bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants and Toddlers, Following Administration of IPV (Inactivated Poliovirus Vaccine)-Containing Vaccines
Condition: Presence of Materials From PCV-1
Study type: Observational

Summary: 
      This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals'
      Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant)
      and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus
      Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine
      products. The samples have been collected at pre-determined time points from a subset of
      subjects who participated in selected studies [217744/085 and 213503/048] conducted in the
      United States.
    

Detailed description: 
      Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are
      used in this study.
    

Intervention name(s): Serum sample
Intervention type(s): Procedure
Intervention description(s): Serum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies.
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infants aged 2 and 6 months who were previously given a primary vaccination series
        consisting of a single dose of combination DTaP-HepB-IPV (PEDIARIX®) vaccine at 2, 4, and 6
        months of age or separately administered DTaP (INFANRIX®), HepB (ENGERIX-B®), and IPV
        (Sanofi-Pasteur's IPOL) vaccines in the study 217744/085 and toddlers aged 4-6 years who
        were previously vaccinated with a single dose of either the combination DTaP-IPV (KINRIX®)
        vaccine or separately administered DTaP and IPV vaccines in the study 213503/048.
      
Biospecimen description: 
      Serum
    
Keywords: Toddlers; Retrospective; Porcine circovirus type 1 (PCV-1); Infants; Laboratory evaluations; IPV
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3b single arm, open label, multicenter study describing the percentage of
      time pediatric participants with ITP have a platelet response while receiving romiplostim,
      defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the
      past 4 weeks.
    


Intervention name(s): Romiplostim
Intervention type(s): Drug
Intervention description(s): Romiplostim subcutaneous weekly injection
Other intervention name(s): Nplate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Immune Thrombocytopenia; Amgen
Tariquidar-ondansetron Combination in Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Prospective, randomized, double-blind, placebo controlled, cross-over proof of concept study.

      To determine the pharmacokinetics and tolerability of co-administration of 5-HT3R antagonist
      ondansetron with a P-glycoprotein inhibitor tariquidar, in patients with neuropathic pain.
    

Detailed description: 
      The investigators hypothesize that co-administration of a 5-HT3 receptor antagonist
      ondansetron (single 16mg dose) with p-glycoprotein inhibitor tariquidar (single 4mg/kg dose)
      vs placebo in a cross-over prospective randomized study, will:

        1. Be tolerable in patients with neuropathic pain.

        2. Increase the cerebrospinal fluid (CSF) to plasma ratio of ondansetron after intravenous
           administration, compare to ondansetron alone

        3. Result in a greater reduction in pain intensity than with ondansetron alone.
    

Intervention name(s): Ondansetron 16 mg with Tariquidar; Ondansetron 16 mg with Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.; In randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective, randomized, double blind, crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effects of daily consumption for 4 weeks of a
      fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain
      Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.
    


Intervention name(s): Probiotics fermented milk; Nutrient drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks; 80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional constipation; Probiotic; Probiotic microorganism; Lactobacillus casei Shirota (LcS)
Resistance Training and Appetite Regulation
Condition: Obesity
Study type: Interventional

Summary: 
      This study plans to learn more about how resistance training impacts appetite and the brain's
      response to food. The study will be evaluating how the brain responds to food images as well
      as how behaviors and hormones change with a 12 week resistance training intervention.
    

Detailed description: 
      Aim 1: To determine if RT impacts neuronal function associated with food intake behavior in a
      manner favoring reduced EI in overweight/obese adults.

      Hypothesis: Compared to pre, post-RT fMRI measures will demonstrate ↓ neuronal responses to
      food cues in the insula, prefrontal cortex, and hypothalamus, brain regions implicated in
      reward, impulsivity, motivation, and regulation of ingestive behaviors. These changes will be
      associated with ad libitum EI.

      Aim 2: To determine if RT impacts appetite-related peptides, ratings, and food intake
      behaviors in a manner favoring reduced EI in overweight/obese adults.

      Hypothesis: Compared to pre, post-RT measures will show changes in appetite-related peptides,
      ratings (↓ hunger ↑ satiety), and behaviors (↓food-related cravings & impulsivity, ↑
      self-efficacy) consistent with EI reduction. Changes in appetite regulation indices will be
      associated with changes in relevant brain networks (Aim 1). These changes will also be
      associated with ↓ ad libitum EI.

      Exploratory Aim: To determine if RT impacts neuronal function and appetite-related peptides
      and behaviors in a manner favoring ↓ EI in Non-Compensators (top tertile of fat mass loss) as
      compared to Compensators (bottom tertile of fat mass loss).

      Hypothesis: Compared to Compensators, Non-Compensators will show ↓ neuronal responses to food
      cues and default network, and changes in appetite-related peptides, ratings, and behaviors
      consistent with ↓ EI.
    

Intervention name(s): Resistance Training
Intervention type(s): Behavioral
Intervention description(s): 12-weeks of a full body resistance training intervention. Intervention will consist of 4 training sessions per week that are approximately 45-minutes in length. Two days will be upper body training and 2 days lower body
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Resistance Exercise; Appetite Regulation
Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, parallel group, chronic dosing,
      active-controlled, 28-week safety extension study of the two pivotal 24-week safety and
      efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the
      long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF)
      combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to
      very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included
      as an active control. To be eligible for this study, a subject must complete participation in
      Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).
    


Intervention name(s): GFF MDI (PT 003); GP MDI (PT001); FF MDI (PT005); Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GFF MDI administered as two puffs BID; GP MDI administered as two puffs BID; FF MDI administered as two puffs BID; Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children
Condition: Diet Habit
Study type: Interventional

Summary: 
      Considering the high prevalence of childhood obesity worldwide, effective interventions are
      needed . Parental involvement in interventions and the use of web-based modalities appear to
      be promising approaches. The aim of the study was to evaluate the efficacy of an innovative
      family and Web-based nutrition intervention called "Family Nutriathlon" on consumption of
      vegetables and fruit and dairy products and/or alternatives and on diet quality among
      children and their parents.
    

Detailed description: 
      Forty-three families, with at least one child with a BMI >85th percentile, participated in
      either the intervention (n=24) or control group (n=19) over an 8-week period. Families in the
      intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to
      increase their consumption and variety of fruits and vegetables and dairy products by
      recording their daily intakes using a Web-based platform. Families in the control group
      received recommendations based on general nutrition guidelines. Three follow-ups with a
      dietitian once every two weeks via Skype to assess progress were scheduled. A three-day food
      record was completed at baseline (week 0), immediately after (week 8) and 6 months after the
      intervention. A two-way repeated measures analysis of variance was used to assess changes in
      consumption of fruits and vegetables and dairy products, diet quality and dietary intakes
      between groups and over time.
    

Intervention name(s): Consumption of fruits, vegetables and dairy products
Intervention type(s): Other
Intervention description(s): Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: vegetables, fruits, dairy, children, habits
ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal
      reflux.
    


Intervention name(s): ADX10059; ADX10059 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux; Heartburn; Regurgitation
Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the research study is to determine if rasagiline is an effective treatment for
      fatigue in patients with Parkinson's disease (PD).
    

Detailed description: 
      Despite the fact that fatigue affects 40-50% of all patients with PD and is a leading cause
      of disability, we currently do not have any effective treatments for this symptom. Rasagiline
      is a well-tolerated and effective treatment for the motor symptoms of PD. Rasagiline is a
      MAO-B inhibitor that may decrease the breakdown of dopamine. Many patients report an
      improvement in their energy levels when on this medication. A proven treatment for PD fatigue
      would significantly improve the quality of life for numerous patients and their caregivers.
    

Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.; Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Other intervention name(s): Azilect
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Fatigue
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study designed to assess the pharmacokinetics and safety
      of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to
      those in subjects with normal hepatic function.

      Twenty-four subjects will be selected and enrolled according to the subject selection
      criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with
      moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic
      hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).
    


Intervention name(s): ABT-493; ABT-530
Intervention type(s): Drug; Drug
Intervention description(s): Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.; Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic Impairment; Hepatitis C Virus Infection
Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; NIDDM
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK),
      and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses
      in patients with type 2 diabetes.
    


Intervention name(s): PF-04937319; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.; Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics PK Pharmacodynamics PD T2DM Phase 1 Type 2 diabetes mellitus safety and tolerability
Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
Condition: Children With Craniosynostoses
MeSH terms: Craniosynostoses
Study type: Observational

Summary: 
      Being the craniostenoses sutural basically a disease, the fact that the brain being trapped
      in an enclosure that does not have complacency required to accompany their growth constitutes
      the challenge of treatment, which aims to restore the complacency of the suture and correct
      the stenotic compensatory cranial deformity.

      This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided
      by the use of springs distracting.
    

Detailed description: 
      As demonstrated by some authors, the curved shape of the helix fits perfectly the remodeling
      of a curved surface as well as the skullcap. If you do not receive fixation, however, trace
      the helicoid of the bone osteotomy can turn on a spring that can expand or contract depending
      on the direction of the force that is received. This form of osteotomy was therefore chosen
      by the authors to induce bone compliance areas of secondary defect that should expand or
      compress indirectly during the process of dynamic remodeling of primary defect with springs.
    

Intervention name(s): dynamic craniotomy
Intervention type(s): Procedure
Intervention description(s): Surgical technique of craniotomy spiral without detachment of dura mater
Other intervention name(s): craniotomy helicoid; Craniotomy spiral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children with craniosynostoses
      
Keywords: craniosynostoses; Osteogenesis Distraction; craniotomy
Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the role of low vitamin D levels on the health of blood
      vessels or vascular function in adolescents and young adults with type 1 diabetes.
    

Detailed description: 
      Vitamin D deficiency is known to be common in patients with type 1 diabetes. Studies in
      adults have shown that vitamin D deficiency is associated with cardiovascular events such as
      stroke, myocardial infarction and peripheral arterial disease. However, the impact of this
      deficiency on vascular health in adolescents with diabetes has not been examined. Furthermore
      given that endothelial dysfunction is reversible, early detection of this process may have
      therapeutic and prognostic implications in this population.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): Dosing If the 25 OH Vitamin D level at Baseline/Screening is less than 20 nmol/L then the subject will receive 2000 IU daily.
If the 25 OH Vitamin D level at Baseline/Screening is between 20 and 37.5 nmol/L then the subject will receive 1000 IU daily.
Other intervention name(s): Ddrops®
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Adolescents and Young Adults; Vitamin D; Cardiovascular Disease
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)
Condition: Overactive Bladder
MeSH terms: Hepatic Insufficiency; Liver Failure; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618)
      administered to participants with moderate hepatic insufficiency and healthy participants
      matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild
      hepatic insufficiency.
    

Detailed description: 
      This study is planned to be conducted in two parts. Part 1 of the study will include
      participants with moderate hepatic insufficiency and healthy participants. If Part 2 is
      conducted, Part 2 of the study will include participants with mild hepatic insufficiency.
    

Intervention name(s): Vibegron
Intervention type(s): Drug
Intervention description(s): 50 mg tablet, oral
Other intervention name(s): MK-4618
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of the Phototoxic Potential of LEO 29102 Cream
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the phototoxic potential of a single application on
      healthy skin of LEO 29102 cream in different doses.
    


Intervention name(s): LEO 29102 cream
Intervention type(s): Drug
Intervention description(s): LEO 29102 cream in different doses and the cream vehicle
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: volunteers
A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will examine how safe and effective apricitabine is when given long term (as
      ongoing treatment) to HIV patients who have already completed the AVX-201 trial
    

Detailed description: 
      An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to
      3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V
      mutation in reverse transcriptase. This extension study (AVX-201E) is available to patients
      who complete the AVX-201 protocol.

      Patients will continue to receive apricitabine open label for a further 96 weeks (making a
      total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety
      markers and efficacy markers will be followed.
    

Intervention name(s): apricitabine
Intervention type(s): Drug
Intervention description(s): 800mg apricitabine twice daily orally for 96 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; apricitabine; drug resistance; reverse transcriptase; lamivudine