Kornimate/medical-research-clean huggingface dataset:
mild versus moderate therapeutic hypothermia in out-of-hospital cardiac arrest patients

Conditions: Cardiac Arrest

Summary: this trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the university of ottawa heart institute (uohi). the plan is to expand the trial shortly as a multi-center project. the patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (ohca). the aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees celsius) versus mild (34 degrees celsius) therapeutic hypothermia (th) following return of spontaneous circulation (rosc) in patients suffering ohca, with rosc defined as the resumption of sustained perfusing cardiac activity. the primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.


Eligibility criteria:
inclusion criteria: 1. out of hospital cardiac arrest patient 2. return of spontaneous circulation 3. glasgow coma score equal or lesser than 8. exclusion criteria: 1. patients residing in a nursing home or patients unable to reside independently, 2. intracranial bleed responsible for the cardiac arrest, 3. severe coagulopathy with clinical evidence of major bleeding, 4. coma that is not attributable to cardiac arrest, 5. pregnancy, 6. life expectancy of \< one year due to any cause unrelated to the cardiac arrest, 7. known coagulation disorder (i.e. inr \>2.0, platelets \<100,000 / mm3), 8. participation in a study with another investigational device or drug \< four weeks, 9. the endovascular cooling (zoll) device is not available.

Keywords: therapeutic hypothermia out of hospital cardiac arrest mild hypothermia moderate hypothermia
evaluation of the performance of the cleanc system-israel

Conditions: Colorectal Cancer (CRC) Screening

Summary: the motus gi colon cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

the study aim to evaluate the post procedure cleansing level as measured by the boston bowel preparation scale (bbps). each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg bysacodyle followed by a colonoscopy procedure with the tested device.

Eligibility criteria:
inclusion criteria: 1. subjects in the age range of 18-75 years 2. subjects with bmi within the range of 18.5-35 3. subject is willing to sign informed consent form exclusion criteria: 1. active or severe inflammatory bowel disease (ibd) 2. subjects with severe diverticulitis \\ diverticular disease (known or detected) 3. known or detected colonic stenosis 4. known or detected bowel obstruction 5. history of prior colon surgery 6. asa≥iv (sever systemic disease) 7. sever renal insufficiency (creatinine≥1.5mg%) 8. sever liver insufficiency (alt/ast≥2unl) 9. contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent 10. pregnancy 11. subjects with altered mental status/inability to provide informed consent 12. subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
spinal anesthesia facilitated sexual intercourse as a treatment option for vaginismus

Conditions: Vaginismus

Summary: painful sex continues to be a relationship issue and can lead to marital dys-harmony. other consequences include infertility, low self-esteem, depression and anxiety.our study shows that spinal anesthesia is an effective last resort management option in women with vaginismus. as a one-off treatment spinal anesthesia provides hope for such couples and brings about a positive change in their relationships.


Eligibility criteria:
inclusion criteria: * virgin married women with non-consummation of marriage for more than two years due to vaginismus exclusion criteria: * partners reported erectile dysfunction * who had vulvar skin conditions (e.g. lichen sclerosus) * vulvovaginal and urinary tract infections * endometriosis.
laparoscopic revision gastric bypass for weight recidivism

Conditions: Weight Regain; Weight Recidivism; Obesity Recidivism; Clinically Severe Obesity

Summary: the main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision roux-en-y gastric bypass surgery for weight recidivism.

there is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. the treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. failure rates have been reported up to 20% and 35% for the morbidly obese (mo) and super obese (so), respectively at 2 to 3 years after surgery. the indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. therefore the approach to these patients must be as individualized as their original operations. we formally analyze our experience with all laparoscopic revisional strategies for weigh regain after failed gastric bypass.

Eligibility criteria:
inclusion criteria: * patients that underwent laparoscopic revisional "rygb" for failed "rygb" with weight recidivism or weight regain "wr" pattern exclusion criteria: * failed rygb with an inadequate initial weight loss "iiwl" pattern * patients with prior major bariatric conversion or esophago-gastric surgeries * rygb patients revised by an open surgical approach * rygb patients who underwent laparoscopic revisional rygb surgery somewhere else and continue their follow-up care with our program * missing records and/or unreachable patients with scant information for analysis

Keywords: obesity recidivism weight regain weight recidivism morbidity complication late complications revisional gastric bypass re-operative gastric bypass revisional bariatric surgery re-operative bariatric surgery
the impact of covid-19 pandemic stress on pregnancy outcomes

Conditions: Covid19

Summary: this study is aiming to evaluate the effects of the covid-19 pandemic stress on pregnancy outcomes including the sex ratio at birth.

* coronavirus disease 2019 (covid-19) is an emerging respiratory disease caused by a single-strand, positive-sense ribonucleic acid (rna) virus, severe acute respiratory syndrome coronavirus-2 (sars-cov-2) virus (masters, 2019). * the sex ratio (ratio of boys to girls) at birth (srb) is about 1.01-1.05 in most populations (abdoli, 2020). various influencing factors affect the srb, including maternal stress, endocrine disruption, maternal inflammatory responses and maternal nutrition (lipner et al., 2019). * these stressful life events consequently influence on maternal immunological and endocrine conditions, and the male fetuses are more vulnerable to be affected by these conditions. it is of interest that male fetus is biologically weaker and more susceptible to prenatal events and diseases than female fetuses. hence, premature death is higher in boys than girls (ahrenfeldt et al., 2017). * the recent pandemic of the coronavirus disease 2019 (covid-19) has been known to have various impacts on pregnant women (rasmussen et al., 2020). placentas of infected mothers show inflammatory, vascular and thrombotic changes (prochaska et al., 2020). among the neonates, children and adults (bjelosevic et al., 2017), higher morbidity and mortality of males than females were reported. it is observed that the incidence of stillbirth was significantly increased during the pandemic period than during the pre pandemic period in london, uk (khalilet al., 2020). * the start of appearance of covid 19 cases in egypt was in march 2020, with subsequent increase in cases with its peak in may, june and july 2020, with lockdown and social and financial affection with great stress on families

Eligibility criteria:
inclusion criteria: - 1. all pregnant women attended to the women health hospital in a period from january 1st 2019 to december 31st 2019 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies. 2. all pregnant women attended to the women health hospital in a period from may 1st 2020 to december 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management. exclusion criteria: * 3. pregnant women attended to the women health hospital in a period from april 1st 2020 to december 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management who conceived before april 1st 2020
real-world outcomes of patients with her2+ metastatic breast cancer after treatment with trastuzumab deruxtecan

Conditions: HER2-positive Breast Cancer

Summary: this study will explore treatment patterns and clinical outcomes using the us-based flatiron health database to describe patients with her2+ mbc who were previously treated with t-dxd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.

this study will utilize a longitudinal, demographically and geographically diverse database derived from electronic health record data. no study medication will be supplied or administered for this protocol. the primary research objective is to describe the real-world progression-free survival (rwpfs) in her2+ mbc patients who initiated a subsequent line of therapy (lot) after a t-dxd-containing lot in the metastatic setting. secondary research objectives include describing the real-world overall survival (rwos), patient demographics and clinical characteristics, real-world time to next treatment (rwttnt), and real-world time to treatment discontinuation (rwttd) in her2+ mbc patients who initiated a subsequent lot after a t-dxd-containing lot in the metastatic setting. treatment patterns and sequencing in her2+ mbc patients for subsequent lots following initial treatment with t-dxd will also be assessed.

Eligibility criteria:
inclusion criteria patients must meet all the inclusion criteria below to be included in the study population: 1. patients with evidence of stage iv or recurrent mbc with a metastatic diagnosis date on or after january 1, 2011. 2. patients aged ≥18 years old at mbc diagnosis date. 3. patients with ≥1 t-dxd-containing lot in the metastatic setting. 4. patients with evidence of a subsequent lot following the first t-dxd-containing lot in the metastatic setting. the lot subsequent to the first t-dxd-containing lot in the metastatic setting will be the index lot. index date will be the index lot start date. 5. patients whose closest her2 test result (defined as immunohistochemistry \[ihc\] 3+ or in situ hybridization \[ish\]+) recorded prior to or on the index date was a her2+ test result. 6. patients with index date occurring at least 90 days prior to end of study period (march 31st, 2024). exclusion criteria no exclusion criteria will be imposed.

Keywords: her2-positive breast cancer real-world outcomes
clinical evaluation of the next generation venue ultrasound system, components, and accessories - canada

Conditions: Ultrasound Use in Emergency/Medical Care

Summary: the purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the next generation venue ultrasound system under clinical conditions. this is a medical device study designed as a clinical, open label, unblinded, non-randomized, prospective, feasibility research study.

adult patients (aged \>18 years) will be enrolled as they present for emergency or immediate medical care, in facilities such as the intensive care unit (icu), cardiac care unit (ccu), and/or other departments. subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. eligible subjects will undergo an ultrasound exam using the investigational ultrasound device. the exam type will be based on the subject's clinical condition. users performing the scans will periodically be asked to provide feedback on user survey forms prepared by the sponsor. image data sets from investigational exam will be stored electronically and de-identified data will be disclosed to the sponsor.results are for use in development and optimization of a next generation ultrasound system being developed by study sponsor, ge healthcare (gehc) prior to future commercial release.

Eligibility criteria:
inclusion criteria: 1. adults (aged 18 years of age or older) at the time of consent; 2. eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); and 3. able and willing to provide written informed consent for participation. exclusion criteria: 1. are pregnant subjects; 2. require procedures that cannot be readily completed using available investigational devices; or 3. require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.

Keywords: ultrasound emergency care
office-based asthma screening intervention

Conditions: Asthma

Summary: in prior work, we found that even children who have been seen by their physicians within the prior six months were frequently misclassified as having mild rather than persistent asthma. this study evaluations whether systematic office-based screening assists primary care physicians in identifying children with significant asthma and improves preventive care for asthma. we hypothesize that standardized screening in the office setting will improve the physician's ability to (a) identify children with significant asthma and (b) prescribe appropriate preventive medications.


Eligibility criteria:
inclusion criteria: * children ages 2-12 * children arriving for an office visit in two rochester, ny pediatric clinics * children with a prior diagnosis of asthma and an exacerbation of symptoms within the previous 2 years exclusion criteria: * children arriving at the office visit with an adult that is not their parent or guardian * children arriving at the office visit with a parent or guardian that does not speak english * children with other medical conditions making the assessment of asthma severity difficult (cystic fibrosis, heart conditions, etc.)
impact of early postoperative treatment with posterior tibial nerve stimulation on the incidence and duration of low anterior rectal resection syndrome

Conditions: Rectal Disorders; Low Anterior Resection Syndrome; Low Anterior Resection

Summary: the treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum, associated with neoadjuvant radiochemotherapy. surgical resections with sphincter preservation are frequently (60% of cases) associated with problems related to intestinal and defecatory function, which together are called anterior resection syndrome (ars) with varying degrees of severity. among the different treatments the investigators find posterior tibial nerve stimulation, a simple and non-invasive technique, which is currently used. the study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome (lars) and therefore on the quality of life of patients undergoing this type of intervention. therefore, treatment with pnts is currently established for the management of lars symptoms. given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome, the investigators intend to apply this treatment before the onset of symptoms in patients at risk for lars. it is also an intervention with a low rate of side effects, the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment. the investigators´ hypothesis is: posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ars and improving the quality of life of patients undergoing anterior rectal resections for cancer.


Eligibility criteria:
inclusion criteria: * patients undergoing elective surgery (scheduled, non-urgent) who underwent anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at the hospital álvaro cunqueiro in vigo after the start date of the study. * anastomotic tightness (absence of dehiscence). * patients older than 18 years old. * acceptance to participate in the study. exclusion criteria: * inability to understand the study instructions and recommendations. * dementia or any type of mental disability. * palliative surgery. * patients with pacemakers. * anti-coagulated patients. * patients with trophic lesions on the skin of the ankles.

Keywords: posterior tibial nerve stimulation (ptns) urgent pc transcutaneous neurostimulator
microfracture combined with suture bridge technique versus greenhouse technique in treating of rotator cuff injuries

Conditions: Rotator Cuff Tears; Microfractures

Summary: several biological augmentation procedures have recently been suggested to enhance tendon healing after arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. the purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. several biological augmentation procedures have recently been suggested to enhance tendon healing after arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. the purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Eligibility criteria:
inclusion criteria: * medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy * between 20-65 years old exclusion criteria: * bilateral rotator cuff tear * underwent ipsilateral surgery * large-to-massive rotator cuff tear * combined with bankart, slap or ac lesion * combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration

Keywords: rotator cuff tear microfractures greenhouse suture bridge technique
autologous bone marrow transplanted via transendocardial catheter to chronic myocardial infarct border zone

Conditions: Ventricular Dysfunction; Myocardial Infarction

Summary: the object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (abm) cells into the myocardium using the helical needle transendocardial (te) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (mi). a secondary goal was to assess the possibility that such cell injections could improve ejection fraction (ef).


Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * able to give informed consent * must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline * must be a candidate for percutaneous heart catheterization * must have identifiable area of transmural scar within the left ventricle exclusion criteria: * be a candidate for concurrent ventricular surgical restoration, aicd placement or valvular surgery * clinical evidence of infection * other complicating cardiovascular abnormalities * clinically significant electrocardiographic abnormalities * active malignancy * recent history or drug or alcohol abuse * pregnancy, planned or current * artificial aortic valve * ejection fraction less than 30 percent at baseline * myocardial infarction in the past 4 weeks

Keywords: bone marrow autologous ejection fraction left ventricle heart attack myocardial infarction left ventricular dysfunction post myocardial infarction
eltrombopag taste testing in healthy adult volunteers

Conditions: Healthy Subjects; Purpura, Thrombocytopenic, Idiopathic

Summary: based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. the subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. the outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.


Eligibility criteria:
inclusion criteria: * healthy adult based on a medical evaluation by a responsible physician * male or female adult between 18 and 55 years old * female subjects who are not pregnant or lactating * females who are unable to have children must have documented medical verification * females who are able to have children must have a negative pregnancy test * capable of giving written informed consent exclusion criteria: * subjects who are unable to taste bitterness or are extrememly sensitive to bitterness * participated in a clinical trial within 30 days * exposure to more than four new medicines within 12 months prior to the first day of dosing * history of sensitivity to any of the study medications

Keywords: healthy adult volunteers eltrombopag
evaluation of mst-188 in acute lower limb ischemia

Conditions: Acute Limb Ischemia

Summary: the purpose of this study is to evaluate the safety and efficacy of mst-188 in subjects receiving catheter-directed rt-pa for acute lower limb ischemia and to evaluate whether treatment with mst-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.


Eligibility criteria:
inclusion criteria: * age ≥30 to \<80 * symptoms consistent with ali in target lower limb classified as rutherford category iia or iib * subject is hospitalized or in the process of hospitalization for the treatment of ali * angiographic confirmation of thrombotic lower limb arterial occlusion exclusion criteria: * prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement * treatment with a thrombolytic agent within the last 48 hours * subject's laboratory results indicate inadequate organ function * nyha class iv congestive heart failure * prior major amputation of the target limb * other complications or contraindications for receiving rt-pa, anticoagulants, or contrast media

Keywords: acute limb ischemia ali acute lower extremity arterial occlusion