bioihbjkbjnl/mcl2 huggingface dataset:
Family Networks (FaNs) for Children With Developmental Disorders and Delays
Condition: Neurodevelopmental Disorders; Developmental Disabilities
MeSH terms: Neurodevelopmental Disorders; Developmental Disabilities
Study type: Interventional

Summary: 
      Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability
      or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of
      concept study, the investigators integrated social, technological and business innovations to
      develop and successfully pilot a sustainable service for such children in one rural
      population of 30,000. Affected families were identified through a mobile phone-based
      interactive voice response system, and organised into family networks. 'Champion' family
      volunteers were trained in evidence-based interventions. A Tablet-based android application
      was developed for training, monitoring and supervision of the champions, based on the World
      Health Organization's guidelines. The champions delivered the intervention to other families
      in the network. The project was sustainable and demonstrated significant improvements in the
      lives of children and their families in the first 6 months of its operation. The
      investigators are scaling-up this intervention to a population of 1 million. The
      investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up
      programme using cluster randomized control trial nested within the scale-up study.
    


Intervention name(s): Family networks program
Intervention type(s): Behavioral
Intervention description(s): Intervention, Family networks Program (FaNs), is administered once weekly over 9-10 weeks in a group format over 3 hours per sessions. Family networks Program (FaNs) is based on WHO mhGAP module for developmental disorders and incorporates WHO parent skills training program for children with developmental disorders and delays. Parents Skills Training Program includes modules on communication, play, daily living skills, managing challenging behavior, coping with stress. Intervention is provided by the family volunteers (members of community, mostly women, who have a child affected in their families).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cluster randomized trial; developmental delays; neurodevelopmental disorders; autism; intellectual disability; low resource settings; family volunteers
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test whether addition of imiquimod to standard antimony therapy provides a
      significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our
      previous results, we hypothesize that lesions in patients who receive the combined treatment
      of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and
      produce less scarring than treatment with pentavalent antimony alone.
    


Intervention name(s): Imiquimod
Intervention type(s): Drug
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The aim of this study is to develop a retrospective, multicenter and observational study in
      Spain in real clinical practice to assess the employment of dapagliflozin and to compare its
      effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely
      used molecule in Spain with a large safety profile. It was chosen as a comparator because of
      the number of patients treated and because it is a real alternative at the time of making a
      decision about the treatment.
    


Intervention name(s): Dapagliflozin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Evaluation of the effectiveness and safety of the Dapagliflozin treatment.; Evaluation of the effectiveness and safety of the Sitagliptin treatment.
Other intervention name(s): iSGLT2; iDPP4
Intervention MeSH terms: Sitagliptin Phosphate; Dapagliflozin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients over 18 years old with stable DM2 with antihyperglycaemic therapy, being included
        in their treatment dapagliflozin or sitagliptin medication.
Effects of Epigallocatechin Gallate (EGCG) in Healthy, Young Adults
Condition: Cognitive Function; Mood
Study type: Interventional
Phase: Phase 4

Summary: 
      Epigallocatechin gallate (EGCG) is the most abundant catechin (sometimes referred to as tea
      flavonoids) in green tea extract. A review by Nagle et al (2006) identifies that a large
      amount of research indicates EGCG (amongst other catechins) is responsible for most of the
      potential health benefits associated with green tea. EGCG is brain permeable (Nakagawa &
      Miyazawa, 1997), and it is considered to have neuroprotective and neurorescue effects
      including modulation of cell survival and cell cycle genes (Levites et al 2002).

      Although there have been several human studies looking at the bioavailability of EGCG when
      administered in varying doses, there have been no studies that have specifically investigated
      the cognitive effects of this catechin in humans. Therefore, the purpose of this study is to
      assess the cerebral blood flow (using Near Infrared Spectroscopy), cerebro-electrical
      activity (EEG) and behavioural effects of EGCG. A randomised, double-blind,
      placebo-controlled, balanced crossover study will assess the effects of 135 mg and 270 mg
      pure EGCG in 24 healthy, young adults (18-35). Prior to the first active study day
      participants will attend a screening/training visit where relevant exclusion criteria will be
      assessed including any food sensitivities. They will also complete a caffeine consumption
      questionnaire in order to control for potential caffeine withdrawal effects as a result of
      restrictions of the study.
    


Intervention name(s): EGCG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute oral administration of capsules containing either: 0mg, 135mg or 270mg. One dosage administered on each of three separate study days.; Pharmaceutical grade silica was utilized as placebo
Other intervention name(s): Teavigo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Epigallocatechin Gallate; cerebral blood flow; Near Infrared spectroscopy; Electroencephalography; cognitive function; mood; cerebro-electrical activity
Motor Control Exercise Program for Pregnant Women With a History of Lumbopelvic Pain
Condition: Lumbopelvic Pain
Study type: Interventional

Summary: 
      This study protocol was designed to establish the feasibility of conducting a motor control
      exercise program with pregnant women presenting a history of lumbopelvic pain (LBPP) in order
      to reduce LBPP occurrence or limit its intensity. This randomized controlled trial also aims
      to preliminary assess the effectiveness of the program. To do so, 40 pregnant women with a
      history of LBPP will be recruited and randomly allocated to one of 2 groups: control (20
      participants) or intervention (20 participants). The control group will receive standard
      care, including basic information on what to do when suffering from LBPP. The intervention
      group will participate in a weekly 40-minute group session and two more 40-minute weekly home
      exercise sessions. The motor control exercise program will be designed to target
      strengthening of the lumbo-pelvic-hip core muscles in order to improve stabilization and
      protection of the spine and pelvis. Participants of this group will also receive standard
      care. Adequate prevention and treatment of LBPP, experienced by women during pregnancy,
      should help reduce LBPP occurrence or limit its intensity during pregnancy.
    


Intervention name(s): Motor control exercise program
Intervention type(s): Other
Intervention description(s): Structure physical training aimed at strengthening muscles of the lumbo-pelvic-hip core complex in order to improve stabilization and alignment of the spine and pelvis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical activity; Non-invasive treatment
Evaluate the Efficacy and Safety of Proso Millet and Wheat Extract(Keranat™) on Hair Health
Condition: Hair Damage
Study type: Interventional

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled study will be to evaluate
      whether the daily intake of Keranat™ for 24 weeks can promote the gloss and elasticity of
      hairs, improve their density and strength, and reduce hair loss.
    


Intervention name(s): Keranat™; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 300 mg/capsule(proso millet and wheat extract 600 mg/day); 300 mg/capsule(600 mg/day as placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hair gloss; Hair elasticity; Hair strength; Hair thickness; Anagen hair; Number of hair loss
Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of the trial is to study whether daily treatment with liraglutide improves
      insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide
      treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of
      type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.
    


Intervention name(s): Victoza® (liraglutide); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.; Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Type 1; Diabetes, Insulin-Dependent; Liraglutide; GLP-1 Analogue; Early diagnosis
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
Condition: Visual Impairment; Age-Related Macular Degeneration; Diabetic Retinopathy; Glaucoma
MeSH terms: Vision Disorders; Vision, Low; Macular Degeneration; Diabetic Retinopathy
Study type: Interventional

Summary: 
      In this study, the study team utilize virtual reality (VR) to simulate visual impairments of
      different types and severity in healthy subjects. The platform implements three of the most
      widespread forms of visual impairment in the United States (US): age-related macular
      degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of
      severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a
      multidimensional visual impairment simulation.

      The platform is utilized: i) to provide a safe, controllable, and repeatable set of
      environments for development and preliminary testing of electronic travel aids (ETAs) in a
      variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii)
      to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility
      (O&M) instructors, with a controlled, tunable training platform for skill/capacity building,
      assessment, and refinement of O&M techniques, as well as visually impaired trainees with a
      safe and immersive environment to improve their O&M skills and learn novel techniques. Two
      sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform
      with respect to these two objectives.
    


Intervention name(s): In-House Developed VR Platform - AMD, DR, Glaucoma; In-House Developed VR Platform - Glaucoma
Intervention type(s): Other; Other
Intervention description(s): Participants will conduct experiments using commercial VR headsets and controllers. Visual impairments will be systematically simulated in VR. There are three visual impairment simulations (AMD, DR, and glaucoma) at three levels of severity (mild, moderate, or severe). Symptoms' simulation tools include a gaussian blur shader, distortion shader, and a culling mask with a gray spot in the middle.; In the second set of experiments, a multidimensional visual impairment simulation of a single pathology (glaucoma) will be used at three levels of severity (mild, moderate, or severe). The post-processing package to simulate includes glare, difficulty in light, change adaptation, ambient occlusion, visual clutter, and overall blurred effect. The shader graph package will be used to create a distortion localized on assets surfaces only.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Postural Drainage With and Without Aerobic Training on Chronic Suppurative Lung Disease
Condition: Lung Disease Chronic
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      This will be a randomized controlled trial Patients will be divided into two groups randomly.
      Both groups will receive postural drainage as baseline treatment thrice a week for two weeks.
      The intervention group will undergo additional Aerobic Training thrice a week for two weeks
      as well along with postural drainage. Aerobic training will include a 5-step stair-climbing
      and a 10-step walk during each session. Data will be collected before and at the end of two
      weeks. Respiratory Rate, Pulse Oximeter, 10-meter Endurance walk test, and Pediatric Cough
      Questionnaire will be used to collect data pre and post-treatment. Data will be analyzed by
      use of SPSS Version 2010. Data will be presented in the form of mean and standard deviation.
    

Detailed description: 
      Chronic suppurative lung disease (csld) is a clinical syndrome in children with respiratory
      symptoms and signs. Children who have bronchiectasis symptoms but non-diagnostic scans are
      described as having chronic suppurative lung disease (csld). Postural drainage improves
      secretion clearance techniques, it is equally as effective as other airway clearance
      techniques. This study will focus on the implementation of postural drainage and aerobic
      training in this disease to find their effect on respiratory rate, oxygen saturation, and
      endurance.
    

Intervention name(s): Postural Drainge and aerobic training; Postural Drainage
Intervention type(s): Other; Other
Intervention description(s): This will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include 5-step stair-climbing and 10 step walk during each session.; Postural Drainage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CSLD, Respiratory Rate, Endurance, Oxygen Saturation
CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer
Condition: Lymph Node; Breastcancer
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis
Study type: Observational

Summary: 
      To establish a predicting system on axillary lymph node metastasis based on peripheral blood
      CK19mRNA and contrast-enhanced ultrasound.
    

Detailed description: 
      The feasibility and predictive accuracy of peripheral blood CK19mRNA and contrast-enhanced
      ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of
      specimen bank; to establish the evaluation system of predicting the lymph node status based
      on CK19 and CEUS, validate the sensitivity, specificity, negative predictive value, positive
      predictive value and ROC curve of the system model and use Youden index, negative likelihood
      ratio, positive likelihood ratio to evaluate the diagnostic efficiency.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Operable breast cancer patients (clinical stage: cTis, cI, cII, cT3N1M0)
      
Biospecimen description: 
      peripheral blood
    
Keywords: lymph node metastasis; breast cancer; CK19; contrast-enhanced ultrasonography
Acute Effects of Benzbromaron on the Pulmonary Circulation
Condition: Idiopathic Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant
      role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this
      channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known
      inhibitor of the TMEM16A channel and is used in patients with gout.

      In this pilot study the investigators plan to investigate if Benzbromarone has an acute
      effect on the pulmonary arteries in humans. This will be investigated within the frame of a
      right heart catheterization performed in patients with known PAH due to clinical reasons. The
      investigators hypothesize that the application of Benzbromarone leads to pulmonary
      vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In
      addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge
      pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons
      patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes
      upon NO and Benzbromarone may be compared.
    


Intervention name(s): Benzbromarone
Intervention type(s): Drug
Intervention description(s): 1x200mg Benzbromarone will be applied after baseline measurements during right heart catheterization. The effects of the drug on the pulmonary hemodynamics will be assessed after 2 hours.
Intervention MeSH terms: Benzbromarone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A first in human study to determine the safety, tolerability and pharmacokinetics of single
      and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
    


Intervention name(s): PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): subcutaneous, single dose 0.3 mg/kg; Subcutaneous normal saline single dose; Subcutaneous, single dose 1.0 mg/kg; Subcutaneous normal saline single dose; Subcutaneous single dose 3 mg/kg; Subcutaneous normal saline single dose; Subcutaneous single dose 6 mg/kg; Subcutaneous normal saline single dose; Intravenous infusion single dose 1 mg/kg; Intravenous infusion normal saline single dose; Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose TBD mg (Days TBD); Subcutaneous injection normal saline multiple dose (Days TBD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: first in human; single dose; multiple dose; escalation; safety study; Type 2 Diabetes Mellitus
Implementing Resistance Exercise to Reduce Frailty for Older Adult
Condition: Sarcopenia
MeSH terms: Sarcopenia; Frailty
Study type: Interventional

Summary: 
      To develop an intervention specifically targeted for these clients who have the frailty
      syndrome. The Investigators propose to develop an exercise intervention that can reduce
      frailty in older adults to facilitate their ability to age-in-place. The long-term objective
      of this work is to develop a package of interventions that can be administered within the
      existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal
      of this proposal is to develop a resistance exercise intervention to reduce frailty in older
      adults receiving long term care services in their home through the Illinois Community Care
      Program, a HCBS Waiver Program.
    


Intervention name(s): Resistance exercise
Intervention type(s): Behavioral
Intervention description(s): resistance exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment