bioihbjkbjnl/mcl2 huggingface dataset:
Post-release Retention in HIV Care for Ex-inmates in South Africa
Condition: Hiv; Adherence, Patient
Study type: Interventional

Summary: 
      HIV remains the leading cause of death in South Africa as a result of a failure of people
      living with HIV to seek HIV treatment and be retained in care. After initiating
      antiretroviral therapy while incarcerated, most ex-inmates fail to remain engaged in care.
      The goal of this research is to reduce mortality, morbidity, and HIV transmission by
      developing an actionable approach to retaining these individuals in HIV care.
    

Detailed description: 
      To pilot a randomized clinical trial (RCT) of a transition adherence club (TCAC) versus
      traditional care, among ex-inmates receiving antiretroviral therapy in South Africa, to study
      feasibility, acceptability, and preliminary effectiveness using mixed methods.

      Investigators will pilot an RCT of the TCAC compared to traditional care among
      inmates/ex-inmates measuring transition in care, six-month viral load suppression, and
      follow-up of participants. Feasibility will be assessed by process measures. Acceptability
      will be assessed using in-depth interviews among 36 participants and 10 staff. Effectiveness
      will be assessed by a difference in proportions in-care with an undetectable viral load at 6
      months and difference in bonding social capital and care satisfaction between arms.
    

Intervention name(s): Transition Community Adherence Club (TCAC)
Intervention type(s): Behavioral
Intervention description(s): A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available.
Other intervention name(s): Transition Community Adherence Club
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individually randomized trial with 2:1 allocation to the intervention compared to care as usual
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: incarceration; linkage to care; retention in care
Smoking Cessation in Alcoholics
Condition: Smoking Cessation; Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate
      whether a specific smoking cessation program (based on cognitive-behavioral therapy) for
      inpatient alcohol-dependent smokers is more effective than a control condition (treatment as
      usual).
    

Detailed description: 
      The study is designed as a randomised, controlled trial conducted in an inpatient alcohol
      treatment institution. Shortly after alcohol detoxification, smokers are offered to
      voluntarily participate in a smoking cessation program. Participation is possible if patients
      either want to stop smoking or to reduce their consumption for at least 50%. Patients are
      asked about their smoking behaviour at the following time points: at admission (T0), after
      finishing the smoking cessation program or the control condition (T1), one month later by
      phone (T2) and six months later in a closing meeting (T3). Urine samples and CO-breath
      controls are taken to check both nicotine and alcohol abstinence.
    

Intervention name(s): Cognitive-behavioural smoking cessation program; Autogenic training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): It's a cognitive-behavioural intervention for smoking cessation. Originally based on a 6 week program designed for outpatients (Batra & Buchkremer 2004). This program was then specifically tailored for inpatient use with additional information addressing the interaction of smoking and drinking and its consequences.; Learning and exercising of autogenic training. There's evidence that autogenic training is not effective in smoking cessation.
Other intervention name(s): Nichtraucher in 6 Wochen (Batra & Buchkremer); Autogenous Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking; Alcohol; Outcome; Harm reduction; Alcohol drinking; Treatment outcome; Treatment effectiveness
Effect of Quetiapine on Sleep Architecture in Bipolar Depression and Major Depressive Disorder
Condition: Bipolar Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects
      may play an important role in restoring quality of sleep in patients with various psychiatric
      conditions who frequently experience sleep disturbances as part of their illness. It is well
      known that depressive disorders are very frequently associated with significant sleep
      disturbance. Sleep disruption is a feature of Bipolar Disorder during both Depressed and
      Manic/Hypomanic episodes. Considering that Seroquel has good antidepressant properties
      (Calabrese, 2004), the investigators suggest that Seroquel's effect on sleep architecture
      contributes to its antidepressant properties.
    

Detailed description: 
      Primary Objective:

      To assess the objective (polysomnographic) change in sleep quality before and after
      introduction of Seroquel (Quetiapine) in treatment of patients with Bipolar Depression or
      Major Depressive Disorder.

      Secondary Objectives:

      To assess the objective (polysomnographic) and subjective changes in sleep quality parameters
      before and at different stages after introduction of Seroquel (Quetiapine) treatment,
      longitudinally, and to correlate these changes with measures of illness severity.

      Study Design:

      Prospective polysomnographic (PSG) study of patients before and after treatment with Seroquel
      (Quetiapine). PSG recordings will be done three (optional four) times during the study:
      before starting the Seroquel (Quetiapine) (baseline), at day 2 to 4 (early) and day 21 to 28
      (longer term). (Optional fourth PSG can be done at day 42-56). PSG will be completed at
      patients home with a portable PSG.
    

Intervention name(s): Seroquel
Intervention type(s): Drug
Intervention description(s): The dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will.
Other intervention name(s): Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with current Major Depressive Disorder or Bipolar Depression
Enforced Reduction in Physical Activity and Recovery in Older Adults
Condition: Muscle Degeneration; Body Weight Changes; Walking, Difficulty
MeSH terms: Body Weight; Body Weight Changes; Mobility Limitation
Study type: Interventional

Summary: 
      Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited
      to the study. All subjects undergo pre-screening for suitability and a physicians
      examination, as well as 7-day habitual daily steps are measured to ascertain baseline
      physical activity. Half of the recruited subjects (n=40) will be randomized into the
      intervention group and half (n=40) randomized into the control group. The intervention group
      is then required to reduce their daily steps to <2000 for a 2-week period. Thereafter, the
      intervention group participates to a 4-week strength+endurance training rehabilitation
      program and no longer has restricted daily step count. The control group continues their
      normal habitual physical activity level throughout the 6-week study period.
    


Intervention name(s): Step-reduction/Exercise Rehab
Intervention type(s): Behavioral
Intervention description(s): 2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial, with 2 parallel groups
Masking: None (Open Label)
Primary purpose: Basic Science
L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia
Condition: Hypothyroxinemia
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental
      impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether
      L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.

      The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less
      than 32 WG with THOP.

      The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the
      Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen
      therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock
      requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage,
      retinopathy of prematurity, deafness.
    

Detailed description: 
      Preterm newborns <32 weeks of gestation (WG) are screened for THOP between day 5 and day 7 of
      life. THOP is defined by thyroid-stimulating hormone (TSH) < 20 mIU/L and FT4 < 0.80 ng/dL.
      After obtaining written consent from the parents, preterm newborns <32 WG with THOP will be
      included. Randomization is stratified by center and 2 age-groups (24-28 WG and 29-32 WG). One
      arm will receive L-thyroxine treatment and the other arm will receive placebo. Treatment will
      be started within one week after diagnosis and will last 6 weeks. TSH and FT4 will be assayed
      2 weeks after stopping treatment.

      The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the
      Brunet-Lézine score.
    

Intervention name(s): L-Thyroxine; water
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.; Oral treatment with water. Equal number of drop of water as compared with the treatment arm (according to the body weight of the newborn) in the morning, once a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant, newborn; Infant, preterm; Thyroid; Outcome; Newborns less than 32 weeks of gestation; TSH < 20 mIU/L and a FT4 < 0.80 ng/dL
Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery
Condition: Stenosis, Internal Carotid Artery
Study type: Interventional

Summary: 
      Comparison of two methods for revascularization of the bifurcation of common carotid artery:
      carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty
      compared with new technique of carotid endarterectomy with autoarterial remodeling of
      bifurcation of the common carotid artery
    


Intervention name(s): Operation carotid endarterectomy with plastic of xenopericardial patch; New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA
Intervention type(s): Procedure; Procedure
Intervention description(s): Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.; Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: carotid endaretectomy
Postprandial IHL and IMCL Measured With Proton Magnetic Resonance Spectroscopy
Condition: Postprandial IHL and IMCL Dynamics
Study type: Interventional

Summary: 
      The major research objective is to assess the potential of Proton Magnetic Resonance
      Spectroscopy to follow Intrahepatic lipid and Intramyocellular lipid dynamics after a single
      meal. Furthermore we aim to investigate whether the addition of protein to a high fat
      breakfast results in a reduced postprandial accumulation of lipids when compared to a high
      fat breakfast alone.
    

Detailed description: 
      Fat accumulation in non-adipose tissue, such as liver and muscle, is associated with reduced
      insulin sensitivity and cardiovascular disease. Little is known about the dietary
      determinants and the time course of this ectopic fat accumulation. Therefore the general aim
      of this project is to develop and validate methodology to follow postprandial hepatic and
      muscular lipid retention. Proton Magnetic Resonance Spectroscopy (1H-MRS) is a
      well-established tool for noninvasive quantification of intrahepatic lipids (IHL) and
      intramyocellular lipids (IMCL). Previous studies have suggested a relatively rapid regulation
      of IHL and IMCL levels, indicated by changes in these total lipid pools after high fat diets
      of 3 or 4 days. Although IHL and IMCL levels seem to change rapidly, data on IHL and IMCL
      levels after a single meal are lacking.
    

Intervention name(s): High fat breakfast; HF breakfast with protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The HF breakfast will consist of sausage rolls ("saucijzenbroodjes"), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands).; For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover,
      the integrity of endothelial glycocalyx plays a vital role in vascular permeability,
      inflammation and elasticity. The purpose of this study is to investigate changes in arterial
      stiffness and endothelial glycocalyx thickness in patients with poorly controlled diabetes
      mellitus type 1 or type 2 after glycemic control by optimal medication.
    

Detailed description: 
      The investigators will study two groups matched for age and sex: 30 patients with
      uncontrolled type 1 diabetes and 30 patients with uncontrolled type 2 diabetes. Individuals
      should not be treated with statins, beta-blockers, ACE inhibitors, sartans, hormonal
      preparations, drugs that interfere with the function of platelets and hemostasis.
      Furthermore, they should not have heart failure, nephropathy and retinopathy. 10 people will
      remain uncontrolled after the expiration of 3 months after the modification of antidiabetic
      medication used as a control group .

      At 0, 3, 6 and 12 months the investigators will measure:

        1. Carotid-femoral pulse wave velocity (PWV, m/sec) and augmentation index (AI%) by the
           method of arteriography (Arteriograph, TensioMed) and Complior (SP ALAM).

        2. Perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels
           (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck).
           Increased PBR is considered an accurate non invasive index of reduced endothelial
           glucocalyx thickness.

        3. Flow mediated dilatation (FMD) of the brachial artery.

        4. Determination of following parameters in blood: glucose, insulin, free fatty acids,
           triglycerides, glycerol, C-reactive protein (CRP), transforming growth factor-b (TGF-b),
           Lipoprotein-Associated Phospholipase A2 (LP-LPA2), tumor necrosis factor-a (TNF-a), IL6
           and IL10 (interleukins), propeptide of type I procollagen (PIP), propeptide of
           procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP), macrophage-colony
           stimulating factor (MCSF), growth differentiation factor-15 (GDF-15), N-terminal pro
           b-type natriuretic peptide (NT-proBNP) and galectin-3.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of 30 patients with uncontrolled type 1 diabetes and 30
        patients with uncontrolled type 2 diabetes.
      
Keywords: Arterial stiffness; Endothelial glycocalyx; Coronary flow reserve
Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being done to compare the effectiveness and safety of two treatment paradigms
      (oral sitagliptin with or without glimepiride versus liraglutide with or without increased
      dosing) for the treatment of participants with Type 2 Diabetes that is not adequately
      controlled with metformin alone. The primary hypothesis postulated that the mean change from
      baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment
      is non-inferior to that of participants treated with a liraglutide-based

      treatment.
    


Intervention name(s): sitagliptin; liraglutide; glimepiride; metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg tablet, orally, once daily.; 0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.; starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.; metformin tablets at a dose of ≥1500 mg per day
Other intervention name(s): MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben®; Victoza®; Amaryl®; Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Menthol in E-cigarettes on Smoking Behaviors
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this proposal is to understand the relationship between nicotine
      metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.
    


Intervention name(s): Nicotine
Intervention type(s): Drug
Intervention description(s): Participants will receive two nicotine concentrations via e-cigarettes. Each exposure will be 10 3-sec puffs and ad libitum use
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg
      against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP)
      as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline.

      The secondary objectives are:

        -  To compare the percentage of patients with normal blood pressure as measured by HBPM and
           at the doctor's office at weeks 16 and 24

        -  To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and
           evening SBP and DBP evaluated by HBPM at weeks 16 and 24

        -  To compare the difference in mean SBP evaluated by HBPM at week 16

        -  To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks
           16 and 24

        -  To determine the incidence and severity of adverse events
    


Intervention name(s): Irbesartan/hydrochlorothiazide; Valsartan/hydrochlorothiazide; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150/12.5mg tablet and 300/12.5mg tablet; 80/12.5mg tablet and 160/12.5mg tablet; 12.5 mg administered orally, once daily in the morning
Intervention MeSH terms: Valsartan; Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Benefit and Tolerability of IQP-AE-103 in Weight Loss
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg
      and 1980mg daily) in reducing body weight in overweight and moderately obese subjects
    


Intervention name(s): IQP-AE-103 (330mg); IQP-AE-103 (165mg); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): High dose capsules; Low dose capsules; Placebo identical to verum capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment