bioihbjkbjnl/mcl2 huggingface dataset:
Respiratory Training in Hemodialysis Patients
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Patients with chronic kidney disease in hemodialysis have complex syndrome with diverse
      effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and
      endocrine-metabolic systems. With regard to the musculoskeletal structure, there is
      progressive muscular loss with consequent increase in muscle weakness, limited resistance,
      exercise intolerance and fatigue, as well as functional and morphological abnormalities
      characteristic of uremic myopathy. Respiratory muscles are also affected as a result of
      uremic myopathy, with decreased strength and resistance. Objective: to analyze the impact of
      respiratory muscle training on muscle strength, functional capacity and quality of life of
      patients with chronic kidney disease on hemodialysis. Method: This is a prospective,
      randomized study involving 46 patients followed by the dialysis unit of a university
      hospital, over 18 years old, of both genders who underwent hemodialysis for more than six
      months and who signed the informed consent form. Patients will be allocated into two groups:
      respiratory muscle training with PowerBreath and control. All will be evaluated for
      demographic data, respiratory muscle strength, lung function, functional capacity and quality
      of life. The intervention group will perform three months of intradialytic training of a
      physical therapy protocol with PowerBreath. Both groups will be reevaluated after three
      months.
    


Intervention name(s): Respiratory muscle training
Intervention type(s): Other
Intervention description(s): The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory muscle strength; Renal insufficiency; Respiratory muscle training
A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
Condition: Complications; Cesarean Section
Study type: Interventional

Summary: 
      A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.
    

Detailed description: 
      This study is being conducted to evaluate an existing FDA approved device called the
      HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing
      the second stage of labor.
    

Intervention name(s): Hem-Avert
Intervention type(s): Device
Intervention description(s): Application of Hem-Avert
Other intervention name(s): Hem-Avert Perianal Stabilizer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the addition of a higher-dose induction treatment period with
      peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with
      PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive
      participants with CHC, genotype 1 infection.
    


Intervention name(s): PEG-IFN alfa-2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.; Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon alpha-2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation
Condition: de Novo Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release
      Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and
      the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients
      1 month after kidney transplantation.
    

Detailed description: 
      This study is a multicenter, open-label, randomized, parallel, and comparative clinical
      trial. All the enrolled subjects will be treated with Prograf® (Tacrolimus), Basilixumab,
      Corticosteroids, and Mycophenolate Mofetil to suppress their immune system for one month (30
      days) after their kidney transplant. After the one month, the experimental group (30
      subjects) will be treated with Advagraf® (Extended Release Tacrolimus) instead of Prograf®
      (Tacrolimus), and the Corticosteroids and Mycophenolate Mofetil will be maintained. The
      control group (30 subjects) will continuously receive Prograf® (Tacrolimus), Corticosteroids,
      and Mycophenolate Mofetil. The clinical progress of the subjects in the experimental and
      control groups up to six months after their transplant will be investigated and compared.
    

Intervention name(s): Advagraf; Prograf; Corticosteroid; Mycophenolate mofetil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; oral; oral
Other intervention name(s): tacrolimus; tacrolimus, FK506
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunosuppressant; new-onset diabetes after kidney transplantation; NODAT
Children With Aluminium Contact Allergy: Cutaneous Exposure Study
Condition: Contact Dermatitis; Contact Allergy; Aluminum Allergy
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact; Hypersensitivity
Study type: Interventional

Summary: 
      Aluminium is used in many different cosmetic products, including make-up, deodorants and
      sunscreen. The purpose of this study is to investigate whether these everyday skin products
      with small amounts of aluminium can cause skin reactions in children diagnosed with contact
      allergy to aluminium.

      The study is conducted as a Repeated Open Application Test study (ROAT), a method originally
      developed to clarify the clinical relevance of questionable and positive patch samples, by
      imitating everyday use of a skin product.
    

Detailed description: 
      The study is conducted as a Repeated Open Application Test study (ROAT), a method originally
      developed to clarify the clinical relevance of questionable and positive patch samples, by
      imitating everyday use of a skin product.

      The skin products will consist of ordinary sunscreens with and without aluminium, with colour
      code red and blue, respectively (masked for both investigator and participants). At the
      beginning of the trial, the study participants will be given the two creams. On the lower
      back of the children, two areas each 10 cm2 are marked with red and blue, respectively. In
      each area, sunscreen corresponding to the generally recommended amounts must be applied twice
      a day.

      The children should be seen on day 0 for interviews and objective examination. They must then
      be seen again on day 7 and day 14. On day 14 of the ROAT, a patch test is made to validate
      the results of the ROAT study. The study is scheduled to last for a maximum of 21 days with
      4-5 consultations per child. If there is a skin reaction in connection with the ROAT study
      before the 14 days have elapsed, the study will end and a patch test will be performed.
    

Intervention name(s): Repeated open application test
Intervention type(s): Other
Intervention description(s): parallel application of two different types of lotion with and without aluminium.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Repeated Open Application test
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: vaccination granuloma; aluminium contact allergy; children; contact dermatitis; repeated open application test; patch test
Maternal Serum Pentraxin 3 in Early Pregnancy to Predict Gestational Diabetes Mellitus
Condition: Pregnancy Complications Affecting Fetus (Diagnosis)
MeSH terms: Diabetes, Gestational; Pregnancy Complications; Diabetes Mellitus
Study type: Observational

Summary: 
      To investigate the association of maternal serum concentrations of pentraxin 3 in early
      pregnancy with gestational diabetes mellitus and to explore its potential value in the
      prediction of GDM.
    

Detailed description: 
      We recruited all pregnant women for the first checkup in our hospital . Maternal fasting
      serum PTX3 levels, fasting plasma glucose and fasting insulin and other factors were
      measured. Oral glucose tolerance test (OGTT) was performed at 24-28 weeks in all
      participants. According to the occurrence of GDM, subjects were divided into two groups: GDM
      group and normal glucose tolerance (NGT) group.
    

Intervention name(s): 75gOGTT
Intervention type(s): Diagnostic Test
Intervention description(s): oral glucose tolerance test (OGTT) was conducted on all participants between the 24th and 28th gestation weeks.The diagnosis of GDM is made when any of the following plasma glucose values are met or exceeded: FPG≥5.1 mmol/L and/or 1h-PG ≥10.0 mmol/L and/or 2h-PG ≥8.5 mmol/ L.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        chinese women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking,
        confirmed gestation≤20 weeks and spontaneous conception
Study the Role of Genetic Variation in the Determining Lipid Profile Response to Dietary Change
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether plasma lipoproteins and lipid
      responsiveness to a dietary modification is influenced by CETP gene polymorphism.
    


Intervention name(s): Dietary experiments
Intervention type(s): Other
Intervention description(s): Dietary Supplement: high PUFA diet followed by high SFA diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Other effects of fluvastatin are investigated in German patients with metabolic syndrome.
    


Intervention name(s): Fluvastatin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Metabolic Syndrome, fluvastatin
A Trial of SAMe for Treatment-Resistant Bipolar Depression
Condition: Bipolar Disorder; Depression; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's
      mechanism of action remains unclear, but it appears to be distinct from that of conventional
      antidepressants. The purpose of this study is to examine the effect of these properties on
      the mood of bipolar subjects with persistent major depression that has been unresponsive to
      standard pharmacotherapy.
    

Detailed description: 
      Depression in bipolar disorder is a significant source of disease-related debility; with
      bipolar individuals typically spending three fold as much time depressed as manic or
      hypomanic. Clinicians treating bipolar disorder often struggle to provide relief from
      depressive symptoms that are more often treatment resistant than in unipolar depression. To
      complicate matters further, the risk/benefit ratio of currently available antidepressants is
      a source of debate within the field of psychiatry.

      S-adenosyl-L-methionine (SAMe) is a dietary supplement with well-established antidepressant
      properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from
      that of conventional antidepressants. The purpose of this study is to examine the effect of
      these properties on the mood of bipolar subjects with persistent major depression that has
      been unresponsive to standard pharmacotherapy.

      An unusual aspect of the current study design is the schedule of SAMe dosing. SAMe tablets
      will be administered intermittently and in steadily increasing dosages. The purpose of this
      gradual and intermittent dosage titration is to lessen the risk of antidepressant-induced
      mania by seeking the minimum effective oral dose of SAMe.
    

Intervention name(s): SAMe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.
Other intervention name(s): S-adenosyl-L-methionine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAMe; alternative treatments; bipolar disorder; depression; bipolar depression; treatment-resistant depression
Ampicillin for DYT-1 Dystonia Motor Symptoms
Condition: DYT-1; Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated
      in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to
      patients treated with a placebo. A placebo is a pill that looks and tastes the same as the
      real drug, but without the active ingredient. The second objective of this study is to
      determine if dystonia symptoms improve while on the study drug.
    

Detailed description: 
      This is a double-blinded and randomized drug study: neither the patient nor the investigator
      know if patients are taking study drug (Ampicillin) or placebo.

      Three study visits will include neurological exams, review of medical history, genetic test
      results and video-taped BFM-DRS motor scales. Patients will receive medication during
      baseline visit, consisting of either Ampicillin drug or placebo, which will be consumed twice
      daily for 28 days. Following a washout period (no drugs) of 7 days, patient will return to
      clinic for second study visit and receive second set of medication (placebo -vs- Ampicillin).
      Medication will be consumed twice daily for 28 days, with patient returning to clinic after a
      washout period of 7 days for final study visit in clinic.
    

Intervention name(s): Ampicillin; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): Ampicillin will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of Ampicillin will be given to the patient, to be taken in the same manner as described above.; The sugar pill will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of the sugar pill will be given to the patient, to be taken in the same manner as described above.
Intervention MeSH terms: Ampicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dystonia; DYT-1; AMPICILLIN
Paravertebral Catheters for VATS Procedures
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Level I randomized prospective outcomes study comparing two groups of patients. One group
      will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will
      receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with
      an infusion of 0.2% Ropivicaine post-operatively and a PCA.
    

Detailed description: 
      Design: Level I randomized prospective outcomes study comparing two groups of patients. One
      group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other
      will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter
      with an infusion of 0.2% Ropivicaine post-operatively and a PCA.

      Sample Size: 50 patients Study Duration: Approximately 24 months Population:. Patients
      presenting to the University of Minnesota Medical Center for elective Video Assisted
      Thoracoscopic Surgery (VATS), for thoracic, lung, or mediastinal lesions or masses.

      Primary Objective: To determine if post-operative paravertebral catheters in patients with
      elective VATS procedures result in decreased pain compared to patients treated with PCA for
      post-operative pain.

      Secondary Objectives:

        1. To determine whether the use of paravertebral catheters impacts the length of ICU and
           hospital stay for patients, compared to a PCA in patients undergoing elective Video
           Assisted Thoracoscopic Surgery (VATS).

        2. To determine whether the use of paravertebral catheters leads to lower risk of
           complications, compared to use of a PCA in patients undergoing elective Video Assisted
           Thoracoscopic Surgery (VATS).

      2. Synopsis and Medical Application:

      Specific Aims:

      Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to
      PCA for post-operative pain from thoracic surgery.

      Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved
      subjective respiratory function compared to patients in the PCA group.
    

Intervention name(s): Paravertebral catheter; opioid iv pca; Ropivacaine; Elastomeric Pump
Intervention type(s): Device; Device; Drug; Device
Intervention description(s): A catheter is placed ultrasound guided at the T5 paravertebral level; opioid pca consisting of hydromorphone; 0.2% ropivacaine infused through paravertebral catheter; Elastomeric pump connected to paravertebral catheter
Other intervention name(s): Naropin; On Q
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
Condition: Bilateral Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the benefit of bilateral implantation with
      bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as
      auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition)
      will not only improve localization abilities, but it will also increase the ability to retain
      words in working memory, compared to performance with only one BAHS (unilateral condition).
    

Detailed description: 
      The patients included in this study are adult patients with a bilateral conductive or mixed
      hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored
      devices (BAHS). The study consists of two visits. At visit 1, the patients are fitted
      unilaterally and bilaterally with the investigational device (Ponto 3 SuperPower). After
      fitting, the patients perform a test of spatial resolution (minimum audible angle, visit 1)
      and an auditory working memory test (visit 2). These two outcome measures are conducted in
      the laboratory using the Ponto 3 SuperPower unilaterally and bilaterally. Additionally, the
      patients fill in a questionnaire (SSQ12) to report perceived performance in their everyday
      life with their own devices. This is a post market study and all products used are CE marked
      and used in clinical practice worldwide.
    

Intervention name(s): Fitting of Ponto 3 SuperPower
Intervention type(s): Device
Intervention description(s): Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting two bone-anchored sound processors (Ponto 3 SuperPower) to patients that are already bilaterally implanted with abutments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bone anchored hearing systems; BAHS; Bilateral benefit; Ponto 3 SuperPower; Minimum Audible Angle; Auditory working memory
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Condition: Pain; Pain, Acute; Anesthesia
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if a single dose of sublingual sufentanil is as or
      more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.
    

Detailed description: 
      This is a level I randomized prospective outcomes study comparing two groups of patients.
      Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the
      patient has a pain score of 4 or greater they will then be randomized to one of two groups.
      Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual
      sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival
      in the post-anesthesia care unit.
    

Intervention name(s): Sublingual Sufentanil; IV Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 30 mcg of sublingual sufentanil; 50 mcg of IV fentanyl
Intervention MeSH terms: Fentanyl; Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment