bioihbjkbjnl/mcl2 huggingface dataset:
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric
      subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to
      demonstrate that the closed loop algorithm is safe as part of the overall system, and to
      assess the PLGM feature in 7-13 years old subjects.
    

Detailed description: 
      The study will proceed as follows:

      Run-in Period - General:

      A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers
      (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.

      Study Period - At Home:

      Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13)
      will participate in a 3-month study period.

      Study Period - Hotel Study Subjects (age 7-13) will participate in a Hotel study (6 days, 5
      nights), with the remainder of the study period to be spent at home. Subjects 2-6 years of
      age are not required to participate in a hotel study. Instead, they will participate in an
      out-of-home study for 5 consecutive days, 4-6 hours per day.

      Continued Access Program Subjects will be given the opportunity to extend use of their study
      devices for a period of up to 3 years . If subjects choose to participate in the continuation
      period, they will retain the study devices at the end of study period visit or receive them
      back in the event they have been returned to study staff already.
    

Intervention name(s): Insulin Pump
Intervention type(s): Device
Intervention description(s): Closed Loop Algorithm
Other intervention name(s): MMT-670G
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of donepezil transdermal
      patch in patients with mild to moderate Alzheimer's disease.

      The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301
      (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks of treatment
      in patients with mild to moderate Alzheimer's disease in terms of improvement in cognitive
      function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) and
      in terms of global assessment as assessed by Clinician's Interview Based Impression of Change
      plus Caregiver Input (CIBIC-plus).
    


Intervention name(s): Donepezil patch; aricept Tab
Intervention type(s): Drug; Drug
Intervention description(s): Treatment; Comparator
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
Condition: Latent Tuberculosis; HIV Infections
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Observational

Summary: 
      HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active
      disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless
      of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function.

      Therefore, an accurate and reliable method for detection of latent tuberculosis in patients
      with HIV is urgently needed.

      This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay,
      T-SPOT.TB,for detection of TB in HIV-infected individuals.
    


Intervention name(s): T-Spot.TB test
Intervention type(s): Other
Intervention description(s): diagnostic test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with HIV confirmed by standard methods
      
Keywords: latent tuberculosis; HIV; IFN-γ based assay
Hepatitis C Infection in World Trade Center Responders
Condition: Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      This study provides Hepatitis C virus screening to the members of the World Trade Center
      Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965,
      and linkage to care for those found infected. The study will also determine if exposure to
      human remains, blood and/or bodily fluids during the World Trade Center Health Program
      activities are associated with Hepatitis C virus infection. These findings would be relevant
      to the larger United States population, especially to persons born during 1945-1965 who are
      at high risk of Hepatitis C virus infection.
    

Detailed description: 
      The purpose of the project is to determine if the World Trade Center Health Program cohort is
      at an increased risk of Hepatitis C virus infection, determine if human exposure to human
      remains, blood and/or body fluids during the World Trade Center recovery activities is
      associated with increased risk of Hepatitis C virus infection, and to determine if referral
      to a co-located site for Hepatitis C virus care is associated with improved linkage to
      Hepatitis C virus care in the members of the World Trade Center Health Program born during
      1945 through 1965.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The World Trade Center Health Program is a longitudinal cohort of World Trade Center rescue
        and recovery workers who participated in the World Trade Center Screening, Monitoring, and
        Treatment Program at the Icahn School of Medicine at Mount Sinai in New York, New York.
        Eligible World Trade Center responders were those who had worked or volunteered in lower
        Manhattan, or the Staten island landfill or barge-loading piers for 4 hours or more from
        September 11, 2001, to September 14, 2001; 24 hours or more during September, 2001; 80
        hours or more from September, 2001, to December, 2001. Persons enrolled in the World Trade
        Center Health Program and were born from 1945-1965 are eligible.
      
Keywords: hepatitis C virus; linkage-to-care; World Trade Center Health Program cohort; Baby Boomer; risk factors for hepatitis C virus infection
Intensified Rituimab Prephase Before FCR in Untreated B-CLL
Condition: B-cell Chronic Lymphocytic Leukemia CLL
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy
      before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated
      symptomatic B-cell chronic lymphocytic leukemia CLL.

      A Study from the Goelams GCFLLCMW intergroup
    

Detailed description: 
      Young fit medically B Cell untreated patients Comparison between FCR treatment = 6 FCR cycles
      and a the addition of a prephase with R Dense treatment before the 6 FCR cycles.
    

Intervention name(s): Rituximab; Rituximab; Cyclophosphamide; Fludarabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cycle 1 Rituximab : 375 mg/m² i.v on day 1
Cycle 2-6 Rituximab:500 mg/m² i.v on day 1, repeated every 28 days; Prephase: Rituximab:500 mg on day 0, 2000 mg on days 1, 8, and D15
Cycle 1-6 cycle 1 beginning at D22: Rituximab: 500 mg/m2 i.v on day 1, repeated every 28 days; •FCR Cycle 1-6: Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days; FCR Cycle 1-6: Fludarabine :40 mg/m² per os, days 2-4, repeated every 28 days
Other intervention name(s): R; R; C; F
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B CLL; Fist line treatment
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study I
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of
      glabellar lines in comparison with placebo, including efficacy after repeat treatments and
      long term safety.
    


Intervention name(s): Botulinum Toxin A; Placebo; Botulinum Toxin A
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area.; Injection, sodium chloride 0.9 mg divided in five 0.1mL i.m. injections into glabellar area; Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles
Other intervention name(s): BoNT/A-DP; sodium chloride 0.9 %
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the safety and efficacy of celgosivir plus
      peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic
      hepatitis C genotype 1 infection.
    


Intervention name(s): Celgosivir
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Celgosivir; HCV; Genotype 1; Non-responders; Early Viral Response; EVR
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Condition: Parkinson Disease; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more
      than a million Americans. It's most prominent pathology is the degeneration of dopaminergic
      neurons in the brain. It is believed that oxidative stress and inflammation play an important
      role in the pathophysiology of Parkinson's disease as well.

      The object of this study is to evaluate whether nutritional supplementation with compounds
      that have been shown to have either anti- inflammatory, or antioxidant effects, might support
      brain function in patients with Parkinson's disease, particularly in regards to the dopamine
      system. Enrolled patients will be randomly assigned to receive oral and intravenous n-acetyl
      cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan) single
      photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance
      spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological
      measures to assess clinical symptoms, in patients with PD. Subjects will receive a DaTSCAN
      and MRS initially and after completing the supplement or NAC regimen.
    

Detailed description: 
      The study consists of two arms. The first arm of this study will receive intravenous and oral
      NAC, which is a strong antioxidant that increases brain glutathione, which may be beneficial
      in PD. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It
      is a common over-the-counter supplement and also is available as an injectable pharmaceutical
      that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed
      some benefits to use of NAC, such as its potential to counteract intracellular damage that
      leads to dopaminergic neuron death. It also has the potential to reduce markers of oxidative
      damage, protect against dopamine cell death from MPTP toxicity, and to increase glutathione
      in blood, which might be useful in preventing oxidative damage in PD patients.The second arm
      will be a waitlist control receiving standard PD care. It should be noted that both arms will
      receive standard PD care which will be augmented with NAC.
    

Intervention name(s): Intravenous and Oral n-acetyl cysteine
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Integrative Medicine; Alternative Medicine; Complementary Medicine; Parkinson's disease; Neurodegenerative Diseases; Idiopathic Parkinson's disease; Single Photon Emission Computed Tomography (SPECT); Central Nervous System Diseases; Movement Disorders; Nervous System Diseases; Brain Diseases; Oral supplements; N-acetyl cysteine
36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite
Condition: Dental Leakage
MeSH terms: Dental Leakage
Study type: Interventional

Summary: 
      Summary The aim of this study was to evaluate the effect of preheating resin composite (RC)
      on clinical performance of class I restorations in a period of 3-years using a split-mouth
      double-blinded randomized design.
    

Detailed description: 
      The description of the experimental design followed the Consolidated Standards of Reporting
      Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner)
      randomized clinical trial anticipating the split mouth design. Thirty-five adult patients
      seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University
      of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No
      advertisement was made for participant recruitment, forming a sample of convenience. Each
      patient much sign a consent form before participating in the current study. The study was
      conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura
      University institution's ethics committee approved the form and protocol before conducting
      the study. The sample size was calculated based on the clinical success rate (100% retention
      rate at 3 years) of posterior class I restorations restored with nanofilled composite
      observed in a previous study.28 According to several parameters including a significance
      level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%.
      Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out,
      sample size was set totalizing 35 subjects.
    

Intervention name(s): Preheating
Intervention type(s): Procedure
Intervention description(s): For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One side of the mouth received preheated composite however in the other side the composite was placed in non-heated state following the manufacturer instructions.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Resin Composite; Pain; Randomized Clinical Trial; Operative Dentistry; Preheating
Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Condition: Acne Prone Skin
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam
      Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.
    

