Kornimate/medical-research-clean huggingface dataset:
rapid diagnosis of antibiotic resistance in gonorrhoea

Conditions: Gonorrhoea

Summary: the purpose of this study is to develop a laboratory-based assay that will be a real-time pcr test to detect the organism n. gonorrhoeae and its most important genetic markers of antimicrobial resistance. this study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * participant is literate in german, french, english or hungarian. * participant is at risk for a n. gonorrhoeae infection. this is defined as: 1. exhibiting signs/symptoms of a n. gonorrhoeae infection. 2. having a sexual partner who has been diagnosed with a n. gonorrhoeae infection. 3. participating in high-risk activities for a n. gonorrhoeae infection. exclusion criteria: * subject does not agree to undergo diagnostic test for gonorrhoea.

Keywords: antimicrobial resistance point-of-care testing neisseria gonorrhoeae
folfirinox in patients with inoperable pancreatic cancer

Conditions: Adenocarcinoma of Pancreas

Summary: the prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. folfirinox therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. based on the folfirinox regimen for advanced pancreatic cancer, a phase ii study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas * patients must have measurable disease as defined by recist 1.1 recist evaluations must have occurred within 4 weeks prior to study entry * no evidence of hepatic or pulmonary metastatic disease by ct or ct/pet scans * male or non-pregnant and non-lactating female age \> or equal to 18 years and \< or equal to 70 years of age * patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer * patients must have adequate blood counts at baseline and blood chemistry levels * patient has ecog performance status 0 to 1 exclusion criteria: * patients with islet cell neoplasms excluded * patients with known brain metastases * therapeutic coumadin for a history of pulmonary emboli or deep vein thrombosis (dvt) * active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * known infection with hiv, hepatitis b or hepatitis c * major surgery or vascular device placement within 4 weeks prior to day 1 of treatment in study * prior chemotherapy or radiation for pancreatic cancer * history of allergy or hypersensitivity to the study drugs * patient is enrolled in any other clinical protocol or investigational trial * metastatic disease on radiological staging * prior malignancy within last 3 years * significant cardiac disease * any prior gastrointestinal (gi) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk * peripheral sensory neuropathy \> or equal to grade 2 at baseline

Keywords: locally advanced unresectable adenocarcinoma of pancreas borderline resectable adenocarcinoma of pancreas
blood and stool molecular biomarkers longitudinal detection study in crohn's disease (cd) patients

Conditions: Crohn's Disease

Summary: to evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.


Eligibility criteria:
inclusion criteria: 1. males and females with cd who are 18 years of age or older on the date of obtaining informed consent and are undergoing a colonoscopy at the study site. 2. the patient must have a confirmed diagnosis of cd based on results a complete medical evaluation and the assessment by a physician specialized in inflammatory bowel disease. 3. all cd patients should have no evidence for another active organic disease of the gi tract or medical problems as specified below in the exclusion criteria. 4. all patients must have a colonoscopic examination performed preferably on the same day as blood specimen is drawn, or blood may be drawn up to one week prior to colonoscopy. stool specimen will be collected prior to the beginning of bowel prep for the colonoscopy, up to 10 days prior to bowel prep. 5. understand the procedures and requirements of the study by providing written informed consent including consent and authorization for protected health information disclosure. exclusion criteria: 1. extensive small bowel resection or short bowel syndrome. 2. surgery for cd within the 6 months previous to enrollment. 3. receipt of any blood products within 3 months prior to study entry. 4. known pregnancy or breast feeding within 3 months of specimen collection. 5. recent history of viral or bacterial gastroenteritis including clostridium difficile infection \< 4 weeks prior to the blood draw 6. concurrent diagnosis of another currently active erosive gi mucosal disease such as erosive esophagitis, gastric or duodenal ulcer, celiac sprue, diverticulitis, etc. 7. history of intestinal or colorectal cancer, of active autoimmune diseases, or of other chronic uncontrolled systemic disorders 8. history of bowel prep within the past 3 months. 9. history of alcohol or substance abuse. 10. history of prior colectomy or stricturing disease that could limit colonoscopy examination of small bowel mucosa. 11. current ostomy or ileoanal pouch. 12. current or previous (of less than 4 weeks prior) participation in in a clinical trial for an investigational drug.
epidemiology of sars-cov-2 and mortality to covid19 disease in french cancer patients

Conditions: Cancer & COVID 19

Summary: to determine the prevalence and the 3-months incidence of sars-cov-2 in cancer patients (part a). to evaluate the covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (part b).


Eligibility criteria:
inclusion criteria: * all types of locally advanced and metastatic malignancy * male/female participants * age\>18 y.o. * signed informed consent for participation in the study * no restriction on eastern cooperative oncology group (ecog)/world health organization (who) performance status * subject should not have received a prior systemic anti-viral treatment for covid19 disease. exclusion criteria: * patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used. * severe hepatic impairment and patients with severe cholestasis. * patients with renal insufficiency with creatinine clearance \< 40 ml/min. * combinations of drugs contraindicated in accordance with the approvals of the specialties used. * patients currently treated with tamoxifen * patients already treated by hydroxychloroquine or azithromycin for covid19 disease or currently treated with other antiviral drugs against coronavirus. * patients with known contra-indication to treatment with the study drug, including retinopathy, g6pd deficiency, qt prolongation and severe hepato-cellular insufficiency. * patients post allogeneic hematopoietic stem cell transplantation are eligible to the part b treatments but the potential toxic effects of hydroxychloroquin and azithromycin on hematopoietic stem cells should be taken into consideration by prescribers. * pregnant or breastfeeding women. women of childbearing potential (wocbp, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
hepatic safety of raltegravir versus efavirenz as hiv therapy for patients with hiv and hcv coinfection

Conditions: Hepatitis C, Chronic; HIV Infection

Summary: the main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line hiv treatment in patients with hiv and hepatitis c coinfection.

the trial will recruit 80 treatment-naive hiv-infected patients with chronic hepatitis c coinfection from two hiv treatment centers in vietnam. patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line hiv therapy over a period of 72 weeks. the primary endpoint is the rate of alanine aminotransferase (alt) elevation during the 72 week study period. secondary endpoints include rates of virological suppression, cd4 count change, numbers of aids events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. patients will be followed monthly for the first 3 months and every 3 months thereafter. at the end of the trial period, patients will be transferred to the national hiv treatment program for continuation of hiv therapy.

Eligibility criteria:
inclusion criteria: * hiv infected patients, age \>18 years, meet vietnam guideline to begin art (cd4 count \< 350 cells/mm3 and/or who stage iii or iv disease) * hepatitis c infection as documented by positive hcv antibodies and a detectable serum hcv rna level * ast and alt ≤ 2 x uln (≤ 80 u/l) * estimated creatinine clearance ≥ 60 ml/min exclusion criteria: * any prior art * positive hepatitis b surface antigen * clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding) * requirement for acute therapy for other aids-defining illness within 14 days prior to study entry * currently on rifampicin therapy * in the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period

Keywords: hiv/hcv co-infection antiretroviral therapy
acupuncture for hemiplegic shoulder pain

Conditions: Shoulder Pain in Hemiplegic Side After Stroke

Summary: shoulder pain has been reported to be one of the most common complications after stroke. several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed. the aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (qol) for stroke patients.


Eligibility criteria:
inclusion criteria: * stroke within 6 months from onset * hemiplegia with shoulder pain (vas \> 2) exclusion criteria: * previous pathology of the shoulder or cardiac pacemaker, and cognition problems

Keywords: electroacupuncture tens shoulder disorder hemiplegia
comparison study of family practice interventions for depression in adults

Conditions: Depression

Summary: to determine if treatment of significant depressive symptoms identified in individuals attending a family practice improves either psychiatric outcome, overall health care costs, or quality of life (qol). two previously developed treatment approaches - an internet-based approach and a comprehensive depression pathway - will be compared to two control groups (those who have treatment as usual after screening for depression and measurement of qol, and a second control group who will have qol data only collected). the investigators hope to help alberta health services identify which approach is best as rapidly as possible so that the best approach can be implemented throughout the province of alberta.


Eligibility criteria:
inclusion criteria: * adults aged 18 and above * cognitively capable of independently understanding and confirming their desire to take part exclusion criteria: * 18 and under * cognitively incapable of independently understanding and confirming their desire to take part
otl38 for intra-operative imaging of folate receptor positive ovarian cancer

Conditions: Ovarian Cancer

Summary: this is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

the phase 3 study is to confirm the efficacy of otl38 in combination with fluorescent light to detect additional folate receptor-positive (fr+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with fr+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Eligibility criteria:
inclusion criteria: * female patients 18 years of age and older * have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and: * who are scheduled to undergo laparotomy for the debulking surgery or * who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy * a negative serum pregnancy test at screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential * female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion * ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments exclusion criteria: * previous exposure to otl38 * known fr-negative ovarian cancer * planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy. * patients with known ovarian cancer miliary disease determined preoperatively to be inoperable. * any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient * history of anaphylactic reactions * history of allergy to any of the components of otl38, including folic acid * pregnancy or positive pregnancy test * clinically significant abnormalities on electrocardiogram (ecg) * presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * impaired renal function defined as egfr\< 50 ml/min/1.73m2 * impaired liver function defined as values \> 3x the upper limit of normal (uln) for alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp), or total bilirubin. * known stage iv ovarian cancer with brain metastases * received an investigational agent in another clinical trial within 30 days prior to surgery * known sensitivity to fluorescent light
cellular immuno-therapy for covid-19 ards randomized clinical trial

Conditions: Covid19; Acute Respiratory Distress Syndrome

Summary: this is a phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (uc) mesenchymal stromal cells (mscs) in patients with covid-19 and acute respiratory distress syndrome (ards). randomized participants (n=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million uc-mscs) or blinded placebo. the msc product will be provided as 2.5 million cells/ml suspended in plasmalyte a containing 5% human albumin. the appearance-matched placebo product contains the same excipients, plasmalyte a and 5% human albumin, as the uc-mscs.


Eligibility criteria:
inclusion criteria: * age of ≥18 years * laboratory-confirmed sars-cov-2 infection during the current admission * on invasive, non-invasive mechanical ventilation (niv) (peep ≥5 cmh20) or high-flow nasal canula (hfnc) oxygen therapy (minimum total flow rate of 40 lpm) * ards (onset \<96h) as per the international consensus definition (p/f ratio \< 300 with peep ≥5cm h20 or on hfnc), not due primarily to cardiac causes. exclusion criteria: * no consent/inability to obtain consent * rockwood clinical frailty score \> 4 * moribund patient not expected to survive 24 hours * any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% * currently receiving extracorporeal life support * pregnant or lactating * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * moderate to severe chronic liver disease (childs-pugh score \> 12) * severe chronic respiratory disease with a baseline paco2 \> 50 mm hg or the use of home oxygen * documented deep venous thrombosis or pulmonary embolism within the preceding 3 months * inability/contra-indications to receiving local standard of care thromboprophylaxis * chronic immunosuppression (any chronic immunotherapy including daily oral steroid use \>6months) * known hiv, hep b/c positive, or active tuberculosis * multisystem shock (sofa score change from baseline of \>2 in \>2 systems) * patient, surrogate, or physician not committed to full support including intubation (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
a study of three drug combination therapies in hiv-infected patients who have never been treated with anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to hiv-infected patients who have never been treated with anti-hiv drugs.

in this open-label, strategic study patients are evaluated at weeks 0, 1, 2, 4, 8, 12 to week 48 after being treated on one of the following regimens: stavudine (d4t) + didanosine (ddi) + lamivudine (3tc) or d4t + ddi + indinavir or d4t + ddi + nevirapine.

Eligibility criteria:
inclusion criteria patients must have: * diagnosed asymptomatic hiv infection. * hiv-1 rna greater than 500 copies/ml. * cd4+ t-cell count greater than 200/mm3. * never received antiretroviral therapy. exclusion criteria co-existing condition: excluded: severe non-hiv-related disease. patients with the following prior conditions are excluded: history of neuropathy. prior medication: excluded: * investigational drug within 1 month prior to study. * immunomodulatory drug within 1 month prior to study. prior treatment: excluded: * radiation therapy within past month. * chemotherapy within past month.
clinical evaluation of a cochlear implant sound processor

Conditions: Hearing Loss; Ear Diseases; Hearing Disorders; Otorhinolaryngologic Diseases

Summary: this is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a hiresolution bionic ear system (hires 90k or newer). subjects will be assigned to one of two cohorts based on audiometric results at the baseline visit

the overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a q90 processor.

Eligibility criteria:
general inclusion criteria: * ability to provide informed consent * 18 years of age or older * unilateral user of a hiresolutiontm bionic ear system (hires 90ktm, hires 90ktm advantage, hirestm ultra, hirestm ultra 3d), including bilaterally implanted subjects that only use one implant in their everyday listening modality * minimum of 6 months of ci experience * having used a naída ci q70 or a naída ci q90 as their primary processor for a minimum of one month * presently using a current steering strategy * at least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the azbio in quiet test using the naída ci q90 research processor * english language proficiency as determined by the investigator * willingness to use a bte processor for the duration of the study arh arm inclusion criteria * residual low frequency hearing sensitivity (pure tone average of \< 70 db hl for 125, 250, and 500 hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 db hl for 1,000, 2,000, 3000, 4,000, and 8,000 hz) in the implanted ear * willingness to use an in-canal acoustic earhook for the duration of the study eo arm inclusion criteria • severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 db hl for 125, 250, and 500 hz) and high frequencies (pure tone average ≥ 70 db hl for 1,000, 2,000, 3000, 4,000, and 8,000 hz) in the implanted ear exclusion criteria: * unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator * unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator