bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia
Condition: Covid 19; Hypoxemic Respiratory Failure
MeSH terms: COVID-19; Pneumonia; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The COVID-19 outbreak is associated with a surge in ICU bed requirement and substantial
      mortality (estimated between 0.5% and 1%). Admission in the intensive care unit (ICU) and
      need for mechanical ventilation is reportedly associated with an estimated hospital mortality
      of more than 30%. Furthermore, the surge in ICU bed requirement is a worldwide-shared issue,
      leading to sub-optimal ICU management.

      In acute respiratory failure due to COVID-19-related pneumonia, vasoplegia with vascular
      enlargement inside the lung lesions and dilation of small vessels seen on chest CT scan
      largely account for severe hypoxemia whose physiological response is hyperventilation leading
      to hypocapnia. Almitrine, initially described to reduce intrapulmonary shunt by enhancement
      of hypoxic pulmonary vasoconstriction in combination with inhaled nitric oxide (iNO),
      redistributes pulmonary blood flow from shunt areas to lung units with normal
      ventilation/perfusion (VA/Q) ratio. Low dose of intravenous almitrine (2 µg.kg-1.min-1) alone
      also improves oxygenation (without combination with iNO) by selective pulmonary
      vasoconstriction of precapillary pulmonary arteries perfusing lung areas exposed to a hypoxic
      challenge with a slight increase in mean arterial pulmonary. Therefore, our hypothesis is
      that 5 days of low dose of almitrine therapy may improve the ventilation-perfusion (VA/Q)
      ratio at a relatively early stage of this specific lung disease and limit respiratory
      worsening and subsequent need for mechanical ventilation.
    


Intervention name(s): Almitrine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous almitrine at a dose of 2 µg.kg-1.min-1 during 5 days; Intravenous glucose 5% during 5 days
Intervention MeSH terms: Almitrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Almitrine; HYPOXEMIC ACUTE RESPIRATORY FAILURE; COVID-19; COVID-19 pneumonia
New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy
Condition: Gastric Cancer; Intestinal Metaplasia; Atrophic Gastritis; Inflammation
MeSH terms: Gastritis; Gastritis, Atrophic; Inflammation; Metaplasia
Study type: Observational

Summary: 
      The aim of the present study was to propose a new pCLE classification of gastric pit patterns
      and vessel architecture, and to assess the accuracy and interobserver agreement of this new
      pCLE classification system in the stomach.
    

Detailed description: 
      Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris,
      France) is a newly developed endoscopic device which allows the application of laser
      microscopy with any conventional endoscope and mosaic imaging. Previous studies have
      demonstrated its application in various GI diseases, including Barrett's esophagus, colonic
      adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the
      application of pCLE in the stomach. Therefore, the aim of the present study was to propose a
      new pCLE classification of gastric pit patterns and vessel architecture, and to assess the
      accuracy and interobserver agreement of this new pCLE classification system in the stomach.
    

Intervention name(s): probe-based confocal laser endomicroscopy
Intervention type(s): Device
Intervention description(s): all patients will receive pCLE examination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
      
Biospecimen description: 
      endoscopic biopsies will be taken at suspicious lesions
Oncoxin® and Quality of Life in Cancer Patients
Condition: Gastric Cancer Stage II; Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage III; Gastric Cancer Stage III
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      It is expected that additional support with certain micronutrients may improve prognosis,
      decrease the frequency of side effects and complications and maintain high relative dose
      intensity of anticancer treatments. Food supplement ONCOXIN (ONCX) contains amino acids,
      vitamins, minerals and biologically active substances of natural origin with high
      immunostimulatory and antioxidant activity. Present study is a real world experience study
      intended to evaluate the efficacy of ONCX in cancer patients.
    

Detailed description: 
      The study was conducted at 9 centers across the Russia and Kazakhstan. Patients were
      allocated in 2:1 comparison groups for the ONCX and control groups, respectively. A total of
      133 patients were enrolled in the study; 84 in the ONCX group and 49 as controls.

      ONCX contains microelements, vitamins, amino acids and certain naturally occurring,
      biologically active substances.

      It is expected that additional support with certain micronutrients may improve prognosis,
      decrease the frequency of side effects and complications and maintain the Quality of life in
      cancer patients.
    

Intervention name(s): ONCOXIN®
Intervention type(s): Dietary Supplement
Intervention description(s): Adjuvant chemotherapy regimen (XELOX or paclitaxel+carboplatin) + Oncoxin 25 ml twice daily for 20 days. In case of nausea/vomiting after ONCX use patients were advised to dilute it in water, juice or milk. Patients with BMI <20 and serum albumin levels <30 g/l received nutritional support.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Study multicenter open-label nonrandomized clinical trial in two parallel groups with a 20-day treatment period. No follow-up period was intended. Following visits were scheduled: Visit 1 - the first day of 2nd and further course of ACT before ACT drugs administration; Visit 2 - 7±1 days before next course of ACT; Visit 3 - the day of next course of ACT before ACT drugs administration (21±3 days after Visit 1).
It is expected, that the proportion of patients with MCID improvement in total SDS ESAS was 50% in ONCX group and 20% in control group (with baseline total SDS ESAS of 30 points). Based on patients' allocation as 2:1 in comparison groups for the ONCX and control groups, respectively, alpha 0.05 and power not less than 0.9 data of 120 patients has to be analyzed. With the dropout of 25% 150 patients has to be included in the study (100 ONCX/50 controls).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Oncoxin; Nutritional supplement; Chemotherapy; Oxidative stress; Antioxidant
Childhood Autism Risks From Genetics and the Environment (The CHARGE Study)
Condition: Autism; Developmental Disabilities
MeSH terms: Autistic Disorder; Developmental Disabilities
Study type: Observational

Summary: 
      The purpose of this study is to understand how genes, environment, and the interplay between
      the two, influences the development of autism and other neurodevelopmental disorders.
    

Detailed description: 
      The causes and contributing factors for autism are poorly understood. Evidence suggests that
      incidence is increasing, but diagnostic changes and improvements may be playing a role. Both
      genetic and environmental factors appear to play a role. Autopsy studies demonstrate
      structural changes in the brain and clinical investigations reveal neurophysiologic
      differences in information processing in autistic versus normal children. Members of our team
      recently demonstrated altered levels of certain neuropeptides at birth in children who later
      developed autism.

      This case-control study is the first large-scale epidemiologic investigation of underlying
      causes for autism and triggers of regression. This study capitalizes on the strengths of the
      case-control design, which is well suited to examine a broad array of factors for rare
      conditions that are thought to be multifactorial. Comparisons will be made with both general
      population controls and mentally retarded children.

      The aims are to assess the influence of exogenous exposures, the role of susceptibility
      factors, and the interplay between these two in the etiology of autism and its phenotypic
      variation. Chemicals with known or suspected neurodevelopmental toxicity, such as PCB's,
      certain pesticides, and metals, are being investigated. This study pursues several hypotheses
      that have recently gained attention, including the combined measles, mumps, rubella vaccine
      and mercury present in vaccines given during infancy and early childhood. Additionally,
      biochemical susceptibility is examined through characterization of metabolic, immunologic,
      and neuronal gene expression profiles and genetic polymorphisms.
    

Time perspective: Other
Keywords: autism; neurodevelopment; neurotoxicology; perinatology; teratology
Assessment of Musculoskeletal Pain and Psychosocial Status of Athletes
Condition: Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational

Summary: 
      The sporty performance exhibited by an athlete faces physiological, biomechanical and
      psychological activity of the athlete. It depends on both the psychological state and the
      elevation of the musculoskeletal system to a certain level so that the athlete can perform
      optimally and excellently. For this reason, we aimed to evaluate the musculoskeletal system
      pain of amateur and professional athletes in different disciplines and the psychosocial
      states such as sports confidence, depression and quality of life.
    

Detailed description: 
      This study consists of 160 sportsmen who are participating in sports by doing sports in
      soccer, basketball, volleyball, athletics, table tennis, field tennis, kickboxing and archery
      branches between the ages of 15 and 36. The Expanded Scandinavian Muscle Skeleton
      Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the
      symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the
      algometer for identifying their pain threshold, the sporty trust will be questioned with the
      Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World
      Health Organization Quality of Life Scale Short Form and Depression will be evaluated with
      Beck Depression Inventory.
    

Intervention name(s): Measuring devices and questionnaires
Intervention type(s): Behavioral
Intervention description(s): Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of athletes. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer for identifying their pain threshold, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be between the ages of 15 and 36.
      
Keywords: musculoskeletal system pain; athlete; psychosocial problems; algometer
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Condition: Hepatic Carcinoma
MeSH terms: Neoplasm Metastasis; Carcinoma, Hepatocellular; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and
      metastasis of hepatocarcinoma after radical hepatectomy.
    

Detailed description: 
      A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for
      Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to
      evaluate the efficacy and safety.
    

Intervention name(s): Huaier Granule
Intervention type(s): Drug
Intervention description(s): Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Other intervention name(s): Huaier
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Huaier Granule;; After radical hepatectomy;; Prevention of Recurrence and Metastasis;; Safety.
Comparison of Two Radial Head Implants
Condition: Radial Head Fractures
MeSH terms: Radial Head and Neck Fractures; Radius Fractures
Study type: Observational

Summary: 
      In severe injuries of the radial head with multiple, displaced fracture fragments and
      concomitant ligament damage, excision of the fragments and replacement of the radial head
      with a metallic implant are indicated. Current radial head implants are composed of metal or
      a combination of metal and high molecular weight polyethylene. The prostheses are assembled
      intra-operatively as a solid unit (monopolar) or as an articulating implant with motion
      between the stem and head (bi-polar). The stem of the implant is inserted into the proximal
      radius for support and can be classified as either loose-fitting or fixed. According to the
      investigators, there are no studies that directly compare the clinical and radiographic
      outcomes between different radial head implant designs. The purpose of this retrospective
      study is to compare the clinical and radiographic results in patients treated for an
      irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a
      monopolar, in-growth radial head implant. The study findings may provide useful clinical
      information regarding the similarities and differences in these two implant designs.
    

Detailed description: 
      Data has been completed.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering radial head fractures, with or without other elbow injuries, requiring
        radial head replacement
Reduction of IgE Antibody in Human Allergic Subjects
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a neuropeptide, substance P, when injected
      along with an allergen, such as ragweed, can reduce allergic reactivity.
    

Detailed description: 
      Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for
      development of asthma. This study utilizes the neurotransmitter, substance P, a small
      molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal
      tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in
      an attempt to reduce allergic reactivity.
    

Intervention name(s): substance P; substance P injections
Intervention type(s): Biological; Biological
Intervention description(s): injections of substance P and low dose allergen or placebo; injections of substance P for 8 weeks
Intervention MeSH terms: Substance P; Neurokinin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: substance P; allergic rhinitis; allergen immunotherapy
Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is compare the safety and pharmacokinetic characteristics of
      DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after
      multiple oral administration in healthy male volunteers.
    

Detailed description: 
      The number of patient is thirthy-six.Patients were randomly assigned either anplag
      tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days
      Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL
      100mg, tid) 3days second.
    

Intervention name(s): Anplag
Intervention type(s): Drug
Intervention description(s): Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
Other intervention name(s): Other Names:; DP-R202 : DP11002-3; Anplag : 0007-1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups:
      dutasteride treatment group and watchful waiting strategy group. According to the study
      protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after
      randomization.

      There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided
      biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate
      cancer development for patients with high grade intraepithelial neoplasia (HPIN).
    


Intervention name(s): dutasteride; prostate biopsy
Intervention type(s): Drug; Procedure
Intervention description(s): 0.5mg; prostate biopsy
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prostate cancer; chemoprevention; dutasteride
The Effect of Motor Control Exercise Versus General Exercise on Lumbar Local Stabilizing Muscles Thickness
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the efficacy of motor control exercises. For this,
      before and after motor control and general exercises, we determined transverses abdominis and
      multifidus thickness, activity limitation and pain. We hypothesized that the motor control
      exercises would increase transverses abdominis and multifidus muscles thickness. Activity
      limitation and pain would decrease following two protocols that it was more in motor control
      group than general one.
    

Detailed description: 
      Musculoskeletal disorders, of which back pain accounts for more than half the number of
      cases, are the most common cause of chronic incapacity in industrialized countries.
      Approximately 10-20 percent of patients with low back pain develop chronic pain, defined as
      low back pain persisting more than 3 months. Low back pain represents a particularly costly
      sociomedical problem because of the expenditure associated with repeated treatment and the
      long-term absence from work and need for social support. These patients use more than 80% of
      health care resources for back problems, and treatment has a low success rate. Thus, the
      development of effective interventions aimed at management of the chronic problems is
      urgently required.

      Review of studies showed that the effectiveness of stabilization exercises in patients with
      nonspecific LBP is not yet fully established. In clinical trials that improvement reported
      after motor control exercise, other intervention accompanied with these exercises. Also, the
      results of motor control exercise studies are different. On the other hand, the evidence
      underpins the primary aim of motor control exercise, which is to re-establish normal control
      of the deep spinal muscles, reducing the activity of more superficial muscles that tend to
      stiffen the spine and have increased activity in low back pain, and then maintain normal
      control during progressively more demanding physical and functional tasks. For these reasons,
      we decided to identify the efficacy of motor control exercises, usually considered as
      specific trunk muscle stabilization exercises. A randomized controlled trial was only way for
      identifying the role of these exercises in treating chronic low back pain. Also, our choice
      coincides with the research agenda set by the 2004 European Guideline.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): exercise
Other intervention name(s): training
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Motor Control Exercise; General exercise; Ultrasonography, Multifidus; Transversus abdominis; Randomized Controlled trial.
The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
Condition: Growth of Term Infants
Study type: Interventional

Summary: 
      This clinical trial will evaluate an investigational infant formula with an alternate source
      of DHA to determine if it provides normal growth and if it is well tolerated by term infants
      as compared to a marketed routine infant formula.
    


Intervention name(s): Control: Marketed routine infant formula; An investigational infant formula containing an alternate source of DHA
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Laparoscopic Gastrectomy for Advanced Gastric Cancer
Condition: Advanced Gastric Cancer; Laparoscopic Gastrectomy
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric
      cancer, there have been few reports of the efficacy of LAG in the management of advanced
      gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic
      safety of laparoscopic gastrectomy for AGC.
    

Detailed description: 
      Prospective phase II clinical trial to evaluate technical and oncological safety of LG for
      AGC

      LG procedure for AGC:

      D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic
      exploration

      Primary end point: 3 year disease free survival secondary end point: postoperative outcomes,
      morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence pattern

      Study duration: 7 years(enrollment: 4year, follow-up: 3year)
    

Intervention name(s): Laparoscopic gastrectomy
Intervention type(s): Procedure
Intervention description(s): Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment