bioihbjkbjnl/mcl2 huggingface dataset:
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment
Condition: Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to develop and validate a work-model in Primary Health Care for
      identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory
      monitoring study.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients visited at Primary Care consultations will be included according to a
        randomization schedule to reach the necessary sample.
      
Keywords: Sleep Apnea Syndrome; Primary Health Care
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release
      Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period
      during fasted study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Rabeprazole sodium 20 mg Delayed Release tablet
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Radiographic Evaluation of a Star-shaped Incision Technique
Condition: Clinical and Radiographic Effect; Thick-gingiva; Thin-gingiva; Implant
Study type: Observational

Summary: 
      To evaluate a star-shaped incision technique to thick-gingiva and thingingiva patients
      treated with implant-supported fixed prosthesis. The star-shaped incision would be an
      effective and simple method to reconstruct gingival papillae and avoid the gingival recession
      in thick-gingiva patients treated with implant-supported fixed prosthesis, and it is worthy
      of clinical extend.
    

Detailed description: 
      Objective: To evaluate a star-shaped incision technique to thick-gingiva and thin-gingiva
      patients treated with implant-supported fixed prosthesis. Methods and Materials: 24 patients
      received cross-shaped incision were assigned into thick-gingiva group (16 cases) and
      thin-gingiva group (8 cases). Follow-up examination was carried out 3 and 12 months after
      final restoration. Clinical and radiographic evaluation including gingival papilla height,
      modified plaque index, modified sulcus bleeding index, periodontal depth, and crestal
      marginal bone level were utilized.
    

Intervention name(s): The biotype of gingiva
Intervention type(s): Diagnostic Test
Intervention description(s): The biotype of gingival was determined by periodontal probe.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study samples were comprised of patients who had been treated with one bone-level
        implant (Osstem, Korea) insertion in the premolar or molar region. Twenty-four subjects
        were selected from the patients who came to the Department of Oral Implantology, West China
        Hospital of Stomatology, Sichuan University in China between June 2019 and June 2021.
The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory
      factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50
      patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be
      randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will
      be advised to adherence our diet and exercise program too. At the first and the end of the
      intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis
      will be assessed and compared between groups.
    


Intervention name(s): synbiotic; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 symbiotics capsules per day for 28 weeks; 2 Maltodexterin capsules as a placebo per day for 28 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of a PCT(Procalcitonin) Rapid Test -Based Approach on ATB (Antibiotics) Use in Children With Fever Without Source
Condition: Fever Without Source
MeSH terms: Fever
Study type: Interventional

Summary: 
      Because a newly available point-of-care test may have real interest especially for children
      in the Emergency Department (ED) setting, by limiting painful and stressful venipunctures and
      decreasing the length of stay in the ED, the investigators hypothesize that integrating this
      new capillary Procalcitonin (PCT) rapid test in the DIAFEVER CPR (Clinical Prediction Rules)
      could represent a highly valuable diagnostic tool to identify a group with low Invasive
      Bacterial Infection (IBI) risk and could limit unnecessary exams and antibiotic
      prescriptions. The aim of this present study is to demonstrate the impact of this new PCT
      rapid-test-based CPR on antibiotic prescription rate in young children with Fever Without
      Source (FWS) presenting to the ED and on morbidity and mortality
    

Detailed description: 
      This prospective multicentric randomized study will include 5000 febrile children aged six
      days to three years, diagnosed with fever without source, in 26 participating French and
      Swiss emergency departments, during a 36-month period.

      During one period, all children will receive usual care. In a second period, the DIAFEVER
      algorithm will be applied in half of the clusters, and in the remaining clusters, children
      will still receive usual care.

      Then in the last period of one year, all centers will apply the new PCT-based algorithm.

      At day 15 after the first consultation, data concerning death, intensive care unit admission,
      disease-specific complications, diagnosis of bacterial infections and proportion of
      antibiotic treatments will be assessed by questioning parents by use of an online electronic
      case report form or a phone call. The endpoints will be compared between the two groups by
      using a mixed logistic regression model adjusted on clustering of participants within centers
      and period within centers.

      To perform complementary studies, a biocollection will be proposed to parents when blood
      tests will be indicated.
    

Intervention name(s): DIAFEVER algorithm
Intervention type(s): Diagnostic Test
Intervention description(s): PCT rapid test-based predictive algorithm
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open cluster randomized clinical trial with random and sequential crossover of clusters from control to intervention until all clusters are exposed. Clusters are defined as EDs.
2 periods will be considered, one when all children will receive usual care, whatever the cluster, and a second one when, in half of the clusters, the DIAFEVER algorithm will be applied, and in the remaining clusters, children will still receive usual care.
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Bacteriemia; meningitis; Urinary tract infection; antibiotic treatment
Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape (SERE) School
Condition: Response to Severe Stress
Study type: Interventional

Summary: 
      The objective of the proposed research is to determine if tyrosine, an amino acid found in
      protein-containing foods, will mitigate the cognitive deficits and adverse effects on
      behavior and mood produced by exposure to military stress. This study will be conducted at
      the Army Survive, Evade, Resist, Escape (SERE) school at Fort Bragg, NC.

      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain
      neurotransmitter that is critical for the central nervous system (CNS) response to various
      types of acute stress. Psychological stress increases catecholamine turnover in the brain,
      increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and
      human studies have shown that tyrosine supplementation can produce beneficial effects on
      cognitive and physiological functions during exposure to a variety of acute stressors.

      This project will determine if volunteers treated with supplemental tyrosine during stressful
      phases of SERE training experience less degradation in cognitive performance and mood than
      volunteers treated with placebo. Tyrosine or placebo will be administered in a specially
      developed food bar provided to volunteers. The bar is part of a prototype of ration-component
      designed for use during assault operations. A between-subjects, double blind experimental
      design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has
      been tested in hundreds of volunteers without adverse effects.

      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 82
      volunteers complete the study. They will be tested during several portions of SERE. A
      comprehensive but brief battery of cognitive tests, as well as saliva and blood samples, will
      be collected in a manner that does not interfere with ongoing training.

      Hypotheses:

        1. The adverse effects of psychological stress on cognitive performance and mood during
           SERE school will be reduced when volunteers are given supplemental tyrosine compared to
           placebo treatment.

        2. Supplemental tyrosine will reduce release of proinflammatory cytokines that may be
           increased by the stressful activities of SERE school.
    


Intervention name(s): Tyrosine-Containing Bar; Placebo Bar
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Prevention of Milk-Borne Transmission of HIV-1C in Botswana
Condition: HIV Infection; Infant Risk for HIV Infection by MTCT
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to find the most effective and safe treatment to prevent the
      passage of HIV from an infected mother to her baby.
    

Detailed description: 
      1. To assess the effectiveness of the addition of a single dose of nevirapine (NVP) to
           Zidovudine (ZDV, also known as AZT) as used in the Botswana mother-to-child transmission
           (MTCT) National Program, in reducing transmission of HIV-1 from mother to child. To
           determine if maternal NVP (per HIVNET 012 protocol) is necessary in the setting of
           maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic
           infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of
           HIV-1 from mother to child.

        2. To assess the effect of prophylactic AZT given to infants during breast feeding on HIV
           transmission.

        3. To confirm the safety and tolerance of one dose of NVP given to mothers and infants

        4. To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age

        5. To determine the association between assigned infant feeding strategy and maternal
           morbidity and mortality

        6. To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52
           weeks after initiating treatment, among HIV+ women who previously received single dose
           NVP versus placebo during labour.
    

Intervention name(s): Nevirapine; No intervention
Intervention type(s): Drug; Drug
Intervention description(s): All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.; All women received a background of zidovudine from 34 weeks'gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.
Intervention MeSH terms: Nevirapine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Snare-assisted POEM for Treatment of Esophageal Achalasia
Condition: Esophageal Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      POEM is a new intervention for the treatment of achalasia and has been reported to relieve
      the dysphagia symptom effectively. Although the cost of POEM method is less than the method
      of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the
      patients with achalasia. In this trial, investigators plan to use snare to assist POEM
      procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared
      with other knifes-assisted procedure.
    


Intervention name(s): snare-assisted POEM; knife-assisted POEM
Intervention type(s): Device; Device
Intervention description(s): POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.
After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall.
A submucosal tunnel from the esophagus to the gastric cardia is created using a snare.
Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare.
The mucosal incision is closed with endoclips.; POEM is performed by using a conventional endoscopic knife.
After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall.
A submucosal tunnel from the esophagus to the gastric cardia is created using a knife.
Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife.
The mucosal incision is closed with endoclips.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peroral endoscopic myotomy; Snare; Endoscopic knife; Esophageal Achalasia
Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model
Condition: Fertility
Study type: Interventional

Summary: 
      Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte
      donation model.
    

Detailed description: 
      There is an intense communication inside the follicular structure. Bidirectional information
      between the oocyte and the granulosa cells is needed for a normal follicular development and
      oocyte competence.

      There are conflicting results on the effect of pre-incubation time in ICSI.

      It is not clear the proper time to denudate the oocyte from the somatic cells prior to ICSI,
      and some authors describe a negative impact of the premature cummulus removal on the ICSI
      results.

      The aim of this study is to investigate wheter a preincubation time between oocyte retireval
      and injection has any effect on the ICSI ( intracytoplasmatic sperm injection) results .
    

Intervention name(s): timing for oocyte denudation and Intracytoplasmatic Sperm injection
Intervention type(s): Procedure
Intervention description(s): Donated oocytes were randomly allocated to two groups concerning the time of cumulus corona removal.
The first group: After oocyte retrieval, cumulus cells were immediately removed and then ICSI was performed; in the second group, the oocyte-cumulus complexes were incubated for 4 hours. Afterwards, the granulosa cells were removedand ICSI was immediately performed.
Other intervention name(s): cumulus corona removed; granulosa cells removed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: oocyte denudation; preincubation; icsi; oocyte donation
Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects
Condition: Neural Tube Defects; Bisphenol-A
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Interventional

Summary: 
      Our aim in this study is in patients with a diagnosis of neural tube defect; is the
      measurement of BPA levels in maternal blood and amniotic fluid.
    

Detailed description: 
      This prospective observational study was conducted with 92 patients aged 18 - 45 years who
      had amniocentesis at 15 - 22 weeks of gestation at Bursa Yüksek İhtisas Training and Research
      Hospital between April 15, 2021 and April 15, 2022. Patients were divided into two groups
      according to amniocentesis indications. Group 1: patients with abnormal maternal serum
      screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings
      (45 patients), Group 2: patients with pre-diagnosis of NTD (47 patients). During the
      amniocentesis procedure, the first 5cc amniotic fluid and maternal serum samples were
      collected from the patients. The obtained samples were stored at -80°C until the end of the
      study. After all samples were collected, BPA values were measured by ELISA method.
    

Intervention name(s): Bisphenol-A
Intervention type(s): Dietary Supplement
Intervention description(s): measurement of BPA levels in maternal blood and amniotic fluid
Intervention MeSH terms: Bisphenol A
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bisfenol A; amniocentesis; neural tube defect
Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether dexamethasone as an adjuvant to
      ropivacaine for adductor canal block increases duration of the sensory block, when
      controlling for a systemic effect using a paired design and bilateral blocks.

      The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block
      duration compared with ropivacaine + placebo.
    


Intervention name(s): Ropivacaine + dexamethasone; Ropivacaine + placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adductor canal block, single bolus; Adductor canal block, single bolus
Intervention MeSH terms: Dexamethasone; Ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: US-guided peripheral nerve block; Anesthetics, Local; duration; Sensation; adductor canal block; lower limb; Adjuvants, Anesthesia
Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis
Condition: Colorectal Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if there is a difference in survival between two
      different treatment strategies for colorectal peritoneal surface disease. The control arm
      administered the currently considered standard treatment which is palliative systemic
      chemotherapy. The experimental arm received the combination treatment cytoreductive surgery
      and intraperitoneal chemotherapy. The investigators hypothesis is that the combination
      treatment will improve the overall survival.
    


Intervention name(s): Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin); Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Intervention type(s): Drug; Procedure
Intervention description(s): Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.; Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; cytoreductive surgery; intraperitoneal chemotherapy; systemic chemotherapy; Peritoneal Metastatic Disease From the Colon or Rectum
Diagnostic Qualities of the Positron Emission Tomography Coupled to the Scanner (PET / CT) in the Assessment of Response to Non-Hodgkin's Lymphoma Therapy in Children and Adolescents
Condition: Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      This is a diagnostic prospective multicenter study. This study will be conducted in 32
      centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent
      (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the
      SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with
      conventional imaging time of remission assessment. Histological examination of residual tumor
      will be conducted whenever practicable in patients with pathologic residual image on
      conventional imaging and / or PET / CT. A central review of conventional imaging examinations
      and PET / CT will be performed independently from each other.

      Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT
      (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The
      results of the early PET / CT should not lead to treatment modifications.

      In case of residual tumor at remission assessment, therapeutics changes as recommended
      therapeutic protocols will be based on histologic findings and not on the results of PET / CT
      alone.
    


Intervention name(s): PET / CT
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Children and adolescents