bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the bioequivalence of a newly
      developed 120 mg nifurtimox tablet formulation (Test treatment) compared with the 120 mg
      nifurtimox tablet currently used in the Bayer pediatric clinical development program
      (Reference treatment). The new tablet formulation assessed in this study is intended to
      replace the 120 mg nifurtimox tablet formulation currently used in clinical practice. It is
      an immediate-release tablet with an altered composition compared to the reference
      formulation. The new tablet overcomes pharmaceutical quality issues seen for the current
      formulation, e.g. sensitivity to humidity. Due to safety reasons, the study drug will be
      administered under fed conditions to adult male and female patients suffering from Chagas'
      disease and not healthy subjects (see also Benefit-risk assessment below).

      In addition, the PK, safety, and tolerability of nifurtimox will be assessed as secondary
      objectives.
    


Intervention name(s): Nifurtimox (Lampit, BAYA2502)_Test; Nifurtimox (Lampit, BAYA2502)_Reference
Intervention type(s): Drug; Drug
Intervention description(s): Orally intake of 1 *120mg new formulation tablet as test treatment; Orally intake of 1 *120mg current clinical formulation tablet as reference treatment
Intervention MeSH terms: Nifurtimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: New formulation
A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937)
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the
      tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective
      disorder delivered.
    


Intervention name(s): Asenapine 3x5mg followed by 1x15mg; Asenapine 1x15mg followed by 3x5mg
Intervention type(s): Drug; Drug
Intervention description(s): Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days; One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
Other intervention name(s): Org 5222, SCH 900274
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus
           (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability
           of 3 different dose escalation regimens of SAR425899 in terms of the relative and
           absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).

        -  Six-month safety extension period: To assess the safety and tolerability of SAR425899
           after 6 months treatment at the maximum dose that was individually well tolerated during
           the main part of the study in terms of the relative and absolute frequency and severity
           of GI AEs.

      Secondary Objectives:

      Main study and 6-month study extension period:

      To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic
      pharmacotherapy:

        -  The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose
           (FPG), and hemoglobin A1c (HbA1c).

        -  Safety and tolerability.
    

Detailed description: 
      Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week
      screening period, 8-week treatment period, 3-day post treatment follow-up period).

      Six-month study extension period: The maximum study duration is approximately 9 months (up-to
      3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).
    

Intervention name(s): SAR425899
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Solution
Route of administration: Subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes
Condition: Fibroid Uterus
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational [Patient Registry]

Summary: 
      The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power
      Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the
      feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the
      purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging,
      2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to
      investigate the added value for daily clinical practice.
    


Intervention name(s): microvascular flow imaging
Intervention type(s): Diagnostic Test
Intervention description(s): microvascular flow imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients were women with one or more uterine fibroids, with a diameter between 1,5
        and 12 cm, of which one was easily recognizable on ultrasound to assure the quality of the
        Doppler images.
      
Keywords: fibroid; microvascular flow; power doppler
The Effect of Alcohol on Food Reward
Condition: Obesity; Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Rationale

      It has been shown in several studies that alcohol increases subsequent food intake. However,
      moderate alcohol consumption has no clear effects on hunger and satiety hormones. In the
      Western world, where palatable food is highly available, food reward may play an important
      role in food intake. Alcohol consumption is known to stimulate neurotransmitters important
      for food reward and may therefore stimulate the reward response on a subsequent meal. This
      may lead to higher food consumption than when no alcohol is consumed. It is hypothesized that
      the reward response of food or beverages can already be generated when food or beverages are
      sensed in the mouth, because oral nutrient sensing is known to induce a satiety response
      (i.e. the cephalic phase response). Moreover, taste buds directly signal brain areas closely
      connected to the reward areas in the brain.

      Primary objective

        -  To determine whether moderate alcohol consumption influences subsequent food reward, as
           measured by questionnaires on food 'wanting' and food 'liking', and salivary and blood
           parameters related to reward.

      Secondary objectives

        -  To determine whether food reward is different when food is consumed than when food is
           sensed in the mouth, as measured by questionnaires on food 'wanting' and food 'liking',
           and salivary and blood parameters related to food reward.

        -  To determine whether moderate alcohol consumption influences subsequent food reward
           differently when food is consumed than when food is sensed in the mouth, as measured by
           questionnaires on food 'wanting' and food 'liking', and salivary and blood parameters
           related to food reward.
    


Intervention name(s): Orange juice; maltodextrin; Vodka; butter cake MSF; butter cake consumption
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.; chewing for 6 min on 40 gram cake and then swallow it.
Other intervention name(s): Orange Juice (Appelsientje); Fantomalt maltodextrin (energy powder), Nutricia; Smirnoff Vodka; cake modified sham feeding; cake consumption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon
Condition: Raynaud's Phenomenon Secondary to Connective Tissue Disease
MeSH terms: Neoplasm Metastasis; Raynaud Disease; Connective Tissue Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical
      cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon.
      The symptoms of this disease include pain, tingling, and numbness in the fingers of the
      affected hand or hands.
    


Intervention name(s): Vascana (0.9% nitroglycerin cream); Vehicle Cream (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Study drug administered topically; Vehicle administered topically
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acceptability of Video Games to Promote Asthma Education and Self-management in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a chronic lung disease affecting over 800,000 Canadian children. Knowing how to
      avoid asthma triggers, to take care of one's health, and to know when and why to do one's
      treatment can help prevent asthma crises, and have a better quality of life.

      Games in health can make the management of asthma easier by helping the child better
      understand his condition, his triggers, and manage his asthma by himself. Games also offer a
      personalized experience, where players can receive feedback about their learning. However,
      few studies explored the use of games in childhood asthma.

      This study will test 4 games for children with asthma. Through different characters and
      scenarios, the goals of the games are to help the child with asthma to better recognize and
      manage his asthma triggers and symptoms. The objectives of this study are:

        -  Evaluate the acceptability of these games in children with asthma

        -  Gather feedback on the games to guide future development
    


Intervention name(s): Video games
Intervention type(s): Device
Intervention description(s): The 4 videos games consists of:
Asthmonaut, a desktop game in which the child navigates through different scenarios and interacts with nine characters to learn about asthma symptoms and management (30 minutes)
Lung Launcher, a mobile game in which the character encounters different asthma triggers (customizable to the child) and the child has to find the correct preventive method to address each trigger (4 minutes)
Asthma Heroes, a desktop game where the player interacts with several characters to learn about their symptoms, treatment and context, and collects objects to help them manage their asthma (30 minutes)
Bloïd, a mobile game where the player uses a pressure sensor as an input device to guide a spacecraft and destroy meteorites in its path (4 minutes).
Intervention model: Single Group Assignment
Intervention model description: Participants will be asked to play 4 video games on asthma.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: video games
Nutrition Education to Promote Calcium Intake Among 30-65 Year-old Women in Vietnam
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Osteoporosis is an important public health problem in Vietnam, with one in ten Vietnamese
      women suffering from it. There is enough evidence demonstrating that low calcium intake is
      one of the risk factors for osteoporosis among Asian women in general and Vietnamese women in
      specific. It is reported that the intake of calcium among Vietnamese women is under 400
      mg/day, which is less than the daily recommendation of 1,000 mg/day by the Vietnam National
      Institute of Nutrition, even though calcium-rich foods are largely available in Vietnam.
      Therefore, the purpose of this study is to promote dietary calcium intake among Vietnamese
      women aged 30-65 years through implementing a nutrition education intervention.
    

Detailed description: 
      Vietnamese women aged 30-65 years without medical problems that could interfere with the
      calcium consumption, such as kidney stone, kidney and liver diseases. The women will be
      excluded if they are blinded, deaf, or have general learning disability.

      Outcomes of the study are dietary calcium intake, calcium knowledge, and osteoporosis health
      belief. A quantitative questionnaire is being used to collect these data.
    

Intervention name(s): Nutrition education intervention about osteoporosis and calcium
Intervention type(s): Behavioral
Intervention description(s): The intervention is designed and developed based on the Intervention Mapping Process and the Health Belief Model. Topics of the intervention include: the importance of osteoporosis and risk factors, role of calcium in bone health and controlling the disease, calcium recommendations and sources, role of vitamin D and physical activity in calcium absorption and bone health, and how to identify calcium-rich foods in the locality and prepare meals with local calcium-rich foods. A recipe booklet containing recipes using local calcium-rich foods will be given to the participants after the end of the two nutrition lessons. Interactive activities are incorporated in each lesson to encourage the participation of participants.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three communities receive the nutrition intervention while three other communities do not. After 1 month, the first 3 communities do not receive the intervention while the later 3 communities receive the same nutrition intervention. Baseline, post intervention data are collected.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: nutrition education; nutrition intervention; calcium intake; calcium-rich foods
Effect of a Preoperative Pulsed Electromagnetic Field and Abdominal Exercises on Muscle Strength Post Ventral Hernioplasty
Condition: Hernia, Ventral
MeSH terms: Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      The aim of this study is to investigate the impact of a preoperative pulsed electromagnetic
      field and abdominal exercises on muscle strength post ventral hernioplasty.
    

Detailed description: 
      Sixty patients, 25-40 years old, diagnosed with a ventral hernia and consulted for surgical
      hernia repair, preoperatively, were randomly assigned either into pulsed electromagnetic
      therapy and graduated abdominal strengthening exercises group (group A), graduated abdominal
      strengthening exercises group (group B), pulsed electromagnetic therapy group (group C) or
      group D who is instructed to presume in normal activities of daily living preoperatively,
      without any abdominal exercises or PEMF. All treatment interventions were applied at a
      frequency of three sessions per week for six weeks preoperatively. Abdominal muscle torque
      was measured by a biodex isokinetic dynamometer preoperatively at baseline and after six
      weeks of intervention and after four months postoperatively.
    

