bioihbjkbjnl/mcl2 huggingface dataset:
Magnetic Resonance Imaging in Myocarditis
Condition: Myocarditis
MeSH terms: Myocarditis
Study type: Observational

Summary: 
      The purpose of this study is the assess the diagnostic performance of magnetic resonance
      imaging in patients with suspected myocarditis by applying different imaging sequences at
      different MR scanners
    

Detailed description: 
      In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is
      performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at
      1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment
      of myocardial edema respectively edema ratio; myocardial hyperemia respectively global
      relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1
      and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared
      to the findings of endomyocardial biopsies is calculated.

      The protocol also includes a follow-up MR can at 3 months.
    

Intervention name(s): Endomyocardial Biopsy
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with clinical suspicion of myocarditis
      
Keywords: myocarditis, myocardial inflammation, imaging, magnetic resonance
Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      In this study respiratory and submental muscle activities during during inspiratory and
      expiratory breathing maneuver at specific workloads will be assessed according to inspiratory
      and expiratory muscle strength of each obstructive sleep apnea syndrome (OSAS) patient's.
    

Detailed description: 
      Recurrent upper airway obstruction, apnea-hypopnea events, arousals and asphyxia during sleep
      increase the respiratory workload in patients with OSAS. This results in chronic overload of
      the inspiratory muscles -especially the diaphragm- and respiratory muscle fatigue in OSAS.
      When the literature was checked, there was no study assessing and comparing the activities of
      M. genioglossus, submental muscles (upper airways dilator muscles) and diaphragm during
      inspiration and expiration in a workload. Differences in the activity of these muscles
      according to the type of respiratory maneuver will provide more appropriate respiratory
      muscle training in patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with OSAS who will be referred to the Cardiopulmonary Rehabilitation Unit of the
        Faculty of Physical Therapy and Rehabilitation of Hacettepe University by Dışkapı Yıldırım
        Beyazıt Educational and Research Hospital Department of Chest Diseases will be included in
        this study.
      
Keywords: obstructive sleep apnea; emg; inspiratory muscles; expiratory muscles
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition; Disease
Study type: Interventional

Summary: 
      To evaluate and compare the relative bioavailability and therefore the bioequivalence of
      fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman
      Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/1000 mg tablets
      manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects
      under Fed Conditions.
    


Intervention name(s): Metformin and Vildagliptin 1000/50 mg
Intervention type(s): Drug
Intervention description(s): 50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of zinc supplementation on insulin
      secretion by genotype of SLC30A8.
    

Detailed description: 
      As diabetes increases at an alarming rate, strategies for prevention of this disease must be
      developed. For a given individual, there are both biologic (e.g., genetic) and environmental
      (e.g., lifestyle) factors that comprise her individual risk of diabetes. Researchers can take
      advantage the accumulating knowledge of these individual factors to design individualized
      strategies for diabetes risk assessment and prevention. For example, a mutation in a
      particular gene, SLC30A8, which encodes a zinc transporter, has been shown to increase the
      risk of diabetes probably through impairment of insulin secretion. In the proposed research
      project, the investigators aim to conduct a pilot study to see the effect of zinc
      supplementation on insulin secretion in people with and without this genetic mutation to see
      if zinc can improve insulin secretion in those with the mutation. The results from this study
      will help the investigators to plan a larger, more definitive study to determine if zinc
      supplementation can be used to prevent or treat diabetes in those with this mutation in
      SLC30A8.
    

Intervention name(s): Zinc acetate
Intervention type(s): Dietary Supplement
Intervention description(s): 50mg of elemental zinc to be administered 2 times daily orally for 14 days.
Other intervention name(s): Orazinc
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: zinc; diabetes; genetics
A Study of Two Facial Sunscreens to Assess Its Effect in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity Under Controlled and Normal Conditions of Use on the Face by Adult Participants
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of 02 facial sunscreens
      (investigational products [IPs]) under controlled and normal conditions of use on the face
      for 28 and 56 days, respectively. This study will consist of 2 groups a) Group 1: will assess
      the safety and efficacy of a facial sunscreen in improving skin hydration and barrier
      function, through 12h of single application on the face in comparison with the control area
      (other side of face) and on the forearm, comparing 02 IPs versus control area (no product
      application) and 03 benchmarks; and through use of the IP under normal conditions for 28 +/-
      2 days on the face, with assessments by instrumental measurements of corneometry,
      transepidermal water loss, image capture (Colorface) and assessments of the efficacy
      perceived by the participant; b) Group 2: will evaluate the safety and efficacy of a facial
      sunscreen in improving skin hydration and barrier function, through 12h of single application
      on the face; and through use of IP under normal conditions for 28 +/- 2 days on the face,
      with assessments by instrumental measurements of corneometry, transepidermal water loss,
      imaging (Colorface) and assessments of the efficacy perceived by the participant; in addition
      to evaluating the improvement in uniformity of facial skin tone through the use of IP under
      normal conditions for 56 +/- 2 days, with assessments by image analysis (Colorface),
      dermatological clinical analyses (radiance and homogeneity of skin tone),assessments of
      perceived efficacy, and emotional testimony by the participant.
    


Intervention name(s): Sunscreen A; Sunscreen B
Intervention type(s): Other; Other
Intervention description(s): Participants will apply sunscreen A topically.; Participants will apply sunscreen B topically.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Different HES Coload Volumes on the 90% ED of Norepinephrine
Condition: Adverse Effect
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of different 6% hydroxyethyl starch
      (130/0.4) coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for
      hypotension during spinal anesthesia for cesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Coload has been highly demonstrated for
      prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some
      evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence
      of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose
      of this study is to investigate the effect of different 6% hydroxyethyl starch (130/0.4)
      coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for
      hypotension during spinal anesthesia for cesarean section.
    

Intervention name(s): Hydroxyethyl starch coload - 0 ml/kg; Hydroxyethyl starch coload - 5 ml/kg; Hydroxyethyl starch coload - 10 ml/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): No fluid coload was given. An initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.; 5 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.; 10 ml/kg 6% Hydroxyethyl starch (130/0.4) coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.
Other intervention name(s): Colloid; Colloid; Colloid
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Norepinephrine; Hydroxyethyl starch 130/0.4; Postspinal anesthesia hypotension; Coload; Cesarean section
In Situ Caries Efficacy of Fluoride Toothpastes
Condition: Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries
      lesions in an in situ model
    

Detailed description: 
      In situ models represent an acceptable approach for testing the anti-caries potential of
      fluoride products. This study is to evaluate the effect of fluoride dentifrice containing
      1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in
      situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be
      compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F),
      NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm
      F) and placebo toothpaste (0 ppm F).
    

Intervention name(s): NaF; Placebo; NaMFP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluoride; Placebo; Fluoride
Other intervention name(s): Fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fluoride; in situ; remineralization; enamel; caries
Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this extension study is to assess the long-term safety and tolerability of
      omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with
      inadequately controlled allergic asthma despite current recommended treatment by providing
      continued treatment with omalizumab to patients who have previously completed the core study.
    


Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): omalizumab lyophilized 150 mg injection
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omalizumab; allergic asthma; pediatric patients
A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration
Condition: Progressive Supranuclear Palsy; Corticobasal Degeneration
MeSH terms: Paralysis; Supranuclear Palsy, Progressive; Corticobasal Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this trial is to evaluate the safety and tolerability of lithium in people with
      progressive supranuclear palsy or corticobasal degeneration.
    

Detailed description: 
      Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are progressive,
      adult-onset neurodegenerative disorders characterized by the accumulation of
      hyperphosphorylated tau. Symptomatic treatment is of minimal benefit to individuals with PSP
      or CBD, and there are no effective disease modifying agents.

      Tau phosphorylation is regulated in part by the enzyme GSK-3β (glycogen synthase kinase-3
      beta ). Inhibition of this enzyme may benefit individuals with PSP or CBD by decreasing the
      levels of phosphorylated tau. Lithium is known to inhibit GSK-3β and, thus, may be a rational
      therapeutic approach.

      The primary objective of this study is to determine the safety and tolerability of lithium in
      people with PSP or CBD. Additionally, this study will evaluate potential biomarkers and
      clinical outcome measures as well as assess study drug compliance.

      In this multicenter, open label study, 45 eligible participants with PSP or CBD will receive
      the study drug, lithium. The dosage of lithium will be titrated over a 5-week period, and
      participants will then be followed prospectively for 6 months. Participants will be evaluated
      at the screening visit, baseline visit, and weeks 2 and 5 during the titration phase. Clinic
      study visits will then occur on alternate months through week 28. Telephone visits will occur
      between clinic study visits.
    

Intervention name(s): Lithium
Intervention type(s): Drug
Intervention description(s): All participants will receive lithium. The dosage will be titrated over a 5-week period and then continued for an additional 6 months.
Intervention MeSH terms: Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: progressive supranuclear palsy; corticobasal degeneration; PSP; CBD; lithium; tau
The Indian POLYCAP Study (TIPS)
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the
      POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one
      additional cardiovascular risk factor.

      STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a
      fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering
      agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.

      STUDY DESIGN

      Randomized controlled double-blind trial of the POLYCAP® versus its components in eight
      formulations.

      STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD
      risk factor.

      INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total
      duration of follow up will be 4 months, from the start of study medication.. Subjects will
      take study medication for 3 months. There will be a final follow up visit 1 month after
      stopping the study medication.

      There will be five follow up visits, the first 7 - 10 days after starting study medication
      and thereafter monthly visits for 4 months. Subjects taking any of the study medications
      prior to enrolment will have one or more additional visits during a defined wash out and
      before enrolment.

      OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of
      the three month period.

      STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and
      platelet activity [as measured by urinary thromboxane] when compared with its different
      components in eight different formulations.
    


Intervention name(s): Thiazides; Ramipril with Thiazide; Thiazide plus atenolol; Ramipril plus atenolol; Ramipril plus atenolol plus thiazide; POLYCAP; Thiazide + Ramipril+Atenolol+Aspirin; Simvastatin; aspirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule (blinded) oral administration once daily for 12 weeks; Capsule (blinded) oral administration 12 weeks; Caspule (blinded) for oral administration once daily for 12 weeks; Capsule ( blinded) for oral administration once daily for 12 weeks; Capsule (blinded) for oral administration once daily for 12 weeeks; Capsule for Oral Administration once daily for 12 weeks; Capsule (Blinded) for oral administration once daily for 12 weeks; Capsule (Blinded) for oral administration once daily for 12 weeks; capsule (Blinded) for oral administration once daily for 12 weeks
Other intervention name(s): Quintapill(R)
Intervention MeSH terms: Aspirin; Atenolol; Ramipril; Simvastatin; Sodium Chloride Symporter Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: POLYCAP, Primary Prevention,CVD
DVT After Cardiac Procedure
Condition: Thromboembolism; Deep Vein Thrombosis
MeSH terms: Thrombosis; Thromboembolism; Venous Thrombosis
Study type: Observational

Summary: 
      Patients undergoing electrophysiology studies (EPS) and cardiac ablation procedure for the
      treatment of cardiac arrhythmias may be at increased risk of deep vein thrombosis (DVT)
      during or after the procedure, which may lead to pulmonary embolus which can be life
      threatening. The study will use Doppler ultrasound scanning at 24h and between 10-14 days
      post EPS and cardiac ablation to assess the incidence of undiagnosed DVT. A positive finding
      may provide support for a larger clinical trial to assess the benefit of prophylactic
      anticoagulation post EPS procedure.
    

Detailed description: 
      Electrophysiological study (EPS) and catheter ablation is an established method for the
      assessment and treatment of many patients with cardiac arrhythmias (altered heart rhythm). It
      is generally carried out in patients who are usually otherwise fairly fit and healthy. In the
      UK many patients undergo this procedure and the numbers are increasing. The procedure
      involves a number of catheters (tubes) being inserted into the femoral vein over a period of
      up to 2 ½ hours. Presence of the catheter in the vein increases the risk of blood clot
      formation, if a clot blocks a deep vein in the leg (deep vein thrombosis), it can lead to
      pain and chronic leg swelling as well as the need for blood thinning (anticoagulant)
      medications. In some patients, fragments of the blood clot can break off and travel to the
      lungs which can be life-threatening. It is important to detect the presence of a clot as soon
      as possible, so that treatment may be given. The investigators hope to establish if the
      condition is more common than originally thought.

      The investigators plan to recruit 100 patients who are due to undergo EPS or catheter
      ablation. Prior to the participant's clinical procedure, the investigators will perform an
      additional blood test to check blood clotting function. After the cardiac procedure, the
      participants will then undergo Doppler ultrasound scans at 24 hours and a second scan between
      10-14 days to check for the presence of blood clots.

      The aim of the study is to increase understanding of how often these blood clots occur and
      confirm if blood tests or current gold-standard imaging is best at showing the early stages
      of blood clot formation. The results of the study will help decide if a clinical trial is
      needed to test whether giving preventative blood thinning treatment after cardiac procedures
      would be beneficial.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred for elective EP study and catheter ablation.