bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      Medical treatment for overactive bladder is acceptable widely. However, the effect of drug
      treatment is different due to compliance and side effect of the drug. Biofeedback-assisted
      pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder.
      The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation
      for continuous treatment and results in compliance difference. This slow effect also changes
      the degree of improvement in the treatment of overactive bladder. This study is designed to
      evaluate the efficacy of combination therapy for treatment of female overactive bladder.
    

Detailed description: 
      Participant will be prescribed with oral medication in combination with biofeedback-assisted
      pelvic floor muscle training (PFMT) for the first month. Participant will continue to have
      biofeedback assisted PFMT for another two months without oral medication. The investigators
      expected that combination therapy will improve the compliance and severity of symptoms in
      women with overactive bladder.
    

Intervention name(s): Solifenacin Succinate 5mg/tab daily; biofeedback-assisted pelvic floor muscle training
Intervention type(s): Drug; Behavioral
Intervention description(s): participants will be taking oral medication for 3 months; participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months
Other intervention name(s): Vesicare 5mg/tab daily
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive; drug only; exercise only; combination of drug and exercise
Different Oils For Frying and Endothelial Function
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of the consumption of different oils
      (olive oil, sunflower oil, sunflower plus dimethyl-polysiloxane, sunflower plus phenols)
      previously submitted to heating in postprandial endothelial function, inflammation and
      oxidative stress in healthy young men.
    

Detailed description: 
      To determine whether the consumption by healthy persons of an oil exposed to high
      temperatures, designed to have a composition of healthy fats (predominantly monounsaturated
      fats and with less than 10% palmitic acid) and to contain an abundance of antioxidants
      typically found in olive oil (phenolic compounds), will improve the vasodilatory response
      that depends on the endothelium, and buffer the inflammatory and postprandial oxidative
      response that is produced by the oils that are being used ever more frequently for frying
      purposes (sunflower oil and oil to which butylated hydroxytoluene (BHT) has been added),
      using virgin olive oil exposed to the same heating regime as a reference oil.
    

Intervention name(s): Olive Oil, SF, SF+DMP, SF+phenols
Intervention type(s): Dietary Supplement
Intervention description(s): All the volunteer subjects will be administered four breakfast meals that have been prepared with four different types of oil, each of which will have been subjected to a standardised frying. The meals will be administered according to a cross-randomized Latin squares design
Other intervention name(s): SF=Sunflower Oil; DMP=dimethylpolysiloxane
Intervention MeSH terms: Phenol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Phenols; Laser-Doppler; Olive Oil; Sunflower Oil; Dimethylpolysiloxane; Postprandial; Inflammation; Oxidative Stress
Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults
Condition: Obesity; Metabolic Syndrome; Impaired Glucose Tolerance
MeSH terms: Metabolic Syndrome; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study was to determine the effects of growth hormone and an insulin
      sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants
      received a combination of two drugs: (1) recombinant human growth hormone (or its placebo)
      and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar
      levels of participants before and after 40 weeks of treatment.
    

Detailed description: 
      Treatment with recombinant human growth hormone (GH) has been shown to reduce visceral
      adipose tissue (VAT) and improve insulin sensitivity in normoglycemic adults, but glucose
      levels may rise transiently. Pioglitazone, a thiazolidinedione (TZD) drug, counters the
      short-term diabetogenic effect of GH in rodents, but combined use of these drugs has not been
      evaluated in humans.

      The purpose of this study was to determine the effects of GH and a TZD, alone and in
      combination, on glucose metabolism, visceral adiposity and insulin sensitivity in abdominally
      obese adults with impaired glucose tolerance. The hypothesis that combined treatment
      attenuates GH-induced increases in glucose concentrations, reduces VAT, and improves insulin
      sensitivity over time was tested. Sixty-two adults received GH and pioglitazone for 40 weeks
      in a double-blind, randomized, placebo-controlled trial.
    

Intervention name(s): Recombinant human growth hormone; pioglitazone
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone; Hormones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Visceral fat; Impaired glucose tolerance; Insulin resistance; Growth hormone; Thiazolidinedione
Association of Oral Lichen Planus and Thyroid Disease
Condition: Oral Lichen Planus; Thyroid Diseases
MeSH terms: Lichen Planus, Oral; Lichen Planus; Thyroid Diseases
Study type: Observational

Summary: 
      Thyroid disease is a common endocrine disorder. Oral lichen planus (OLP) is a chronic
      autoimmune disease that occurs on the oral mucosa in 1-2% of the general population.The
      purpose of this study was to determine whether there is an association between thyroid
      disease and oral planus lichen in the population of our patients. In the last few years, a
      couple of studies have been published in the world literature that have studied the possible
      association of these diagnoses in different populations. Most of the results showed a higher
      prevalence of thyroid disease in the population of lichen patients, compared with patients
      without lichen, although some results are contradictory. Some authors believe that the onset
      of OLP precedes thyroid dysfunction. In the population of Croatian patients with lichen, no
      research has been done to study the possible connection between these two diseases. The
      obtained results could help clarify whether there is a connection between these two diagnoses
      in the population of our lichen patients and enable earlier detection of patients with
      thyroid hypofunction.
    


Intervention name(s): determination of thyroid hormones and antibodies
Intervention type(s): Diagnostic Test
Intervention description(s): TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample
Intervention MeSH terms: Antibodies; Hormones
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study included female patients of the Department of Oral Medicine, age matched, with
        oral lichen planus and without oral lichen planus or other immune disorders. All patients
        included in the study made blood test and the results were analyzed with statistical
        methods.
      
Keywords: oral lichen planus; thyroid diseases
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
Condition: Osteoporosis; Vitamin D Deficiency
MeSH terms: Osteoporosis; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety, tolerability and effectiveness of an
      investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and
      deficiency during the treatment of osteoporosis in men and postmenopausal women.
    


Intervention name(s): MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks
Intervention type(s): Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gather mHealth India RCT for Behavior and Health Outcomes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this trial is to explore the impact of the Gather Health diabetes management
      platform diabetics' health behaviors and health outcomes and how providers and diabetics
      interact with the Gather Health platform.
    

Detailed description: 
      The overall aim of the study is to estimate the impact of the Gather Health diabetes
      management platform on HbA1c, glycemic control, patient behavior, and physical and
      psychosocial measures. Additionally, this study will investigate patient and provider
      satisfaction with the platform.

      Primary Objective:

      Estimate the impact of the Gather Health diabetes management platform on HbA1c among
      diabetics in 3 cities in India.

      Secondary Objective:

        1. Estimate the impact of the Gather Health diabetes management platform on medication
           adherence, blood glucose (BG) control, body mass index (BMI), blood pressure (BP), and
           other behavior and health measures among diabetics in 3 cities in India.

        2. Estimate patient and provider's satisfaction with the platform and the perceived
           usability and time spent on the platform

        3. Generate ideas for future changes to the platform to make it more effective and
           user-friendly
    

Intervention name(s): Gather app
Intervention type(s): Other
Intervention description(s): Participants in the intervention group will receive the Gather Health software free for the duration of the study. Their medication and BG testing goals will be entered into the system and they will receive automated reminders. Their data will be regularly reviewed by study staff and feedback provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mHealth; Telemedicine; Randomized Controlled Trial; Glucose control
Improved Sitting Balance: Body Functions to Participation
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The aim of this study is to evaluate the changes in activity and participation domains of
      International Classification of Functioning, Disability and Health (ICF) in children with
      cerebral palsy (CP) who received integrated Botulinum Toxin-A (BoNT-A) injections into the
      lower limb(s) with a treatment goal of improved sitting balance.
    

Detailed description: 
      Postural problems play a substantial role in activities of daily living in children with CP
      having Gross Motor Function Classification System (GMFCS) levels IV or V. Improvement in
      sitting balance may positively effect the performance and caregiving of vital tasks of daily
      life in these children and may furtherly improve the quality of life of both the child and
      family. BoNT-A is an important treatment in children with CP because it is safe in young
      children and allows combined treatment. In the current literature its efficacy on body
      functions and structures by hypertonia management is well known. However there is
      inconclusive evidence for improvement in activity and participation domains of ICF with
      BoNT-A. CP is a very heterogenous population and in most of the studies the inclusion
      criteria do not adress level of underlying motor control and the primary efficacy assessment
      methods were usually chosen to cover hypertonia. Besides generally the efficacy endpoints
      were so soon to detect changes in activity or participation domains of ICF. Lack of
      association of rehabilitation programs is another important concern for the current clinical
      studies.

      In this present study a well defined subpopulation of CP children having GMFCS levels of IV
      or V who each received integrated BoNT-A treatment with a primary goal of improved sitting
      balance will be recruited to identify the probable changes in activity and participation
      domains of ICF as well as changes in quality of life of the family and the child.
    

Intervention name(s): Botulinum toxin type A
Intervention type(s): Drug
Intervention description(s): Injections to hypertonic muscles
Other intervention name(s): Botox, Dysport
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children diagnosis of cerebral palsy with respect to Rosenbaum criteria having received
        BoNT-A injections to lower limb(s) as well as an integrated treatment approach
      
Keywords: Cerebral Palsy, Botulinum Toxin A, Participation
Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The goal of the research is to optimize an online and mobile multicomponent 12-month diet and
      lifestyle intervention for improving the blood glucose control of individuals with type 2
      diabetes.
    

Detailed description: 
      The core of the program, administered to all participants, includes recommendations to follow
      a very low carbohydrate, ketogenic diet. The researchers will test whether adding the
      following experimental components will enhance the intervention's ability to improve health
      outcomes: (1) active vs. periodic self-monitoring of dietary intake using an "app"; (2)
      training vs. no training in positive affect; and (3) training vs. no training in mindfulness
      and mindful eating.
    

Intervention name(s): diet and lifestyle program; positive affect informational materials; mindfulness informational materials; dietary tracking
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.; Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.; Participants will be taught about mindfulness and mindful eating techniques.; Participants will be asked to track their diet consistently.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Internet Intervention for Alcohol Problems With or Without Assistance From a Health Educator
Condition: Alcohol Problem
MeSH terms: Alcohol-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an internet intervention for alcohol
      problems is more effective when delivered with assistance from a health care educator via
      e-mail during the first two weeks after randomization, as compared to simply providing the
      intervention without any such assistance.
    

Detailed description: 
      This project aims to study the previously evaluated multi-module internet intervention
      Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance
      will be in the form of email contact with the participant during the first two weeks after
      randomization. AHC+A will be tested against a group receiving access to the intervention
      without any such assistance (AHC).

      The Investigators hypothesize that

        1. participants allocated to AHC+A will display significant reductions in drinking (drinks
           preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared
           to AHC

        2. participants allocated to AHC+A will display greater engagement with the intervention in
           terms of a higher number of modules completed compared to AHC

        3. engagement with the intervention will mediate any effects on drinking behavior.

      A 2-arm parallel group randomized controlled trial will be used to test these specified
      hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media
      advertisements will be used to recruit people with current alcohol problems, and will target
      people who are 'experiencing difficulties in controlling or cutting down on their drinking.'
      The advertisements will be placed across Canada using locations found successful in previous
      trials to rapidly recruit participants (e.g. Google AdWords).
    

Intervention name(s): Alcohol Help Center; Assistance from a health educator
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems; This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the lipid-altering efficacy and safety of switching to
      co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or
      rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not
      achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis
      is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to
      both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in
      low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.
    

Detailed description: 
      This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of
      a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases;
      each 6 weeks in duration). Only those participants who do not meet low density
      lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to
      continue into Phase II (Week 12).
    

Intervention name(s): ezetimibe 10 mg; atorvastatin; Comparator: rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metabolism and Pharmacokinetics of Oral Solution of [14C]-BI 201335 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including
      excretion mass balance, excretion pathways and metabolism following the oral administration
      of [14C]-BI 201335 at steady state.
    


Intervention name(s): BI 201335 NA soft gelatin capsule; [14C]-BI 201335 NA radiolabelled drug
Intervention type(s): Drug; Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
Condition: Tonsillopharyngitis; Respiratory Tract Infection Viral
MeSH terms: Respiratory Tract Infections; Pharyngitis; Virus Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of this study is to investigate safety and efficacy of A. Vogel Sore throat lozenges for
      the treatment of of acute sore throats
    

Detailed description: 
      75 patients aged 12-75 years with acute sore throats (symptoms not older than 48 h) were
      recruited by the study site/CRO via local general practitioners and are allocated to acute
      treatment with A. Vogel Sore throat lozenges. The patients who are confirmed to meet the
      study entry criteria and after having given written informed consent will be assigned to
      receive a study treatment according to study procedures described in the study plan.

      The patients will visit study site twice. At the first visit (Visit 1) a screening will be
      performed to finally decide if patient will be included/excluded in the study. Then he or she
      will be taking one single lozenge under supervision of the investigating physician and acute
      efficacy/safety ratings recorded before intake and repeatedly every 15 minutes for 90 minutes
      after intake of first lozenge. He or she will be supplied with the remaining 19 lozenges in a
      bottle and provided with patient diaries for home recording of efficacy/safety. After four
      days (max 5 days) or until complete resolution of symptoms the patients were obliged to
      return to the study centre for final visit 2. Daily ratings of efficacy/safety was done by
      the patient once in the morning and once in the evening. Daily dosage was 5 lozenges per day
      every 3rd hour during daytime.

      At final visit 2, patients will be evaluated physically by the physician at the study centre
      and again assessed for safety/efficacy parameters. At last, patients returned their patient
      diaries and remaining study medication before compensation is handed out and patients finally
      excluded from the study.
    

Intervention name(s): A. Vogels Sore Throat lozenges
Intervention type(s): Drug
Intervention description(s): 5 times 1 A. Vogels sore throat lozenges daily for 4 days
Other intervention name(s): Sore Throat lozenges
Intervention MeSH terms: Menthol
Intervention model: Single Group Assignment
Intervention model description: Eligible patients fulfilling the inclusion criteria will :
First suck under supervision in the study centre one lozenge and document every 15 minutes the pain on a 100mmVAS for 90 minutes
Receive the rest of the bottle still containing 19 lozenges and have to take them for 4 days (5 lozenges per day). The patients have to fill out a diary in the morning and in the evening filling out the Tonsillopharyngitis Score (TSS), pain on a 100mm VAS and occurrence of adverse events, intake of other medication.
After the end of the treatment period patients will return to the study centre for the final visit
Masking: None (Open Label)
Primary purpose: Treatment