bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients
Condition: Endothelial Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a
      major modifiable risk factors and one of the most important public health problems. Mortality
      from cardiovascular disease increases progressively with increasing blood pressure (BP) in a
      linear, continuous and independent. The pathophysiological mechanisms involved in the
      pathogenesis of hypertension exhibit metabolic abnormalities, which are related to
      endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of
      plants, but in our food, mainly present in red wine and grapes, has shown protective effects
      in cardiovascular diseases, such as preventing the damage caused by oxidative stress,
      decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective
      effect of vascular endothelium, with increased release of nitric oxide and decreased
      production of free radicals in animal models, but human studies are limited and insufficient
      to clarify the possible effects of trans-resveratrol (biologically active form) on
      endothelial function, blood pressure and central aortic pressure in treated hypertensive
      individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol
      supplementation on endothelial function in treated hypertensive patients.
    


Intervention name(s): Trans-resveratrol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Used for trans-resveratrol substance 300 mg single dose; Used for placebo substance single dose
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypertension; endothelium; resveratrol; clinical trials
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
Condition: Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose
      of this study is to evaluate the safety and initial effectiveness of this technique.
    

Detailed description: 
      Carotid atherosclerotic plaque is an important cause of ischemic stroke. Treatments for
      patients with carotid plaque include lifestyle changes, medical management(such as control of
      hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid
      endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and
      composition are important determinants of plaque stability, using serial MR imaging of the
      carotid artery allowed observation of changes in plaque composition. Contrast enhanced
      ultrasound (CEUS) is a well accepted technique for detection of intraplaque
      neovascularization(IPN) in carotid atherosclerotic disease. The purpose of this trial is to
      evaluate the safety and initial effectiveness of SDT. The SDT can induce macrophage
      elimination and inhibit matrix degradation, which will promote plaque lipid depletion,
      inflammation level decrease and changes in other plaque tissue components, leading to plaque
      stabilization and reduction.
    

Intervention name(s): Sonodynamic therapy (SDT)
Intervention type(s): Combination Product
Intervention description(s): Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.6W/cm2 for carotid lesions, resonance frequency: 1.0 MHz and duty factor: 30%.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Contact Lenses and Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The objective of this study is to determine if multifocal contact lenses affect accommodation
      and/or binocular vision when worn by pediatric patients. This will be accomplished through
      subjective and objective accommodative and binocular experiments in children wearing single
      vision and multifocal soft contact lenses.
    


Intervention name(s): Contact lenses
Intervention type(s): Device
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population includes children and teens that are recruited from the University Eye
        Center at SUNY College of Optometry and from the greater New York City area.
      
Keywords: Pediatrics; Contact lenses
Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin
Condition: Acute Coronary Syndrome; Diabetes Mellitus
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that
      platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic
      therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is
      responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is
      to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary
      syndrome.
    


Intervention name(s): aspirin 100 mg bis in die; aspririn 200 mg once daily; aspirin 100 mg once daily
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.; Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.; Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: platelet aggregation, acute coronary syndrome, diabetes
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
Condition: In Development for Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics and safety of a single dose
      of VX-770 in subjects with moderate hepatic impairment.
    


Intervention name(s): VX-770
Intervention type(s): Drug
Intervention description(s): 150 mg oral tablet
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
Condition: Atopic Dermatitis; Eczema
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The utility of functionally relevant signature genes in assessing the clinical outcomes of
      dupilumab treatment in the adult onset atopic dermatitis
    

Detailed description: 
      The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic
      dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/
      skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels
      will be obtained at the beginning and end of treatment. Subjects will complete daily diaries
      assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each
      visit
    

Intervention name(s): Dupilumab Prefilled Syringe
Intervention type(s): Biological
Intervention description(s): open-label
Other intervention name(s): dupixent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients
Condition: Multiple Sclerosis; Urinary Tract Infections; Bladder Dysfunction
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these
      patients are prone to have recurrent urinary tract infections. Cranberry has been
      traditionally used for the treatment and prophylaxis of urinary tract infections but there is
      no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this
      disease. The aim of our study is to assess the efficacy and safety of cranberry in the
      prophylaxis of urinary tract infections in patients with multiple sclerosis with a
      prospective randomized, double-blind and placebo-controlled clinical trial.
    

Detailed description: 
      Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and
      these patients are prone to have recurrent urinary tract infections (UTI), leading to an
      important morbidity. Cranberry has been traditionally used for the treatment and prevention
      of UTI and research suggests that its mechanism of action is preventing bacterial adherence
      to host cell surface membrane.

      However, systematic reviews show the small sample sizes and the poor quality of available
      trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI
      prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients
      with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled
      trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of
      treatment.
    

Intervention name(s): Cranberry; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening).; Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
Other intervention name(s): Vaccinium macrocarpon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prophylaxis; Cranberry; Neurogenic bladder
SPOG 2015 FN Definition. A Multi-center Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia
Condition: Cancer; Pediatrics; Fever; Neutropenia; Fever in Neutropenia
MeSH terms: Neutropenia; Fever; Hyperthermia
Study type: Interventional

Summary: 
      In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover
      non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer
      requiring chemotherapy, primarily the safety, and secondarily the efficacy and other
      endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for
      the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is
      assessed by the rate of safety relevant events per chemotherapy exposure time, a composite
      endpoint including serious medical complications and bacteremia during FN. Patients are
      repeatedly randomized (cluster: study site) to the high or the low TLDF every month,
      resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be
      inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of
      safety relevant events is proven, with a single-sided non-inferiority margin of 1.33,
      applying mixed Poisson regression.
    


Intervention name(s): 39.0°C temperature limit defining fever; 38.5°C temperature limit defining fever
Intervention type(s): Other; Other
Intervention description(s): Diagnosis of FN, correspondingly hospitalization and start of empirical intravenous broad-spectrum antimicrobial therapy. Further treatment according to treating physician.; Diagnosis of FN, correspondingly hospitalization and start of empirical intravenous broad-spectrum antimicrobial therapy. Further treatment according to treating physician.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis; Psoriasis; Skin Diseases
MeSH terms: Psoriasis; Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects
      with moderate to severe plaque psoriasis.
    


Intervention name(s): JTE-451 Tablets; Placebo Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Active drug tablets containing JTE-451; Placebo tablets matching in appearance to the active drug tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: JTE-451; Psoriasis; Plaque psoriasis; IMPACT-PS
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Condition: Type 2 Diabetes (Adult Onset); Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin
      resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic
      neuropathy.
    


Intervention name(s): Alpha lipoic acid; Roflumilast
Intervention type(s): Drug; Drug
Intervention description(s): Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.; Administration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months.
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; diabetic neuropathy; hyperglycemia
Patent Foramen Ovale in Children With Migraine Headaches
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Foramen Ovale, Patent; Headache
Study type: Observational

Summary: 
      This study will be the first to provide data about the relationship between PFO and migraine
      in children. By establishing the actual prevalence, we will better understand if PFO plays a
      role in the occurence of pediatric migraine and, thus, provide the incentive to perform
      additional studies evaluating whether PFO closure is an effective treatment option for
      pediatric migraine. For children with migraine headaches, discovering novel and effective
      treatments would be life altering.
    

Detailed description: 
      Specific Aim 1 Using contrast transthoracic echocardiography, compare the prevalence of a PFO
      in children with migraine headache with the established incidence of PFO published for the
      general population.

      Specific Aim 2 Using contrast transcranial Doppler, examine the relationship between the
      degree of right to left atrial shunting with the presence or absence of aura in children with
      migraine.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        pediatric neurology clinic
      
Keywords: Children; Migraine headaches
USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose was to evaluate the effect of USG-guided adductor canal block and infiltration
      popliteal artery capsule knee block combination on postoperative analgesia before total knee
      arthroplasty.
    

