bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility
Condition: Musculoskeletal Manipulations
Study type: Interventional

Summary: 
      No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on
      neurodynamic mobility, as compared to a sham intervention. This study aims to determine the
      immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test
      (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.
    

Detailed description: 
      A convenience sample will be utilized to obtain subjects. Subjects will be given a brief
      questionnaire to identify possible contraindications for spinal treatment techniques and
      exclude individuals if necessary. Subjects will be randomized into one of two groups (spinal
      manual therapy or spinal range of motion which will serve as the name for the placebo group)
      and participate in neurodynamic testing procedures of the upper extremity (Upper Limb
      Provocation Testing) as well as lower extremity (Seated Slump Test). Subjects who are
      determined to be positive for one or more limbs will receive either a thoracic spine
      manipulation technique (spinal manual therapy) or a thoracic spine sham manipulation
      technique (spinal range of motion/placebo). After application of the technique, previously
      positive limbs will be retested. In attempt to determine validity and believability of the
      sham procedure and perception of its effect, subjects will be asked if they believe their
      upper/lower quarter mobility will change based on the group name and after the technique is
      applied. Subjects will also be asked if they believed they were in the treatment or placebo
      group.
    

Intervention name(s): Spinal Manual Therapy; Spinal Range of Motion
Intervention type(s): Procedure; Procedure
Other intervention name(s): Active treatment group; Placebo/Sham group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracic Spine Manipulation; Neurodynamics; Sham
Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
      letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy
      using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor
      cells. If is not yet known which treatment regimen is most effective for breast cancer.

      PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole
      with that of tamoxifen in treating postmenopausal women who have breast cancer that has been
      surgically removed.
    

Detailed description: 
      OBJECTIVES:

        -  Compare adjuvant letrozole vs tamoxifen administered for 5 years in postmenopausal women
           with operable, hormone receptor-positive breast cancer.

        -  Compare these treatment regimens given sequentially vs continuously in this patient
           population.

        -  Compare these treatment regimens in terms of overall survival, disease-free and
           systemic-free survival, safety, and tolerability in this patient population.

      OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
      according to adjuvant chemotherapy (prior therapy vs no prior or concurrent therapy vs
      concurrent therapy), prior surgery (modified radical mastectomy vs a lesser surgical
      procedure), and participating center. Patients are randomized to one of four treatment arms.

        -  Arm I: Patients receive adjuvant oral tamoxifen daily for 5 years.

        -  Arm II: Patients receive adjuvant oral letrozole daily for 5 years.

        -  Arm III: Patients receive adjuvant oral tamoxifen daily for 2 years followed by adjuvant
           oral letrozole daily for 3 years.

        -  Arm IV: Patients receive adjuvant oral letrozole daily for 2 years followed by adjuvant
           oral tamoxifen daily for 3 years.

      Patients may receive concurrent radiotherapy. Some patients receive concurrent adjuvant
      chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6 months.

      Patients are followed annually.

      PROJECTED ACCRUAL: A total of 5,180 patients (1,295 per treatment arm) will be accrued for
      this study within 6 years.
    

Intervention name(s): letrozole; tamoxifen citrate
Intervention type(s): Drug; Drug
Intervention description(s): Letrozole 2.5 mg daily oral administration.; Tamoxifen 20 mg daily oral administration.
Intervention MeSH terms: Tamoxifen; Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; breast cancer in situ; recurrent breast cancer; ductal breast carcinoma; lobular breast carcinoma in situ
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids
Condition: Healthy; Modeling Psychosis
MeSH terms: Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the gene-environment interaction of the COMT-genotype on the effects of
      the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on
      induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal
      processing, and neural oscillations. In addition the effects of the phytocannabinoids on
      lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal
      processing assessed by EEG and fMRI.
    


Intervention name(s): delta-9-tetrahydrocannabinol; Cannabidiol; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Dronabinol
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: delta-9-tetrahydrocannabinol; cannabidiol; COMT; Volunteers
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
Condition: ADHD; Autism; Bipolar I Disorder; Conduct Disorder; Oppositional Defiant Disorder
MeSH terms: Nervous System Diseases; Central Nervous System Diseases; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages
      6 to <13 years with CNS disorders.
    

Detailed description: 
      A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics,
      safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders
      who are receiving antipsychotic treatment for their medical condition.
    

Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Tablet
Other intervention name(s): OPC-34712
Intervention MeSH terms: Brexpiprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CNS Disorders; Brexpiprazole
Dietary Intervention and Vascular Function
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      It is well established that diet plays an important role in both the development and
      progression of heart disease. Different types of dietary fat have varying effects on heart
      disease risk factors. The elasticity of an individual's blood vessels is strongly associated
      with heart disease risk and recent evidence suggests that dietary manipulation may influence
      elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and
      polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence
      exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and
      rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in
      vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels.
      However, the influence of these dietary fats on the elasticity of blood vessels remains
      unclear.The main purpose of the DIVAS study is to determine the effects of the substitution
      of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel
      elasticity and to determine the effects of these different dietary fats on other risk factors
      for heart disease including lipoproteins and inflammatory biomarkers.
    


Intervention name(s): SFA diet; MUFA diet; n-6 PUFA diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers are following a high saturated fat diet for a 4-month period; Volunteers are following a high monounsaturated fat diet for a 4-month period; Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: fatty acids; cardiovascular disease; vascular function; microparticles
Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium
Condition: Cervical Artery Dissection
MeSH terms: Aortic Dissection; Recurrence
Study type: Observational

Summary: 
      Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause
      of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have
      been described, suggesting that pregnancy and puerperium may be potential risk factors for
      CAD. The purpose of this study is to determine whether pregnancy and puerperium are also
      recurrence risk factors for CAD.
    

Detailed description: 
      In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are
      selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text
      search with key words ("cervical or carotid or vertebral dissection") has been created in a
      data warehouse of the University Hospital of Nantes.

      To determine the recurrence of CAD during pregnancy and puerperium, the participating women
      will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be
      conducted by the same investigator, an experienced neurologist. Information about recurrence
      of CAD, number of pregnancies before and after the event will be recorded, as well as, the
      site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case
      of further pregnancy. In case of no further pregnancy after the dissection, the reason will
      be explored.
    

Intervention name(s): questionnaries
Intervention type(s): Other
Intervention description(s): Study on questionnaries
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          -  Extracranial carotid or vertebral dissection

          -  Symptomatic dissection (with symptom onset within the last four weeks)

          -  Spontaneous dissection

          -  Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.
      
Keywords: Pregnancy; Puerperium Recurrence; Cervical artery dissection
Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure
Condition: Smokers; Never Smokers
Study type: Interventional

Summary: 
      This study intends to evaluate the nasal mucociliary clearance (NMC) by determining the value
      obtained for saccharin transit time (STT) test over the course of 12 hours following a single
      cigarette use in adult smokers, to compare it relative to never smokers, and to examine the
      relationship between plasma nicotine levels and STT value in smokers and never smokers.
      Safety will also be monitored during the study.

      The planned maximum study duration for a single study participant from Screening through
      completion of study will be 33 days.
    


Intervention name(s): Cigarette
Intervention type(s): Other
Intervention description(s): After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: nasal mucociliary clearance; saccharine transit time
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Condition: Chronic Kidney Disease; Kidney Transplantation
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      People with kidney transplants often develop bone disease. One reason for bone disease may be
      overactivity of a gland in the neck called the parathyroid gland. Overactivity of the
      parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been
      discovered that many patients with kidney transplants have low Vitamin D levels. The
      investigators are examining the effects of doxercalciferol on parathyroid hormone levels,
      proteinuria and bone turnover markers in people who have had a kidney transplant.
    

Detailed description: 
      People with kidney transplants often develop bone disease. One reason for bone disease may be
      overactivity of a gland in the neck called the parathyroid gland. Overactivity of the
      parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been
      discovered that many patients with kidney transplants have low Vitamin D levels.

      25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D
      levels but it may not be enough to treat the parathyroid problems and bone disease.
      Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and
      parathyroid problems in dialysis patients but has not yet been studied in patients with
      kidney transplants. We are interested in seeing whether doxercalciferol given together with
      25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone
      disease than 25-OH Vitamin D3 alone in patients with kidney transplants.
    

Intervention name(s): Doxercalciferol; placebo; 25-OH Vitamin D3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active group receives doxercalciferol (Hectorol) 1mcg; Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol); All groups received cholecalciferol
Other intervention name(s): Hectorol (the other name for Doxercalciferol); Placebo for doxercalciferol; (cholecalciferol)
Intervention MeSH terms: Vitamin D; Cholecalciferol; 1 alpha-hydroxyergocalciferol; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: kidney transplantation; kidney transplant recipients
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to learn if it is safe for rheumatoid
      arthritis patients to take BMS-582949 along with methotrexate.
    


Intervention name(s): BMS-582949 and Methotrexate
Intervention type(s): Drug
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery
Condition: Analgesia; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of our study is to reduce postoperative pain by performing external oblique
      intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed
      post-operative analgesia.
    

Detailed description: 
      The patients will be divided into two groups and general anesthesia will be applied to all of
      them. There will be no regional anesthetic technique to be performed, on the other hand,
      external oblique intercostal nerve block will be applied to patients in the other group
      before the patients are extubated. Study randomization is done with computer-generated
      randomization codes (computer-generated) by a physician who will not participate in patient
      follow-up. Interfascial plane block (external oblique intercostal block) will be given to the
      anesthesiologist in a sealed envelope by an independent assistant staff outside the study,
      the patient will not know which block is applied. The anesthetist who made the block will not
      participate in the pain follow-up of the patients. Postoperative pain assessment and data
      collection will be performed by another anesthetist blinded to the study.

      For the standardization, the block procedure will be performed by an experienced
      anesthesiologist who has performed at least 20 previous successful and uncomplicated
      procedures.
    

Intervention name(s): Pain Management
Intervention type(s): Other
Intervention description(s): Regional anesthetic techniques for peri-operative pain management after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One interventional group and one control group.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: External oblique intercostal block; Pain management
Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
Condition: Acute Unilateral Rupture of the Achilles Tendon
MeSH terms: Rupture
Study type: Observational

Summary: 
      Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the
      usual treatment in young subjects, and although the optimal technique is still a matter of
      debate, conventional surgery with a direct approach is still the reference technique in young
      sportsmen and women. Studies investigating the evolution of ankle muscle strength following
      surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to
      determine the possibility of returning to the sport. This project thus proposes to study, in
      comparison with the healthy ankle:(1) the evolution of muscle strength in the
      flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic
      dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12
      months, following surgery for acute unilateral rupture of the Achilles tendon, operated on
      using the conventional technique in young sportsmen and women and in comparison with the
      healthy side.
    


Intervention name(s): Questionnaire; Static stabilometry; Isokinetic test
Intervention type(s): Other; Other; Other
Intervention description(s): Interview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire; on a force plate, in a double- then single-foot stance, with the eyes open and then closed; Isokinetic test of the flexors/extensors and invertors/evertors of the ankle
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU
Effectiveness of Internet-based Depression Treatment
Condition: Mild to Moderate Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      Care for people suffering from depressive symptoms should be given in a step-wise approach.
      One first step can be the provision of self-help material. Online self-help is an innovative
      way of providing self-help. The investigators want to study the effect of an interactive
      online self-help-program (Deprexis) in the treatment of mild to moderate depressive symptoms.
      Participants will be randomised to either twelve weeks of online-self help or a waiting-list
      control. Symptoms of depression and other aspects will be assessed over a one year period.
      Thereafter the controls will also receive online-self help. The investigators hypothesise
      that online self-help is superior to the control condition in alleviating depressive symptoms
      and preventing full blown depression.
    

Detailed description: 
      This study is supported by the German Ministry of Health (BMG) and is a collaborative project
      of Universität Bern (PD Dr. Thomas Berger), Charité Berlin (PD Dr. Matthias Rose),
      Universität Bielefeld (Prof. Dr. Wolfgang Greiner), Universität Hamburg (Prof. Dr. Steffen
      Moritz, Prof. Dr. Bernd Löwe), GAIA AG Hamburg (Dr. Björn Meyer), Universität Tübingen (Prof.
      Dr. Martin Hautzinger) and Universität Trier (Prof. Dr. Wolfgang Lutz).
    

Intervention name(s): Deprexis
Intervention type(s): Behavioral
Intervention description(s): Online self-help with and without e-mail-support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment