bioihbjkbjnl/mcl2 huggingface dataset:
Microparticles in Cirrhosis and Portal Hypertension
Condition: Liver Cirrhosis; Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional

Summary: 
      research on interactions between portal hypertension and microparticles
    

Detailed description: 
      It has already been shown that increased certain markers of stress, such as prolonged
      elevation of CRP in the absence of bacterial infection, increased free cortisol and serum
      copeptin, are associated with an excess of mortality in cirrhosis.

      MPs are membrane vesicles of variable size between 0.1 and 1 .mu.m, released into the
      extracellular space following activation or cellular apoptosis. MPs are also found in the
      circulating blood of healthy volunteers and their plasma levels rise in certain diseases to
      increased thrombotic risk, such as in cancer. Their membrane is composed of antigens whose
      organization is characteristic of the parent cell and negatively charged phospholipids,
      phosphatidylserines, conferring pro-coagulant properties to these MPs.

      Currently, work on the MPs are increasing following the discovery of their involvement in
      physiological processes such as proliferation, differentiation, cell activation and immune
      response but it is certainly their pro-thrombogenic power that was the most studied.

      Recent studies have also implicated MPs in the pathophysiology of chronic liver disease.
      Cirrhotic patients have elevated concentrations of MPs from leukocytes, endothelial cells and
      hepatocytes compared to control subjects, and concentrations of MPs increase with worsening
      liver function. Increasing MPs during the cirrhosis may be related on the one hand with a
      decreased clearance and secondly with an excess of proinflammatory cytokines by increasing
      the phenomenon of intestinal bacterial translocation. The assumption of the role of systemic
      inflammation in the training of MPs is reinforced by the existence of a significant
      correlation between the original MPs hepatocyte or buffy endothelial and CRP Thus, the
      increase in MPs observed with the increase of PH could increase the risk of thrombosis in
      intestinal microcirculation leading to enterocytic suffering from ischemic, reflected by an
      increase in serum concentrations of I-FABP ( intestinal fatty acid binding protein). This
      suffering enterocytes leads to increased intestinal bacterial translocation and ultimately to
      increased formation of MPs. These MPs could also worsen liver function by the same phenomenon
      of thrombosis in the hepatic microcirculation.
    

Intervention name(s): research on interactions between portal hypertension and microparticles
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
Condition: Eczema
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity
      and impaired quality of life due specially pruritus and physical visible skin lesions. The
      purpose of this trial is evaluate the effectiveness of two different topic associations of
      drugs.
    

Detailed description: 
      Study design:

        -  Experiment duration: 22 days

        -  2 visits (days 0,7,15 and 22)

        -  Reducing eczema area and severity index evaluation

        -  Adverse events evaluation

        -  Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.
    

Intervention name(s): polymyxin B sulphate + prednisolone + benzocaine + clioquinol; betamethasone + gentamicin + tolnaftato + cleoquinol
Intervention type(s): Drug; Drug
Intervention description(s): applied 3 times / day at lesion; applied 3 times / day at lesion
Intervention MeSH terms: Gentamicins; Polymyxins; Polymyxin B; Prednisolone; Betamethasone; Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dermatitis; Dermatitis, Atopic
Intraoral 30% Glucose Effect In Newborns
Condition: Epilepsy; Hydrocephaly
MeSH terms: Hydrocephalus
Study type: Interventional
Phase: Phase 3

Summary: 
      Newborn often sedated during MRI but sedation itself creates adverse events and management is
      more challenging in the MR environment. The investigators describe the investigators initial
      experience with oral 30% glucose administration through a pacifier during MRI for imaging of
      newborns. Using this technique, majority of newborns can complete MRI examination without the
      need for sedation and also offers the availability of administering sedatives to unsuccessful
      patients.
    

Detailed description: 
      19 consecutive newborns over 10 months period were assessed retrospectively. 0.5-1 mL 30%
      glucose solution was administered orally and after suckling, the motionless and sleepiness of
      newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of
      glucose was added. After 2 consecutive oral glucose administration the newborns who did not
      keep motionless or sleep and had motion artefacts sedated with midazolam. The outcome measure
      was the success of the procedure which was determined by providing qualitative images
      appropriate for interpretation following 30% glucose administration. The routine blood
      glucose level measurement of the newborns after imaging procedures in the ICU was also
      performed for each patient.
    

Intervention name(s): 30% Glucose; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): ORAL 30% GLUCOSE 0,5-2 ML; INTRAVENOUS 0.1 MG/KG MIDAZOLAM
Other intervention name(s): POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71; ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intraoral 30% glucose, newborn, MRI
Effects of a Physical Education Programme in Preschool Children
Condition: Motor Activity; Child Development
Study type: Interventional

Summary: 
      Unlike other European countries, Italian kindergartens do not include the physical education
      teacher in the school organic personnel. This is frequently associated with the lack of
      opportunities to perform physical education by preschool children. The aim of this study was
      to analyse the effects of a specific 16-week-long physical education programme (PEP) of
      16-week length on the development of locomotor and object control skills in preschool
      children.
    

Detailed description: 
      We conducted a school-based non-randomised controlled trial to evaluate the effect of a
      specific 16-week-long physical education program (PEP) on the quotient of gross motor
      development (QGMD) in preschool children. This study involved 119 children who were clustered
      in a control group (CG, n= 29, age: 52.1±8.65 months; height: 1.1±0.07 m, body weight:
      19.2±5.55 Kg, BMI: 16.9±3.16) and an intervention group (IG, n= 90, age: 57.4±9.42 months;
      height: 1.1±0.06 m, body weight: 19.3±3.65 Kg, BMI: 16±1.75). Participants were assessed for
      locomotor ability and object control skills using the Italian version of gross motor
      development test, before and after the experimental period.
    

Intervention name(s): physical activity
Intervention type(s): Other
Intervention description(s): Physical education program (PEP) of 16-week length
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sport; physical activity; education; fundamental motor skills; childhood; exercise; health; training; intervention; gross motor development
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients
Condition: Office Hysteroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain
      experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the
      ease of insertion of hysteroscope as reported by the hysteroscopist.
    

Detailed description: 
      hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during
      the removal of an intrauterine device or foreign body.Cervical ripening is made possible by
      the use of medication through different routes.The most commonly used agent is misoprostol,a
      synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use
      in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy,
      dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage,
      and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics
      for cervical ripening and the stimulation of uterine contractions to induce labor.
    

Intervention name(s): Dinoprostone 3Mg Vaginal Tablet; placebo vaginal tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.; 1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the relative bioavailability of two different batches of Frademicina® drug product,
      containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The
      formulations' comparative bioavailability after oral administration will be assessed based on
      the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the
      drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured
      by a proper and validated analytical method.
    


Intervention name(s): Lincomycin; Lincomycin
Intervention type(s): Drug; Drug
Intervention description(s): Single Dose Hard Gelatin Capsule - oral - 500 mg; Single Dose Hard Gelatin Capsule - oral - 500 mg
Other intervention name(s): Lincomycin Hydrocloride; Lincomycin Hydrocloride
Intervention MeSH terms: Lincomycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Lincomycin Hydrocloride
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet
      formulation for oral administration, using an intravenous microtracer approach with
      [14C]-labelled BI 1015550. These data are considered necessary to further support the
      understanding of the pharmacokinetics of BI 1015550.
    


Intervention name(s): BI 1015550; BI 1015550 mixed with [C-14]-BI 1015550
Intervention type(s): Drug; Drug
Intervention description(s): Treatment T; Treatment R
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Toric Contact Lens Performance Study
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This study seeks to quantify digital visual performance and subjective visual acceptance of
      toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.
    

Detailed description: 
      This is a prospective, single site, randomized, masked, crossover study. This study will
      evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and
      improve digital reading performance. Symptoms and objective near vision outcomes will be
      measured at baseline and after 1 week of wear with each correction.
    

Intervention name(s): Dailies Aqua Comfort Plus Toric; Dailies Aqua Comfort Plus Sphere
Intervention type(s): Device; Device
Intervention description(s): Daily disposable soft toric contact lens; Daily disposable soft spherical contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive
      study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo
      in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a
      8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment
      there will be an interim analysis.
    


Intervention name(s): Qizhitongluo Capsule; Naoxintong Capsule; Aspirin Enteric-coated Tablets; the routine recovery training; placebo
Intervention type(s): Drug; Drug; Drug; Behavioral; Drug
Other intervention name(s): QZTL group; NXT group
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Stroke,adaptive design, randomized, double-blind
Coagulation Disturbances in COVID-19 Septic Patients
Condition: Coagulation Disorder; COVID 19 Associated Coagulopathy; Sepsis; Septic Shock
MeSH terms: COVID-19; Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Objective of this study was to determine the relationship between CAC and septic condition in
      COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential
      Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings:
      platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP),
      fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular
      coagulation (DIC) score were recorded on the day of admission and on the day of starting of
      invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary
      outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill
      patients.
    


Intervention name(s): CAC in septic patients
Intervention type(s): Diagnostic Test
Intervention description(s): Data collected included demographic parameters, comorbidities, vasopressors requirement, laboratory findings, in-hospital mortality scoring and diagnostic colagulation scores. Demographic parameters were taken on the day of admission, all other variables were taken on the day of admission to the ICU and on the day of initiation of invasive mechanical ventilation or on the day of discharge from the ICU.
Demographic parameters included age and sex of the patient, followed by comorbidities which was marked with Yes or No on the day of admission in the ICU. Mortality was assessed according to the qSOFA score and vasopressor requirements on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge. Laboratory analysis included analysis of platelets, neutrophils, lymphocytes, PCT, CRP, fibrinogen, D-dimer on the day of admission and on the day of initation of invasive mechanical ventilation or on the day of discharge.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study was conducted in the COVID-19 Intensive Care Unit in the Department of
        Anesthesiology, Resuscitation and Intensive Care, Cantonal Hospital Zenica. Electronic data
        from 100 patients in 2021. were retrospectively analyzed after obtaining approval of the
        ethics committee of our hospital.
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to see if there's any difference in the amount of facial irritation when two
      acne products are used together on one side of the face, compared to one acne treatment
      product used alone on the other side of the face. All people participating in this trial will
      be required to return to the same study center every weekday for two weeks for the
      investigator to check for irritation on the face and to have the products applied - on
      weekends they will have to put them on at home. If one side of the face is more irritated
      than the other side, a picture will be taken as well.
    

Detailed description: 
      This is an investigator-blind, randomized, balanced study comparing two treatment regimens in
      a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and
      Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications,
      applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in
      a randomized scheme for two consecutive weeks. Subjects will return to the study center daily
      for evaluation and for application of both products (weekend applications will be done at
      home). At each visit the subject will be evaluated and scored for irritation and cutaneous
      treatment effects. Subjects presenting with differences in irritation between one side of the
      face and the other will be photographed and have chromometer readings taken. A single
      treatment center is expected to enroll at least 24 subjects.
    

Intervention name(s): Dapsone plus Tretinoin Gel; Tretinoin Gel
Intervention type(s): Drug; Drug
Intervention description(s): Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks; Tretinoin gel applied once daily to the assigned side of the face for 2 weeks
Other intervention name(s): Aczone Gel 5% plus Retin-A Micro Gel 0.1% Pump; Retin-A Micro Gel 0.1% Pump
Intervention MeSH terms: Dapsone; Tretinoin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Acne; Irritation
EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
Condition: Pancreatic Adenocarcinoma Non-resectable
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a
      prospective randomised trial in patients with inoperable PDAC.
    

Detailed description: 
      The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite
      of the advances in management of cancers in the last few decades. Endobiliary application of
      radiofrequency ablation (RFA) has been developed in our unit and used in patients with
      unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary
      obstruction. Various techniques of EUS-guided tumour ablation have been described, including
      RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic
      ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a
      19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis
      .
    

Intervention name(s): Endoscopic ultrasound guided radiofrequency ablation; chemoradiotherapy
Intervention type(s): Procedure; Radiation
Intervention description(s): Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.; Receive chemoradiotherapy
Other intervention name(s): EUS-RFA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pancreatic adenocarcinoma; radiofrequency ablation; Endoscopic ultrasound
Study of the Safety and Efficacy of Dietary Buglossoides Oil
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a
      rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between omega-3
      fatty acids found in other plants (such as flax) and those found in fish oils.

      The objectives of this study to collect safety data and to investigate the accumulation of
      long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation
      with Ahiflower oil in healthy adults.
    

Detailed description: 
      This is a single-center, randomized, comparator-controlled, double-blind study in healthy
      subjects. Forty subjects will be randomly assigned to 2 supplementation groups (n=20 per
      group). One group will consume 10 ml of Buglossoides oil daily and one group will consume 10
      ml of flax seed oil daily for a 4 week period. Baseline data will be obtained at week 0.
      Subjects will return to the clinic after 2 weeks and again after 4 weeks for measurement of
      safety and efficacy endpoints.

      The efficacy parameters are statistically significant changes from baseline and between
      groups in plasma, red blood cell and leukocyte omega-3 fatty acid content.

      The primary efficacy endpoint will be:

      Plasma EPA concentration expressed as μmol/L plasma.

      The secondary efficacy endpoints will be:

        1. Plasma 20:4n-3 and DPA individually as μmol/L;

        2. Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids;

        3. Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids;

        4. Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids;

        5. Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids;

        6. The omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations),
           expressed as % total fatty acids.

      Safety endpoints will be:

        1. fasting serum chemistry

        2. fasting hematology profile

        3. fasting blood lipid profile
    

Intervention name(s): Ahiflower oil; Flaxseed oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 9.73 ml per day for 28 days; 9.73ml per day for 28 days
Other intervention name(s): Buglossoides oil; Buglossoides arvensis oil; Linseed oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dietary vegetable oil; Stearidonic acid; Tissue; Fatty Acid; composition