bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Condition: Disease Associated Underweight
MeSH terms: Thinness
Study type: Interventional

Summary: 
      The purpose of this study is to test whether the provision of ONS to malnourished children
      across Europe, in addition to standard counselling, will improve weight gain and other
      outcomes.

      The hypothesis to be tested is:

      • Supplementation with ONS in malnourished paediatric patients will lead to increased WFH
      gain, as well as less malnutrition related complications (e.g. infections).

      Primary outcome • The change in BMI z-score over the intervention period of 3 months

      Secondary outcomes

      • The change in WFH-weight for height (z-scores) over the intervention period of 3 months
    


Intervention name(s): The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
Intervention type(s): Dietary Supplement
Intervention description(s): The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: malnutrition; Underweight; Oral Nutrition Supplements; Children
A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Condition: Non - Small Cell Lung Cancer NSCLC
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy
      and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1
      positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab
      (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the
      treatment of male and female patients with locally advanced or metastatic NSCLC (Stage
      IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1
      platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth
      factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase
      (ALK) rearrangements are not eligible for the study (prospective testing is not planned
      within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor
      (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)
    

Detailed description: 
      The study has an umbrella design with 2 sub-studies: sub-study A (randomizing patients with
      PD-L1 positive tumours 1:1 into MEDI4736 (durvalumab) vs. Standard of Care) and sub-study B
      (randomizing patients with PD-L1 negative tumours 2:3:1:2 into MEDI4736 (durvalumab) vs.
      MEDI4736 (durvalumab) plus tremelimumab vs. tremelimumab vs. Standard of Care. The two
      substudies may have different durations of recruitment periods due to differences in patient
      population (PD-L1 expression). They may not run concurrently with start and completion of
      recruitment potentially occurring at different time points.
    

Intervention name(s): MEDI4736 (durvalumab); Vinorelbine; Gemcitabine; Erlotinib; MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4); tremelimumab (anti-CTLA4)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MEDI4736 (durvalumab) treatment by intravenous infusion; Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.; Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.; Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration; MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion; tremelimumab (anti-CTLA4) treatment by intravenous infusion
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride; Durvalumab; Vinorelbine; Tremelimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in
      the interstitial fluid) during a dietary intervention using meals with either a high with a
      low glycemic load.
    

Detailed description: 
      The aim of this study is to determine the suitability of a continuous glucose monitor to
      detect the impact of a dietary intervention on postprandial blood glucose levels in normal,
      healthy, free living subjects. We will compare a dietary intervention of meals with a high
      glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low
      post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained
      both via venous blood sampling and via continuous glucose monitor following a standard
      carbohydrate load will be compared.
    

Intervention name(s): Low glycemic load; High glycemic load
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days; High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glucose; Continuous glucose monitor; Glycemic load; Dietary intervention
Modeling Stress-precipitated Smoking Behavior for Medication Development
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether guanfacine will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking
      daily smokers.
    


Intervention name(s): guanfacine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.; placebo
Other intervention name(s): Tenex
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking lapse behavior; guanfacine
Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Condition: Overweight and Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucosanol™, the medical device to be investigated contains a proprietary plant extract that
      is a natural inhibitor of alpha-amylase and can reduce starch digestion.

      The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body
      weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the
      efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
    

Detailed description: 
      Preparations that reduce absorption of calories from dietary carbohydrates could be
      decisively meaningful for the regulation of bodyweight or obesity. Hence, Glucosanol™ may be
      used as a tool for the treatment of obesity and weight management through reduced
      carbohydrate absorption.

      The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body
      weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the
      efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.

      The specific hypotheses to be accepted or rejected by statistical data from the clinical
      investigation are beneficial effects of the device on weight loss (kg) and body fat content.
    

Intervention name(s): Glucosanol; Placebo
Intervention type(s): Device; Device
Intervention description(s): 2 tablets 3x daily for 12 weeks; 2 tablets 3x daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: overweight; obesity; weight loss; body fat; waste cirumference; satiety; appetite
Acute and Chronic Nicotine Modulation of Reinforcement Learning
Condition: Nicotine Addiction
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to use functional magnetic resonance imaging (fMRI) to
      investigate the acute and chronic effects of nicotine on motivational behavior and prediction
      error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will undergo fMRI
      scans on two separate occasions while performing a decision-making task that will elicit
      prediction error signals in the mesocorticolimbic pathway of the brain. Nonsmokers will be
      scanned once following an acute dose of nicotine and once following placebo administration.
      Smokers will be scanned once following smoking as usual and once following 24-hours of
      smoking abstinence, in order to measure the effects of nicotine withdrawal. The study team
      hypothesizes that acute nicotine will increase the prediction error signal in nonsmokers
      compared to placebo, and that nicotine withdrawal will decrease the prediction error signal
      in smokers compared to the normal satiated condition. Furthermore, nonsmokers (during the
      placebo condition) will have greater prediction error activation than smokers (during the
      satiated condition). The results of this study will inform whether the initiation and
      maintenance of smoking behavior could be facilitated by the effects of nicotine on
      reinforcement learning.
    


Intervention name(s): Nicotine polacrilex; Placebo; satiety; abstinence
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): nonsmokers will be measured following nicotine administration; nonsmokers will be measured following placebo administration; smokers will be measured in a smoking satiated condition; smokers will be measured following 24-hours of smoking abstinence
Other intervention name(s): nicotine condition; placebo condition; smoking satiated condition; smoking abstinence condition
Intervention MeSH terms: Nicotine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Nicotine; Smoking; Cigarettes; Reinforcement Learning; fMRI
Dietary Treatment Study of Pediatric NAFLD
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This is an investigator initiated study being conducted in equal numbers at two sites,
      University of California, San Diego (UC San Diego) and Emory University (EU). The purpose of
      this study is to understand the potential of a low sugar diet for the treatment of
      nonalcoholic fatty liver disease (NAFLD) in children. Forty boys with NAFLD will be randomly
      assigned to either an intervention group or a habitual diet control group. The intervention
      will be a low sugar diet for a period of 8 weeks. The effect of this dietary change will be
      assessed using advanced magnetic resonance imaging (MRI) testing to measure liver fat.
    


Intervention name(s): Dietary modification
Intervention type(s): Other
Intervention description(s): The intervention is a modification of the family's habitual diet with a low sugar version of their diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAFLD; Steatohepatitis; Nonalcoholic Steatohepatitis (NASH); Liver; Diet; Pediatric; Adolescent
Identification of Hepatitis C Virus (HCV) Specific T Cells
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of
      the global population. Contrary to other chronic infections such as HIV, clearance of HCV is
      possible. While much is now known about the response to treatment in chronic HCV patients,
      the fact that acute HCV infection is typically asymptomatic (~80% of patients show no
      clinical signs) has made it challenging to define the mechanisms involved in spontaneous
      clearance.

      Immune protection against HCV is thought to be largely dependent upon the CD8 T cell
      response. Therefore using the latest T cell detection technology the investigators will
      develop a panel of tetramers specific for all potential HCV epitopes. To produce the
      tetramers the investigators will utilize HLA ligand exchange technology which allows the
      production of very large collections of peptide-HLA multimers for T cell staining. The
      investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T
      cell epitopes using published viral sequences and algorithm prediction databases. Using this
      information the investigators are currently in the process of developing collections of
      peptide-HLA multimers for T cell staining. Therefore the investigators require large
      lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each
      tetramer on the CD3+CD8+ T cells.

      The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be
      able to test and compare the frequency of possible conserved epitopes present in both HCVg1
      and HCVg4 infections. Once developed this technique will allow us to examine all
      virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller
      quantities of blood. The development of these technologies will also allow us to tailor such
      future diagnostic tests to local populations where a viral subspecies is prevalent; for
      example using North-African HLA alleles for HCVg4 epitopes.

      The work carried out using such assays will provide important immunological correlates of
      viral clearance that will impact vaccine design for HCV infections. Finally, the
      identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with
      predictive powers of disease progression that can be used on any flow cytometer machine.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic HCV Patients
      
Biospecimen description: 
      PBMCs
    
Keywords: Hepatitis C; CD8 epitopes
Osteopathic Otitis Media Research Study
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the application of osteopathic manipulative
      medicine speeds the rate of resolution of middle ear effusion (fluid) in children following
      an episode of acute otitis media.
    

Detailed description: 
      Acute otitis media is a significant world wide problem commonly affecting children between 6
      and 18 months, and is the most frequent reason for childhood illness visits to a physician in
      the US. By three years of age, 50-70% of children will have had one episode, while one-third
      will have had more than three. Persistence of middle ear effusion following an episode of
      acute otitis media is thought to predispose the child to recurrent infection. The standard
      care for recurrent acute otitis media includes long term antibiotic prophylaxis and surgery.
      The risks of standard care are recognized, and alternative means of treating acute disease
      and preventing recurrent otitis media are needed.

      For over a century, osteopathic physicians have reported favorable clinical outcomes in
      children treated with osteopathic manipulative medicine (OMM) in addition to standard medical
      care. To determine if a standardized OMM protocol will reduce the duration of middle ear
      effusion (MEE) after onset of acute otitis media, we outline a prospective, randomized,
      blinded, multi-center efficacy study of children ages six months to two years with a single
      episode of acute otitis media. Subjects will be randomized into one of two treatment groups:
      standard care plus OMM and standard care only. Subjects will be followed for one month to
      determine rate of resolution of middle ear effusion following onset of the acute otitis
      media. Statistical analysis will determine any differences between subjects in the two
      treatment groups.
    

Intervention name(s): osteopathic manipulative medicine (OMM)
Intervention type(s): Procedure
Intervention description(s): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Otitis Media; Effusion; OMM; OMT; Resolution
Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.
Condition: Partially Edentulous Maxilla, Mandible
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Aim: to evaluate and compare radiographic marginal bone loss (MBL) and soft tissue parameters
      around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body
      design and surface, same thread design and distance, and same collar surface
      (laser-microgrooved), after 3 years of loading.
    

Detailed description: 
      Materials and methods: 20 submerged/two-stage implants and 20 nonsubmerged/one stage implants
      were placed randomly with a split mouth design, in 20 partially edentulous patients.
      Radiographic and clinical examinations were carried out at the implant placement (Baseline,
      BSL), at the delivery of prosthetic restorations (T0), and at each year of the follow-up
      period (T1, T2, T3). Plaque index (PI), probing depth (PD), bleeding on probing (BOP), and
      gingival recession (REC) were recorded. Radiographic marginal bone levels (MBL) were assessed
      at the mesial (MI) and distal (DI) aspect of implant sites. In addition, the influence of
      keratinized tissue thickness (KTT) on MBL was investigated.
    

Intervention name(s): Microgrooved dental implants
Intervention type(s): Device
Intervention description(s): Dental Implant placement
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The cases were randomly divided into two groups as two-stage/submerged, and one-stage/nonsubmerged. Thus, in each patient, the two implants (submerged and nonsubmerged) were placed randomly in the left and right hemi-mandible or in the left and right hemi-maxilla
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: submerged two-stage, nonsubmerged one-stage, dental implants, marginal bone loss
Smartphone Applications to Improve Lifestyles in Olders Over 65 Years
Condition: Telemedicine
Study type: Interventional

Summary: 
      This is a randomized controlled clinical trial performed in urban primary care centers in
      Salamanca (Spain). Its objective is to evaluate the effect of an intervention based on the
      use of new information and communication technologies in a population of people over 65 years
      of age in the improvement of lifestyles, body composition, quality of life, cognitive
      performance and daily life activities.
    

Detailed description: 
      -  Objective: To evaluate the effect of an intervention based on the use of new information
           and communication technologies in a population of people over 65 years of age.

        -  Design and setting: A randomized clinical trial of two parallel groups. Population: 140
           participants over 65 years of age will be included, selected by consecutive sampling in
           primary care centers of Salamanca (Spain.

        -  Measurements and intervention: Lifestyles (physical activity, sedentarism and
           mediterranean diet), body composition, health-related quality of life, cognitive
           performance and daily life activities will be evaluated at 3 months. The advice on
           healthy diet and physical activity recommendations will be common to both groups. The
           intervention group will be added a training for 3 months in use of a Smartphone
           application, designed to promote a healthy diet, increased physical acivity and
           decreased sedentary.
    

Intervention name(s): Intervention (training in use of a Smartphone application); Control (Advice on healthy diet and physical activity recommendations)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.; Advice on healthy diet and physical activity recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mHealth; Lifestyles; Elderly; Body composition; Cognitive performance; Quality of life
Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition
Condition: Menopause
Study type: Interventional

Summary: 
      The goal in this study is to evaluate the effectiveness of a cognitive remediation program
      that was designed specifically to address the concerns related to cognitive difficulties that
      are often reported among women in the menopausal transition. This cognitive remediation
      program has been created to provide our clients with an opportunity to learn more about the
      relation between menopause and cognitive function, to learn new strategies to enhance
      thinking skills (e.g., memory, attention) and to hear about lifestyle changes that are known
      to have a beneficial effect on mental functioning.
    


Intervention name(s): Cognitive remediation
Intervention type(s): Behavioral
Intervention description(s): Participants will be taught compensatory strategies for subjective cognitive impairment in addition to learning about lifestyle modifications that are known to be beneficial on cognition.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment