bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers
Condition: Norovirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different
      dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1
      VP1 and dsRNA adjuvant administered orally to healthy volunteers
    

Detailed description: 
      This study will enroll approximately 60 subjects in four cohorts of 15 subjects each. The
      cohorts may be enrolled and run in parallel or overlap; they do not have to run sequentially.
      The dosing for each cohort will be as follows:

      Cohort 1: Multiple low dose on Days 1 and 8 Cohort 2: Multiple low dose on Days 1, 3 and 5
      Cohort 3: Multiple low dose on Days 1 and 29 Cohort 4: Multiple high dose on Days 1 and 29

      All subjects receiving study drug will have safety and immunogenicity assessments completed
      through Study Day 57 following their initial vaccination. Subjects may also be evaluated for
      persistent immunogenicity at Day 180 and will be followed for safety for 12 months following
      initial vaccination (Study Day 365).
    

Intervention name(s): VXA-G1.1-NN Oral Vaccine
Intervention type(s): Biological
Intervention description(s): The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses.
Other intervention name(s): Active VXA-G.1.1-NN Oral Tablet Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of the study is to determine the effetiveness of the intensive upper and lower limbs
      therapy to improve the funtional outcomes and to minimize ther energetic spendings during
      funtional activities in Cerebral Palsy patients.
    

Detailed description: 
      The aim of the study is to determine the effetiveness of the intensive upper and lower limbs
      therapy to improve the funtional outcomes and to minimize ther energetic spendings during
      funtional activities in Cerebral Palsy patients. Also to know paretns and caregivers
      perceptions.
    

Intervention name(s): Intensive bimanual therapy; Intensive neurodevelopmental therapy
Intervention type(s): Other; Other
Intervention description(s): Ninety hours of intensive bimanual therapy; Ninety hours of intensive neurodevelopmental therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intensive Therapy; Cerebral Palsy
Glucose Response From Antioxidant Rich Potato Chips
Condition: Glycemic Response
Study type: Interventional

Summary: 
      Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release
      from products in a pilot human study.
    

Detailed description: 
      Preclinical data obtained using an Caco-2 intestinal cell model and enzyme assays suggest
      phenolic-rich potato extracts decrease intestinal glucose transport. The aim is to determine
      if these effects extend to the the an in vivo situation. Specifically, the glycemic response
      following consumption of phenolic rich pigmented potatoes compared to white potatoes with
      lower phenolic content will be measured. Gastric emptying will also be measured to show the
      effects are in fact due to rate of carbohydrate digestion and intestinal glucose transport
      and not gastric emptying rate.
    

Intervention name(s): Purple Majesty potato chips; Mountain Rose potato chips; White potato chips; Crackers
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Purple Majesty potato chips; Mountain Rose potato chips; White potato chips; Crackers
Intervention MeSH terms: Iproplatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Compliance to ERAS After Gastric Surgery
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to prospectively evaluate the overall compliance to the enhanced
      recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.
    

Detailed description: 
      The feasibility and effectiveness of ERAS program for various major surgical procedures have
      been well studies in the literature. However, ERAS program has not been widely accepted for
      patients undergoing gastric cancer surgery because of the paucity of evidence about its
      feasibility and efficacy. In this study, we developed ERAS program for gastric cancer
      surgery, based on the systemic review about perioperative cares. The main elements of ERAS
      program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3)
      provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs
      before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic
      infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube
      insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic
      compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen
      supply during immediate postoperative period, 13)restrictive postoperative fluid
      administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early
      removal of the urinary catheter, 17)patient education before discharge, and 18)hospital
      discharge based on discharge criteria.

      The aim of study is to evaluate the compliance to these main elements of ERAS program in
      patients undergoing gastric cancer surgery.

      Previously reported data about ERAS program for colon surgery reported overall compliance as
      about 65%. Considering that this is a single center study, we expected overall compliance
      rate of 70%. Therefore, the sample size of 173 patients was calculated based on this expected
      compliance rate, with permitted error of 95% confidence interval of 14%.
    

Intervention name(s): Enhanced recovery after surgery
Intervention type(s): Procedure
Intervention description(s): The main 18 elements of ERAS program included are described in detail in the brief summary of the study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Perioperative care; Enhanced recovery after surgery; Multimodal rehabilitation; Fast track surgery; Gastrectomy
A Phase 1 Study of SMP-100 in Normal Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first clinical study of oral administration SMP-100 in healthy subjects. The
      proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single and multiple
      ascending dose study in approximately 72 healthy male and female subjects.
    

Detailed description: 
      SMP-100 is a novel serotonin receptor 3 (5-HT3) partial agonist which has been designed to be
      a safe and effective therapy for irritable bowel syndrome (IBS) patients .

