bioihbjkbjnl/mcl2 huggingface dataset:
Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the transcutaneous application of
      unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal
      and mechanical experimental pain and cause changes in peripheral nerve conduction. Moreover
      evidence whether the effect and comfort of this current is greater than Conventional TENS
      (Transcutaneous Electrical Nerve Stimulation) commonly used for the treatment of clinical
      pain.
    

Detailed description: 
      In the last years several animal experimental studies have evidenced that high frequency
      unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric
      currents with these high frequencies that are usually used for the treatment of pain in
      humans are interrupted or modulated (i.e. interferential currents)

      This evidences in animals could have application in pain treatment, characterized by
      overactive nervous system. For this reason it was decided to compare the effects on
      experimental pain and peripheral nerve conduction of this new electric current versus sham
      stimulation and TENS (Transcutaneous Electrical Nerve Stimulation).

      The scientific literature on transcutaneous electrical stimulation in humans and changes in
      nerve conduction and / or somatosensory thresholds focuses mainly on TENS (Transcutaneous
      Electrical Nerve Stimulation). Therefore TENS is a good reference standard to compare the
      effect of this new currents.
    

Intervention name(s): 5 KHz; TENS; Sham stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): 5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands); TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands); Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcutaneous Electric Nerve Stimulation; Electric Stimulation Therapy; Unmodulated Alternating Currents; Neural Conduction; Pain Threshold
Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.
Condition: Postprandial Hyperglycemia; Metabolic Syndrome; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Metabolic Syndrome; Hyperglycemia
Study type: Interventional

Summary: 
      It has previously been shown in healthy subjects, that a carbonated water containing a mix of
      amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these
      findings, a flavored sparkling water product called Good Idea® with a proprietary blend of
      five amino acids and chromium picolinate has been developed. This product, along with an
      identical placebo, are included in this study to evaluate the effects on postprandial blood
      glucose in healthy, overweight adults when consumed with a standardized, high glycemic test
      meal. The study will be conducted in a cross-over design, double-blinded and placebo
      controlled, including 45 participants. The primary endpoint of the study is the incremental
      area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of
      the meal.
    


Intervention name(s): Carbonated water with amino acids and chromium; Placebo Carbonated Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes; The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Aliskiren, Irbesartan, and the Combination in Hypertensive Patients With Type 2 Diabetes and Diabetic Nephropathy
Condition: Diabetes Type 2
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the reno-protective effect of renin inhibition with aliskiren as an
      alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic
      nephropathy.
    

Detailed description: 
      Antiproteinuric Effects of Aliskiren (Renin Inhibitor), Irbesartan (Angiotensin Receptor
      Antagonist) and the Combination in Hypertensive Patients With Type 2 Diabetes and
      Incipient/Overt Diabetic Nephropathy
    

Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Placebo-controlled study; assess the renoprotective effect of renin inhibition; Aliskiren as an alternative to irbesartan; Type 2 diabetes patients; incipient/overt diabetic nephropathy
Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education
Condition: Under Oral Anticoagulation Patients
Study type: Observational

Summary: 
      To assess the value of a dedicated knowledge questionnaire, filled by the patient prior
      consultation. Indeed, it could allow to target specific shortcomings of patients first, and
      help the cardiologist to prioritize the other therapeutic education, targeting specifically
      the information provided.
    

Detailed description: 
      The main objective is to study the impact of a pre-consultation questionnaire on the
      knowledge gained by the patient on anticoagulant treatment at the exit of cardiology
      consultation.

      The assumption is that this questionnaire would help educate patients about their
      shortcomings and educate cardiologists lack of knowledge of his patient.

      The secondary objectives are :

        -  Target specific areas in which patients have the greatest lack of information

        -  Assess the impact of educational level on information

        -  Assess the impact of age on information

        -  Evaluate the satisfaction of the information delivered

        -  Assess patient anxiety vis-à-vis their treatment

        -  Evaluate the failure rate of the questionnaire to know the number of patients refusing
           to participate in the study
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Complete a survey prior to the consultation and a questionnaire after
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients scheduled for cardiac consultation treated with oral anticoagulation
A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit
Condition: Paraplegia; SCI
MeSH terms: Paraplegia
Study type: Interventional

Summary: 
      The ReWalk enables people with lower limb disabilities to carry out routine ambulatory
      functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such
      as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other
      severe walking impairments. The device promises to restore the dignity of disabled persons,
      enabling them to work and improve their general health and quality of life, as well as
      significantly reduce medical and other related expenses.
    

Detailed description: 
      The ReWalk comprises light wearable brace support suit, which integrates DC motors at the
      joints, rechargeable batteries, an array of sensors and a computer-based control system. It
      is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new
      realization of the Powered Exoskeleton concept, first tried about fifty years ago with no
      success. Employing an innovative, non-robotic design approach, it uniquely matches the user's
      capabilities with the control mechanisms. Upper-body movements of the user are detected and
      used to initiate and maintain walking processes. User stability and safety during ambulation
      is secured by concurrent use of safety aids such as crutches for walking and railing for
      stairs.
    

Intervention name(s): ReWalk - a motorized exoskeleton suit
Intervention type(s): Device
Intervention description(s): The subject will wear the ReWalk suit and have training sessions for walking with the device.
Other intervention name(s): Exoskeleton suit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ReWalk, Paraplegia, SCI
CC-4047 in Treating Patients With Myelofibrosis
Condition: Chronic Myeloproliferative Disorders; Secondary Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in
      different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer
      cells by blocking blood flow to the cancer.

      PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well
      it works in treating patients with myelofibrosis.
    

Detailed description: 
      OBJECTIVES:

      Phase I:

      Primary

        -  To determine the Maximum Tolerated Dose of CC-4047 in the treatment of Primary, Post
           Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or
           post-ET MF).

      Phase II:

      Primary

        -  Best overall response as determined by International Working Group Criteria over the
           first 6 cycles (168 days) of study treatment.

      Secondary

        -  Safety (type, frequency, severity [National Cancer Institute (NCI) Common Terminology
           Criteria for Adverse Events (CTCAE) version 3.0] of adverse events (AEs), and
           relationship of AEs to CC-4047.

        -  Duration of response.

        -  Time to response.

        -  Best overall response as determined by International Working Group Criteria over the
           first 12 cycles (336 days) of study treatment.

      OUTLINE: Patients receive oral CC-4047. Treatment repeats every 28 days in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed at 28 days and then every 6 months
      for up to 3 years.
    

Intervention name(s): CC-4047
Intervention type(s): Drug
Intervention description(s): CC-4047: taken orally each day in a 28 day cycle.
Intervention MeSH terms: Pomalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: secondary myelofibrosis; polycythemia vera; essential thrombocythemia; primary myelofibrosis
Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      prospective multicenter study The main aim is to study the impact of maternal COVID-19 on
      breast milk immune, microbiological, and metabolic profile and infant growth and development
    


Intervention name(s): maternal SARS-CoV-2 infection
Intervention type(s): Other
Intervention description(s): positive PCR in nasopharinx and/or presence of antibodies in serum
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with SARS-CoV-2 infection at the end of pregnancy, before delivery following
        hospitals COVID19 screening protocols.
      
Keywords: Breast milk; Microbiota; Sars-CoV-2; metabolites; immune compounds; infant growth and development
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Condition: HC-BPPV
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to compare the immediate efficacies of each treatment maneuvers
      in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).
    

Detailed description: 
      A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of
      HC-BPPV were randomized to one of each three treatment groups at their first clinic visit.
      These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in
      apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning
      maneuver immediately after each treatment method based on resolves of vertigo and positional
      nystagmus.
    

Intervention name(s): Gufoni maneuver; Head-shaking maneuver; sham maneuver
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).; For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.; For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BPPV(benign paroxysmal positional vertigo); HC-BPPV(BPPV involving the horizontal semicircular canal); Nystagmus; Treatment outcome; Horizontal Canal Benign Paroxysmal Positional Vertigo
Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated
      Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy
      (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic
      control in Type 2 Diabetes patients.
    

Detailed description: 
      Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal
      junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is
      interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA
      staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects
      were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body
      upto angle of His with a sizing bougie ranging from size 32--58 Fr.
    

Intervention name(s): Ileal Interposition with Sleeve Gastrectomy
Intervention type(s): Procedure
Intervention description(s): Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.
Other intervention name(s): Laparoscopic Ileal Interposition surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ileal Interposition; Sleeve Gastrectomy; Type-2 Diabetes
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
Condition: Spinal Fusion; Cardiopulmonary Bypass
Study type: Interventional

Summary: 
      The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and
      compare obtained results versus standard laboratory coagulation parameters prothrombin time
      (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results
      will also be examined. A total of 100 pediatric patients undergoing spinal surgery or
      cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be
      obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck®
      device. If the two results are comparable, this could have immediate clinical application and
      impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2
      hours for standard laboratory samples.
    


Intervention name(s): CoaguChek; Hospital Laboratory
Intervention type(s): Device; Other
Intervention description(s): Hand held coagulation monitor.; Coagulation testing done by hospital laboratory.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers
Condition: Advanced Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine safety and maximum tolerated dose of brivanib alaninate when administered in
      combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel
      chemotherapy to subjects with advanced or metastatic solid tumors
    


Intervention name(s): Capecitabine; Doxorubicin; Ixabepilone; Docetaxel; Paclitaxel; Brivanib alaninate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression; IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression; IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression; IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression; IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression; Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression
Other intervention name(s): Xleoda®; Adriamycin®; IXEMPRA®; BMS-247550; Taxotere®; Taxol®; BMS-540215
Intervention MeSH terms: Paclitaxel; Docetaxel; Doxorubicin; Capecitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic, chemotherapy combination
Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is
      more effective in the prevention of renal graft rejection (considering an acute rejection
      rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).
    

Detailed description: 
      Major advances in immunosuppressive therapy have resulted in long-term graft survival by the
      use of various drug combinations.However, these combinations carry the risk of e.g.
      infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism,
      cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to
      reduce immunosuppression without increasing risk of rejections.

      Based on good results of a pilot study (not a single acute rejection episode during the 18-20
      months observation period despite low level of Tacrolimus and absence of steroids) this
      randomised trial was designed to further evaluate the safety and efficacy of Campath-1H.
    

Intervention name(s): Alemtuzumab; Tacrolimus; Alemtuzumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Day 0: Campath-1H 20 mg IV infusion over 3-6 hours
Day 1: Campath-1H 20 mg IV infusion over 3-6 hours; Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml.
till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months).
Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.; Day 0: Campath-1H 30 mg IV infusion over 3-6 hours
Day 1: Campath-1H 30 mg IV infusion over 3-6 hours
Other intervention name(s): MABCAMPATH; Prograf; Advagraf; MABCAMPATH
Intervention MeSH terms: Alemtuzumab; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Campath-1H; Alemtuzumab; Tacrolimus; renal transplantation; immunosuppression; prevention of acute rejection
Saccharomyces Boulardii in Irritable Bowel Syndrome
Condition: Diarrhea Dominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Various studies have been conducted in past using different strains of probiotics in
      evaluating IBS symptoms. The results are by no means consistent and the overall impact of
      probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that
      Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was
      associated with normalization of the ratio of an anti-inflammatory to a proinflammatory
      cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this
      disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the
      antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It
      ameliorates intestinal injury and inflammation caused by a wide variety of enteric
      pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess
      the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant
      IBS and its effect on quality of life. We also plan to assess the changes in the relative
      production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8
      and TNFα).
    


Intervention name(s): Saccharomyces boulardii; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Saccharomyces boulardii one capsule 250mg TDS for 6 weeks
Ispaghula husk 1 Tsf daily after dinner for six weeks; Cap Placebo TDS for six weeks
Ispaghula husk 1 Tsf daily after dinner for six weeks
Other intervention name(s): Enflor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS; Saccharomyces boulardii; probiotics; cytokine; histology; Efficacy