bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study Image Guided, Auto-Targeted Neurostimulation for the Treatment of Non-Specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  Initial evaluation of the clinical effectiveness of Image Guided Transcutaneous
           Electrical Stimulation (TENS) device for treatment of non-specific low back pain.

        -  To assess the tolerability and acceptability of the device by the caregiver ("User
           Friendly").

        -  To evaluate patients' tolerance by monitoring side effects and tolerability during
           treatment.
    

Detailed description: 
      Transcutaneous electrical nerves stimulation (TENS) devices are a drug-free alternative for
      managing pain. For the past thirty years, doctors have been prescribing FDA approved TENS
      worldwide as an effective way to relieve pain. TENS device currently utilized includes a
      variety of types of devices and pulse modulations. Most of these devices are applied on large
      surface areas, and are designed to block the pain signal (gate mechanism) to the brain.
      Others manual TENS devices are applied to small surface areas to stimulate peripheral nerve
      ends, and by that causing the release of endorphins with a significantly superior clinical
      outcome. Such treatments are time consuming and cumbersome and requires previous knowledge of
      location of nerve ends.

      A novel device capable of scanning a large skin surface area, automatically locating nerve
      ends responsible for pain relief by utilizing skin impedance measurements and image
      processing with anatomical matching will be tested for stimulating these peripheral nerve
      ends (NeMa-st, Nervomatrix Ltd., Netanya, Israel).

      For this purpose an open study to initially evaluate safety and efficacy of the intervention
      is designed. 20 patients will undergo 2 treatment sessions per week for a period of 4 weeks,
      while maintaining their pain relief medication treatment regime.
    

Intervention name(s): Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)
Intervention type(s): Device
Intervention description(s): Patients will undergo 2 treatments per week during 4 weeks using the device. During the study Patients are allowed to maintain/continue taking medications/ analgesics for pain relief prescribed to them before the study. Medication use will be recorded.
Other intervention name(s): Nervomatrix Ltd. Auto-Targeted Neurostimulation, NeMa-st
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the absorption, metabolism, excretion, mass balance, safety, and
      tolerability of a single oral administration of [14C]-CTP-543 in healthy male subjects.
    


Intervention name(s): [14C]-CTP-543
Intervention type(s): Drug
Intervention description(s): Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass Balance; Radiolabeled; Pharmacokinetics
Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Children between the ages of 5-17 years old who have or display symptoms of emotional
      dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited
      to participate in a 12-week research study to determine the effectiveness and safety of the
      natural treatment N-acetylcysteine (NAC) for children with emotional and behavioral problems.
      After undergoing a comprehensive evaluation by medical doctors with a specialty in this area,
      children who are found eligible to participate in this research study will be treated with
      NAC. Following the evaluation period, this research study requires 12 weekly visits, either
      in our office or over the phone, in an effort to closely monitor each child's response to the
      medication. Eligible participants will receive study-related evaluations and weekly study
      visits with our study doctors at no cost.
    

Detailed description: 
      This will be a 12-week, open-label study of NAC in the treatment of bipolar disorder in
      children and adolescents. Subjects will include youth ages 5-17 years with a bipolar spectrum
      disorder (type I, II, or NOS), mixed, manic, or hypomanic state, according to the Diagnostic
      and Statistical Manual of Mental Disorders, Fifth Edition DSM-5 (American Psychiatric
      Association, 2013). The primary outcome measures will be improvement in manic symptoms as
      measured by the Young Mania Rating Scale (YMRS) and improvement in depressive symptoms as
      measured by the Child Depression Rating Scale (CDRS).

      Bipolar diagnoses will be made according to the DSM-5 in a clinical evaluation by a Child
      Psychiatrist and confirmed using the Schedule for Affective Disorders and Schizophrenia for
      School-Age Children - Epidemiological Version (K-SADS-E)(Orvaschel, 1994). All subjects must
      have a YMRS score of at least 15. Only patients who are not responding to their current
      treatment regimen will be tapered from their medications; youth on concomitant psychiatric
      medications will be permitted to continue those medications as listed in the concomitant
      medication section.
    

Intervention name(s): Open-label Treatment with N-Acetylcysteine
Intervention type(s): Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mania; temper tantrum; irritability; mood; bipolar
ARREST PAD (Peripheral Arterial Disease)
Condition: Arterial Occlusive Disease; Intermittent Claudication; Insulin Resistance
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication; Arterial Occlusive Diseases; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial will test the hypothesis that inflammation and insulin resistance contribute to
      reduced walking distance in subjects with intermittent claudication by impairing vascular
      reactivity and skeletal muscle metabolic function.
    

Detailed description: 
      People with peripheral arterial disease (PAD), an important clinical manifestation of
      atherosclerosis, often suffer symptoms of intermittent claudication that impair their walking
      ability and adversely affect their quality of life. People with PAD are also at increased
      risk for adverse cardiovascular events, including myocardial infarction, stroke and death.
      Unfortunately, medical therapies directed to the functional and limb-threatening
      manifestations are limited. Little attention has been paid to the biologic processes that
      cause PAD, and to atherogenic mechanisms that may preferentially affect the peripheral
      circulation.

      Vascular inflammation and insulin resistance are two important and interdependent conditions
      that are associated with atherosclerosis. Subjects in this trial (160 adults with stable
      intermittent claudication who are not taking insulin or insulin-sensitizing medications, such
      as thiazolidinediones) will be randomized in a placebo-controlled, parallel design manner, to
      atorvastatin 80 mg orally daily (to reduce inflammation) and pioglitazone 45 mg orally once
      daily (to improve insulin sensitivity). Forty healthy adult subjects, age and gender-matched
      to a subset of the study group, will be enrolled to serve as a control population. Primary
      and secondary study endpoints include: treadmill walking time, endothelium-dependent
      vasodilation, and insulin-mediated skeletal muscle glucose uptake.
    

Intervention name(s): atorvastatin and pioglitazone; atorvastatin/placebo; pioglitazone/placebo; placebo/placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity); atorvastatin 80 mg orally once daily and matching placebo orally twice daily; pioglitazone 30 mg orally once daily and matching placebo orally once daily; placebo orally three times daily
Other intervention name(s): atorvastatin: lipitor; pioglitazone: actos; atorvastatin: lipitor; pioglitazone: actos
Intervention MeSH terms: Pioglitazone; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: peripheral arterial disease; intermittent claudication
Early Removal of the Urethral Catheter Following Trans-urethral Resection of Prostate
Condition: Urinary Retention
MeSH terms: Urinary Retention
Study type: Observational

Summary: 
      Transurethral resection of prostate is the gold standard operation for bladder outflow
      obstruction due to benign prostatic enlargement. However, catheter removal day is variable.
      The objective of this study is to compare early and delayed catheter removal groups in terms
      of, urinary retention after catheter removal, length of hospital stay, weight of resected
      prostate, duration of resection, peri-operative blood transfusion, and postoperative
      complications.
    

Detailed description: 
      This randomized controlled trial will carried out in Urology clinic at Jordan university
      hospital. Patients with benign prostate hyperplasia will be selected by simple random
      sampling technique after taking informed consent and will divided into two groups: Group A-
      early catheter removal group( catheter removed after 24 hours) and Group B-delayed catheter
      removal group ( catheter removed after 48 hours). in this study we will exclude patients with
      large post-void urine volume, simultaneous internal urethrotomy and transurethral resection
      of prostate, co-morbidity( diabetes mellitus, CVA) spinal cord injury, urethral stricture,
      prostate cancer proved by biopsy and intra-operative complications. Patients will discharged
      after removal of catheter if they voided successfully.
    

Intervention name(s): removal of the urinary catheter
Intervention type(s): Other
Intervention description(s): in group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 adult males from urology clinic atJordan university hospital, with benign prostate
        hyperplasia who undergo trans-urethral resection of the prostae will be included in this
        study,
      
Keywords: Benign Prostate Hyperplasia; Urinary retention; Re-catheterization
Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients
Condition: Anemia; Coronary Artery Bypass Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a less restrictive strategy of red blood
      cell transfusion in elderly patients following coronary bypass surgery results in enhanced
      postoperative recovery as determined by quality of life assessment, exercise tolerance and
      clinical outcomes.

      Two postoperative transfusion strategies:

        1. Liberal - transfused when Hgb is <100g/L

        2. Restrictive - transfused when Hgb is <70g/L
    


Intervention name(s): Blood Transfusion
Intervention type(s): Procedure
Intervention description(s): Blood transfusion will be administered when the transfusion trigger is met.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative care; Cardiac Surgery; Blood Transfusion
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to examine efficacy and safety of tiotropium compared
      to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification
    


Intervention name(s): tiotropium; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Shivering Control After Percutaneous Nephrolithotomy
Condition: Shivering Control
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of the study is comparing the effect of amino acid versus magnesium sulfate infusion on
      postoperative shivering in patients undergoing elective percutaneous nephrolithotomy surgery
      under general anesthesia.
    

Detailed description: 
      A written informed consent was taken from the patients. Patients were assigned randomly to
      two groups (40 subjects each) to be anesthetized and infused with either an iv amino acid
      starting just before and during anesthesia (group A) or an iv magnesium sulphate starting
      just before and during anesthesia (group M) in the perioperative period.
    

Intervention name(s): Aminoacid; Magnesium sulfate
Intervention type(s): Drug; Drug
Intervention description(s): amino acid infusion 150 ml/kg/hr starting preoperative; magnesium sulphate bolus and infusion 60 mg/kg starting preoperative
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oxytocin and Alcohol Withdrawal and Dependence
Condition: Alcoholism; Substance-Related Disorders
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence
      in adults admitted for detoxification of alcohol, and during the following 4 weeks in an
      outpatient setting. Half of the participants will receive oxytocin nasal spray, the other
      half placebo nasal spray.
    


Intervention name(s): intranasal oxytocin spray; intranasal spray without oxytocin
Intervention type(s): Drug; Other
Intervention description(s): 6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30.; 6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30.
Other intervention name(s): Syntocinon; placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxytocin; Administration, Intranasal; Ethanol
Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed
      to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60
      mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS.

      This study will consist of two treatment arms, MN-166 and matching placebo. Randomization
      will occur in a 2:1 ratio (MN- 166: placebo).

      Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months;
      Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last
      dose.

      During treatment phase, subjects return to the clinic at Months 3 and 6 and will be
      telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new
      or concomitant medications.

      All subjects (subjects who complete the Double-blind Phase and subjects who complete the
      Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately
      2 weeks after the last dose of study drug to assess adverse event status and to document
      concomitant medications.

      Safety will be assessed by monitoring and recording all treatment-emergent adverse events
      (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional
      assessments will include regular monitoring of hematology, blood chemistry, and urine values,
      regular measurement of vital signs, ECGs, medical history, physical and neurological
      examinations.
    


Intervention name(s): Placebo (for MN-166); MN-166; riluzole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patient is given 50 mg riluzole twice daily.
Other intervention name(s): Sugar pill manufactured to mimic MN-166 10 mg tablet; ibudilast; Rilutek
Intervention MeSH terms: Ibudilast; Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; pharmacotherapy; intervention; prospective; safety endpoint; preliminary efficacy; ibudilast
Sleep and Memory in Children
Condition: Sleep Apnea; Temporo-central Epilepsy; Narcolepsy; High Intellectual Potential; Healthy Subject
MeSH terms: Epilepsy; Narcolepsy
Study type: Interventional

Summary: 
      Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good
      daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning
      is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated
      in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain
      plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been studied
      during childhood and in children affected by sleep disorders. Yet, sleep disorders concern
      almost 30% of children and are frequently related to a worsening in academic performances.
      Classical neuropsychological evaluations of these children, based on daytime learning, often
      fail to determine cognitive profiles explaining their academic difficulties. The
      investigators hypothesize that a lack of sleep-dependent consolidation could take an active
      part in these children's cognitive and academic difficulties. This proposal aims at
      characterizing interactions between sleep, learning and memory processes that have not been
      studied in children of elementary school age (6-12 years). The investigators will evaluate
      sleep-dependent memory consolidation processes in children with sleep disorders before and
      after treatment and healthy controls. Neuropsychological testing and academic performances
      will be also evaluated.. The comparison of performances obtained before and after medical
      treatment, will allow to understand whether normalisation of sleep quality permits the
      restoration of sleep-dependent memory consolidation.
    


Intervention name(s): memory evaluation at V1 and V2 (with treatment); memory evaluation at V1 (without treatment); memory evaluation at V1 and V2 (without treatment)
Intervention type(s): Other; Other; Other
Intervention description(s): Overnight episodic and procedural memory consolidation performance will be assessed at V1 and V2. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance. The children receive drug treatment (BECTS and Narcolepsy) or surgical (OSA) as part of their routine care.; Overnight episodic and procedural memory consolidation performance will be assessed at V1. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance.; Overnight episodic and procedural memory consolidation performance will be assessed at V1 and V2. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Memory; sleep; narcolepsy; apnea; epilepsy
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood Pressure
Condition: Mild Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase 2, double-blind, randomized, placebo-controlled study of IONIS-AGT-LRx
      conducted in mild hypertensive participants.
    

Detailed description: 
      Participants were randomized in a 2:1 ratio to receive a once-weekly subcutaneous treatment
      and an additional loading dose on Study Day 3 with either IONIS-AGT-LRx or placebo for 6
      weeks.

      All participants completed a 13-week Post-Treatment Period.
    

Intervention name(s): Placebo; ISIS 757456
Intervention type(s): Drug; Drug
Intervention description(s): Placebo matching solution administered as SC injection.; Administered as SC injection.
Other intervention name(s): IONIS-AGT-LRx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Hypertensive; AGT; Angiotensinogen; Blood Pressure; High Blood Pressure