Kornimate/medical-research-clean huggingface dataset:
use of ketamine vs methohexital for electroconvulsive therapy (ect) on patient recovery and re-orientation time

Conditions: Post-anesthesia Recovery; Orientation

Summary: when undergoing ect treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.

ect treatments are done under general anesthesia, and the induction is commonly done with methohexital. we will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.

Eligibility criteria:
inclusion criteria: * all patients eligible for ect with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - patients must have decisional capacity and must be able to consent for this study. exclusion criteria: * patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an american society of anesthesiologist (asa) status of greater than 3; * patients with a known allergic reactions to methohexital , ketamine and succinylcholine; * patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension; * patients with uncontrolled severe hypertension.

Keywords: orientation post-anesthesia recovery electroconvulsive therapy
a study for efficacy of side-by-side compared to stent-in-stent technique in the endoscopic management of malignant hilar biliary obstruction

Conditions: Cholangiocarcinoma; Gallbladder Cancer; Pancreatic Cancer; HCC; AOV Cancer

Summary: malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gb cancer, and pancreatic cancer. in biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (sems) for palliation is the therapy of choice in these patients. on hilar biliary malignant obstruction, bilateral stent used to be inserted. there are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (stent in stent vs. side by side) previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. biliary drainage and stent patency was a little superior in side by side than stent in stent. but, complication related with bilateral metal stent was increased in patients with side by side method. another study showed that there was no significant difference between those bilateral stent insertion methods. the most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial. the purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized m type) compared to stent in stent method (10mm sized lcd type) in patient with hilar malignant biliary obstruction.


Eligibility criteria:
inclusion criteria: * pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction * older than 20 years old exclusion criteria: * operable case * non-hilar biliary malignant obstruction * duodenal obstruction * other cancer except biliary malignancy * uncontrolled infection status * eastern cooperative oncology group ≥ 3 * no signed informed consent * failed endoscopic approach to duodenum or biliary tract

Keywords: hilar malignant biliary obstruction bilateral metal stent stent in stent side by side
efficacy of endothelin receptor antagonism in coronary artery spasm

Conditions: Coronary Spasm

Summary: the goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation cft (fucft) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index cft) and ongoing angina(-like) complaints. participants will * use either endothelin receptor antagonist or placebo for 10 weeks * undergo follow-up acetylcholine spasm provocation test after 10 weeks * answer online questionnaires on angina and quality of life


Eligibility criteria:
inclusion criteria: 1. definitive diagnosis of epicardial vasospasm on maximal acetylcholine dose of 100µg (at icft) 2. at least 18 years of age 3. on optimal regular care ( current or previous treatment with at least 2 daily anti-anginal medicines i.e. nitrate and calcium channel blocker 4. continuing episodes of angina(-like) complaints at least once weekly despite 3. 5. signed online informed consent for participation in nl-cft registry (the netherlands registry of invasive coronary vasomotor function testing), or willing to co-sign for registry at time of inclusion in edit-cas 6. written informed consent for edit-cas exclusion criteria: 1. systolic blood pressure (sbp) \<85 mmhg measured at visit 1 2. significant hepatic impairment at time of icft lab (asat/alat \>3x upper limit of normal (uln)) or history of liver cirrhosis (child-pugh 7-15) 3. severe anemia (hb\<6.0mmol/l) without identified cause at time of inclusion 4. patients with limited life expectancy (\<1 year) 5. participation in another randomized clinical study with an use of an investigational medicinal product (imp) up to one month prior to enrolment. 6. pregnancy, active desire to become pregnant or unwilling to take adequate\* contraceptive measures when of child bearing potential for the duration of 6 months (active medication period + 3 months safety). 7. known heart failure with reduced ejection fraction\<35% 8. known pulmonary hypertension of any type 9. potentially dangerous interaction due to the use of another cyp3a4 or cyp2c9 substrate (e.g. ciclosporin a, glibenclamide, fluconazole, rifampicin, tacrolimus/sirolimus, lopinavir/ritonavir) 10. repeat spasm provocation test deemed unsafe (e.g. allergic reaction at icft) * adequate in this case meaning if on hormonal contraceptives, additional measures to be taken (e.g. condom).

Keywords: epicardial spasm endothelin receptor antagonism angina
robotic assisted vs custom made total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the goal of this clinical trial is to compare robotic assisted, functionally aligned vs custom made total knee arthroplasty in patients with knee osteoarthritis. the main questions it aims to answer are: * which implant/philosophy yields better clinical outcomes? * which implant/philosophy yields better satisfaction? * which system is more or efficient? participants will be followed for 2 years postoperatively.


Eligibility criteria:
inclusion criteria: * - the patient is a male or non-pregnant female between the ages of 40 and 90 years * the patient requires a primary total knee replacement * patient is deemed appropriate for a cruciate retaining knee replacement * the patient has a primary diagnosis of osteoarthritis (oa) * the patient has intact collateral ligaments * the patient is able to undergo ct scanning of the affected limb * the patient has signed the study specific, ethics-approved, informed consent document * the patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations exclusion criteria: * - the patient has a history of total, unicompartmental reconstruction or fusion of the affected joint * patient has had a previous osteotomy around the knee * the patient is morbidly obese (bmi \> 41) * the patient has a deformity which will require the use of stems, wedges or augments * the patient has a varus deformity ≥ 15° * the patient has a valgus deformity \>3° * the patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device * the patient is unable to speak german * the patient is pregnant
follow up of patients after a visit to tourcoing emergency department for an ankle sprain

Conditions: Ankle Sprains

Summary: ankle sprain is very common. in france, its daily incidence is estimated at 6000. it often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. therefore, an early management and follow up treatment is necessary. now, functional treatment is clinically the treatment strategy of choice for ankle sprain. it is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). to evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.


Eligibility criteria:
inclusion criteria: consulted for ankle trauma as primary reason agreeing to participate in the telephone survey 6 weeks after trauma affiliation in a social security scheme exclusion criteria: patients deprived of liberty patients with an unbalanced psychiatric disease if consultation delayed 48 hours due to trauma patients with fracture patients with chopart or lisfranc injury pregnant women people who do not speak french

Keywords: inversion trauma ankle sprain physical examination therapy recurrence
evaluation of colorectal cancer screening strategies in china

Conditions: Colorectal Neoplasms

Summary: a large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in china.


Eligibility criteria:
inclusion criteria: * 50-74 years old * informed consent is available exclusion criteria: * previous colorectal cancer * previous colorectal resection * previous received cancer-related treatment (except non-melanoma skin cancer) * colonoscopy, sigmoidoscopy, ct colonoscopy, and barium enema were performed within 5 years * fecal occult blood or fecal dna was performed within one year * symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight - suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)
symptom burden guiding invasive electrophysiological study in paroxysmal supraventricular tachycardia

Conditions: Supraventricular Tachycardia

Summary: believe-svt is a european multi-centre, retrospective registry in tertiary hospitals performing electrophysiological study in patients with palpitations considered clinically suggestive of paroxysmal supraventricular tachycardia by a cardiologist and without electrocardiographic documentation of tachycardia or preexcitation. clinical characteristics, results of electrophysiological study and ablation, complications, and clinical outcomes during follow-up will be analysed.

the "symptom burden as guiding principle for invasive electrophysiological study in paroxysmal supraventricular tachycardia (believe-svt)" study was a multi-centre, retrospective, observational registry carried out in tertiary european hospitals. inclusion criteria were: symptoms that were considered suggestive of paroxysmal supraventricular tachycardia by a cardiologist and/or cardiac electrophysiologist; absence of any sort of electrocardiographic tracing during episodes (including wearables and other single lead devices), and having undergone an electrophysiological study aimed at the diagnosis of paroxysmal supraventricular tachycardia.

Eligibility criteria:
inclusion criteria: * symptoms that were considered suggestive of paroxysmal supraventricular tachycardia by a cardiologist and/or cardiac electrophysiologist * absence of any sort of ecg tracing during episodes (including wearables and other single lead devices) exclusion criteria: * documentation of preexcitation * prior electrophysiological study aimed at the assessment of ventriculo-atrial conduction or induction of supraventricular tachycardias.
an observational study of treatment patterns and effectiveness and safety outcomes in advanced basal cell carcinoma and basal cell carcinoma nevus syndrome patients(regisonic)

Conditions: Basal Cell Carcinoma

Summary: this multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. the total study duration is anticipated to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with basal cell carcinoma (bcc) who meet either of the following definitions: * patients who were determined with advanced disease (abcc) within 90 days prior to study enrollment, have not been diagnosed with basal cell carcinoma nevus syndrome (bccns) and have not been treated with an investigational or approved hedgehog pathway inhibitor * patients with abcc who have not been diagnosed with bccns and who were previously treated with vismodegib as part of genentech study shh4476g, shh4437g, or shh4811g (eap) * patients with bccns who either have abcc or multiple bccs of any stage as defined by protocol (may include patients previously enrolled in genentech study shh4476g, shh4437g, or shh4811g (eap)) exclusion criteria: * participation in a clinical trial within 90 days prior to study enrollment that has either involved treatment of abcc or involved treatment with an investigational or approved hedgehog pathway inhibitor, except for patients treated with vismodegib as part of genentech study shh4476g, shh4437g, or shh4811g (eap)
safety and immunogenicity study of tdap vaccinations for plasma donors

Conditions: Tetanus, Diphtheria and Acellular Pertussis Vaccination

Summary: the goal of this clinical trial is to investigate the safety and tetanus antibody response to a tdap vaccine in healthy plasma donors. the main question it aims to answer are: * is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years? * what is the tetanus antibody response over time in these donors after receiving the vaccine multiple times during the study? participants will receive a tdap vaccination every 3 months ±2 weeks for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. after obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (aes) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. as these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.


Eligibility criteria:
inclusion criteria: * male or female ages 18 to 63 years * females of childbearing potential who agree to employ highly effective birth control measures during the study * signed the informed consent form (icf) * met all of the criteria required to be a normal source plasma donor * subject is not participating in any other immunization program * subject has not had a tdap vaccination in the last 90 days before the first study vaccination exclusion criteria: * subject is pregnant * subject has a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data * subject has repeated reactions or hypersensitivity to components in the vaccine * subject has history of a severe reaction to any immunization * subject has a history of guillain-barré syndrome * the investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for ae assessment

Keywords: plasma plasma donor plasma donation hyperimmunization tetanus immunoglobulin
hypofractionated radiotherapy post-lumpectomy in women with node negative breast cancer

Conditions: Breast Cancer

Summary: to determine if hypofractionated radiotherapy to the whole breast (4,250 cgy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cgy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy. the primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.


Eligibility criteria:
inclusion criteria: 1. the female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease. 2. has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue. 3. patient has not had an axillary dissection, or for patients who have had an axillary dissection, all nodes are negative for metastatic disease. exclusion criteria: 1. tumour greater than 5 cm in greatest diameter on pathological examination. 2. the presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins. 3. clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer. 4. bilateral malignancy of the breast (synchronous or metachronous). 5. more than one primary invasive tumour in the same breast. 6. previous surgery for breast cancer. 7. pathological status of axilla is unknown. 8. status for adjuvant systemic therapy not determined. 9. for patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast. 10. for patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy. 11. serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment. 12. currently pregnant or lactating. 13. breast deemed too large to permit satisfactory radiation (ie. separation \> 25 cm). 14. previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \\fiin situ\\fr of the cervix which have been effectively treated. 15. geographic inaccessibility for follow-up. 16. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Keywords: breast cancer hypofractionated radiotherapy lumpectomy
the effect of losartan and losartan plus isosorbide mononitrate on central blood pressure measurements (0954-317)

Conditions: Hypertension

Summary: this study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.


Eligibility criteria:
inclusion criteria: * patient is in good health with the exception of mild to moderate hypertension * patient is willing to comply with the study restrictions * patient does not smoke exclusion criteria: * patient has a history of any illness that might confound the results of the study or make participation in the study unsafe * patient is taking a prescription medication that is contraindicated for use with cozaar® or imdur® * patient has a condition for which there is a warning, contraindication, or precaution against the use of cozaar® or imdur®
concussion pen screening tool

Conditions: Fixation, Ocular; Brain Concussion

Summary: to compare the use of the concussion pen to current clinical care practice. this will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). all subjects will undergo clinical evaluation for concussion and will also be evaluated using the concussion pen. randomization to being evaluated using clinical care first then the concussion pen and vice versa will be utilized. this randomization will help to control for evaluation fatigue on the part of study participants.

this will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). all subjects will undergo clinical evaluation for concussion and will also be evaluated using the concussion pen. all subjects (both controls and concussion patients) will undergo all eye tracking measurements. randomization to being evaluated using clinical care first then the concussion pen and vice versa will be utilized. this will be a multi-disciplinary team with members of physical therapy (pt)/ occupational therapy (ot), medical doctor (md), doctor of osteopathic medicine (do), and doctor of philosophy(phd)s who specialize in concussion assessment. this study will include a population of concussed patients as well as non-concussed patients (controls) who will be seen in cm clinics per standard of care.

Eligibility criteria:
inclusion criteria: inclusion criteria for both control and study cohorts, unless stated otherwise below * patients cognitively 11 to 18 years of age. * patients undergoing evaluation for concussion in children's mercy (cm) clinics for concussion population. * patients with a history of concussion at any previous point in time (no time limits to this date). * patients with no history of concussion and being seen at cm pt/ot for other diagnoses for control population. * patients able to give verbal assent or consent (dependent on patient cognitive age), and legally authorized representatives (lar)s able to give verbal parental permission. * english-speaking families. exclusion criteria: * patients not within the inclusion criteria as outlined above. * patients with congenital vestibular dysfunction will not be included. * patients diagnosed with dyslexia or attention deficit hyperactive disorder (adhd) will not be included. * non-english-speaking families. * wards of the state will not be approached for this study. * patients with a previous diagnosis of strabismus or convergence insufficiency will be excluded.

Keywords: ocular motor function concussion