Kornimate/medical-research-clean huggingface dataset:
daart vs pta/supera stenting for popliteal artery lesions

Conditions: Popliteal Artery Stenosis; Atheroma

Summary: the purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (daart technique) and angioplasty/supera stenting for the treatment of popliteal atherectomy lesions.

atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with poba. nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall. moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, daart), theoretically might further improve the clinical outcomes of drug coated angioplasty. the "leave nothing behind" strategies have gained support among interventionalist. many studies claim that atherectomy improves results when combined with adjunctive dcb. the supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. it mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions. the purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.

Eligibility criteria:
inclusion criteria: * patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by daart of pta/supera stenting and at least a 12-months of follow-up exclusion criteria: * exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.

Keywords: popliteal artery drug-coated balloon supera stent directional atherectomy
assessment of the effectiveness of vibroacoustic therapy for respiratory failure caused by covid 19

Conditions: Respiratory Distress Syndrome; Hypoxemia

Summary: vibroacoustic pulmonary therapy in patients with covid19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

this study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with covid 19. obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. optional performance criteria will be represented by oximetry values and standardization of laboratory parameters

Eligibility criteria:
inclusion criteria: 1. adults 2. p/f less 300 torr 3. ards by berlin convention 4. covid 19 bilateral pneumonia exclusion criteria: 1. children 2. acute brain stroke 3. acute coronary syndrome 4. pulmonary embolism 5. implanted pacemaker

Keywords: vibroacustic therapy covid19 pneumonia
domatinostat in combination with avelumab in patients with advanced merkel cell carcinoma progressing on anti-pd-(l)1

Conditions: Merkel Cell Carcinoma

Summary: this phase ii trial studies how well domatinostat (4sc-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic merkel cell carcinoma that have progressed on a previous therapy with an anti-pd-(l)1 antibody


Eligibility criteria:
inclusion criteria: * histologically confirmed merkel cell carcinoma (mcc) * ecog performance status ≤ 1 * mcc in an advanced, unresectable stage iii or metastatic stage iv (includes patients who refused surgical resection or are not eligible for such surgical resection) * progressing on previous anti-pd-(l)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication exclusion criteria: * history of serious anti-pd-(l)1 therapy-related adverse reactions prohibiting further avelumab treatment * more than one line of previous systemic anti-neoplastic therapy other than anti-pd-(l)1 antibody monotherapy * palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication * presence of significant active or chronic disease (infections, immunodeficiencies, cardiovascular, psychiatric disorders)
study of exparel versus epidural for pain control after thoracotomy

Conditions: Pain Following Thoracotomy Surgery

Summary: unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.

in this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. although the anesthesiologists involved in providing care for patients having thoracotomy incisions at st. mary's hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.

Eligibility criteria:
inclusion criteria: * age 18 years and older * undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy). exclusion criteria: * planned chest wall resection or abdominal incision and/or gastroesophageal surgery; * current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution); * daily opioid therapy; * current gabapentin or pregabalin therapy; * allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement; * severe psychological disorders or inability to understand the study protocol; -prisoners or other institutionalized individuals; * severe hepatic, renal or cardiovascular disorders. * women who are pregnant will not be included in this study.

Keywords: thoracotomy pain
cognition intervention study dortmund

Conditions: Cognition - Other

Summary: major aim of this study is to add scientifically proven insights into cognitive effects of meals to the existing recommendations for school meals in germany. as a first step the short-term effects of skipping lunch on children's cognitive functioning in the afternoon will be examined in a cross-over trial. the study is conducted in a large comprehensive school in gelsenkirchen (germany) including about 150 children.

because of cerebral particularities, children may react sensitive to short-term variations of nutrient supply. therefore, an optimised composition of meals at nutritionally favourable mealtime should be considered for optimal cognitive performance. the increasing implementation of all-day schools in germany requires the children's catering at school. however, also the number of 'meal skippers' is increasing among children. thus, the effect of skipping of the midday meal at school on cognitive functioning is examined in this experimental cross-over trial. as prior intake of food can have an influence on the physiological effect of test meal, the children's dietary intake in the morning is standardized. the intervention is integrated in the usual everyday school life: 9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m. everyday school life, 12.25 p.m. either lunch (control) or only a non-caloric beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. computerized tests of cognitive functioning, 2 p.m. lunch for the 'skipping meal'-group. parameters of cognition with relevance to everyday school life are measured by a computerized test battery of the 'wiener testsystem'. usual eating behaviour, sleep behaviour, physical activity, parental education and migration background are determined as control variables by questionnaires for children, parents and teachers. beside the body mass index, the individual iq is measured by a paper-pencil-test.

Eligibility criteria:
inclusion criteria: * all sixth grade students of gesamtschule berger feld with the consent of parents and child exclusion criteria: * metabolic diseases or special diet
study of pelvic hypofractionated radiotherapy in endometrial cancer

Conditions: Endometrial Cancer

Summary: this study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).


Eligibility criteria:
inclusion criteria: * diagnosis of primary cervical cancer or uterine cancer of any histology * age ≥ 18 years. * non-metastatic disease according to the international federation of gynecology and obstetrics (figo). * must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively. * recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. chemotherapy before or after radiotherapy is acceptable. * eastern cooperative oncology group (ecog) ps≤ 2 * able to provide informed consent and willingness to sign an approved consent form exclusion criteria: * distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer. * concurrent (or other) chemotherapy occurring at the time of study. * gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment. * history of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis. * unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation. * recommendation to undergo para-aortic nodal irradiation.
safety and efficacy of bone marrow derived mncs for treatment of cells for the treatment of hunting tons chorea.

Conditions: Huntington Disease

Summary: this study is single arm, single centre trial to check the safety and efficacy of bone marrow derived autologous mononuclear cell {mnc} (100 million per dose).trial to be conducted for 36 months in patients with diabetes mellitus in india,primary outcome measure are improvement in cognitive and psychiatric symptoms and improvement in jerky,random, and uncontrollable movements called chorea.

this study is single arm, single centre trial study the safety and efficacy of bone marrow derived autologous mononuclear cells (mncs) ,to be conducted for 36 months in patients with diabetes mellitus in india,primary outcome measure are improvement in cognitive and psychiatric symptoms and improvement in jerky,random, and uncontrollable movements called chorea.

Eligibility criteria:
inclusion criteria: * patient should suffer from hunting tons chorea, * hunting tons chorea commonly become noticeable between the ages of 35 -44 * willingness to undergo bone marrow derived autologous cell therapy. * ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required informed consent form(icf) for the study. * ability and willingness to regular visit to hospital for protocol procedures and follow up exclusion criteria: * patient with history of immunodeficiency hiv+,hepatitis b virus ( hbv) and history of life threatening allergic or immune -mediated reaction. the site of bone marrow aspiration potentially limiting procedure. * alcohol and drug abuse / dependence. * severe skin infection. * haemodynamically unstable. =subject with primary and secondary diabetes , insulin dependence. * neurological disease caused by autoimmune or genetic cause. * patients suffering from peripheral muscular dystrophy.

Keywords: huntington disease,stem cell therapy
ici 182780 in treating women with stage i or stage ii primary breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can stimulate the growth of breast cancer cells. hormone therapy using ici 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. it is not yet known if ici 182780 is effective in preventing breast cancer metastases. purpose: randomized phase iii trial to study the effectiveness of ici 182780 given before surgery in treating women who have stage i or stage ii primary breast cancer.

objectives: * determine the inhibitory effect of ici 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage i or ii primary breast cancer. * determine toxicity of this regimen in these patients. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal). patients are randomized to receive either ici 182780 im or placebo im over 2 minutes on day 1. patients undergo surgery between days 8 and 29. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage i or ii primary operable breast cancer * surgery planned within next 1-4 weeks * hormone receptor status: * estrogen receptor positive or unknown * no known estrogen receptor negative tumor * unknown progesterone receptor status eligible patient characteristics: age: * any age sex: * female menopausal status: * premenopausal or postmenopausal performance status: * not specified life expectancy: * not specified hematopoietic: * no bleeding diathesis not compatible with an im depot injection hepatic: * not specified renal: * not specified other: * not pregnant * negative pregnancy test * fertile patients must use effective non-hormonal contraception during and for 2-3 months after study * no other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix * no psychological, familial, sociological, or geographical condition that would preclude study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * at least 2 months since prior ici 182780 radiotherapy: * no prior radiotherapy to primary tumor surgery: * see disease characteristics other: * no other concurrent preoperative therapy for breast cancer

Keywords: stage i breast cancer stage ii breast cancer
feeding the patient at nutritional risk: does the clinical outcome improve?

Conditions: Malnutrition

Summary: the aim of the present study is to take stronger action in solving the problems of malnutrition in the hospital setting and in the first two months after patient's discharge. the main objective is to evaluate the clinical benefit (eg. qol, body composition and body function) of nutritional intervention (nutritional therapy) in a sample of patients at nutritional risk according to the nrs 2002.


Eligibility criteria:
inclusion criteria: * all patients coming on station exclusion criteria: * patients with a screening total score \<3 according to the nrs-2002 system * less than 18 years of age, expected hospital stay less than 4 days * expected survival less than 1 month * pregnant or lactating women * patients with psychiatric disorders * patients with cardiac failure as defined by the goldmann classification class \>ii (recent rest pain, unstable angina pectoris) * patients with respiratory failure (peak flow rate: pefr \<50%) * patients with hepatic dysfunction (child \>a) * patients suffering from an intestinal obstruction or ileus * patients with renal failure (creatinine \>250 μmol/l) or receiving haemodialysis * patients that are already receiving, or are planned to receive parenteral nutrition * patients unable to understand the german language

Keywords: internal medicine patients
ecg leadwires: disposable versus cleaned, reusable

Conditions: Critically Ill Patients; Cardiovascular Surgery Telemetry Patients

Summary: null hypothesis: (1) there is no difference in rates of icu-acquired infection based on using disposable or cleaned, reusable ecg leadwires and (2) in cardiac surgical telemetry floors, there is no difference in false or nuisance sightings or crisis calls based on using disposable or cleaned, reusable ecg leadwires.

primary purposes: using a randomized controlled trial methodology and randomizing similar (matched) intensive care units (icu) to either disposable or cleaned, reusable ecg-lw: 1. is there a difference in the rate of blood stream infection (bsi) and ventilator-associated pneumonia (vap) in icu environments (medical icu, surgical icu, cardiothoracic icu, and neuroscience icu) and surgical site infection (ssi); specifically, sternal wound infections in cardiothoracic icu that utilize disposable vs. cleaned, reusable ecg-lw? 2. is there a difference in icu length of stay based on ecg-lw used: disposable vs. cleaned, reusable? 3. after controlling for patient age, comorbidity index and after removing patients who's date of bsi or vap infections were within 48 hours of admission to the icu, is there a difference in the rate of (a) blood stream infection (bsi), (b) ventilator-associated pneumonia (vap) and (c) ssi in icu environments (when applicable) that utilize disposable vs. cleaned, reusable ecg-lw? secondary purposes: using a randomized controlled trial methodology and randomizing similar telemetry units to either disposable or cleaned, reusable ecg-lw: 1. is there a difference in the number of false/nuisance sightings/crisis calls (i.e., lead off, no telemetry, lead failure or other false alarms) identified by the central monitoring unit (cmu)? 2. is there a difference in true sightings/crisis calls identified by the cmu based on unit assignment of disposable or cleaned, reusable ecg-lw? 2b. if yes to #2, is there a difference in types of true sightings/calls identified by the cmubased on assignment of disposable or cleaned, reusable ecg-lw?

Eligibility criteria:
inclusion criteria: * primary ho: patients treated in an icu setting; secondary ho: patients treated in cardiac telemetry setting exclusion criteria: * none

Keywords: icu telemetry ecg lead wire monitoring infection nuisance alarms
a reliability and validity study of urdu version of lysholm knee scoring scale.

Conditions: Anterior Cruciate Ligament Injuries

Summary: the study will be intended to translate and check if the urdu version of lysholm knee scoring scale is reliable and valid in the pakistani patients with anterior cruciate ligament injuries.

a detailed research will be conducted on nearly 100 patients after ethical approval from the ethical review board of riphah international university faisalabad campus. a total of 100 patients with anterior cruciate ligament injuries will be selected from different areas of community and rehabilitation centers. informed consent will be taken from each patient. the tool will be used three times in the same pakistani population with anterior cruciate ligament injuries to check inter and intra-observer reliability of the final urdu-lks. the lysholm questionnaire translation will be carried out in 6 steps by the guidelines of the early researches and the consensus-based standards for the selection of health measurement instruments standard. statistical package of social sciences 23 will be employed to do data analysis.

Eligibility criteria:
inclusion criteria: * from17 years old to 60 years old * presence of an anterior cruciate ligament injury or ligament repair * no intervention between the test-retest assessments. exclusion criteria: * to complete the forms because of a psychological impairment. * illiteracy or lack of understanding of urdu language * had a condition that couldn't be settled after a second assessment for different sicknesses like cancer, any other serious infection, or inflammatory disease * the presence of neurologic or musculoskeletal disorders other than the knee condition.

Keywords: lysholm knee scale anterior cruciate ligament injuries knee disorders validity urdu version reliability arthroscopic knee
effect of telitacicept on transitional regulatory b cells in patients with systemic lupus erythematosus

Conditions: Telitacicept; Systemic Lupus Erythematosus; Therapy

Summary: the effect of telitacicept treatment on the changes of transitional regulatory b lymphocyte t1, t2b cell subsets and plasma blasts and the expression levels of cytokines il-10, il-35, april and baff in sle.


Eligibility criteria:
inclusion criteria: 1. the diagnosis meets the 2019 eular/acr classification criteria for sle; 2. age 18-70 years old; 3. to be on a stable sle regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (telitacicept); 4. lupus activity index score (selena-sledai) ≥ 8 at screening; 5. positive anti-nuclear antibody or anti-dsdna antibody; 6. combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion. exclusion criteria: 1. active infections (such as shingles, hiv infection, active tuberculosis, etc.) during the screening period; 2. central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by sle or not caused by sle in the last 2 months; 3. have active hepatitis or a history of severe liver disease; 4. patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer; 5. pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months; 6. allergic reaction: history of allergic reaction to human biological products; 7. those who received live vaccine within the last month; 8. participants who have participated in any clinical trial within 28 days prior to initial screening/or 5 times the half-life of the study compound (taking an older time); 9. b cell targeted therapy, such as rituximab or epazumab, within one year; 10. use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year; 11. patients receiving intravenous gamma globulin (ivig), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis; 12. psychopaths with depression or suicidal thoughts.