bioihbjkbjnl/mcl2 huggingface dataset:
Magnesium and Platelet Function Testing
Condition: Eclampsia Preeclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      Magnesium has built up the reputation of a 'natural calcium antagonist'. However, the exact
      effect of magnesium on coagulation and more specifically on platelet function is still
      disputed. An important discrepancy between in vivo and in vitro studies exists. Magnesium has
      thus been reported to antagonize platelets in some studies, and to stimulate platelets in
      other studies. Current evidence seems to point in the direction of a general antagonization
      of aggregation and coagulation.

      Intravenous magnesium is often administered in pre-eclampsia as seizure prophylaxis.
      Therapeutic regimens usually consist of an intravenously administered loading dose (2-3
      grams) and a maintenance infusion, targeting a plasma level of 2-3 mmol/L. Therapeutic drug
      monitoring is needed, as magnesium toxicity is an important concern.
    


Intervention name(s): Collect a study-specific blood sample of healthy subjects
Intervention type(s): Other
Intervention description(s): One heparin tube (4ml) and one hirudin tube (4ml) blood sample will be collected through standard venipuncture. After applying a tourniquet with moderate pressure around the arm of the patient's choice, skin will be disinfected over a suitable vein in the elbow or fore-arm. A hirudin and a heparin tube will be filled with venous blood through a single puncture with a 22 Ga needle (manufacturer, location). After release of the tourniquet, bleeding will be stopped by applying local pressure for 5 minutes with a sterile gauze.
Other intervention name(s): Collect an extra blood sample of pregnant woman during a routine control with an already planned blood sample collection
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Females over 18 years of age (and younger or equal to 50 years of age) that meet the
        American Society of Anesthesiologists physical fitness scale 1 (non smoker, no or minimal
        alcohol use, ..)
The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients
Condition: Uncomplicated Hypertension; Hypertension; Essential
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The sustained reduction in elevated blood pressure and lower incidence of adverse events of
      Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium
      channel blockers). This study is to compare the efficacy and safety of Lacidipine with
      Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.
    


Intervention name(s): Lacidipine 4 or 6 mg (oral); Amlodipine 5 or 10 mg(oral)
Intervention type(s): Drug; Drug
Other intervention name(s): Lacidipine 4 or 6 mg (oral)
Intervention MeSH terms: Amlodipine; Lacidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: essential hypertension; Amlodipine; blood pressure; lacidipine
Perianal Fistula (PAF) Validation and Burden of Illness Study
Condition: Inflammatory Bowel Disease; Perianal Fistula; Crohns Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases; Rectal Fistula; Fistula
Study type: Observational

Summary: 
      The purpose of this study is to gain a better understanding of the disease burden and unmet
      need of perianal fistulas within Crohn's disease (CD) in Ontario.
    

Detailed description: 
      This is a retrospective follow-up observational study of participants with CD with and
      without complex perianal fistula (CPAF) from January 2002 to March 2017. The study will
      verify the potential of using procedure codes to reliably identify participants with CPAF in
      Validation Study (Objective 1), compare Crohn's participants with CPAF (cases) to matched
      participants without CPAF (controls) to determine the disease burden and healthcare resource
      utilization of Crohn's related CPAF in Ontario, and will describe the participant's journey
      among Crohn's participants following the first diagnosis of CPAF (Objective 3).

      The study will enroll approximately 600 participants (300 participants with CPAF and 300
      participants without CPAF). All participants will be enrolled in 2 observation groups:

        -  CD Participants with/without CPAF (ICES data)

        -  CD Participants with CPAF - The Ottawa Hospital (TOH)

      The data will be collected through Ontario health administrative data. Participants will be
      observed retrospectively who were diagnosed with CD with and without fistula between index
      period: April 2002 and July 2013. Participants will be followed up retrospectively from the
      index period (that is onset of CPAF) to the end of study (Objective 2), and for 5 years
      following the (Objective 3) index date defined as onset of CPAF will be selected based on the
      first time they meet the first code in the case definition identified in Objective 1 between
      April 1, 2005 to March 31, 2012. The overall time for data collection in this study will be
      approximately 7 months.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants diagnosed with CD with and without CPAF will be observed retrospectively in
        this study.
      
Keywords: Drug therapy
Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic
Condition: Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      This study focuses on how enriched environment along with the traditional physical therapy
      improves the gross motor function in spastic quadriplegic cerebral palsy children. And how
      much dosing is required to gain that clinically significant improvement.
    

Detailed description: 
      There is still a blurred area regarding dosage parameter in cerebral palsy rehabilitation.
      This study is focused primarily on the fact that level appropriate selection of time, type,
      frequency, and intensity of intervention (sensory and motor) plays a very vital role in
      developing gross motor functions. Secondly it is very important to establish the impact of
      enriched environmental inputs and foster parent capacity as an early intervention taking into
      account cerebral palsy (CP) specific positioning and handling along with level appropriate
      sensory inputs.
    

Intervention name(s): Enriched Environment; Traditional Physcial Therapy
Intervention type(s): Other; Other
Intervention description(s): Enriched Environment (EE) consisted of motor and sensory enriched play environment to promote participant's self-generated movements, exploration and task success. EE also included positioning in a graded manner. Visual stimulus and level appropriate vestibular stimulus was also given. Dosing of positioning and sensory inputs was done throughout the therapy. Primary Intervention will be given for 20 to 25 minutes intermittently for period of 4-5 hours a day, 5 days a week for 24 weeks.; Participants of this group received traditional physical therapy based NDT. No additional dosing guidance was given to this group. No home program was specifically assigned to this group. No specific environmental modifications were made for this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Therapeutic Dosing; Enriched Environment
Effects of a Dietary Supplement on Markers of Glucose Control and Quality of Life
Condition: Blood Glucose
Study type: Interventional

Summary: 
      This study is a double-blind, randomized, two-arm, placebo-controlled trial of apparently
      healthy men and women to be recruited at a single investigational center in Northeast Ohio
      (i.e. The Center for Applied Health Sciences). Subjects will attend four study visits. During
      Visit 1, subjects will be screened for participation (i.e., medical history, physical exam,
      routine blood work [also HgA1c, insulin], background baseline diet). Over the next 12 weeks,
      subjects will attend Visits 2-4, wherein assessments of serum glucose, insulin, HOMA-IR,
      2-hour glucose tolerance test (GTT), HgA1c, C-reactive protein, adiponectin, ferritin, waist
      circumference, quality of life questionnaire, and various visual analog scales for appetite,
      satiety, and cravings will be made.
    


Intervention name(s): Placebo; Chromium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Maltodextrin tablet; A tablet consisting of a blend of Crominex® 3+, Capros® Amla Extract (Fruit), PrimaVie® Shilajit), and MetaviveTM complex (Salacia Chinensis Extract (Fruit) and a Citrus Bioflavonoids)
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections; Vertigo; Dizziness
Study type: Interventional

Summary: 
      The recently emerged coronavirus named Severe Acute Respiratory Syndrome Coronavirus 2
      (SARSCoV-2) is the newest threat to human health. It has already infected more than half a
      million people worldwide, leading to a lot of deaths. Patients with Coronavirus Disease
      2019(COVID-19) will experience high levels of anxiety and low sleep quality due to isolation
      treatment. Purposes: Was to investigate the effect of aerobics and balancing exercises on
      anxiety and dizziness in patients with COVID-19. Subjects: Thirty anxiety and dizziness
      patients with COVID-19 aged from 45-65 years of both sexes, randomly divided into two groups,
      selected from outpatient clinic ,General
    

Detailed description: 
      In December 2019, a series of pneumonia cases of unknown cause emerged in Wuhan, Hubei,
      China, with clinical presentations greatly resembling viral pneumonia. Deep sequencing
      analysis from lower respiratory tract samples indicated a novel coronavirus, which was named
      2019 novel coronavirus Disease (COVID-19). On February 12, 2020, WHO officially named the
      disease caused by the novel coronavirus as Coronavirus Disease 2019 (COVID-19),and by March
      11th, 2020 when the number of countries involved was 114, with more than 118,000 cases and
      over 4000 deaths, the WHO declared the pandemic status
    

Intervention name(s): Aerobics exercises, Balance exercises
Intervention type(s): Other
Intervention description(s): Aerobic exercise, or endurance exercise, is a subdivision of physical exercise that improves cardiovascular and respiratory health. Additionally, it is generally assumed to increase well-being and reduce negative mood states such as anxiety and depression.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Finally, it could be concluded that aerobic exercise and balancing exercise with relaxation exercises decrease anxiety and dizziness in patients with COVID-19. So, it considered as effective, safe, cheap and successful adjunct treatment methods in reducing anxiety and dizziness in patients with COVID-19.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobics - Balance exercises -anxiety - dizziness disorder
TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional

Summary: 
      Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of
      Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between
      the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.
    

Detailed description: 
      Perineal Rectopexy is performed by an incision in the intersphincteric space followed by
      dissection till the sacral promontory then Proctoscope is inserted to complete the dissection
      .Mesh is inserted and fixed to the sacrum with laparoscopic tacker ( or can be left unfixed)
      then postanal repair is conducted in two layers ( levatorplasty then sphincteroplasty) and
      finally Ana cerclage is done with polyglactin 0 sutures
    

Intervention name(s): TEM perineal rectopexy
Intervention type(s): Procedure
Intervention description(s): perineal rectopexy using polyprolene mesh assisted by TEM technique and special proctoscope postanal repair in two layers to narrow the postanal space anal cerclage with absorbable sutures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TEM; Rectopexy; rectal prolapse
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will study the effect of paracetamol on the steady state metabolism of
      lamotrigine in 12 healthy male volunteers.

      Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28
      days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject
      will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be
      repeated.

      Primary outcome parameter is Lamotrigine AUC before and after coadministration of
      paracetamol.
    


Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AUC exposure to lamotrigine
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
Condition: Schizophrenia; Bipolar I Disorder
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, sequential-group, two site, multiple dose escalating study of
      sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I
      disorder; in one study cohort (3a) participants with other conditions treatable with chronic
      antipsychotic medication can also be enrolled. Participants will receive a single sublingual
      placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily
      (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a
      final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12
      (Cohort 3a).
    


Intervention name(s): Asenapine 2.5 mg; Asenapine 5 mg; Asenapine 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7.; Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7.; Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose on final day). For Cohorts 3b, 3c and 3d, rising dose schedule begins with asenapine 5 mg b.i.d. on Day 1 and dosing occurs through Day 8. For Cohort 3a, rising dose schedule begins with asenapine 2.5 mg b.i.d. on Day 1 and dosing occurs through Day 12.
Other intervention name(s): SCH 900274; Org 5222; SCH 900274; Org 5222; SCH 900274; Org 5222
Intervention MeSH terms: Asenapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asenapine; pediatric schizophrenia; bipolar I disorder
Biomarkers for Intestinal Permeability in Patients With Constipation
Condition: Intestinal Diseases; Irritable Bowel Syndrome; Constipation
MeSH terms: Irritable Bowel Syndrome; Intestinal Diseases; Constipation
Study type: Observational

Summary: 
      Our overall objective with this study is firstly to provide a comprehensive assessment of
      intestinal permeability, mucosal barrier function using existing biomarkers and secondly to
      explore novel biomarkers for measuring intestinal permeability in patients with constipation
      predominant Irritable Bowel Syndrome (IBS-C).
    

Detailed description: 
      In order to determine the differences in permeability in IBS-C in comparison with healthy
      volunteers, the following will be determined: differences in in vivo small intestinal and
      colonic permeability, differences in small intestinal and colonic mucosal barrier function,
      differences in effects of fecal supernatants on barrier function of T84 monolayers, and
      differences in novel biomarkers for intestinal permeability
    

Intervention name(s): Permeability measurement; Esophagogastroduodenoscopy; Flexible sigmoidoscopy
Intervention type(s): Diagnostic Test; Procedure; Procedure
Intervention description(s): Saccharide excretion was compared between IBS-C and healthy volunteers; Duodenal biopsies were collected from IBS-C and healthy volunteers; Colonic biopsies were collected from IBS-C and healthy volunteers
Other intervention name(s): 12C Mannitol; 13C Mannitol; Lactulose
Intervention MeSH terms: Mannitol; Lactulose
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        IBS-Constipation patients and healthy volunteers
      
Biospecimen description: 
      Colonic Biopsies Duodenal Biopsies Blood Urine Fecal
Evaluation of Mangoselect® in Improvement of Exercise/Activity-induced Knee Joint Discomfort in Subjects Suffering From Osteoarthritis Grade I or II
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of the present investigation is to evaluate the efficacy of Mangoselect®, a
      mangosteen extract, and of a formulation containing Mangoselect®, in subjects suffering from
      activity/exercise-induced knee joint pain/discomfort, during a 12-week supplementation
      period. Subjective discomfort improvement will be assessed with both WOMAC questionnaire and
      pain Visual Analogic Scale (VAS); functional joints features, quality of life, and
      inflammatory markers, will also be assessed. Finally, long lasting benefits will additionally
      be evaluated 4 weeks after the end of the supplementation period. The design of the study is
      double-blind, randomized, multi-arm, parallel and placebo controlled.
    


Intervention name(s): Placebo; Verum A; Verum B; Verum C
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.; Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.; Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.; Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
Condition: Cerebral Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Observational

Summary: 
      Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes
      following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage
      literature. How the brain injury affects cerebral oxygenation in patients with CVT is not
      currently known. Some of the factors that can affect cerebral oxygenation in patients with
      CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in
      Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how
      these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the
      cerebral oxygenation.
    


Intervention name(s): NIRS based Cerebral Oximetry
Intervention type(s): Device
Intervention description(s): Cerebral Oximetric measurement before and after decompressive craniectomy
Other intervention name(s): Equanox, Nonin Medical, Inc. Plymouth, Minnesota, USA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Cerebral venous thrombosis for Decompressive craniectomy
      
Keywords: Cerebral Oximetry; Cerebral Venous Thrombosis; Decompressive Craniectomy
Comparison of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminium Garnet (EO QS Nd:YAG) Laser to a Fractionated Laser System
Condition: Photodamage; Irregular Pigmentation; Acne Scars
Study type: Interventional

Summary: 
      The purpose of this study is to compare the results of treatment between the side of the face
      treated with the RevLite Laser and the side of the face treated with a fractionated laser
      system.
    


Intervention name(s): RevLite laser treatment; Fractionated Laser treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Electro-optic Q-Switched Nd: YAG Laser treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment