bioihbjkbjnl/mcl2 huggingface dataset:
Surgical Treatment for Degenerative Scoliosis
Condition: Scoliosis; Kyphoscoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The study aims to analyze the surgical treatment of low back pain due to degenerative
      kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico
      Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back
      pain and functional ability before and after the surgical treatment will be performed by
      administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry
      Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be
      matched to a purely objective and radiological assessment according to international
      guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity
      from this field, considering that the concept of "shared decision-making" for the therapeutic
      approach to low back pain requires the evaluation of all these parameters.
    


Intervention name(s): Surgical correction of the deformity
Intervention type(s): Procedure
Intervention description(s): Three different surgical techniques are used:
lumbar fusion vs thoraco-lumbar fusion
iliac fixation vs fixation to the sacrum
posterior + interbody fusion vs posterior interbody fusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community sample
      
Keywords: Degenerative scoliosis; Pain; Deformity correction; Instrumented arthrodesis
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen
      with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and
      well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium
      (EC-MPS) and cyclosporine microemulsion, but results in better renal function.
    


Intervention name(s): Everolimus; Cyclosporine; Enteric-coated mycophenolate sodium; Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.; Tablets orally twice a day to maintain protocol specific target blood levels; Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.; Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
Other intervention name(s): certican; Sandimmun Optoral; Myfortic
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplantation, everolimus, immunosuppressants, CNI-free
A Thorough EKG Safety Study of TA-1790 (Avanafil)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic
      (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy
      volunteers.
    


Intervention name(s): moxifloxacin; avanafil; avanafil; sugar pill
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400mg; 100mg single dose; 800mg single dose; single dose
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
Condition: Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is an open, national, multi-centre trial. The trial will be initiated in December
      2013 and subjects will receive treatment for 6 weeks.

      Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with
      immediate access to Adverse Events registered in the clinical database. The composition,
      procedures and deliverables of the Clinical Safety Group will be detailed in a Safety
      Agreement prior to trial start.
    


Intervention name(s): AVANZ Salsola
Intervention type(s): Biological
Intervention description(s): AVANZ Salsola
Intervention model: Single Group Assignment
Masking: None (Open Label)
Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
Condition: Post Operative Pain; Cesarean Section Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 1 in 5 women who undergo CS will experience severe acute postoperative pain.
      The severity of pain in the acute postoperative period is a significant predictor for the
      development of chronic pain, which occurs in 9.2%-18% of women who undergo CS. Furthermore,
      severe acute post-cesarean pain triples a woman's risk of developing postpartum depression
      and negatively affects breastfeeding and infant care. For these reasons, it is imperative to
      provide adequate postoperative analgesia in this patient population
    

Detailed description: 
      Local wound infiltration is an attractive strategy since it is efficacious and side effects
      are minimal. Nowadays, there is a trend toward preferring ropivacaine over other local
      anesthetic agents due to the longer duration of action and better safety profile. Local
      anesthetic infiltration, however, has a limitation in that pain relief is offered till the
      effects of local anesthetic action lasts. Efforts are being made to prolong the duration of
      action of local anesthetic skin infiltration, and dexmedetomidine is one such agent which can
      potentiate and prolong the duration of local anesthetic wound infiltration for pain relief.

      A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral
      abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within
      the fascial plane between the transversus abdominis and internal oblique muscles: bilateral
      block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional
      blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then
      injected between the internal oblique and transverse abdominis muscles just deep the fascial
      plane, the plane through which the sensory nerves pass
    

Intervention name(s): NSAID , NALUFIN , local anesthetic andTAP Block
Intervention type(s): Drug
Intervention description(s): The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present.
In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Surgical Telemedicine in the COVID-19 Pandemic Era
Condition: COVID; Surgery
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The current COVID-19 pandemic has caused delays in initial or follow-up encounters between
      surgical patients and physicians. While this delay allows for resource allocation to those
      most severely affected by the pandemic, surgeons are faced with potential important delays in
      diagnosis and the expanding backlog of elective cases and initial evaluations.

      This project will assess surgeon and patient telemedicine perspectives. Pre-pandemic views on
      telemedicine among a cohort of surgeons will be obtained and compared to views at 3 months
      from the peak of the pandemic. Patients will be surveyed following telemedicine appointments
      with an anonymous questionnaire to learn about patient receptiveness to telemedicine.
      Barriers to implementation will be addressed throughout the duration of the study.
    


Intervention name(s): Completion of pre-pandemic survey; Completion of survey after peak of pandemic; Completion of post telemedicine encounter survey
Intervention type(s): Other; Other; Other
Intervention description(s): Surgeons will take a pre-pandemic survey to determine surgeon perceptions to telemedicine and barriers to implementation.; Surgeons will take another survey after the peak of pandemic to determine surgeon perceptions to telemedicine and barriers to implementation.; Patients will take a post telemedicine encounter survey to determine patient perceptions to telemedicine and barriers to implementation.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Surgical faculty at participating institutions will be able to complete pre and post
        pandemic surveys regarding telemedicine and barriers to implementation.

        Surgical patients who complete a telemedicine encounter from the start of the study through
        a 6-month period will be included in the study. They will be able to complete an optional
        anonymous survey regarding perceptions to telemedicine and perceived barriers to
        implementation.
      
Keywords: Telemedicine; COVID; Surgery
PERINE : Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain : an MRI Study
Condition: Effects of Neurotoxicants on the Brain
Study type: Interventional

Summary: 
      This project aims at evaluating the consequences of prenatal exposure to neurotoxicants
      (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to
      12 years.
    


Intervention name(s): MRI; neuropsychological assessment
Intervention type(s): Device; Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: neurotoxicants; MRI; developing brain
A Controlled Trial on Recreational Runners With Patellofemoral Pain
Condition: Patellofemoral Pain (PFPS)
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      From a rehabilitation point of view, while several approaches exist to retrain runners with
      PFPS, it is not clear which one is most effective, or why. The goals of this
      randomised-controlled trial are: 1) to compare the effectiveness of three rehabilitation
      programs on pain and functional limitations of runners with PFPS and 2) to explain why the
      programs are effective or not based on laboratory analyses. After baseline evaluation,
      runners will be randomly assigned to one of three treatment groups, each with a specific
      8-week rehabilitation program aimed at addressing the efficiency of a specific type of
      retraining. These groups are: 1) Control; 2) muscle recruitment; 3) reducing knee loading
      during running.

      The investigators hypothesis is that the intervention targeting a reduction in knee loading
      will be significantly more effective in reducing symptoms and improving function of runners
      with patellofemoral pain syndrome.
    

Detailed description: 
      Hypothesis will be tested using symptoms and functional status questionnaires. In addition,
      mechanistic analyses will be conducted using a running assessment using an instrumented
      treadmill and kinematics analyses.
    

Intervention name(s): Education; Exercise program; Gait retraining
Intervention type(s): Other; Other; Other
Intervention description(s): Education on running training modifications depending on symptoms (decrease running speed, spread running volume throughout the week, run/walk intervals, avoid downhill and stairs running). Education about symptoms will also be provided.; A home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks.; Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control
      through innovative devices supporting usual care. In the first study arm, a new application
      (DragONE) for iOS and Android will be only used for patient monitoring. In the second study
      arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily
      assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main
      outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every
      4 weeks for 12 weeks.
    


Intervention name(s): DragONE; SmartOne
Intervention type(s): Device; Device
Intervention description(s): The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.; A little portable spirometer connected to DragONE allows daily PEF monitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose
      combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an
      inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The
      objective of this safety trial was to assess the effect of treatment on the incidence of
      serious asthma exacerbations, defined as asthma related hospitalization and/or intubation
      and/or death. This was an event driven trial.
    


Intervention name(s): QMF149 Twisthaler®; Mometasone Twisthaler®
Intervention type(s): Drug; Drug
Intervention description(s): Once daily via multi-dose dry-powder inhaler; Once daily via multi-dose dry-powder inhaler
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; LABA; Safety
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial
Condition: Quality of Life; Sexual Function; Urinary Incontinence; Anal Incontinence
MeSH terms: Fecal Incontinence; Urinary Incontinence
Study type: Interventional

Summary: 
      Quality of life after rectal surgery is reported to be impaired. Side effects of surgery
      and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary
      incontinence, anal incontinence or stoma problems are commonly experienced. The investigators
      hypotheses is that structured rehabilitation program addressing these problems will improve
      quality of life. A RCT are performed in order to document the effects of the rehabilitation.
    


Intervention name(s): Structured Rehabilitation program
Intervention type(s): Behavioral
Intervention description(s): Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary function; Anal function
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate)
      Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one
      of two different regimens:

        1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray
           treatment twice daily on weekends (Sat - Sun) for 28 days

        2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days
    


Intervention name(s): Vectical™ Ointment weekdays and Clobex® Spray weekends regimen; Clobex® Spray morning and Vectical™ Ointment evening regimen
Intervention type(s): Drug; Drug
Intervention description(s): Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days; Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
Other intervention name(s): calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%; clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g
Intervention MeSH terms: Calcitriol; Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram
      (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with
      relapsing Multiple Sclerosis.
    


Intervention name(s): Rebif®; Copaxone®
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).; Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Other intervention name(s): Recombinant interferon beta-1a; Glatiramer acetate
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza Vaccine
Condition: Healthy; Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized controlled trial to evaluate the safety of Lactobacillus
      rhamnosus GG (LGG) versus placebo in elderly subjects receiving the live attenuated influenza
      vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of several
      strains of Lactobacilli that is used as a probiotic or microorganism administered to confer
      "health benefits". Our research is focused on studying the possible therapeutic effects of
      LGG. The study hypotheses are:

        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly
           subjects who have just received the live attenuated influenza vaccine,

        2. The immune response to the influenza vaccine at day 21, 28, and 56 will be higher in the
           LGG group than the placebo group,

        3. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, and
           56 will be greater in the LGG group than the placebo group.
    


Intervention name(s): Lactobacillus rhamnosus GG ATCC 53103 (LGG); Placebo; Live attenuated influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days; Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.; 0.2 mL pre-filled, single use intranasal spray
Other intervention name(s): Culturelle; FluMist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: LGG; Immune response; Influenza vaccine; Elderly; Healthy; Microbiome
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
Condition: Schizophrenia
MeSH terms: Psychomotor Agitation; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This local registration study is to confirm the hypothesis of the efficacy, tolerability and
      safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in
      schizophrenia
    


Intervention name(s): Intramuscular ziprasidone mesylate; Intramuscular haloperidol
Intervention type(s): Drug; Drug
Intervention description(s): The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.; The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.
Other intervention name(s): Zeldox, Geodon; Haldol
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intramuscular ziprasidone, agitation, efficacy and safety