bioihbjkbjnl/mcl2 huggingface dataset:
Foundations of Fitness Program Pilot
Condition: Pediatric Obesity; Health Behavior; Body Mass Index; Self Esteem
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Approximately 17% of US children have obesity resulting in significant childhood
      co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease
      and cancer. Guidelines recommend intensive lifestyle programs as first-line treatment, yet
      few pediatric practices are equipped to provide this. Clinical-community partnerships are
      well-positioned to address this care gap. This proposal aims to assess whether a
      community-delivered lifestyle program offered in adjunct to primary care obesity management
      is feasible, acceptable, effective, and easily implemented in a rural care setting. In this
      study, approximately 40 children aged 7-13 years old and their caregiver pairs will be
      recruited from a primary care pediatric clinic. Child-adult dyads will participate in a
      24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention
      phase. The intervention phase will include bi-weekly meetings of a community intensive
      lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and
      support for individual and family behavior change. A mixed-methods approach using qualitative
      interviews and study questionnaires, combined with objective measures of adiposity and
      fitness will assess study outcomes.
    


Intervention name(s): Foundations of Fitness Program
Intervention type(s): Other
Intervention description(s): The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review. Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families. Content will be offered in a context that supports self-esteem and behavior change. The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
Condition: Plague Vaccine
MeSH terms: Plague
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at
      a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four
      parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts
      (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or
      Days 0, 56 and 121).
    

Detailed description: 
      The objectives of this trial are: to compare the safety of rF1V vaccine administered in two
      different schedules through 28 days after each vaccination and cumulatively to Day 210; to
      compare the immunogenicity of rF1V vaccine administered in two different schedules through 28
      days after Vaccination 3; to compare the safety and immunogenicity of rF1V vaccine
      administered by two different schedules through 12 months after Vaccination 3; and to assess
      the contribution of the adjuvant to the immunogenicity of the rF1V antigen.
    

Intervention name(s): rF1V vaccine (with Adjuvant); rF1V vaccine (without Adjuvant); rF1V vaccine (with Adjuvant); rF1V vaccine (without Adjuvant)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182; 80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182; 80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121; 80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Other intervention name(s): Recombinant Plague Vaccine rF1V; Recombinant Plague Vaccine rF1V without Adjuvant; Recombinant Plague Vaccine rF1V; Recombinant Plague Vaccine rF1V without Adjuvant
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Plague; Vaccine
Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
Condition: Anovulation; Oligo-ovulation; Hypothalamic-pituitary Dysfunction; Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Pituitary Diseases; Anovulation; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the
      efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single
      5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin
      (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation.
      Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective
      is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.
    


Intervention name(s): MSJ-0011; urinary hCG (u-hCG); Follitropin alpha
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 250 microgram (mcg) MSJ-0011 (choriogonadotropin alfa [recombinant human Chorionic Gonadotropin, r-hCG]) subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).; Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.; Low-dose step-up protocol involves starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days (Day 8, 15, 28) will be done if no ovarian response will be observed for maximum of 28 days.
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japanese
Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Condition: Cytoreductive Surgery
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The Tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal
      saline over 20 minutes after induction of anesthesia and before surgical incision. In the
      control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary
      endpoint is reduction in blood loss, while the secondary endpoint was the number of patients
      needing transfusion and occurrence of postoperative thrombotic complications (myocardial
      infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days
      after surgery.
    


Intervention name(s): tranexamic Acid infusion; saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): The tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision.; In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Study of the Cleavage of the Egg in Relation to the Stimulation Treatment
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      This post-marketing, single-center prospective study will be conducted in an open-label,
      non-interventional setting, for women seeking fertility treatment and will describe cleavage
      dynamics in relation to the age of the oocyte and gonadotrophin treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women suffering from infertility
Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease
Condition: Crohn Disease
MeSH terms: Paratuberculosis; Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      An open label extension to the RHB-104-01 Study.
    

Detailed description: 
      An Open Label Phase III Study to Assess the Efficacy and Safety of Fixed-Dose Combination
      RHB-104 in Subjects with Active Crohn's Disease Despite 26 Weeks of Participation in the MAP
      US RHB-104-01 Study.
    

Intervention name(s): RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
Intervention type(s): Drug
Intervention description(s): For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks
Other intervention name(s): RHB-104
Intervention MeSH terms: Clarithromycin; Rifabutin; Clofazimine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Active
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease,; moderate to severe; remission; Mycobacterium avium paratuberculosis; antibiotic
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
Condition: Nosocomial Infections; Pneumonia, Ventilator-Associated
MeSH terms: Cross Infection; Pneumonia, Ventilator-Associated
Study type: Interventional

Summary: 
      The study is a first step in establishing the safety and efficacy of the CytaCoat technology
      when applied to a medical device such as a nasal prong and the clinical data generated will
      serve as a basis for continuous studies in clinically significant settings such as the
      neonatal care units.
    


Intervention name(s): CytaCoat Nasal Prong; Inspiration Healthcare Inspire nCPAP Nasal Prong
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
Condition: Tick Borne Encephalitis (TBE)
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the durability of antibody responses in children and adolescents
      after primary immunization with TBE vaccine
    


Intervention name(s): Serology blood draw
Intervention type(s): Other
Intervention description(s): Blood draw only, no vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TBE; Tick Borne Encephalitis
Sildenafil for the Treatment of Lymphatic Malformations
Condition: Lymphatic Malformations; Lymphatic Diseases
MeSH terms: Lymphangioma; Lymphatic Diseases; Lymphatic Abnormalities; Congenital Abnormalities
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 study to evaluate safety and efficacy of sildenafil taken orally to improve or
      resolve lymphatic malformations in children. Subjects may receive either placebo or treatment
      in an oral dosage with an open label extension for subjects who received placebo. The study
      treatment assignment will be randomized in a double blind fashion. MRI examination will
      evaluate change in lesion volume due to treatment. Other safety and efficacy measures will be
      taken through the 32-week study duration.

      Funding Source - FDA OOPD
    

Detailed description: 
      Lymphatic malformations (LMs) are localized areas of abnormal development of the lymphatic
      system that commonly occur in the head and neck of children. LMs are considered a rare or
      orphan disease which causes complications including pain, ulceration, secondary infection,
      infiltration of other organs, and death. Current therapies involve surgical excision or
      methods of chemical or physical destruction of portions of lesions. No therapies are
      uniformly effective and all have the risk of significant adverse events. We recently
      witnessed almost complete resolution of a LM lesion in a child who was treated with
      sildenafil oral therapy for pulmonary arterial hypertension. We have subsequently evaluated
      additional subjects who improved with sildenafil. The goal of this clinical research trial is
      to document the benefit or absence of benefit of sildenafil therapy for LMs and identify
      which type of patient will benefit from sildenafil. This study is a double-blind
      placebo-controlled trial which involves precise documentation of volume changes associated
      with therapy or placebo by using MRI segmentation techniques. We will also observe and
      document the clinical response to sildenafil or placebo using clinical evaluation scores and
      surveys. The results of the study should identify characteristics of LM lesions which may
      suggest a beneficial response to sildenafil therapy. Sildenafil has very low risk of side
      effects in the dosage used in this trial. Documentation of an effective response of LMs to
      sildenafil will accelerate the interest in, and the ability to understand, the mechanisms of
      LM formation and treatment.
    

Intervention name(s): Sildenafil 20 mg tablets; Placebo tablets (resembling Revatio)
Intervention type(s): Drug; Other
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Sildenafil; Magnetic Resonance Imaging; Dermatology; Pediatrics
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to determine the safety and efficacy of teriflunomide
      in multiple sclerosis (MS) with relapses.

      Secondary objectives were:

        -  To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI)
           variables as well as clinical and quality of life measures.

        -  To investigate the pharmacokinetic and pharmacodynamic relationships.
    

Detailed description: 
      The total duration of the study period per participants was 46 weeks comprising 3 periods:

        -  a 4-week screening period,

        -  a 36-week double-blind treatment period,

        -  a 6-week post-treatment follow-up period.

      Participants who successfully completed the double-blind treatment phase were offered the
      possibility to continue study treatment in the extension study LTS6048 - NCT00228163.
    

Intervention name(s): Teriflunomide; Placebo (placebo for teriflunomide)
Intervention type(s): Drug; Drug
Intervention description(s): film-coated tablet
oral administration; film-coated tablet
oral administration
Other intervention name(s): HMR1726
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: The investigators studied the effects of respiratory muscle stretching in an
      8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled
      trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y,
      percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching
      group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise
      program that had 3 sessions per week. The investigators measured inspiratory and expiratory
      muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise
      capacity (by 6-minute walk distance), dyspnea and quality of life.
    


Intervention name(s): respiratory muscle stretching
Intervention type(s): Behavioral
Intervention description(s): stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc
Other intervention name(s): pulmonary rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; diaphragm; muscle; stretching; exercises; dyspnea; respiratory muscle stretching; pulmonary rehabilitation; exercise training; improved exercise capacity, dyspnea, quality of life
Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomised, double-blind placebo-controlled, 2-part study to assess the
      safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and
      multiple oral doses of HSK31858 in healthy volunteers
    


Intervention name(s): HSK31858, tablet; Placebo, tablet
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose in single ascending dose: 5 mg; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: HSK31858; NCFBE; phase I
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with
      parameters like Cmax, AUC(INF), and AUC(0-T).
    


Intervention name(s): BMS-986141; Dilitazem
Intervention type(s): Drug; Drug
Intervention description(s): Single dose BMS-986141 and Multiple doses of Dilitazem; Single dose BMS-986141 and Multiple doses of Dilitazem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Computer Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study examines the efficacy of two computer-based attention training systems, one with
      and one without neurofeedback. The training systems intend to help children learn to focus
      and attend more effectively.
    

Detailed description: 
      The current study is examining a neurofeedback (NF) computer attention training system that
      teaches children to alter their brainwave activity with a Cognitive Training attention
      training system (CT). The investigators hypothesize that both treatments will show
      improvement in ADHD symptoms and academic outcomes compared to a control condition.

      104 children with ADHD in grades 2 and 4 are randomly assigned to receive the NF, CT, or a
      Waitlist-Control (WLC) condition that receives NF or CT the following academic year. Children
      receive forty 45-minute sessions three times a week at school for 4 months. A comprehensive
      assessment, consists of data completed by teachers, parents, participants, and double-blind
      classroom observations.
    

Intervention name(s): Neurofeedback; Cognitive Training; Waitlist Control
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 3 times per week for 45 minutes for a total of 40 sessions; 3 times per week for 45 minutes for a total of 40 sessions; 6 30 minute calm breathing sessions over the course of 4 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; neurofeedback; biofeedback; computer attention training
Effects of Dietary Supplements on Sarcopenic Elders
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Sarcopenia is defined as a syndrome characterized by decline of skeletal muscle mass and
      strength or an alteration in physical function. Although some studies showed nutritional
      supplementation alone might have health benefits for older sarcopenic patients, the results
      were inconsistent and remain controversial. The objective of this study was to evaluate if a
      sufficient protein diet including supplements with leucine-enriched whey protein and vitamin
      D can lead to better improvement than sufficient dietary protein alone in maintaining muscle
      mass and strength among sarcopenic elders.
    


Intervention name(s): Protison with High Protein 51(Original Flavor)
Intervention type(s): Dietary Supplement
Intervention description(s): Contents of each supplement sachet has a calorie of 88 kcal, 12.8 g protein( including 8.5 g whey protein concentrate), 1.2 g leucine, 7.3 g carbohydrates, 0.8 g fat and 120 IU vitamin D per serving. This supplement was added 200 ml water and stirred well, then drank before meal.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment