bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Rate of Hospitalization in Participants With Schizophrenia Treated With Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary purpose of the study is to compare the rate of hospitalization associated with
      psychotic relapse in participants with schizophrenia treated one year before with oral
      antipsychotics and one year after with long acting injectable atypical antipsychotics.
    

Detailed description: 
      This is a retrospective (take a look back at events that already have taken place),
      observational, multicenter (when more than one hospital or medical school team work on a
      medical research study) study to review medical records of adults with a diagnosis of
      Schizophrenia during the time period from 01 January 2009 through 31-December-2013 (only for
      Mexican population). Data will be collected from clinical practice. The medical records of
      participants will be screened and eligible participants data will be collected. The period of
      observation will span from 12 months before initial Long Acting Injectable (LAI) use and in
      12 months after the initial LAIs use. The rate of hospitalization will be primarily
      evaluated.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants (both gender and 18 to 55 years of age) with schizophrenia treated with oral
        anti-psychotics then switched to long acting Injectable anti-psychotics.
      
Keywords: Schizophrenia; Oral antipsychotics; Long acting Injectable antipsychotics
Inferior Vena Cava Retrievable Filters: Spanish Register
Condition: Vena Cava Filters
Study type: Observational [Patient Registry]

Summary: 
      Spanish registry of retrievable vena cava filters.

      This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology
      (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive
      Techniques) of the University of Zaragoza (Spain).

      A software tool hosted on the official website of SERVEI and the journal Intervencionismo
      will be used for data collection a(https://estudios.watsoncme.com).
    

Detailed description: 
      This is an prospective observational study of patients that have been implanted a inferior
      vena cava filter with intention to be retrieved.

      Patients are recruited when the filter is implanted, and the investigators observe when is it
      finally retrieved (dwell time), if retrieval is possible or not, and if there is any
      complication at the retrieval of the filter.
    

Intervention name(s): Inferior vena cava filter placement and retrieval
Intervention type(s): Other
Intervention description(s): There are really no interventions in this study. This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved.
Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved, and if there is any complication at the retrieval of the filter.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in whom a vena cava filter has been implanted with intention of being retrieved
        (non-permanent).
      
Keywords: Retrievable Inferior Vena Cava Filters; Pulmonary Embolism
Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children
Condition: Difficulty Writing
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting
      Interventions Guidelines (OTHIG) in enhancing handwriting performance among children.

      Method:

      Forty-two children recruited from private centers with occupational therapy indications and
      with handwriting issues, aged five to nine years, will be assigned to the experimental and
      control groups.

      Participants will receive a total of 10-week sessions, including training, intervention, and
      outcome measures.

      The experimental group will receive the developed OTHIG during handwriting skills
      intervention. Meanwhile, the control group will receive conventional interventions which not
      exposed to the OTHIG.

      This study is expected to provide evidence for the effectiveness of using the developed OTHIG
      to OTs in delivering their services, targeting children struggling with handwriting skills.
    

Detailed description: 
      The study is a Cluster Randomised Controlled Trial (C-RCT) that systematically clusters the
      centers into the treatment and control groups.

      A total of 10 centers will be involved in this study.

      The clustering of all ten centers will allocate randomly into the treatment and control
      groups based on submitting the consent letter to the researcher and after an assessment of
      TPT and TVPS-4 are conducted.

      Ten early interventions have similar characteristics such as (1) hiring graduated
      occupational therapists from recognized universities in Malaysia, (2) having occupational
      therapists working daily at the centre, (3) having children aged five to nine years who
      receive OTs intervention.

      This randomization will be allocated based on the list of the centers that give an early
      submission of a signed consent form. The randomization will be carried out with a mechanism
      that neither the researcher nor children or center owners will know which group of
      intervention they will be assigned.
    

Intervention name(s): OTHIG
Intervention type(s): Other
Intervention description(s): Occupational Therapy Handwriting Intervention Guideline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: handwriting; intervention; effectiveness; children; study protocol; clustered randomized controlled trial
Digital Mammography: Computer-Aided Breast Cancer Diagnosis
Condition: Tumors, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to develop computer programs to assist radiologists in finding
      breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on
      direct digital and film mammograms.
    

Detailed description: 
      To develop a computer-aided diagnosis (CAD) system for full field digital mammography (FFDM)
      using advanced computer vision techniques and to evaluate the effects of CAD on
      interpretation of digital mammograms (DMs). This system will assist radiologists with the
      four most important areas in mammographic interpretation: (1) detection of masses, (2)
      classification of masses, (3) detection of microcalcifications, (4) classification of
      microcalcifications. The proposed approach is distinctly different from previous approaches
      in that image information from two-view and bilateral mammograms will be fused with that from
      the single-view mammogram to improve lesion detection and characterization.
    

Intervention name(s): digital mammography
Intervention type(s): Procedure
Intervention description(s): Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Condition: Respiratory Tract Infections; Asthma; Avitaminosis
MeSH terms: Respiratory Tract Infections; Avitaminosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods.
      Vitamin D levels are alarmingly low in many North American children. Several health issues
      have been linked with low vitamin D. These include colds caused by viruses and asthma
      attacks. However, no study has determined whether vitamin D supplementation can reduce the
      risk of these conditions in young children where they are most common and most severe.

      The goals of this study are to determine whether wintertime high dose vitamin D
      supplementation of preschoolers can prevent colds and asthma attacks. The investigators also
      aim to work out how much money would be saved by the health care system and society if
      preschoolers were routinely supplemented with Vitamin D during the winter. The investigators
      believe that preschoolers receiving 'high dose' vitamin D supplementation during the
      wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and
      will be less likely to use the medical system and keep their parents away from work.
    


Intervention name(s): Vitamin D - Cholecalciferol 400 IU; Vitamin D3 - Cholecalciferol 2000 IU
Intervention type(s): Drug; Drug
Intervention description(s): One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up; One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up
Other intervention name(s): Baby Ddrops; Health Canada NPN #80001869; Ddrops 2000 IU
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Randomized Controlled Trial; Child, Preschool; Dietary Supplements; Respiratory Tract Infections; Asthma
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this project is to conduct a community-based randomized clinical trial to compare
      the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride
      varnish applied every six months and fluoride releasing glass ionomer sealants applied
      annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
    

Detailed description: 
      Community-based, stratified (by location) randomized clinical trial (RCT) to determine the
      relative efficacy of topically applied fluoride varnish (FV) applications alone vs FV with
      fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in
      reducing the caries incidence and increment in 3-6 year old children. A parallel groups
      design RCT stratified by study site (one dental and one non-dental location) will be
      conducted among 596 initially 2.5- to 3-year-old children. Those eligible will be randomized
      to one of 2 groups (FV or GIS+FV) and followed for 36 months. The RCT will take place at two
      sites serving primarily underserved, minority and low-income populations in Southern
      California: 1) the dental facility of the San Ysidro Health Center (SYHC) located near the
      U.S.-Mexican Border serves mainly Latino immigrants, and 2) the Comprehensive Health Center -
      Ocean View (CHC-OV), in a non-dental setting in close proximity to its dental clinic, which
      serves Latinos and African Americans. Both sites are part of a consortium of community
      clinics (SYHC Inc) and are located 15 miles apart from each other.

      Annual study dental examinations will be performed by trained, calibrated, study dentists to
      determine caries (precavitated and cavitated) incidence and increment. Children identified as
      needing dental care will be referred for appropriate treatment.
    

Intervention name(s): Fluoride Varnish; Glass Ionomer Sealant
Intervention type(s): Device; Device
Intervention description(s): Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.; Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar.
Other intervention name(s): 3M ESPE CavityShield® single-dose fluoride varnish units; GC Fuji TRIAGE CAPSULE and its conditioner
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Children; Fluoride varnish; Glass ionomer sealant; Prevention
Topotecan in Treating Patients With Recurrent Brain Tumors
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Oligodendroglioma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with
      recurrent brain tumor.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic
      oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and
      quantitative toxicity of topotecan in this patient population on this schedule.

      OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes
      daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or
      unacceptable toxicity. Patients will be followed every 3 months until death.

      PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.
    

Intervention name(s): topotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult anaplastic oligodendroglioma; adult mixed glioma
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
Condition: Lung Cancer
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Both pemetrexed and erlotinib are second-line treatment options for patients with advanced
      non-small cell lung cancer. It is controversial that whether it is necessary to detect
      epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after
      the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive
      marker remains controversial. Therefore, we investigate the efficacy of erlotinib and
      pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR
      FISH-positive advanced lung adenocarcinoma.
    

Detailed description: 
      Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually
      consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most
      patients. Second-line treatment options available to patients who suffer failure of
      first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted
      therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great
      efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was
      associated with great sensitivity and prolonged progression-free survival of NSCLC from
      EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib
      compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive
      lung adenocarcinoma.
    

Intervention name(s): Erlotinib; Pemetrexed
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg Given orally; 500mg/m2 Given IV
Other intervention name(s): Tarceva; ALIMTA
Intervention MeSH terms: Pemetrexed; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Non-small-cell lung cancer; Adenocarcinoma; EGFR gene mutation; Chemotherapy; Pemetrexed; Erlotinib
Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress
Condition: Mood
Study type: Interventional

Summary: 
      The aim of this study is to assess the chronic effects (14 days) of Euphytose® on
      psychological state, physiological stress responses and any resulting changes in gut
      microflora communities as compared to placebo.
    

Detailed description: 
      The aim of the proposed study is to assess the effects of chronic (14 days) supplementation
      with Euphytose® on psychological state with regards perceived stress and overall mood as well
      as psychological and physiological stress responses during a laboratory stressor. The trial
      will employ the Observed Multitasking Stressor (OMS), with psychological state and
      physiological responses assessed before and after its completion. The main mood/psychological
      stressor assessment will take place pre-treatment and following 14 days of treatment. Stool
      samples will also be collected from participants in order to assess changes in gut microflora
      communities at visits 1 and 2.
    

Intervention name(s): Euphytose®; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): (50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.); Placebo comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Balanced crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: cognition; anxiety; herbal supplements
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Condition: Type 1 Diabetes; Organ Transplantation; Immunosuppression
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This single center phase 2 clinical trial, is designed for confirming the efficacy and safety
      of sequential islet allotransplantation with steroid free immunosuppression in patients with
      previous kidney transplantation.
    

Detailed description: 
      The beneficial effects of glycemic control on both survival and function of transplanted
      kidneys in patients with type 1 diabetes mellitus have been recognized.

      The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell
      transplantation, in patients with type 1 diabetes mellitus who have a stable kidney
      allograft.

      The study primary efficacy endpoint is graft survival defined as insulin independence and
      HbA1c < 8% at 1 year post first transplant. Secondary outcomes are graft function and
      metabolic control

      The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus
      regimen 6 months before islet transplantation to exclude negative effects on kidney graft
      function.
    

Intervention name(s): islet transplantation
Intervention type(s): Procedure
Intervention description(s): Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
Other intervention name(s): surgical catheterisation; percutaneous catheterisation
Intervention model: Single Group Assignment
Intervention model description: Islet transplantation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes type 1; kidney transplantation; islet; hypoglycemia
Perioperative vs Postoperative Chemotherapy + Bevacizumab in Colorectal Cancer, Liver Mets
Condition: Colorectal Cancer; Liver Metastasis
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Early-stage colorectal cancer(CRC)is localized and resectable, but 20% of the patients have
      metastatic disease at the time of diagnosis and 50% of all patients eventually die of the
      disease. The most frequent site of colorectal metastases is the liver, which accounts for 30%
      to 60% of cases. In these patients, the extent of liver disease is the main determinant of
      survival. Hepatectomy is the only potentially curative therapy for colorectal liver
      metastases (CLM), but when traditional criteria for resectability were used, only 10% of
      patients were candidates for surgical resection.

      Although adjuvant systemic therapy after resection of primary colorectal tumors is well
      established, there are relatively few data on the use of postoperative therapy vs. surgery
      alone in patients who have undergone resection of liver metastases. In this trial, the
      absolute increase in the 3-year PFS rate with the addition of FOLFOX4 was a modest but
      significant 9% in patients who had resection (from 33% to 42%; P = .025). For improving
      survival in patients with CLM, several studies with biologic agents have been tried. The use
      of bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), has
      resulted in increased response rates in patients with stage IV colorectal cancer and improved
      OS and PFS. In an ongoing phase II trial presented in ASCO 2008, in patients who were
      potentially curable through resection of liver metastases, perioperative treatment with
      capecitabine and oxaliplatin (XELOX) plus bevacizumab yielded an overall response rate of 73%
      with stable disease in 21% and a mean PFS of 27 months. Response to chemotherapy
      significantly correlated with a prolonged PFS (P < .001).

      On the basis of these backgrounds, we designed a phase II study to compare the effectiveness
      of combination chemotherapy with perioperative or postoperative bevacizumab treatment in
      patients with CLM.
    


Intervention name(s): Bevacizumab, mFOLFOX, FOLFIRI; Bevacizumab, mFOLFOX, FOLFIRI
Intervention type(s): Drug; Drug
Intervention description(s): ArmA (postoperative arm)
Postoperative mFOLFOX or FOLFIRI regimen, every 2weeks for 12cycles Bevacizumab 5mg/kg IV, every 2weeks for 11cycles beginning with cycle 2; ArmB (perioperative arm)
Perioperative CTx mFOLFOX or FOFIRI regimen, every 2 weeks for 6 cycles Bevacizumab 5mg/kg IV, every 2 weeks for 5cycles (cycles 1-5)
Postoperative CTx mFOLFOX or FOLFIRI regimen, every 2weeks for 6 cycles Bevacizumab 5mg/kg IV, every 2weeks for 5cycles(cycles 8-12)
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer, liver metastasis, bevacizumab, perioperative/postoperative chemotherapy