bioihbjkbjnl/mcl2 huggingface dataset:
Single and Multiple Dose Study in Japanese Subjects
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore the safety, tolerability, and serum uric acid lowering effect of
      RDEA3170 in healthy Japanese males to allow comparison with the Western population.
    

Detailed description: 
      While clinical studies of RDEA3170 to date have been limited to a Western population, it is
      recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose
      response in different ethnic populations. The purpose of this study is to explore the safety,
      tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of
      RDEA3170 in healthy Japanese males, and to allow comparison of these parameters with the
      Western population.
    

Intervention name(s): RDEA3170 and Placebo
Intervention type(s): Drug
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Yoga Training on Menopausal Symptoms on Menopausal Women
Condition: Menopause
Study type: Interventional

Summary: 
      Parallel to the increase in life expectancy by years, the population of women living in the
      post-menopausal period is also increasing. In order to have a healthy menopause, which is an
      important part of women's life, it is thought that the adoption of yoga practice without
      health risks by women and its implementation as a lifestyle may be effective in reducing the
      symptoms of menopause experienced by women. In line with this information, it is aimed to
      determine the effect of yoga training on menopausal symptoms. The research will be carried
      out with menopausal women between the ages of 40-60 in Famagusta region. Women will be
      divided into two groups as intervention and control. Personal information form and menopause
      rating scale will be used in the research. The intervention group will be given yoga practice
      two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and
      control group before and after the research.
    

Detailed description: 
      Parallel to the increase in life expectancy by years, the population of women living in the
      post-menopausal period is also increasing. In order to have a healthy menopause, which is an
      important part of women's life, it is thought that the adoption of yoga practice without
      health risks by women and its implementation as a lifestyle may be effective in reducing the
      symptoms of menopause experienced by women. In line with this information, it is aimed to
      determine the effect of yoga training on menopausal symptoms. The research will be carried
      out with menopausal women between the ages of 40-60 in Famagusta region. Women will be
      divided into two groups as intervention and control. Personal information form and menopause
      rating scale will be used in the research. The intervention group will be given yoga practice
      two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and
      control group before and after the research.
    

Intervention name(s): yoga
Intervention type(s): Behavioral
Intervention description(s): Yoga practice will be done two days a week for 10 weeks.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: menopause; yoga; symptoms
A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci
Condition: Skin and Subcutaneous Tissue Bacterial Infections; Wound Infection; Cutaneous Abscess; Burn Infection; Cellulitis
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Wound Infection; Cellulitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety, tolerability and effectiveness of
      AFN-12520000 for in the treatment of Staphylococcal infections of the skin.
    

Detailed description: 
      This open-label Phase 2 study is designed as a proof-of-concept study to evaluate the
      efficacy of a total daily dose of 400 mg of AFN-12520000 using a number of newly defined
      early endpoints, conventional endpoints, and composite endpoints to determine clinical
      response. Safety and tolerability will also be evaluated by conventional endpoints.

      The study will enroll up to 100 patients with a clinically documented diagnosis of Acute
      Bacterial Skin and Skin Structure Infections (ABSSSI) due to staphylococci. Patients meeting
      eligibility criteria will be identified and evaluated in a hospital or specialized clinic.
      After consent is obtained, the first dose of study medication will be administered. Daily
      clinical assessments will be conducted at the hospital and/or outpatient clinic during the
      first 5 days of treatment. Adverse events (AEs) and response to therapy will also be
      assessed.

      The study will consist of a screening period, which includes the baseline visit; a treatment
      period, and an end-of-treatment (EOT) visit; and a follow-up period, which includes a
      short-term (Test-of-Cure [TOC]) follow-up (STFU/TOC) visit and a long-term follow-up (LTFU)
      visit.

      Treatment regimens as short as 5 days (10 doses) and as long as 14 days (28 doses) will be
      permitted depending on individual response to treatment. The anticipated time commitment for
      patient participation in the study will be approximately 20 to 42 days from
      screening/baseline to the LTFU visit. The total duration of the study will be < 12 months.
    

Intervention name(s): AFN-12520000
Intervention type(s): Drug
Intervention description(s): Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg
Other intervention name(s): AFN-1252; API-1252
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin and Subcutaneous Tissue Bacterial Infections
Gut Permeability Assessment in Celiac and Gluten Sensitive Children
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      This study will assess the effect of gluten on gut barrier function. Investigators at the
      Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water
      solution), and are hoping to prove its effectiveness in a clinical setting.
    

Detailed description: 
      The aim of this study is to assess effect of gluten on the gut barrier function in patients
      at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study
      will assess the gut permeability in three groups of patients 1) children who are at high risk
      for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children
      who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender.
      Patients will undergo celiac serologic and genetic testing, after which the rhamnose test
      will be performed to assess the presence of increased gut permeability.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of three groups of children, aged 2-17 years. The first
        group will be children with siblings that have celiac disease, the second group will be
        children with non-celiac gluten sensitivity and the third group will be healthy children.
      
Keywords: Celiac; Gluten; Sensitivity; Permeability; Non-celiac gluten intolerance; Gastrointestinal Diseases; Digestive System Diseases
Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee
Condition: Osteoarthritis of the Hip or Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      Medical condition under investigation: Osteoarthritis of the hip or knee

      Number of patients planned: 480 adult patients

      Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg
      powder for oral suspension compared to Ibuprofen 400 mg in patients with painful
      osteoarthritis of the hip or knee

      Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for
      oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints
      due to painful osteoarthritis of the hip or knee
    


Intervention name(s): Dexibuprofen; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 400mg powder for oral suspension, daily dose 800mg; 400mg, powder for oral suspension, daily dose 1600mg
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the safety and tolerability of single ascending and
      multiple ascending oral doses of NIP292 tablets administered following an overnight fast in
      healthy adult subjects.
    


Intervention name(s): NIP292 tablet; NIP292 tablet; NIP292 tablet; NIP292 tablet; NIP292 tablet; NIP292 tablets; NIP292 tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): NIP292 (oral tablet at 10 mg) or placebo; NIP292 (oral tablet at 30 mg) or placebo; NIP292 (oral tablet at 100 mg) or placebo; NIP292 (oral tablet at 300 mg) or placebo; NIP292 (oral tablet at 500 mg) or placebo; NIP292 (oral tablet at dosage 1) or placebo; NIP292 (oral tablet at dosage 2) or placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Virtual Exercises in Patients With Parkinson's Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few
      studies describe the effects the virtual exercises on the clinical and functional outcomes in
      this disease.

      Objectives: To analyze the effectiveness of virtual exercises on functional exercise
      capacity, fatigue and quality of life in patients with PD.

      Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups:
      group of virtual exercises associated with conventional exercises (n = 10) and control group
      with conventional exercise group (n = 10).

      The following variables are evaluated: functional exercise through walking test in 6 minutes,
      fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life
      Questionnaire-PDQ-39.
    


Intervention name(s): Virtual exercises
Intervention type(s): Other
Intervention description(s): The exercises will be performed with the Nintendo ® Wii Balance Board ® platform, and consist in: 1) Table Tilt; 2) Obstacle Course; 3) Tilt City; 4) Basic step; 5) Penguin; 6) Heading Soccer; 7) Basic Run. All patients underwent 12 sessions, twice a week for a period of 06 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson disease, Physical Therapy, Fatigue, Quality of Life
Effect of Exercise Training in Coronary Artery Disease Patients After Stenting
Condition: Stent Restenosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      To determine the effects of exercise training on ankle-brachial index and Quality of Life in
      coronary artery disease patients after stenting. There is a need to develop strategies, not
      only to prevent restenosis but also to improve patients' functional status and perception of
      well-being. In particular, it is not well defined whether exercise training can reduce the
      restenosis rate and improve the outcome after percutaneous intervention (PCI), and its
      effects on the Ankle-brachial index are not yet well known.
    

Detailed description: 
      The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the
      risk of cardiovascular morbidity and mortality. Almost half of the patients, after an initial
      encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal
      with recurrent chest pain that requires medical attention, reduces functional capacity, and
      creates a status of psychological distress.
    

Intervention name(s): Structured In-patient and Home plan; Conventional Therapy
Intervention type(s): Other; Other
Intervention description(s): A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).; In-Patient: Wound care, Bed mobility:
AROMS (10 Reps*3sets*TD), Breathing Exercise (10 Reps*3sets*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ankle-Brachial Index; Coronary artery diseases; Exercise training; Quality of life; Stenting
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
Condition: Wearing Comfort
Study type: Interventional

Summary: 
      The purpose of this test is to evaluate the comfort level of several model configurations of
      the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by
      the device, mainly due to tubes around the ears and on the face skin, the cannula itself
      (especially in the nostrils and the mouth surrounding) and the smell.
    

Detailed description: 
      This test compares 4 models for the duration of up to 3 days each and 2 models with duration
      of up to 24 hours. Each subject will tested the models and will provide feedback at
      predefined times during the test. During the test and according to initial result the team
      may decide to shorten the test duration.

      The testing staff will include a dermatologist and a technical representative that will
      supervise the test in order to monitor and control the required performance of the subjects
      according to test protocol, and relevant outcomes. During the test the dermatologist will
      monitor any unexpected skin reaction or patient discomfort.
    

Intervention name(s): Oridion Smart CapnoLine® H Plus with Wedge cannula; Oridion Smart CapnoLine® Plus with Non-Wedge cannula; Experimental sample line Model 3; Experimental sample line Model 4; Experimental sample line Model 5; O2/CO2 cannula w/female luer (Westmed comfort plus #0504)
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): The subjects will assess the comfort level of the different cannulas; The subjects will assess the comfort level of the different cannulas; The subjects will assess the comfort level of the different cannulas; The subjects will assess the comfort level of the different cannulas; The subjects will assess the comfort level of the different cannulas; The subjects will assess the comfort level of the different cannulas
Other intervention name(s): Usability test for arm 1; Usability test for arm 2; Usability test for arm 3; Usability test for arm 4; Usability test for arm 5; Usability test for arm 6
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Device Feasibility
Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a
      particular patient's immune cells possess influences how they respond to rituximab and other
      monoclonal antibodies.
    

Detailed description: 
      -  A medical data collection survey sheet will be filled out by the patient or doctor with
           medical information pertaining to how the patient responded to rituximab and other
           monoclonal antibodies for use in this study.

        -  Blood work will be performed to analyze the blood by molecular technology to find the
           kind of Fc gamna RIIIa receptor the patient possess and correlate these findings with
           the outcome of treatment with rituximab or other monoclonal antibodies.
    

Intervention name(s): Rituximab; monoclonal antibodies
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rituximab; Antibodies; Antibodies, Monoclonal
Keywords: monoclonal antibody; Fc gamma RIII receptor expression; rituximab
Effect of I31 Probiotic on Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional

Summary: 
      This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo,
      in the treatment of symptoms of lactose intolerance.
    

Detailed description: 
      People with lactose intolerance are unable to fully digest the sugar (lactose) in milk. As a
      result, they may have diarrhea, abdominal pain, gas and bloating after eating or drinking
      dairy products. A deficiency of lactase - an enzyme produced in your small intestine - is
      usually responsible for lactose intolerance. Many people have low levels of lactase but are
      able to digest milk products without problems. In lactose intolerance, though, lactase
      deficiency leads to symptoms after eating dairy foods.

      I31 is a probiotic formula composed of Pediococcus acidilactici strain CECT7483 and
      Lactobacillus plantarum strains CECT7484 and CECT7485, previously shown to improve intestinal
      sensitivity in patients with Irritable Bowel Syndrome (IBS). IBS is a functional intestinal
      disease in which recurrent abdominal pain is associated with defecation or a change in bowel
      habits, often accompanied by bloating. Given the overlap in symptoms between IBS and lactose
      intolerance, it is hypothesized that I31 formula could be beneficial for individuals with
      lactose intolerance.
    

Intervention name(s): Placebo; I31 Probiotic
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Placebo treatment (maltodextrin), once daily (u.i.d); I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation is 2:1 to probiotic and placebo arms
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Probiotic; Diarrhea; Abdominal pain; Flatulence
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced
      gingivitis state.
    

Detailed description: 
      A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for
      therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten
      the resolution of disease.
    

Intervention name(s): Stannous Fluoride Toothpaste; Colgate fluoride toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): 0.454% stannous fluoride toothpaste; 0.76 % Sodium MonoFluorophosphate (MFP)
Other intervention name(s): Colgate Total SF; Colgate Dental Cream
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesized that hypnosis is an alternative technique that could be
      applied to help patients with obesity to lose weight.

      The possibility that a self-conditioning technique (self-hypnosis) added to traditional
      approach (diet, exercise and behavioral recommendations) will be effective in determining
      weight loss with respect to the traditional approach in subjects with a body mass index (BMI)
      between 35 and 50 kg/m2 will be studied.
    

Detailed description: 
      Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed,
      overeating often involves loss of control and compulsive behaviors.

      Hypnosis could increase the ability to control emotional impulses. Self-conditioning
      techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management
      of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained
      patients to go into self-hypnosis in a few minutes and to repeat the experience in complete
      autonomy, employing a short time of the day only.
    

Intervention name(s): self-conditioning techniques; standard care (diet, exercise and behavioral therapy)
Intervention type(s): Other; Other
Intervention description(s): Self-hypnosis to increase self-control before meals and every food compulsion episode; dietary recommendations, exercise recommendations, and behavioral recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment