bioihbjkbjnl/mcl2 huggingface dataset:
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Condition: Weight Loss
MeSH terms: Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to learn if providing a family-based group program using mobile
      health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child
      weight, nutrition, and physical activity.
    

Detailed description: 
      This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program
      versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The
      iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss
      program to kids and families in rural settings. This study will include kids from schools in
      rural cities/counties, and their parents, and they will be randomly assigned to a group by
      their school.

      The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It
      delivers behavioral, nutritional, and physical activity topics for kids and their families.
      The total length of the intervention will be about 8 months, which coincides with the length
      of a typical school year.
    

Intervention name(s): iAmHealthy Healthy Lifestyles Program; Newsletter
Intervention type(s): Behavioral; Other
Intervention description(s): iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.; Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the bioavailability of a test formulation
      of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone®
      (buprenorphine and naloxone) sublingual film, under fasted conditions.
    


Intervention name(s): SL spray; SL film
Intervention type(s): Drug; Drug
Other intervention name(s): Buprenorphine naloxone sublingual spray; Buprenorphine and naloxone sublingual film
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Treat Major Depressive Disorder With a New Medication
Condition: Depressive Disorder; Anhedonia
MeSH terms: Anhedonia; Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a
      novel treatment target for mood disorders through the administration of the KCNQ-selective
      channel opener ezogabine (Potiga, GlaxoSmithKline; FDA-approved for the treatment of seizure
      disorders).
    

Detailed description: 
      Depressive disorders are among the most disabling medical conditions worldwide and currently
      available treatments fall short of addressing this large public health burden. Dysfunction
      within the brain reward system is emerging as a core feature of depressive disorders, in
      particular related to deficits in motivation, interest, and response to pleasure (e.g.,
      anhedonia: markedly diminished response to pleasure). Evidences from a series of preclinical
      studies from our group highlighted the KCNQ subtype of neuronal potassium (K+) channel as a
      novel target for the treatment of depressive disorders and our human pilot study showed a
      reduction in anhedonia and related symptoms, and an increased brain response to reward (as
      measured by functional magnetic resonance imaging [fMRI]) following treatment with ezogabine.
      Building on this data, the current project will assess reward circuit activity following
      treatment with ezogabine in depressed patients with a current depressive disorder (Major
      depressive disorder [MDD], persistent depressive disorder, other specified depressive
      disorder) and anhedonia (defined by a score ≥ 20 on the Snaith-Hamilton Pleasure Scale
      [SHAPS]), using fMRI to investigate the cortico-striatal circuit to reward.

      This study represents the first part of the R61/R33 National Institutes of Health (NIH)
      founded project. A clear increase in reward circuit activation in at least one ezogabine
      treatment group compared to placebo, given acceptable tolerability, will constitute a "go"
      and the project will move to the next phase (R33), where we aim to examine the relationship
      between treatment, reward circuit activity, and behavioral and clinical outcomes in a larger,
      confirmatory efficacy trial of ezogabine for depression with anhedonia.
    

Intervention name(s): Ezogabine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): daily for 5 weeks; placebo pill daily for 5 weeks
Other intervention name(s): Potiga
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: depression; anhedonia; reward
Brain Morphometry in OA Patients Treated With Duloxetine
Condition: Pain; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This is a two week,single-blind study evaluating pain response and changes in brain imaging
      upon treatment with placebo in people with knee OA.
    

Detailed description: 
      In this study, all the participants will be receiving placebo. However this study will be
      single blinded in that participants will be told that they will be given a pill that may or
      may not help with their pain. The researcher, however, will know that all participants are
      receiving placebo

      At the initial visit, participants will undergo screening to determine that they meet all
      inclusion and exclusion criteria. They will sign consent and then complete pain assessment
      instruments as well as one high resolution anatomical scan (T1) and one functional scan (a
      resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute
      functional scan (a resting scan) will be done two weeks from the first scan and pain
      assessment instruments will be completed at this visit as well. After finishing this second
      scan (done two weeks after the initial scan), the participants will have completed the study.
    

Intervention name(s): Duloxetine; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time; Lactose capsule
Other intervention name(s): Cymbalta; Placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: placebo; pain; osteoarthritis
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the
      abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with
      spastic diplegia cerebral palsy.
    

Detailed description: 
      Cerebral Palsy (CP) is the leading cause of disability in children, with the most widespread
      type of CP being spastic CP which negatively affects physical function. Specifically it is
      reported that there is an increase in energy expenditure and oxygen consumption in children
      with CP. Single event multi level chemoneurolysis with abobotulinumtoxinA has been found to
      be an effective treatment for patients with spasticity to reduce energy expenditure by
      increasing walking efficiency; however many of these studies have conflicting methodological
      approaches. Therefore this study aims to evaluate the single event multilevel chemoneurolysis
      with Dysport® on energy expenditure and gait in children with spastic diplegia CP.
    

Intervention name(s): Dysport Injectable Product
Intervention type(s): Drug
Intervention description(s): Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session.
Other intervention name(s): Botulinum toxin A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum toxin A; Walking efficiency; Spasticity; Dysport; Pediatric
BO and DO in Women With Cystocele Before and After Cystocele Repair
Condition: Bladder Oversensitivity; Detrusor, Overactive
MeSH terms: Cystocele; Urinary Bladder, Overactive
Study type: Observational

Summary: 
      The changes of lower urinary tract function after cystocele repair are important for
      perioperative consultation and management. Thus, the aim of this retrospective study was to
      evaluate the prevalence of bladder oversensitivity and detrusor overactivity in women with ≥
      stage II cystocele and the changes of storage function after cystocele repair.
    

Detailed description: 
      Bladder oversensitivity and detrusor overactivity are two important diagnosis of urodynamic
      study regarding storage function of bladder. Between November 2010 and October 2020, all
      women with ≥ stage II cystocele who visited the urogynecological department of a medical
      center for cystocele repair were reviewed. Those women who had complete data of preoperative
      and postoperative 3-month follow-up urodynamic data were excluded from this study. Bladder
      oversensitivity was diagnosed if the volume of strong desire was less than 300mL. Detrusor
      overactivity was defined as the occurrence of involuntary detrusor contractions during
      filling cytometry.

      STATA software was used for statistical analysis. Chi2 test, univariate and multivariable
      logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was
      considered as statistically significant.
    

Intervention name(s): Cystocele repair
Intervention type(s): Procedure
Intervention description(s): Repair of endopelvic fascia and anterior colporrhaphy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women with ≥ stage II cystocele who visited the urogynecological department of a medical
        center for cystocele repair
      
Keywords: Bladder oversensitivity; Detrusor Overactivity; Cystocele
Support for Increased Physical Activity (Stöd Till Aktivare Motion)
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to improve and analyze the level of physical activity in
      immigrant women from the Middle East and Latin America living in Sweden. The investigators
      will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone
      production; and subclinical inflammatory activity are affected by the intervention. The
      follow-up period is 2 years.
    


Intervention name(s): Support for Increased Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Exercise referral combined with individual support, access to structured group exercise programs, and motivational support
Other intervention name(s): STAM; Stöd Till Aktivare Motion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: overweight; physical inactivity; physical fitness; lifestyle change
A Study of ALKS 5461 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to test the safety of ALKS 5461 in healthy adults.
    


Intervention name(s): ALKS 5461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual tablet; Sublingual tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALKS 5461; samidorphan
Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD
Condition: Choledocholithiasis; Cholangiocarcinoma; Benign Stricture of Common Bile Duct
MeSH terms: Bacteremia; Cholangiocarcinoma; Choledocholithiasis; Constriction, Pathologic
Study type: Interventional

Summary: 
      When a doctor performs Endoscopic retrograde cholangiopancreatography "ERCP" (Endoscopy to
      examine the bile duct) a flexible tube is inserted into the mouth and into the stomach. The
      tube passes beyond the stomach and into an opening in the liver called the bile duct. Another
      small flexible endoscope is inserted inside the ERCP scope to directly visualize the bile
      duct to ensure that there are no cancers or stones in the bile duct and occasionally to take
      a sample from the bile duct. The purpose of our study is to examine wither performing this
      procedure can transmit bacteria from the bile duct to the main blood stream.
    

Detailed description: 
      This is a prospective study to measure the frequency of bacteremia in patients undergoing
      ERCP with direct cholangioscopic examination of the Common Bile Duct "CBD". A blood culture
      will be drawn from patients prior to the procedure, 5 minutes after the procedure and 30
      minutes after the procedure. The patient will be followed up for 7 days after procedure for
      fever and sepsis. The estimated sample size is 60 patients.
    

Intervention name(s): Blood culture ( aerobic and anaerobic)
Intervention type(s): Other
Intervention description(s): Blood culture 5 minutes and 30 minutes after the procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ERCP; Direct cholangioscopic examination of the common bile duct; Choledocholithiasis; Cholangiocarcinoma; Benign stricture of common bile duct
HAIC Versus TACE for Large and Unresectable Hepatocellular Carcinoma Staged BCLC A/B
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion
      chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with
      large and unresectable hepatocellular carcinoma staged BCLC A/B.
    

Detailed description: 
      Transarterial chemoembolization (TACE) is the most widely used palliative treatment for
      hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of
      TACE for patients with large hepatocellular carcinoma staged BCLC A/B. Our previous
      prospective study also revealed similar results of large HCC patients treated with TACE.
      Recently, the results of our preliminary pilot study suggested that, compared with TACE,
      hepatic arterial infusion chemotherapy (HAIC) may improve tumor response for HCC with large
      HCC.

      Thus, the investigators carried out this prospective nonrandomized control to demonstrate the
      superiority of HAIC over TACE.
    

Intervention name(s): Hepatic arterial infusion; Transarterial chemoembolization; Folfox Protocol; TACE Drug Protocol
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially; Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.; oxaliplatin,leucovorin and 5-FU; lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)
Other intervention name(s): Folfox for TAI; Drugs for transarterial chemotherapy and embolization
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic arterial infusion chemotherapy; Transarterial Chemoembolization; Large and unresectable HCC
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening
Condition: Prolonged QT Interval in EKG and Sudden Death
MeSH terms: Torsades de Pointes; Long QT Syndrome; Jervell-Lange Nielsen Syndrome; Death, Sudden
Study type: Interventional
Phase: Phase 2

Summary: 
      Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia
      (irregular heartbeat) known as torsades de pointes (TdP), which is associated with
      prolongation of the corrected QT (QTc) interval on the electrocardiogram (ECG). Mechanisms
      for this increased risk in women are not well-understood. QTc interval duration has been
      shown to fluctuate throughout the phases of the menstrual cycle. Evidence indicates that the
      QTc interval response to drugs that may cause TdP is greater during the menses and ovulation
      phases of the menstrual cycle, during which serum progesterone concentrations are lowest, and
      lesser during the luteal phase, during which serum progesterone concentrations are highest.
      Additional evidence from our laboratory suggests that progesterone may be protective against
      TdP. Specific Aim 1: Establish the influence of oral progesterone administration as a
      preventive method by which to diminish the degree of drug-induced QT interval prolongation in
      women. Working hypothesis: Oral progesterone administration effectively attenuates enhanced
      drug-induced QT interval response in women. To test this hypothesis, progesterone or placebo
      will be administered in a crossover fashion to women during the menses phase of the menstrual
      cycle. QTc interval response to low-dose ibutilide, a drug known to lengthen the QT interval,
      will be assessed. The primary endpoint will be individually-corrected QT interval (QTcI)
      response to ibutilide, in the presence and absence of progesterone, which will be assessed
      by: 1) Effect on maximum change in QTcI, and 2) Area under the QTcI interval-time curves
      (AUEC). At the conclusion of this study, we will have established that oral progesterone
      administration is a safe and effective method of attenuating drug-induced QT interval
      prolongation.
    


Intervention name(s): Progesterone; Placebo; Ibutilide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days; Subjects will receive oral placebo two capsules once daily every evening for 7 days; Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval
Intervention MeSH terms: Ibutilide; Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Torsades de pointes; Progesterone; Clinical trial; Risk reduction; Electrocardiography
Database Creation and Evaluation of Motor Function of Finger Tapping Measured by Magnetic Sensor System in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to create a database of quantified finger movements. Using the
      evaluation system with magnetic sensors, the movements of finger tapping are measured and
      assessed by various indices, such as finger tapping interval, maximum amplitude of finger
      taps, and so on. In this study, the investigators will accumulate the data from healthy
      subjects for the purpose of applying this evaluation system to diagnosis support of nervous
      diseases in the future.
    


Intervention name(s): magnetic sensor system to measure the movements of finger tapping
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
Condition: Multifocal Motor Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European
      Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet
      all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01
      (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients
      receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and
      the Guy's Neurological Disability Scale（GNDS） et al.

      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
      events by one year after the start of the study treatment.
    


Intervention name(s): NPB-01
Intervention type(s): Drug
Other intervention name(s): immunoglobulin
Intervention MeSH terms: Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVIG in Multifocal Motor Neuropathy; Patients with Multifocal Motor Neuropathy