bioihbjkbjnl/mcl2 huggingface dataset:
Low-calorie Sweeteners and Adipose Signaling
Condition: Nutritional and Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS)
      exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese
      adolescents and young adults. We will examine changes in gene expression in subcutaneous fat
      and will correlate these molecular changes with plasma biochemistry.
    

Detailed description: 
      The proposed study will investigate LCS-induced changes in metabolically "at-risk" young
      adults, under conditions that reflect typical beverage consumption. We will first identify
      molecular pathways potentially affected by LCS (adipose transcriptomics via global RNAseq)
      and then identify links between LCS-induced gene expression changes and circulating levels of
      key metabolic biomarkers and clinical outcomes. We will perform subcutaneous adipose biopsies
      before and after consumption of 12 ounces of diet soda three times daily for eight weeks.
      Within-subjects changes in adipose gene expression will be evaluated using RNAseq. We will
      then correlate transcriptomic changes with circulating levels of key inflammatory and
      metabolic biomarkers, to provide mechanistic insight into which pathways drive
      clinically-relevant LCS-induced metabolic impairments. We will measure glucose, insulin,
      inflammatory markers and adipose-derived hormones before and after eight weeks of LCS
      exposure.
    

Intervention name(s): Diet Soda
Intervention type(s): Other
Intervention description(s): Subjects will be asked to consume diet soda three times daily for eight weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diet soda; low-calorie sweeteners; obesity
Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status
Condition: Zinc Deficiency
Study type: Interventional

Summary: 
      The objective of this research is to test the efficacy of Zn biofortified wheat in increasing
      Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.
    


Intervention name(s): Biofortified wheat; Fortification; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Wheat was grown by foliar Zn application and is therefore biofortified; Wheat flour is fortified before testmeal preparation; wheat flour is used as control comparator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc; deficiency; biofortification; wheat
LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years
      inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant
      over a period of 12 months.

      Secondary objectives are to observe the bleeding patterns, adverse event profiles and the
      occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions
      and implant site complications will be collected.
    


Intervention name(s): LNG-IUS (BAY 86-5028); 68 mg etonorgestrel implant for subdermal use (Nexplanon)
Intervention type(s): Drug; Drug
Intervention description(s): LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months with an follow-up extension for up to 3 years; Implant insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months, may be continued up to 3 years under standard care.
Intervention MeSH terms: Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation Between Zirconia and Stainless Steel Crowns
Condition: Tooth Diseases
MeSH terms: Tooth Diseases
Study type: Interventional

Summary: 
      Introduction and Research Problem:

      The aim of this project is to evaluate and compare two full coronal restorations on primary
      posterior molars over a period of 3, 6 and 12 months in terms of restoration failure,
      marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The
      restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).

      Materials and Methods:

      Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who
      need restorations will be screened for inclusion criteria till 120 teeth are recruited (60
      teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used
      to ensure equalizing variables for both groups, each patient will have side restored with SSC
      and the opposite side will be restored with Nu/ZR crowns.

      Randomization will be done using Statistical Package for the Social Sciences (SPSS) software
      version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for
      each age group separately with a uniform random variable generation. A simple descriptive
      statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used.
      Level of significance will be set at (α = 0.05) and level of confidence at (95%).
    


Intervention name(s): Stainless Steel Crown (Group A); NuSmile Zirconia Crowns (Group B)
Intervention type(s): Device; Device
Intervention description(s): Full coverage restoration for multi-surface carious teeth; Full coverage restoration for multi-surface carious teeth
Other intervention name(s): Stainless Steel Crown; Zirconia crowns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stainless Steel Crowns; Zirconia Crowns; Aesthetic restorations
Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The goal of this study is to evaluate non-drug approaches to reducing dental anxiety prior to
      non-surgical root canal treatment. This will be done by comparing two relaxation methods
      which will be performed immediately prior to scheduled, clinical non-surgical root canal
      treatment. Measures of anxiety will be evaluated prior to, and after, the relaxation
      intervention, as well as after the non-surgical root canal treatment is completed.
      Participation in the study is completed in a single study visit.
    


Intervention name(s): Auditory Alone; Relaxation Virtual Reality
Intervention type(s): Other; Device
Intervention description(s): Participants randomized to this arm will receive earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants will listen to the recording prior to their dental procedure.; Participants randomized to this arm will receive will receive virtual reality goggles and choose a scene of their liking to experience. Participants will choose from 11 different themed environments (such as savannah, beach, meadow, or space), and will experience the chosen virtual reality environment for 8 minutes. Participants will complete the virtual reality intervention prior to their dental procedure.
Other intervention name(s): ABR; RVR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Erythropoietin (EPO) in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is
      safe in the treatment of patients with Parkinson's Disease.
    

Detailed description: 
      After onset of Parkinson's Disease (PD)- in spite of the use of medications that constitute
      the symptomatic treatment- the disease is worsens with an inevitable progression, thus
      causing complications that lead to the loss of patient´s manual skills and independent gait.
      At present, the treatment of PD with the use of medications is based on dopamine precursors
      and dopaminergic agonists but as the disease advances, other symptoms that do not respond to
      dopaminergic stimulation do appear.

      For this reason, it is a priority to find a way to focus on neuroprotection during the course
      of the disease. There are evidences of neuroprotecting therapeutic alternatives in such
      substances as erythropoietin (EPO).

      Positive results on the neuroprotective/neurotrophic efficacy of EPO in neurological and
      psychiatric diseases have been obtained from treatment trials, but nevertheless, it is
      indispensable demonstrate that with the proposed medication doses it's well tolerated by PD
      patients.
    

Intervention name(s): Erythropoietin human recombinant (EPOrh)
Intervention type(s): Drug
Intervention description(s): Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks
Other intervention name(s): EPOCIM® (Center of Molecular Immunology, Habana, Cuba)
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neuroprotection; Parkinson Disease; Erythropoietin
A Study of AK111 in Healthy Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single dose-escalation
      first-in human study to evaluate the safety, tolerability, PK, PD and immunogenicity of AK111
      in healthy subjects following SC administration. The study will consist of cohorts of healthy
      subjects. Cohort 1, four unique subjects will be randomized to receive either active AK111
      (N=3) or matching placebo (N=1). Cohorts 2, 3, 4 and 5, eight unique subjects will be
      randomized to receive either active AK111 (N=6) or matching placebo (N=2). Approximately 36
      subjects will be treated in this study.
    


Intervention name(s): AK111 or Placebo
Intervention type(s): Drug
Intervention description(s): All the subjects in each cohort will be randomized in a 3:1 ratio to receive either AK111 or Placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Condition: Complicated Urinary Tract Infection Including Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated
      Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
    


Intervention name(s): Benapenem; Ertapenem
Intervention type(s): Drug; Drug
Intervention description(s): Benapenem for IV injection administered as a 1-gram IV infusion; Ertapenem for IV injection administered as a 1-gram IV infusion
Intervention MeSH terms: Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
XC8 in the Treatment of Patients With Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, double-blind, randomized, parallel-group comparative Phase II clinical study
      to assess the efficacy and safety of different doses of XC8 vs Placebo in patients with
      partly controlled bronchial asthma receiving stable treatment with low doses of inhaled
      corticosteroids with or without long-acting beta2-agonists during 12-weeks treatment period.

      Study design was developed by Pharmenterprises LLS, Russia in cooperation with Eurrus Biotech
      GmbH, Austria and FGK Clinical Research GmbH, Germany.

      The primary objective of the study was to evaluate the effect of different doses of XC8 on
      change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (% of predicted
      value) at Week 12 as compared to baseline at Week 0 vs. Placebo in patients with partly
      controlled bronchial asthma (BA).
    

Detailed description: 
      Twenty Russian centers were approved for participation in this study. Twelve centers were
      initiated. Patients were enrolled in 12 centers. The study consisted of 4 periods: Screening,
      Run-In Period, Treatment Period, and Follow-up. All eligible patients were randomized into
      one of four treatment groups in a ratio of 1:1:1:1.

      Treatment group of XC8 2 mg daily (30 patients) Treatment group of XC8 10 mg daily (30
      patients) Treatment group of XC8 100 mg daily (30 patients) Treatment group of Placebo (30
      patients) The study drug was manufactured by order Pharmenterprises LLS, Russia and Eurrus
      Biotech GmbH, Austria. During the treatment period (12 weeks) patients took the study drug or
      Placebo once a day in addition to stable low doses of Inhaled Corticosteroids (ICS) with or
      without long-acting beta2-agonists (LABA). The follow-up period lasted for 4 weeks.
    

Intervention name(s): XC8 Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of XC8 in a dose according to the treatment group + 2 tablets of placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.; Placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
Other intervention name(s): Histamine glutarimide
Intervention MeSH terms: Histamine; Glutarimide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At Visit 2, Week -1 the patients who meet all inclusion/exclusion criteria were included in the single-blind placebo run-in period. At Visit 3, Week 0 all patients were randomized to 4 treatment groups in 1:1:1:1 ratio (30 patients per each group of XC8 2 mg, 10 mg or 100 mg; and 30 patients to Placebo group).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Point Prevalence of Side Strain in Fast Bowlers and Effectiveness of Core Strength Training.
Condition: Sport Injury; Sports Physical Therapy
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      To find out the prevalence of side strain in fast bowlers and determine the effectiveness of
      core strength training in treating side strain
    

Detailed description: 
      A fast bowler needs to have strong core muscles in order to prevent side strain, which can
      hider the performance. Variation in deliveries , bowling speed and bowling action can be
      compromised due to side strain injuries specifically in fast bowlers.

      A strong and stable core helps to maintain balance and provide strength while performing
      repetitive movements such as bowling. Core strengthening program should include exercises
      that are sports specific, conditioning exercises that focus on anterior and posterior
      musculature of the trunk and hip.

      The aim of this study is to find out the prevalence of side strain in fast bowlers and to
      incorporate strengthening exercises for core muscles to evaluate its effectiveness for side
      strain.
    

Intervention name(s): Core Strength Training Group; Conventional Training Group
Intervention type(s): Other; Other
Intervention description(s): The participants of experimental group will perform core strength training regime for 6 weeks (3 days per week). Each exercise session will last for a period of 45 mins, the exercises would be performed in 3 sets of 5 repetitions with 5 seconds hold time and 10 seconds rest between each repetition and a minutes rest in between each set.
Following exercises would be performed :
Bridge, Crunch, Plank, Side Plank, Mountain Climb.; The participants of conventional group will perform following exercises :
Running (10 repetitions X 3 sets), Jogging (10 repetitions X 3 sets), Stretching (10 repetitions X 3 sets)
Rest between Exercises : 10-15 Seconds Rest between Set of Exercises : 30-60 Seconds Cricketers will receive exercises for 8 weeks. There will be 3 sessions per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators long term-goal is to help YMCA programs across the nation successfully
      acheive the Y of USA "Healthy Eating and Physical Activity Standards". Our objective here is
      threefold. First, the investigators will work with South Carolina YMCA leadership to achieve
      the "Healthy Eating and Physical Activity Standards" and implement our HEPA Strategies in
      YMCA programs across the state, evaluate the uptake of and adherence to the standards and
      strategies, and identify factors that influence their implementation. Second, the
      investigators will evaluate the impact of acheiving the standards on children's MVPA and the
      serving and consumption of FV and water during the programs. Third, the investigators will
      evaluate the costs associated with and the cost-effectiveness of meeting the standards in
      terms of improvements in activity and healthy eating.
    

Detailed description: 
      The investigators research team developed a conceptual framework that identifies critical
      modifiable levers within Out of School Time programs that can be altered and/or strengthened
      to reach policy or standards goals. These include the policy environment at the national,
      state and local levels; characteristics of the individual site, program leadership, staff,
      and children; and existing outside organizational partnerships. This framework was informed
      by complex systems change, social ecology, systemic capacity building , and the literature on
      the impact of public health policy that identifies key elements of the system to be targeted
      as well as possible influences on those elements.

      Viewing OST programs as complex systems, "Healthy Eating and Physical Activity Standards"
      represent one of many leverage points within a system. Existing efforts to implement
      standards rest solely upon the voluntary adoption of the standards, with little to no other
      changes to the OST program setting. It is clear from our preliminary work and comprehensive
      reviews that OST programs are falling short of meeting goals set forth in the standards.
    

Intervention name(s): Healthy Eating and Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
Other intervention name(s): HEPA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure
Condition: Pain, Postoperative; Thoracic Surgery, Video-Assisted; Polymorphism, Single Nucleotide
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Postoperative pain remains relatively high within 48h for Chinese patients who receive
      video-assisted thoracoscopic surgery. Different patients experience different pain intensity.
      This suggests that there may be genetic variants that make some patients susceptible to
      analgesic failure. Using blood samples from patients, the investigators are going to analyze
      the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be
      involved in analgesic failure.
    


Intervention name(s): Genetic analysis
Intervention type(s): Genetic
Intervention description(s): Collect 2ml intravenous blood from patients after anaesthesia.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving single-port video-assisted thoracoscopic surgery.
Lonafarnib With and Without Ritonavir in HDV (LOWR-1)
Condition: Chronic Hepatitis D Infection
MeSH terms: Hepatitis D; Hepatitis D, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in
      Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).
    

Detailed description: 
      Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with
      the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major
      structural protein (HDV antigen) for replication. Twenty-one subjects with chronic delta
      hepatitis will be randomized to receive one of seven different doses of lonafarnib. Dosing
      will occur over 4-12 weeks, depending on treatment arm, and during that time, evidence of
      antiviral response will be assessed by frequent measurements of HDV-RNA. The primary
      therapeutic endpoint will be an improvement in quantitative serum HDV RNA levels after
      treatment with lonafarnib therapy. The primary safety endpoint will be the ability to
      tolerate the drug at the prescribed dose for the treatment duration. Several secondary
      endpoints will be measured, including side effects, ALT levels, and symptoms. Therapy will be
      stopped for intolerance to lonafarnib. This study is designed as a phase 2a study assessing
      the safety, tolerance and antiviral activity of seven dose combinations of lonafarnib with
      and without ritonavir boosting.
    

Intervention name(s): lonafarnib; peginterferon alfa-2a; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): antiviral farnesyl transferase inhibitor; immunomodulator; CYP 3A4 inhibitor, lonafarnib booster
Other intervention name(s): Sarasar; EBP994; Pegasys; pegylated interferon-alfa; PEG IFN-alfa; PEG IFN-a; Norvir; RTV
Intervention MeSH terms: Interferons; Ritonavir; Interferon-alpha; Peginterferon alfa-2a; Lonafarnib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment