bioihbjkbjnl/mcl2 huggingface dataset:
Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini
Condition: Conductive Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Conductive
Study type: Interventional

Summary: 
      Patients with conductive hearing loss fitting the inclusion criteria will be asked to
      participate in the study. All subjects will be randomized to wear either first the adhesive
      or the conventional bone conduction hearing aid. They will wear either device for two weeks.
      They will use the second device for another two weeks. Audiologic tests and quality of life
      questionnaires will be assessed at the beginning of the study after two weeks with the first
      device and after two weeks with the second device. Additionally, all patients will be asked
      to keep a diary including daily wearing time of the device.
    

Detailed description: 
      The primary objective of this study is to show, that the ADHEAR will be worn ~75%(~11 to 15
      hours per day) of the waking hours, whereas the Contact Mini will be worn ~ 50% (~5 - 8 hours
      per day) of the waking hours (p<0.05). The authors expect this difference due to increased
      wearing comfort, reduced/no pressure to the skin of the ADHEAR. The primary objective will be
      assessed with the diary patients are asked to use.

      Audiologic testing will consist of free field audiometry, Freiburger monosyllables test and
      Oldenburg sentence test. All tests will be performed with and without the devices.

      Quality of life and hearing related questionnaires will consist of the AQoL-8D and the SSQ12.
    

Intervention name(s): Adhear; Contact Mini (CM)
Intervention type(s): Device; Device
Intervention description(s): Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks; Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)
Condition: Depression; Depressive Disorders; Psychotic Disorders
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether subjects with psychotic major
      depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be
      compared to placebo in this international multicenter study. The duration of this trial is 6
      weeks.
    

Detailed description: 
      Major depression with psychotic features (psychotic depression) is the most debilitating
      disorder in the depressive disorders spectrum. It is associated with severe symptoms,
      prolonged course, poorer response rates, more residual symptoms, more frequent relapses and
      higher mortality, as compared to major depressive disorder.

      The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to
      investigate whether the HPA axis would be a target for pharmacotherapy in depression.

      The primary purpose of this study is to determine whether subjects with psychotic major
      depression benefit from adjunctive treatment with GR antagonist Org 34517. Two doses of Org
      34517 will be compared to placebo in this international multicenter study. The duration of
      this trial is 6 weeks.
    

Intervention name(s): Org 34517; Org 34517; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low dose Org 34517; high dose Org 34517; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
Condition: Bacterial Infections; Obesity
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to better understand how clindamycin works in children who fall
      in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The
      results of the study will help better understand if children in higher BMI ranges process the
      medication differently and whether dosing should be adjusted in these children.
    

Detailed description: 
      This is a prospective, open-label pharmacokinetic and safety study of multiple doses of IV
      and oral clindamycin in overweight and obese children ages 2 to 17 years of age. The total
      study duration is expected to be approximately 24 months; each subject will participate in
      the study for up to 18 days (screening day; treatment days 1-14 [may be as short as 2 days]
      followed by an observation period of 3 days post discontinuation of clindamycin therapy or
      after day 17 (on day 18) of therapy in those who are treated with more than 14 days of
      clindamycin).
    

Intervention name(s): Clindamycin
Intervention type(s): Drug
Intervention description(s): Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.
Other intervention name(s): Clindamycin phosphate (intravenous); Clindamycin hydrochloride (oral capsules); Clindamycin palmitate (oral solution)
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bacterial infections; Obesity; pharmacokinetics; clindamycin
Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo
Condition: Wrinkle; Fatigue; Puffiness Around the Eyes
MeSH terms: Fatigue
Study type: Observational

Summary: 
      The study aims at evaluating skin wrinkling, puffiness and fatigue and dark circle appearance
      on asian and african-american healthy volunteer cohorts receiving a cosmetic formulation
      containing NMN (2%). The product will be evaluated after 28 and 56 days of twice-daily
      application in comparison with a reference cosmetic formulation using clinical scoring under
      dermatological control. Cosmetic acceptability and future use will also be subjectively
      evaluated by analysis of the subjects answers to an evaluation questionnaire.
    


Intervention name(s): Test product creme; Reference creme
Intervention type(s): Other; Other
Intervention description(s): twice daily application of creme containing 2% NMN; twice daily application of reference creme
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type: Chinese and Afro-American subjects

          -  In each group, 50% of the subjects will have normal skin, 50% will have mild dry skin
             (declarative)

          -  100% will have wrinkles or fine lines on the crow's feet

          -  50% will have dark circles (half of them in the Active group, half of them in the
             Placebo group)

          -  50% will have puffiness (half of them in the Active group, half of them in the
             Placebo)
      
Keywords: Skin aging
Energy Expenditure of People Living With HIV/AIDS
Condition: HIV/AIDS; HIV Lipodystrophy Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; HIV-Associated Lipodystrophy Syndrome; Lipodystrophy
Study type: Observational

Summary: 
      Background: Several studies have reported increased resting energy expenditure (REE) in
      people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV
      lipodystrophy syndrome.

      The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in
      resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive
      for HIV in treatment of lipodystrophy.
    

Detailed description: 
      REE was measured by indirect calorimetry.

      TEE was measured by doubly labeled water (DLW) technique and an activity monitor based on
      accelerometry (AM).
    

Intervention name(s): use of lipid-lowering drugs.
Intervention type(s): Drug
Intervention description(s): The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.
Other intervention name(s): statins and fibrates
Intervention MeSH terms: Hypolipidemic Agents
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Men previously diagnosed with HIV infection, on antiretroviral therapy.
      
Biospecimen description: 
      urine.
    
Keywords: energy expenditure; doubly labeled water; accelerometer; HIV; lipodystrophy syndrome.
Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted as a multi-center, randomized, double-blinded, placebo
      controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating
      Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT
      during Period 1 or 2; the blinded matching placebo will be given as a single administration
      during the opposing period. The random code will determine the order of active drug
      (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be
      recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non
      investigational drug product (vasodilator), Procardia XL, will be background treatment for
      hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for
      at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the
      requirement that all subjects will be male, are between the ages of 65 and 80 years, and will
      have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size
      will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this
      analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the
      ages of 70 and 80 years. The total duration of the study will be approximately one year from
      first subject treated to last subject treated, including replacement of any subjects who fail
      to complete both periods of crossover dosing.
    


Intervention name(s): Vardenafil ODT, (Staxyn, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 10 mg of vardenafil ODT, taken without water; Single dose of placebo to match 10 mg vardenafil ODT. taken without water
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: drug-drug interaction
Personal Health Records and Elder Medication Use Quality
Condition: Adverse Reaction to Drug; Health Behavior; Medication Adherence; Physician-Patient Relations
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional

Summary: 
      Purpose: To examine the impact of a personal health record (PHR) on medication use safety
      among older adults.

      Background: Online PHRs have potential as tools to manage health information. We know little
      about how to make PHRs accessible for older adults and what effects this will have.

      Methods: A PHR was designed and pretested with older adults and tested in a six-month
      randomized controlled trial. After completing mailed baseline questionnaires, eligible
      computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or
      serve as a standard care control group (n=273). Follow-up questionnaires measured change from
      baseline medication use, medication reconciliation behaviors, and medication management
      problems.
    


Intervention name(s): Personal Health Record (PHR)
Intervention type(s): Behavioral
Intervention description(s): Iowa PHR is a Web-based application that features a tabbed interface design. Users can enter, view, and print their current and past medicines, allergies, health conditions, and health event tracking over time. An embedded tutorial video provides assistance with the system. The PHR was developed and refined using participatory design and focus group sessions as well as evaluation in a usability laboratory. The resulting design emphasizes the reduction of physical and cognitive demands on users, focusing on simplicity, readability, and quick navigation.
Iowa PHR displayed a message when a user entered a medication with an associated Assessing Care of Vulnerable Elders project (ACOVE-3) safety concern. This included 16 safety issues for 12 drugs or drug classes with safety concerns. We also adapted four general medication use patient safety indicators from the ACOVE project and displayed them to all users on a rotating basis upon login.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Personal health record; medication management; patient safety
Home Monitoring of Patients With Chronic Diseases - an eRehab Test-retest Study
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis, Rheumatoid; Chronic Disease
Study type: Observational

Summary: 
      The aim of the study is to establish the intrarater-reliability, criterion validity and
      responsiveness of the ADL-Questionnaire applied on an eHealth platform to be used by patients
      diagnosed with rheumatoid arthritis.

      The study is designed as a repeated test-retest study including 240 patients filling in the
      ADL-Q, HAQ-DI and PDQ at day 1, 3, 56 and 58. The study provides an eHealth platform (a
      home-module in the DANBIO database) which makes it possible for the patients to complete
      their assessments and send information from their own home.

      Intrarater reliability will be assessed by calculating the intraclass correlation
      coefficients (ICCs). Criterion validity will be evaluated based on correlational analysis and
      responsiveness based on effect sizes, in both cases involving HAQ-DI. PDQ scores will be used
      to classify participants based on pain phenotype to explore any relationship between pain
      phenotype and reliability.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients, diagnosed with RA, referred for regular controls in the rheumatology
        clinic at Copenhagen University Hospital, Bispebjerg and Frederiksberg, will be screened
        via the database, DANBIO, for in- and exclusion criteria.
      
Keywords: Reproducibility of Results
Cohort of Swedish Men
Condition: Cancers; Cardiovascular Diseases; Cataract; Gastrointestinal Diseases; Osteoporosis; Fractures
MeSH terms: Osteoporosis; Gastrointestinal Diseases; Digestive System Diseases; Cataract; Cardiovascular Diseases
Study type: Observational

Summary: 
      The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing
      in two counties in central Sweden received a questionnaire including about 350 items
      concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.
    

Detailed description: 
      The Cohort of Swedish Men was established in 1997, when all men born between 1918 and 1952
      and residing in Västmanland and Örebro counties in central Sweden received a questionnaire
      concerning diet and other lifestyle factors. Of the 100,303 eligible men, 48,850 (49%)
      responded to the questionnaire. The questionnaire included items about diet, physical
      activity, medical history, and lifestyle factors such as cigarette smoking history and use of
      dietary supplements.

      During 2008-09, the exposure information was updated and extended by sending out two new
      questionnaires - one questionnaire on health including several signs of symptoms, sleeping,
      social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors
      (2009). Majority of questions in the questionnaires have been validated.

      Incident cases of cancer are ascertained by record linkages of the study population with the
      National Swedish Cancer Register and the Regional Cancer Registers. Cardiovascular and other
      diseases as well as surgeries and causes of death are identified by linkage to the National
      Inpatient and other registries at the Swedish Board of Health and Welfare. Ascertainment of
      cancer cases and other diseases is almost 100% complete. Dates of deaths are ascertained
      through the Swedish Death Register (100% complete), and information on date of moving out of
      the study area is obtained by linkage with the Swedish Population Register.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men born between 1918 and 1952, living in central Sweden (Örebro and Västmanlands counties)
      
Biospecimen description: 
      Saliva Blood
Obesity Childhood in Cuenca-Ecuador: Prevalence and Risk Factors
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Hypothesis: Obesity in children of Cuenca is related with socioeconomical status and physical
      activity habits.

      Summary:

      The prevalence of obesity and overweigh in all age groups are increasing rapidly in the
      world. Some factors like physical activity, socioeconomical status, dietary habits, gender,
      besides genetic factors influence in the development of obesity.

      In Cuenca - Ecuador lack information related to prevalence of overweight and obesity in
      children and the risk factors related.

      Socioeconomical status and quality of physical activity are assessed using specially designed
      questionnaires in a randomized sample of children 6 to 9 years of age of Cuenca city.
      Nutritional status is assessed using body mass index, relation weight/age and height/age.
      These data are helpful to develop programs focused to improve nutritional status in scholars
      of Cuenca.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children (girls and boys) 6 to 9 years of age. Sample ramdomized of urban schools of Cuenca
        Ecuador
      
Keywords: Nutritional status of scholars; Risk factors of obesity; Socioeconomical status; Physical activity habits
Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism
Condition: Depression; Anger; Anxiety; Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      Alcohol dependent patients show comorbid psychiatric symptoms, related to malfunction of
      dopamine, norepinephrine and serotonin neurotransmission, during early recovery. Ziprasidone
      can improve malfunctioning of these disregulated systems, thereby improving anxiety,
      depression, anhedonia, anger, and alcohol craving.
    

Detailed description: 
      60 alcohol-dependent patients will be included, once finished alcohol detoxification
      treatment.Thirty patients will receive ziprasidone treatment, in progressively increasing
      doses, starting from 40 mg per day, and the other 30 patients will receive placebo, in a
      double blind procedure
    

Intervention name(s): Treatment of psychiatric symptoms associated to alcoholism
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Psychiatric symptoms associated to alcoholism recovery; Alcoholism treatment; Alcohol craving; Relapse to heavy drinking; Abuse of other substances during alcoholism recovery
Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the iontophoretic application of terbinafine gel
      is safe and effective for teh treatment of distal subungual onychomycosis
    


Intervention name(s): Terbinafine Hydrochloride; Purified Water
Intervention type(s): Drug; Other
Intervention description(s): 4% w/w Terbinafine Hydrochloride Gel; Purified Water
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Onychomycosis
1,5-AG as a Marker of Postprandial Hyperglycemia and Glucose Variability in Well-controlled Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Observational

Summary: 
      The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients
      with HbA1C <7%, and glycemic excursions as assessed by the continuous glucose monitoring
      system compared to fructosamine.
    

Detailed description: 
      1,5-Anhydroglucitol (AG) is a glucose analogue present in the plasma of healthy subjects.
      Physiologically, the plasma levels of 1,5-AG are very stable and only a small quantity is
      excreted in the urine. It is competitively reabsorbed with glucose in the renal tubules.
      Therefore, in the hyperglycemic state where glycosuria is present, glucose competitively
      inhibits renal tubular reabsorption of 1,5-AG and consequently the plasma 1,5-AG levels
      decrease. When glycemia is normalized and glycosuria is resolved, 1,5-AG levels increase.

      The usefulness of 1, 5-AG in reflecting glycemic excursions have been demonstrated in
      moderately controlled patients to some extent, although some studies reveal controversial
      results.

      Therefore, the aim of this study was to evaluate the association of 1,5-AG and postprandial
      hyperglycemia determined using the Continuous Glucose Monitoring System (CGMS) in DM patients
      with HbA1C<7% and evaluate the usefulness of 1,5-AG as a marker of glycemic control compared
      to HbA1C and fructosamine.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Well-controlled patients with type 2 diabetes with HbA1c<7%
      
Biospecimen description: 
      serum (HbA1c, fructosamine, 1,5-anhydroglucitol)
    
Keywords: 1,5-Anhydroglucitol