bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of the study is to study the safety and tolerability of Naltrexone in patients with
      Alcohol liver disease over a 12 week duration without liver related side effects. The project
      will be conducted at ILBS from March 2020 to February 2021. The concept is to estimate the
      usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving
      and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the
      progression of alcoholic liver disease as continued ethanol consumption is an important
      predictor in increasing overall morbidity and mortality.

      All ALD patients will be included as per inclusion and exclusion criteria, after taking
      informed consent from the patient or their relatives. In case of any reactions, the drug will
      be stopped as per the study stopping rule.

      After following the inclusion and exclusion criteria, ALD patients will be recruited into the
      study. It's a double blind RCT, hence both the patient and the investigator will be blinded
      and the drug will be issued by the trial co-ordinator after taking informed written consent
      and explaining the side effects. Naltrexone at a dose of 50 mg per day and placebo are
      included in the tablets. Placebo tablets will be identical in size, colour, shape, and taste.
      Naltrexone tablets will be entrusted to a family member to administer every dose and monitor
      for side effects.
    


Intervention name(s): Naltrexone; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone at a dose of 50 mg per day; Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study will evaluate the safety in healthy people aged 1- 45 years (male and
      female) after single intramuscular (IM) dose of trivalent subunit inactivated influenza
      vaccine till the 30-days follow-up period.
    


Intervention name(s): Seasonal flu vaccine
Intervention type(s): Biological
Intervention description(s): This phase II is performed as a monocenter study site in a population of healthy subjects aged 1 to 45 years. Enrolled subjects received one single IM dose of trivalent subunit inactivated influenza vaccine during the vaccination visit, according to the study protocol (follow-up period: 30 days)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Seasonal influenza; Vaccine
Effect of OPC Factor on Energy Levels
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the food supplement OPC Factor will be tested to determine its effectiveness
      for increasing energy levels in healthy people aged 45-65 when compared to a placebo. All
      subjects will receive both active product and placebo at some time during the study. The
      study is nine weeks in duration. It involves three visits, taking an effervescent powder in
      water twice a day, and answering 24 multiple choice questions once a week. Subjects who
      complete the study can elect to receive a two month supply of the study product free of
      charge.
    

Detailed description: 
      OPC Factor, a food supplement which contains grape seed extract, pine bark extract,vitamins
      and minerals, has shown during clinical observation the effect of raising energy levels in
      people aged 45-65. It is believed that the mechanism of action is based on enhanced
      production of ATP by mitochondria.

      In this study subjects will be assigned by chance to either the active product group or the
      placebo group. Subjects will take the product for three weeks. Then there will be a two week
      wash out period followed by subjects being crossed over to the other group for a three week
      period. Subjects, assessors, and health providers will be masked as to who is in the active
      product group and who is in the placebo group. Subjects will meet with the primary
      investigator three times during the study, will fill out very short questions once a week,
      and receive phone calls once a week from study personnel.

      This study is a randomized, placebo controlled, triple-blinded, cross-over study that tests
      the hypothesis that OPC Factor produces a response rate of 70% in the active product phase
      versus a 30% response rate during the placebo phase. A response is defined as at least a 20%
      absolute increase on the Energy subscale of the Activation-Deactivation Adjective Check List.
    

Intervention name(s): OPC Factor(TM); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Evervescent poweder containing oligomeric proanthocyanidins (OPCs)and other nutrients.; Effervescent powder similar in taste and appearance to the intervention but without the OPCs and nutrients.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Energy; Energy Level
Defining Axonal Injury in Children With Mild Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      To measure Axonal Injury in children with mild traumatic brain injury enrolled in an
      Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.
    

Detailed description: 
      Objective: To determine if children with mild traumatic brain injury (mTBI) have acute axonal
      injury defined by disruption of diffusion of water in white matter using diffusion tensor
      imaging (DTI) as compared to orthopedic injury (OI) controls.

      Methods: Children ages 11-16 years who presented within 6 hours of either a mTBI or an
      isolated OI were recruited from the emergency department (ED). Patients had Diffusion Tensor
      Imaging (DTI) study performed within 96 hours of injury. Voxel based analysis approach was
      used to quantify the group differences for common DTI measures. In the ED and at the time of
      the scan, symptom burden was measured using the post concussion symptom scale.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to a Pediatric Emergency Department
      
Biospecimen description: 
      Whole blood and serum
    
Keywords: mTBI; Mild Traumatic Brain Injury; Axonal Injury
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic
      hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will
      receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular
      filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following
      48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug
Intervention description(s): 180 micrograms or 135 micrograms sc weekly for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective open label study of acute and maintenance treatment of MDD. The acute
      phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight
      weeks followed by 10 weeks of once a week treatments.
    


Intervention name(s): H-coil dTMS
Intervention type(s): Device
Intervention description(s): treatment with deep TMS stimulation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MOOD EVALUATION
Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations
Condition: Healthy
Study type: Observational

Summary: 
      The reported normal values used in diagnosing and treating pediatric kidney stone formers are
      based on adult values or historic data from small studies. Urinary supersaturation indices
      which are now described in the adult stone literature as more sensitive predictors of stone
      composition, and precise predictors of response to therapy, are not established in children.
      The goals of this prospective study are to redefine normal values for pediatric urinary
      metabolites and supersaturation indices based on samples from a large number of healthy
      children and to identify if a difference in urinary supersaturations in children is
      protective.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All normal, healthy volunteer children between the ages of 3 and 18, inclusive, with no
        personal or first relative family history of urolithiasis. Both boys and girls will be
        enrolled with an effort to enroll an equal number of children of all ages after toilet
        training.
      
Keywords: urine; pediatric; Normal urine from healthy pediatric population
Response to Supplement and Placebo in GERD
Condition: Gastroesophageal Reflux Disease (GERD); Heartburn; Dyspepsia
MeSH terms: Gastroesophageal Reflux; Dyspepsia; Heartburn
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a widely available over the
      counter supplement marketed for heartburn symptoms on symptoms and health-related quality of
      life in patients with gastroesophageal reflux disease (GERD). This study is designed as a
      pilot trial to assess safety and feasibility and to provide preliminary estimates of effect
      sizes.
    


Intervention name(s): Supplement; Placebo; Expanded Interview; Standard Interview
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C; Lactose tablets
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux disease (GERD); Heartburn; Dyspepsia
Transverse Abdominal Block for Analgesia in Casarean Section
Condition: Analgesia Disorder
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      In this study, the investigators will compare the analgesic effect of bupivacaine and
      bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP
      block, on the patients for whom the operation will be performed under general anesthesia.
    

Detailed description: 
      The investigators will study 60 ASA [American Society of Anesthesiologist] physical status I
      and ІІ patients undergoing elective cesarean delivery at tanta University Hospital, in a
      prospective, randomized, comparative, clinical trial.

      Patients will be randomly allocated to two equal groups (n = 30) using closed envelopes
      labeled 1,and 2 reflecting group 1and 2 respectively.

      The drugs are prepared by the anesthesiologist who is not involved in the study or data
      collection.

      Group I: (n=30) will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 %
      mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2.

      Group II: (n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5
      % mixed with 10 ml saline in 20 ml syringe labeled G2.
    

Intervention name(s): Bupivacine group; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine group(n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe; Dexamedtomedine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe
Other intervention name(s): Bucaine; precdex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Analgesia, casarean section, TAP block
The Success of Pediatric Percutaneous Nephrolithotomy
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Study type: Interventional

Summary: 
      Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by
      senior surgeons. Data was disunited into 2 groups.

      The study showed that PCNL is an operator-dependent procedure, with the improvement of
      outcomes over time, presumably due to increased operator experience and the involvement of a
      team member with substantial prior experience During 20 years, by gaining experience and with
      the development of new tools and optics, fluoroscopy time, operation time, blood loss and
      complication rates decreased and stone-free rates increased.
    


Intervention name(s): Percutaneous nephrolitotomy
Intervention type(s): Procedure
Intervention description(s): Pediatric PCNL
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: the data into two groups. In group-1, PCNL was performed in the first 10 years period (1997-2007); in group-2, PCNL was performed in the second ten years period from 2008 to the present.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Urolithiasis; Pediatrics; Percutaneous
Dynamic Gait Index in Children With Dyslexia
Condition: Dyslexia; Gait Disorders, Neurologic
MeSH terms: Dyslexia; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      The aim of the present study is to investigate reliability in dyslexic children and compare
      it with healthy peers.
    

Detailed description: 
      Assessments methods are very important for the detection and treatment of such problems and
      there is a need for studies that can be applied for the dyslexia group. However fewer
      attempts have been made to demonstrate the reliability of balance impairments tools in
      dyslexic children. The DGI is a test that has been used a lot lately because of its minimal
      requirement for space and equipment, as well as its ability to be used with different
      patients' groups. The aim of the present study is to investigate reliability in dyslexic
      children and compare it with healthy peers.
    

Intervention name(s): Dynamic Gait Index
Intervention type(s): Other
Intervention description(s): The Dynamic Gait Index (DGI) measures functionality and dynamic balance in walking and stair climbing. The DGI consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over an obstacle, gait around obstacles and steps up and downstairs. The performance on each item is rated on a 4-point scale ranging from 0 (severe disorder) to 3 (independent walking). The total score is 24.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 dyslexia patients, between 8 - 14 years of age, and 30 healthy volunteer peers
      
Keywords: Dynamic Gait Index; Reliability; Balance; Gait
Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study is designed to evaluate in children (aged between 3 and 9 years) the
      immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A)
      administered following a two-administration schedule (21 days apart). Subjects in the control
      group will receive Fluarix. The Protocol Posting has been updated in order to comply with the
      FDA Amendment Act, Sep 2007.
    

Detailed description: 
      This 107066 study is a participating study to the broader NCT00502593 study, which included 2
      other studies, the 108498 and 108500 studies. The NCT00502593 study had a staggered design
      (subjects from each group being enrolled sequentially into 2 age strata, '6-9 years' 1st, and
      '3-5 years' next) and was run in 3 phases, phases A (Study 107066), B (Study 108498) and C
      (Study 108500). In each phase, the decision to vaccinate subjects aged 3-5 years and to
      administer a 2nd injection to subjects aged 6-9 years was made based on safety data collected
      on Days 0-6 after the 1st injection for the subjects aged 6-9 years. Decision to start Phase
      B was made on complete safety data including those collected on Day 28 of Phase A (7 days
      after the 2nd injection) for each age group. A similar approach was to be used to start Phase
      C. As safety data in Phase A did not raise any safety concerns, Phases B and C were run in
      parallel.
    

Intervention name(s): Pandemic Influenza Vaccine (GSK1562902A); Fluarix™
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.; 2 doses, intramuscular injection on Days 0 and 21.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Pandemic Influenza Vaccine (GSK1562902A)
Collection of Tissue Samples From Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Condition: Ovarian Cancer
MeSH terms: Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to
      test in the laboratory may help the study of cancer.

      PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from
      patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To generate a translational ovarian cancer model using tumor tissue and cells from
           patients with stage III-IV ovarian/primary peritoneal/fallopian tube epithelial cancer
           for drug response and development.

      OUTLINE: Tissue and fluid samples are collected at the time of surgery or paracentesis and
      used in laboratory experiments and in animal models. Health data is collected from patient
      medical records before, during, and after surgery.

      After surgery, patients are followed up for 5 years.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females age 18-80 with a diagnosis of Stage III-IV ovarian cancer, primary fallopian tube,
        or primary peritoneal papillary serous carcinoma and scheduled treatment for epithelial
        ovarian malignancies.
      
Biospecimen description: 
      Metastatic and primary tumor tissue.
    
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer
Pathway Taking Into Account PeriConceptional Environment for Infertile Couple
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Infertility is defined as the inability to conceive after 12 months of unprotected
      intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors of
      the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee,
      drugs, exercise, stress, sleep, pollution...) are risk factors for infertility. Weight gain,
      in both members of the couple, is associated with an increased risk of Assisted Reproduction
      Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle makes the
      risk of infertility three times less likely to happen. Idiopathic infertility may greatly
      benefit from lifestyle factors optimization.
    

Detailed description: 
      To evaluate and optimize periconceptional habits (diet and lifestyle factors) of unfertile
      couple may have favorable impact on conception and pregnancy.

      The investigators propose to undertake a controlled trial of the efficiency of an integrated
      global care program. This trial of an intervention on lifestyle factors will be compared with
      the ""cohort multiple randomised controlled trial"" methodology in order to strengthen
      external validity by limiting bias that may result from initial consent to randomisation, or
      from deception of allocated treatment.

      At any visit in a participating ART center, all attending couples will be invited to
      participate in an observational survey in order to allow access to their data. In this whole
      cohort, all eligible couples will be identified as consultations go. An ""on the fly""
      randomisation process (ration 2 usual / 1 experimental) will select candidate couples from
      all eligible ones, who will be ten offered the experimental PEPCI intervention. In case of
      refusal of the experimental care, they will be given the usual care.
    

Intervention name(s): PEPCI
Intervention type(s): Procedure
Intervention description(s): Both parents will receive:
consultation with a psychiatrist then psychologist follow-up if required, addiction specialist physician consultation then liaison nurse follow-up if required
endocrinologist consultation then dietitian follow-up if required
actiphysician consultation and follow-up if required This program will be added to the usual routine course Both parents will receive a 3 months personalized follow-up if required from the multi disciplinary consultation and before the first ART attempt.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: periconceptional habits; Pregnancy; Infertility