bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of 300 mg Gabapentin
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of gabapentin (capsules) are
      bioequivalent.

      Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product
      Nerotin® 300 mg (Pfizer). One capsule was the single dosage.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 26 healthy volunteers, both genders, adults between 18-55
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Gabapentin 300 mg; Gabapentin 300 mg
Intervention type(s): Drug; Drug
Intervention description(s): Test product; Reference product
Other intervention name(s): Darbetin®; Laboratorios Dermatologicos Darier; Nerotin®; Pfizer
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gabapentin; Bioequivalence; Pharmacokinetics; Mexico
Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III long-term safety study of Effexor XR in patients with major depression.
    


Intervention name(s): Effexor XR
Intervention type(s): Drug
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression
Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain
Condition: Mechanical Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Among all disabling musculoskeletal condition, non specific low back pain is most prevalent
      and universal condition. Its prevalence has increased over years and affects almost all at
      some phase in their life. Though, there are many causes of low back pain such as, sedentary
      life style, depression, poor nutritionist diet and so on, yet faulty posture is also one of
      the noteworthy causes of low back pain which cannot be overlooked. Faulty posture can result
      from any out of order body component, such as atypical foot biomechanics. Since lower limb is
      connected in a closed chain, atypical foot biomechanics leads to disruption in the whole
      chain ascending up to the spine, stressing spine soft tissues, upsetting its normal
      anatomical position and causing low back pain.
    

Detailed description: 
      The lower limb is made up of all the structures from feet to pelvic, forming a closed
      mechanical chain. In this chain if any one segment is out of its neutral position it affects
      the whole chain. Like, if a foot is out of its alignment can be flattened or highly pronated,
      it will results in ankle internal rotation i,e. during the early stance phase of gait When
      the foot pronates, the calcaneus everts while the talus adducts and the plantar flexes. This
      inferomedial translation of the talus, results in inward rotation of shin and knee. Knee
      internal rotation, then make femur to rotate medially (internally) and pelvic to tilt
      anteriorly. This increased tilting of pelvic increases the curvature of the lumbar spine.
      Excessive curve at lumbar spine places excessive strain on the muscles, tendons and ligaments
      of the lower back, causing them to inflame and resulting pain. This domino effect, explains
      how a misalignment in the foot end up negatively effecting the health of one's lower back and
      a source of non specific low back pain.Though the direct treatment of lumbar region is
      important for LBP,yet ankle strategy is needed in order to correct the spinal imbalance. This
      research proceeded with the thought of taking a whole approach i.e. treating the main cause,
      causing LBP rather than just applying specific approach i.e. giving only symptomatic
      treatment for pain alleviation. With this approch talocrural/ankle joint is being taken
      within physical therapy treatment sphere through manipulation technique along with
      conventional physical therapy protocol for LBP in the current study.
    

Intervention name(s): Group A, excercises
Intervention type(s): Other
Intervention description(s): Each group will receive treatment three times per week for 3 weeks total 7 sessions.
Other intervention name(s): Group B,manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with
      active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver
      plays an important role in this stress-catabolism by increasing the production of urea during
      the inflammatory process.

      The purpose of this study is to examine the effect of the anti-inflammatory drugs
      prednisolone and infliximab on the regulation of the urea synthesis in patients with active
      ulcerative colitis and Crohn's disease.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with active inflammatory bowel disease seen in the out-patients' clinic or
        admitted to hospital for treatment.
      
Biospecimen description: 
      Serum, plasma and urine.
    
Keywords: Inflammation; Urea synthesis; Catabolism; Nitrogen balance
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to help us to a better understanding of how nose and eye
      symptoms are related in patients with allergies.
    


Intervention name(s): fluticasone furoate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 puffs in each nostril once daily for 1 week; 2 puffs in each nostril once daily for 1 week
Other intervention name(s): Veramyst
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Impact of Hospitalization on Ambulatory Blood Pressure and Intraocular Pressure
Condition: Blood Pressure
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory
      blood pressure (ABP) in hypertensive subjects.Treated or untreated hypertensive adults with
      open angle glaucoma underwent in-hospital and outpatient 24-hour ABP monitoring, in random
      order 4 weeks apart.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with untreated ocular hypertension and stage 1 arterial hypertension with or
        without treatment with anti-hypertensive agents.
      
Keywords: Hypertension; Ambulatory measurement
Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support
Condition: Other Specified Respiratory Problems in Fetus or Neonate
Study type: Interventional

Summary: 
      Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the
      diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount
      of support provided is determined in part by the NAVA level, where a higher NAVA level will
      provide higher level of support and unload more of the work of the diaphragm. The purpose of
      this study is to compare the optimal NAVA level in neonates while on mechanical ventilation
      while intubated and after being extubated.
    

Detailed description: 
      Baseline measurements will be taken. The NAVA titration study will then be done. The NAVA
      level will be set at a starting value of 0.1 cm H2O/mcV and systematically increased by 0.5
      cm H2O/mcV every three minutes to a maximum of 3 cmH2O/mcV. Once the NAVA titration study has
      been completed, the patient will be extubated. There will be a stabilization period following
      extubation (15-30 minutes), and then the NAVA titration study will be repeated.
    

Intervention name(s): NAVA level; NAVA level
Intervention type(s): Procedure; Other
Intervention description(s): Peak inspiratory pressure will be measured at each NAVA level; Increase NAVA level every 3 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel
Condition: Ischemic Heart Disease; Acute Coronary Syndromes
MeSH terms: Heart Diseases; Acute Coronary Syndrome; Myocardial Ischemia; Coronary Artery Disease; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Clopidogrel and statins are frequently coadministered in patients with ischemic heart
      diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine
      diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain
      statins. The objective of the present study is to define which kind of statins might
      interfere with the antiaggregation property of clopidogrel in patients with acute coronary
      Syndrome after percutaneous coronary intervention (PCI).

      In this prospective randomized study, all patients in test group will receive clopidogrel
      plus atorvastatin, and all patients in control group will receive clopidogrel plus
      pravastatin. All patients will be followed up for one year. The primary endpoints include
      death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage
      events and subacute thrombosis events at 1 year.
    


Intervention name(s): atorvastatin,pravastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic heart disease; acute coronary syndromes; percutaneous transluminal coronary angioplasty; statin; clopidogrel
PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic
Condition: Inflammatory Bowel Diseases; Coronavirus Infection
MeSH terms: Coronavirus Infections; COVID-19; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      To find out what adaptations have been made by Inflammatory bowel disease physicians and
      patients in relation to therapies in flaring IBD patients during severe acute respiratory
      syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19
      and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the
      outcome of patients with COVID-19 symptoms or COVID-19 disease
    

Detailed description: 
      An observational, retrospective, case-controlled study to determine the status of IBD during
      development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in
      therapies for active IBD during SARS COV 2 in patients with active IBD and positive or
      negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19
      symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with
      COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes
      resulting from adaptations to treatments during COVID-19
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        About 1 in 100- to 1 in 200 patients have IBD and up to 550,000 patients are estimated in
        the UK.
Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery
Condition: Postoperative Pain; Edema; Swelling Lips & Face
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      A randomized clinical trial will be performed in parallel, placebo controlled, triple-blind
      to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in
      escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery
      following surgery periodontal and implant surgery.
    

Detailed description: 
      At least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to
      perform one of the interventions described above and that fall within the criteria of
      inclusion.

      The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies
      and will be initiated with the approval of the Internal Review Board of the University of
      L'Aquila.

      The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be
      recorded on the data base clinicaltrials.gov.
    

Intervention name(s): Bromelains and Escin Oral Tablet; Placebo
Intervention type(s): Other; Other
Intervention description(s): Supportive care after oral surgery; Oral tablet without the active principle
Other intervention name(s): Noflogo®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in
      subjects age 2 - 80 years, for the span of 170 hours (7 days).
    

Detailed description: 
      The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in
      subjects age 2 - 80 years, for the span of 170 hours (7 days).

      This is a multi-center study.
    

Intervention name(s): Continuous Glucose Monitoring
Intervention type(s): Device
Intervention description(s): CGM and frequent sample testing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Single Ascending Oral Doses of SY-009 in Healthy Subjects
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ⅰ，single-center, randomized, double-blinded, placebo-controlled, single
      ascending dose trial of SY-009 in healthy subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic /
      pharmacodynamic study of a single oral SY-009 capsule for Chinese healthy subjects. Plan to
      screening no more than 64 healthy subjects ， dividing them into 7 dose groups.
    

Intervention name(s): SY-009
Intervention type(s): Drug
Intervention description(s): The study will be initiated in healthy subjects at a 0.5mg dose that is the maximum recommended starting dose(MRSD) . Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 2,5, 10, 20, 40mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel ，Placebo control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER
      Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in
      healthy, adult, human subjects, under fasting conditions and to monitor adverse events and
      ensure the safety of subjects.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,
      crossover oral bioequivalence study of Divalproex Sodium Extended Release Tablets 500 mg of
      Dr. Reddy's Laboratories Limited, and Depakote ER 500 mg mg Tablets of Abbott Laboratories in
      healthy, adult, human subjects, under fasting conditions.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium ER Tablets, 500 mg
Other intervention name(s): Depakote
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Divalproex Sodium; Crossover
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an international, multicentre, parallel-group, event-driven, randomised,
      double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of
      dapagliflozin 10 mg versus placebo, given once daily in addition to background regional
      standard of care therapy, including treatments to control co-morbidities, in reducing the
      composite of CV death or heart failure events.
    

Detailed description: 
      This is an international, multicentre, parallel-group, event-driven, randomised, double-blind
      study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo,
      given once daily in addition to background regional standard of care therapy, including
      treatments to control co-morbidities, in reducing the composite of CV death and heart failure
      events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with
      HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association
      (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be
      randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients
      and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for
      24 hours can be randomised. It is estimated that approximately 11000 patients at
      approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target
      of approximately 6100 randomised patients.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg tablets given once daily, per oral use.; Placebo matching dapagliflozin 10 mg
Other intervention name(s): Forxiga TM; Farxiga TM
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: International, Double-blind, Randomised, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for White Spot Lesions in Primary Teeth
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      The present study aimed to compare the remineralisation capacity of white spot enamel lesions
      between two commercially available tooth pastes (Remin Pro and MI PASTE PLUS), applied at
      home twice a day on the anterior upper primary teeth by the patient and parents.
    

Detailed description: 
      Objective: To evaluate and compare the clinical efficacy of Remin Pro® and MI Paste Plus® for
      the remineralisation of white spot lesions (WSL) on the enamel of primary teeth.

      Methods: The selected design for this study was a randomised double-blind clinical trial
      based on CONSORT guidelines. Patients with at least one upper anterior primary tooth with a
      WSL on the enamel surface, with units of fluorescence (UF) ranged from 11-20 (evaluated with
      DIAGNOdent) were included in the study. Patients were randomly assigned to receive either the
      twice-daily at-home topical application of Remin Pro® or MI Paste Plus® (both as experimental
      pastes) or Colgate Total® (as control paste). The degree of remineralisation was quantified
      by the change in the number of UF from the baseline evaluation and at days 10 and 21. The
      difference between groups was statistically evaluated using ANCOVA and ANOVA techniques.
    

Intervention name(s): Remin Pro® and MI Paste Plus®
Intervention type(s): Procedure
Intervention description(s): Te toothastes were applied at home twice a day over the six anterior upper primary teeth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised double-blind clinical trial, with three parallel study groups (two experimental and one control), whose participants were randomly assigned to one of te three groups.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Primary teeth; Enamel; Remineralisation