bioihbjkbjnl/mcl2 huggingface dataset:
Follicular Fluid, Bioavailable Vitamin D and Embryo Quality Markers
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      To determine the correlation between bioavailable Vitamin D values and euploid status of the
      embryos in larger size follicles from UAE women undergoing in vitro fertilization procedures.
    

Detailed description: 
      To study the possible correlation between bioavailable vitamin D values in follicular fluid
      and embryo quality markers.

      To correlate bioavailable Vitamin D values in follicular fluid from large size follicles with
      embryo euploid status as our main objective. Secondly, looking at morphokinetics and
      mitochondrial content of these embryos.

      Taking into account that most of UAE patients have deficiency or insufficiency of Vitamin D,
      if there is a correlation found we will understand better the underlying mechanism by which
      bioavailable Vitamin D levels may be affecting embryo quality, therefore IVF outcomes.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        UAE patients with infertility (primary or secondary) and indication for IVF/ICSI treatment
        with PGS
      
Biospecimen description: 
      follicular fluid,serum sample
Phase I Pharmacokinetic Study (BF-BLOCK)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess if charcoal prevents the absorption of budesonide and
      formoterol via GI track. The assessment will be based on comparing the pharmacokinetic
      parameter area under the concentration-time curve.
    


Intervention name(s): Budesonide/formoterol capsule.; Budesonide/formoterol capsule for oral adm.
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration with concomitant charcoal.; Oral administration without concomitant charcoal.
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma
Vacuum Cupping for Chronic Neck and Back Pain
Condition: Chronic Pain; Neck Pain; Back Pain
MeSH terms: Back Pain; Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      Small clinical pilot studies have shown that vacuum massage-related techniques such as
      traditional dry cupping can reduce musculoskeletal pain such as back and neck pain. At the
      same time, little is yet known about the potential mechanisms of action of these therapies. A
      vacuum pump induces a massaging effect of the skin including the deeper tissue layers. The
      resulting massage technique corresponds to a kind of tissue manipulation similar to dry
      cupping. In this procedure, suction force and air flow can be individually adjusted. This is
      an advantage that can be used for patients with varying degrees of sensitivity or who are
      preloaded by patients with varying degrees of sensitivity or a history of pain. The aim of
      this study is to investigate the mechanisms of action of the therapeutic effects of the
      vacuum cupping in chronic neck or back pain using the biomarker QST.
    


Intervention name(s): AERO vacuum cupping device
Intervention type(s): Device
Intervention description(s): The treatment consists of 5 sessions (approx. 30 min) of vacuum massage. The vacuum pump provided by the device provides a type of vacuum massage, that can be adjusted according to applied suction and air flow. The resulting massage technique provides a type of soft tissue manipulation similar to the ancient traditional medicine technique of cupping. Nonetheless, this automated technique allows for more precise determination of the massage characteristics.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vacuum cupping; Quantitative sensory testing
Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Stress is a common problem with significant consequences for health. It can be a trigger for
      somatic diseases as well as psychological disorders and leads through missed working days and
      healthcare cost to a high economic loss. It is for health and economic reasons essential to
      develop and evaluate effective interventions that can inoculate against stress and build
      inner strength.

      A cognitive-behavioural training for groups that is well evaluated and has shown to be
      effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of
      methods of the complementary and alternative medicine is increasing a rigorous evaluation is
      needed. Integrative Kinesiology is a popular method that has been said to be effective
      against stress and its symptoms.

      The investigators propose a randomized controlled evaluation and comparison of the
      interventions to each other and to a waiting-list control group. Hypothesis: Healthy
      volunteers attending a two dayseminar will show significantly reduced psychobiological
      reactivity, decreased stress perception and less anxiety to a standardized psychosocial
      stress test compared to the waiting list group. A total of 64 healthy volunteers will be
      randomly assigned to one of the three groups. The efficacy of the interventions will be
      measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress
      reactivity.
    


Intervention name(s): Cognitive Behavioural Training; Integrative Kinesiology Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Two day seminar; Two day seminar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy; Primary Prevention; Stress; Kinesiology; cognitive behavioural therapy; Prevention
Reduction of the Glycemic Index by a Novel Viscous Polysaccharide
Condition: Blood Glucose, Postprandial
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Reductions of postprandial glucose levels have been demonstrated previously with the addition
      of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This
      study explores whether these reductions are sustained when NVP is added to a range of
      commonly consumed foods.
    

Detailed description: 
      Recently, a commercial novel viscous polysaccharide (NVP)complex has been developed which is
      marketed in both the USA and Canada under the trade name PGX® (PolyGlycopleX) (InovoBiologic
      Inc, Calgary, AB, Canada). This complex consists of three viscous non starch polysaccharides
      which are processed using proprietary technology (EnviroSimplex®) to produce compressed
      granules which delays the onset of viscosity and increases palatability of the fiber when
      added to food. Previously, this fibre was shown to lower postprandial glucose levels in a
      dose responsive manner when mixed with a glucose drink and sprinkled onto a standard white
      bread demonstrating that the processing did not interfere with the effectiveness of the
      fiber. From this study the reduction in GI was calculated to be 7 units per gram of NVP when
      added to a solid food, however it is not known whether this relationship would be maintained
      when the NVP was added to a range of commonly eaten foods. This study therefore evaluates the
      effect of the addition or incorporation of NVP into a range of foods on postprandial glycemia
      and whether the reductions in glycemic index could be predicted using.
    

Intervention name(s): PolyGlycopleX (PGX); PolyGlycopleX (PGX); PolyGlycopleX (PGX)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2.5 grams of PGX; 5.0 grams of PGX; 0 grams of PGX
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: viscous; fibre; polysaccharide; blood glucose; postprandial
Phase I/II Study of Taxotere,CDDP and 5-FU(TPF) in Pre-treated Pts With Metastatic Esophageal Cancer.
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting
      toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and
      5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. The
      usefulness of the this regimen is evaluated by response rate, median survival time, and
      progression free survival.
    

Detailed description: 
      Patients with pre-treated measurable metastatic esophageal cancer were included in this
      trial. Patients received this combination chemotherapy repeated every 28 days until
      progression disease. Starting dose (dose level 1) were docetaxel 30 mg/m2 on day 1, fixed
      dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on
      day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia
      lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia
      accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea,
      appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the
      incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be
      calculated according to RECIST criteria.
    

Intervention name(s): Taxotere; 5-Fluorouracil; Briplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.; 800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.; 15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.
Other intervention name(s): Docetaxel; fluorouracil; Cisplatin
Intervention MeSH terms: Cisplatin; Docetaxel; Fluorouracil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim is to compare the blood pressure lowering effect of the combination of candesartan
      cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32
      mg alone, HCT 25 mg alone and placebo in hypertensive adults.
    


Intervention name(s): Candesartan cilexetil; Hydrochlorothiazide; Candesartan/HCT 32/25 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 32 mg oral tablet; 25 mg oral tablet
Other intervention name(s): ATACAND; HCTZ
Intervention MeSH terms: Hydrochlorothiazide; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood pressure reduction; combination therapy; candesartan cilexetil; hydrochlorothiazide
A Pilot Study on Edoxaban for the Resolution of Left Atrial Thrombosis in Patients With Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Isolated reports have indicated that complete Left Atrial or Left Atrial Appendage thrombus
      resolution may be achieved also with use of oral Factor Xa inhibitors, which have
      demonstrated the same efficacy but a better safety profile compared to warfarin.

      The aim of this open-label pilot study is to investigate the percentage of Left Atrial /Left
      Atrial Appendage thrombus resolution with edoxaban therapy in patients with non-valvular
      atrial fibrillation. The subordinated aim is the design a larger and longer study to compare
      edoxaban and warfarin in the same patient population.

      With the exception of few case reports, there are no data in the same patient population
      referred to antithrombotic treatments other than vitamin K antagonists.
    

Detailed description: 
      This is a non-controlled, open-label, 4 weeks pilot study.

      As the main goal of this exploratory study is the estimation of the magnitude of the Left
      Atrial /Left Atrial Appendage thrombus resolution with edoxaban, no control group with
      vitamin K antagonists has been considered, providing that, for the purpose of this study, the
      magnitude of the response of warfarin is satisfactory defined.
    

Intervention name(s): Edoxaban
Intervention type(s): Drug
Intervention description(s): Edoxaban 60 mg once a day for 4 weeks. Edoxaban 30 mg/day in patients with body weight ≤60 kg, or with concomitant therapy with verapamil/quinidine/dronedarone.
Other intervention name(s): Lixiana
Intervention MeSH terms: Edoxaban
Intervention model: Single Group Assignment
Intervention model description: Non-controlled, open-label pilot study.
Masking: None (Open Label)
Primary purpose: Treatment
Sodium Nitrate for Muscular Dystrophy
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators' previous work in males with Becker Muscular Dystrophy shows that
      functional sympatholysis is restored by acute inorganic nitrate supplementation. This was
      translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown
      that there is a frank improvement in grip strength when mdx mice are treated with an
      inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic
      treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond
      blood flow regulation.
    


Intervention name(s): Sodium Nitrate
Intervention type(s): Drug
Intervention description(s): Patients will be given sodium nitrate daily in the form of beetroot juice.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Becker; Dystrophy
Application of Photogrammetry for Manual Skills Training in Undergrad Physiotherapy Students
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      Education research shows that healthcare professional training can be made more efficient and
      effective with the integration of simulation technology. Despite the relevance of this
      technology in the training of medical students, evidence on its effectiveness in
      physiotherapy manual skills training is limited.

      To compare the effectiveness of real-object three dimensional (3D) produced by Photogrammetry
      versus two dimensional (2D) images for the introduction of manual therapy skills to
      undergraduate physiotherapy students, with a blended learning activity.
    

Detailed description: 
      Using a randomised controlled trial design, first-year students enrolled in a 4-year bachelor
      with honours physiotherapy degree, participated in a 2-hour blended learning session. Three
      manual assessment techniques were presented - cervical compression, distraction and
      flexion-rotation tests. The techniques were demonstrated through two sets of learning
      materials with either real-object rotatable 3D images using Close-range Photogrammetry
      (experimental group) or traditional 2D computer images (control group). Students were
      examined after the training using an objective structured clinical evaluation (OSCE)
      procedure. The OSCE required the participants to demonstrate the three techniques learnt with
      the assessment criteria as therapist's position and skills, patient's position and overall
      management of the physical examination. The score of the standardized 9 item-practical
      performance test, with a maximum score of 54, was used as the primary outcome measure for
      analyses.
    

Intervention name(s): Simulating video; Conventional video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 360-degree simulating video showing physiotherapy assessment in lumbar area; A conventional video showing physiotherapy assessment in lumbar area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Simulation; Physiotherapy training; 360-degree video
Stress & Social Cognition in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The investigators will examine whether perceived social exclusion provoke a reduction in
      prosocial behavior in BPD patients.
    

Detailed description: 
      The investigators will examine whether perceived social exclusion provoke a reduction in
      prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight"
      pattern is also seen in other relevant aspects of social behavior, such as sharing and
      punishment behavior. To induce social exclusion all participants will play cyberball, either
      the exclusion condition or the (over)inclusion condition before testing
    

Intervention name(s): inclusion condition
Intervention type(s): Behavioral
Intervention description(s): cyberball game: ex- versus over-inclusion condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Parathyroidectomy on Cardiovascular Risk Factors in Primary Hyperparathyroidism
Condition: Primary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary
Study type: Observational

Summary: 
      Primary hyperparathyroidism (PHPT) is associated with increased cardiovascular morbidity. The
      benefit of surgical treatment in this respect is unclear.

      This study was performed to evaluate the impact of parathyroidectomy (PTX) on cardiovascular
      risk profile.
    

Detailed description: 
      Patients with primary hyperparathyroidism (PHPT) have been shown to have an increased
      morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of
      cardiovascular disease in PHPT is not well understood and probably multifactorial. Functional
      or structural alterations of vascular endothelial and smooth muscle cells may impair the
      vascular reactivity and lead to accelerated atherogenesis. Several cardiovascular risk
      factors such as obesity, hypertension, insulin resistance and hyperlipidemia are more
      prevalent in PHPT compared with controls.Patients with severe form of PHPT had a greater
      probability of metabolic syndrome (MS) and insulin resistance than patients with mild PHPT
      and eucalcemic subjects. Although the excess in cardiovascular mortality is significantly and
      independently related to serum calcium, the connection between the biochemical disturbances
      and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect
      relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular
      risk factors and mortality is controversial. Some studies suggest that hypertension,
      dyslipidemia, and derangement of glucose metabolism improve after removal of overactive
      parathyroid tissue. Others have shown that cardiovascular risk markers remained unaltered
      after parathyroidectomy (PTX).

      The aim of this study was to evaluate whether successful PTX is associated with decreased
      cardiovascular risk. We investigated indices of metabolic syndrome and insulin resistance as
      well as various cardiovascular risk factors in patients with manifest PHPT before and one
      year after successful PTX.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Primary hyperparathyroidism referred to Endocrine clinic. Controls recruited
        in community-based health centers.
      
Biospecimen description: 
      serum, urine
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Condition: Tonsillectomy
Study type: Interventional

Summary: 
      The purpose of this study is to assess safety and performance with the use of the BiZact™
      device in tonsillectomy procedures in children and adolescents.
    

Detailed description: 
      A prospective, multi-center, single arm, study of BiZact™ on children and adolescents
      undergoing tonsillectomy.

      Study Visits:

        -  Screening/Baseline

        -  Surgery, Day 0

        -  Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments)

        -  Post-Op Follow-up Day 28 (Office Visit)
    

Intervention name(s): BiZact™: A bipolar instrument for tonsillectomies
Intervention type(s): Device
Intervention description(s): A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
Condition: Diabetic Macular Edema; Epiretinal Membrane
MeSH terms: Macular Edema; Epiretinal Membrane; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the use of the dexamethasone implant (Ozurdex) in patients with
      macular edema associated with an epiretinal or preretinal membrane requiring surgical
      intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will
      be placed in the eye. Patients will be followed for 1 year.
    

Detailed description: 
      The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars
      plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine
      its effect on macular edema (measured by OCT), and visual recovery (measured by visual
      acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular
      edema with associated taut membrane. This will be a prospective pilot study with patients to
      receive an Ozurdex implant at the time of vitrectomy.
    

Intervention name(s): Ozurdex
Intervention type(s): Drug
Intervention description(s): Ozurdex .7 mg injected into the treated eye
Other intervention name(s): Dexamethasone
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Macular Edema; Epiretinal Membrane; Vitrectomy