Intervention name(s): Pulsed electromagnetic field; Graduated abdominal strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): Pulsed electromagnetic field therapy was applied directly over the abdominal muscle from a supine position after the removal of metals or things that can be affected by a magnetic field will be assured prior to magnetic field application. The treatment parameters were set as 15 Hz frequency, 20 gauss amplitude with a rectangular waveform for 20 minutes.; Four specific muscle core exercises were performed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulsed electromagnetic field; abdominal exercises; ventral hernia repair
Eicosanoid Lipids by Airway Cells During Infection With Human Rhinoviruses
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The long-range goal of this protocol is to more completely understand the risks and the
      pathophysiology of asthma exacerbations, in order to develop prevention strategies and/or
      expedite a return to complete control of baseline asthma symptoms.
    

Detailed description: 
      Theinvestigators and others have shown that airway epithelial cell infection with human
      rhinovirus (HRV) is a major risk factor for subsequent exacerbation. Additionally, the
      investigators have shown that the nucleotide receptor, P2X7, is an important host factor in
      the prevention of exacerbations, and have data to suggest that this may occur at the level of
      the alveolar macrophage. Alveolar macrophages facilitate the resolution of inflammation in
      part by generating eicosanoid metabolites of arachidonic acid including prostaglandin E2
      (PGE2) and lipoxin A4 (LXA4). Patients with severe asthma have a reduced capacity to generate
      PGE2 and LXA4 when compared to those with non-severe asthma, despite alveolar macrophage
      expression of two of the key enzymes involved in their production. These and other data
      suggest that pro-resolving eicosanoid metabolism is most efficient when airway epithelial
      cells are in communication with alveolar macrophages, and that these pathways may be
      defective in patients with severe asthma. Moreover, inoculation experiments with human
      rhinovirus (HRV) demonstrate that alveolar macrophages express cox-2 during resolution. These
      and other data have led to the central hypothesis that transcellular generation of PGE2 and
      lipoxins is regulated by P2X7-induced cox-2 expression in alveolar macrophages, and that this
      process facilitates resolution of an HRV-triggered exacerbation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with mild asthma from Madison, WI region
      
Biospecimen description: 
      whole blood, serum, plasma, DNA, RNA, bronchoalveolar lavage, bronchial brushings
    
Keywords: mild; asthma; allergic
Effects of Fats on Blood Glucose in People With and Without Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      People with type 2 diabetes mellitus (earlier known as maturity onset diabetes mellitus) have
      high blood levels of sugar and fat. This study is being done to determine if excessive sugar
      entering the blood in people with type 2 diabetes mellitus is caused by excessive fat. We
      will also evaluate how the anti-diabetic medications, pioglitazone and metformin taken by
      mouth work to control blood sugar in people with diabetes.
    

Detailed description: 
      The ultimate goal of this application is to determine the cause(s) of type 2 diabetes
      mellitus. The role of the liver in the evolution of type 2 diabetes has not been as
      extensively studied as that of muscle. This has been, in part, due to the inherent difficulty
      of measuring hepatic insulin action in humans under physiologic conditions. Plasma free fatty
      acids (FFA) can cause insulin resistance in non-diabetic humans and are commonly elevated in
      people with type 2 diabetes. We will re-examine the mechanism(s) by which elevated FFA cause
      hepatic insulin resistance in non-diabetic humans, will determine whether elevated FFA alter
      insulin induced suppression of endogenous glucose production (EGP) in diabetic humans and if
      so, whether this is due to changes in glycogenolysis and/or gluconeogenesis. We will also
      seek to determine whether treatment with a pioglitazone (a thiazolidinedione) blunts or
      prevents FFA induced hepatic (and extrahepatic) insulin resistance in people with type 2
      diabetes and whether the effects of FFA on insulin action are influenced by gender. We will
      examine if use of thiazolidinediones reduces cortisol production by changing the overall
      activity of 11 beta hydroxysteroid dehydrogenase type 1. We will also investigate whether use
      of thiazolidinediones alters objectively measured breathing or sleepiness in people with type
      2 diabetes.
    

Intervention name(s): Metformin vs Thiazolidinedione (Pioglitazone)
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Pioglitazone; 2,4-thiazolidinedione
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Trial of Centanafadine Efficacy, Safety, and Tolerability in Adult Subjects With Binge Eating Disorder
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy of 2 doses of centanafadine
      sustained-release (SR) (200 milligrams [mg] and 400 mg total daily dose [TDD]) compared with
      placebo in adults with moderate to severe binge eating disorder (BED).
    


Intervention name(s): Centanafadine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sustained-release oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Centanafadine; Binge Eating Disorder
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
Condition: Evaluate PK Profile
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of
      Nirsevimab in Healthy Chinese Adults.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the PK,
      safety and tolerability, and ADA of nirsevimab when administered as a single fixed IM dosage
      to healthy Chinese adult subjects. Enrolment is planned at a single study center in China.
      Approximately 24 subjects will be randomly assigned in a 3:1 ratio to receive nirsevimab (n =
      18) or placebo (n = 6). All subjects will be followed for approximately 150 days after dosing
      to assess safety, PK, and ADA response.
    

Intervention name(s): nirsevimab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Drug: injection, a single fixed IM dose on day 1 only.; Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
Other intervention name(s): MEDI8897
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: PK; safety; tolerability; Nirsevimab; healthy Chinese Adults; Respiratory Syncytial Viral (RSV)