Kornimate/medical-research-clean huggingface dataset:
efficacy of pancrelipase on postprandial belching and bloating.

Conditions: Postprandial Bloating; Postprandial Belching; Postprandial Eructation

Summary: the hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.

subjects will complete a double-blind crossover study in which, for one week periods, they will receive two pancrelipase tablets with each of the three major meals or a similarly administered identical placebo. three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.

Eligibility criteria:
inclusion criteria: * subjects will have either bothersome upper abdominal discomfort, bloating (feeling of abdominal distention) or belching following meals for at least 12 month's duration. subjects must have had a normal upper gastrointestinal endoscopy and/or upper gi series during the preceding three years. exclusion criteria: * individuals with a history suggestive of organic disease such as recent weight loss, nausea, vomiting, gerd, recent changes in bowel habits will be excluded from the study.

Keywords: pancrelipase abdominal bloating abdominal pain eructation
blurring strength & aberrometric changes following corneal cross-linking (cxl) and cxl combined with photorefractive keratectomy (prk) in keratoconus

Conditions: Keratoconus

Summary: primary objective of this study was to assess the impact of the two prevalent therapeutic options, cxl and cxl combined with topography-guided photorefractive keratectomy (t-prk), on both anterior and posterior corneal high order aberations (hoas).

the pentacam classic (oculus optikgerate gmbh, heidelberg, germany, software version 1.14r04) was used for the sake of the study.32 patients with keratoconus were included in the study. of them, 19 patients underwent cxl treatment (cxl group), while the rest 13 patients underwent cxl combined with t-prk (tcxl) \[tcxl group\]. if both eyes were eligible, only one eye was enrolled in the study.regarding scheimpflug camera (pentacam classic, oculus optikgerate gmbh, heidelberg, germany, software version 1.14r04 ) measurements, acceptable maps had at least 10.0mm of corneal coverage. moreover, images with extrapolated data in the central 9.0mm zone were excluded. for both anterior and posterior corneal surfaces, pentacam-derived hoas parameters for both pupil diameters of 4mm and 6mm were calculated, as well as the hoa root mean square (rms)values. pentacam-derived hoa measurements were obtained one day prior to treatment and then one year post-op.the impact of the surgical technique (either cxl or tcxl) on spherocylindrical error was evaluated by power vector analysis as described before. furthermore, manifest refractions comprising of sphere (s), cylinder (c) and axis (φ), were converted into three dioptric powers (m, j0 and j45). moreover, we calculated the overall blurring strength (b) of the spherocylindrical error by measuring the length of the produced vector.

Eligibility criteria:
inclusion criteria: * progressive keratoconus exclusion criteria: * glaucoma or suspicion for glaucoma, * central corneal thickness (cct) less than 400μm, * k-readings more than 60d, * history of herpetic keratitis, * pregnancy or nursing, * underlying autoimmune disease

Keywords: keratoconus cxl cxl combined with t-prk
percutaneous dilatational tracheostomy: ultra-perc versus ciaglia blue dolphin

Conditions: ICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients

Summary: the aim of this study is to compare ultra-perc single stage dilator technique with ciaglia blue dolphin ballon dilatation technique for intubated unweanable icu patients with respect to procedure difficulties and complications.

the investigators conducted a prospective randomized trial to compare ultra-perc single stage dilator technique (up) and ciaglia blue dolphin ballon dilatation technique (cbd) from january 2013 to december 2015. the investigators compared the two groups as regards procedure difficulties including difficult dilatation, difficult tube insertion, failed tube insertion, false passage and tracheal stoma over dilatation. and procedure complications including cardiac arrest, pneumothorax, pneumomediastinum, subcutaneous emphysema, hemorrhage and lung atelectasis.

Eligibility criteria:
inclusion criteria: * sepsis * cerebrovascular accidents * cervical cord injury * traumatic brain injury * post arrest and chronic obstructive pulmonary disease exclusion criteria: * patient or family refusal * emergency tracheostomy * distorted abnormal anatomy * bleeding diathesis * morbid obesity * previous tracheostomy * infected surgical site * adult respiratory distress syndrome patients requiring high positive end expiratory pressure and high oxygen demands
r1vascular hepatectomy for hcc patients

Conditions: Hepatocellular Carcinoma

Summary: since the previous decade, the authors introduced the r1 vascular (r1vasc) resection for the treatment of hepatocellular carcinoma (hcc), and colorectal liver metastases (torzilli et al. j am coll surg 2005; viganò et al. ann surg oncol 2016; torzilli et al. surgery 2017). however, oncological reliability of tumor exposure in surgery for hcc remains controversial since it has never been validated. the aim of the study is to determine the oncological adequacy of r1vasc hepatectomy in patients with hcc.

a prospective cohort of patients who underwent hepatectomy for hcc between january 2005 and december 2015 is reviewed. the following definitions are adopted: r0 is any resection with at least 1 mm of negative margin; r1vasc is any resection with tumor exposure due to the detachment from major intrahepatic vessel (1st/2nd order glissonean pedicles and hepatic vein at caval confluence); r1-parenchymal (r1par) is any resection with tumor exposure at parenchymal margin.

Eligibility criteria:
inclusion criteria: * only patients with a primary untreated hcc were included; * complete follow-up data with available computed tomography (ct) and/or magnetic resonance imaging (mri) images showing the first recurrence exclusion criteria: * patients who underwent vascular resection for direct infiltration of the vessel wall * patients who had radiofrequency ablation in association to surgery
efficacy and safety of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma

Conditions: Esophageal Superficial Mucosal Lesion

Summary: to evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.

this multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in esd of superficial esophageal squamous cell carcinoma (escc). specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for esd with indication of escc.

Eligibility criteria:
inclusion criteria: * ≥18 years; * biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (hgin)which were eligible for conventional esd indications; * suspected localized mucosal lesions detected by endoscopy. exclusion criteria: * malignancy or other advanced disease with a life expectancy of \< 6 months as judged by the investigator. * the asa classification of physical status ≥ 4 as judged by the investigator. * severe hepatic disease or renal disease * ability to understand and the willingness to sign a written informed consent document. * major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. * haemorrhagic disorder. * patients who had a history of esophagectomy or a recurrent lesion. * planned treatment with: warfarin (including other vitamin k antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine. * pregnancy, planned pregnancy or lactation. women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. * known or suspected alcohol, drug or medication abuse. * any condition associated with poor compliance as judged by the investigator. * participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. * involvement in the planning and conduct of the study. previous enrollment in the present study

Keywords: endoscopic submucosal dissection endoscopic submucosal tunnelling dissection procedure time
benidipine in hypertensive and/or chronic coronary syndrome patients

Conditions: Chronic Coronary Syndrome; Hypertension; Angina Pectoris

Summary: evaluation of the clinical outcomes of benidipine initiated by physician's preference in patients with hypertension and/or angina pectoris (chronic coronary syndrome) presenting to cardiology outpatient clinics in turkey.

* benidipine is a dihydropyridine calcium channel blocker used in the treatment of hypertension and angina pectoris. there are currently no large-scale observational studies in these patient groups in turkey. * there is no record of benidipine in clinicaltrials.gov, which is an important database especially for the registration of drug and interventional studies. * therefore, it will be extremely important to include this study in clinicaltrials.gov and to evaluate the clinical efficacy of bendipine in patients with hypertensive and/or angina pectoris in 7 geographical regions of turkey.

Eligibility criteria:
inclusion criteria: * patients with hypertension and/or angina pectoris on the background of chronic coronary syndrome who have been receiving benidipine treatment for at least 1 month and will continue to receive benidipine treatment * male or female outpatients, 18-80 years of age * patients with mild to moderate essential hypertension who have been receiving or will continue benidipine treatment for at least 1 month * outpatients with clinically stable angina pectoris and patients who have been receiving or will continue benidipine treatment for at least 1 month * those who signed the written informed consent form exclusion criteria: * patients with secondary hypertension * emergency hypertensive patients * having to take other medications during the study that may affect blood pressure * allergic to dhp calcium antagonists * evidence of decompensated congestive heart failure, unstable angina or severe arrhythmia * severe renal or hepatic dysfunction * pregnant or lactating women * participation in other clinical trials within 3 months prior to this study * patients who did not sign the consent form of the study

