bioihbjkbjnl/mcl2 huggingface dataset:
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
Condition: Birch Pollen Allergy; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this clinical phase I single centre, randomized, double-blind, placebo-controlled
      study with open comparator is to investigate tolerability and safety as well as the
      immunological effects of BM41 in comparison to placebo (double blind) and to a standard
      subcutaneous immunotherapy Alutard SQ (open) in birch allergic patients.
    

Detailed description: 
      Please see original article.
    

Intervention name(s): BM41; Placebo; ALK Alutard SQ Betula verrucosa
Intervention type(s): Drug; Other; Drug
Intervention description(s): Subcutaneous injection of increasing doses of BM41; Subcutaneous injections of placebo containing aluminium hydroxide.; Subcutaneous injections with increasing doses of Alutard according to cluster up-dosing scheme.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, placebo-controlled, single centre Phase I study with an open comparator group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diabetes Lifestyle Assessment and Educational Tools
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and
      education among Arab people with diabetes who have varying literacy skills using an
      interactive computerized tool and graphically-enhanced patient logs for dietary and physical
      activity.

      The investigators hypothesize that this tool will: a) increase patients' knowledge and
      understanding of the role of lifestyle (diet and physical activity) in diabetes management;
      b) improve patients' engagement in monitoring dietary intake and physical activity; c)
      improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM)
      practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle
      assessment, education and counseling while increasing patients' engagement in the process.
    

Detailed description: 
      Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and
      education among Arab people with diabetes who have varying literacy skills using an
      interactive computerized tool and graphically-enhanced patient logs for dietary and physical
      activity. The investigators will evaluate the effectiveness of this method for: a) increasing
      patients' knowledge and understanding of the role of lifestyle (diet and physical activity)
      in diabetes management; b) improving patients' engagement in monitoring dietary intake and
      physical activity; c) improving dietary and physical activity behaviors and self-blood
      glucose monitoring (SBGM) practices; d) improving glycaemic control; and, e) improving the
      efficiency of lifestyle assessment, education and counseling while increasing patients'
      engagement in the process.
    

Intervention name(s): I-ACE intervention; Standard Lifestyle Advice
Intervention type(s): Procedure; Procedure
Intervention description(s): lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.; lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Lifestyle counselling; Lifestyle assessment; Randomized controlled trial; Diabetes education
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction
Condition: ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major
      anterior wall infarction or where coronary blood flow is less than normal in spite of
      successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no
      medical treatments that specifically reduce risk in these patients. The acute inflammatory
      reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the
      infarction and the signals leading to left ventricular remodelling.

      This study is designed to assess the efficacy and safety of single intravenous injection with
      ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with
      STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.
    


Intervention name(s): ATH3G10; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous; intravenous
Other intervention name(s): PC-mAB; 0.9% sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the change in glycemic control, as measured by
      hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin
      glulisine as mealtime insulin following a variable bolus insulin regimen (based on
      carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal
      insulin in both arms of the study.
    


Intervention name(s): insulin glulisine; insulin glargine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of photoirritation and photosensitization potential of the product
      Dermacyd Silver Frutal.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of
      GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35
      months.

      This protocol posting has been updated following protocol amendment 4, March 2010. The
      protocol posting sections impacted are number of subjects, primary and secondary endpoints
      and intervention.
    


Intervention name(s): Pandemic influenza vaccine GSK2340272A
Intervention type(s): Biological
Intervention description(s): Two primary intramuscular (IM) injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A
Drug Discrimination in Methadone-Maintained Humans Study 2
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves giving psychoactive drugs intramuscularly (injected into the muscle of
      the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the
      difference between one drug and another, as well as measuring the effects of the drugs on
      mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each
      subject will receive 2-4 of the listed interventions.
    


Intervention name(s): 2-4 of the drugs listed below
Intervention type(s): Drug
Intervention description(s): Cycloserine: 500, 675, 750 mg oral capsule may possibly be given Diltiazem: 30, 60, 120 mg oral capsule may possibly be given Gabapentin: 100, 200, 400 mg oral capsule may possibly be given Isradipine: 5, 10 mg oral capsule may possibly be given Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given Nifedipine: 5, 10, 20 mg oral capsule may possibly be given Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given Saline: I.M. injection may possibly be given Verapamil: 30, 60, 120 mg oral capsule may possibly be given
Other intervention name(s): Cycloserine: Calan, Veralan; Diltiazem: Cardizem; Gabapentin: Neurontin; Isradipine: DynaCirc; Naloxone: Narca; Nifedipine: Adalat, Procardia; Placebo; Saline; Verapamil: Veralan
Intervention MeSH terms: Cycloserine; Verapamil; Diltiazem; Isradipine; Nifedipine; Gabapentin; Naloxone
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: methadone; opioid dependence; opioid
The Effect of Gluten on Gut Microbiome and Metabolic Health.
Condition: Metabolic Diseases; Injury of Gastrointestinal Tract
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Objective: To identify how specific changes of the gluten content in the diet affect the
      host-gut microbiome interactions with implications for metabolic health.

      Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of
      two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60
      participants will be included.

      Intervention: low vs high gluten intake.
    

Detailed description: 
      The study is designed as a randomized, controlled, single-blinded, cross-over intervention
      trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period.
      A total number of 60 participants will be included. Participants consume, in randomized
      order, a gluten-poor diet (<5 g/d) in the active treatment period and a gluten-rich diet (>25
      g/d) during the control period.

      Measurements: Altered quantitative metagenomics at bacterial gene- and species levels is the
      primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers,
      circulating appetite hormone levels,serum metabolomics, gastrointestinal transit time and
      intestinal permeability. Furthermore, selected control measures are included; 4-day food
      records and a study intervention dietary records.
    

Intervention name(s): High gluten; Low gluten
Intervention type(s): Other; Other
Intervention description(s): Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population); Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
Condition: Anaesthesia; Anxiety; Postoperative Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to
      additional discomfort, increased pain sensation and increased stress symptoms. Virtual
      exposure has proven to be successful in exposure therapy for the treatment of the narrowest
      patients. Patients are not confronted with the real stimuli or situations that trigger the
      branches, but with virtual representations of them. Virtual reality (VR) makes it possible to
      create scenarios that would not be possible in reality because of the organisational, time or
      financial expenditure involved.The effectiveness of virtual stimulus exposure is well
      documented, especially in the case of object or situation-related fears in the context of
      specific phobias. It is therefore obvious that virtual stimulus exposure could also be
      suitable for minimising operation-associated fears.The research project described is designed
      to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this
      purpose, a virtual tour of the operating setting has been created, which enables patients to
      explore the surroundings in detail by means of VR glasses.
    

Detailed description: 
      Anxiety and apprehension are common among patients prior to surgery. This anxiety can lead to
      additional discomfort, increased pain sensation and increased stress symptoms. Virtual
      exposure has proven to be successful in exposure therapy for the treatment of the narrowest
      patients. Patients are not confronted with the real stimuli or situations that trigger the
      branches, but with virtual representations of them. Virtual reality (VR) makes it possible to
      create scenarios that would not be possible in reality because of the organisational, time or
      financial expenditure involved.The effectiveness of virtual stimulus exposure is well
      documented, especially in the case of object or situation-related fears in the context of
      specific phobias. It is therefore obvious that virtual stimulus exposure could also be
      suitable for minimising operation-associated fears.The research project described is designed
      to investigate the effect of virtual stimulus exposure on perioperative anxiety. For this
      purpose, a virtual tour of the operating setting has been created, which enables patients to
      explore the surroundings in detail by means of VR glasses.
    

Intervention name(s): virtual reality tour
Intervention type(s): Other
Intervention description(s): Patients will be guided via VR on their way through the hospital to the operating theater
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: virtual reality (VR); anxiety preoperative; opearting theater
Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes
Condition: Energy
Study type: Interventional

Summary: 
      A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects
      on energy levels, focus, appetite and other health outcomes
    

Detailed description: 
      This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult
      participants per study arm (3000 total), age 21 and older and residing in the United States.

      Eligible participants will (1) endorse a desire for more energy (less fatigue and/or better
      concentration/focus during screening); (2) indicate a willingness to refrain from taking
      cannabinoids during the study period, and (3) indicate an interest in taking a plant derived
      cannabinoid product to help with their energy and/or focus.

      Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to
      become pregnant, or breastfeeding will be excluded. Those taking medications that warn
      against grapefruit consumption will be excluded. People with a calculated BMI of 18.5 or less
      will be excluded.

      Self-reported data are collected electronically from eligible participants over 5 weeks.
      Participant reports of health indicators will be collected during baseline, throughout the
      active period of study product use, and in a final survey. All study assessments will be
      electronic; there are no in-person visits or assessments for this real-world evidence study.
    

Intervention name(s): Energy Study Product Usage
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be stratified based on gender and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms
Masking: Double (Participant, Investigator)
Primary purpose: Other
Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC)
Condition: Hypersensitivity, Immediate
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a pilot trial in cat allergic participants, designed to compare allergic responses in
      each participant to a specific allergen by two methods of exposure. The methods of exposure
      to be used are: the environment exposure chamber (EEC) and nasal allergen challenge (NAC).
      Potential participants will be screened for evidence of cat allergy.

      Participants with a range of allergic sensitivities to cat allergen will be enrolled. To help
      ensure some breadth in the level of allergic sensitivity among participants, individuals with
      both high and low exposures to cat allergens in their daily lives will be enrolled.
    


Intervention name(s): Nasal Allergen Challenge; Environmental Exposure Chamber; Cat allergen (FelD1)
Intervention type(s): Procedure; Other; Biological
Intervention description(s): Cat allergen (FelD1) applied directly to the nasal tissues; The mobile EEC (mEEC) is a movable facility, designed with clean-room technology, used to expose subjects to aeroallergens (in this trial, the allergen FelD1 from cats) at controlled, consistent airborne levels, similar to that experienced in subjects' daily lives.
Other intervention name(s): EEC
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cat Allergy; Feld1
Infectivity of Norovirus in Groundwater-Human Challenge Study
Condition: Healthy
Study type: Interventional

Summary: 
      Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of
      stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United
      States. These viruses are sometimes found in drinking water, ice, shellfish and in other
      foods. They can be spread easily from contact with water, food, objects or hands that have
      even small amounts of feces from someone who was sick.

      The purpose of this research study is to see how long Norwalk virus can survive in water and
      still be able to cause sickness. When this is determined the researchers will be able to
      recommend risk levels for norovirus contaminated waters. Another purpose for this study is to
      see how a person's body's immune cells respond to Norwalk virus in the body. During this
      study volunteers will receive a dose of Norwalk virus in water that may make them sick.
    


Intervention name(s): Safety tested norovirus inoculum
Intervention type(s): Biological
Intervention description(s): This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards
Other intervention name(s): Norwalk virus in groundwater
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Norovirus; Gastroenteritis; Clinical Trial; Stomach flu
A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the effect of CT327 to placebo against
      experimental induced superficial, deep and hyperalgesic pain.

      The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain
      models.
    


Intervention name(s): CT327 (or placebo) followed by placebo (or CT327)
Intervention type(s): Drug
Intervention description(s): During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.
During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
the Treatment of Human Bone Marrow Mesenchymal Stem Cells in Ocular Corneal Burn
Condition: Chemical Burns
MeSH terms: Burns; Burns, Chemical
Study type: Interventional
Phase: Phase 2

Summary: 
      Ocular chemical burn is one of the cause of vision loss in our country, and there are no
      satisfactory treatment. Human bone marrow mesenchymal stem cells (MSC) have the biological
      characteristics of self-renewal, immune regulation, multidirectional differentiation and
      tissue repair. Our preliminary research showed that in corneal alkali injury rats, the MSC
      can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access
      the efficacy and safety of mesenchymal stem cell in the treatment of corneal burn in human.
    

Detailed description: 
      Corneal burn is a ocular damage disease included chemically burned and thermally burned.
      Surgery of corneal transplantation，amniotic membrane transplantation are some of
      effective,however,these therapy are expensive and the transplantation resources are limited.
      To arrest the inflammatory phase, several types of immunosuppressive treatments have been
      investigated. Corticosteroids also is important, however, long time usage of corticosteroids
      often cause severe side-effects. Human bone marrow mesenchymal stem cells (MSC) have the
      biological characteristics of self -renewal, immune regulation, multidirectional
      differentiation and tissue repair. Our preliminary research showed that in corneal alkali
      injury rats, the MSC can accelerated the cornea repair, inhibited angiogenesis. Many animal
      research also revealed that MSC have effect on the ocular alkali burned. And subconjunctivity
      injection is efficient, the clinical study of MSC on treating other disease have been
      developed rapidly recently, in further ,the outcome are encouraging, and no side-effect
      related MSC was reported, MSC can come from bone marrow, Umbilical cord blood，Adipose tissue
      and so on, but bone marrow MSC is mostly common used. The investigators propose to assess the
      efficacy and safety of human bone marrow mesenchymal stem cell in the treatment of corneal
      burn in human.
    

Intervention name(s): human bone marrow MSC
Intervention type(s): Other
Intervention description(s): The arms of active comparator :human bone marrow MSC subconjunctival injection once time. If persistent epithelial defect was noted thereafter, a second MSC injection was performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment