bioihbjkbjnl/mcl2 huggingface dataset:
RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM
Condition: Tuberous Sclerosis; Lymphangioleiomyomatosis
MeSH terms: Tuberous Sclerosis; Lymphangioleiomyomatosis; Angiomyolipoma; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to find out what effects RAD001 has on angiomyolipomas
      of a person with Tuberous Sclerosis Complex and to determine the safe dose of RAD001 without
      toxicity.

      The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly
      even cause regression.
    

Detailed description: 
      Tuberous sclerosis complex is a genetic disorder with a birth incidence of approximately one
      in six thousand. Angiomyolipomas occur in eighty percent of persons with TS, and in up to 60%
      of persons with LAM. They are fatty tumors that often occur in kidney or liver as well as
      other parts of the body. They can grow and cause damage to surrounding kidney tissue and even
      renal failure. They may also leak blood causing potentially life-threatening hemorrhage.

      Laboratory studies have shown that RAD001 suppresses the chemical that cause tumors to grow
      in tuberous sclerosis and sporadic LAM.

      The primary goal of this study is to evaluate the clinical effectiveness of RAD001 in a 24
      month trial. Although the primary goal is to determine if the drug RAD001 has effects on
      angiomyolipomas, other diseases associated with tuberous sclerosis will be monitored too,
      specifically any change in involvement of your brain or lungs with tuberous sclerosis. The
      use of RAD001 to treat angiomyolipomas in tuberous sclerosis or sporadic LAM is considered
      experimental
    

Intervention name(s): RAD001
Intervention type(s): Drug
Intervention description(s): 5 and 10 mg/day or 30, 50, 70mg/week
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberous Sclerosis Complex (TSC); Lymyphangioleiomyomatosis; Mammalian Target of Rapamycin (mTOR); RAD001; Angiomyolipmas
Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional
      treatment of mild to moderate plaque psoriasis. Half of the patients will receive the
      probiotic per os, while the other half will receive a placebo; all patients will continue
      with their regular psoriasis treatment.
    

Detailed description: 
      The aim of this study is to evaluate the efficiency of a probiotic in capsules as a
      coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. The efficiency
      is measured as the reduction in the PASI score in the patients (18 to 70 years old) included
      in the study, with a mild to moderate plaque psoriasis treated exclusively with topic
      treatment in the moment of being included in the study. Apart from the PASI score reduction
      from the first visit to the end of the study, the ability to reduce the improvement time in
      those patients will be evaluated as well. Additionally, the following markers of systemic
      inflammation are also compared between both active and placebo branches: Tumor necrosis
      factor, Interferon-gamma, interleukines 1b, 12, 16 and 23.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments); one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: mild to moderate; probiotic
Continuous Glucose Monitoring and Inflammation in Nondiabetic and Diabetic Patients Undergone Hemodialysis
Condition: Diabetes; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      Evaluation of different glycemic variations between the dialysis period and non-dialysis
      period in two groups: nondiabetic and diabetic patients undergone two different hemodialysis
      methods. Thirty-six patients, males and females, aged 50-80 years, with end stage renal
      disease (ESRD) will undergo hemodialysis and continuous glucose monitoring (CGM). The
      investigators will evaluate also inflammation markers before and after the different
      hemodialysis methods.
    


Intervention name(s): Continuous Glucose Monitoring (CGM)
Intervention type(s): Device
Intervention description(s): CGM allocated one time for 3 days
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        outpatients will undergo CGM at two different hemodialysis methods in a croos-over design.
        At the end of the study, it will evaluate inflammation markers intra-and inter-groups
        during the different hemodialysis methods.
      
Keywords: Diabetes mellitus; ESRD; CGM; Inflammation markers; Hemodialysis; Diabetic patients; Nondiabetic patients; All with ESRD; All undergone hemodialysis
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or
      GCFLU Quadrivalent Pre-filled syringe inj..
    

Detailed description: 
      Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or
      GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be
      evaluated.
    

Intervention name(s): GC3114; GCFLU Quadrivalent
Intervention type(s): Biological; Biological
Intervention description(s): High-dose Quadrivalent influenza vaccine; Quadrivalent influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effect Of AVANDIA On The Late Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the effects of AVANDIA on the asthmatic response.
    


Intervention name(s): Rosiglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.; Subjects will also receive placebo oral tablet.
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Asthma AVANDIA Inflammation
Can Postprandial Reactive Hypoglycaemia be Reduced in Patients After Roux-en-Y Gastric Bypass With a Low Carbohydrate Diet?
Condition: Bariatric Surgery (Gastric Bypass)
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      Roux-en-Y gastric bypass (RYGB) accelerates nutrient delivery to the small intestine causing
      higher peak blood glucose concentration early after meal intake. In the late postprandial
      period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. In some
      patients, overt postprandial hypoglycaemia develops, and is typically reported as a
      complication 1-5 years postoperatively, when maximal weight loss has been obtained. The
      pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of
      insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1
      (GLP-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole
      body glucose disposal. We hypothesize that lowering carbohydrate content of meals reduces
      postprandial glucose excursions whereby GLP-1 and insulin secretion is reduced and reactive
      hypoglycemia prevented.
    


Intervention name(s): Low carbohydrate meals; Standard carbohydrate meals
Intervention type(s): Other; Other
Intervention description(s): Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%; Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Reactive hypoglycemia; Hyperinsulinaemia; Diet; Glucagon-like Peptide-1; Glucagon; Peptide YY; Ghrelin
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at the preliminary safety profile of an investigational
      drug in children 3 to 6 months of age with bronchiolitis.
    


Intervention name(s): MK-0476, montelukast sodium
Intervention type(s): Drug
Intervention description(s): Duration of Treatment: 14 Days
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Reading Together: How to Promote Children's Language Development Using Family-based Shared Book Reading
Condition: Language Development
Study type: Interventional

Summary: 
      The aim of this project is to determine how shared reading promotes child language
      development, and to use this knowledge to make it an effective language-boosting tool for
      children from all social and economic backgrounds.
    

Detailed description: 
      Two interventions will be created which are intended to boost children's vocabulary and
      grammar abilities, and will be assessed on how they are implemented by caregivers across
      different socio economic groups, and how they affect children's development of these language
      skills. Previous research has found dialogic reading interventions to be less effective for
      children from low socio-economic backgrounds. This project will investigate whether a shared
      reading intervention, designed to require less of a behaviour change from caregivers than
      dialogic reading, can be used to effectively boost vocabulary and grammar development in
      children across the whole socio-economic spectrum.
    

Intervention name(s): Reading Together - Pausing for Reading; Reading Together - Dialogic Reading; Reading Together - Shared Reading Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shared Book Reading; Dialogic Reading; Language Development; Syntax; Vocabulary; Young Children; Randomised Control Trial; Language Intervention
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the LAP-BAND system is safe and effective
      in morbidly obese adolescents.
    

Detailed description: 
      The primary objective of this study was to evaluate the safety and effectiveness of the
      LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary
      objectives were to assess associated changes from baseline in obesity-related comorbidities
      as well as psychosocial functioning.
    

Intervention name(s): LAP-BAND System
Intervention type(s): Device
Intervention description(s): Restriction of food intake
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modafinil Effects on EEG Biomarkers of Reward and Motivation
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 4

Summary: 
      The effects of modafinil on measures of brain electrical activity will be tested.
    


Intervention name(s): Modafinil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: modafinil Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
Other Names:
Provigil Alertec Modavigil; Drug: Placebo Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Experimental medicine model; not an intervention. Within-subject double-blind placebo-controlled dose-response study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study design is a randomized, double-blind, intra-individual controlled, single-center,
      phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are
      judged to be eligible for this study will be intramuscularly injected with the study drug or
      the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor
      digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days
      and pharmacodynamic and safety assessments will be conducted for total 90days.
    

Detailed description: 
      This is a randomised, double-blind, intra-individual controlled, dose escalation study to
      assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in
      comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the
      first-in-human study for MT10107, and will be performed in healthy volunteers.

      Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by
      intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible
      subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group
      D (20 U dose) and Group E (30 U dose).

      The foot in which each drug is to be administered (i.e. left or right) will be assigned in a
      randomized manner.
    

Intervention name(s): MT10107; Botox
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.; Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
Other intervention name(s): Coretox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection
Condition: Latent Tuberculosis Infection; Tuberculosis
MeSH terms: Infections; Communicable Diseases; Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of
      RUTI® vaccine administered four weeks apart after one month pre-treatment with INH.

      The trial will be double-blinded, randomized and placebo-controlled with 96 subjects (48 HIV-
      and 48 HIV+ subjects).

      Three different RUTI® doses and placebo will be tested, randomizing assigned both in HIV+ and
      HIV- subjects. Each subject will be randomized to receive one of the four treatments
      (placebo, 5, 25, 50 μg), after completion of one month INH pre-treatment (one tablet of
      300mg/day, vp.o.). Each subject will receive two administrations of the same treatment, 28
      days apart. Subjects will be monitored until one month after the second inoculation with
      RUTI®.
    

Detailed description: 
      RUTI is a therapeutic vaccine made from virulent M.tuberculosis bacteria, grown in stressful
      conditions, fragmented, detoxified, heat inactivated (FCMtb) and liposomed. RUTI provides a
      strong humoral and cellular immune response against antigens from active growing and latent
      bacilli but also against structural antigens, as it has been proved in animal models of
      latent tuberculosis infection and in phase I clinical trial of Healthy Volunteers. The
      vaccine has been designed to be used against Latent Tuberculosis Infection as a therapeutic
      vaccine after 1-month of chemotheraputic treatment, instead the current treatment based on
      6-9 months of chemotherapy.
    

Intervention name(s): RUTI; RUTI; RUTI; RUTI Matching Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): dose:5 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.; dose:25 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.; dose:50 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.; Placebo of the vaccine RUTI; given subcutaneously twice, on days 28 and 56.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LTBI (Latent Tuberculosis Infection); TB (Tuberculosis); Vaccine
Compression Bandages in Upper Limb Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      Despite different types of bandages are using in the lymphedema treatment, numerous of them
      have not been directly compared. The aim of this study is to compare the efficacy of five
      different kinds of bandages on limb volume and lymphedema-related symptoms. It was also
      measured as secondary variables the comfort of the bandage related by the participants and
      the directly cost of each kind of bandage during the treatment.
    


Intervention name(s): Multilayer bandage; Double compression bandage; Cohesive bandage; Adhesive compression bandage; Kinesiotaping bandage; Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Upper limb exercises; Educational strategy
Intervention type(s): Device; Device; Device; Device; Device; Other; Other; Behavioral
Intervention description(s): See arm/group descriptions; See arm/group descriptions; See arm/group descriptions; See arm/group descriptions; See arm/group descriptions; MLD using a modification of the strokes described by Leduc will be applied to lymphedema "resorption". It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression ("EureducTM") with a pression of 40 mmHg.; After the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise.; Instructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment