bioihbjkbjnl/mcl2 huggingface dataset:
Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the
      treatment of resistant depression. No accordance exists on which are the involved mechanisms
      of action and on which stimulation parameters, frequency and side are optimal.
    

Detailed description: 
      To compare these different procedures we study patients with unipolar recurrent resistant
      major depressive disorder in a double-blind, controlled trial randomized to either sequential
      bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on
      the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1
      Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive
      low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed
      by a reduction of Hamilton Depression Scale score will be recorded in both the groups of
      patients.
    

Intervention name(s): repetitive transcranial stimulation (rTMS); unilateral stimulation
Intervention type(s): Device; Device
Intervention description(s): Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils.
In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days.; Patients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; TMS
Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease
Condition: Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective: To investigate the potential anti-proteinuric and renoprotective efficacy of
      aliskiren in addition to losartan in patients at risk of developing end-stage renal disease
      (ESRD)

      Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic
      patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the
      following treatment groups for 3 years:

        -  Group A: Losartan (Control arm: conventional treatment)*

        -  Group B: Aliskiren plus Losartan (Intervention arm)*

             -  With optional addition of other anti-hypertensive agents to achieve an optimal
                target blood pressure of <130/80 mmHg.
    

Detailed description: 
      Aliskiren is a direct renin inhibitor that has been shown to reduce proteinuria and retard
      renal deterioration in type 2 diabetic patients with overt nephropathy. However, it is not
      known if these therapeutic effects can be extended to nondiabetic chronic renal disease. The
      current study aims to explore this research question by randomly assigning patients with
      various stages of chronic renal disease to receive either aliskiren on top of losartan, or
      continuation of losartan.
    

Intervention name(s): Aliskiren; Losartan
Intervention type(s): Drug; Drug
Intervention description(s): For CKD treatment; Control
Other intervention name(s): Rasilez; Cozaar
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD; proteinuria; eGFR; Progression of chronic kidney disease
Treatment of Feeding Problems in Children With Autism
Condition: Treatment of Feeding Problems in Children With ASD
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      The primary aim of the project is to develop and pilot a manualized, individually delivered
      Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder
      (ASD) to assess feasibility and parent acceptance of the program. The secondary aim of the
      project is to assess the success of the PT-F program in improving mealtime behavior problems
      when compared to the wait-list control.

      Exploratory aims include obtaining preliminary data on the impact of PT-F on child and parent
      functioning (reducing parent stress and improving parent sense of competency and parent-child
      interactions at mealtime), assessing the impact of treatment on interfering behaviors around
      mealtime/snack times, and measuring nutritional improvements after treatment.
    

Detailed description: 
      Fifty well characterized children will be randomly assigned to either the 20 week PT-F or a
      waitlist control group. Study assessments evaluating feeding and mealtime behaviors,
      nutritional intake, daytime behaviors, repetitive behaviors, sensory sensitivities, parent
      stress and parent-child interactions will be completed at Baseline, Week 10, and Week 20
      timepoints. Treatment Fidelity forms will be completed by the therapist at the end of each
      treatment session to assess achievement of session goals and parent adherence during each
      session.
    

Intervention name(s): Parent Training Program
Intervention type(s): Behavioral
Intervention description(s): An 11-session manualized behavioral parent training program for the treatment of feeding problems teaching parents to use a range of behavioral procedures to address a variety of common feeding problems.
Other intervention name(s): PT-F
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism spectrum disorder (ASD); feeding problems
Preventive Intervention in Nursery School Teachers
Condition: Low Back Pain; Neck Pain
MeSH terms: Back Pain; Low Back Pain; Neck Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Childcare in nursery schools has been shown to be associated with an elevated prevalence of
      neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem
      to be the only effective preventive intervention. Thus the purpose of this study is to
      determine the effectiveness of an extension-oriented exercise program in preventing low
      back/neck pain and functional disability in nursery school teachers. In addition, the
      investigators also sought to identify the occurrence of musculoskeletal complaints in this
      category of workers.
    

