bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Condition: Severe Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate the safety, the potential beneficial effect of epidural
      anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute
      pancreatitis.
    

Detailed description: 
      High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal
      studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and
      decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its
      effect on pancreatic perfusion and clinical outcome of patients with AP.
    

Intervention name(s): Epidural anesthesia; Patient controlled intravenous analgesia
Intervention type(s): Procedure; Drug
Intervention description(s): Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour; Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidural anesthesia; pancreatic perfusion; pancreatic necrosectomy
A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
Condition: Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      In the continuing efforts to understand the benefits and risks of in utero exposure to 17P
      this study is designed to evaluate differences in developmental outcomes of children, aged 23
      to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic
      (Protocol number 17P-ES-003).
    

Detailed description: 
      This will be a prospective, noninterventional follow-up study designed to provide a
      developmental assessment of children born to mothers who participated in the 17P Efficacy
      Trial. When subjects reach an age of 23 months after adjustment for gestational age, they
      will be screened for developmental delay using the 24 month ASQ version 3. Subjects who score
      positive (fall below the specified cut-off) for developmental delay in 1 or more domains will
      be referred for the 24 month Bayley Scales of Infant and Toddler Development (3rd edition,
      Bayley-III) and a neurological examination.
    

Intervention name(s): ASQ-3, Bayley III, Neurologic exam
Intervention type(s): Drug
Intervention description(s): Developmental Scales of infant development - Children born to mothers who participated in the 17P-ES-003 study will be enrolled in this study and evaluated using the ASQ-3. Those meeting protocol criteria based on ASQ-3, will be evaluated using the Bayley III and have a neurologic examination.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children whose mothers received 17P and those who received vehicle in the 17P Efficacy
        Trial
      
Keywords: 17P Efficacy Trial Follow up
Influence of Supportive Sandals on Y-Balance Performance on Healthy Young Individuals
Condition: Y-balance Performance
Study type: Interventional

Summary: 
      The Y-balance test is a lower extremity, dynamic test performed in single limb stance that
      measures a person's ability to reach in 3 directions. The test is typically conducted in
      barefoot. The purpose of this study is to assess the impact of footwear on Y-Balance test
      scores. The investigators hypothesize that by improving alignment and augmenting muscle
      mechanics, sandals with medial arch support may improve Y-Balance scores.
    


Intervention name(s): Sandal
Intervention type(s): Other
Intervention description(s): Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal
Other intervention name(s): Orthaheel Sandal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Y-Balance test
Carboxytherapy for Periorbital Dark Circles
Condition: Periorbital Disorder
Study type: Interventional

Summary: 
      the study evaluates carboxytherapy for the treatment of periorbital dark circles
    

Detailed description: 
      two different concentrations of carboxytherapy administered to patients are compared
      regarding efficacy
    

Intervention name(s): Caboxy30; Caboxy60
Intervention type(s): Other; Other
Intervention description(s): carboxy30 to periorbital dark halos; carboxy60 to periorbital dark halos
Other intervention name(s): Carboxy30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: carboxytherapy; dark circles
Evaluation of Non-ablative and Fractional Combination Treatment for Improvement in Skin's Appearance
Condition: Laser Therapy; Rejuvenation
Study type: Interventional

Summary: 
      The study is designed to determine the safety, efficacy, patient comfort and patient
      satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved
      under 510k clearances. The evaluations will include skin condition, physician/subject
      improvement assessment, and subject comfort and satisfaction score by questionnaires.
    

Detailed description: 
      The Refirme ST and the Matrix RF applicators are both FDA approved devices indicated for
      improvement of skin appearance. The Matrix RF applicator has FDA clearance for ablation,
      resurfacing of the skin, and for wrinkles treatment, whereas the Refirme-ST applicator has
      FDA clearance for non-invasive wrinkles treatment. The combined treatment of Refirme ST and
      Matrix RF is intended to improve skin appearance both by enhancement of collagen production
      as the result of the Refirme ST primary heating of the treated area and by causing ablation
      and resurfacing of the skin with the Matrix RF. In the current clinical setting, each
      applicator is used in a separate session although there is no contra-indication preventing
      the usage of these applicators in the same treatment session. A combined treatment in one
      session is believed to be more efficient and will be more time effective for the patient and
      therefore will have a commercial benefit for the manufacturer.
    

Intervention name(s): Refirme ST Applicator and Matrix RF Applicator
Intervention type(s): Device
Intervention description(s): 5 treatments with combination of devices every 4 weeks to the facial (or sub facial regions).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin wrinkling; Skin aging; Skin pigmentation
Pharmacotherapy and Intensive Treatment of Drug Abuse - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine
      craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric
      disorders.
    


Intervention name(s): Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Primary purpose: Treatment
Keywords: drug abuse
Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This observer-blind, randomized, active controlled trial will be conducted among 2-29 year
      olds in two sites (Mali and The Gambia). The objectives of the study are to assess and
      compare the immunogenicity and safety of NmCV-5 with that of Menactra.

      A total of 1800 eligible participants (who or their parents/guardians have given written
      informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata
      18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in
      each age strata).

      Each subject will receive a single dose of study vaccine and will be followed up for 6 months
      post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days)
      and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood
      sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for
      immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement
      (rSBA).
    


Intervention name(s): NmCV-5; Menactra
Intervention type(s): Biological; Biological
Intervention description(s): Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.; Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine
Other intervention name(s): MenACYWX; MenACYW-D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neisseria meningitidis; conjugate meningococcal vaccine; Meningococcal serogroup X
Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by
      proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled
      with metformin alone.
    


Intervention name(s): Anagliptin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Anagliptin 100mg, tablet, twice a day (BID); Sitagliptin 100mg, tablet, once a day (QD)
Intervention MeSH terms: Sitagliptin Phosphate; Anagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CWP-0403; Sitagliptin; Metformin; type 2 DM
Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during
      elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata:
      neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.
    

Detailed description: 
      Few data are available in current literature about pharmacokinetics (PK) of antibiotics
      administered as surgical prophylaxis to children scheduled for cardiac surgery with CPB. In
      particular, vancomycin PK during CPB has been studied only in small case series, whereas no
      specific study has been conducted, so far, in the specific setting of children receiving
      cefoxitin during CPB.

      CPB affects patients' volemia and drugs PK is eventually altered. On the other side during
      and after surgery for heart defects, many risk factors may decrease renal and hepatic
      clearance, including altered renal perfusion, use of vasoactive agents, and use of
      concomitant nephrotoxic medications.

      Primary Objective of the study will be:

      • To study the pharmacokinetic profile of vancomycin and cefoxitin administered, as
      antibiotic prophylaxis to children undergoing elective CPB.

      Secondary Objectives will be:

        -  To evaluate if a significant difference in blood levels will occur in the four
           predetermined patients' categories.

        -  To evaluate the role of hemodilution during CPB on studied antibiotics' serum
           concentration

        -  To verify the incidence of post-operative infections in the studied population with
           particular attention to sensitive bacteria

        -  To evaluate the impact of ultrafiltration in studied antibiotics' clearance

        -  To evaluate safety of the administered antibiotics This is a prospective monocentric,
           open label, not controlled clinical trial.
    

Intervention name(s): vancomycin pharmacokinetics; cefoxitin pharmacokinetics
Intervention type(s): Other; Other
Intervention description(s): vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations; cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
Intervention MeSH terms: Vancomycin; Cefoxitin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic
        prophylaxis with vancomycin and cefoxitin
      
Keywords: antibiotic prophylaxis; pharmacokinetics; cardiopulmonary bypass
The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer
Condition: Gastric Cancer; Complication,Postoperative; Complications; Gastrointestinal, Postoperative; Morality
MeSH terms: Stomach Neoplasms; Postoperative Complications
Study type: Observational [Patient Registry]

Summary: 
      Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is
      still the most effective treatment modality, depending on the stage and location. Despite
      many radiological, surgical and anesthetic innovations, serious complications such as
      anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to
      gastrectomy. Many clinical studies have been conducted to prevent and predict these
      complications.

      The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international
      normalized ratio (INR) and serum creatinine values were used to determine surgical risks in
      patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to
      the formula. The MELD-Na score is used to predict postoperative complications in
      non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score
      was later used to predict complications for surgical procedures other than liver surgery such
      as colorectal surgery.

      In this study, we aimed to investigate the importance of the Meld-Na score in predicting the
      perioperative and postoperative outcomes in patients with gastric cancer.
    


Intervention name(s): MELD-Na score
Intervention type(s): Other
Intervention description(s): MELD-Na scores will be compared between the groups
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing gastrectomy due to gastric cancer
Transcriptomic Profile of Endometrium in Different Histological Dating of Natural Cycle
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      At present, the evaluation criterion of endometrial receptivity is controversial. The
      development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for
      diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown
      that the window of implantation (WOI) is displaced in only a quarter of these patients and
      use of a personalized embryo transfer (pET) on the day designated by ERA improves
      reproductive performance with higher cost .what is known to the others'population? The
      morphological changes observed on histology for each specific day after ovulation were
      described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference
      of more than 2 days between the histologic dating and actual day after ovulation is
      considered to be ''out of phase''. But such pET studies according to the Noyes criterion are
      lacking . The aim of this study is to explore the transcriptomic profile of endometrial
      receptivity in different histological dating of natural cycle and its clinical application.
    


Intervention name(s): personal embryo transfer
Intervention type(s): Procedure
Intervention description(s): According to the histological dating and transcriptomic profile of endometrium of natural cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .
The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on 7 days after ovulation. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy. outcome of the FET cycle .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2
Condition: Diabetes Mellitus, Type 2; Glucose Intolerance; Vitamin D Deficiency
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Vitamin D Deficiency; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if treatment with vitamin D increase beta cell
      function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes
      mellitus type 2.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral drops 30000 IU weekly; Matching placebo
Other intervention name(s): Vigantol oil
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluating an eHealth Solution for Screening in Pediatric Care
Condition: Pain; Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will evaluate the predictive validity of a game-based screening system based on
      child self-report measures.

      The core study hypotheses are that (1) in-game assessments will predict problematic recovery
      (child pain and posttraumatic stress symptoms [PTSS]) and (2) parents in the intervention
      group will report greater confidence in managing child recovery.
    

Detailed description: 
      This study will evaluate the predictive validity of a game-based screening system based on
      child self-report measures.

      The core study hypotheses are that (1) in-game assessments will predict problematic recovery
      (child pain and PTSS) and (2) parents in the intervention group will report greater
      confidence in managing child recovery.

      Study Design:

      This study is a randomized controlled trial that will examine validity of eScreen measures
      (primary aim) and assess the impact of the eScreen system on parent confidence in managing
      child symptoms and recovery (secondary aim).

      At T1, after baseline assessment (questionnaires), children will be randomized to the usual
      care plus eScreen (eScreen) or usual care alone (Usual Care) groups. In the eScreen group,
      children will use the game-based screening component and parents the parent information
      component for 6 weeks. All participants will complete follow-up research assessments by
      phone, online, or mail at T2 (6 weeks) and T3 (12 weeks). Following their T3 research
      assessment, child participants in the Usual Care group will have the option to play and
      provide feedback on the game (with no in-game assessment and no parent information
      component).
    

Intervention name(s): eScreen system
Intervention type(s): Behavioral
Intervention description(s): The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Kinesiophobia
Study type: Observational

Summary: 
      Objective: The aim of this study is to examine the relationship between kinesiophobia, pain,
      functional status and self efficacy in patients with knee osteoarthritis.
    

Detailed description: 
      Material and Methods: The study was performed on 72 individuals diagnosed with Stage 2 and
      Stage 3 knee osteoarthritis according to the Kellgren Lawrence classification. The Tampa
      Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia, and the Visual Analogue
      Scale (VAS) was used to assess pain. The Western Ontario and McMaster Universities Arthritis
      Index (WOMAC) was used to asses the functional status. Self efficacy was assessed using the
      Arthritis Self Efficacy Scale (ASES).
    

Intervention name(s): Kellgren Lawrence classification
Intervention type(s): Diagnostic Test
Intervention description(s): The Kellgren Lawrence classification was used in the radiological evaluation. It is a classification method used in the staging of knee osteoarthritis. Five stages were defined according to the anteroposterior X-ray.(Stage 0-5)
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
      
Keywords: Knee; Osteoarthritis; Kinesiophobia; Pain; Functional Status; Self Efficacy
Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1
      study. Sixteen subjects in two groups (at least 40% of subjects of either male or female
      sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to
      100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending
      doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60
      mg, 80 mg, and 100 mg.
    


Intervention name(s): ACT-128800; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ACT-128800