bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
Condition: Cognition
Study type: Interventional

Summary: 
      The effect of supplementation using both protein and multiple micronutrients in preschool age
      children on cognitive performance and growth is unknown. The study will compare the effect of
      combination of protein and multiple micronutrients on indicators of cognitive performance and
      growth in preschool age children. Cognitive performance and anthropometric assessments will
      be measured at baseline and at 6 months.
    


Intervention name(s): Test beverage powder (High Proteins and added micronutrients); Control beverage powder (Low protein and no added micronutrients)
Intervention type(s): Other; Other
Intervention description(s): High protein and added Micronutrients at recommended dietary allowance levels; Low protein and no added micronutrients
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors; Advanced Recurrent Ovarian Tumors
MeSH terms: Neoplasms; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the maximum tolerated dose or optimal biological dose, and the safety profile of
      MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in
      subjects with advanced solid malignancies resistant to standard therapy.
    


Intervention name(s): MEDI3617; Bevacizumab; Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.; Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.; Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.; Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced solid tumors; Advanced recurrent ovarian tumors; MEDI3617; Ang2; Ovarian cancer; Malignant glioma
A Phase 1 Safety and PK Study of IV TP-271
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, placebo-controlled, double-blind,
      multiple-ascending-dose, inpatient study to assess the safety, tolerability, and
      pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the
      inclusion/exclusion criteria will be enrolled in this study.
    

Detailed description: 
      Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. The 8
      subjects within each cohort will be randomized 6:2 to receive multiple IV doses of TP-271 or
      placebo. Study drug will be administered IV once daily on the morning of Days 1 through 7
      following an overnight fast (minimum 8 hours). The planned doses for study drug for Cohorts A
      - E are 0.5 mg/kg TP-271 or placebo, 1.0 mg/kg TP-271 or placebo, 2.0 mg/kg TP-271 or
      placebo, 2.5 mg/kg TP-271 or placebo and 3.0 mg/kg TP-271 or placebo respectively.

      During the Screening period (Days -28 to -2 prior to the subject receiving TP-271 or
      placebo), each subject will be assessed for eligibility. Each subject must sign and date the
      ICF prior to undergoing any study-related procedures.

      All cohorts will follow the same study design. On Day -1, subjects will be admitted to the
      study unit and eligibility confirmed. On Day 1, eligible subjects will be enrolled and
      randomized to receive either TP-271 or placebo and will receive the assigned drug from Days 1
      through 7. Subjects will be required to stay at the study unit from Days -1 through 11 to
      assess safety and obtain the required PK samples. On Day 11, subjects will be discharged from
      the study unit. A final safety assessment will be performed once between Days 14 and 20, 7 to
      13 days following administration of the subject's final dose of study drug.

      After all 8 subjects in a cohort have completed study procedures through Day 11, the
      Principal Investigator and the Sponsor's Medical Monitor will evaluate all blinded safety and
      plasma PK data to determine whether any criteria that would require a meeting of the Safety
      Monitoring Committee (SMC) are met. If no such criteria are met, the study may proceed to the
      subsequent cohort at the next higher dose of TP-271 without consulting the SMC.
    

Intervention name(s): TP-271; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): multiple oral doses of TP-271 or placebo, dosed once daily for 7 days, randomized 3:1, doses escalating as 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 2.5 mg/kg, and 3.0 mg/kg; Placebo is sterile 0.45% saline randomized 3:1 to receive
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Five Multiple-Ascending Doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical
      effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.
      The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of
      UDCA, and has been approved by state food and drug administration in China for treatment of
      cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the
      treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,
      double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of
      patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total
      bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or
      UDCA for 24 weeks.
    


Intervention name(s): Tauroursodeoxycholic Acid Capsules; Ursodeoxycholic Acid Capsules
Intervention type(s): Drug; Drug
Intervention description(s): 250mg.tid.po; 250mg.tid.po
Other intervention name(s): Taurolite; Ursofalk
Intervention MeSH terms: Ursodoxicoltaurine; Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tauroursodeoxycholic Acid; Primary Biliary Cirrhosis; Safety; Efficacy
Long Term Effect of High-intensity Training After Heart Transplantation
Condition: Heart Transplant Recipients
Study type: Observational

Summary: 
      High-intensity training (HIT) has repeatedly been documented to have superior positive
      effects compared to moderate exercise in patients with coronary heart disease and heart
      failure. Since heart transplant recipients (HTx), have a denervated heart with different
      respond to exercise, HIT has previously not been introduced among these patients.
      Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found
      that this form of exercise also was highly effective and safe in long term HTx with
      clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and
      even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we
      ask the following questions in this follow-up study:

        1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study
           period continue during long term follow up (5 years)?

        2. Is the intervention group more physical active after HIT compared to the control group?
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The TEX population.
      
Biospecimen description: 
      Blodsamples from the patients will be studied:

      Standard samples: RBC, WBC, plates, CRP, kreatinin, urea, liver tests, thyorid gland tests,
      lipid profile, fasting- glucose og hba1c, Pro BNP, troponin T, uric acid.

      Supplement: Inflammation cytokines/chemokines such as TNF alfa, sTNFR2 og IL-6, IL-10, MCP-1
      og IL-8. Growth factors and inhibitors for innervation. Markers for endothelial function;
      endotelin and von- Willebrand faktor and anti- trombotic factors; fibrinogen, plasminogen
      activator inhibitor-1.
Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Recently, high flow oxygen therapy (HFOT) is becoming more popular in the treatment of any
      kind of respiratory failure. Pediatric mechanical ventilation consensus conference (PEMVECC)
      guidelines suggest measuring oxygen saturation by pulse oximetry (SpO2) in all ventilated
      children and furthermore to measure partial arterial oxygen pressure (PaO2) in
      moderate-to-severe disease in order to prevent excessive use of oxygen while preventing
      hypoxemia and hyperoxemia. This study aims to compare the safety and efficacy of a
      closed-loop FiO2 controller (CLOC) with conventional control of FiO2 during HFOT of pediatric
      patients in a pediatric intensive care unit (PICU). The hypothesis of this study is:
      Close-loop FiO2 controller increases the time spent within clinically targeted SpO2 ranges
      and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen
      control in PICU patients treated with HFOT.
    


Intervention name(s): Close-loop FiO2 controller; Conventional
Intervention type(s): Device; Device
Intervention description(s): Close-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range.; Conventional FiO2 adjustment by the clinician according to SpO2 values
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute respiratory failure (ARF); Pediatric acute respiratory distress syndrome (PARDS),; oxygen; Closed-loop
A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in
      Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)
    

Detailed description: 
      An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce
      Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)
    

Intervention name(s): ORMD-0801 QD; ORMD-0801 BD
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg, QD; 8 mg, BD
Other intervention name(s): Oral Insulin; Oral Insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is an open, multi-center study
Masking: None (Open Label)
Primary purpose: Treatment
Appetite Profile After Intake of Rye Breakfast Meal
Condition: Obesity Prevention
Study type: Interventional

Summary: 
      Food structure influence metabolic response including appetite. Whole grain foods include a
      wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in
      foods such as breads, breakfast cereals and pasta.
    

Detailed description: 
      The aim of the present study was to investigate if rye grain structure influence perceived
      appetite. A comparison of whole rye kernels and milled rye kernels were done in two study
      parts. In the first part the rye was served as porridge breakfasts and in the second one
      milled and whole kernels were included into bread breakfasts. In order to observe potential
      effects that would arise when the remains of the meal reaches the colon, the period of
      measurement was set to 8 h after intake of iso-caloric rye bread and rye porridge breakfasts.

      A randomized, crossover design was used to compare the effects of iso-caloric breakfast meals
      on subjective appetite during 8 h after consumption.
    

Intervention name(s): Effect of breakfasts with whole vs milled rye kernels on appetite
Intervention type(s): Other
Intervention description(s): Iso-caloric portions of the three breakfast foods along with identical additional foods are tested in a cross over design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: satiety; grain structure; rye
MD2Me - Texting to Promote Chronic Disease Management
Condition: Cystic Fibrosis; Inflammatory Bowel Disease; Type 1 Diabetes; Chronic Disease Management
MeSH terms: Cystic Fibrosis; Intestinal Diseases; Inflammatory Bowel Diseases; Diabetes Mellitus, Type 1; Fibrosis; Chronic Disease
Study type: Interventional

Summary: 
      UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self
      management web and text message based program on health-related self-efficacy and frequency
      of adolescent-conducted healthcare interactions. We hypothesize that users of the program
      will demonstrate greater gains between baseline and 8 month measures of health related
      self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care
      comparison group.
    

Detailed description: 
      The MD2Me study (or also known as TAHLC), sponsored by the National Institutes of Health is a
      2-year randomized controlled trial to develop and test a text message and Internet based
      intervention among adolescents and young adults with cystic fibrosis, type 1 diabetes, or
      inflammatory bowel disease. Adolescents and young adults have been a difficult population to
      engage in healthcare. It is estimated that 1 in 5 adolescents do not get the healthcare they
      need. Interventions must address how the healthcare system can engage adolescents with
      chronic disease and provide opportunities to discuss health-related matters and improve
      disease outcomes.

      This study will help fill multiple gaps in the literature by exploring the utility of a push
      AND pull SMS texting-based application for chronic disease management among youth. Based on
      social cognitive theory, the intervention will use accessible technology to promote disease
      management among adolescents with chronic disease as they transition to adult care. The
      popularity and usage of SMS already demonstrated by adolescents suggests notable promise for
      the SMS-based TAHLC program to promote chronic disease self-management and healthcare
      engagement with substantial positive impacts on health among youth with chronic disease.
    

Intervention name(s): MD2ME
Intervention type(s): Behavioral
Intervention description(s): The goals of the MD2Me intervention include increasing disease self-efficacy, disease knowledge, and the ability to control one's disease independently. The intervention includes an 8-week web program with weekly behavioral skills, topics on how to navigate the healthcare system, lifestyle tips, a Discussion Board, and text messages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cystic Fibrosis; Inflammatory Bowel Disease; Type 1 Diabetes; Chronic Disease Management; SMS; Text messages; Internet; Healthcare Interactions
Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being conducted to evaluate the safety and immunogenicity and antibody
      persistence of the candidate dengue vaccine.
    


Intervention name(s): TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
Intervention type(s): Biological
Intervention description(s): Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Intermittent Vibrational Force During Orthodontic Treatment With Aligners
Condition: Orthodontic Tooth Movement; Gingival Crevicular Fluid; Biomarkers
Study type: Interventional

Summary: 
      This three-arm cross-over randomized clinical trial (allocation ratio of 1:1:1) will aim to
      explore whether the application of intermittent vibratory forces modify RANKL and OPG
      concentrations in patients undergoing orthodontic treatment with clear aligners. The specific
      objective will be to compare gingival crevicular fluid concentrations of RANKL and OPG among
      groups according to the application or not of Acceledent® treatment at different time points
      and frequencies of aligner changes.
    

Detailed description: 
      Application of intermittent forces by vibration is supposed to be an easy-to-use accelerator
      of dental movement. The purpose of this study is to determine the effect of intermittent
      vibrational force application during orthodontic aligner treatment on RANKL and OPG
      concentrations in crevicular fluid as markers of bone remodelling. This randomized clinical
      trial will include candidates for malocclusion treatment with aligners, randomly assigned to
      3 groups: group A, vibrational forces from onset of treatment; group B, vibrational forces at
      6 weeks after treatment onset; and group C, no vibration (controls). The frequency of aligner
      adjustment will also differ among groups and measurement time points. At different time
      points, a paper tip will be used to draw crevicular fluid samples from a moving lower incisor
      for RANKL and OPG analysis using ELISA kits.
    

Intervention name(s): Vibrational forces; Orthodontic treatment with clear aligners
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vibration forces
Association Between ORA and Residual Refractive Astigmatism After SMILE
Condition: Refractive Errors; Astigmatism
MeSH terms: Astigmatism; Refractive Errors
Study type: Observational

Summary: 
      The aim of our study is to analysis and compare the relationship between ORA and
      postoperative astigmatism in low astigmatism (less than 1D) and moderate to high (1D to 3D)
      astigmatism patients after SMILE (Small Incision Lenticule Extraction) refractive surgery.
    


Intervention name(s): Small Incision Lenticule Extraction
Intervention type(s): Procedure
Intervention description(s): A 500 kHzVisumax (Carl Zeiss Meditec AG) femtosecond laser was used with cap thickness ranging from 100 to 130μm, cap diameter from 7.3 to 7.9 mm. The lenticule was dissected with a blunt spatula through a 30 to 60-degree incision at the 10 o'clock position and removed using forceps afterward. Treatment targets of both eyes were set to emmetropia, the refraction corrections were based on manifest refractions
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study was conducted by retrospective chart review in Taipei Nobel Eye Clinic from 2020
        to 2022.
A Study of LY3305677 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of LY3305677 and any side effects that
      might be associated with it.

      This study will also look at how much LY3305677 gets into the blood stream, how long it takes
      the body to remove it.

      This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).

      Participation in this study is expected to last up to 16 weeks.
    


Intervention name(s): LY3305677; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science