Detailed description: 
      Seventy-one nursery school teachers working in nine school buildings were randomly divided
      into two groups, with each school as a unit of randomization. All the teachers in both groups
      received an ergonomic brochure; teachers in the experimental group also received an
      extension-oriented exercise program, conducted by a physical therapist. Data were collected
      at baseline and at a two-month follow-up. The primary outcome measure recorded was the level
      of disability (Roland Morris Disability Questionnaire and Oswestry Disability Index), while
      secondary outcome measures included LBP and neck pain presence (Pain Drawing) and intensity
      (Visual Analogue Scale). At follow-up, a significant improvement was registered in the
      experimental group for all the outcomes evaluated. In conclusion a six-session
      extension-oriented exercise program proved decisive in preventing low back and neck
      complaints and in reducing consequent LBP functional disability among nursery school
      teachers.
    

Intervention name(s): Extension-oriented exercise program; Informative Brochure
Intervention type(s): Other; Other
Intervention description(s): The exercise program was composed of six graded sessions, two per week for three consecutive weeks. Sessions, each of one hour length, were conducted after the working hours in a wide room of the nursery school, gathering together all the teachers from each school. The exercises were selected in order to reinforce lumbar extension and to strengthen the primary stabilizers of the spine (transversus abdominis, oblique abdominal, multifidus, quadratus lumborum and erector spinae muscles); The brochure showed the correct way to lift loads, and provided ergonomic suggestions to prevent musculoskeletal complaints, according to the Italian legislation
Other intervention name(s): EOTA; Educational; Informative Pamphlet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Low back pain; Neck pain; Functional disability; Nursery school teachers; Exercise program; Prevention
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital
Condition: Adverse Effect of Oxytocic Drugs; Uterine Hemorrhage; Inappropriate Dose of Drug Administered
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of the study was to determine whether 2.5 international units of oxytocin gives
      adequate uterine tone and is safe as compared to 10 international units of oxytocin following
      caesarean section delivery at Mulago hospital.
    


Intervention name(s): 2.5 units Oxytocin; 10 units Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 2.5 units of oxytocin after clamping of umbilical cord; Administration of 10 units of oxytocin after clamping of umbilical cord
Other intervention name(s): pitocin; pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxytocin; Uterine tone; Mulago Hospital; Dose; Side effects
Azithromycin Combination Therapy for Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to develop a safe, well tolerated, and highly efficacious
      azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a
      drug that has shown potential for malaria treatment. It will be combined with other malaria
      drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be
      enrolled in Thailand. Participants will have severe cases of malaria and they will be
      hospitalized 28 days for treatment.
    

Detailed description: 
      The study is aimed at identifying a well tolerated, practical and highly efficacious
      treatment regimen of azithromycin in combination with artesunate or quinine for uncomplicated
      falciparum malaria for future studies, to monitor for the tolerability and safety of these
      combination regimens and to compare tolerability, safety and efficacy of azithromycin when
      given in combination with artesunate as compared to quinine. This study is also aimed at
      comparing tolerability, safety and efficacy of the combination of artesunate and azithromycin
      when given as a single daily dose (200mg As+1000mg Az) for 3 days as compared to 2 doses of
      100mg As+750mg Az per day for 3 days and to compare the tolerability, safety and efficacy of
      the combination of quinine and azithromycin when given as 3 daily doses of quinine (10mg/kg)
      + Az 500mg vs. 2 daily doses of quinine (10mg/kg) + Az 750mg when given for 3 days.
    

Intervention name(s): Artesunate; Azithromycin; Quinine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Azithromycin; Artesunate; Quinine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria
Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Condition: Femoral Neck Fracture
MeSH terms: Emergencies; Fractures, Bone; Femoral Neck Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      Femoral neck fracture is very common in the elderly and can produce severe to moderate pain.
      As this pathology is not life-threatening, waiting time in the emergency department may be
      prolonged due to the high number of unforeseen cases with patients remaining in pain.

      Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca,
      resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves,
      with effective analgesia.
    

Detailed description: 
      The objective of this trial is to compare the fascia iliaca block with a sham injection on
      patients arriving in the emergency department with a femoral neck fracture.

      The fascia iliaca block will be performed with an anatomical landmark technique and a volume
      of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL will be injected.
    

Intervention name(s): Fascia iliaca block; Sham injection
Intervention type(s): Procedure; Procedure
Intervention description(s): injection of 30 mLs below the fascia iliaca; subcutaneous of 5 cc of normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Emergency medicine; Anesthesia, Regional
BAY38-9456 - Pivotal Trial for Diabetes Patient
Condition: Erectile Dysfunction; Diabetes Mellitus
MeSH terms: Erectile Dysfunction; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was
      confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was
      no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg
      regimens. Overall the tolerability was considered good with both regimens.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BAY 38-9456 10 mg tablet prior to intercourse on demand; BAY 38-9456 20 mg tablet prior to intercourse on demand; Placebo tablet prior to intercourse on demand
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vardenafil; PDE5 inhibitor; Erectile Dysfunction; Diabetes Mellitus; Sexual Dysfunction
Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis
Condition: Chronic Bronchitis; COPD
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Observational

Summary: 
      To determine whether an average population of males and females who smoke 10 pack years or
      more of cigarettes in a primary care setting with chronic bronchitis has already developed
      significant changes on pulmonary function testing.
    

Detailed description: 
      The incident of COPD is dramatically increasing while other chronic disease states are
      decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD.
      Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function
      tests. It is imperative that we define this patient population to determine whether early
      intervention will alter pulmonary function over the years.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care
      
Keywords: Smokers; Chronic Bronchitis; Pulmonary Function Test Abnormalities; COPD
Empower Opioid Misuse & Chronic Pain
Condition: Chronic Pain; Opioid Use
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional

Summary: 
      This study evaluates the effects of peripheral nerve stimulation on opioid craving and use
      and pain in participants with chronic non-cancer pain (NCP) and opioid misuse. Participants
      will be randomized to receive the active or sham control treatment for the duration of the
      study.
    

Detailed description: 
      This pilot study aims to examine the feasibility, acceptability, and preliminarily examine
      efficacy of peripheral nerve stimulation with the Empower Neuromodulation System on reducing
      opioid craving and use and decreasing pain. Opioid prescribing for chronic pain has increased
      dramatically over the past several decades, with devastating public health consequences,
      including high rates of opioid misuse and overdose deaths. Safe nonpharmacological treatments
      are urgently needed. In this randomized, controlled study, thirty Veterans with chronic
      non-cancer pain (NCP) and opioid misuse will be recruited and randomly assigned (1:1) to
      either the Active or Control treatment. On Days 1-7, participants will undergo baseline
      monitoring, and on Days 8-21, participants will undergo daily nerve stimulation treatment.
      Pain scores, craving, and opioid use will be measured daily Days 0-21. Our goal is to provide
      an intervention that, alone or in conjunction with current treatments, reduces craving and
      reduces reliance on opioids in high-risk chronic pain patients.
    

Intervention name(s): Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Device
Intervention description(s): Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery
Condition: Abdominal Neoplasms
MeSH terms: Abdominal Neoplasms
Study type: Interventional

Summary: 
      the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine
      wound infiltration versus epidural analgesia on the inflammatory cytokines response following
      radical cytectomy
    


Intervention name(s): epidural catheter; preperitoneal catheter
Intervention type(s): Device; Device
Other intervention name(s): PEA block; preperitoneal infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Back to School COVID-19 Simulation Study
Condition: Covid19; Schools
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This will be a prospective study simulating return to school for two full days prior to the
      start of the school year in September. Volunteer students and teachers from six grade ranges
      will be recruited to participate in the study. In each grade range, there will be two classes
      that will participate, one that will be assigned to wear face masks/coverings at all times
      (experimental group/class) and the other that will not wear face masks/coverings at all times
      (control group/class). Students will be randomized to either the masking at all times
      (experimental across all grades) or no masking (control across JK-Grade 4) / masking only
      when physical distance can be maintained (control across Grade 5-Grade 12) class in their
      appropriate grade. Personal behaviours and person-to-person interactions will be recorded
      using video cameras. In addition, a safe biological indicator will be applied to the hands to
      simulate potential asymptomatic infection in a subset of students. Other students will have
      sanitizer applied so that students are blinded to who has the indicator. Cameras will be used
      to document how the indicator moves throughout the classroom.
    

Detailed description: 
      Grade ranges will include 1) Senior Kindergarten (children who have just completed JK or SK
      in the 2019-2020 year), 2) Grades 1-2, 3) Grades 3-4, 4) Grades 5-6, 5) Grades 7-8 and 6)
      high school. A total of 14 teachers and up to 240 students will be recruited. Final class
      sizes will be in accordance with Ministry of Education and public health guidelines.
    

Intervention name(s): Wearing a face mask at all times
Intervention type(s): Behavioral
Intervention description(s): Children in this group will be asked to wear a face mask in the classroom and common areas during the simulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other