bioihbjkbjnl/mcl2 huggingface dataset:
Glistenings and PCO Evaluation for the Envista MX60
Condition: Cataract
MeSH terms: Cataract; Capsule Opacification
Study type: Observational

Summary: 
      Posterior capsule opacification (PCO) and glistenings development is among the primary
      reasons for sub-optimal visual capacity following cataract extraction surgery. Primary
      objective of this study is to evaluate the incidence of PCO and glistenings of the popular
      envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who
      underwent phacoemulsification at least 1 year prior to their enrollment at the study
    


Intervention name(s): Phacoemulsification
Intervention type(s): Procedure
Intervention description(s): Phacoemulsification for cataract extraction with Envista MX-60 implantation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with senile cataract
      
Keywords: cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of the study is to determine the effects of Androxal on morning testosterone and
      reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less
      than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The
      effects of Testim versus placebo on reproductive status will also be examined. Study subjects
      must not be currently using a topical testosterone.
    

Detailed description: 
      This study is a phase IIb, 4 arm study with three month active dosing period. Three of the
      four treatment groups will be randomized to either Androxal or placebo in a double-blind
      fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal
      in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
    

Intervention name(s): Placebo; topical testosterone; Androxal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo capsule 1x daily for 3 months; testosterone gel applied 1x daily for 3 months; Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
Other intervention name(s): Testim; AndroGel; Enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Study of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the efficacy, safety and tolerability of oral dose of YM060, 5-HT3
      receptor antagonist, in patients with d-IBS.
    


Intervention name(s): YM060
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome, Diarrhea
Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects
      who have been challenged with ozone.
    


Intervention name(s): SB-656933-AAA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.; Placebo tablets will be intended to be administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: SB-656933-AAA,; ozone challenge; single dose,
A Long-term Study for the Treatment of Painful Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate safety and efficacy of duloxetine for patients
      with painful diabetic neuropathy at long-term use.
    


Intervention name(s): Duloxetine hydrochloride; Duloxetine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine 40 mg QD, PO, 1 year; Duloxetine 60 mg QD, PO, 1 year
Other intervention name(s): LY248686; Cymbalta; LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the existence of heart abnormalities in patients with
      diabetes and the effect of pioglitazone in correcting these abnormalities.
    

Detailed description: 
      PRIMARY OBJECTIVES

        1. To quantitate myocardial insulin sensitivity using positron emission tomography (PET)
           with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.

        2. To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control
           subjects.

        3. To quantitate cardiac function using magnetic resonance imaging and echocardiography in
           T2DM and control subjects.

        4. To examine the effect of pioglitazone on myocardial insulin sensitivity, pericardial fat
           content, and cardiac function.

      SECONDARY OBJECTIVES To examine the relationships between myocardial insulin sensitivity,
      pericardial fat content, and cardiac function.
    

Intervention name(s): pioglitazone
Intervention type(s): Drug
Intervention description(s): 45 mg per day for 6 months
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Intervention model: Single Group Assignment
Intervention model description: this study includes single arm intervention with pioglitazone. T2DM individuals will be studied at baseline and after 6 months treatment.
as a reference group, healthy subjects will be studied in cross sectional fashion. Because healthy subjects will not be treated nor restudied at 6 months, they can not be considered a separate arm in the study but rather a reference group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diastolic function; mitochondria; pioglitazone; pericardial fat
Gamification in Knee Replacement Rehabilitation
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      After total knee arthroplasty (TKA), knee is usually swollen, painful, and stiff. The main
      goal of post-operative physical rehabilitation is to achieve full extension and flexion of
      the knee to avoid contractures and stiffness. Also strengthening of quadriceps muscle and
      balance to help activities of daily living and overall mobility are important. The
      post-operative knee replacement rehabilitation includes the standard protocol in hospital
      phase and the standard home exercise instructions. Computer based exercising games
      (exergames) may be new method to increase training adherence and volume after TKA and thus
      improve results and effectiveness of the rehabilitation. However, evidence of effectiveness
      of rehabilitative exergaming on physical functioning is sparse and more research is needed to
      conduct evidence-based rehabilitation practices.

      Therefore the present study examines the effectiveness of a 16-week gamified physiotherapy on
      physical functioning, life satisfaction and pain for patients after TKA compared to treatment
      as usual home exercise. The second objective is to validate the psychometric properties of
      WHODAS 2.0 (WHO Disability Assessment Schedule) and brief ICF (International classification
      of functioning, disability and health) core set of osteoarthritis questionnaire. Other
      objectives are to find out, what kind of understanding and experiences the participants have
      about the rehabilitation with exergames and to evaluate the usability and user experience of
      exergames.
    


Intervention name(s): Exergame; Control
Intervention type(s): Other; Other
Intervention description(s): 16-week home-based exercise intervention with exergaming system and usual treatment.; 16-week home-based exercise by standard protocol and usual treatment.
Other intervention name(s): Gamified rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee replacement; Exergame; Total knee arthroplasty; Exercise; Physiotherapy; Physical functioning
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will design an alternative urodynamic platform to better evaluate treatment
      effects of medications for overactive bladder. Part II is dependent on results of Part I and
      may not be conducted.
    


Intervention name(s): tolterodine tartrate; Comparator: Placebo to tolterodine tartrate
Intervention type(s): Drug; Drug
Intervention description(s): Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose tolterodine tartrate 4 mg capsule; Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate the influence of 2 different dosage regimens (5 mg once
      daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of
      orally administered BI 1356.
    


Intervention name(s): BI 1356, high dose; BI 1356, low dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care
Condition: Persistent Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      A randomized controlled trial of a texting intervention to increase adherence to preventative
      asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.
    

Detailed description: 
      Our first aim is to determine the feasibility, acceptability and use of a low intensity text
      messaging intervention to improve adherence to inhaled corticosteroid (ICS) therapy among
      high risk adolescents with persistent asthma. Our second aim is to determine effect sizes of
      the intervention to improve adherence (As measured by electronic monitoring and self-report);
      clinical asthma control; and asthma related quality of life among adolescents with persistent
      asthma. Our third and final aim is to determine the temporal relationship between text
      message receipt and ICS canister actuation in order to understand mechanisms by which text
      messaging may increase ICS adherence.
    

Intervention name(s): Text Messaging
Intervention type(s): Behavioral
Intervention description(s): Website that allows adolescents to create, schedule and send one-time or recurring text messages that will serve as a reminder to take asthma medication or follow up with another health-related matter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: persistent asthma; adherence; text message reminders
Depressed Mood and Anhedonia in Healthy Adults
Condition: Anhedonia; Depressed Mood
MeSH terms: Consciousness Disorders; Anhedonia; Depression
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of nutraceutical supplement on depressed mood
      and anhedonia in volunteers after 8 weeks of consumption.
    


Intervention name(s): Nutraceutical; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Food supplements are consumed during 8 weeks by healthy volunteers; Food supplements are consumed during 8 weeks by healthy volunteers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: saffron extract
Impact of Ban on Smoking in Pubs, Restaurants and Nightclubs on Endothelial Function in Workers
Condition: Smoking
Study type: Interventional

Summary: 
      Endothelium is considered a real member, so it is contributing to determine the vascular
      homeostasis. The presence of endothelial dysfunction, evaluated in peripheral arteries by
      non-invasive study of the variation of gauge of the brachial artery as a result of
      post-ischemic hyperemia (FMD), is predictive of occurrence of major cardiovascular events.
      Several recent studies have shown that passive smoking is correlated with endothelial
      dysfunction and, therefore, non-smokers exposed subjects to passive smoking, have an
      increased risk of occurrence cardiovascular pathologies. From January 2008, a ministerial
      decree will ban smoking in bars, restaurants and nightclubs. The impact of exposure end to
      smoking in non-smoking subjects, as part of a prospective study and controlled, has never
      been evaluated.
    


Intervention name(s): Medical interrogatory; Medical examination; Specific bioassay; Endothelial function evaluation; General bioassay
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated; Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation; Exhaled carbon monoxide measure and nicotine in the urine are evaluated; Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation; Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Smoking; Endothelium; Passive smoking
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
Condition: Organ Transplantation; Immunosuppression
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      This study sought to determine the safety of the varicella vaccine pre- and
      post-transplantation when given to pediatric patients listed for solid organ transplantation.
      The study assessed the antibody response to a two-dose vaccine regimen and determined the
      durability of that antibody response at several intervals in the post-transplant period. As a
      secondary objective, the relationship between antibody titers and different variables were
      explored
    


Intervention name(s): varicella vaccine (VARIVAX)
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: organ transplantation; immunosuppression; vaccine; varicella; pediatrics
Telephone Interview Study for Men and Women With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The telephone interviews will be conducted to gather information on goal setting and goal
      attainment from men and women with osteoarthritis.
    

Detailed description: 
      Interview data used to develop a new self-administered questionnaire
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        US residents
      
Keywords: osteoarthritis, arthritis
Mic-Key Versus Mini One Family Preference Comparison
Condition: Gastroesophageal Reflux; Feeding Disorder; Family Satisfaction
MeSH terms: Gastroesophageal Reflux; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The objective of this study is to compare two low profile balloon gastrostomy button enteral
      feeding devices, both currently used as standard of medical care. The investigators aim to
      compare family preference and rate of complications between the two devices in a prospective
      cohort of children. This is the first step in comparing initial and long-term outcomes along
      with the need for seeking medical advice for gastrostomy site-related complications.

      The secondary aim of this study is to follow this population long term (4 years) to document
      the prevalence of: granulation tissue, infection, skin breakdown, and how long the
      gastrostomy tube balloon remains functional (does not lose water).
    

Detailed description: 
      This is a single center prospective, randomized study with a crossover design, comparing two
      low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely
      used at CMH. Each subject will be randomly assigned to one button type at the time of initial
      placement. After placement, standard practice is to perform the first gastrostomy change in
      the clinic at 2 months where the primary caregivers replace the button under supervision.
      Therefore, the initial device after randomization will remain in place for 2 months. At the
      first scheduled device change, the other type of button will replace the original gastrostomy
      button device. This will remain in place for another 2 months. At the routine visit at 4
      months the parents will be asked to choose which button they prefer to keep. This will meet
      the primary outcome endpoint of the study. The investigators will continue to follow as many
      subjects as possible to 4 years in order to identify any potential differences in secondary
      end points.

      A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this
      survey will be also be used in the study analysis.
    

Intervention name(s): GT button change - Mic-Key; GT button change - Mini One
Intervention type(s): Other; Other
Intervention description(s): After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.; After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gastroesophageal Reflux; Feeding Disorder; Gastrostomy tube; Family Satisfaction; GT button; Enteral nutrition; Gastrostomy button
Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to
      compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg
      tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3
      days to matched placebo lozenges in the treatment of acute pharyngitis in adults.
    

Detailed description: 
      In this randomized, double-blind, placebo-controlled trial, adult patients with
      non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity
      on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm
      visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy
      was assessed at the investigating center for 2 hrs after first dosing, and 3 days later
      (visit 2). The primary efficacy end-point is the percentage of total responders assessed at
      visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72
      hrs after first application of treatment, Safety and local tolerability are also assessed.
    

Intervention name(s): Benzalkonium Chloride-Benzocaine Topical; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Dorithricin = tyrothricin, benzalkonium chloride, benzocaine; Placebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge.
Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
Other intervention name(s): triple combination; Placebo lozenge
Intervention MeSH terms: Benzalkonium Compounds; Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized allocation of participants to verum or placebo (1:1)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dorithricin; Tyrothricin; Benzalkonium chloride; Benzocaine; placebo-controlled; Pharyngitis; sore throat; throat pain; difficulty swallowing; complete responder; lozenge; Non-streptococcal Infections