bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Condition: Preterm Birth; Pain
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Pilot prospective randomized, double blinded, controlled study to test effect of music based
      intervention (MBI) on pain response and neurodevelopment in preterm infants.
    

Detailed description: 
      Aim 1: Premature infant pain profiles (PIPP) include physiologic, behavioral, and contextual
      measures which identifies differences in pain responses between music-based intervention
      (MBI) and controls while still in the neonatal intensive care unit (NICU). Central EEG
      amplitude changes have been time-locked with painful procedures in term infants. We will
      explore if PIPP scores and central EEG amplitude changes are attenuated with MBI in
      comparison to controls.

      Hypothesis 1: MBI will show improved pain responses, with lower PIPP scores and attenuated
      central EEG amplitude changes during painful procedures, in comparison to the control cohort.

      Aim 2: EEG is a surrogate marker for real time brain function during sleep-wake cycles.
      Because preterm brain networks develop during sleep, sleep duration is a strong indicator of
      brain maturation. Serial biweekly EEGs of preterm infants can quantify sleep duration trends
      and track MBI's influence on sleep. To enhance objectivity, innovative EEG machine-learning
      tools will be applied to the analyses.

      Hypothesis 2: MBI will enhance preterm EEG brain maturation in comparison to controls.

      Due to the natural limitations of evaluating immature neonatal nervous systems, ERPs have
      been utilized to study early neurodevelopment. ERPs quantify electrical brain potentials
      changes time-locked with a stimulus. Auditory ERPs performed at 1 month corrected age
      evaluates attention and discrimination between familiar and novel stimuli - early
      neurodevelopmental signs of recognition memory function and perceptual learning.

      Hypothesis 3: ERPs at 1 month corrected age will show that MBI has a greater impact on early
      neurodevelopment when compared to controls.
    

Intervention name(s): Music Based Intervention; Sham Treatment
Intervention type(s): Other; Other
Intervention description(s): Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.; Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music Based Intervention; Preterm Infant Pain Profile
Improving Access to Control of Diseases for Women
Condition: Cardio-vascular Disease; Stroke Cancer; Breast Cancer; Oral Cancer; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Mouth Neoplasms; Vascular Diseases; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the feasibility and acceptability of the model of
      delivering CHW-driven home-based comprehensive NCD control services aimed to prevent
      premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in
      the hard-to-reach women.
    

Detailed description: 
      Specific objectives of this study are the evaluation of:

        1. The social, cultural and behavioral factors that impact the uptake of the NCD control
           services among rural women using the Rapid Assessment, Response and Evaluation (RARE)
           approach;

        2. The feasibility and acceptability of the strategy to deliver the following NCD control
           services to the rural women at their homes by the trained CHWs:

             -  Counselling of the tobacco habitués to give up the practice

             -  Early detection of hypertension and diabetes to ensure prompt and regular treatment

             -  Creating breast awareness and ensuring access to prompt diagnosis and treatment of
                the women with symptoms suggestive of breast cancer

             -  Screening for cervical cancer by self-collected HPV test and ensuring prompt
                treatment of screen detected precancers and cancers

             -  Screening of the habitual tobacco/alcohol users for oral cancer by OVE and ensuring
                prompt treatment of screen detected precancers and cancers
    

Intervention name(s): Evaluation of social, cultural and behavioral factors; Evaluation of the feasibility and acceptability of delivery of early detections services
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Evaluation of the social, cultural and behavioral factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology; Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings
Intervention model: Single Group Assignment
Intervention model description: 35,000 households in 228 villages, among which women between 30 to 60 years residing in the villages of the block are eligible to participate
Masking: None (Open Label)
Primary purpose: Screening
Keywords: cardio-vascular disease; stroke cancer; breast cancer; oral cancer; cervical cancer
The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
Condition: End Stage Renal Disease; Hemodialysis Complication
MeSH terms: Kidney Failure, Chronic; Arteriovenous Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      Written informed consent must be obtained before any study specific procedures are
      undertaken. Informed consent will be obtained during pre-operative assessment.
    

Detailed description: 
      The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will
      receive general anesthesia and brachial plexus block. Patients will be randomly allocated
      into two groups. Study and control group received propofol target-controlled infusion (TCI)
      and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be
      assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2,
      analgesics dosage, pain intensity and perioperative adverse events.
    

Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Device
Intervention description(s): Propofol works by increasing GABA-mediated inhibitory tone in the CNS. Propofol decreases the rate of dissociation of the GABA from the receptor, thereby increasing the duration of the GABA-activated opening of the chloride channel with resulting hyperpolarization of cell membranes.; sevoflurane inhalation 2~4%
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Vibrational-proprioceptive Resistance Exercise Training Versus Neuromuscular Electrical Stimulation Training in Elderly People With Muscle Weakness
Condition: Muscle Weakness Condition; Therapy Effect
MeSH terms: Muscle Weakness; Paresis; Asthenia
Study type: Interventional

Summary: 
      Study the structural behaviours of weak muscle of elderly and evaluate the efficiency of two
      different types of training.
    


Intervention name(s): Vibrational-proprioceptive Resistance Exercise Training; Neuromuscular Electrical Stimulation Training
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First in Human (FIH), double-blinded, parallel-group, randomised,
      placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single
      and multiple ascending oral doses of GS-248 in healthy subjects.
    

Detailed description: 
      Part I (SAD); In the SAD part of the study, single oral doses of GS-248 will be administered
      in 6 sequential cohorts, each consisting of 8 subjects randomised to receive either GS 248 or
      placebo in a 3:1 ratio. The first 2 subjects in each cohort will be dosed in a sentinel
      fashion; 1 subject will receive GS-248 and the other will receive placebo as randomised. The
      subjects will be carefully monitored by clinical staff during and after dosing. Vital signs,
      safety laboratory and ECG will be checked at regular intervals.

      Part II (MAD); The MAD part of the study will explore multiple ascending dosing of GS-248
      administered for 10 days. The proposed starting dose is 25 mg/day. However, the starting dose
      as well as subsequent dose levels may be adjusted based on safety and PK evaluation in
      previous cohorts. GS-248 will be administered in 4 sequential cohorts, each of 8 subjects
      randomised to receive either GS 248 or placebo in a 3:1 ratio. The subjects will be carefully
      monitored by clinical staff during and after dosing. Vital signs, safety laboratory and ECG
      will be checked at regular intervals.
    

Intervention name(s): GS-248; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GS-248 oral solution; Placebo oral solution with the same composition to match active drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part I (SAD) Within each cohort, subjects will be randomised in a 3:1 ratio to receive either GS 248 (n=6) or placebo (n=2) in a blinded fashion.
Part II (MAD) Within each cohort, subjects will be randomised in a 3:1 ratio to receive GS-248 (n=6) or placebo (n=2) in a blinded fashion.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of LAF237 on Gastric Function in Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to
      enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In
      addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric
      accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D).
      However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be
      administered by continuous intravenous infusion. This would be a drawback in clinical usage.
      LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and
      potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of
      LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to
      study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with
      T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of
      this compound on postprandial glucose metabolism.
    


Intervention name(s): LAF237 = vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Genetic Factors That Influence Chronic Obstructive Pulmonary Disease in Hispanics
Condition: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to examine genetic factors that influence the development of
      chronic obstructive pulmonary disease (COPD) in Hispanics, a minority group at high risk for
      the disease.
    

Detailed description: 
      DESIGN NARRATIVE:

      This study will concentrate on a genetically isolated Hispanic population with a high
      prevalence of COPD living in the Central Valley of Costa Rica. Nine hundred individuals from
      descendants of the Costa Rican Central Valley founder population will be enrolled. To
      identify regions of the genome that are likely to contain genetic determinants of
      COPD-related phenotypes in this population, the study will collect phenotypic and genotypic
      data on 30 large families with a history of moderate to severe COPD that have multiple
      individuals affected with smoking-related airflow obstruction. A genome scan will be
      conducted on these individuals using short-tandem repeat (STR) markers. Linkage analysis will
      be performed on 6 COPD-related phenotypes, which will include the following: 1) chronic
      bronchitis; 2) airflow obstruction; 3) forced expiratory volume in one second (FEV1); 4)
      FEV1/FVC[forced vital capacity];5) bronchodilator responsiveness; and 6) total serum
      immunoglobulin E. Within genomic regions demonstrating linkage to COPD-related phenotypes in
      the genome scan, narrowly spaced STR markers will be genotyped and tested for linkage between
      these markers and COPD-related phenotypes. Within selected genomic regions, the association
      will be tested between single nucleotide polymorphisms (SNPs) in candidate genes and
      COPD-related phenotypes. By enrolling a large number of participants of a genetically
      isolated population and utilizing a family-based study design, this study should be able to
      address an important yet unstudied issue: the genetic influences on the expression of the
      COPD phenotype in Hispanics.
    

Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Families of individuals with physician-diagnosed COPD and smoking-related airflow
        obstruction who are younger than 71 years.
      
Biospecimen description: 
      Serum
    
Keywords: Chronic Obstructive Pulmonary Disease
Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study is to examine concurrent validity of 8 computerized tests intended
      for the assessment of cognitive function in participants with Major Depressive Disorder
      (MDD), relative to 8 corresponding and previously validated examiner-administered cognitive
      tests.
    


Intervention name(s): Computer- administered test battery; Examiner- administered test battery
Intervention type(s): Device; Device
Intervention description(s): Participants in this observational study will only undergo sequential cognitive performance evaluations by computer- administered cognitive test battery.; Participants in this observational study will only undergo sequential cognitive performance evaluations by examiner- administered cognitive test battery.
Other intervention name(s): REVERE.D
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants enrolled in substudy A and main study will be man or woman with major
        depressive disorder (MDD) and participants enrolled in substudy B will be healthy
        participants to evaluate cognitive performance at the clinic site.
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is an international, multi-center, open-label study designed to provide oral
      treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have
      completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety
      of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
    


Intervention name(s): UT-15C (treprostinil diolamine)
Intervention type(s): Drug
Intervention description(s): UT-15C extended release oral tablet three times daily
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAH; PH; FREEDOM; 6 minute walk test; treprostinil; open label
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to
      placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3
      months and the target sample size is 100-500 individuals.
    


Intervention name(s): DPP-IV Inhibitor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses po bid or qd; po bid or qd
Intervention MeSH terms: Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the rate and routes of excretion of OPC and the
      mass balance in urine, faeces and expired air.
    

Detailed description: 
      This was a single-centre, open-label ADME study in 6 healthy male subjects. Subjects received
      a single dose of 100 mg OPC, containing 3.39 MBq of [14C] OPC as oral capsules.

      The study consisted of an eligibility screening period within 3 weeks prior to drug
      administration, admission on Day -1, a treatment period involving drug administration on Day
      1 followed by matrix collections for PK purposes and safety evaluations up to Day 11,
      discharge on Day 11, six 24-hour hospitalizations on Days 14/15, 21/22 (+/ 1 day), 28/29 (+/-
      1 day), 42/43 (+/- 2 days), 56/57 (+/- 2 days) and 77/78 (+/ 3 days) for PK sample
      collections, and a follow up visit performed at least 14 days after discharge from the last
      24-hour hospitalization or at early discontinuation.
    

Intervention name(s): OPC
Intervention type(s): Drug
Intervention description(s): The drug substance of 100 mg OPC was administered as 1 capsule.
Other intervention name(s): BIA 9-1067
Intervention MeSH terms: Opicapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone
Clinical Trial to Evaluate the Reduction of Cardiovascular Risk
Condition: Cholesterol
Study type: Interventional

Summary: 
      Randomized parallel and double blind clinical trial in which it is intended to analyze the
      efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of
      a product for eight weeks.
    


Intervention name(s): Apigenin, luteonin, grapefruit extract and citrolive; maltodextrina
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two capsules daily at breakfast and dinner.; Two capsules daily at breakfast and dinner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 6-year Follow-up Study of the Effect of Neurorehabilitation Training in Patients With Parkinson's Disease
Condition: Follow up; Parkinson Disease; Rehabilitation
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Individualization of exercise is recommended but rarely performed in patients with
      Parkinson's disease (PD). Unusually High Intensity and Individual Sensor Motor with
      Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. After
      3 weeks of intensive treatment, treated patients and the control group were subjected to a
      two-year observation. Objectives: The effect of the unusually highly intense and strictly
      individualized sensomotor and visuomotor agility program was determined for the clinical
      symptoms, mobility and stability of non-demented PD patients with a two-year follow-up.
      Detection and comparison of results of patients undergoing biphasic maintenance with the
      results of intensively treated patients and the control group. Patients were recalled every 3
      months after the first intensive examination and one year after a one-year control. The
      results of the active group were continuously compared with the results of the passive and
      control groups, thus determining the effectiveness of our treatment and the deterioration of
      the other groups in life-quality. The treated groups will be divided into two. One
      Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 6
      years. The other group does not undergo a special series of exercises after 3 weeks of
      intensive therapy. Main outcome measures: Movement disorder Society Unified Parkinson Disease
      Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad
      spectrum of PD symptoms. In group time, repeated measurements of variance analysis were
      compared to MDS-UPDRS M-EDL, Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale
      for Parkinson's Disease. The TUG test and 12 static posturographic measurements are compared
      and compared to the healthy group as a standard. An at-limit and individualized sensorimotor
      and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage
      2-3 PD patient's clinical symptoms, mobility, and postural stability by functionally
      meaningful margins. As a long-term solution, a follow-up treatment can slow down the
      progression of clinical symtoms.
    


Intervention name(s): Exercise+FU; Active Comparator group Exercise
Intervention type(s): Other; Other
Intervention description(s): 6 years intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training; After 3 weeks of intensive therapy, we withdrew treatment and monitored their condition for 6 years and received only hospital base treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: balance; Posturograpy