bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
Condition: Postoperative Pain; Intracranial Hypertension
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      Caudal epidural block has been a widely used regional anesthesia method, especially in
      pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on
      non-invasive methods used for intracranial pressure measurement have shown that optic nerve
      sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement
      has high diagnostic accuracy for detecting increased intracranial pressure in children. The
      aim of the study is to investigate the effect of the caudal block on optic nerve sheath
      diameter in pediatric patients.
    


Intervention name(s): Bupivacaine Hydrochloride
Intervention type(s): Drug
Intervention description(s): 1 ml / kg, % 0.25 bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
A Pilot Study of Xifaxan to Treat Patients With PSC
Condition: Primary Sclerosing Cholangitis (PSC)
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 1

Summary: 
      In the current protocol, we propose the assessment of potential beneficial effects of the
      antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15
      adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice
      daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or
      equal to 40 kg will receive Xifaxan, 550 mg twice daily.
    


Intervention name(s): Xifaxan
Intervention type(s): Drug
Intervention MeSH terms: Rifaximin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Sclerosing Cholangitis; Xifaxan
An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Accumulating evidence suggests a role of oxidative stress in the pathophysiology of
      schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived
      from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels
      sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation
      of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II
      detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as
      the electrophilic responsive element or antioxidant responsive element. Recently, we reported
      that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist
      phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that
      SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to
      determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with
      schizophrenia.
    


Intervention name(s): Sulforaphane-rich Broccoli Sprout Extract
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Sulforaphane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Sulforaphane; Psychosis; Cognition; Oxidative stress; Antioxidant; Anti-inflammatory
Xpede Clinical Study
Condition: Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder); Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
MeSH terms: Neoplasms; Osteoporosis; Disease; Fractures, Bone; Fractures, Spontaneous; Spinal Fractures
Study type: Interventional

Summary: 
      The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™
      Bone Cement in human use in China.
    


Intervention name(s): Xpede™ Bone Cement; Mendec Spine Bone Cement
Intervention type(s): Device; Device
Intervention description(s): Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.; Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Diabetes Group Visits
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This pilot study aims to increase access to diabetes education by delivering it in a
      culturally-appropriate community setting and by involving different members of the diabetes
      care team including physicians, diabetes educators, and health promoters/community health
      workers.

      Diabetes medical group visits will be held at the Grady North DeKalb satellite clinic the
      third Thursday of the month starting in October 2009. There will be two cohorts of patients-
      English speaking patients and Spanish speaking patients. Each group will be scheduled for 4
      2-hour group visits throughout a period of 9 months. These visits will be every 8 weeks for
      each group. During the visit, the patient will be seen by a physician, attend a diabetes
      education session, re-fill their diabetes medications and receive lab orders.
    

Detailed description: 
      Patients who participate in the diabetes group visits should achieve improvement in Clinical
      outcomes - better A1C levels, reduced blood pressure, reduced cholesterol levels ; adherence
      to evidence-based medicine - keeping appointments and scheduling eye exams, foot-checks,
      and/or taking medication as prescribed; behavioral outcomes- goal setting, achievement of
      goals, problem solving; access - attendance at educational sessions; ability to obtain
      affordable medications and devices; and satisfaction among patients and health professionals.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We plan to study a total of 40 patients with a known history of type 1 or type 2 diabetes,
        ages 18-80. Patients included within this study will be determined by the set of inclusion
        and exclusion criteria.
GSK1349572 Drug Interaction Study With Atazanavir/Ritonavir and Atazanavir
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the amount of GSK1349572 (study drug) in the blood
      when given with and without atazanavir/ritonavir or atazanavir and to compare the blood
      levels of atazanavir when given with GSK1349572 to historical data for atazanavir.
    

Detailed description: 
      GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV
      infection. As GSK1349572 progresses into clinical trials in HIV-infected patients where
      combination antiretroviral therapy is the standard of care, it is likely that it will be
      dosed with protease inhibitors (PIs) including atazanavir/ritonavir (ATV/RTV) and atazanavir
      alone. Ritonavir is a substrate of CYP3A and inhibitor of CYP3A and Pgp and atazanavir is an
      inhibitor of UGT1A1. Ritonavir is also a known inducer of CYP and UGT enzymes. As GSK1349572
      likely undergoes metabolism by CYP and UGT enzymes and is a Pgp substrate, a drug interaction
      study between GSK1349572 and ATV is warranted. GSK1349572 is not an inhibitor or inducer of
      CYP3A and is not expected to have impact on pharmacokinetics (PK) of atazanavir and
      ritonavir. Accordingly, the primary objective of this study is to compare steady-state plasma
      PK, safety and tolerability of GSK1349572 30 mg every 24h (q24h) with and without ATV/RTV
      300/100 mg q24h or ATV 400mg q24h.

      Approximately 24 subjects will receive GSK1349572 30mg q24h for 5 days (Treatment A).
      Subjects will then be administered GSK1349572 30mg q24h in combination with either ATV/RTV
      300/100 mg q24h (Treatment B, n=12) or ATV 400 mg q24h (Treatment C, n=12) for 14 days. There
      will be no washout between treatments. Safety evaluations and serial PK samples will be
      collected during each treatment period. A follow-up visit will occur 7-14 days after the last
      dose of study drug.

      This study will be conducted at one center in the US, with healthy adult male and female
      subjects.
    

Intervention name(s): GSK1349572; Atazanavir 300 mg; Atazanavir 400 mg; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK1349572 30 mg once a day for 5 days in Period 1 and 14 days in Period 2; Atazanavir 300 mg once per day for 14 days in Period 2; Atazanavir 400 mg once a day for 14 days in Period 2; Ritonavir 100 mg once a day for 14 days in Period 2
Other intervention name(s): ATV; REYATAZ. REYATAZ is a registered trademark of Bristol-Myers Squibb Company; REYATAZ. REYATAZ is a registered trademark of Bristol-Myers Squibb Company; ATV; NORVIR. NORVIR is a registered trademark of Abbott Labs; RTV
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GSK1349572; Atazanavir; Ritonavir; Reyataz; Norvir; healthy; pharmacokinetic
Efficiency of Physiotherapy Treatments for Low Back Pain in Women.
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or
      Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.

      Design: Single-blind experimental prospective study of clinic intervention. Setting:
      Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.

      Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were
      divided into three randomized groups: Back School (group 1), TENS with Back School (group 2),
      and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of
      treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were
      measured, at the beginning and at the end of the treatment and after three and six months.
      Anthropometric and physical activity variables were collected.
    


Intervention name(s): Electromagnetic Therapy; Transcutaneous Electrical Neurological Stimulation; Back School
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 20 sessions from Monday to Friday of 20 minutes of Electromagnetic Therapy, using the next parameters: 10 Hz of frequency and 60% of intensity, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.; Procedure/Surgery: Transcutaneous Electrical Neurological Stimulation (TENS)
20 sessions from Monday to Friday of 20 minutes of TENS Therapy using the next parameters: 100μs of impulse width, 80 Hz of impulse frequency, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.; 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase 1 PK Study of XOMA 3AB
Condition: Botulism
MeSH terms: Botulism
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study
      of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be
      hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the
      24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum
      monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in
      which they will receive a single intravenous infusion of active drug or placebo. Placebo will
      be normal saline. Volunteers will be followed for safety for up to 120 days after infusion
      depending on dose cohort.
    

Detailed description: 
      This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study
      of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be
      hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the
      24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum
      monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in
      which they will receive a single intravenous infusion of active drug or placebo. Placebo will
      be normal saline. Volunteers will be followed for safety for up to 120 days after infusion
      depending on dose cohort.
    

Intervention name(s): XOMA 3AB; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single intravenous infusion of XOMA 3AB in three cohorts at different concentrations.; Normal saline 100 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Botulism, Clostridium
Effects of Epidural Local Anesthetics on Propofol Induction
Condition: General Anesthesia; Propofol Target-controlled Infusion; Thoracic Epidural Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a prospective, randomized, placebo-controlled study to determine
      whether thoracic epidural anesthesia(TEA) with different local anesthetics has different
      influences on the propofol dose during induction.
    


Intervention name(s): Lidocaine; Bupivacaine; Ropivacaine; Normal Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): General anesthesia combined with thoracic epidural 1% lidocaine; General anesthesia combined with thoracic epidural 0.25% bupivacaine; General anesthesia combined with thoracic epidural 0.3% ropivacaine; General anesthesia combined with thoracic epidural 0.9% normal saline
Intervention MeSH terms: Lidocaine; Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)
Condition: Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Background

             1. PET/CT (positron emission tomography/computed tomography) using FDG
                (fluorodeoxyglucose) is widely used for evaluation of cancer patients.

             2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.

             3. There is no widely-accepted method to reduce the bowel FDG uptake.

        2. Purpose

             1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce
                bowel uptake of FDG.

             2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.

             3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel
                contraction during PET/CT acquisition.

        3. Method

             1. Intervention versus control: administration of single tablet of pinverin (50mg)
                perorally versus simple water (~100mL).

             2. Timing of administration: At the time of FDG injection. PET/CT images will be
                acquired 1hr post FDG injection.

        4. Primary outcome

             1. SUV (standardized uptake value) difference between pinverin administered patient
                group versus control group.

             2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in
                mCi/mL) x (body weight in g) / (injected radioactivity in mCi)
    


Intervention name(s): pinaverium bromide; water
Intervention type(s): Drug; Drug
Intervention description(s): pinverin 50 mg per oral single dose versus simple water ingestion; same amount of water for pinverin administration
Other intervention name(s): pinverin; water~100mL
Intervention MeSH terms: Pinaverium; Bromides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: fluorodeoxyglucose; positron emission tomography; computed tomography; bowel; pinaverium bromide
Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed
      release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in
      patients with Gastroesophageal Reflux Disease (GERD).
    


Intervention name(s): Rabelis DDR 50 mg Capsules; Pariet 20 mg Enteric Coated Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Rabelis DDR 50 mg Capsules once daily for seven days.; Pariet 20 mg Enteric Coated Tablets once daily for seven days.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ScanBrit Dietary Intervention in Autism
Condition: Autism; Autism Spectrum Disorder (ASD)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      A growing body of research indicates that dietary intervention excluding foods containing the
      proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum
      disorder (ASD) may have a positive effect on behaviour and developmental outcome.

      In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a
      gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD
      concurrently with an abnormal urinary profile. Following random allocation to a diet or non-
      diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight
      months initially - progressing to 12 months if required. A non-diet control group continued
      with a normal diet.

      Assuming significant changes for the dietary group on the various outcome measures of
      behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary
      intervention for a further 12 months when outcome measures were again assessed at study end.
    

Detailed description: 
      Eligibility criteria: diagnosis of autism, no co-morbid diagnosis of Fragile X syndrome,
      epilepsy or tuberous sclerosis, aged between 4-10y11m.

      Experimental hypothesis: children with an autism spectrum disorder (ASD) on a GFCF diet would
      show a significantly improved group developmental outcome in the medium- and long-term with
      regards to core autism and/or secondary symptoms.

      Main outcome measures: change in scores of dietary participants on one or more measures
      against predefined statistical thresholds as evidence of improvement, alongside changes to
      intra- and inter-group scores at study endpoint.

      Main outcome measures ascertained by: Autism Diagnostic Observation Schedule (ADOS), Gillam
      Autism Rating Scale (GARS), Vineland Adaptive Behaviour Scales (VABS), Attention Deficit
      Hyperactivity Disorder - IV (ADHD-IV) scales.
    

Intervention name(s): Gluten- and casein-free diet
Intervention type(s): Other
Intervention description(s): Removal of foods containing gluten (cereal produce) and casein (dairy produce)
Other intervention name(s): Gluten-free (wheat-free), casein- free (milk-free) diets
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: autism; autism spectrum disorder; diet; gluten; casein; intervention; peptide; randomised; controlled; adaptive design; Autism Diagnostic Observation Schedule (ADOS); Gilliam Autism Rating Scale (GARS); Vineland Adaptive Behaviour Scale (VABS); Attention-Deficit Hyperactivity Disorder (ADHD)-IV Scale