      This will be a single center, Phase 1, double-blind, placebo-controlled, randomized,
      sequential single ascending dose (SAD)/ multiple ascending dose (MAD) study to assess the
      safety, tolerability, and PK of SMP-100 in healthy adult male and female subjects. The study
      will be divided into two parts:

      Part A: SAD cohorts Part A will consist of 6 cohorts (1 cohort per dose level) of 8 subjects
      (6 subjects receiving the study drug and 2 receiving matching placebo), for a total of 48
      subjects. Each subject will participate in only one cohort. Efforts will be made to randomize
      at least 3 subjects of each gender in each cohort.

      Part B: MAD cohorts Part B will consist of 3 cohorts (1 cohort per dose level) of 8 subjects.
      Six subjects will receive study drug and 2 subjects will receive matching placebo, daily for
      14 consecutive days, for a total of 24 subjects (18 study drug; 6 placebo). Each study
      subject will participate in only one cohort. Efforts will be made to randomize at least 3
      subjects of each gender in each cohort.

      For both Part A and Part B, subjects who withdraw or are withdrawn from the study after
      dosing, for reasons other than safety and tolerability, may be replaced after consultation
      between the Safety Review Committee (SRC) members. The total number of subjects dosed
      (including potential replacement subjects) will remain within a maximum of 10 subjects per
      cohort.
    

Intervention name(s): SMP-100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAD/MAD; Placebo
Other intervention name(s): SMP-100 oral solution; ALB-137391(a); CSTI-300; Placebo oral solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of a mobile phone-based dietary and physical activity
      intervention on body fatness, dietary intake and physical activity of preschoolers
    

Detailed description: 
      Childhood overweight and obesity is an increasing health problem globally, and can be
      established as early as 2-5 years of age. Mobile phone based (mHealth) interventions have
      been successful for weight management in adults; however, their potential in young children
      is yet to be established. Therefore, the ultimate goal of MINISTOP (Mobile-based INtervention
      Intended to STop Obesity in Preschoolers) trial is to help parents of four year old children
      to achieve a healthy weight and body fat via a smartphone app (MINISTOP). More specifically
      this trial aims to reduce body fat (primary outcome), increase the intake of fruits,
      vegetables as well as decrease the intake of candy, and sweetened beverages, and increase the
      amount of time spent in moderate-to-vigorous physical activity and decrease sedentary
      behaviors (secondary outcomes) in healthy preschool aged Swedish children. If the MINISTOP
      app is effective, it has the potential to be incorporated into the child health care to aid
      in counteracting overweight and obesity.
    

Intervention name(s): Mobile phone based intervention
Intervention type(s): Behavioral
Intervention description(s): Parents in the intervention group receive a six month mHealth program (the MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet and physical activity behaviors. The program includes information, advice, and strategies to change unhealty behaviours and the possibility to register the child's intake of fruits, vegetables, candy, sweetened beverages, moderate-to-vigorous physical activity, and sedentary time. Feedback is then provided on reported variables. In addition, the parents are able to ask questions through the app to a dietician and a psychologist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS
Condition: GERD; EPS
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or
      epigastric pain
    

Detailed description: 
      Comparison of heartburn or epigastric pain severity following administration of Neobianacid®
      (Group B) or omeprazole (Group A) from day 0 to day 27. An ad-hoc placebo will be also
      administered in both treatment arms. Then, a following phase (day 28-55) will follows in
      which Neobianacid® will be administered (on demand) to both treatment arms.
    

Intervention name(s): Neobianacid®; Omeprazole 20mg; Neobianacid® placebo; Omeprazole placebo
Intervention type(s): Device; Drug; Other; Other
Intervention description(s): Oral administrations of Neobianacid® (30' after meals and on demand); Daily administration Omeprazole 20mg (per os, 30' before breakfast).; Oral administrations of Neobianacid® placebo (30' after meals and on demand); Daily administration Omeprazole placebo (per os, 30' before breakfast).
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 2 Week, Crossover Trial of Dietary Nitrate in HTN
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic
      blood pressure in multiple populations including newly diagnosed, untreated hypertensives.
      The additional effect in hypertensives on blood pressure lowering medications is uncertain.
    

Detailed description: 
      Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic
      blood pressure in multiple populations including newly diagnosed, untreated hypertensives.
      The additional effect in hypertensives on blood pressure lowering medications is uncertain.

      The investigators hypothesize that chronic nitrate consumption might decrease blood pressure
      in hypertensives who are suboptimally controlled on at least one blood pressure medication
      compared to a placebo beetroot juice.

      This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline,
      mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with
      demographics and blood draw. After baseline measures, each subject will be randomized to
      consume nitrate rich beetroot juice for 7 consecutive days when assessments will be repeated
      followed by 7 days of placebo and endpoint assessments or the converse.
    

Intervention name(s): Dietary nitrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.; 140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
Other intervention name(s): Beetroot juice; Nitrate depleted beetroot juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This project aims to develop and evaluate the effectiveness of an Personalized Normative
      Feedback (PNF) intervention via the internet, through a randomized clinical trial for alcohol
      consumption among Brazilian college students, as well as evaluating the most effective
      components of the PNF (normative and list of consequences). The sample is composed of college
      students aged between 18 and 30 years. Participants allocated into four different groups:
      control, full intervention (PNF), feedback with normative components (FN) and feedback with
      list of consequences (FLC). The investigators will use the dismantling design to study the
      most effective components. Participants will be followed-up at 1, 3 and 6 months.
    


Intervention name(s): Consequences List Feedback; Personalized Normative Feedback
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Study of Psychological Defense Mechanisms Used by Liver Transplant Patients
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Organ transplantation has a special place in the medical field. It symbolizes a medicine
      whose limits always seem to be repelled. Because transplantation is unusual, it places people
      in front of outstanding issues which he has to cope with his personality and history. Factors
      involved in the psychology of patient presenting with graft are past and present psychic
      functioning, object relations, experience of transplantation itself and quality of social
      environment.

      Before or after graft defense mechanisms can be so intense that they can make the patient
      unable to overcome the graft. Yet as a pathological mechanism that denial was considered
      beneficial provided it is short.

      The aim of this study is to evaluate on psychopathological influence of psychological defense
      mechanisms used by liver transplant patients on their somatic psychological and social
      outcome.
    

Detailed description: 
      The objective is to measure the influence of variations of psychological defense mechanisms.

      The investigators want to measure the influence of personal history of patients, causal
      disease pre-existing, conditions of graft's realization, structure of patient's social
      environment (family or institutional); and wish to identify which of those elements can be
      protective or vulnerability factors with a view to allow adequate support (especially for
      patients who had multiple poor prognostic factors)

      The investigators will study pre-transplant psychological defense mechanisms of the subjects
      using the Bond Defense Style Questionnaire and structure of personality using the SCID II
      personality scale. They will evaluate post-transplant patient outcomes on clinical and social
      developments with DSQ 88 and General Health Questionnaire (GHQ 28) to six months, twelve
      months and five years after transplantation. Meanwhile, they will address each time you visit
      the data on consumption, misuse and alcohol dependence using the AUDIT questionnaire (Alcohol
      Use Disorders Identification Test).

      The hypothesis is that the defense mechanisms, their variations and personality of the
      patients are both vulnerability factors as protective factors in different phases of the
      graft. Identification should allow to optimize care and improve overall health. Results of
      this research could make it possible to determine the factors used in liaison psychiatry in
      the long term to ensure an adequate medical and psychiatric support to transplant patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients awaiting liver transplantation and registered on the waiting list in the
        transplant center of University Hospital of Lille
      
Keywords: liver transplant patients; hepatic transplantation
Verticality Perception - Multisensory Contribution
Condition: Verticality Perception in Healthy Human Subjects; Individual Contribution of Different Sensory Systems
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the relative contribution of head- and trunk-based
      sensory systems to internal estimates of direction of gravity in healthy human subjects. To
      implement this assessment experimentally, the investigators will use a motor-driven
      3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°)
      or aligned with the trunk. The investigators will then obtain measurements of the subjective
      visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis
      will be driven by a state-of-the art Bayesian integration model. The investigators
      hypothesize that different sensory input signals are combined in a statistically optimal
      fashion.
    


Intervention name(s): Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk); 3D-video-head impulse testing; Vestibular-evoked myogenic potentials (VEMPs)
Intervention type(s): Other; Other; Other
Intervention description(s): Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study; Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vestibular; proprioception; spatial orientation; bayesian
Effects of Rosuvastatin on Aortic Stenosis Progression
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic; Disease Progression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effects of rosuvastatin compared to usual care in
      patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to
      moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering
      agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year
      recruitment period, and a treatment duration of a minimum of 3 years from the time of the
      last patient randomized to a maximum of 5 years.
    


Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg, oral, single dose; oral, single dose
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: progression of aortic stenosis
Evaluation of a Wearable Exoskeleton for Functional Arm Training
Condition: Stroke; Post-Stroke Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can
      assist task performance during 3D arm movement tasks under various experimental conditions in
      healthy individuals and patients with stroke. This study is designed to test motor learning
      with the robotic rehabilitative device CAREX under three conditions in healthy subjects and
      subjects with post-stroke hemiparesis.
    


Intervention name(s): Gravity Elimination Alone; Path Assistance Alone; Path Assistance and Gravity Elimination
Intervention type(s): Other; Other; Other
Intervention description(s): CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration; CAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care