Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of single port laparoscopic appendectomy in acute appendicitis

Conditions: Appendicitis

Summary: the aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. in addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. when compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. in this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Eligibility criteria:
inclusion criteria: * clinically diagnosed acute appendicitis exclusion criteria: * age less than 7 or more than 75 years old * gangrenous appendicitis * combined generalized peritonitis * asa score more than 3 point * pregnant women * cases requiring draining tube
validation of cagib score for in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding

Conditions: GastroIntestinal Bleeding

Summary: acute gastrointestinal bleeding is potentially lethal in liver cirrhosis. accurate assessment of prognosis is critical in a timely fashion. a novel model, cagib score, has been developed based on our chinese multicenter retrospective study. now, a prospective, international multicenter, observational study will be performed to further compare the performance of cagib versus child-pugh and meld scores for evaluating the in-hospital mortality of patients with liver cirrhosis and acute gastrointestinal bleeding.


Eligibility criteria:
inclusion criteria: 1. patients with liver cirrhosis; 2. patients with acute gastrointestinal bleeding presenting with hematemesis, melena, and/or hematochezia; 3. adults (age≥18 years old). exclusion criteria: 1. components of child-pugh, meld, and cagib scores are not available; 2. in-hospital outcomes are not evaluable.
negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections

Conditions: Postoperative Surgical Site Infections

Summary: the purpose of this study is to determine, in patients who undergo an elective colorectal resection through a midline laparotomy incision, whether the use of negative pressure wound therapy (npwt) applied to the site of the laparotomy compared to standard care alone, reduces the incidence of surgical site infection (ssi) in the first 30 days postoperatively. the investigators hypothesize that the use of npwt will reduce the rate of postoperative ssi, as well as decrease the need for nursing home care for ssi, length of hospital stay and return visits related to ssi.

the proposed trial will be pragmatic in nature whereby the investigators are trying to simulate usual circumstances to inform their everyday clinical decisions on the utility of negative pressure wound therapy (npwt). a prospective randomized open label blind endpoint (probe) trial design was chosen. all patients scheduled to undergo elective colorectal resections (crr) at london health sciences centre (lhsc) will be identified at the time of a pre-operative clinic visit with one of the 13 surgeons performing crr at their institution. included patients will be randomized to receive either usual care or usual care plus npwt. all patients will be followed for 30 post-operative days to identify the development of an ssi and other secondary outcomes. given the nature of the intervention, the surgeon and patients cannot be blinded to the intervention. outcome assessors and statisticians will be blinded to the patient's allocated group.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * planned elective colorectal resection (those that occur as a scheduled operation in the surgeons' planned operative list) exclusion criteria: * palliative colorectal resection where predicted remaining lifespan is likely less than 30 days * abdominoperineal resection or pelvic exenteration * known allergy/sensitivity to adhesive * cases in which there is a suspicion of bowel perforation * pregnancy

Keywords: surgical site infections colorectal resection negative pressure wound therapy
efficacy study of oxygenated glycerol triesters to treat xerostomia

Conditions: Xerostomia

Summary: the objective of the trial was to evaluate the efficacy and clinical safety and acceptability of oxygenated glycerol triesters in the relief of symptoms of xerostomia versus a reference comparator.

xerostomia is due to inadequate (hyposialia) or inexistent (asialia) saliva secretion. there are may causes. transitory xerostomia may occur in the presence of anxiety (stage fright, fear or dehydration). prolonged xerostomia is most often related to a systemic disease, certain medicines or to radiotherapy of the head or neck. salivation depends upon the autonomic (sympathetic and parasympathetic) nervous system for its production and on the central nervous system for stimuli-dependant excretion. substances acting on alpha an beta sympathetic receptors, whether agonists or antagonists, may induce hyposialia. atropine, the main antagonist of the parasympathetic system, is present in many medicines used for pulmonary, ophthalmic or neurological purposes, potentially causing hyposialia. similarly, imipramine antidepressants, phenothiazine neuroleptics, antihistamines and disopyramide predispose to the onset of hyposialia. xerostomia is often accompanied by buccal signs such as impaired sense of taste, halitosis and buccal ulcers and interferes with functions such as speech, chewing and swallowing. because of reduced salivary secretion , there is a disturbance of the microbial colonization of the buccal cavity. xerostomia has significant untoward effects on the buccal cavity and the quality of life of patients. the basis of the treatment of xerostomia involves the use of saliva substitutes and/or saliva stimulants. oxygenated glycerol triesters is neither a replacement for nor stimulant of saliva. it is a lubricant and protective solution for endobuccal spray.

Eligibility criteria:
inclusion criteria: * men or women over 18 years of age * with a diagnosis requiring the prescription of psychotropies (antidepressants, tranquilizers, etc) for more than 6 weeks * having received no palliative treatment for xerostomia for a minimum of the past 2 weeks * having xerostomia meeting the questionnaire selection criteria and the sialometer method parameters * patients legally competent to give their consent * capable of and accepting to participate in the trial and capable of and accepting to answer trial questionnaires exclusion criteria: * combined treatments incompatible with the trial, un particular alcoholic solutions * diabetes, any buccal condition requiring antimicrobial treatment * sjögren's syndrome or othermedical causes of xerostomia * current participation in other clinical trials * patient suffering from cancer * patients with allergy to or known intolerance of any of the constituents of the investigational products * patients treated with pilocarpine

Keywords: multicenter controlled parallel groups
residual sample collection for respiratory viral panel

Conditions: Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

Summary: collect de-identified, residual samples to support a clinical trial. samples may be prospectively or retrospectively collected. overall study objective obtain clinical performance data to characterize clinical performance of the respiratory viral panel on the genmark sample-to-answer platform.

the purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (ivd) respiratory viral panel on the genmark sample-to-answer platform. data obtained from the samples will be used to support premarket submissions/registrations for this genmark product. samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing. sample collection may be prospective or retrospective. prospective collection will preserve prevalence. retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. the sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.

Eligibility criteria:
inclusion criteria: * sample from patients exhibiting signs/symptoms of respiratory viral infection * all medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor. exclusion criteria: * samples that are incorrectly de-identified

Keywords: respiratory viruses
watchpat device validation study compared to polysomnography

Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep

Summary: validation study of a novel sleep device compared to a traditional sleep study.

this is an investigator-initiated validation study for the watchpat 200 device compared to the gold standard polysomnography procedure (sleep study). to evaluate the accuracy of the watchpat device compared to an in-laboratory polysomnogram (psg), measurements including obstructive apnea hypopnea index (oahi), apnea hypopnea index (ahi), oxygen desaturation index (odi) and other relevant sleep parameteres and indices will be compared. ultimately, the diagnostic agreement of the watchpat device in detecting between normal sleep and mild sleep apnea architecture will be assessed.

Eligibility criteria:
inclusion criteria: 1. age 5 through 12 years of age. 2. referral to the sleep lab due to concerns for obstructive sleep apnea (osa) and presenting with symptoms such as: * snoring, * witnessed apneas, * daytime sleepiness, and * mouth breathing, etc. 3. informed consent obtained. exclusion criteria: 1. medical conditions that can affect the tonometer reading such as: * peripheral vascular disease, * cyanotic heart disease, * systemic hypertension, and * sickle cell crisis. 2. medical conditions that can potentially limit tolerance of the watchpat 200 device such as: * autism spectrum disorder, * trisomy 21, and * neurodevelopmental disorders. 3. history of neuromuscular malformation 4. history of current supplemental oxygen use 5. history of current vasoactive, cardiac or seizure medication use 6. inability or unwillingness to provide informed consent

Keywords: polysomnogram sleep disordered breathing
echinacea angustifolia (anxiocalm) in anxiety

Conditions: Generalized Anxiety Disorder

Summary: this study evaluates whether echinacea angustifolia (anxiocalm) is a safe and effective treatment for mild to moderate generalized anxiety disorder (gad) symptoms. half the participants will receive echinacea angustifolia and half will receive placebo.

echinacea angustifolia root extract (anxiocalm), standardized for the content of echinacoside and its alkamide profile, is intended to be used for 'amelioration of sub-threshold and mild anxiety which are risk factors in the development of generalized anxiety disorder (gad) and depression' in symptomatic people 'who are not eligible for anxiolytic medication.' existing medical interventions, which require long periods of repeated administration, have significant safety concerns.

Eligibility criteria:
inclusion criteria: * men and women 18 years of age (all races and ethnicity) * meet diagnostic and statistical manual of mental disorders (dsm iv) any criteria for generalized anxiety disorder (gad from 5 to 9) * mild to moderate symptom severity on the beck anxiety inventory (bai from 8 to 15) * hamilton anxiety rating scale (ham-a) score from 14 to 17 * hospital anxiety and depression scale (hads-a) \[hospital anxiety and depression scale - anxiety subscale\] - 8-10 * participants score 45-57 points of above on either the state or trait anxiety subscale of the state and trait anxiety inventory of speilberger (stai) * able to understand and provide signed informed consent * able to participate in a 5-week study exclusion criteria: * any diagnosed dsm-iv axis ii disorder * current dsm iv axis i diagnosis of major depressive disorder in the 6 month that precede the study. \[to exclude confounding psychiatric factors\] * danger of suicidality * treatment with echinacea preparations in the 3 month that precede the study * psychotropic medication (especially anxiolytics) in the 3 month that precede the study * psychotherapy in the 3 month that precede the study * allergic reactions to plants of the asteraceae family (echinacea species, etc.) * treatment for aids or cancer * pregnant or lactating women * unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition) * alcohol or drug dependence within 3 months * allergy to echinacea preparation * allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum) * allergy to mugwort, radioallergosorbent test (rast), or birch tree pollen concurrent tranquilizer, antidepressant or mood stabilizer therapy; * subjects receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or ssri) * concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., chamomile, st. john's wort, kava kava) * women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc) * any other condition that precludes participation according to the judgement of the investigator

Keywords: echinacea, subthreshold anxiety
post marketing surveillance (pms) study of ryzodeg™ (insulin degludec/insulin aspart) in patients with diabetes mellitus in routine clinical practice in india

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in india.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. (study-related activities are any procedures that are related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g., hba1c (glycated haemoglobin ), fpg (fasting plasma glucose), pppg (postprandial plasma glucose), severe hypoglycaemia before the start of ryzodeg™ therapy) can be used for baseline data * patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with ryzodeg™ based on the clinical judgment of their treating physician exclusion criteria: * known or suspected allergy to ryzodeg™ any of the active substances or any of the excipients * previous participation in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * patients who are or have previously been on ryzodeg™ therapy * patients who are participating in other studies or clinical trials * patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
triplet (folfoxiri) vs. doublet (folfox or folfiri) regimen as a 1st line treatment in metastatic colorectal carcinoma

Conditions: Metastatic Colorectal Cancer

Summary: this is a prospective randomized phase ii trial was done in clinical oncology department at kasr alainy hospital, cairo university (nemrock) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes \& assess tolerance to the intensified treatment

patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio. patients were assigned to receive folfoxiri (experimental arm) or folfiri or folfox4 (control arm) biweekly up to 12 cycles. randomization was done by enclosed envelope method evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. in the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. in case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal

Eligibility criteria:
inclusion criteria: * patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease * no previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study * adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm * adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dl, serum bilirubin ≤ 1.5 mg/dl and ast, alt and alkaline phosphatase 2.5 x upper normal values or less. * patient had no co-morbidity disease exclusion criteria: * poor performance status 3-4 according to ecog score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female

Keywords: first line chemotherapy folfoxiri standard doublet efficacy toxicity
effects of remote ischaemic preconditioning in cemented hip arthroplasty.

Conditions: Osteoarthritis, Hip; Cardiovascular Diseases; Bone Cement Implantation Syndrome; Kidney Diseases

Summary: total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. the aim of this project is to elucidate whether remote-ischemic preconditioning (ripc) has multi-organ protective effect in cemented hip arthroplasty patients.

total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. cemented hip arthroplasty is strongly associated with bone cement implantation syndrome (bcis). it is characterized by hypoxia, hypotension and/or unexpected loss of consciousness occurring around the time of cementation, prosthesis insertion or reduction of the joint. it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. remote-ischemic preconditioning has shown kidney, myocardial and brain injury protective effect on non-cardiac surgery patients. the aim of this project is to elucidate whether remote-ischemic preconditioning (ripc) has multi-organ protective effect in cemented hip arthroplasty patients.

Eligibility criteria:
inclusion criteria: * age \>65 years * undergoing total hip cemented hip arthroplasty exclusion criteria: * previously diagnosed peripheral artery disease on both upper limb * ripc is contraindicated
endostar + gt in pulmonary metastases of soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this exploratory phase ii study is to assess the effectiveness and safety profile of endostar®(recombinant human endostatin injection) plus gemcitabine and docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.

anticipated 30 subjects will be enrolled to receive endostar, gemcitabine and docetaxel. endostar at a dosage of 7.5 mg/m2 will be administered on day 1-14 of each cycle. gemcitabine (1000 mg/m2) will be administered on day 1 and day 8 of each cycle. docetaxel (75 mg/m2) will be administered on day 2 of each cycle. an individual cycle of therapy will be defined as a 3-week (21-day) period. cycles will be repeated every 3 weeks. multiple cycles may be administered until the subject is pd or until a maximum of 6 cycles. time-to-progression (ttp) will be assessed using the kaplan meier method. overall response rate (orr) as well as individual categories of response (cr, pr, sd, and pd) will be determined using recist (v1.1). evaluation of 1- and 2-year overall survival will also be performed. safety measures will be recorded using the nci-ctcae (v4.0).

Eligibility criteria:
inclusion criteria: * age between 18-70 years, male or female. * ecog performance status \<=2. * life expectancy \>= 3 months. * histologically or cytologically confirmed soft tissue sarcoma (gist excluded). * patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen. * at least one measurable pulmonary metastasis tumor lesions according to recist 1.1 criteria. * laboratory values: hemoglobin (hb) \>= 90 g/l and no blood transfusion within 14 days, absolute neutrophil count (anc) \>= 1.5 x 10\^9/l, platelet (plt)\>= 80 x 10\^9/l, total bilirubin (tbil)=\ 50 ml/min (cockcroft-gault). * women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last imp administration. * willingness to participate in study and sign informed consent form. exclusion criteria: * females who are pregnant or breastfeeding or have childbearing potential unwilling to use effective contraception. * prior therapy with gemcitabine, docetaxel and endostar. * subjects participating in other clinical trials within 4 weeks before enrollment. * accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction. * uncontrolled central nervous system disorder or psychiatric illness. * current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment. * patients with abnormal bone marrow function: anc \< 1.5 x 10\^9/l, plt \< 75 x 10\^9/l, hb \< 90g/l. * patients with renal dysfunction: cr \> 1.5 x uln. * patients with liver dysfunction: tbil \> 1.5 x uln. * uncontrolled brain metastases. * unwillingness or inability to comply with the study protocol.

Keywords: soft tissue sarcoma pulmonary metastases
versailles hospital cardiac arrest registry

Conditions: Cardiac Arrest

Summary: out-of-hospital and in-hospital cardiac arrest (ca) requiring intensive care unit management. data collection using a standardized form : demographic data and data related to the ca according to the utstein guidelines.. circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures). on-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of ca. dates and times of eeg monitoring, eeg results. outcomes including vital status and cerebral performance category scale score at icu and hospital discharge, day-90 and 1-year after ca and determined based on data in the icu and/or hospital/neurologist charts and/or general practitionner phone interview.


Eligibility criteria:
inclusion criteria: * cardiac arrest requiring intensive care unit management * age \>= 18 years exclusion criteria: - refusal to participate