bioihbjkbjnl/mcl2 huggingface dataset:
Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in
      children presenting with acute asthma.Study perfoma consists of demographic
      variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2
      at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.
    

Detailed description: 
      After getting informed consent from guardian,148 patients of acute moderate ro severe asthma
      with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will
      receive nebulization with magnesium sulphate and other will receive intravenous magnesium
      sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in
      either groups after 6 hours.
    

Intervention name(s): Nebulized Magnesium sulfate; Intravenous magnesium sulphate
Intervention type(s): Drug; Drug
Intervention description(s): MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes; pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour
Other intervention name(s): Nebulized MgSO4; IV MgSO4
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: asthma in children; intravenous magnesium sulphate; nebulized magnesium sulphate
Genes, Intermediate Phenotypes and Response to Quetiapine RX
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Pharmacological treatment of schizophrenia is still characterized by a certain proportion of
      patients who are resistant to common antipsychotics. Variability in individual response
      ranges from patients who experience complete or near complete symptom remission to a subset
      of patients who remain treatment-refractory despite extensive drug trials over years. The
      investigators propose to take advantage of the simultaneous acquisition of clinical and of
      intermediate phenotypes to ascertain the possible contribution of SNPs within putative
      causative genes to response to treatment with quetiapine XR.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be carried out in a hospital unit of the psychiatric assistance system.We
        will recruit 100 patients with schizophrenia with recent exacerbation of psychotic
        symptomatology.
Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction
Condition: Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Stage I：preoperative therapy

        -  Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone
           ; Stage II: Perioperative therapy

        -  Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to
           adjuvant Capecitabine plus oxaliplatin alone;

        -  A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with
           incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal
           cancer . The investigators assessed whether the addition of a perioperative regimen of
           XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate
           and survival among patients with curable locally advanced adenocarcinoma of stomach and
           gastroesophageal cancer
    


Intervention name(s): Oxaliplatin; Capecitabine; Oxaliplatin; Capecitabine; concurrent radiotherapy
Intervention type(s): Drug; Other
Intervention description(s): Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation; Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT
Other intervention name(s): Xeloda; Oxaliplatin; Xeloda; Oxaliplatin; XRT
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Capecitabine; Oxaliplatin; Preoperative Concurrent Chemoradiotherapy; Gastroesophageal Junction Adenocarcinoma
Physical Fitness in Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Observational

Summary: 
      Although there are some studies investigating the physical activity levels of children with
      autism in the literature, no comprehensive study investigating the relationship between
      posture and physical fitness parameters, family anxiety level and quality of life of
      individuals with autism who have continued physical activity program has not been found. The
      aim of our study is to compare postural disorders and physical fitness parameters, family
      anxiety level and quality of life between individuals with autism and healthy individuals
      attending physical activity program.
    


Intervention name(s): physical fitness assessment
Intervention type(s): Other
Intervention description(s): assessment
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Autism is a spectrum disorder, each person with autism has a distinct set of strengths and
        challenges. The ways in which people with autism learn, think and problem-solve can range
        from highly skilled to severely challenged. Some people with ASD may require significant
        support in their daily lives, while others may need less support and, in some cases, live
        entirely independently.
Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery
Condition: Rectum Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      To evaluate the influence to the blood supply of the anastomosis and the harvest of the No.
      253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and
      resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or
      dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of
      rectal carcinoma.
    

Detailed description: 
      Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will
      receive the radical resection of rectal carcinoma. We preserve the left colic artery and
      resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior
      mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal
      site of the anastomosis and measure the blood pressure of the arterial arcade in the
      operation, which can reflect the blood supply of the anastomosis. Besides, We will measure
      the length of the colon from the anastomosis to the level of the root of the IMA. Expecting
      Results：The blood pressure of the arterial arcade in Group A will be higher than that in
      Group B. And the patients in Group A will have less chance to get anastomotic fistula.
      Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically
      in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis
      and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No.
      253 lymph node.
    

Intervention name(s): preserving the left colic artery; not preserving the left colic artery
Intervention type(s): Procedure; Procedure
Intervention description(s): The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .; The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
VEC-162 Study in Adult Patients With Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind
      treatment period of VEC-162 as compared to placebo in male and female patients with primary
      insomnia.
    


Intervention name(s): VEC-162 20 mg; Placebo; VEC-162 50 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks; Placebo capsules, PO daily for five weeks; 50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fat-Associated Cardiovascular Organ Dysfunction
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      This is an observational study of cardiovascular risk factors and arterial or cardiac
      function in subjects with overweight or obesity. Subjects must be between 30 and 65 years of
      age, have a body mass index >27.0 kg/m2 and free from known heart disease and digestive or
      psychiatric disorders. Study aims include identifying sex-differences in traditional
      cardiovascular risk factors and structural and functional abnormalities in arteries and the
      heart in subjects with overweight or obesity, and how this is influenced by physical fitness.
    

Detailed description: 
      FATCOR is an observational study of women and men with overweight or obesity. In particular
      prevalences of conventional cardiovascular risk factors and subclinical arterial or cardiac
      dysfunction are explored. The study aims at identifying sex differences in presence and
      clustering of cardiovascular risk factors and presence of subclinical cardiovascular organ
      damage. The influence of physical fitness on these factors will also be assessed. All
      participants undergo extensive cardiovascular risk factor assessment including oral glucose
      tolerance test and ambulatory blood pressure recording. Subclinical cardiovascular
      dysfunction is assessed by carotid and femoral vascular ultrasound, echocardiography and
      carotid-femoral pulse wave velocity using applanation tonometry. Physical fitness is assessed
      from peak oxygen uptake during maximal exercise testing on a treadmill.
    

Intervention name(s): There is no intervention
Intervention type(s): Other
Intervention description(s): This is a prospective observational cohort study without any intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Norwegian women and men
      
Biospecimen description: 
      The FATCOR Research biobank has been approved by Health authorities and includes samples from
      serum, whole blood, urine
N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression
Condition: Major Depressive Episode
MeSH terms: Depression
Study type: Interventional

Summary: 
      The first part is a double-blind placebo-controlled trial to identify the effects of omega-3
      polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part
      is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients
      with IFN-induced depression.
    

Detailed description: 
      We have done a preliminary analysis in 63 HCV patients receiving IFN-α therapy enrolled in
      our current NSC project (NSC95-2320-B-039-037-MY3) and found that patients who later
      developed IFN-α-induced depression (case group, 21/63) had lower PUFA levels before starting
      IFN-α therapy than control group (p=0.024). In addition, there was a trend for a negative
      correlation (r=-0.224; p=0.078) between baseline DHA levels and the highest scores of BDI
      during IFN therapy in the whole group. These findings indicate that n-3 PUFAs might play a
      protective factor.

      This 3-year proposal is divided into 2 clinical studies. In study 1, we aim to test the
      prophylactic effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic
      oil) for IFN-α-induced sickness behaviour and depressive symptoms, in a two-week,
      double-blind, placebo-controlled trial of 152 patients with HCV starting IFN-α therapy. In
      study 2, we will test the antidepressant effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d
      versus placebo: high oleic oil) on IFN-α-induced depression during IFN-α therapy, in an
      eight-week, double-blind, placebo-controlled trial in 80 HCV patients who have already
      developed depression.
    

Intervention name(s): Omega-3 fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): A daily treatment of 5 identical capsules of EPA (3.5 g/d), DHA (1.75 g/d) or placebo (high oleic oil), in single or divided administration for 2 (Study 1) or 8 weeks (Study 2)
Other intervention name(s): Omega-3 PUFAs or fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Condition: Bloodloss; Surgical Procedures, Operative
MeSH terms: Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and identify the optimal dose(s) of
      ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery
      including the use of cardio pulmonary bypass.
    


Intervention name(s): ecallantide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): infusion administered IV over the duration of the surgical procedure; solution for IV infusion over the duration of the surgical>> procedure
Intervention MeSH terms: Ecallantide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the short-term safety and efficacy of a single
      intravitreal injection of autologous bone marrow stem cells in patients with retinitis
      pigmentosa.
    

Detailed description: 
      A prospective phase II, nonrandomized open-label study of retinitis pigmentosa patients with
      best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic
      evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following
      intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be
      used to evaluate the short-term safety of intravitreal of ABMDSC: 1) severe visual loss,
      defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3)
      decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in
      intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+
      for more than 1 month after injection according to a classification described elsewhere ; 2)
      decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4)
      qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary
      outcome measures will be used to evaluate the short-term efficiency of intravitreal of
      ABMDSC: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT >
      50um and not related to macular edema; 4) increase > 5 letters on BCVA
    

Intervention name(s): intravitreal injection of autologous bone marrow stem cells
Intervention type(s): Biological
Intervention description(s): One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
Other intervention name(s): autologous bone marrow stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinitis pigmentosa; stem cell; bone marrow; retinal dysprophy
The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to compare the safety and effectiveness of two different dose ranges of
      risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.
    

Detailed description: 
      This is a clinical study of an investigational drug called risperidone in the treatment of
      schizophrenia in adolescents. Initially children (age 2 to 12 yrs) and schizophreniform
      subjects were also allowed but excluded following protocol amendment.

      The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of
      schizophrenia. Subjects will be randomly assigned to one of two groups on enrollment and will
      be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose
      different ranges, according to the assigned study group.

      Initially the two dose range were 0.15-0.4 mg/day and 1.5-4mg/day but were changed in
      protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and
      maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm) Risperidone lower
      dose (0.35-0.6 mg/day [subjects >=50kg] or 0.007-0.012 mg/kg/day [subjects <50 kg]) as 0.1
      mg/mL oral solution or risperidone higher dose (3.5-6 mg/day [subjects >=50 kg] or 0.07-0.12
      mg/kg/day [subjects <50 kg]) as 1 mg/mL oral solution for 8 weeks. Daily dose can be given
      all at once or through 2 administrations (in morning and evening); the dose is increased
      based on efficacy and tolerability.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Adolescents; Schizophrenia; risperidone
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Polycystic Kidney Disease, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 3

Summary: 
      This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus
      placebo in patients with ADPKD.
    

Detailed description: 
      This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an
      adequate safety profile, by reducing the rate of total kidney volume increase, while
      impacting the onset, severity, and progression of other important consequences of ADPKD.

      During the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from
      lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and
      90/30 mg orally upon awakening and approximately 9 hours later. As soon as a subject could
      not tolerate a given dose, the titration phase was over and the maintenance phase began at
      the dose level tolerated. The maintenance phase lasted to Month 36. Subjects were able to
      titrate down at any point during the study. Subjects were able to titrate up during the
      maintenance phase with Medical Monitor approval.
    

Intervention name(s): Tolvaptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolvaptan was supplied as tablets.; Placebo was supplied as tablets.
Other intervention name(s): OPC-41061; OPC-156
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADPKD; Polycystic; kidney; ADPKD (Autosomal Dominant Polycystic Kidney Disease)
This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after
      single IV doses.
    


Intervention name(s): AZD9742; Placebo to match AZD9742
Intervention type(s): Drug; Drug
Intervention description(s): Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee; Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteer; First time in human