bioihbjkbjnl/mcl2 huggingface dataset:
Validation of iPelvis App for Female Pelvic Floor Dysfunction
Condition: Female Sexual Dysfunction; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The iPelvis app aims to improve adherence to pelvic physiotherapy on women with pelvic floor
      related dysfunctions, such as urinary or fecal incontinence, sexual dysfunction, etc.
    

Detailed description: 
      Urinary dysfunctions are widely discussed because they cause problems in social, emotional,
      sexual life and the quality of life of incontinent women. The overall objective of this
      research is to evaluate the use of the Application. Ipelvis in women with urinary
      incontinence. This is a longitudinal study of the type randomized controlled trial. Women
      with urinary incontinence of urgency, effort and effort will be evaluated and treated.
      Frequently asked questions, questions and answers, Quality of Life Questionnaires, Health
      Requirements, ICIQ-SF, ICIQ-OAB, FSFI and evaluation of pelvic, manual and electromyographic
      floor musculature function. As volunteers are drawn in four groups (Group I: Household
      Exercise Sheet / Group II: Ipelvis application / Group III: Household Exercise Sheet + Pelvic
      Physiotherapy / Group IV Ipelvis Application + Pelvic Physiotherapy).
    

Intervention name(s): Home Exercise Sheet; Ipelvis mobile application; Home exercise sheet + Pelvic Physiotherapy; Ipelvis mobile application + Pelvic Physiotherapy
Intervention type(s): Other; Other; Behavioral; Behavioral
Intervention description(s): Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.; Received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.; Performed 12 Pelvic Physiotherapy sessions, in group, once a week and received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.; Performed 12 pelvic physiotherapy sessions, in group, once a week and received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: urinary incontinence; female sexual dysfunction; quality of life; adherence; pelvic physiotherapy; post-partum
Trigeminal Brainstem Mapping
Condition: Headache Disorders, Primary; Migraine
MeSH terms: Headache Disorders; Headache Disorders, Primary; Headache
Study type: Interventional

Summary: 
      To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as
      the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula
      can be mapped using functional imaging and BOLD in humans is not known but might play an
      important role in imaging headache diseases. The aim is to map their somatotopy by random
      stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of
      BOLD-fMRI.
    


Intervention name(s): Electric Current Stimulation
Intervention type(s): Device
Intervention description(s): Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Condition: Beta Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional

Summary: 
      the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on
      cardiac iron overload and cardiac functions in multi-transfused children with beta
      thalassemia major
    

Detailed description: 
      the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on
      cardiac iron overload using magnetic resonance imaging and cardiac functions in
      multi-transfused children with beta thalassemia major
    

Intervention name(s): Spirulina; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months; Amlodipine in a dose of 5 mg/day orally for 3 months
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study evaluates the effect of inactivation of the immune system with chemotherapy and
      immunotherapy and infusion of bone marrow stem cells in early onset type 1 diabetes mellitus.
      We hypothesize that reprograming the immune system will stop immune aggression to the insulin
      producing cells allowing their regeneration and thus decreasing or eliminating the need of
      exogenous insulin.
    

Detailed description: 
      Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta
      cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study.
      Peripheral blood hematopoietic stem cells will be mobilized from bone marrow of the patient
      with cyclophosphamide plus G-CSF (granulocyte-colony stimulating factor), collected by
      leukapheresis and cryopreserved. After 2-3 weeks, high dose immunosuppression is given
      (cyclophosphamide 200 mg/kg plus rabbit antithymocyte globulin 4.5 mg/kg) and stem cells are
      thawed and injected intravenously. This procedure is performed in isolated rooms at the Bone
      Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto, University of São
      Paulo, Brazil. Patients are discharged from the hospital after engraftment and closely
      followed up to 2 months after transplantation (with at least weekly outpatient visits) and
      continue the followup for 5 years after transplantation. Clinical, hematological, metabolical
      and immunological evaluations are performed to analyse the effect of the transplant in the
      disease and in the hematopoetic and immunologic systems of the body. Patients fitting the
      inclusion criteria but not agreeing to perform the transplantation are the control group and
      they will be followed in parallel with transplanted patients.
    

Intervention name(s): Immunosuppression and autologous stem cell transplantation
Intervention type(s): Procedure
Intervention description(s): Immunosuppression and autologous stem cell transplantation: Mobilization of hematopoietic stem cells (HSC) with cyclophosphamide (2 g/m2) and granulocyte-colony stimulating factor (G-CSF, 10 ug/kg/d), followed by collection and cryopreservation of unselected HSC and conditioning with cyclophosphamide (200 mg/kg) plus rabbit anti-thymocyte globulin (ATG 4.5 mg/kg).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Stem cells; Autologous stem cell transplantation; Autoimmune diseases
Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis
      (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol
      concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus
      control product.
    


Intervention name(s): 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL; 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1- Intervention with test product ( >10E8 to <5.10E9 cfu/ml of L. delbruckii lactis ); 2- Intervention with control product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Midly hypercholesterolemic subjects; Probiotic; Cholesterol lowering; Dairy
Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Echo intensity (EI) assessment using ultrasonography helps monitoring disease-induced muscle
      quality changes. However, there are no study investigating the reliability of EI in patients
      with knee osteoarthritis (OA). The primary aim of the present study was to investigate the
      inter and intra-rater reliability of EI evaluation by grayscale histogram analysis of
      quadriceps femoris muscle in patients with knee OA. The second aim was to compare the mean
      grayscale values obtained using both the Free Hand Tool (FHT) and Rectangular Marquee Tool
      (RMT) methods in ImageJ. Thirty patients with knee OA were included in this cross-sectional
      study. The echogenicity measurements of the Rectus Femoris, Vastus Inter-medius, Vastus
      Lateralis and Vastus Medialis were performed by two different researchers. Reliability
      analysis of EI measurements were calculated with using intraclass correlation coefficient
      (ICC), standard error of measurement (SEM) and coefficient of variation (CV) and Bland and
      Altman plot analysis.
    


Intervention name(s): ultrasonographic Assessment,; Echo intensity Measurements
Intervention type(s): Other; Other
Intervention description(s): Ultrasound assessment was performed on rectus femoris (RF), vastus intermedius (VI), vastus medialis (VM) and vastus lateralis (VL) muscles using with an ultrasound-imaging device (Philips Medical Systems EPIQ 5 Release 5.0.2, Amsterdam).; All images were analysed using the Image J software (Version 1.48v, National Institutes of Health, Bethesda, MD, USA) by two different analysers (five years and one-year of experience in US image analysis).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients had tibiofemoral joint OA in at least one knee according to the American College
        of Rheumatology classification criteria with knee pain most days of the past month, and
        osteophytes apparent on knee radiograph were included to the study. Patients were excluded
        if they had a history of lower limb joint replacement and fracture, rheumatoid arthritis,
        diabetic neuropathy or polyneuropathy, and cardiovascular and neuromuscular problems.
      
Keywords: Reliability,Echo intensity,Knee Osteoarthritis
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin
      Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin)
      Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male
      subjects under fed condition.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, oral bioequivalence study of Isotretinoin Capsules 40 mg under fed conditions.
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin Capsules,40 mg
Other intervention name(s): AMNESTEEM
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DFDBA and Xenograft (Cerabone)TM With Decortication in Intrabony Defects
Condition: Periodontal Intrabony Defects
Study type: Interventional
Phase: Phase 4

Summary: 
      DFDBA is an allograft that possesses osteoconductive and osteoinductive properties. It has
      the potential for osteoinduction due to increased expression of bone morphogenetic protein
      (BMP).Cerabone™ has shown maximum resemblance to human bone with the potential to reconstruct
      bone defects. Decortication is performed as a part of guided bone regeneration (GBR)
      procedure as it enhances the healing process.Therefore a combination of decortication and
      bone graft when applied in periodontal intrabony defect would enhance the regeneration of
      periodontium.
    

Detailed description: 
      There have been great strides in the management of periodontal intrabony defects, especially
      with the use of bone graft materials. It is necessary to choose the most appropriate material
      and procedure in order to obtain the desired regeneration. Among the bone grafts,
      Demineralised freezed dried bone allograft (DFDBA) and xenografts have shown good results in
      the management of intrabony defects. Recently, a novel bovine xenograft i.e., Cerabone™ has
      shown maximum resemblance to human bone with the potential to reconstruct bone defects.
      Decortication or intramarrow penetration of the bone has shown favourable results in guided
      bone regeneration procedures. So the goal of the present study was to check the efficacy of
      decortication with decalcified freeze dried bone allograft (DFDBA) and Cerabone™ bone grafts
      and to compare the response between the bonegrafts placed following decortication using RVG
      and CBCT, in intrabony defect.

      The combination of decortication with bone grafts i.e., DFDBA and (Cerabone)TM can be an
      added advantage in the treatment of intrabony defects. To the best of the investigators
      knowledge no clinical trial reports this combination therapy in scientific literature. There
      is need for further research in this area.
    

Intervention name(s): Decortication + bone grafts
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Immunity to Hepatitis B Vaccine
Condition: Hepatitis B; Immunization; Infection
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Infection and cancer is a major cause of death and morbidity, and may be preventable through
      vaccination. It is not fully understood at the molecular level why some people respond better
      than others to vaccines until now the technology to assess this has not been available. This
      has impaired vaccine development. The overall goal of the Human Vaccines Project is to
      understand the 'rules' of how vaccines work. In this demonstration project the investigators
      will vaccinate healthy adults with hepatitis B vaccine to start to understand better how it
      works, ultimately helping with rational vaccine design in the future.
    


Intervention name(s): Hepatitis B vaccine
Intervention type(s): Drug
Intervention description(s): 1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection
Other intervention name(s): ENGERIX®-B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment of Pediatric Hypertension With Altace Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of
      hypertension since 1991. It has been shown to be effective in reducing both systolic and
      diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used
      to treat hypertension in children, however ramipril has not been extensively tested in
      children, and information regarding the efficacy and safety would therefore be of benefit to
      children. This study is designed to demonstrate the efficacy and safety of ramipril in the
      treatment of hypertension in children ages 6 through 16 years.
    

Detailed description: 
      In adults, common side effects include persistent dry mouth, dizziness, fatigue, and
      headache. Rare cases of angioedema have been reported. When used in pregnancy during the
      second and third trimesters, ACE inhibitors can cause injury and even death to the developing
      fetus. When pregnancy is detected, ramipril should be discontinued as soon as possible.
      Ramipril is contraindicated in patients who are hypersensitive to the product or have a
      history of angioedema related to previous treatment with an ACE inhibitor.
    

Intervention name(s): ramipril
Intervention type(s): Drug
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ACE inhibitor; high blood pressure; pediatric
Cardiorespiratory Response During Whole Body Vibration Training in Patients With Chronic Lung Disease
Condition: Chronic Obstructive Lung Disease (n=10); Interstitial Lung Disease (n=10)
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Whole body vibration training seems to be a useful adjunct in exercise training in patients
      with severe COPD. The basic principle relies on reflectory muscle contractions caused by a
      vibration stimulus. Until now the impact of whole body vibration training on cardiopulmonary
      parameters remained unknown. Therefore aim of this study is to investigate cardiopulmonary
      parameters during whole body vibration training in patients with chronic lung disease.
    


Intervention name(s): Whole body vibration
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Whole body vibration, cardiorespiratory response
A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
Condition: Bilateral Nasal Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effect of ACT-774312 on the nasal polyps and will assess the
      safety and tolerability of ACT-774312 in the patients with bilateral nasal polyposis
    

Detailed description: 
      The clinical trial has 3 periods:

      Screening and run-in period (4 Weeks). This period starts with the screening visit, and ends
      on Day 1, just before the first study treatment administration. At Visit 1, all participants
      will enter a run-in period of 4 weeks on mometasone furoate nasal spray of 2 actuations (50
      μg per actuation) in each nostril twice daily (total daily dose of 400 μg), unless they were
      intolerant to twice daily intranasal corticosteroids, in which case they could use a lower
      dose regimen, i.e., 200 μg once daily.

      Treatment period (ACT-774312 or placebo for 12 weeks). This period will start on Day 1 with
      the first administration of study treatment and consists of 4 visits: Week 2, Week 4, Week 8,
      and Week 12. Provided that the nasal polyp score (NPS) does not change during the run-in
      period, participants will be randomized to ACT-774312 (400 mg twice daily) or placebo (twice
      daily) for 12 weeks. During the double-blind randomized treatment all participants will
      continue with mometasone furoate nasal spray background therapy.

      Post-treatment period (4 Weeks). This period will start after the Week 12 Visit and end at
      Week 16 (End-of-Study).
    

Intervention name(s): ACT-774312; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACT-774312 will be available as hard gelatin capsules containing 200 mg of ACT-774312; Matching placebo hard gelatin capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Acquisition and Utilization of Skills Using Innovative Smartphone Application for Regular Eating
Condition: Bulimia Nervosa; Bulimia; Binge Eating; Purging; Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

Summary: 
      The study seeks to evaluate the acceptability, feasibility, target engagement, and validity
      of an innovative smartphone application with ecological momentary interventions to augment
      cognitive behavioral therapy for bulimia nervosa.
    


Intervention name(s): CBT+ application
Intervention type(s): Behavioral
Intervention description(s): Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions
Other intervention name(s): CBT+
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bulimia Nervosa; Eating Disorder; Binge Eating; Bulimia; Purging
Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to determine the efficacy (how well the drug works), safety, and any side
      effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents.
      Both the potential benefits and side effects of olanzapine will be evaluated throughout this
      trial.
    


Intervention name(s): Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Iron Supplementation in Hip/Knee Surgery
Condition: Orthopedic Disorder; Hip Arthropathy; Knee Arthropathy; Anemia; Iron Poor Blood
MeSH terms: Joint Diseases; Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing
      the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective
      prosthetic hip or knee surgery.
    


Intervention name(s): Sucrosomial iron plus ascorbic acid
Intervention type(s): Dietary Supplement
Intervention description(s): A number of 41 subjects are supplemented with 30 mg of iron plus 70 mg of ascorbic acid daily for 30+/-5 days before orthopedic surgery.
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment