bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of Kukoamine B Mesilate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single
      intravenous injection Kukoamine B Mesilate in health volunteer
    


Intervention name(s): Kukoamine B Mesilate
Intervention type(s): Drug
Intervention description(s): Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy
Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia
Condition: Pain
Study type: Interventional

Summary: 
      To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation
      (TENS) in reducing patient's discomfort during colonoscopy
    

Detailed description: 
      Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic
      methods.
    

Intervention name(s): Acupuncture; Transcutaneous electrical stimulation; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy; Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy; Patients are monitored for pain and discomfort
Other intervention name(s): Electroacupuncture; TENS; No treatment (only sedative drugs if request)
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pain; Acupuncture; Transcutaneous electrical nerve stimulation; Colonoscopy
Functional Bioactive Supplement Effect in Lost Weight Treatment
Condition: Obesity and Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose this study is to evaluate the therapeutic effect of a functional bioactive
      supplement associated with a hypocaloric equilibrated diet to treat obese and overweight
      individuals. The functional bioactive supplement, containing antioxidant extracted from
      rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to
      satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as
      well as to weight loss.
    

Detailed description: 
      A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic
      effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet
      to treatment of obesity and overweight.

      Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC >25<35 kg/m2)
      were included in the study. The clinical trial will be performed in the Clinical Nutrition
      Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a
      dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.
    

Intervention name(s): Functional bioactive supplement; Control supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Other intervention name(s): antioxidant, oligosaccharides and bioactive peptides
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Clinical trials; Adult; Women; Functional food; Dietary Supplements; Overweight; Obese; Absorptiometry, Dual X-Ray; Rosmarinus; Oligosaccharides; Lactulose; Bioactive peptide
Prevention Program Promoting Self Resilience,Positive Self-Image and Body Image Among Adolescence Aged 15-17
Condition: Primary Prevention
Study type: Interventional

Summary: 
      The study was a group randomized controlled trial. Within each school Classes of high school
      students were allocated by randomization to the intervention or control group by a function
      Randomization in Excel program. Outcomes were measured by questionnaire at pre- intervention,
      post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai college
      institutional review board. Parents of all participants, in the intervention and in the
      control group, received information about the program and the study and were choose whether
      to provided informed consent or not.
    

Detailed description: 
      Participants and setting Two high schools were recruited for the study, in each school
      classes from grades 9th and 10th were chosen to participate in the study all mixed gender
      classes. The two high schools are in northern Israel, one in a rural area and the second in a
      small city, both serving the Jewish population. The size of the schools were similar. All
      data were collected within the school setting.

      Program description "Towards a more resilient self" is an interactive, cognitive behavior
      program aiming to address low resilience, low self-esteem and body dissatisfaction. The
      program contains a range of coping strategies to help adolescents improve resilience,
      self-esteem and body image. The program consists of nine 90-min sessions delivered by one
      group leader in the presence of the classes' teachers. Participants in the control group
      received one session of 90 minutes with health nutrition education.
    

Intervention name(s): program "In Favor of Resilience Self"
Intervention type(s): Other
Intervention description(s): A prevention program aiming at improve self-resilience ,self-esteem and body image, contains nine interactive activities, based on a cognitive dissonance method.
Other intervention name(s): "In Favor of myself"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: resilience; prevention program; body image; self esteem
Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
Condition: Varicella; Rubella; Mumps; Measles
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this observer blinded study is to provide information on vaccine
      immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when
      administered with Hepatitis A vaccine and Pneumococcal vaccine.
    


Intervention name(s): Priorix-Tetra™ (MMRV vaccine 208136); ProQuad®; Havrix®; Prevnar®
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One subcutaneous injection.; One subcutaneous injection.; Two intramuscular injections.; One intramuscular injection.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccines; Rubella; Varicella Vaccine; Children; Humans; Mumps; Immunogenicity; Safety; Measles; Combined Vaccine
Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage; Hematoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being
      independent at 6 months. There is currently no approved treatment for ICH which has been
      shown to improve outcomes. In an effort to develop a new treatment for ICH, this research
      focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing
      absorption of the blood clot with medication.
    

Detailed description: 
      Intracerebral hemorrhage (ICH) remains a devastating disease and current treatment options
      lag far behind those for ischemic stroke. Current treatment efforts for ICH are targeted
      towards the primary brain injury caused by the hemorrhage and growth of the hematoma. This
      research targets the secondary injury caused by the persistence of toxic blood degradation
      products in the brain parenchyma.