Detailed description: 
      This was a open-label, single center study conducted in the United States that evaluated the
      tolerability of Cetaphil® DermaControl™ skin care products used at least once daily for 22
      days in male and female subjects age 7 to 11 with acne prone skin. There were 4 visits during
      the course of the study: screening (within 7 days of visit 1), visit 1(baseline /day1), visit
      2 (day 8), and visit 3 (day 22/exit). Tolerability assessments were performed by a board
      certified dermatologist at all visits. Subjects completed the baseline skin care regimen
      questionnaire at visit 1. Hydration assessments were competed at visits 1, 2, and 3. A
      subject satisfaction questionnaire was completed at visit 3. Adverse event assessments were
      conducted for all subjects at every clinic visit after informed consent/assent was signed.
    

Intervention name(s): Facial Cleanser and Moisturizer SPF 30
Intervention type(s): Drug
Intervention description(s): Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30
Other intervention name(s): Cetaphil® DermaControl™ skin care products
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acne, pediatric
Older Adult Training Study With Creatine and CLA
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could
      enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM);
      decrease body fat) following resistance exercise training in older adults (> 65 y). Our study
      hypothesized that administering CrM and CLA would yield greater strength and body composition
      benefits than the placebo group over the six months of resistance exercise
    

Detailed description: 
      Men (N=19) and women (N=20) completed six months of resistance exercise training with
      Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized,
      double-blind, allocation.Outcomes included; strength and muscular endurance, functional
      tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose,
      systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance
      (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption
      (Ν-telopeptides).
    

Intervention name(s): Training; Creatine Monohydrate, Conjugated Linoleic Acid
Intervention type(s): Behavioral; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Influence of Cataract Surgery on Early DME The DICAT-II Study
Condition: Diabetic Macular Edema; Cataract Senile; Surgery--Complications
MeSH terms: Cataract; Macular Edema
Study type: Observational

Summary: 
      To determine if cataract surgery may have an impact on the natural history of early DME
      (E-DME)
    

Detailed description: 
      Cataract surgery worsens preoperative DME, deserving an adequate pre and postoperative
      treatment. A large British study demonstrated that even eyes without preexisting edema are at
      risk of DME development after surgery according to the gravity of retinopathy. A new DME
      classification (the ESASO Classification of DME) defines a new category of DME, named early
      DME (E-DME) as follow: presence of small intraretinal cysts associated with well-recognizable
      and detectable inner retinal layers, ellipsoid zone (EZ) and external limiting membrane
      (ELM), with increase in central subfield thickness (CST) and/or macular volume (MV) less than
      30% of maximum normal values.

      Due to its undetectable or minimal impact on visual function, E-DME has not yet been studied,
      and retinologists usually restrict treatment to more advanced cases.

      E-DME is the most frequent type of DME among the population undergoing cataract surgery,
      estimated by DICAT-I Study in 20.7% of the diabetic subjects, corresponding to 5.4% of the
      general population.

      It has been demonstrated that cataract surgery has a negative impact both on diabetic eyes
      with no DME and in eyes with advanced DME. Even E-DME therefore probably worsens after
      surgery but there are no data on this matter.

      Study Objective: to determine if cataract surgery may have an impact on the natural history
      of early DME (E-DME) Study Design: prospective multi-center observational case-control study
    

Intervention name(s): cataract surgery
Intervention type(s): Procedure
Intervention description(s): phacoemulsification
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Groups GROUP 1: Eyes with E-DME scheduled for cataract surgery GROUP 2: Control
        Group. Eyes with E-DME and clear media, non-significant cataract, pseudophakic (Group 2a:
        phakic; Group 2b: pseudophakic) or eyes with cataract scheduled for surgery after the end
        of follow up.

        Gold candidate: patient with bilateral E-DME and cataract in at least one eye.
      
Keywords: diabetic macular edema; cataract; surgery
An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to provide biological samples from patients with
      Huntington's disease to allow characterisation of the pharmacological mechanism of action of
      SEN0014196.
    

Detailed description: 
      This study will establish the acute phenotypical and biological effects of repeated dose
      application of SEN0014196 in patients with Huntington's disease, providing biomaterials for
      biomarker studies (levels of circulating huntingtin, acetylation status of mutant huntingtin,
      innate immune markers, transcriptional profiles). Evaluation of phenotypic effects will
      include UHDRS scores, total functional capacity. Safety assessments will include ECG, vital
      signs, laboratory safety tests and physical examination.
    

Intervention name(s): SEN0014196 (Low Dose); SEN0014196 (High Dose); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg once daily administration (immediate release capsule); 100 mg once daily administration (immediate release capsule); Once daily administration (immediate release capsule)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Huntington Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Cognition Disorders; Mental Disorders