
Intervention type(s): Biological
Intervention description(s): Viable female Schistosoma mansoni cercariae of the Puerto Rican strain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla
Condition: Observation of Major Duodenal Papilla (MDP)
Study type: Interventional

Summary: 
      Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden
      standard. However, side-viewing duodenoscope is not available in some endoscopic centers.
      Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of
      the scope has emerged as an alternative method for the observation of MDP. A recent study
      showed that complete examination of MDP could be achieved in 97% of patients. The
      investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of
      MDP.
    

Detailed description: 
      Interim analyses were planned to be performed by the data and safety monitoring board after
      data collection has been completed for 50% of the enrollment.
    

Intervention name(s): Cap-EGD; Duo
Intervention type(s): Device; Device
Intervention description(s): Undergoing cap-assisted endoscopy; Undergoing side-viewing duodenoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Motor Imagery in High-Risk Pregnants
Condition: Pregnancy, High Risk
Study type: Interventional

Summary: 
      The aim of this study is to determine the acute effects of motor imagery exercises on fetal
      heart rate, uterine contractions, maternal heart rate, blood pressure, oxygen saturation and
      well-being in high-risk pregnant women.
    

Detailed description: 
      Bed rest is often recommended in high-risk pregnant women to prevent complications from
      reaching dangerous levels.

      Pregnant women recommended bed rest can benefit from exercise in order to overcome this
      process more easily, to reduce the negative consequences of inactivity and to prevent
      possible risks.

      However, there may be differences between the view of high-risk pregnant women and the view
      of healthy pregnant women. Motor imagery refers to a mental process in which an individual
      mentally imagines that movement without actually eliciting an active movement. Studies have
      shown that similar brain regions are activated during movement performance and movement
      imagery. It has been reported in the literature that progressive relaxation exercises
      performed under mental/motor imagery guidance in healthy pregnant women and pregnant women
      lead to an improvement in maternal anxiety, stress and fetal attachment scales and a decrease
      in maternal systolic/diastolic blood pressure. However, as far as the investigators know,
      there is no study that applies the exercise protocol that can be given to healthy pregnant
      women to high-risk pregnant women with motor imagery and examines acute responses on fetal
      and maternal parameters.
    

Intervention name(s): Motor imagery; Diaphragmatic breathing
Intervention type(s): Other; Other
Intervention description(s): Motor imagery will be performed according to the PETTLEP (Physical,Environment,Task,Time,Learn,Emotion,Perspective) model for 15 minutes.
To imagine walking activity in different environments (seaside, beach, walking path).
The rest activity will be imagined by sitting on a bench.
Upper extremity strengthening exercises with dumbbells, lower extremity strengthening exercises with elastic band and trunk-oriented bridging, posterior pelvic tilt and table top stabilization exercises will be visualized.
The rest activity will be imagined by sitting on a bench.
Imagination will end with homecoming and domestic activities.; Diaphragmatic breathing will be shown to pregnant women in the supine position, eyes closed, with one hand on the chest and the other hand on the abdomen. This practice will last for five minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective randomized controlled study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events
Condition: Stroke; Transient Ischemic Attack
MeSH terms: Stroke; Ischemic Attack, Transient
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel
      initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days
      versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke
      (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom
      onset in high-risk patients with TIA or minor stroke.
    

Detailed description: 
      Inclusion criteria:

        1. Adult subjects (male or female ≥ 40 years)

        2. Acute non-disabling ischemic stroke (NIHSS≤3 at the time of randomization) that can be
           treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by
           the "last see normal" principle.

        3. TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the
           deficit within 24 hours of symptom onset), that can be treated with study drug within 24
           hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score
           ≥ 4 at the time of randomization). Symptom onset is defined by the "last see normal"
           principle.

        4. Informed consent signed

      Primary Efficacy Endpoint:

      Percentage of patients with the 3-month new vascular events, defined as any event of the
      following:Any stroke (ischemic or hemorrhage).
    

Intervention name(s): Clopidogrel; Placebo of clopidogrel and Asprin
Intervention type(s): Drug; Drug
Intervention description(s): The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.; The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.
Other intervention name(s): Plavix; Acetylsalicylic acid
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: stroke; transient ischemic attack; acute treatment; acute non-disabling cerebrovascular event; clopidogrel; clopidogrel combined with ASA; recurrence of stroke and other vascular events
Timing Frozen Embryo Transfer by Following Two Different Methods
Condition: Fertility Disorders
Study type: Interventional

Summary: 
      This proof of concept study is designed to determine the practicality of using home ovulation
      tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in
      comparison to the standard ultrasound and serum monitoring currently conducted by many IVF
      clinics.
    

Detailed description: 
      The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo
      Transfer (FET) directly compared to standard clinical procedures. In addition, women's
      likability and stress associated with timing a FET cycle using both methods will be evaluated
      by collecting qualitative data using standardised questionnaires.

      The impact of psychological stress on FET outcome such as implantation rates and viability at
      first scan will be considered in order to gather information for the design of a larger
      clinical study and basic financial data will also be collected, in order to pilot a
      cost-effectiveness evaluation of the two FET timing methods.

      A subset of volunteers will collect daily urine samples from day after embryo transfer until
      confirmation of pregnancy.
    

Intervention name(s): Test use
Intervention type(s): Device
Intervention description(s): Use of home ovulation test to predict ovulation
Intervention model: Single Group Assignment
Intervention model description: Parallel use of ovulation test and standard hospital monitoring, for agreement of methods
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study was to obtain information about the safety and
      tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics
      data (steady state and accumulation factor)
    


Intervention name(s): BIIF 1149 BS - single rising dose; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of a Single Dose of Danicopan in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single ascending dose, randomized, double-blind study assessing the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
      Four different doses (200 milligrams [mg], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo
      were administered under fasted and fed conditions.
    


Intervention name(s): Danicopan; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): ACH-0144471 (formerly); ALXN2040; ACH-4471; ACH4471; 4471
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Factor D Inhibitor; Pharmacokinetics; Pharmacodynamics; Ascending Dose