bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
Condition: Healthy
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract,
      equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
    

Detailed description: 
      Flow mediated dilation (FMD) is a non-invasive measurement technique performed using
      ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from
      prospective studies suggests that FMD is independently inversely associated with
      cardiovascular events.
    

Intervention name(s): Nutrition intervention study with a black tea extract; Nutrition intervention study with a control
Intervention type(s): Other; Other
Intervention description(s): Tea extract: 1800 mg/day standardized Brooke Bond black tea extract equivalent to 400 mg flavonoids dissolved in 240 ml hot water.
Products will be consumed for 8 days. On measurement days tea will be given to the subjects as a single acute dose and 2 grams of sugar will be added.
On day 2-7 subjects will consume 3 cups or tea, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added.; Control: 1800 mg/day of a powder that gives a flavoured beverage with a color similar to black tea dissolved in 240 ml hot water.
Products will be consumed for 8 days. On measurement days control will be given to the subjects as a single acute dose and 2 grams of sugar will be added.
On day 2-7 subjects will consume 3 cups of control, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added.
Other intervention name(s): Black tea extract; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Black tea; Flow Mediated Dilation; Vascular function; India
Local Field Potentials Recorded From Deep Brain Stimulating (DBS) Electrodes
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This study will be recording and evaluating brain activity from Deep Brain Stimulating (DBS)
      electrodes in patients with Parkinson's disease.
    


Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's disease patients undergoing DBS implantation.
      
Keywords: brain activity; implanted with DBS electrodes
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this multicenter, randomized, double-blind study was to evaluate the
      efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given
      every other week SC in maintaining remission in subjects with moderate to severe
      non-radiographic axial spondyloarthritis.
    

Detailed description: 
      The study duration included a 42-day Screening Period, a 28-week open-label 40 mg adalimumab
      every other week (eow) treatment period (Period 1), a 40-week double-blind placebo controlled
      eow treatment period (Period 2) with an opportunity to receive at least 12 weeks of rescue
      therapy with open-label adalimumab (participants that flared at Weeks 60, 64 or 68 were
      allowed 12 weeks of rescue therapy and final visits were at Weeks 72, 76 or 80 respectively),
      plus a 70-day follow-up phone call. Participants in sustained Ankylosing Spondylitis Disease
      Activity Score (ASDAS) inactive disease were randomized at Week 28 at a 1:1 ratio to receive
      either blinded adalimumab 40 mg eow or matching placebo. The length of exposure to adalimumab
      depended on remission or flare status and ranged from 20 (first time Ankylosing Spondylitis
      Disease Activity Score [ASDAS] remission was calculated) to 80 weeks of treatment.
    

Intervention name(s): adalimumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 40 mg every other week; every other week
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spondylitis; Spondylarthropathy; Ankylosing Spondyloarthritis; Spondyloarthritis; Spinal Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Adalimumab; Antirheumatic Agents; Anti-Inflammatory Agents
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      doses of intramuscular INGAP Peptide given for the first time in humans as a potential
      treatment for diabetes.
    


Intervention name(s): INGAP Peptide
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Astrocytoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
      therapy in treating patients who have newly diagnosed anaplastic astrocytoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to
      and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects
      associated with this regimen in these patients. III. Evaluate this regimen in terms of
      fatigue, depression, excessive daytime somnolence, and quality of life in these patients.

      OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21
      and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8
      weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of
      chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4
      years, and then annually for 5 years. Patients are followed every 3 months for 5 years and
      then annually thereafter.

      PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.
    

Intervention name(s): carmustine; cisplatin; etoposide; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Etoposide; Carmustine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult anaplastic astrocytoma
Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
Condition: Oropharyngeal Leak Pressure
Study type: Interventional

Summary: 
      The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA)
      with a second port, providing gastric access to drain gastric content and air and it has an
      intergrated bite-block that helps avoiding rotation of the SGA.

      It has been described and it is known from daily routine, that SGA in edentulous patient
      provide inferior oropharyngeal leak pressure (OLP).

      The aim of the study is to evaluate if the placement of a gastric tube through the second
      orifice leads to better OLP and lowers the number of intervention needed for replacing the
      SGA.

      The study also evaluates the OLP after 15 minutes and after 30 minutes.
    


Intervention name(s): Gastric Tube; No gastric Tube
Intervention type(s): Device; Device
Intervention description(s): SGA is inserted with a gastric tube as guide for insertion; SGA is inserted without a gastric tube as guide for insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Breast Cancer Risk Biomarkers in Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to gather information on how the prescription drug Lovaza™ which
      contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.
      This drug is currently approved by the FDA for reducing blood levels of triglycerides.
    

Detailed description: 
      The central hypothesis is that 6 months of administration of high dose omega-3 fatty acid
      esters [eicosapentaenoic acid (EPA) 1860 mg, and docosahexaenoic acid (DHA) 1500 mg] daily in
      the form of a standard prescription strength dose of Lovaza™ (two 1 gram capsules twice
      daily) will have a favorable side effect profile and potential efficacy as demonstrated by
      favorable modulation of one or more blood and breast tissue risk biomarkers for breast cancer
      in postmenopausal women.
    

Intervention name(s): Lovaza™
Intervention type(s): Drug
Intervention description(s): 4 capsules daily for 6 months
Other intervention name(s): esters of EPA and DHA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Lactobacillus Reuteri Strains for Gingivitis Reduction
Condition: Gingival Inflammation
MeSH terms: Gingivitis; Inflammation
Study type: Interventional

Summary: 
      The aim of the present study was to investigate the potential beneficial effects in volunteer
      young adults of orally administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival
      inflammation. The null hypothesis was that no difference would be manifested by probiotic
      therapy regarding the conventional mechanical treatment (without probiotic administration).
    

Detailed description: 
      Aim. To investigate the potential beneficial effects in volunteer young adults of orally
      daily administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The
      null hypothesis was that no difference would be manifested by probiotic therapy regarding the
      conventional mechanical treatment (without probiotic administration).

      Methods. A randomized controlled parallel clinical trial was conducted in sixty young adults
      (18-35 yrs old) with chronic marginal gingivitis for one month. Initially, both study groups
      underwent conventional mechanical periodontal therapy/oral anti-plaque hygiene. However, the
      experimental group additionally received the administration of two daily tablets, containing
      both L. reuteri strains, for 30 days, while the control group did not. Different clinical
      outcome variables (plaque (PI) and gingival (GI) indices, bleeding on probing (BOP), and
      crevicular fluid volume (CFV)) were recorded and compared between the study groups, both at
      baseline and at the end of the interventions, 30 days later. Statistical descriptive and
      inferential tests were performed (data distribution normality, Student's t, and
      Wilcoxon-Mann-Whitney tests).
    

Intervention name(s): L. reuteri (DSM 17938 and ATCC PTA 5289) in form of oral tablets
Intervention type(s): Dietary Supplement
Intervention description(s): Each subject of the experimental group was instructed to dissolve inside the mouth two tablets per day (in the morning and before going to bed at night), during the experimental period of 30 days. The tablets were provided by BioGaia ProDentis® (Stockholm, Sweden). The tablets contained two strains of L. reuteri (DSM-17938 and ATCC PTA 5289), at a dose of 2 x 108 CFU/tablet.
Other intervention name(s): Conventional mechanical periodontal therapy and oral anti-plaque hygiene training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both study groups underwent conventional mechanical periodontal therapy/oral anti-plaque hygiene. However, the experimental group additionally received the administration of two daily tablets, containing both L. reuteri strains, for 30 days, while the control group did not.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis; Lactobacillus reuteri; Bacteriotherapy; Clinical randomized trial
High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Condition: Decompression Sickness; SCUBA Diving
MeSH terms: Decompression Sickness
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in
      the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and
      subtype of circulating microparticles, complete blood counts, and the quantification of
      venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.
    


Intervention name(s): High intensity exercise
Intervention type(s): Other
Intervention description(s): Subjects performed a repeated Wingate protocol for the exercise condition of the study. This consisted of 4, 30 s maximal efforts on a weight-braked cycle ergometer (Monark 894E, Monark Exercise AB, Sweden) with 4 min active recovery between efforts, preceded by a 5 min warm up. The resistance was set at 7.5% bodyweight for the intervals and 2% for the warm up and active recovery periods.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SCUBA diving; exercise,; microparticles; neutrophil activation,; high intensity exercise
A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors
Condition: Malignant Glioma; Recurrent Ependymoma
MeSH terms: Glioma; Ependymoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the administration of AdV-tk followed by valacyclovir in children
      with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma
      (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary
      objective is to determine if this approach is safe and can be effectively delivered without
      disturbing standard therapy.
    

Detailed description: 
      This is an Open label, Phase I, dose escalation study. Patients will receive an injection of
      AdV-tk into the tumor or tumor bed during the surgical procedure followed by 14 days of
      anti-herpetic prodrug, valacyclovir, starting 1-3 days after vector injection. Standard
      radiotherapy will begin 3-7 days after AdV-tK injection. Standard chemotherapy may begin
      after completion of valacyclovir at the discretion of the treating physician and family. Two
      dose levels of AdV-tk will be evaluated with a fixed dose of valacyclovir.
    

Intervention name(s): AdV-tk; valacyclovir; Radiation
Intervention type(s): Biological; Drug; Radiation
Other intervention name(s): Prodrug; Radiation therapy
Intervention MeSH terms: Valacyclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malignant glioma; Glioblastoma multiforme; Anaplastic astrocytoma; Recurrent ependymoma; Gene therapy; Immunotherapy
Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome
Condition: Healthy Athletes
Study type: Interventional

Summary: 
      It has recently been suggested that cocoa may improve exercise performance and recovery. This
      study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation
      during the training period in recreational athletes to detect possible metabolites involved
      in the observed benefits of cocoa in athletes
    


Intervention name(s): cocoa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sachets of 5 grams of cocoa daily supplementation; Sachets of 5 grams of maltodextrin daily supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to investigate the buffering effect of a calcium
      glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic
      challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part
      in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the
      volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the
      volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per
      million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm,
      respectively). The pH measurements were taken from a single-site using a microelectrode, with
      salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference
      electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a
      cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets
      of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after
      test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12
      hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.
    

Detailed description: 
      Although the mechanisms of action of fluoride are reasonably understood, the mechanism of
      calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has
      been suggested that CaGP increases the phosphorus content in the biofilm and, as a result,
      the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are
      maintained above the 5.0-5.5 range. This is above the critical range for enamel
      demineralization.
    

Intervention name(s): calcium glycerophosphate; no active ingredient; fluoride; CAGP + fluoride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): use of a dentifrice containing CaGP (0.13%) and no fluoride; dentifrice without calcium glycerophosphate and no fluoride; use of a dentifrice containing fluoride (1500ppm) only; calcium glycerophosphate and fluoride dentifrice
Other intervention name(s): CaGP; dentifrice only (placebo); sodium fluoride; Experimental dentifrice with CAGP + fluoride
Intervention MeSH terms: Calcium; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Calcium glycerophosphate; Fluoride; Dentifrice; Biofilm; Dental caries
Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation
Condition: Video-assisted Thoracoscopic Surgery; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation,
      and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled
      iloprost has been researched in animal study, but not yet in human during one-lung
      ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic
      obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or
      PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation. The primary outcome is
      pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of
      cardiac function including Tei-index during nebulizing iloprost. The investigators
      hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic
      obstructive pulmonary disease during one-lung ventilation.
    


Intervention name(s): Inhaled iloprost; normal saline (Saline 0.9%)
Intervention type(s): Drug; Drug
Intervention description(s): Nebulized agents (Iloprost or normal saline) were randomized by computer-generated randomization. The patients and anesthesiologist, who administered inhalation and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication, was the only person recognizing of the randomization code during trial.
Enrolled patients were received 20 μg iloprost or placebo (norma saline). Iloprost was diluted in normal saline to obtain 2ml solution. Control group were inhaled comparable dose of normal saline. Iloprost or normal saline was inhaled through an ultrasonic nebulized system in inspiratory limb.
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone
Condition: Congenital Adrenal Hyperplasia; Adrenal Insufficiency
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenal Insufficiency; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open label, randomized, single dose, three period crossover pharmacokinetic study
      of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups
      (Group 1, n=18 and Group 2, n=12).
    


Intervention name(s): Hydrocortisone; Chronocort
Intervention type(s): Drug; Drug
Intervention description(s): Generic hydrocortisone; Modified formulation of hydrocortisone
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment