bioihbjkbjnl/mcl2 huggingface dataset:
Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
Condition: Sciatic Radiculopathy
MeSH terms: Radiculopathy; Sciatica
Study type: Interventional

Summary: 
      The objective of this Interventional case-control clinical study is to evaluate the
      effectiveness of physiotherapy combined with the administration of Alpha Lipoic Acid,
      L-acetylcarnitine, Resvelatrol, Vit D3 in the treatment of sciatica due to herniated disc in
      young patients.

      The main questions we intend to answer are:

        -  Is this combined treatment more effective in reducing pain?

        -  Is the combined treatment useful for improving postural alterations, reducing the intake
           of painkillers and the number of days of absence from work and improving the quality of
           life?
    


Intervention name(s): supplementation; rehabilitation
Intervention type(s): Other; Other
Intervention description(s): daily pharmacological therapy with Alpha Lipoic Acid 600 mg, L-acetylcarnitine 1000 mg, Resvelatrol 50 mg, vit D3 800UI for 30 consecutive days in combination with a rehabilitation protocol lasting 20 sessions; rehabilitation protocol lasting 20 sessions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Depakote ER in Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar
      depression and to evaluate metabolic and GABA changes with Depakote ER administration using
      PET and MRI/MRS brain imaging techniques.
    

Detailed description: 
      Mood disorders are important public health problems. Bipolar disorder is a major psychiatric
      disorder characterized by mood cycles alternating between mania and depression and affects
      approximately 1% of the population. Most patients are treated beginning in the early twenties
      and then embark on a course marked by multiple recurrences, hospitalizations, and encounters
      with legal authorities. These disorders inflict substantial morbidity which yields important
      deficits in occupational and interpersonal function. The risk of suicide in mood disorders
      may be as high as 10%.

      Although the outlook for recovery from acute manic or depressive episodes is generally
      excellent, the long-term prognosis of the disorder varies tremendously across the patient
      population. The introduction of lithium, anticonvulsants and atypical antipsychotics
      significantly changes the outlook for bipolar disorder, with some individuals on chronic
      treatment attaining complete remission and indefinite prophylaxis against mood episodes.
      However, such optimum outcomes may be limited to as few as one-third to one-half of all
      treated patients. The remaining experiences various combinations of breakthrough mood
      episodes, including chronic mood instability, persistent depression, and rapid cycling.

      Very little research has been conducted with bipolar disorder, and no medications have an FDA
      indication to treat bipolar depression. Previous studies suggest that Depakote is promising
      in the treatment of mixed and depressed episodes of bipolar disorder. This study utilizes the
      extended release formulation of divalproex sodium, with demonstrated increased tolerability.

      We propose investigating safety, tolerability and efficacy of Depakote ER monotherapy in
      Bipolar I, II or NOS depression, and monitoring associated changes in brain GABA levels. In
      addition, we intend to evaluate and assess the differences between brain metabolic rate and
      GABA levels in bipolar disorder patients and healthy volunteers.
    

Intervention name(s): Depakote ER
Intervention type(s): Drug
Intervention description(s): Depakote ER
Intervention MeSH terms: Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is the most common neurological disorder in children and one of the major
      causes of motor disability. CP causes changes in postural and sensory integration, balance,
      coordination disorders and muscle weakness due to problems in muscle tone. An effective
      rehabilitation program is of great importance in solving many problems that can be associated
      with decreased balance control. Researchers have stated that rehabilitation programs with
      repetitive special tasks are effective. The aim of the study was to compare the effects of
      conventional physiotherapy and dual task exercise training in addition to conventional
      physiotherapy on balance, mobility, physical performance and quality of life in children with
      cerebral palsy.
    


Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pin Site Infection Prevention for Open Tibial Fracture
Condition: Tibial Fracture
MeSH terms: Infections; Fractures, Bone; Tibial Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aimed to compare the efficacy of pin-tract infection prevention between
      silversulfadiazine and dry dressing.

      Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from
      September 2007 to June 2008 and treated by emergency debridement and external fixation were
      randomized into two groups, one treated with silversulfadiazine for infection prophylaxis
      (15) and a control group treated with dry dressing only (15). All patients were followed
      until the external fixator was removed. Pin-site infections were assessed and graded at each
      follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin
      site was done if an infection occurred.
    


Intervention name(s): silversulfadiazine
Intervention type(s): Drug
Intervention description(s): apply once a day
Intervention MeSH terms: Silver Sulfadiazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pin-site infection; silversulfadiazine; open fracture; open tibial fracture underwent external fixator
Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery
Condition: Cardiac Disorder; Hypotension
MeSH terms: Hypotension; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension
      can occur during surgery, it usually occurs following induction of GA (i.e. following the
      injection of drugs to enable intubation). This is due to the injection of large doses of
      anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep
      sleep to allow intubation to take place for artificial ventilation.

      The prevention of hypotension during surgery has been extensively studied. In contrast, the
      prevention of hypotension following GA induction has been the subject of only two randomised
      studies in the ICU and three non-randomised studies in the OR with small numbers of patients.
      The level of evidence for the use of noradrenaline in the operating theatre remains low.

      The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce
      the incidence of hypotension during induction of general anaesthesia.
    


Intervention name(s): noradrenaline
Intervention type(s): Drug
Intervention description(s): noradrenaline
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: general anesthesia; intubation; cardiac surgery; hypotension; noradrenaline
The Use of Paravertebral Block for Cardiac Surgery
Condition: Mitral Valve Insufficiency
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain after robotic cardiac surgery is a known problem and is often difficult to manage.
      Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A
      paravertebral block has been shown to provide good pain relief with minimal side effects,
      however, paravertebral blocks for robotic surgery have not been well studied. Currently the
      investigators routinely perform PVB on this patient population (of 50 MV robotic cases done
      between January and October 2012, 36 received paravertebral blocks with no adverse events
      noted). The investigators believe this should be studied further and that paravertebral
      blocks will reduce the amount of additional pain medication patients require in the first 24
      hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
    

Detailed description: 
      Pain after robotic cardiac surgery is a known problem and is often difficult to manage.
      Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A
      paravertebral block has been shown to provide good pain relief with minimal side effects,
      however, paravertebral blocks for robotic surgery have not been well studied. Currently we
      routinely perform PVB on this patient population (of 50 MV robotic cases done between January
      and October 2012, 36 received paravertebral blocks with no adverse events noted). We believe
      this should be studied further and that paravertebral blocks will reduce the amount of
      additional pain medication patients require in the first 24 hours after surgery, decrease
      intubation time and improve PACU and hospital discharge times.
    

Intervention name(s): Paravertebral Block; Placebo Comparator
Intervention type(s): Other; Other
Intervention description(s): Paravertebral nerve block injection; No block
Patients who did not receive PVB
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Multiple Myeloma; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the maximum tolerated dose (MTD) of OPB-51602
    


Intervention name(s): OPB-51602
Intervention type(s): Drug
Intervention description(s): once daily during the treatment period
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma [MM]; non-Hodgkin lymphoma [NHL]; acute myeloid leukemia [AML]; acute lymphoid leukemia [ALL]; chronic myeloid leukemia [CML]
Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new
      chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically
      purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial
      Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using
      with post-exposure rabies intradermal vaccination with or without equine rabies
      immunoglobulin.
    

Detailed description: 
      Rabies is an important world health problem especially in developing countries.Although the
      case-fatality ratio of human rabies is 100%,the disease is preventable by the modern
      cell-culture vaccine and rabies immunoglobulin.Post-exposure rabies vaccination with the
      modified Thai Red Cross intradermal(modified TRC-ID)regimen has been approved by WHO and
      proven to be immunogenic and effective. It represents a significant saving in vaccine cost
      and is now established in several developing countries. SPEEDA,chromatography purified vero
      cell derived rabies vaccine,approved by Thai FDA on 8 April 2009 and drug registration code
      of SPEEDA is 1C 90022/51. This study has a goal to determine the immunogenicity and safety of
      SPEEDA and TRCS-SPEEDA (SPEEDA which is filled by Queen Saovabha Memorial Institute)vs.
      reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies
      intradermal vaccination with or without equine rabies immunoglobulin.
    

Intervention name(s): SPEEDA and TRCS SPEEDA
Intervention type(s): Biological
Intervention description(s): For modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28.
For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28.
For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI
Other intervention name(s): SPEEDA; TRCS SPEEDA
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rabies vaccine; vero cells; serology; safety
Rhinovirus Study With Lactobacillus Rhamnosus GG
Condition: Respiratory Tract Infections [C08.730]
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus
      rhamnosus GG during rhinovirus infection.
    


Intervention name(s): Fruit juice with Lactobacillus rhamnosus GG, version 1; Fruit juice with Lactobacillus rhamnosus GG, version 2; Standard fruit juice
Intervention type(s): Other; Other; Other
The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
Condition: Calorie Restriction; Aging
Study type: Interventional

Summary: 
      Calorie restriction extends life span and prevents aging-related diseases in several species.
      Odorants from live yeast restrain the beneficial effects of calorie restriction in Drosophila
      Melanogaster. The investigators hypothesize that visual and odorous food stimuli impact the
      neuroendocrine and metabolic response to starvation in healthy humans.

      In this randomized cross-over intervention study 12 healthy, young men will fast twice for
      60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline
      and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be
      performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured by
      functional MRI.
    


Intervention name(s): Stimuli of food smell and vision; No stimuli of food smell and vision
Intervention type(s): Other; Other
Intervention description(s): 60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues; 60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
Other intervention name(s): Stimuli; No Stimuli
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fasting; starvation; calorie restriction; fMRI
The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for
      detecting intracranial hypertension. The aim of this study is to evaluate the effect of
      epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing
      osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural
      block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20).
      Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine
      for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15%
      ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve
      sheath diameter after epidural block measured by optic nerve ultrasonography between groups.
    


Intervention name(s): Bolus group for epidural block; Infusion group for epidural block
Intervention type(s): Drug; Drug
Intervention description(s): Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.; Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
Other intervention name(s): ripivacaine; ripivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidudral block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Apremilast in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many
      comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical
      as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in
      cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study
      has been done on use of Apremilast in Pakistan. It has recently become available here.
      Keeping in view all the benefits of this drug, a study has been planned to check its
      effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque
      psoriasis based on Psoriasis area and severity index and Body surface area assessments in our
      population.
    


Intervention name(s): Apremilast 30mg
Intervention type(s): Drug
Intervention description(s): Apremilast 30mg twice daily
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Condition: Obesity, Morbid
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      in all loop bypass bariatric procedure (mini gastric bypass & single anastomosis sleeve
      jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small
      intestine length rather than fixed length
    

Detailed description: 
      in all loop bypass bariatric procedure (mini gastric bypass & single anastomosis sleeve
      jejunal bypass), biliary limb is fixed length we count the length of small intestine and do
      it as a percentage from total small intestine length rather than fixed length
    

Intervention name(s): biliary limb as fixed length; biliary limb as a percentage from small intestine length
Intervention type(s): Other; Other
Intervention description(s): n all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature; in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: biliary limb length in bypass bariatric surgery
Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the ability of a single dose of a live attenuated
      recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect
      against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169)
      or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus
      infection.
    

Detailed description: 
      This study will evaluate the ability of a single dose of a live attenuated recombinant
      tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against
      infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3
      (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.

      Participants will be randomly assigned to receive either TV003 or placebo at study entry (Day
      0) and either rDEN2Δ30-7169 or rDEN3Δ30 on Day 28.

      Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 32, 34, 36, 38, 40, 42,
      44, 49, 56, 84, 118, and 208. Visits may include a physical examination and blood collection.
    

Intervention name(s): TetraVax-DV-TV003 (TV003); rDEN2Δ30-7169 (DENV-2); rDEN3Δ30 (DENV-3); Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): TV003 contains 10^3.3 plaque-forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. Administered by subcutaneous injection in the deltoid region of the upper arm; Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm; Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm; Administered by subcutaneous injection in the deltoid region of the upper arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention