bioihbjkbjnl/mcl2 huggingface dataset:
A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
Condition: Arsenic Metabolites Measured in Urine
Study type: Interventional
Phase: Phase 4

Summary: 
      Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking
      water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L.
      Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart
      disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on
      one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine
      (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for
      the recruitment and transfer of methyl groups, but other nutrients, including choline and
      betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study
      of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show
      that plasma choline and betaine concentrations are positively associated with As methylation.
      These findings suggest that choline and/or betaine may play an important role in As
      methylation and elimination and that simple interventions may have therapeutic potential for
      the many populations at risk for As-induced health effects.

      The investigators aim to recruit and follow 60 participants for this pilot study which will
      allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor
      participants for any potential side effects, 3) identify any difficulties that might be
      encountered in daily follow-up, and 4) generate preliminary data regarding the effects of
      choline and/or betaine supplementation on arsenic methylation.
    


Intervention name(s): Placebo; Choline bitartrate; Betaine; Choline bitartrate + Betaine
Intervention type(s): Other; Drug; Drug; Drug
Intervention MeSH terms: Choline; Betaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: arsenic; Bangladesh; choline; betaine; methylation
EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to explore short and longer-term effects of the Endobarrier™
      implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps.
      In addition changes in gut peptides and gut permeability after implantation of a removable
      duodeno-jejunal bypass device to induce diabetes remission in obese subjects with
      sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body
      weight and body composition, the change in global cardiovascular risk from baseline to 12
      months, estimated using the UKPDS risk engine will be recorded.
    

Detailed description: 
      Obesity and diabetes probably represent the most challenging threat to public health in the
      21st century. Obesity has multiple deleterious effects on health, significantly increasing
      the risk of fatal and non-fatal diseases including type 2 diabetes (T2DM). Bariatric surgery
      is a well-established method for the treatment of morbid obesity and has increasingly been
      recognized as an effective, long-lasting treatment option for T2DM.

      Recently a potential, non-invasive alternative to bariatric surgery, a duodenal-jejunal
      bypass liner (EndoBarrierTM) has been introduced. It is an endoscopically implantable and
      removable device that prevents contact between partially digested nutrients and the proximal
      intestine. This device was shown to reduce body weight and to improve glycaemic control in
      subjects with diabetes. Small pilot studies suggested a change in incretin levels, similar to
      that observed after gastric surgery with an improvement of insulin sensitivity and glucose
      metabolism. To better understand and characterize the hormonal and/or metabolic effects after
      the implantation and removal of the EndoBarrierTM, this monocentric, prospective, trial is
      being performed.

      The primary objective of this study is to clarify the changes in gut peptides and gut
      permeability after implantation the EndoBarrierTM in obese subjects with sub-optimally
      controlled type 2 diabetes mellitus. Additionally, the investigators aim to determine the
      changes in body weight and measure of adiposity, the change in global cardiovascular risk
      from baseline to 12 months as well as the changes in insulin sensitivity and beta-cell
      function over time.
    

Intervention name(s): EndoBarrier
Intervention type(s): Device
Intervention description(s): implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
Other intervention name(s): duodeno-jejunal bypass liner
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has
      better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients
      with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into
      this study.
    

Detailed description: 
      Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a
      （according to AJCC2002）

      Scheme:

      Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging
      (N0 or N1), then randomized to 2 arms at 1:1 ratio.

      Arm Cisplatin:

      Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.

      Arm Paclitaxel:

      Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant
      chemotherapy for 2 cycles.
    

Intervention name(s): Paclitaxel plus 5-fluorouracil; Cisplatin plus 5-fluorouracil; Radiation therapy; Radiation therapy
Intervention type(s): Drug; Drug; Radiation; Radiation
Intervention description(s): 5-ﬂuorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-ﬂuorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).; cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).; A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.; A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
Intervention MeSH terms: Paclitaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal squamous cell carcinoma; chemoradiotherapy
A Mobile Health Solution for Homework During CBT
Condition: Anxiety; Depression; Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to preliminarily evaluate a web-based app to improve provider
      implementation and patient engagement in homework (i.e., between-session practice of skills
      learned during therapy) during child mental health treatment by conducting a small-scale
      feasibility trial in community practice settings comparing Cognitive Behavioral Therapy (CBT)
      to CBT enhanced with the app.
    


Intervention name(s): Cognitive Behavioral Therapy (CBT); CBT+App
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.; Participants receive CBT as usual enhanced with a simple, HIPAA compliant, web-based application to help mental health providers implement homework during CBT with children with elevated PTSD, anxiety, and/or depression, and their caregivers. The three major components of the app help providers to (1) Practice interactive, digitized CBT exercises with patients in-session; (2) Remind patients to practice CBT exercises for homework, and (3) Review homework during the next session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mhealth; mental health; youth mental health; adolescent mental health; homework
TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)
Condition: Post-cesarean Pain
Study type: Interventional

Summary: 
      This is a randomized trial of 134 individualized post-cesarean delivery who will be
      randomized to twice daily use of non-invasive bioelectronic treatment with TrueRelief device
      or identical appearing sham device for post-cesarean pain management.
    


Intervention name(s): TrueRelief device; Sham TrueRelief device
Intervention type(s): Device; Device
Intervention description(s): TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced.; The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, randomized, sham-controlled trial parallel arm study using TrueRelief as the experimental treatment and a TrueRelief device with sham capabilities as a placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Post-cesarean pain; Non-opioid; Non-invasive device
Learning a Motor Task Through Observation
Condition: Healthy
Study type: Observational

Summary: 
      Motor training results in use dependent plasticity (UDP), thought to underlie recovery of
      motor function after brain injury. The purpose of this protocol is to determine (a) if
      movement observation results in encoding of a motor memory in the primary motor cortex and
      (b) if observation of motor training can enhance the effects of physical training in healthy
      volunteers. If so, this may become an important tool in rehabilitative treatment for patients
      who are unable or partially able to train. We will test our hypotheses by means of focal
      single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our
      outcome measure will be the change in TMS-evoked movement direction as a function of training
      strategy. So far we found that this is the case in healthy volunteers (see data in analysis
      of the study). The purpose of this amendment is to determine if action observation can elicit
      the same effects in adult chronic ischemic stroke patients who have had originally
      significant motor weakness but recovered to the point of being able to perform the motor
      tasks, possibly resulting in a useful rehabilitative strategy.
    

Detailed description: 
      Motor training results in use dependent plasticity (UDP), thought to underlie recovery of
      motor function after brain injury. The purpose of this protocol is to determine (a) if
      movement observation results in encoding of a motor memory in the primary motor cortex and
      (b) if observation of motor training can enhance the effects of physical training in healthy
      volunteers. If so, this may become an important tool in rehabilitative treatment for patients
      who are unable or partially able to train. We will test our hypotheses by means of focal
      single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our
      outcome measure will be the change in TMS-evoked movement direction as a function of training
      strategy. So far we found that this is the case in healthy volunteers (see data in analysis
      of the study). The purpose of this protocol is to determine if action observation can elicit
      the same effects in adult chronic ischemic stroke patients who have had originally
      significant motor weakness but recovered to the point of being able to perform the motor
      tasks, possibly resulting in a useful rehabilitative strategy.
    

Keywords: Mirror Neurons; Performance; Use-Dependent Plasticity; Attention; Premotor Cortex
Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia
Condition: Fibromyalgia; Postural Lordosis; Postural Kyphosis; Proprioception; Postural Stability; Balance
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Kyphosis; Lordosis
Study type: Observational

Summary: 
      This study aims to investigate trunk position sense, postural stability and spine posture in
      fibromyalgia patients and healthy women.
    


Intervention name(s): Evaluation
Intervention type(s): Other
Intervention description(s): Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy women and Fibromyalgia patient
MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury
Condition: Traumatic Brain Injury; Post-concussive Symptoms
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Wounds and Injuries
Study type: Observational

Summary: 
      The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic
      brain injury (TBI) are due to selective disruption of the long association white matter
      tracts of the cerebral hemispheres, with resulting functional impairment of the network of
      cortical regions that are interconnected by these long-range association pathways. We propose
      that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and
      that the impaired cortical activation can be detected with magnetoencephalography (MEG), and
      that the results of these imaging examinations will correlate with neurocognitive status and
      functional recovery after TBI.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited through the neurosurgery clinic at San Francisco General
        Hospital or referred to us by colleagues.
      
Keywords: Traumatic brain injury; Post-concussive symptoms; Brain imaging; Neurocognitive testing
A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVES: I. Evaluate the safety and immunogenicity of single and multiple doses of M-T412,
      a chimeric murine-human anti-CD4 monoclonal antibody, in patients with multiple sclerosis.

      II. Evaluate the pharmacokinetics of M-T412. III. Obtain preliminary data on the clinical
      response to M-T412.
    

Detailed description: 
      PROTOCOL OUTLINE: This is an open label, dose escalating study. Escalating doses of M-T412
      are administered to cohorts of 5 patients each receiving a single dose intravenously over 2
      hours.

      Patients who complete the single dose assessment of M-T412 may receive up to 3 additional
      single doses of M-T412 IV over 2 hours, with each repeated dose given at least 1 month apart.

      Then, patients receive one dose level of M-T412 IV over 2 hours at 3 month intervals over a
      period of 12 months for a total of 5 doses. Once recovery of CD4 cells is obtained, the next
      scheduled infusion of M-T412 begins. Patients are omitted from study if CD4 cells remain
      attenuated following 2 scheduled infusion sessions.

      Patients are followed at 3, 6, 12, and 24 months after the first infusion.
    

Intervention name(s): monoclonal antibody M-T412
Intervention type(s): Drug
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; neurologic and psychiatric disorders; rare disease
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and
      naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
    


Intervention name(s): Combination Product (sumatriptan succinate / naproxen sodium); RELPAX(eletriptan) 40mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): sumatriptan/naproxen sodium; eletriptan tablets
Other intervention name(s): Combination Product (sumatriptan succinate / naproxen sodium)
Intervention MeSH terms: Naproxen; Sumatriptan; Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy
A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of
      lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
    

Detailed description: 
      A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to
      Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered
      Intravenously in Healthy Adult Volunteer Subjects
    

Intervention name(s): Lanadelumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.; Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.
Other intervention name(s): TAK-743
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time finafloxacin was administered to humans intravenously. The principal
      aim of this study was to obtain safety and tolerability data when finafloxacin was
      administered intravenously as single and multiple doses to healthy subjects.
    


Intervention name(s): Finafloxacin i.v. solution 200 mg; Finafloxacin i.v. solution 400 mg; Finafloxacin i.v. solution 600 mg; Finafloxacin i.v. solution 800 mg; Finafloxacin i.v. solution 1000 mg; Placebo i.v. solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Finafloxacin; Fluoroquinolones; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetic
Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes
Condition: Embryo Implantation
Study type: Interventional

Summary: 
      This study evaluated whether laser acupuncture at the time of embryo transfer (following in
      vitro fertilization) improves implantation rates. Patients were randomized to one of 4 groups
      at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham laser
      acupuncture, 4) no treatment.
    


Intervention name(s): Needle Acupuncture; Laser Acupuncture; Sham Laser Acupuncture
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): See above; See above; See above
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a
      signaling molecule for inflammation in inhaled steroid-treated asthmatics.
    


Intervention name(s): Simvastatin; B1-6-12
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg once daily for 8 weeks; 1 tablet once daily for 8 weeks
Other intervention name(s): Zocor
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate persistent asthma; Inhaled corticosteroids