bioihbjkbjnl/mcl2 huggingface dataset:
Implementation of an Epidemiological and Clinical Registry of Emergency Surgery Patients in a Costa Rican Hospital
Condition: Surgical Complication; Emergencies
MeSH terms: Emergencies
Study type: Observational [Patient Registry]

Summary: 
      A retrospective cross-sectional study was conducted in a quaternary level university hospital
      of the Costa Rican public health system. The study included all patients aged 12 years and
      older who required emergency surgery by the hospital's emergency surgery and trauma service,
      admitted through the hospital's emergency service.
    

Detailed description: 
      This research consists in a retrospective cross-sectional study carried out in a quarterly
      level university hospital of care of the Costa Rican public health system (high complexity).
      The study included all patients aged 12 years or older who required emergency surgery for the
      hospital's emergency surgery and trauma service, admitted to this center between 2020 and
      2022. Only those patients who required emergency surgery by another surgical specialty during
      this period were excluded from the register. A non-probabilistic convenience sampling was
      performed, based on the pre-established selection criteria and determined by the number of
      patients treated in the shock room of the hospital, that subsequently received general
      emergency or trauma surgery in the period under study. Sociodemographic variables,
      hemodynamic status, period of hospitalization, related to the procedure performed and the
      underlying comorbidities, as well as the clinical outcome, were included in the study
      database.
    

Intervention name(s): Abdominal surgery
Intervention type(s): Procedure
Intervention description(s): surgical interventions by gastrointestinal emergencies, hepatobiliary emergencies and trauma
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients requiring emergency surgery by the hospital's emergency surgery and trauma
        service, admitted through the hospital's emergency service.
      
Keywords: Registry; Trauma; General surgery; Emergency
Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
Condition: Multimorbidity; Polypharmacy; Other Diagnoses, Comorbidities, and Complications
Study type: Interventional

Summary: 
      This study assesses the effectiveness of a complex intervention in young-old patients with
      multimorbidity and polypharmacy aimed at improving physician drug prescription in primary
      care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and
      12 (T2) months from baseline compared to usual care.
    

Detailed description: 
      Design: Pragmatic cluster randomized clinical trial with 12 months follow-up.

      Unit of randomization: general practitioner.

      Unit of analysis: patient.

      Setting: Primary Health Care Centres in three different Spanish Autonomous Communities
      (Aragón, Madrid and Andalucía).

      Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and
      polypharmacy (5 or more drugs taken for at least three months). N=400 patients (200 in each
      arm, 5 patients per physician) will be recruited by general practitioners before
      randomization.

      Intervention: complex intervention.

      Control group: usual care.

      Variables: MAI, health care utilization, quality of life (Euroqol 5 Dimensions (5D-5L), drug
      therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic
      factors. Economic appraisal variables: time spent training FPs, cost of teaching staff, time
      spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L.

      Analysis: All analyses will be carried out adhering to the intention-to-treat principle.
      Description of baseline characteristics. Basal comparison between groups. Analysis of main
      and secondary effectiveness (between-group difference in T1-T0 MAI score, with corresponding
      95% Confidence Interval); multilevel analysis will be used to adjust models. Estimated
      quality-adjusted life years (QALYs) gained at the population level. Calculation of
      cost-utility ratio.
    

Intervention name(s): Multi-PAP; Usual care
Intervention type(s): Other; Other
Intervention description(s): Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.; Patients will receive the usual clinical care based on current clinical practice guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Multimorbidity; Primary Health Care; Polypharmacy; Comorbidity; Medication Adherence; Medication Appropriateness Index; Patient-Centered Care
Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 200mg of Dr.
      Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing
      Lamotrigine) Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC in
      healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other intervention name(s): LAMICTAL XR
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lamotrigine Extended Release; crossover
Methadone and Ketamine for Neuropathic Pain Treatment
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      Methadone and ketamine are effective for neuropathic pain management. However, the benefits
      of the association of both drugs are uncertain. Here, the investigators conducted a
      randomized, double-blind, in parallel, active controlled clinical trial to test the
      hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than
      methadone or ketamine alone in reducing neuropathic pain.
    

Detailed description: 
      Either oral methadone or ketamine have been used in neuropathic pain management, however, the
      benefits of the association of both drugs are uncertain. Here, we conducted a randomized,
      double-blind, in parallel, active controlled clinical trial to test the hypothesis that
      methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine
      alone in reducing neuropathic pain.

      Methods: Fourthly two patients with neuropathic pain refractory to conventional therapy were
      randomly assigned to receive during three months oral methadone (n= 13), ketamine (n=13) or
      methadone combined with ketamine (n=13). The primary outcome was pain score on visual
      analogical scale (VAS) assessed on baseline, 8, 15, 30, 60 and 90 days throughout the
      treatment, and the secondary outcomes were symptoms of neuropathic pain such as allodynia,
      burning or shooting pain as well the side effects.
    

Intervention name(s): Methadone; Ketamine; Methadone plus Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The solution of methadone was prepared by mixing 10 ml of methadone (10 mg/ml) and 90 ml of saline 0.9% (Baxter, São Paulo, Brazil); The solution of ketamine was prepared by mixing 20 ml of S(+)-ketamine hydrochloride (50 mg/ml, Cristália®, São Paulo, Brazil) and 80 ml of saline 0.9% (Baxter, São Paulo, Brazil), obtaining a concentration of 10 mg/ml of ketamine.; the solution of methadone, ketamine was prepared by mixing 10 ml of methadone hydrochloride (10 mg/ml, Cristália®, São Paulo, Brazil), 20 ml of S(+)-ketamine hydrochloride (50 mg/ml, Cristália®, São Paulo, Brazil) and 70 ml of saline 0.9% (Baxter, São Paulo, Brazil), obtaining a concentration of 1 mg/ml of methadone and 10 mg/ml of ketamine.
Other intervention name(s): Methadone hydrochloride, Cristália® (São Paulo, Brazil); S(+)-ketamine hydrochloride, Cristália®, São Paulo, Brazil; methadone and S(+)-ketamine, Cristália®, São Paulo, Brazil
Intervention MeSH terms: Ketamine; Methadone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathic pain; Methadone; Ketamine; Multimodal analgesia
Tailored Therapeutic Model According to the Expression of Genes in Inflammatory Bowel Disease Patients
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This study is a randomized controlled study conducted at five tertiary university hospitals.
      Patients who are 20-80 years old, diagnosed as having Inflammatory Bowel Disease(IBD) and who
      are planned to start thiopurines for the first time for the treatment of IBD are enrolled.
      Patients are assigned to the genotyping group or to the non-genotyping group. The patients
      who carry any heterozygotic variant among the three genes receive 50 mg azathioprine (AZA) or
      25 mg of 6-mercaptopurine, while those who have any homozygotic variant are recommended to
      take other alternative drugs. The patients who do not carry any genetic variant or are
      assigned in non-genotyping group receive the standard dose of thiopurines based on the
      conventional approach.

      Patients in the non-genotyping group receive the standard dose of thiopurines based on the
      conventional approach.
    


Intervention name(s): genotyping for three genes (TPMT, NUDT15 and FTO); non-genotyping
Intervention type(s): Genetic; Other
Intervention description(s): Patients who carry any heterozygotic variants receive 50 mg AZA or 25 mg 6-mercaptopurine (6-MP), while those who have any homozygotic variants are recommended to take other alternative drugs instead of thiopurines; Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. Conventional regimen starts with 50 mg of AZA, then the dose is increased by 25 mg in every 1-2 weeks to 2.0-2.5 mg/kg along with regular monitoring of general blood tests including WBC counts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Autologous Cord Blood Stem Cells for Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the efficacy of one infusion of stem cells from autologous umbilical cord blood in
      patients with autism over six months after infusion as measured by changes in expressive and
      receptive language.

      Also demonstrate improved behavior, learning, and changes in Serum tumor necrosis factor
      alpha (TNF-α), tumor necrosis factor beta (TNF-β), interleukin 1-alpha (IL-1α), interleukin
      1-beta (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 13 (IL-13).
    

Detailed description: 
      This is a single-center, randomized, placebo-controlled, crossover outpatient study with 15
      subjects receiving one infusion of autologous umbilical cord blood (AUCB) containing a
      minimum of 10 million total nucleated cells per kilogram (TNC/kg) and 15 subjects receiving
      an infusion of placebo (saline). After the 24-week follow-up testing is conducted, the groups
      will crossover so that patients who initially received AUCB will receive placebo and patients
      who received placebo at baseline will receive the cord blood. Both groups will be tested
      again 24-weeks after infusion. The neuropsychologist, PI, staff from Cord Blood Registry
      (CBR), and parents will be blinded as to the infusion sequence.

      The duration of participation for each study subject is approximately 55 weeks. This includes
      one screening visit over a period of approximately 6 weeks, one visit for baseline testing,
      one day for infusion of TNC (minimum 10 million/kg) or saline placebo followed by 24 weeks of
      follow-up. A second baseline visit is conducted at week-24 with the second infusion of TNC or
      saline placebo occurring 5-7 days after. Twenty-four additional weeks of follow-up occur
      after the second infusion.
    

Intervention name(s): Autologous Cord Blood Stem Cells; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): One infusion of 60 ml syringe of study product; Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the effectiveness of a peer outreach intervention in preventing HIV
      infection in adults at high risk for contracting HIV and other sexually transmitted diseases
      (STDs).
    

Detailed description: 
      The persistence of HIV and STD epidemics indicates that more effective, sustainable
      preventive interventions are needed, particularly for low-income, inner-city populations.
      This study will determine the effectiveness of a theoretically based peer outreach program in
      preventing HIV and STD transmission among adults in the Baltimore, Maryland area.

      Participants will be randomly assigned to receive either a network-oriented peer program
      emphasizing one's social identity and the goals of protecting one's family and community or
      group cognitive behavioral therapy (CBT). The peer program will also train participants to
      provide HIV/STD education to their peers. Participants will be assessed at study entry and
      during several subsequent follow-up visits. At these study visits, participants will complete
      questionnaires about their sexual health knowledge and sexual behaviors. Participants and
      members of their peer network will have follow-up visits at Months 6, 12, and 18.
    

Intervention name(s): Peer-oriented intervention; Group cognitive behavioral therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.; Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sex Education; Peer Group; Social Identity Theory; HIV Seronegativity; Intervention; women; Social Networks; Peer Education
CLA and Vitamin D on Protein Turnover
Condition: Protein
Study type: Interventional

Summary: 
      To conduct a randomized, double-blind, controlled clinical trial to determine the independent
      and combined effects of dietary conjugated linoleic acid (CLA) and vitamin D supplementation
      on anabolic signaling, the expression of growth regulatory factors, and muscle protein
      turnover in older adults.
    


Intervention name(s): Conjugated linoleic acid; Vitamin D; Conjugated linoleic acid and Vitamin D; Corn oil (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.; Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.; Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) and vitamin D3 (2000 IU) daily.; Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.
Other intervention name(s): Tonalin
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
Condition: Postoperative Adhesion of Uterus
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      This study is intended to evaluate the efficacy and safety of ABT13107 compared to
      Hyalobarrier applied to postoperative intrauterine.
    


Intervention name(s): ABT13107; Hyalobarrier
Intervention type(s): Device; Device
Intervention description(s): Dose: 3mL, maximum 10mL; Dose: 10mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial investigates the effects of FE 999049 compared to GONAL-F.
    


Intervention name(s): Follitropin Delta (FE 999049); Follitropin Alfa (GONAL-F)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer is one of the most frequent and it prognosis is still serious. In France,
      diagnosis and screening applicated in numerous departements, and now in a path of
      generalization to the all country, is based on combination of searching blood into bowel
      movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74
      years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the
      patients with a high risk.Even if the efficiency of this strategy is proved, searching blood
      into the bowel movement by Haemoccult is still imperfect (a lot of false negative).
      Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and
      it constitute an invasive method, with complications, with a compulsory general anesthesia,
      implicating a high cost. The alternative of a screening method based on a non invasive method
      is required.
    


Intervention name(s): diet and absorption of ColoPEG; Colonoscopy with colic videocapsule; Standard colonoscopy
Intervention type(s): Behavioral; Procedure; Procedure
Intervention description(s): 4l of PEG during 2 days; 2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative); 1l of PEG the morning just before colonoscopy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: patients; medium risk; asymptomatic; between 50 and 74 years old; high risk; case; history of neoplastic colic; cancers; polyps
The Effects of Fish Oil on Patients With Chronic Nonspecific Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Objectives:

      To investigate the efficacy of omega-3 polyunsaturated fatty acids (PUFA) on patients with
      chronic nonspecific low back pain (NLBP).

      Methods and Materials:

      Twenty-nine patients with chronic NLBP were randomly divided into experimental and control
      groups. For 8 weeks, participants in the experimental group received omega-3 PUFA at 3000
      mg/day plus physical therapy, while those in the control group received placebo plus physical
      therapy. The visual analog pain scale, pressure algometer, Biering-Sorenson test,
      Roland-Morris Low Back Pain and Disability Questionnaire (RMQ), and occupational burnout
      inventory (OBI) were used in assessments at baseline (T0) and after 4 (T1) and 8 weeks (T2).
      Serum erythrocyte sedimentation rate (ESR) and hypersensitive C-reactive protein (hs-CRP)
      were checked at baseline and T2.
    

Detailed description: 
      Low back pain is a common symptom in modern society. However, nearly 85% of those who seek
      medical care for low back pain have no specific history and no specific finding in image
      study, and therefore do not receive a specific diagnosis. This type of low back pain is
      termed "nonspecific low back pain." Fish oil contains omega-3 polyunsaturated fatty acid,
      including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). EPA and DHA can reduce
      the synthesis of prostaglandin E2. They are also the precursors of the E-resolvin and
      D-resolvin that suppress inflammatory cytokine production and act to resolve inflammation.
      Several previous studies showed that fish oil has the effect of anti-inflammation and pain
      reduction without side effect that affecting stomach and renal function. Therefore, fish oil
      is considered a new type of NSAID, and many studies are investigating its effect of
      anti-inflammation and pain reduction on different diseases. The purpose of this study is to
      investigate the effects of fish oil on patients with chronic nonspecific low back pain.
    

Intervention name(s): Fish oil; Placebo; Hotpacking; Transcutaneous electrical nerve stimulation (TENS)
Intervention type(s): Dietary Supplement; Dietary Supplement; Procedure; Procedure
Intervention description(s): Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks; Five 1000mg sunflower oil soft capsules per day for 8 weeks; Hotpacking 15min on low back, three times a week for 8 weeks; Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks
Other intervention name(s): omega 3 polyunsaturated fatty acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; fish oil; omega 3