      Based on preclinical work in our lab, the peroxisome proliferator activated receptor-gamma
      (PPARγ), a member of the nuclear receptor superfamily, represents a possible target for the
      treatment of ICH aimed at promoting hematoma absorption, limiting the pro-inflammatory
      response, and protecting salvageable tissue from the damage produced by the persistence of
      toxic blood degradation products.

      Our primary specific aim is to assess the safety of the PPARγ agonist, pioglitazone (PIO) in
      increasing doses for 3 days, when administered to patients with ICH within 24 hrs of symptom
      onset. Secondarily, we aim to determine the duration of treatment of PIO for hematoma/edema
      resolution in ICH. Lastly, we aim to determine whether speed of hematoma/edema resolution in
      ICH represents a radiographic biological marker of activity which can be correlated with
      clinical outcome and treatment effect of PIO. The ultimate purpose is to provide baseline
      data on an aspect of ICH which has not been previously targeted for treatment in an effort to
      develop a safe and effective treatment strategy that may be practical and applicable for both
      specialized stroke centers and community hospitals.
    

Intervention name(s): Pioglitazone; Placebo Control
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses for 3 days, then 30 mg orally daily for the duration of the study as determined by MRI; Lactose Capsule administered by mouth daily for the duration of the study as determined by MRI
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intracerebral Hemorrhage; Treatment; MRI
Effect of an Educational and Explanatory Program for a Surgical Act on Preoperative Anxiety
Condition: Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the impact on preoperative anxiety of an
      education and information program conducted prior to non-urgent coronary angiography
      performed in patients hospitalized at the Nîmes University Hospital.
    

Detailed description: 
      The secondary objectives of this study are to assess the impact of the HEARTLINK program on
      the following parameters:

      A. Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction
      (visual analog scale).
    

Intervention name(s): Inclusion visit; Nurse consultation; Telephone contact; Coronarography on day 0
Intervention type(s): Other; Other; Other; Procedure
Intervention description(s): This visit takes place between days -15 and -7 preceding a coronarography scheduled for Day 0. It is part of standard care and corresponds to a required cardiology consultation.; This visit takes place on the same day as the inclusion visit and includes practical advice concerning the hospital stay, explanations concerning the surgical act and practical advice on its implementation, information on the length of stay and after. An explanatory booklet concerning the surgical procedure is provided to the patient.; A nurse will telephone the patient 72h to 48h before the coronarography scheduled for day 0. During the telephone conversation the nurse will assess the patient's knowledge about his/her pathology, his/her examination and the course of hospitalization. The nurse will answer any questions and if needed provide further information.; This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Coronary Angiography
A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid
      Arthritis patients who showed unsuccessful response against methotrexate.
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Prograf; Calcinurin inhibitor; Rheumatoid arthritis(RA)
BIOTRONIK 4French for AMBulatory Peripheral Intervention
Condition: Peripheral Artery Disease; Access Site Complication; Outpatient Treatment
MeSH terms: Peripheral Arterial Disease
Study type: Observational

Summary: 
      BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial
      comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity
      peripheral artery disease in an ambulatory setting: BIO4AMB
    

Detailed description: 
      Controlled, multicenter, non-inferiority trial to compare the rate of access site
      complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular
      interventions.
    

Intervention name(s): Biotronik 4 French Portfolio; 6 French Portfolio
Intervention type(s): Device; Device
Intervention description(s): Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease; Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular
        treatment
Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
Condition: Lumbar Disc Herniation; Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement; Sciatica; Constriction, Pathologic; Hernia
Study type: Observational

Summary: 
      The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar
      disc herniation and 60-70% in patients with spinal stenosis.

      At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc
      herniation and spinal stenosis are treated by a multidisciplinary team comprising
      rheumatologists, physiotherapists, chiropractors, and social workers according to current
      guidelines. Therefore we have a unique opportunity to report the long term outcome in
      candidates for surgery, regardless of whether they have surgery or not, after having received
      optimal but unsuccessful nonsurgical treatment.

      The purpose of this study is to answer the following questions: 1) What is the proportion of
      patients operated upon after referral to surgical evaluation with positive MRI findings,
      persistent low back pain, and poor outcome following non-operative treatment? 2) What was the
      outcome in these patients 2 years following referral? 3) Where any baseline variables
      predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in
      patients with or without surgery?
    


Intervention name(s): Low back pain surgery
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with low back pain referred to surgical evaluation with positive MRI findings,
        persistent low back pain, and poor outcome following non-operative treatment
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
Condition: Restless Legs Syndrome; Insomnia; Sleep Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aim to determine the effect of suvorexant on actigraphically-derived total
      sleep time in patients with effectively treated restless legs syndrome with persistent
      insomnia in a two-arm, double-blind, randomized placebo-controlled crossover 2.5-month trial.
    

Detailed description: 
      Restless Legs Syndrome (RLS) is a sensory-motor neurological disorder characterized by an
      irresistible urge to move the legs. Persistent difficulties with all phases of sleep are
      common in patients whose RLS symptoms are resolved with treatment. Multiple potential causes
      for treatment-refractory sleep disturbance exist, including activating effects of dopamine
      agonists (which are first-line RLS treatments), conditioned insomnia and poor sleep habits as
      a result of chronic RLS-related sleep disturbance, and comorbid medical and psychiatric
      illness. Suvorexant provides an important therapeutic option to treat insomnia in the context
      of RLS. It has demonstrated long-term efficacy, particularly in shortening the duration of
      nocturnal awakenings and increasing total sleep time. Similarly, it has a comparatively
      benign side effect profile compared to many other agents typically prescribed to treat
      insomnia. The investigators aim to determine the effect of suvorexant on
      actigraphically-derived total sleep time, as well as actigraphically-derived wake after sleep
      onset, Insomnia Severity Index score, subjective sleep endpoints, and RLS symptom severity.
    

Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10-mg or 20-mg suvorexant capsules; Matching placebo capsules
Other intervention name(s): Belsomra
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized in a 1:1 ratio to suvorexant 10-20 mg or equivalent placebo for four weeks followed by crossover (after a 2-week washout) to the alternate treatment.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Suvorexant
Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy
Condition: Neurological Diseases, Heart or Respiratory Failure,; Sepsis, Trauma.
MeSH terms: Respiratory Insufficiency; Nervous System Diseases
Study type: Observational

Summary: 
      The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask
      during percutaneous tracheostomy.
    

Detailed description: 
      Percutaneous tracheostomy is routinely performed while patients are being ventilated with a
      laryngeal mask. The efficacy of ventilation during tracheostomy may be affected by length of
      previous endotracheal intubation.

      This is an observational and monocentric study aimed to evaluate the impact of length of
      endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. Two groups of
      patients who have to undergo elective percutaneous tracheostomy after either a short or long
      endotracheal intubation will be enrolled.

      Data on the correlational effects of the endotracheal tube on the integrity of laryngeal
      structures and on ventilation will be collected.

      Statistical analyses will use standard tests to compare the two groups of patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ICU patients.
      
Keywords: Endotracheal intubation; tracheostomy; laryngeal mask
Descriptive Study of Pain, Anxiety and Depression
Condition: Pain
MeSH terms: Depression
Study type: Observational

Summary: 
      The purpose of the study is to investigate pain, anxiety and depression in chronic pain
      patients with and without neuropathic pain compared with healthy volunteers
    

Detailed description: 
      Primary outcome measures:

        -  Symptom checklist 92

      Secondary outcome measures:

        -  Hamilton Depression and Anxiety Rating Scale

        -  Major Depression Inventory

        -  GAD-10 Anxiety Scale

        -  Health Survey SF-36

        -  McGill Pain Questionnaire

        -  Sweat test

        -  Heart rate variability testing

        -  Coping Strategy Questionnare

        -  Quantitative sensory testing

        -  Pain Catastrophizing Scale

        -  Pain rating (VAS)

        -  Interview
    

Intervention name(s): Observation
Intervention type(s): Behavioral
Time perspective: Prospective
Keywords: Neuropathic pain; Chronic pain; Depression; Anxiety
Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic Polymorphism
Condition: Healthy
Study type: Observational

Summary: 
      The purposes of this study are:

        -  To determine the absolute bioavailability of voriconazole after a single oral dose (400
           mg voriconazole [VFEND brand]) in comparison to intravenous (i.v.) administration (400
           mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole
           [VRC]) in healthy individuals stratified according to the three predominant CYP2C19
           genotypes

        -  To investigate the possible pathways of metabolism and their modulation according to
           genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.
    

Detailed description: 
      As CYPs are mainly involved in VRC metabolism it is likely that also gut wall metabolism by
      CYPs occurs. However, no substantial first pass metabolism of VRC has been reported. In
      humans the VRC metabolism has not been studied systematically. It is therefore important to
      assess VRC metabolism on its own and in addition the influence of CYP2C19 genetic
      polymorphisms on the formation of the different VRC metabolites.
    

Observational model: Defined Population
Time perspective: Other
Keywords: voriconazole; genotype; bioavailability; metabolic clearance