bioihbjkbjnl/mcl2 huggingface dataset:
Alpha-linolenic Acid and Blood Pressure
Condition: Hypertension; Lipid Metabolism Disorders
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Rationale: Increased intakes of n-3 long chain polyunsaturated fatty acids eicosapentanoic
      acid (EPA) and docosahexaenoic acid (DHA), mainly found in fatty fish, are recommended for
      the prevention of coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most
      common vegetable-oil based n-3 fatty acid. Evidence exists that ALA supplementation can also
      have a protective effect on the development on cardiovascular disease, but may exert its
      cardio protective effects through different routes. The benefit may (partly) be due to blood
      pressure lowering. However, evidence for beneficial effects of ALA on blood pressure is
      conflicting. Therefore, we propose to investigate the effect of flaxseed oil, high in ALA,
      using a study powered on 24-hour blood pressure, in a population with high normal blood
      pressure and mild hypertension.

      Objective: To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial
      pressure (MAP) in men and women with high-normal blood pressure and mild hypertension
      compared to high oleic sunflower oil, poor in ALA.

      Study design: Using a double blind randomized, placebo-controlled parallel design, subjects
      will receive at random daily 10 g of flaxseed oil or a high-oleic acid sunflower oil (HOSF)
      as control for twelve weeks, with a run-in period of 14 days in advance.

      Study population: 72 men and women, aged 40-70 years, with untreated high-normal blood
      pressure and stage I hypertension and a body mass index between 25 and 35 kg/m2 will
      participate in the run-in and intervention period. It is estimated that 144 subject have to
      be screened to find 72 subjects that will enter the run-in period.

      Intervention: During the run-in period, subjects will receive daily 10 g of palm super olein
      oil. During the intervention period subjects receive either 10 g of HOSF or flaxseed oil. All
      oils are provided in bottles of 5 g, one will be consumed at breakfast or lunch and one at
      dinner.

      Main study parameters/endpoints: The main study parameter is the change in 24h-ambulatory
      mean arterial pressure (MAP)
    


Intervention name(s): Flaxseed oil; high oleic sunflower oil (HOSF)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The flaxseed oil will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day; The HOSF will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: n-3 polyunsaturated fatty acids; Alpha-linolenic acid; Blood pressure; Vascular function
Effect of Acute Ethanol Consumption on The Activity of Major Cytochrome P450 Enzymes, NAT2 and P-glycoprotein
Condition: AOD Effects and Consequences
Study type: Interventional

Summary: 
      Protocol title: Effect of acute alcohol consumption on the activity of major cytochrome P450
      enzymes, NAT2 and P-glycoprotein.

      Objectives: The study is mainly conducted to evaluate the effect of acute alcohol consumption
      on the activity of the most important drug metabolising cytochrome P450 enzymes CYP1A2,
      CYP2C9, CYP2C19, CYP2D6, intestinal CYP3A4, hepatic CYP3A4, NAT2 and on the activity of the
      drug transporter p-glycoprotein (intestinal and renal).

      The study should also provide basis for a planned clinical study on interactions caused by
      chronic alcohol intake.

      Design: Single center, open-label, two-way, cross-over study with randomly allocated
      sequences Test-Reference or Reference-Test.

      The study is not a clinical drug study according to the German Drug Act.

      Clinical phase: Not applicable

      Volunteers: 16 healthy male and female subjects are planned for completion in accordance with
      the protocol, i.e. with evaluable/analysable data for all periods and treatments.

      Clinical centre: Department of Pharmacology, Clinical Pharmacology Unit (KPH), University of
      Cologne, Gleueler Str. 24, 50931Köln, Germany
    


Intervention name(s): caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses; ethanol multiple doses plus caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses
Intervention type(s): Drug; Drug
Intervention description(s): Reference period; Test period
Other intervention name(s): Percoffedrinol, Tolbutamide PCH, Omepazol Ratiopharm, Hustenstiller Ratiopharm, Digacin and Midazolam-ratiopharm; Percoffedrinol, Tolbutamide PCH, Omepazol Ratiopharm, Hustenstiller Ratiopharm, Digacin, Midazolam-ratiopharm and Wodka Gorbatschow 50%
Intervention MeSH terms: Tolbutamide; Ethanol; Digoxin; Midazolam; Dextromethorphan; Caffeine; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024
      (ceftibuten) when administered as single agents and with co-administration in a single dose
      cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching
      placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8
      hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
    


Intervention name(s): VNRX-7145; VNRX-5024 (ceftibuten); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): β-lactamase inhibitor; β-lactam antibiotic; Placebo
Intervention MeSH terms: Ceftibuten
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: Crossover Parts 2&3: Parallel
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG
      (electrocardiogram) in comparison to placebo
    


Intervention name(s): BI 1744 CL solution for inhalation; Placebo matching BI 1744 CL; Moxifloxacin (Avalox®)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Condition: Alopecia; Alopecia, Androgenetic; Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia
      (AGA).
    


Intervention name(s): Bimatoprost Solution 1; Bimatoprost Solution 2; Bimatoprost Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.; Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.; Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Avonex®: Safety, Blood Levels and Effects
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective was to determine the tolerability of a new inhaled formulation of
      interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and
      compared with standard intramuscular (IM) AVONEX® when given as a single dose.

      The additional objectives were:

      To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon
      beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when
      given as a single dose, when given once per week for 4 weeks, and compared with standard IM
      AVONEX® when given as a single dose.

      To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon
      beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose,
      when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a
      single dose.
    


Intervention name(s): Interferon beta 1a; (IM) AVONEX®
Intervention type(s): Drug; Drug
Other intervention name(s): AVONEX
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: inhaled; interferon beta-1a; healthy subjects
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Condition: Heart Transplantation; Lung Transplantation; Pancreas (Including SPK) Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison of tacrolimus blood levels in adults who have received a transplant and are taking
      either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is
      followed by checking of safety and effectiveness for one year.
    


Intervention name(s): Advagraf; Prograf
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): FK506E; MR4; tacrolimus modified release; tacrolimus; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Advagraf; Heart; Lung; Pancreas; Transplant; Immunosuppression; Pharmacokinetics
Kazakh Version of Reflux Symptom Index
Condition: Laryngopharyngeal Reflux Symptoms; Laryngopharyngitis Chronic; Gastro Esophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Laryngopharyngeal Reflux
Study type: Observational

Summary: 
      Reflux symptoms index (RSI) were developed to identify a clinical index of suspicion for
      laryngopharyngeal reflux (LPR) in patients with ear, nose, and throat symptoms. RSI is an
      efficient diagnostic tool for LPR/ It is easy to use, even for those who know little about
      LPR. It does not require special equipment or examinations and is inexpensive. Thus, it can
      be considered highly efficient and cost-effective. The study will focus on translating and
      testing the RSI into Kazakh language and comparing its results in healthy people and people
      with laryngopharyngeal reflux.
    


Intervention name(s): Reflux Symptom Index Inventory (diagnostic survey); Reflux finding score
Intervention type(s): Other; Other
Intervention description(s): Kazakh versions of the Reflux Symptom Index Inventory will be filled patients; laryngoscopy with a score RFS
Other intervention name(s): RSI; RFS
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult female patients between 18 to 74 years of age with a laryngopharengeal symptoms and
        patients without symptoms of laryngopharyngeal reflux who applied for an appointment with
        an otorhinolaryngologist/
      
Keywords: Laryngopharyngeal Reflux; Laryngopharyngeal Reflux Symptoms; Laryngitis; Laryngopharyngitis Chronic; Gastro Esophageal Reflux
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in
      combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration
      and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an
      extension treatment for up to 52 weeks.
    


Intervention name(s): Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea); Teneli / Teneli + SU
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea; Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea
Other intervention name(s): MP-513; Amaryl; glimepiride; MP-513; Amaryl; glimepiride
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance
Early Rehabilitation of Cancer Patients
Condition: Breast Cancer; Colorectal Cancer; Lymphoma; Prostate Cancer; Testicle Cancer
MeSH terms: Testicular Neoplasms
Study type: Interventional

Summary: 
      A life threatening disease such as cancer may lead to post traumatic stress disorder, and
      even when reporting low levels of side-effects from cancer disease and treatment, 80% report
      high levels of stress symptoms. The purpose of the present randomised controlled trial is to
      examine the psychosocial effects of a stress management intervention based on cognitive
      behaviour therapy and with focus on increased physical activity in patients with various
      cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is
      possible to study the level and intensity of stress management intervention required to
      achieve increased well-being. A cost-utility analysis will also be performed. 300 adult
      patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or
      lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland
      University Hospital, will be consecutively included in the prospective intervention study.
      The patients will be randomized to intervention or control. In step 1, all patients in the
      intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically
      significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by
      Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression
      Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There
      will also be a focus on motivating to increase physical activity level. Both the intervention
      (I) and control group (C) are allowed to take part in the common rehabilitation program with
      patient education and physical training. Data will be collected with self-reported
      standardized questionnaires. Objectively measures of physical activity level, sleep and daily
      energy expenditure are recorded with SenseWear™ Pro3 Armband. Measure point is at inclusion
      and than after 6 week, 4, 8, 12 and 24 month.
    


Intervention name(s): Stressmanagement
Intervention type(s): Other
Intervention description(s): Individual stepped-care approach stressmanagement by specially trained counsellor
Other intervention name(s): I-a; I-b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
Condition: Healthy Men and Women
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet
      formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation
      of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.
    


Intervention name(s): Flupentixol/melitracen film-coated tablet; Flupentixol/melitracen coated tablet (Deanxit®)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-Op Quality of Life After Colorectal Surgery
Condition: Colorectal Neoplasms; Colitis, Ulcerative; Diverticulitis; Colonic Polyps; Crohn Disease
MeSH terms: Colorectal Neoplasms; Crohn Disease; Diverticulitis; Colitis, Ulcerative; Colonic Polyps
Study type: Observational

Summary: 
      The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire
      - to accurately assess early quality of life in patients after abdominal colorectal surgery
      from the first day after surgery to 6 months after. The study will also compare this
      questionnaire to the other currently available assessment tools. Patients are invited to
      participate if they are undergoing abdominal colorectal surgery at University Hospitals of
      Cleveland.
    

Detailed description: 
      The purpose of this study is to produce a user-friendly tool to accurately assess early
      quality of life in postoperative patients following abdominal colorectal surgery in the early
      postoperative period (from surgery to 6 months) that is practical for routine application.
      The study will also compare this tool to the current available tools, namely the Short Form
      (SF-36), the short form inflammatory bowel disease questionnaire (IBDQ), the Cleveland Clinic
      Global Quality of Life (CGQOL). Patients will be invited to participate if they are
      undergoing abdominal colorectal surgery at University Hospitals of Cleveland.
    

Intervention name(s): Laparoscopic or open colorectal surgery
Intervention type(s): Procedure
Intervention description(s): Application of a post-operative diary to be completed by subjects. The intervention is standard of care laparoscopic or open surgery.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled to undergo laparscopic or open procedures from the Deopartment of
        Surgery at University Hospitals of Cleveland.
      
Keywords: Colorectal Surgery; Abdominal Surgery; Diverticulitis; Colon Cancer; Rectal Cancer; Colon Polyp; Rectal Polyp; Crohn's Disease
Analysis of Balance in the Aging Process
Condition: Aging
Study type: Observational

Summary: 
      Introduction: While growing older, it is possible to notice a decrease in the functional and
      physiological reserves in the organism which impairs the the abilities in the elderly in
      doing some tasks. A simple balance becomes a challenge.

      Objective: To evaluate the functional balance in the aging process.

      Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation
      instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment
      (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.
    

Detailed description: 
      48 individuals of both sexes and aged between 10 and 85 years were chosen. These individuals
      were divided according to age, into four groups (each group containing 12 individuals, 6 men
      and 6 women): Group I (G1): 10 - 18, Group II (G2): 20 - 35; Group III (G3): 45 - 60, Group
      IV (G4): 65 - 85.

      The instruments used for assessment of the balance were: (1) Berg Scale - consists of 14
      items with common activities of daily life, with progressive degree of difficulty (2)
      Assessment of Gait and Balance for Performance Oriented (POMA), consists of a protocol that
      evaluates the static and dynamic balance, with operations similar to the activities of daily
      living, (3) Test Support Unipodal; (4) adapted Functional Reach Test, which assesses the
      stability in the standing position, (5) Test and Romberg Romberg's test Romberg-Barré or
      sensitized conducted in stable and unstable soil, and all positions were first with open eyes
      and then with closed eyes. The duration of each exposure was 30 seconds, with different
      positioning of the feet.
    

Sampling method: Non-Probability Sample
Study population: 
        The participants were selected in dependency of Unifran (University of France) and the
        homes of the neighborhood. The choice of groups was based according to the degree of
        functionality and independence in order to analyze the lack of balance in the process of
        aging.
      
Biospecimen description: 
      The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented
      Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the
      Romberg's Test.
    
Keywords: Aging; Postural Balance
Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
Condition: Growth and Development
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the impact of a beverage containing carbohydrate
      powder fortified with micronutrients on agility, speed, and power in school going children
    


Intervention name(s): Carbohydrate beverage powder; Calorie matched beverage powder; Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Carbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day; Calorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day; lukewarm water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other