Kornimate/medical-research-clean huggingface dataset:
tourniquet vs. no tourniquet during high tibial osteotomy

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during high tibial osteotomy.

tourniquet is widely used in orthopedic surgery, but its effect and safety in high tibial osteotomy have not been studied. this study evaluated the efficacy and safety of tourniquets by comparing different timing of use.investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

Eligibility criteria:
inclusion criteria: * 1.simple knee medial compartment osteoarthritis high tibial osteotomy. * 2. with varus deformity, medial proximal tibia angle \<85° * 3. unilateral high tibial osteotomy * 4. informed consent: participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process exclusion criteria: * 1.patients who underwent other knee surgery within 6 months * 2.preoperative combined anemia (hb\<100g/l) * 3.patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
a prospective comparative study of induction of labor with a cervical ripening double balloon vs foley catheter

Conditions: Induction of Labor; Cesarean; Endometritis

Summary: hypothesis: the induction of labor in patients with unfavorable bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. we will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (cook medical, gpn: g48149). we will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

we will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (cook medical, gpn: g48149). we will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. the study will include 200 parturients, 100 primiparous and 100 multiparous women. we will randomize each group to induction with the foley catheter or the cervical ripening double balloon. we will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Eligibility criteria:
inclusion criteria: * term pregnancy * parturients candidates for mechanical induction of labor exclusion criteria: * suspected amnionitis * vaginal discharge * pre induction pyrexia * immunocompromised parturients

Keywords: induction of labor cesarean endometritis foley infections
impact of concomitant genetic alterations in egfr mutated adenocarcinoma by ngs analysis: a multicenter study

Conditions: Adenocarcinoma of Lung; EGFR Activating Mutation

Summary: the concomitant co-mutation with epidermal growth factor receptor (egfr) mutation might influence the clinical outcomes. the investigators will identify the impact of concommitant mutation on clinical outcome in patients with advanced -egfr mutated adenocarcinoma. the investigators will compare the genetic alterations between tumors of pre and post tyrosin kinase inhibitor(tki) treatments and predict the resistance mechanism for egfr-tkis by next-generation sequencing(ngs) analysis.

the current standard therapies in the treatment of advanced egfr-mutated lung cancer patients are the 1st or 2nd egfr-tkis. although 70-80% of patients treated by egfr-tkis show good responses, they have progression after around 12 months. the concomitant co-mutation with egfr mutation might influence the drug response of egfr tki. the investigators will compare the progression-free survival (pfs) of egfr-tki according to co-occuring mutations. the patients experience the change of molecular profiles after using the tki. therefore, the investigators will investigate the molecular profiles through ngs panel with foundation medicine in the tissue of pre/post egfr-tki, compare the change of the molecular profiles and tumor mutation burden(tmb), and identify novel mechanisms of drug resistance. the investigators will collect the tumor tissues and blood of around 80 patients in multi-centers prospectively. then, they will be sent to foundationone in the us and perform ngs analysis. the type of egfr-tkis would be selected according to physicians' preference. ngs will be performed twice before the egfr-tkis treatment and after the progression.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. age ≥19 years 3. egfr-mutated stage iv lung adenocarcinoma patients 4. archival biopsy tissues which are from core needle biopsies, endobronchial ultrasound (ebus) guided- lymph node biopsy or lymph node excisional biopsy at baseline and at radiologic progression 5. availability of the 10 unstained slides and 1 h\&e slides at pre/ post tki treatment 6. samples should contain a minimum of 20% viable tumor cells that preserve exclusion criteria: tumor tissue from bone metastases that have been decalcified are not acceptable. -

Keywords: next generation sequencing
primary vaccination with either synflorix™ or prevenar 13™ or both vaccines and booster vaccination with synflorix™

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Summary: the primary aim of this study is to assess the reactogenicity of synflorix vaccine and prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either synflorix or prevenar 13 vaccine or prevenar 13 and synflorix, respectively. in addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the synflorix vaccine and prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either synflorix or prevenar 13 vaccine or prevenar 13 and synflorix, respectively. this study also aims at assessing the safety, reactogenicity and immunogenicity of the synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either synflorix vaccine or prevenar 13 vaccine or prevenar 13 and synflorix respectively.

this study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * a male or female between, and including, 6-12 weeks of age at the time of the first vaccination. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a gestation period of at least 36 weeks. * written informed consent obtained from the parent(s)/lar(s) of the subject. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine. * major congenital defects or serious chronic illness. * history of any seizures or progressive neurological disease. * administration of immunoglobulins and/or blood products since birth or planned use during the study. * acute disease and/or fever at the time of enrolment. * previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

Keywords: pneumococcal conjugate vaccine synflorix prevnar 13 pneumococcal diseases
use of a proliferation saturation index to determine personalized radiotherapy for hpv + oropharyngeal cancers

Conditions: Oropharyngeal Cancer

Summary: this study is to determine whether a mathematical model can be used to choose a radiation delivery method to improve the rate of a rapid response.

investigators hypothesize that using individual patient proliferation saturation index (psi) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).

Eligibility criteria:
inclusion criteria: * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged ≥ 18 years * pathologically (histologically or cytologically) proven diagnosis of p16+ or hpv+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. clinical evidence should be documented, and may consist of pathology, palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for t stage). * american joint committee on cancer (ajcc) 8th edition staging t1-3 n0-1 mo * patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. * ct or mri performed at least 1 week apart. this can consist of diagnostic imaging and radiation therapy planning imaging. * no evidence of distant metastases * eastern cooperative oncology group performance status 0 to 3 exclusion criteria: * age \< 18 * positive urine pregnancy test * evidence of distant metastases * gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that remove all clinically and radiographically evident disease * prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * patients with a medical condition or social situation that at the discretion of the pi would preclude them from completion of the trial

Keywords: hpv radiotherapy fractionation proliferation saturation index larynx pharynx
impact of icu on the quality of life in cancer patients

Conditions: Solid Tumor, Adult

Summary: this is an observational, prospective, monocentric, case-control study. investigators aim to compare the quality of life and oncological treatment strategy in cancer patients admitted or not in icu.

inclusion of cancer patients (cases) at discharge of surgical, cardiovascular and thoracic and medical icu of the grenoble alpes university hospital. cases will be matched with cancer patients identified in oncologist's consultation. inclusion of controls from oncologist consultations (2 controls for 1 case) for cases and controls, medical data will be collected at inclusion, 3 and 6 months.

Eligibility criteria:
inclusion criteria: * \> 18 ans * non-opposition of the patient or relatives * lung, head and neck or colorectal cancer * non scheduled icu admission * at least 24 hours of icu stay * alive at icu discharge * able to answer by phone to quality of life questionary exclusion criteria: * unable to answer by phone to quality of life questionary * patient participating in another clinical study that could interfere with the results of the study

Keywords: quality of life oncological care intensive care unit solid tumor
quantum spectrum radiation emitter for adhesive capsulitis

Conditions: Shoulder Pain

Summary: this is a prospective, self-controlled study to evaluate the efficacy of the quantum spectrum radiation emitter for adhesive capsulitis.

adhesive capsulitis (also termed frozen shoulder, stiff painful shoulder, or periarthritis) is a common cause of shoulder pain estimated to affect 2-5% of the general population. the disorder is characterized by spontaneous onset of shoulder pain and progressive global stiffness of the glenohumeral joint accompanied by significant disability. most studies have suggested a self-limiting condition lasting an average of two to three years, although significant numbers of people have residual clinically detectable restriction of movement beyond three years, and smaller numbers have residual disability. many interventions have been advocated for the treatment of adhesive capsulitis, although only limited data from randomised controlled trials are available. in addition, there are not enough data to either support or refute the efficacy of any of the commonly used interventions for this condition, including non-steroidal anti-inflammatory drugs, corticosteroid injections, and physiotherapy. oral steroids were first advocated in the 1950s, with claims that they expedited recovery and reduced the need for manipulation under anaesthesia. however, these medications are associated with many adverse reactions. the aims of this study are to determine whether three weeks' treatment with quantum spectrum radiation emitter in patients with adhesive capsulitis is effective for improving pain, function, and range of motion.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * over 18 years old * with pain and stiffness in one shoulder predominantly for three weeks or more * restriction of passive motion in at least one shoulder by more than 30˚ in two or more planes of movement, measured at the time of the onset of pain with a gravity inclinometer. exclusion criteria: * hypertensive patients * patients with cardiac arrhythmias * patients with epilepsy * patients with pacemakers, hearing aids or other electronic components * pregnant patients * patients with radiological evidence of osteoarthritis of the shoulder or fracture;calcification about the shoulder joint;reason to suspect a complete rotator cuff tear (weakness of arm elevation, a positive"drop arm sign", a high riding humerus visible on x ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound) * patients likely not to comply with follow up (for example, living too far away to attend for follow-up assessment, or indicating they would be unable or unwilling to attend for outcome assessment) * patients without written informed consent.
step: proglide® versus femoseal®: a trial to compare the efficacy of arterial closure devices following endovascular peripheral arterial procedures

Conditions: Peripheral Arterial Disease

Summary: over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. these devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures. however, main arterial closure devices use different technology to close the arterial puncture point. for some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). for others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles. the investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (pad) patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years, * patient with peripheral arterial disease * endovascular examination or treatment compatible with a 5f to 7f sheath * walking ability * patient affiliated with a social security scheme * patient's signed informed consent form exclusion criteria: * under-age patient * patient of age, but under legal guardianship or care * contraindication to endovascular treatment * use of a 8f or greater sheath * morbidity contraindicating same-day walking * history of ipsilateral open common femoral artery surgery * stent at the puncture site * radial or brachial puncture * antegrade femoral puncture * acute ischemia * life expectancy of less than one month * patient refusal to take part in the study * participation in another therapeutic trial * pregnant woman * allergy to clopidogrel or aspirin
gene therapy trial for the treatment of x-linked retinitis pigmentosa associated with variants in the rpgr gene

Conditions: X-Linked Retinitis Pigmentosa

Summary: a clinical trial of aav5-rpgr vector for participants with x-linked retinitis pigmentosa (xlrp)


Eligibility criteria:
inclusion criteria: * male or female * 3 years of age or older * has xlrp confirmed by a retinal specialist and has a predicted disease-causing sequence variant in rpgr confirmed by an accredited laboratory exclusion criteria: * has had ocular surgery within 3 months prior to screening or is anticipated to require ocular surgery within 6 months after the study intervention administration * any investigational ocular treatment or any other ocular treatment that could confound the interpretation of the efficacy results or affect participant compliance with the visit schedule * has undergone prior retinal surgery involving the macula, macular laser photocoagulation, external-beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery
clinical & web-based diet & activity counseling for men

Conditions: Obesity

Summary: pace project researchers at ucsd are conducting a 2-year study to test the men in motion program. the study aims to learn more about how to help men lose weight, become more physically active, and improve their dietary habits. the study is sponsored by the national institutes of health.

this is a randomized controlled trial that will evaluate the effects of a web-based intervention to improve physical activity and dietary behaviors in overweight and moderately obese men age 25 through 55 years. the study will complement our currently funded nci project evaluating a similar intervention among overweight female primary care patients. overweight is related to multiple cancers, cvd, and niddm, and the prevalence of overweight is increasing rapidly (nih 1998). patient-centered assessment and counseling for exercise plus nutrition - internet (pacei) targets weight-related behaviors and gives patients a tool for addressing these behaviors with their primary care practitioners should they choose to do so. pacei includes a web-based assessment and progress planning tool, and 12 months of tailored internet and telephone contact. the components are integrated through a common theoretical framework. subjects will be randomized to pacei or to a low intensity intervention.

Eligibility criteria:
inclusion criteria: * subjects will be 360 men age 25 through 55 years with bmis of 25 to 39.9 (those characterized as "overweight" or "obese i" in the recent nih report on obesity). exclusion criteria: * more severely obese participants will be excluded because they may need more intense behavioral, pharmacological or surgical intervention.

Keywords: obesity men overweight
a large surgical registry for abdominal aortic aneurysms (aaa)

Conditions: Abdominal Aortic Aneurism

Summary: in the spirit of improving patient safety and quality of healthcare in our region, the dallas-fort worth hospital council education and research foundation (foundation) and baylor research institute sought and obtained federal funding support (ahrq grant) to develop an abdominal aortic aneurism (aaa) surgery registry in north texas. participating centers will directly benefit from this project and will have access to a de-identified version of the registry data through their collaboration. these data may be used for quality improvement initiatives and/or to conduct your own research. in summary, this effort represents a substantial investment (with no costs to facilities) in improving outcomes for patients with aaa.

currently, little is known about who receives which type of surgery. what data are available are largely from single-centre studies, with study populations of a few hundred to a thousand patients, comparing outcomes for open and endovascular repair and collecting patient characteristic data largely for risk adjustment. data on endovascular vs open aaa repair from the population-based registry will provide important information regarding the current use of these two treatment strategies, as well as allowing comparison of long-term outcomes for each according to different patient characteristics. the proposed registry has the potential to provide means for internal quality assessment for the participating institutions. the de-identified registry will be made available to researchers at their request. this registry, focusing on aaa in the dallas-fort worth metroplex, will provide data with the potential to improve treatments for more than 800,000 patients in the us.

Eligibility criteria:
inclusion criteria: * men and women who received endovascular or open aaa repair (primary/secondary procedure codes: icd-9=38.44 for open, icd-9=39.71 for endovascular repair) at any of the 138 dallas-fort worth area hospitals that report aaa data to the dfwhc data initiative. * patients age 50 years old or older. exclusion criteria: * patients with hiv and substance abuse * patients with substance abuse * patients \> 50 years old
fna guided ultrasonography needle technique axial vs lateral approach study

Conditions: Thyroid Nodule

Summary: ultrasound-guided fine needle aspiration cytology (fnac) has been proven to be an accurate and efficient tool in thyroid nodule evaluation. thyroid nodule aspiration is performed by the use of either two techniques; the short axis approach by which only the tip of the needle is observed, or the long axis approach by which the entire needle is observed. controversial remains of which approach produces better diagnostic adequacy and less non-diagnostic (bethesda category i) results.

200 patients presenting electively for thyroid fna will recruited. patients will be randomly assigned to two groups: short axis or long axis fna. fna will be performed by a single physician at the ziv medical center ent clinics. patient group randomization will be performed according to a random number sequence generated by the spss system. randomization will be performed on admission prior to the procedure. fnac sample diagnosis will be performed according to the regular protocol. laboratory personnel will be blinded to the sample group. sample results will be compared and analyzed. a p value of less than 0.05 will be regarded as significant.

Eligibility criteria:
inclusion criteria: * suspected thyroid nodule requiring diagnostic fna, exclusion criteria: * under or above age limit, no informed consent
intermittent hypoxia intervention in ms patients

Conditions: Multiple Sclerosis

Summary: this observational cohort study investigates the safety and feasibility of an intermittent hypoxia intervention in multiple sclerosis.


Eligibility criteria:
inclusion criteria: * 18-60 years * confirmed ms (all types of ms) * ability to come to the outpatient clinic 2-3x/week for 3 months * edss ≤ 6.5 * inconspicuous medical examination * inconspicuous ecg exclusion criteria: * relapse in the last 3 months * edss progression in the last 6 months * pregnancy * contraindication for mri * severe heart disease * severe asthma, copd * cancer * severe cognitive deficits * chronic headache * renal insufficiency * anaemia (hb \< 10 g/dl) * insulin-dependent diabetes mellitus * severe vascular stenosis * former episodes of severe high mountain sickness * cancer