bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Condition: Food Preferences
MeSH terms: Noncommunicable Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in
      Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being
      pursued, but there is little empirical data on how such labels influence people. The primary
      aim of this study is to test the association between sugar-sweetened beverage (SSB) warning
      posters compared to control posters and change in SSBs purchased compared to baseline by
      adolescents shopping at school cafeterias in Guatemala City, Guatemala. The hypothesis is
      that posters with information warning people of the health harms associated with
      overconsuming SSBs and promoting low sugar beverages will be associated with greater
      reductions in SSB purchases compared to a control poster.
    


Intervention name(s): Exposure to beverage health information; Exposure to beverage calorie information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information; Calories for sugar-sweetened and non-sugar-sweetened beverages
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three private schools will be enrolled in the study (two larger, one smaller) that have students between the ages of 12 and 18. There will be no posters displayed at any of the schools during the baseline period. The two larger schools will be randomized to either an SSB warning/non-SSB promoting poster or a calorie/control poster that will be implemented in the school cafeterias during a four-week intervention period. To increase the sample size for the intervention condition, the intervention will also be implemented at a smaller school. For the primary analysis, data only from schools that were randomized to condition will be used. Data was collected from both a sample of participants & from the cash registers directly.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Food Labeling; Adolescents
Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes
Condition: Mechanical Ventilation; Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Observational

Summary: 
      Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well
      as a high-frequency cardiac pulsatile component. The aim of the study is to compare the
      low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural
      pressure, to estimate trans-pulmonary pressure (PL).
    

Detailed description: 
      The investigators will enroll mechanically ventilated patients admitted to the intensive care
      unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric
      catheter and a central venous catheter for measuring Pes and CVP, respectively.
      Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of
      inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a
      dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP,
      fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure
      formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be
      compared to assess the correlation of the two methods.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to ICU treated with mechanical ventilation.
      
Keywords: esophageal pressure; transpulmonary pressure; central venous pressure; acute respiratory failure
Effect of Low Amplitude Vibration Therapy on Flexibility of Hamstring Muscle in Athletes of Pakistan
Condition: Hamstring Contractures; Whole Body Vibration
MeSH terms: Contracture
Study type: Interventional

Summary: 
      Whole body vibration therapy is rapidly becoming a topic of interest for the researchers
      around the world. Evidence suggests that Whole body vibration has an effect on improving
      flexibility of hamstring muscle and balance in athletes. The purpose was to examine the
      effect of low amplitude Whole body vibration on the flexibility of hamstring muscle and
      improving balance in athletes of Pakistan
    

Detailed description: 
      A total 60 number of athletes were analyzed and out of these 40 were included in the study
      who full fill the inclusion criteria, selected athletes were randomly assigned into two
      groups (control & experimental). After a total 2 drop outs from control group and 3 drop outs
      from experimental group, there were 18 athletes in control group and 17 in experimental group
      who continued till the analysis. Experimental group was given five sessions of low amplitude
      whole body vibration therapy for almost duration of 10 minutes, on alternative days, along
      with static stretching of hamstring muscles for 5 minutes and the control group was given
      only the static hamstring muscle stretches for five minutes, and same five sessions alike on
      alternative days. Static stretching protocol had 10 stretches in total with 15 seconds
      stretch time and 30 seconds relaxing time of hamstring muscle. All participants were assessed
      using Biodex Whole body vibration plate, Biodex balance system , Goniometer and a
      questionnaire.
    

Intervention name(s): Conventional static hamstring muscle stretching; Low amplitude whole body vibration therapy; Biodex Balance System; Range of motion of hamstring muscle
Intervention type(s): Other; Device; Device; Procedure
Intervention description(s): Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle.; Given five sessions of low amplitude whole body vibration therapy for duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles.
Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle.; Pre and post balance assessment by Biodex balance system; Straight Leg Raising to check pre and post Range of Motion by using Goniometer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 40 were included in the study who full filled the inclusion criteria, athletes were randomly assigned into two groups: Control and Experimental group. Additionally, data was collected from healthy athletes doing their training at Pakistan Sports Board, Islamabad.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: whole body vibration; Hamstring flexibility; ROM; Balance; Postural stability index
A Study of Controlled Lactulose Withdrawal
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional

Summary: 
      After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is
      routinely continued indefinitely as maintenance therapy. Although widely used for this
      indication, lactulose has never been shown in randomized, controlled trials to be effective
      for preventing exacerbations of HE. Indeed, lactulose was found to be ineffective at
      preventing HE when administered prophylactically to patients undergoing portosystemic shunt
      insertion. While some patients may be lactulose dependent following an initial episode of HE,
      it is likely that most could have their lactulose discontinued with no adverse consequences.

      This goal is worth pursuing because lactulose is not innocuous. It has an unpleasant taste,
      and it routinely produces gastrointestinal symptoms, including bloating, gas and diarrhea. In
      high doses it can cause incontinence, dehydration and electrolyte derangements. Patients
      universally dislike taking lactulose and often are noncompliant with treatment. A recent
      trial showed that patients on lactulose had a substantial risk of hospital admissions due to
      lactulose-related complications and treatment non-compliance.
    

Detailed description: 
      In this pilot study we propose to perform controlled lactulose withdrawal in selected
      patients with HE whose initial presentation follows a clearly defined, reversible
      precipitating event or those with stable, chronic HE. We hypothesize that a majority of these
      patients can be withdrawn from daily lactulose therapy without deterioration of cognitive
      function, and that lactulose withdrawal will improve symptoms and quality of life for these
      individuals. We propose to carry out a comprehensive battery of clinical, laboratory,
      microbiological and psychometric evaluations before and after lactulose withdrawal. We will
      closely follow changes in cognitive function and re-institute lactulose therapy at the first
      sign of clinical deterioration. Through multivariate analysis we propose to develop a model
      to discriminate between treatment dependent and treatment independent patients.
    

Intervention name(s): lactulose
Intervention type(s): Drug
Intervention description(s): withdrawal of lactulose
Intervention MeSH terms: Lactulose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
New Approaches to Cocaine Abuse Medications (A) - 6
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to measure the effect of desipramine in cocaine abusers selected
      for major depression or dysthymia.
    

Detailed description: 
      This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting
      DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID
      interview). Participants were treated with desipramine, up to 300 mg per day, or matching
      placebo. All patients received weekly individual manual-guided relapse prevention therapy.
      Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine
      use and craving, urine toxicology, and the Hamilton Depression Scale.
    

Intervention name(s): Desipramine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.; Participants were treated with matching placebo. All participants received weekly individual manual-guided relapse prevention therapy.
Other intervention name(s): desmethylimipramine
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Desipramine, cocaine, depression
Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is a continuation of a previous DEX PK study. It is examining the
      absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This
      study will help us determine the best dosing amount for children undergoing sedation or
      anesthesia with DEX.
    

Detailed description: 
      The study will be a prospective study of plasma concentrations after intranasal or buccal DEX
      to determine the early pharmacokinetics and bioavailability of a single dose via nasal or
      oral administration.

      Dexmedetomidine sedation is commonly used at Cincinnati Children's Medical Center and other
      pediatric institutions. This compound is typically delivered intravenously or intranasally
      for sedation in children with or without congenital heart disease. Intranasal DEX is very
      effective for sedation although it has significant variability in the onset and peak effect.
      Patient care will be improved if factors that determine this variability can be determined.
      Investigators will determine the important clinical variables of peak plasma DEX
      concentration (Tmax and Cmax) of intranasal and buccal DEX in children.
    

Intervention name(s): Dexmedetomidine buccal; Dexmedetomidine Intranasal; Dexmedetomidine Intranasal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DEX 2 mcg/kg buccal; DEX 3 mcg/kg intranasal; DEX 4 mcg/kg intranasal
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; Sedation; Dexmedetomidine
Intensive Therapies in Children With Hemiplegia
Condition: Infantile Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      This is a comparative study where two protocols of intensive therapies will be applied to
      study the improvements in the functional performance of the affected upper limb of children
      with hemiparesis and check whether to increase their quality of life.
    

Detailed description: 
      the intervention protocols combine different doses of intensive therapy, being 80 hours of
      modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol
      2 would be the application of protocol 1 inverted, with this, the investigators want to
      compare how both protocols interfere in the function of the affected upper limb of children
      with different levels of bimanual functional performance.
    

Intervention name(s): intensive therapies(CIMT/BIT): protocol 1 or protocol 2
Intervention type(s): Combination Product
Intervention description(s): The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.
the protocols were carried out at home through the family
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: infantile hemiplegia; upper extremity; physical therapy
Investigating Predictors of Treatment Response in Treatment-Resistant Depression (TRD) With Interleaved TMS/fMRI
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      The purpose of this trial is identify biomarkers of response to repetitive transcranial
      magnetic stimulation (rTMS) in individuals with first episode or treatment resistant
      depression. These biomarkers include simultaneous TMS-fMRI (functional magnetic resonance
      imaging), a blood smear, cognitive and behavioural assessments, questionnaires, and
      neurophysiology.
    

Detailed description: 
      This study is enrolling 60 individuals with treatment-resistant depression.

      All patients will receive four weeks of 1-Hz rTMS to the right dorsolateral prefrontal cortex
      (R_DLPFC). In addition, all patients will undergo baseline and post-treatment measures,
      including rTMS while they are in the MRI scanner, neurophysiology (Electroencephalography
      (EEG)/Near-Infrared Spectroscopy (NIRS)), cognitive testing, behavioural assessments and a
      blood smear. There will also be a 1-week, 4-week, and 12-week follow-up following completion
      of the treatment course.
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): rTMS is a Health-Canada- and FDA-approved treatment for treatment-resistant depression (TRD), using focused magnetic field pulses to stimulate brain regions involved in emotion regulation, safely and non-invasively. rTMS can be applied at varying discharge frequencies which have differential effects on cortical excitability. At a low frequency (≤ 1Hz), rTMS reduces cortical excitability, while at frequencies greater than 1 Hz, rTMS facilitates cortical excitability3. In MDD, either high- frequency rTMS (HF-rTMS) applied over the left dorsolateral prefrontal cortex (DLPFC) or low- frequency rTMS (LF-rTMS) applied over the right DLPFC have similar efficacy. This study utilizes low frequency rTMS to the right DLPFC.
Other intervention name(s): rTMS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation; rTMS; neurostimulation; biomarker; treatment-resistant
The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Therapeutic play (TP) is a non-pharmacological method used in the pain management in
      children. This study was conducted to determine the effect of therapeutic play on children's
      pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC).
    

Detailed description: 
      The hospitalisation of children due to an acute or chronic illness interrupts play, disrupts
      their daily routines, places them in an unfamiliar environment, forces them to encounter with
      unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and
      anxiety. Peripheral intravenous catheterisation (PIVC) is probably the most common procedure
      performed in paediatric clinics. It has been estimated that 80% of hospitalised children have
      a peripheral intravenous catheter in place. PIVC is a painful and traumatic experience that
      children usually go through for the first time and frequently during the hospitalisation.
      This experience of children impairs effective communication between them and healthcare
      professionals and also causes problems in adaptation to the care and treatment process in the
      hospital setting. As one of the non-pharmacological pain relief methods, therapeutic play
      (TP) is a distraction that is defined as "the directed use of toys and materials, which can
      facilitate children to gain knowledge about the environment and the world they live in, to
      improve their perceptions thereof and to gain control, for a specific purpose". In order to
      call play with a child who is hospitalised as therapeutic, the play should encourage children
      to express their feelings and thoughts during the hospitalisation, assume an educational role
      in their positive or negative hospital experiences, and bring psychosocial and physical
      benefits. Children could be told facts such as the hospitalisation, the procedures to be
      followed and the time when this procedure would end through therapeutic play
    

Intervention name(s): Therapeutic play group
Intervention type(s): Behavioral
Intervention description(s): The dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pain; anxiety; Peripheral intravenous catheterisation; therapeutic play
Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different
      single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous
      (SC) insulin lispro in a euglycemic clamp setting.

      Secondary Objectives:

      To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single
      doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a
      euglycemic clamp setting.

      To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza
      inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp
      setting.

      To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza
      inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp
      setting.

      To assess the safety and tolerability of 3 different single doses of Afrezza inhaled
      Technosphere insulin.
    

Detailed description: 
      The total study duration for one patient is approximately 6.7 to 22.7 weeks (minimum to
      maximum duration, excluding screening). The duration of the study includes a screening period
      of 3 to 28 days (D -28 to D -3), 6 treatment periods of 1 or 2 days each (1 overnight stay),
      a washout period of 7 to 28 days (preferentially 7 days between consecutive dosing), and an
      end-of-study visit of 7 to 14 days after the last study drug administration.
    

Intervention name(s): SAR439065; Insulin lispro
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:dry powder insulin
Route of administration: inhalation; Pharmaceutical form:solution for injection
Route of administration: subcutaneous
Other intervention name(s): Afrezza Technosphere insulin; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science