Keywords: coronary artery disease hypertension angina pectoris
efficacy and safety of neoadjuvant sintilimab plus flot versus sintilimab plus sox phase ii clinical trial for patients with locally advanced gastric cancer

Conditions: Neoadjuvant Chemotherapy; Sintilimab; Locally Advanced Gastric Cancer

Summary: this study aims to investigate the efficacy and safety of sintilimab combined with folt versus sintilimab combined with sox in patients with locally advanced gastric cancer. the research design is intended to observe the comparison of conversion therapy effects, disease-free survival, r0 resection rate, and safety evaluation between the two groups.


Eligibility criteria:
inclusion criteria: * 1. age \>=18 years and \<100 years. * 2. diagnosed with locally advanced gastric cancer. * 3. eastern cooperative oncology group ecog ps score 0-1. * 4. adoption of preoperative chemotherapy treatment and pd-1 antibody therapy. * 5. deficient mismatch repair identified by pathological detection. exclusion criteria: * 1. locally advanced unable to resect or metastatic tumors. * 2. patients with recurrence of residual gastric cancer * 3. patients refusing surgical resection after preoperative chemotherapy therapy. * 4. have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment. * 5. patients with confirmed allergy to the study drug and/or its excipients. * 6. severe malnutrition and active autoimmune diseases. * 7. pregnant or lactating women. * 8. patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy. * 9. patients with acute infections requiring antibiotic treatment. * 10. patients with acute infections requiring antibiotic treatment. * 11. patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial. * 12. positive test result for hepatitis b or hepatitis c virus. * 13. untreated central nervous system metastatic peripheral neuropathy (\>grade 1). * 14. history of malignancy within the past 5 years (with the exception of curative, localized cancer). * 15. patients who are not expected to achieve r0 resection. * 16. weight loss greater than or equal to 20% within 4 weeks before the first dose. * 17. patients with multiple factors affecting oral medication. * 18. vaccination within 4 weeks prior to the first dose of study drug. * 19. patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled. * 20. the investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
the impact of an art and philosophy-based intervention on children's eco-anxiety

Conditions: Eco-anxiety; Psychological Distress; Tolerance to Distress; Hope; Mental Health

Summary: objective: to examine the impact of climate change on children's mental health by comparing the effectiveness of an arts only intervention (abi) and an arts and philosophy-based intervention (apbi) on children's eco-anxiety, tolerance to distress and hope for the future in school settings. the investigators hypothesized that the children assigned to the combined arts and philosophy intervention would show reductions in self-reported eco-anxiety, as well as increases in tolerance to distress and hope for the future in the context of climate change, when compared to children assigned to the arts-only intervention. setting: this study is conducted in public primary schools from england. participants: participants are students in grades 3 to 6. main outcomes and measures: the primary outcome is self-reported eco-anxiety scores. secondary outcomes are self-reported tolerance to distress, hope for the future and mental health (depression and anxiety symptoms).


Eligibility criteria:
inclusion criteria: * being an elementary school student exclusion criteria: * not being an elementary school student

Keywords: art-based interventions philosophical inquiry eco-anxiety children schools mental health
a safety and tolerability study of medi-570 in systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the safety and tolerability of medi-570 in adult subjects with moderately to severely active systemic lupus erythematosus (sle).

this is a phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of medi-570 in adult subjects with moderately to severely active sle.

Eligibility criteria:
inclusion criteria: * meet or have met at least 4 of the 11 revised american college of rheumatology (acr) classification criteria for systemic lupus erythematosus (sle) * score greater than or equal to (\>=) 6 points on the systemic lupus erythematosus disease activity index 2000 (sledai-2k) at screening * ability to complete the study period, including follow-up period through day 169 * willingness to forego other forms of experimental treatment during the study. exclusion criteria: * history of cancer except basal cell carcinoma treated with apparent success with curative therapy \>=1 year before randomization into the study * evidence of active or latent tuberculosis (tb) * history of primary immunodeficiency * evidence of infection at any time with hepatitis b or c virus or human immunodeficiency virus (hiv)-1 or hiv-2, or active infection with hepatitis a, as determined by results of testing at screening * history of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before baseline visit) serious infection * any history or evidence of opportunistic infection within 6 months of screening including severe cytomegalovirus (cmv) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes) * receipt of cyclophosphamide (intravenous or oral) within 6 months of screening * have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.

Keywords: systemic lupus erythematosus sle medi-570
study to investigate lp352 in subjects with developmental and epileptic encephalopathies

Conditions: Developmental and Epileptic Encephalopathy; Dravet Syndrome; Lennox Gastaut Syndrome

Summary: the objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of lp352 in adults and adolescents with developmental and epileptic encephalopathies.

this is a randomized, double-blind, parallel-group, dose-escalation, placebo-controlled study of lp352 in adults and adolescents with developmental and epileptic encephalopathies (dee) with an average of ≥ 4 observed/countable motor seizures per 4-week period during the 12 weeks before screening while on stable antiseizure medicine (asm). subjects will be randomized 4:1 to lp352 or placebo. the study will have a baseline period of 28 days, followed by a 15 day up-titration period during which time subjects will titrate up to their highest tolerated doses, and a 60-day maintenance period. after day 75, subjects will be tapered down over a period of up to 15 days, with a follow-up visit 30 days after last dose. enrolled subjects will be allowed to continue treatment with up to 4 concomitant asms at a stable dose.

Eligibility criteria:
key inclusion criteria: 1. male or non-pregnant, non-lactating female, age 12 to 65 years 2. diagnosis of dravet syndrome, lennox-gastaut syndrome, or other developmental and epileptic encephalopathy 3. has a minimum number of seizures per 4-week period while taking 1 to 4 anti-seizure medications 4. all medications and epilepsy interventions must be stable for 4 weeks before screening and are expected to remain stable during the study 5. the patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed key exclusion criteria: 1. current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure 2. has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject 3. current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior 4. currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss 5. positive test result on the drug screen, except tetrahydrocannabinol (thc) for patients taking prescribed cannabidiol

Keywords: cdkl5 deficiency disorder developmental and epileptic encephalopathy dravet syndrome epilepsy lennox-gastaut syndrome treatment resistant epilepsy tuberous sclerosis complex
detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate

Conditions: Chlorhexidine; Intensive Care

Summary: recent meta-analysis have suggested that the safety of oral care with chlorhexidine in patients under mechanical ventilation could be questionable. whatever the hypothetical mechanisms involved (direct cellular toxicity, underdiagnosis of ventilator-associated pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the cornerstone of this potential side effect of the routine oral care with chlorhexidine gluconate. the demeter study assessing the medico-economical impact of the subglottic secretions drainage study (nct02515617) provides the opportunity to perform this proof of concept study (detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on this potential detection of chlorhexidine. this ancillary study will be performed in one of the centers participating to the demeter study.


Eligibility criteria:
inclusion criteria: * age over 18 years * invasive mechanical ventilation (mv) delivered via an endotracheal tube and mv required more than 72 hours * intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (ssd) will be available during the ssd period of the trial * information delivered exclusion criteria: * previous inclusion in the study * patients moribund at the icu admission * pregnant, parturient or breast-feeding woman * patient hospitalized without consent and/or deprived of liberty by court's decision * patient under guardianship or curators * lack of social insurance * concomitant inclusion in a trial on vap prevention * patient with no comprehension of the french language

Keywords: chlorhexidine gluconate oral care mechanical ventilation critically ill patients tracheal secretions subglottic secretions
pilot study of botox for migraine headaches

Conditions: Migraine Headache

Summary: the purposes of this study are to assess whether subjects treated with botox will: 1. have a decrease in the frequency and intensity of migraine headaches 2. experience improvements in quality of life 3. experience a reduction in the frequency of health care services obtained.


Eligibility criteria:
inclusion criteria: * subjects \> 18 years of age * subject has an established history of migraine headache, with or without aura, per ihs criteria (1.2.1 or 1.1), for at least 6 months prior to screening. * subject receives primary health care from park nicollet health services. exclusion criteria: * subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation. additional eligibility will be discussed at point of contact

Keywords: migraine headache botulinum toxin type a botox btx-a