Detailed description: 
      In the present study, the purpose was to evaluate the effect of Ultrasound(USG)-guided
      adductor canal block(ACB) and infiltration popliteal artery capsule knee block(IPACK)
      combination on postoperative analgesia before total knee arthroplasty(TKA). A total of 40
      patients,who were aged 18-75 with the American Society of Anesthesiologists score(ASA) I-III
      physical status,and who were scheduled for TKA under general anesthesia,were included in the
      present study.ACB and IPACK were performed in group A(ACB+IPACK) accompanied by USG,
      Bupivacaine and 10 mL of 0.9% sodium chloride were applied in each block application.No block
      was applied to the patients in group B.Patient-controlled analgesia was administered to both
      groups 30 minutes before the end of the surgery.Tramadol HCL was infused at a concentration
      of 4mg/ml.A bolus of 20 mg of tramadol hydrochloride was given with a lock-in interval of 30
      minutes.Postoperative systolic arterial pressure(SAP),diastolic arterial pressure(DAP),mean
      arterial pressure(MAP),heart rate(HR),visual analog scale(VAS),analgesic
      consumption,nausea,vomiting, and patient satisfaction scores were recorded.
    

Intervention name(s): Tramadol; Morfin
Intervention type(s): Drug; Drug
Intervention description(s): ACB and IPACK were performed in USG-guided adductor canal block and infiltration popliteal artery capsule knee block accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.; No block was applied to the patients in control
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Postoperative pain; Adductor canal block; Infiltration popliteal artery capsule knee block; Tramadol; Bupivacaine
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Condition: Involutional Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with
      involutional osteoporosis.
    


Intervention name(s): Minodronic acid hydrate
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ONO-5920; osteoporosis; bisphosphonate
Immediate Loading of Implants in Totally Edentate Upper and Lower Jaw. Trial to Evaluate Survival of the Implants and Bridges, Quality of Prosthetic Work and Patient Satisfaction
Condition: Dental Implants
Study type: Interventional

Summary: 
      This study is an evaluation of the survival of the implants and bridges, quality of
      prosthetic work and patient satisfaction after immediate loading of the implants in a totally
      edentate upper and lower jaw.
    

Detailed description: 
      This study is an evaluation of the survival of the implants and bridges, quality of
      prosthetic work and patient satisfaction after immediate loading of the implants in a totally
      edentate upper and lower jaw.
    

Intervention name(s): Immediate loading of implants in totally edentate upper and lower jaw
Intervention type(s): Procedure
Intervention description(s): Immediate loading of implants in totally edentate upper and lower jaw.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal
Condition: Postprandial Glycemia; Postprandial Insulinemia
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract
      (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard
      meal composed of white bread, in healthy male and female volunteers.
    


Intervention name(s): MealShape cinnamon extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute administration of 1 g PO (2 capsules of 500 mg); Acute administration of 1 g PO (2 capsules of 500 mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cinnamon extract; Postprandial glycemia; Glycemic index; Pre-diabetes; Metabolic syndrome
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
Condition: Atrophic Vaginitis
MeSH terms: Vaginitis; Atrophic Vaginitis; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol
      vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol
      describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7
      day treatment.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was
      designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream
      USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace®
      (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis.
      Additionally, both the Test and the RLD formulations were tested for superiority against a
      Placebo.

      Following the 14-day screening period, patients who continued to meet the inclusion/exclusion
      criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.

      Five hundred and thirty-five (535) patients were randomized to one of the three study
      products as follows:

        -  Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)

        -  Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)

        -  Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)

      Patients completed up to three clinic visits as follows:

        -  Visit 1 - Screening: Day -14 to Day -1

        -  Visit 2 - Randomization: Day 1

        -  Visit 3 - End of Study: Day 8, maximum Day 10

      Study product was self-administered by the patient for 7 days according to the dosing
      instructions provided. Each patient was required to dose once daily at approximately the me
      of day for 7 consecutive days.
    

Intervention name(s): Estradiol; Placebos; Reference
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estradiol Vaginal Cream; Placebo with no active pharmaceutical ingredients. Topical vaginal cream; Estrace Vaginal Cream
Other intervention name(s): Estadiol Vaginal Cream; Topical Vaginal Cream; Topical Vaginal Cream
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other