bioihbjkbjnl/mcl2 huggingface dataset:
Functional Tests in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Objectives: to evaluate and compare the responses to the various functional tests, and the
      concordance between the six-minute walk test in hallway (6MWT) and the of oval track
      (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute
      step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive
      Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of
      life. Methods: Ten patients with COPD (71±8years, FEV1<80%predicted) were assessed using the
      functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and
      the Medical Research Council scales; and the quality of life was assessed using the St
      George's Respiratory Questionnaire (SGRQ).
    

Detailed description: 
      Results: In the interests analysis, there was lower walking distance in the 6MWTT and 6MWTTI
      was observed, to compare in the 6MWT and 6MWToT; the ΔSp,O2 (delta of arterial oxygen
      saturation measured by pulse oximeter) in the 6MWTTI was significantly greater that in the
      6MWT, but not between to change in dyspnea and fatigue/pain in the lower-limbs between rest
      and exercise of peak (Δ). Concordance and correlation was observed between the lower Sp,O2 of
      the 6MWT with the 6MWToT, 6MWTT, 6MWTTI, 6MST and STST. Strong correlations was observed
      between the performances on the 6MST and 6MWT, 6MWToT and 6MWTT; and between the physical
      activity domain of the SGRQ with the performances in the 6MWT, 6MWToT, 6MWTT,6MST and STST.
      Conclusion: The functional tests produced similar subjective responses; however, the 6MWTTI
      caused greater desaturation that 6MWT. The concordance between the 6MWT and the tests
      performed, suggests acceptable use of any these tests in the physiotherapeutic clinical
      routine of the individuals COPD. The tests in performed, except the 6MWTTI, shown to be
      indicators of the quality of life (physical activity domain).
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        chronic obstructive pulmonary disease.
      
Keywords: chronic obstructive pulmonary disease; walking; exercise test; quality of life; dyspnea; desaturation
Tailored Radiofrequency Ablation of Uterine Myomas
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      To perform the use of radiofrequency myolysis (RFM) for the treatment of intra-uterine
      fibroids through less invasive access by combining trans-vaginal ultrasound, hysteroscopy and
      laparoscopy
    

Detailed description: 
      Given that the RF ablation of solid tumors of the liver and other organs is successfully used
      as a usual approach, the investigators have decided to transfer this technology to an
      original treatment of uterine fibroids. The access to each individual fibroid was determined
      considering passage of the needle towards its centre through only compromised tissue and by
      the shortest possible route by combining trans-vaginal ultrasound, hysteroscopy and
      laparoscopy. To optimize radiofrequency myolysis, in fact, the investigators decided to
      improve the procedure by inserting three innovative elements: application of a virtual needle
      tracking system to follow the RF electrode during the ablation session, real-time monitoring
      of RF ablation by contrast-enhanced ultrasound and systematic biopsy of the lesions before
      electro-coagulation.
    

Intervention name(s): RADIOFREQUENCY ABLATION OF UTERINE MYOMAS
Intervention type(s): Device
Intervention description(s): The ablation device consisted of an radiofrequency (RF) energy generator (STARmed, RF generator VRS01) and an electric pump for the continuous cooling of the electrode tip. The RF generator to which the electrode (STARmed Gyeonggi-Do, Korea) is connected displays simultaneously the temperature of the electrode tip, the tissue impedance characteristics, the power and the ablation time. A 35 cm long 18Gauge internally cooled electrode with an exposed tip of 10 mm or a variable exposed tip was used
Other intervention name(s): Radiofrequency myolysis (RFM); RF lesion generator for tissue ablation during surgical procedures. Sterile single-use RF coagulation monopolar electrode.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
Condition: Diabete Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study is a non-randomized, single-arm, multi-center study that is designed to evaluate
      the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in
      pediatric populations.
    

Detailed description: 
      Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United
      States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be
      given to the subject. All Readers will be masked during the study (i.e. subjects will not be
      able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be
      asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary
      Reader. Interstitial glucose readings from each Sensor will be obtained with the
      corresponding Readers immediately following each BG test. Subjects will be instructed to
      report any problems with the device. Subjects will make two (2) to five (5) scheduled visits
      to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the
      subjects age and weight, subjects will have up to two (2) in-clinic visits during which
      intravenous blood draws and Yellow Springs Instrument (YSI) reference testing will occur.
    

Intervention name(s): FreeStyle Libre Flash Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged 4-17 years, with type 1 or type 2 diabetes who currently perform capillary
        blood glucose (BG) testing at least four (4) times a day.
Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and
      pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers
    


Intervention name(s): DWC202005, alone; DWP14012 + DWC202005; DWP14012 + DWC202005, after multiple doses of DWP14012
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DWC202005, as a single dose; DWP14012 and DWC202005, as a single dose; DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days
Intervention MeSH terms: Fexuprazan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of High-intensity Inspiratory Muscle Training in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Condition: Complications Due to Coronary Artery Bypass Graft
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Even with the advances in clinical therapy and percutaneous interventions, coronary artery
      bypass grafting (CABG) is still widely used in the treatment of patients with coronary artery
      disease (CAD). However, it is a complex procedure that triggers important organic
      implications especially on pulmonary function. In relation to the treatment of patients
      undergoing CABG, the recovery is linked to the cardiac rehabilitation programs. These
      programs can also be associated with other muscle training measures, among these there is
      inspiratory muscle training (IMT). Most studies has been implemented moderate-intensity IMT
      daily, but there are few studies about the effects of high intensity training loads performed
      on alternate days. In this context, is justified the use of a device such as the recent
      Powerbreathe, which uses higher training loads that would provide greatest benefits, whereas
      the magnitude of the response to training tends to increase with load.

      OBJECTIVE: To investigate the efficiency of high intensity IMT associated with combined
      aerobic and resistance training on maximal exercise capacity, submaximal exercise capacity,
      respiratory muscle strenght, pulmonary function, oxidative stress, quality of life and
      endothelial function in patients who underwent CABG in phase II cardiac rehabilitation
      program.

      METHODOLOGY: This is a clinical trials, controlled, randomized,double-blind being developed
      in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria (HUSM), Santa
      Maria, RS, Brazil. Patients will undergo the evaluation of pulmonary function and respiratory
      muscle strength (spirometry and digital manovacuometry), as well on the maximal exercise
      capacity (Ergospirometry), submaximal functional capacity (6MWT and 6MST), of quality of live
      (MLHFQ) of Oxidative stress and endothelial function (blood biomarkers). After the evaluation
      will be randomly allocated into two groups: the control group will perform cardiac
      rehabilitation associated with the Sham of IMT, and the experimental group cardiac
      rehabilitation associated with the IMT High-intensity. The intervention will last twelve
      weeks for both groups and after this phase patients will be submitted again to the assessment
      tools.

      EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation
      (phase II) after coronary artery bypass surgery patients.
    


Intervention name(s): High-intensity IMT + combined exercise
Intervention type(s): Device
Other intervention name(s): Sham Control H-IMT + combined exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ADHD Treatment for Latino Families
Condition: ADHD
Study type: Interventional

Summary: 
      The current pilot study aims to close the existing gap in our knowledge about effective
      psychosocial treatments for Latino families by providing preliminary data regarding the
      acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators
      that will support a future R01. Specifically, the current pilot study is the first step in a
      larger program of research aimed at definitively determining if culturally-modified ADHD
      treatment outperforms standard treatment when examining engagement and acceptability
      outcomes, as well as symptomatology and parental functioning, and if so, which treatment
      modifications are necessary and for whom. The following study aims will be examined.

        1. Aim 1 is to explore if the culturally-modified treatment results in better engagement
           and acceptability outcomes (i.e., parental attendance, retention, engagement, and
           satisfaction) than standard treatment and to determine the strength of these effects.

        2. Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD
           symptomatology, as well as parental functioning (i.e., parenting stress and efficacy),
           to explore if the modified treatment results in similar or greater improvements than
           standard treatment, and to determine the strength of these effects.

        3. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral
           and cognitive acculturation) that may explain the relationship between treatment type
           (i.e., standard versus culturally-modified) and outcomes and to determine the strength
           of these interactions.
    


Intervention name(s): Parent training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Food-Effect Study of E7386 in Healthy Participants
Condition: Food Effect in Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effect of food in healthy
      participants on the bioavailability of E7386 following single dose administration with and
      without a meal.
    


Intervention name(s): E7386
Intervention type(s): Drug
Intervention description(s): E7386 oral tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Participants; E7386; Bioavailability; Food Effect
Effect of Feedback and Practice on Probabilistic Decision Making in Attention Deficit and Hyperactivity Disorder
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine how feedback and practice affect decision making in
      adolescents with attention deficit and hyperactivity disorder.

      Participants will have to choose between low and certain outcome and a higher but uncertain
      outcome, with or without serial feedback after each trial. Participants will perform the task
      twice to examine practice effects.
    


Intervention name(s): probabilistic choice
Intervention type(s): Behavioral
Intervention description(s): subjects should choose between low-certain outcome and high-uncertain outcome
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: ADHD; probabilistic; choice; feedback; practice
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
Condition: Radiculopathy Lumbar
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of two parts. Part A will evaluate the safety and tolerability of
      intravenous LAT8881 in healthy volunteers using an ascending dose schedule. Part B will
      evaluate the analgesic efficacy of a single intravenous dose of LAT8881, compared with
      placebo, in patients with lumbar radicular pain.

      Healthy volunteers are not accepted for Part B.
    

Detailed description: 
      Part A of this study is a double-blind, randomized, placebo-controlled, single ascending dose
      study of intravenous administration of LAT8881 over 5 minutes in healthy volunteers. Eight
      participants will be enrolled. Each participant has three treatment days, 1 infusion per
      dosing day, on Days 1, 4 and 7 as well as two short visits for safety blood sampling on Days
      3 and 6. Participants are randomised, so on each treatment day, 6 participants receive
      LAT8881 and 2 receive placebo (different participants to receive placebo each treatment day).
      LAT8881 doses administered are 0.8 mg/kg on Day 1, 1.2 mg/kg on Day 4 and 1.8 mg/kg on Day 7.

      Part B of this study is is a placebo-controlled randomized double blind cross-over safety and
      efficacy study of LAT8881 in up to 20 patients with lumbar radicular pain. Participants will
      be randomly assigned to one of two groups, to receive either LAT8881 then placebo or placebo
      then LAT8881. Participants will receive a either single dose of LAT8881 [the Maximum
      Tolerated Dose from Part A of the study] or placebo via intravenous administration over 5
      minutes on two consecutive days.
    

Intervention name(s): LAT8881; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In Part A, LAT8881 will be given as a single intravenous infusion at doses of 0.8, 1.2 and 1.8 mg/kg.
In Part B, a single intravenous infusion of LAT8881 will be given, the dose to be determined by the results in Part A; Matching placebo'given as a single intravenous infusion at all dose levels
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 200mg of Dr.
      Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing
      Lamotrigine) Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC in
      healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other intervention name(s): LAMICTAL XR
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lamotrigine Extended Release; crossover
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 2

Summary: 
      Background:

      Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and
      urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols
      (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP
      diet in FI patients is needed.

      Aims:

        1. Compare the treatment response with a low FODMAP vs. psyllium based on number of
           episodes in patients with FI.

        2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on
           pre-specified clinical and quality of life endpoints.

      Methods:

      This is a prospective, randomized control trial of adults meeting the Rome III criteria for
      FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period
      and randomization, during which the severity of symptoms will be assessed and eligibility
      determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total
      of 20 patients will be recruited for each arm.

      The primary endpoint will be treatment response based on number of incontinence episodes. A
      treatment response is defined as a reduction in the number of FI episodes/week.
    


Intervention name(s): low fodmap diet; Psyllium
Intervention type(s): Other; Dietary Supplement
Intervention description(s): dietary teaching; 7.1g of psyllium daily
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fodmap diet
Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis
Condition: Pediatric Urinary Lithiasis
MeSH terms: Urolithiasis; Urinary Calculi; Lithiasis
Study type: Interventional

Summary: 
      To evaluate and compare the results of conventional and stepwise shock wave lithotripsy
      treatment modalities in pediatric urinary lithiasis.
    

Detailed description: 
      Between March 2008 and February 2012, 81 patients were randomized and included in this study.
      Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument.
      Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and
      ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group.
      In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up
      to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000.
      Patients were followed up with 15 days interval. In each visit, patients were respectively
      questioned for pain, hematuria and history of stone passage. In case of treatment failure,
      shock wave lithotripsy was repeated.
    

Intervention name(s): Shock wave lithotripsy
Intervention type(s): Procedure
Intervention description(s): All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the long-term safety and tolerability of ABT-089
      in adults with ADHD.
    


Intervention name(s): ABT-089
Intervention type(s): Drug
Intervention description(s): Open label study, subjects will take up to 80mg daily for 24 months.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD
Safety Analysis of Implantation of Stromal Vascular Fraction
Condition: Safety Issues
Study type: Interventional

Summary: 
      Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient
      in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The
      SVF includes a variety of different cells and growth factors where the adipocyte (fat cell)
      population has been removed. The use of SVF in the clinic for a variety of indications is
      analyzed for incidences of safety and tolerability.
    


Intervention name(s): Stromal Vascular Fraction
Intervention type(s): Procedure
Intervention description(s): The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment