bioihbjkbjnl/mcl2 huggingface dataset:
Motivations and Psychological Aspects of the Gametes' Donation
Condition: Gametes Donors
Study type: Observational

Summary: 
      The main objective is to study donors' personality and motivations characteristics of the
      different recruitment methods and thus to answer questions related to the donation's
      approach, its representations as well as motivations and the profile of the donors.
    

Detailed description: 
      The methodology used is mixed with a quantitative and qualitative approach. The first one is
      a psychosocial approach with two groups: donors of gametes without children, and donors who
      have already procreated. Two questionnaires will be used in this survey. The first aims to
      study the donors' socio-personal characteristics and motivations. The latter studies donors'
      personality traits.

      The second approach is qualitative by a clinical case study. It is a psycho-dynamic approach,
      taking into consideration the donor (men and women), with all their subjectivity, their
      personal and family history and their representations.
    

Intervention name(s): Interview and questionaires
Intervention type(s): Other
Intervention description(s): Quantitative method : Two questionnaires will be used to define sociodemographic data, motivations and personality traits of donors.
Qualitative method : Clinical interviewing allows data collection adapted to study the motivations of sperm/egg donors, their representations, the experience and the inscription of the donation in their personal stories.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volonteers are recruted in the different CECOS. These subjects (who have already
        procreated, or not) are going to donate sperm/egg.
      
Keywords: donors; gametes; motivation; psychological
Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir
      phosphate capsule in participants with End-stage renal disease without hemodialysis using
      matched healthy participants as a control group.
    


Intervention name(s): Yimitasvir Phosphate Capsule
Intervention type(s): Drug
Intervention description(s): DAG181 100 mg (100 mg Capsule) administered orally
Other intervention name(s): DAG181
Intervention MeSH terms: Yimitasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
Condition: Chronic Periodontitis; Clinical and Microbiological Effects
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      • Background: Peridontitis is a group of diseases with complex bacterial etiology that
      affects a large proportion of the Chilean and worldwide population. Its treatment, based on
      an anti-infective mechanical therapy including scaling and root planning procedures, has been
      highly effective in numerous short and long term clinical trials. The use of adjunctive
      systemic antibiotics has shown significant improvements in the initial therapy results of
      specific periodontal disease types or patient profiles.

      The synergic combination of Metronidazole plus amoxicillin has been widely and successfully
      used for the treatment of aggressive and severe chronic periodontitis, demonstrating
      additional benefits in clinical and microbiological parameters over scaling and root planning
      alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates
      the impact of antimicrobials intake at different times of the mechanical treatment,
      emphasizing the necessity of a study that compares, simultaneously, the variation of the
      adjunctive antibiotic effects when they are administered in different moments through the
      periodontal therapy course.
    


Intervention name(s): Administration of Metronidazole plus Amoxicillin
Intervention type(s): Drug
Intervention description(s): Metronidazole plus Amoxicillin after, during and after root planning
Intervention MeSH terms: Amoxicillin; Metronidazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic periodontitis; Metronidazole plus Amoxicillin; Mechanical periodontal therapy; Scaling and Root Planning; Periodontal treatment
Prospective Randomised Study of a New an Uncemented Stem.
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The
      groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will
      be done at two years.
    


Intervention name(s): Hip Arthroplasty
Intervention type(s): Device
Intervention description(s): Patients are operated with hip replacement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hip arthroplasty; Joint replacement; Uncemented stem; Anatomical stem
A First-in-Human Study to Assess the Safety and Tolerability of PDNO
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, single-blind, placebo-controlled, single-centre study designed to
      assess the safety and tolerability of PDNO in healthy male and female subjects. In addition,
      the exposure of 1,2 propanediol (PD) will be evaluated.

      There are 2 parts to the study:

      Part I: single ascending dose (SAD), 7 cohorts, 30 minutes intravenous (i.v.) infusion of
      placebo followed by 1-hour i.v. infusion of PDNO to assess safety, tolerability and PD
      exposure in healthy male and female subjects.

      Part II: ascending doses of PDNO in 2 cohorts, 30 minutes i.v. infusion of placebo followed
      by 3 ascending doses of PDNO in cohort 1 and 3 ascending doses of PDNO in cohort 2. The first
      2 doses in each cohort will be i.v. infused for 30 minutes whereas the last will be i.v.
      infused for 3 hours to assess safety, tolerability and PD exposure in healthy male and female
      subjects.

      If indicated by emerging data and recommended by the internal safety review committee (iSRC),
      2 additional dose groups/cohorts (4+4 subjects) may be added to Part I and 1 dose
      group/cohort (4 subjects) may be added to Part II.
    


Intervention name(s): PDNO; Sodium chloride (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): PDNO consists of propylene glycol (1,2-propanediol, PD) chemically combined with NO (to be donated). The drug substance is formulated as an inherent mixture of 4 structure analogues. The mixture consists of an equilibrium of the 2 regioisomers 1-(nitrosooxy) propan-2-ol and 2-(nitrosooxy) propan-1-ol. In addition, each regioisomer is a racemic mixture.; Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)
Other intervention name(s): Nitrosooxypropanol; NaCl
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: In Part I, each subject will receive a 30 minute i.v. infusion of placebo followed by a 1-hour i.v. infusion of PDNO in parallel with a carrier sodium bicarbonate buffer, the infusion of which will start 5 minutes prior to start of placebo infusion and continue until 15 minutes after end of PDNO infusion. Between the end of placebo infusion and prior to the start of PDNO infusion, there will be a 20-minute stabilisation period with infusion of sodium bicarbonate buffer only.
In Part II, each subject will receive a 30 minute i.v. infusion of placebo followed by 2 x 30 minute infusions of PDNO at 2 ascending dose levels and one 3-hour infusion of PDNO at a third dose level.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Pulmonary Hypertension
Advancing Nutritional Science for Children With Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      This study evaluates four different meals and how they induce gastrointestinal symptoms in
      children with functional dyspepsia. All subjects will receive each meal and rate their
      gastrointestinal symptoms during each meal.
    

Detailed description: 
      Food can often exacerbate gastrointestinal symptoms in adults and children with functional
      dyspepsia. However, it is unclear which foods exacerbate symptoms more than others.

      Children with post-prandial distress functional dyspepsia will receive four different meals
      with variables being: semi-solid vs. solid and high fat vs high carbohydrate. At the time of
      ingestion and for up to 3 hours after each meal, subjects will rate their gastrointestinal
      symptoms. Comparisons of symptom onset and severity will be made for each meal.

      Enrolled subjects will have undergone previous gastrointestinal evaluations: gastric emptying
      study and/or upper endoscopy. In addition, subjects will complete psychosocial measures:
      Behavioral Assessment for Children-3, childhood somatization inventory.

      The first goal is to compare the severity of gastrointestinal symptoms with different
      composition and consistency meals. The second goal is to correlate the severity of
      postprandial gastrointestinal symptoms to psychosocial distress, gastric neuromotor function
      (emptying and accommodation), and duodenal inflammation.
    

Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will receive 4 meals of different composition.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Thoracolumbar Junction
Condition: Spinal Curvatures
MeSH terms: Spinal Curvatures
Study type: Observational

Summary: 
      Several studies have investigated the mechanical behavior of the thoracolumbar spine.
      However, an accurate reference for normal functional local alignment and segmental motion at
      the thoracolumbar junction is still illusive. Therefore, we conducted a cross-sectional
      cohort study with a balanced distribution of age and sex of healthy subjects to examine the
      normal alignment and segmental motion at the thoracolumbar junction using dynamic plain
      radiography. This study aimed to provide data that can be used when planning surgery or
      performing rehabilitation in pathological situations.
    


Intervention name(s): plain radiography (x-ray)
Intervention type(s): Radiation
Intervention description(s): Radiographic imaging of the subjects was performed, and anteroposterior, lateral, flexion-extension, and right-left lateral bending radiograph views were obtained
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain
        complaints
      
Keywords: Thoracolumbar spine; Alignment; Range of motion
Amsterdam Stool Scale: Usefulness in Clinical Setting
Condition: Stool Assessment
Study type: Observational

Summary: 
      The aim of this study is to assess interobserver and intraobserver variability of the
      Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating
      in the study it will be assessed using the Amsterdam Stool Scale independently by one of the
      parents and the medical doctor. At the same time a parent will take 2 photos that will be
      independently evaluated by another doctor.
    

Detailed description: 
      INTRODUCTION:

      Description of stool appearance is important in clinical practice. Parents are often asked to
      evaluate stool of their child. At present parents also take more frequently photos using
      smartphone camera when they are concerned with child's stool appearance and show it to their
      doctors. To make stool evaluation easier there have been stool form scales created. One of
      this is Amsterdam Stool Scale that enables stool assessment of children who are not yet
      toilet trained. This scale facilitates to describe amount, consistency and color of the
      stool.

      AIM:

      To assess interobserver and intraobserver variability of the Amsterdam Stool Scale in
      clinical practice.

      METHODS:

      After passing a stool by the child participating in the study, within a short-time interval
      (<5 min), the stool will be assessed independently by one of the parents and the medical
      doctor. At the same time a parent will take 2 photos with phone camera. The photographs then
      will be independently evaluated by another doctor who will be unaware of both the "in vivo"
      stool appraisal and child condition.

      STATISTICAL ANALYSIS:

      Then the interobserver (between a parent, the doctor and the doctor assessing photograph)
      variability will be evaluated by calculating the kappa (κ) statistics for nominal data for
      the stool consistency, amount and color separately.
    

Intervention name(s): Stool Assessment
Intervention type(s): Other
Intervention description(s): After passing a stool by the child participating in the study, within a short-time interval (<5 min), the stool will be assessed independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos with phone photographic camera. Then the photographs will be independently evaluated by another doctor who will be unaware of both the "in vivo" stool appraisal and child condition.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The group will be selected from the children admitted to the Department of Pediatrics The
        Medical University of Warsaw
Effects of Forest Therapy on Physical and Psychological Parameters in the General Population
Condition: General Population
Study type: Interventional

Summary: 
      In recent years, nature and forest therapy has increasingly become the focus of medical
      research. Recent scientific findings indicate overall positive effects of nature and forest
      therapy on physical and mental health. In Asia and Australia, it has already been implemented
      as a public health concept of prevention and health promotion. The aim of the project is to
      replicate the experience gained in Asia over the last three decades on the physical and
      psychological effects of nature/forest therapy in the context of the German forest and to
      investigate it further scientifically.
    


Intervention name(s): Two days forest therapy; Three days forest therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants attend two days (with a break day in between) of two-hour forest therapy at the Friedrichsruh, Barntrup or Wernigerode sites, led by an INFTA-certified forest therapy guide.; Participants attend three days of two-hour forest therapy at the Friedrichsruh, Barntrup or Wernigerode sites, led by an INFTA-certified forest therapy guide.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
Condition: Cognitive Impairment; Executive Dysfunction; Endothelial Dysfunction; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Complaints about memory and thinking are common in women as they go through menopause and
      estrogen levels fall. The ovarian hormone estrogen is important for supporting normal
      cognitive function, and changes in brain activity and function occur when estrogen levels are
      decreased. Estrogen is also important for maintaining healthy blood vessels which also
      support normal cognitive function. In Alzheimer's disease and other types of dementia, there
      is significant damage to the blood vessels in the brain. This study will test whether changes
      in brain activity and function with the loss of estrogen are related to changes in vascular
      function. The investigators will measure vascular function using ultrasound, and brain
      activity using MRI scans in women who are enrolled in the Females, Aging, Metabolism and
      Exercise (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either
      take a medication to decrease their estrogen levels, or a placebo. This sub-study may provide
      new information about how estrogen affects vascular function and cognitive function, and lead
      to new ways to prevent or delay cognitive impairment or dementia.
    


Intervention name(s): Leuprolide acetate; Estradiol; Medroxyprogesterone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.; Climara transdermal patch 0.075mg/day applied weekly months 6-9; Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.; placebo
Other intervention name(s): Lupron; Climara; Provera
Intervention MeSH terms: Leuprolide; Medroxyprogesterone Acetate; Medroxyprogesterone; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cognitive impairment; Executive function; Arterial stiffness; Endothelial function; Menopause; Women's health; Hormone therapy; functional MRI
BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS
Condition: Bladder Cancer; Diabetes
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      patients om metformin from diabetic clinic were checked for bladder cancer
    


Intervention name(s): metformin
Intervention type(s): Other
Other intervention name(s): glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: pathology
Reward Mechanisms in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits
      in human obesity and to better understand its effects on weight loss (in patients without
      diabetes).

      According to the study protocol, 70 obese patient will be evaluated at baseline and at
      16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg)
      or Placebo by pen injector.

      All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session
      while being presented with gustatory stimuli. Second, participants will complete behavioural
      tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing
      apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated
      with food intake. Third, metabolic parameters and hormones involved in appetite regulation
      will be assessed and studied in relation to fMRI.

      These measurements will be repeated after 16 weeks in obese individuals. The control group of
      normal body weight individuals will be evaluated once at Baseline.
    


Intervention name(s): Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo
Intervention type(s): Drug
Intervention description(s): Patients will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GLP-1; fMRI
A Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy
      Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center,
      placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single
      center, randomized, open-label study that consists of two sequential two-way crossover
      studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg
      group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In
      cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2
      subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to
      XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study
      drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In
      cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects)
      to receive study drug in the sequence shown below.

      Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose =>
      XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d.,
      multiple dose (fed)

      Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) =>
      XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple
      doses (fasted)
    


Intervention name(s): APD356 10 mg; APD356 XR-20 mg; APD356 10 mg matching Placebo; APD356 XR-20 mg matching Placebo; APD356 20 mg; APD356 20 mg matching Placebo; APD356 XR-20 mg (orange tablet); APD356 XR-20mg (orange tablet, fed state)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One tablet of APD356 10 mg will be orally administered in fasted state.; One tablet of APD356 XR-20 mg will be orally administered in fasted state.; One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.; One tablet of APD356 XR matching placebo will be orally administered in fasted state.; Two tablets of APD356 10 mg will be orally administered in fasted state.; Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.; One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.; One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subjects; Japanese Adult