bioihbjkbjnl/mcl2 huggingface dataset:
Motivational Intervention for Physical Activity in Psychosis
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether motivational intervention is effective in
      promoting exercise habit in patients with psychosis.
    

Detailed description: 
      The current study aims to investigate the beneficial effect of motivational intervention in
      promoting exercise habit in patients with psychosis. Outpatients will be recruited and will
      be randomized to a 12-week motivational intervention program. They will be assessed for their
      clinical symptoms, cognitive function, physical fitness, and quality of life. All patients
      will have cognitive function assessments at baseline, 12 weeks after the completion of the
      program and 6 months. The primary hypothesis of the current study is that motivational
      intervention can help patient to develop exercise habit in patients with early psychosis.
    

Intervention name(s): Motivational Interviewing; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational Interviewing is a patient-centered, tailored counselling intervention for exercise, through which patients' motives to change are identified. Personal ideas and ambivalence are explored. The discrepancies between the present behavior and the patient's own future goals are amplified. The patient's intrinsic motivation for change is increased through the process.; General education about healthy lifestyle and diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Motivational Interviewing; Exercise
Effects of Emulsification and Lipid Droplet Size on Postprandial Metabolic Responses
Condition: Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of emulsification and lipid droplet size on
      gastric emptying rate, and to determine if the change in gastric emptying rate can in turn
      influence postprandial glycemic, insulinemic and lipidemic responses.
    

Detailed description: 
      This study will be conducted using a randomized, crossover design with three dietary phases:
      1) fine emulsion beverage (small lipid droplet size), 2) coarse emulsion beverage (large
      lipid droplet size) and 3) non-emulsified oil and water. All treatments will be consumed
      together with bread. All participants will be randomly allocated to the three test meals.
      Fifteen to twenty participants aged between 21 and 50 years will be recruited from the
      general public in Singapore.

      During the testing sessions, participants' glycemic, insulinemic, lipidemic responses and
      gastric emptying to the test meals will be measured. Gastric antral distention ultrasound
      measurement is an indirect measure of gastric emptying rate. Participants' metabolic satiety
      for the test meals will also be assessed at regular intervals throughout the testing session.
      Each testing session will take approximately four hours in duration and the testing sessions
      will take place at least five days apart.
    

Intervention name(s): Fine emulsion; Coarse emulsion; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.; Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.; Beverage is made up of distilled water and olive oil. Beverage will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Evaluating the Safety and Immune Response to Different Combinations of the DNA-HIV-PT123 and AIDSVAX® B/E Vaccines in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and immune response to different
      combinations of two experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E
      vaccine-in healthy adults who are not infected with HIV.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      combination of two different experimental HIV vaccines-the DNA-HIV-PT123 vaccine and the
      AIDSVAX® B/E vaccine-administered in different sequences or simultaneously, in healthy adults
      who are not infected with HIV.

      Participants will be randomly assigned to four groups. Depending on which group participants
      are in, they will receive different combinations of the DNA-HIV-PT123 vaccine, the AIDSVAX®
      B/E vaccine, a placebo for DNA-HIV-PT123 vaccine, and/or a placebo for AIDSVAX® B/E vaccine.
      Study visits will occur at study entry, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12.
      All participants will receive their assigned combinations of vaccines at study entry and
      Months 1, 3, and 6. At each vaccination visit, participants will receive one injection in
      each upper arm. Following each vaccination, participants will remain in the clinic for 30
      minutes for monitoring. All study visits will include a physical examination, HIV risk
      reduction counseling, and questionnaires and assessments. Select study visits will also
      include a urine collection, a blood collection, a pregnancy test for participants who were
      born female, and HIV testing and counseling.
    

Intervention name(s): AIDSVAX B/E Vaccine; DNA-HIV-PT123 Vaccine; Placebo for DNA-HIV-PT123; Placebo for AIDSVAX B/E
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 600 mcg/mL to be administered as 1 mL intramuscular (IM) injection; 4 mg/mL to be administered as 1 mL IM injection; Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection; Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Empagliflozin & Metformin HCL from Empagliform 12.5/1000 mg F.C.T (Hikma
      Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH,
      Germany)
    

Detailed description: 
      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. 24 subjects will participate in the study. All dosed subject samples will
      be analyzed and their data will be included in the final study report.

      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Empagliflozin & Metformin (Test); Empagliflozin & Metformin (Reference)
Intervention type(s): Drug; Drug
Intervention description(s): one tablet administrated according to a randomization scheme with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing.; one tablet administrated according to a randomization scheme with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing.
Other intervention name(s): Empagliform; Synjardy
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Hemorrhoids and Metalloproteinases, Observational Study
Condition: HEMORRHOIDS; Extracellular Matrix Alteration
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been
      described previously. MMPs regulate extracellular structural proteins and tissue remodeling.
      Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP
      activity. The aim of this work was to study the relationship between the levels of MMPs and
      NGAL and different stages hemorrhoids.

      The study provides potentially important insights to the understanding of the natural history
      of Hemorrhoids and MMPs and NGAL regulation.
    

Detailed description: 
      Introduction. An association between hemorrhoidal disease and matrix metalloproteinases
      (MMPs) has been described previously. MMPs regulate extracellular structural proteins and
      tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the
      regulation of MMP activity. The aim of this work was to study the relationship between the
      levels of MMPs and NGAL and different stages hemorrhoids.

      Methods. In a multicenter, open-label, prospective study, patients with hemorrhoids were
      recruited and represented the Group I (patients with symptomatic hemorrhoids - Grade I to IV
      sec. Goligher), a further group of healthy volunteer subjects were also recruited as the
      control group (Group II).

      Enzyme-linked immunosorbent assay and Western blot analysis will evaluate the levels of
      immunoreactive MMPs and NGAL in all patients with hemorrhoids.
    

Intervention name(s): Hemorrhoidectomy; blood sampling; tissue sampling
Intervention type(s): Procedure; Other; Other
Intervention description(s): Grade III and IV patients were treated with surgery according to Milligan-Morgan (Milligan-Morgan laser optical fibers variant) procedure.
All patients will perform blood sampling for MMPs and NGAL plasma levels evaluation; blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test); tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hemorrhoids; MMP; NGAL; Matrix Metalloproteinases
A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary
      vein ablation procedures in patients with paroxysmal atrial fibrillation.
    


Intervention name(s): Conventional cryotherapy dosage; Experimental cryotherapy dosage; Arctic Front Advance ST Cryoenergy Balloon Catheter; Adenosine triphosphate; nECG platform Nuubo®
Intervention type(s): Other; Other; Device; Drug; Device
Intervention description(s): Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds; cryotherapy dosage: applications "time to block of the vein" plus 60 seconds long until block of the vein plus 1 bonus freezing of 120 seconds; Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon; 12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected; 30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cryotherapy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended
      release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories
      Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg)
      manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP
      Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.
    

Detailed description: 
      All the subjects were subjected to breath test for alcohol and test for drugs of abuse
      (opioids and cannabinoids) prior to admission in each period. Only subjects with negative
      results in these tests were preceded for further activities.

      Following an overnight fast of at least 10 hour, a high-fat highcalorie breakfast was served
      to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of
      felodipine extended release tablets 10 mg of either test or reference formulation was
      administered during each period of the study, along with 240 mL of drinking water at ambient
      temperature under low light condition and under supervision of trained study personnel.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study.
    

Intervention name(s): Felodipine; Felodipine (Plendil®)
Intervention type(s): Drug; Drug
Intervention description(s): Extended Release Tablets, 10mg
Intervention MeSH terms: Felodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of Smoking on Saliva Composition and the Development of Dental Erosion
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Study type: Observational

Summary: 
      The aim of this study is to investigate whether smoking is associated with changes in
      salivary composition and/or predisposition to erosion.

      Healthy volunteers are observationally wearing an intraoral device with both bovine tooth
      specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards,
      specimens are eroded extraorally and calcium release into the acid is measured.

      Total protein concentration and protein composition of the salivary pellicles on the resin
      samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva
      flow rate, pH, buffer capacity, total protein content and protein composition as well as
      concentration of inorganic calcium, phosphate, and fluoride) are measured.
    


Intervention name(s): Use of fluoridated toothpaste; Wearing of an intraoral device with bovine tooth samples; Wearing of an intraoral device with resin samples
Intervention type(s): Other; Other; Other
Intervention description(s): Use of fluoridated toothpaste; Wearing of an intraoral device with bovine tooth samples; Wearing of an intraoral device with resin samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Exploratory study
      
Biospecimen description: 
      Saliva samples are obtained and retained for 10 years.
Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease
Condition: Autoimmune Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      This study was a retrospective clinical observation cohort study. All patients with
      autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of
      Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical
      University, were enrolled. Clinical follow-up data including demographics, hematuria, and
      liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte
      sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies,
      special proteins and liver imaging (liver ultrasound) examination. The clinical effect of
      glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and
      the safety during treatment were analyzed.
    

Detailed description: 
      This study was a retrospective clinical observation cohort study. All patients with
      autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of
      Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical
      University, were enrolled. Clinical follow-up data including demographics, hematuria, and
      liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte
      sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies,
      special proteins and liver imaging (liver ultrasound) examination. The clinical effect of
      glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and
      the safety during treatment were analyzed.
    

Intervention name(s): Glycyrrhizic acid preparation
Intervention type(s): Drug
Intervention description(s): To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment
Intervention MeSH terms: Glycyrrhizic Acid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the
        diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver
        Disease (2015);
      
Keywords: Autoimmune liver disease; glycyrrhizic acid; liver function
Hyperoxic Oxidative Stress During Abdominal Surgery
Condition: Response to Hyperoxia
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative
      stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality,
      preanesthetic and postanesthetic expiration tidal volumes.
    


Intervention name(s): Fraction of inspired oxygen 40%; Fraction of inspired oxygen 80%
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the
      pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In
      Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either
      RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy
      Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523
      or placebo orally daily for 14 days.
    


Intervention name(s): RO4917523; RO4917523; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral doses; multiple oral doses; oral doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Shoulder Pain
Study type: Interventional

Summary: 
      The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an
      improvement in pain levels and range of motion.
    

Detailed description: 
      To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated
      with osteoarthritis.
    

Intervention name(s): EUFLEXXA
Intervention type(s): Drug
Intervention description(s): 2.5 mL of EUFLEXXA (per injection) x 3 injections
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
Condition: Locally Advanced Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin
      (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer.
      Patients will be treated until disease progression or until the investigator has determined
      that treatment is not in the best interest of the patient, whichever occurs first.
    


Intervention name(s): Fulvestrant; Exemestane
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular injection; oral capsule
Other intervention name(s): Faslodex; ZD9238; AROMASIN™
Intervention MeSH terms: Fulvestrant; Exemestane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Locally advanced breast cancer; metastatic breast cancer; Breast Cancer; Cancer of Breast; Cancer of the Breast