Kornimate/medical-research-clean huggingface dataset:
evaluation of outcomes of feminizing genitoplasty in children with disorders of sex development

Conditions: Disorders of Sex Development

Summary: evaluate the short term outcomes of feminizing genitoplasty including vaginoplasty,clitroplasty, labioplasty and urethroplasty in children with disorders of sex development as regarding cosmetic and functional aspects.

disorders of sex development (dsd) are a wide range of congenital conditions characterized by incongruent development of the components involved in sex differentiation including chromosomes, gonads, brain and anatomic sex.sex assignment is a critical aspect in management of dsd and it is determined by investigations, genital appearance, fertility potential and cultural practices and pressurs. it is recommended that genital surgery for a child raised as a female considered only in cases of severe virilization (prader 3-5) and that surgery for the clitoris not be performed for reasons of cosmesis only.feminizing genital reconstruction has evolved considerably over the past decades as a result of improved understanding of anatomy , modification of surgical procedures and audit of outcomes. for patients with congenital adrenal hyperplasia (cah) with severe virilization raised as a female , it is recommended that clitorial and perineal reconstruction be considered in infancy and those with a low vaginal confluence undergo vaginoplasty at an early age , the appropriate timing for those with higher vaginal confluence is still less certain. cosmetic outcomes after genitoplasty are variable. most studies have detected only functional and cosmetic outcomes rated by the physician, but satisfaction ratings may differ between physicians and patients or their parents . the present prospective , interventional study aimed to describe the frequency of sex assignment and types of surgery performed in a cohort of patients with moderate to severe genital ambiguity and also evaluate surgical outcomes of feminizing genitoplasty in these patients .

Eligibility criteria:
inclusion criteria: 1. age : infants and children from 18 months old age to 14 years. 2. virilized external genitalia. exclusion criteria: * (1)children who did any corrective genitoplasty before. (2)children with debatable sex of rearing;ovotesticular dsd, mixed gonadal dysgenesis and partial androgen insensitivity.

Keywords: feminizing genitoplasty
start - early thrombocyte administration to patients with ruptured abdominal aortic aneurism

Conditions: Ruptured Abdominal Aortic Aneurism

Summary: the purpose of this study is to investigate the effect of platelet infusion prior to transfer to a vascular surgical department in patients with a ruptured abdominal aortic aneurism.


Eligibility criteria:
inclusion criteria: * diagnosed with raaa either by clinical evaluation or ct or ul exclusion criteria: * formerly randomized in the study * aneurism not ruptured during operation

Keywords: raaa platelets teg massive bleeding coagulopathy
chronic kidney disease, hyperkalemia and echocardiographic changes

Conditions: Chronic Kidney Disease (CKD); Hyperkalemia; Hemodialysis

Summary: patients with ckd ( egfr \&lt; \&lt;60 ml/min/1,73 m2) presenting to emergency department with isolated hyperkalemia will be study population. pre and post treatment ecg and echocardiographic findings will be recorded. investigator will not intervene with the treatment decision of responsible physician and will not delay any intervetion or treatment for the sake of study. data will be compared in terms of echo and ecg findings depending on hyperkalemia level and response to treatment.

in this study, the ecg and echocardiography (echo) findings in patients with chronic kidney failure who present to the etlik city hospital emergency medicine department will be recorded and compared with literature. echocardiography is a rapid, reliable, and non-invasive examination widely used by physicians for the monitoring of critically ill patients in emergency departments and intensive care units worldwide. for patients with known chronic kidney failure brought to the emergency department, a blood sample (blood gas and/or biochemistry) will be taken for potassium measurement. subsequently, an ecg, which is a quick and non-invasive test, will be performed, followed by an echo, also a quick and non-invasive test, conducted by an experienced physician. the physician performing the echo will not be involved in the treatment process. ecg and echo findings will be recorded and compared before and after treatment. patient mortality will be monitored at 24 hours, 7 days, and 30 days, and other causes of mortality will be excluded. the relationship between ecg and echo findings and mortality will be statistically investigated. based on the premise that hyperkalemia can cause cardiac arrest during diastole, it is hypothesized that there may be right ventricular enlargement in patients with ecg findings indicative of hyperkalemia. in animal studies, echocardiography results during resuscitation have shown right ventricular enlargement in animals with hyperkalemia. based on this information, we believe that echocardiography findings in hyperkalemic patients may be associated with mortality, and that the combined use of echocardiography and ecg may be effective in predicting mortality

Eligibility criteria:
inclusion criteria: 1. patients over 18 years old 2. chronic kidney disease patients with egfr \&lt; 60 ml/min/1.73 m² 3. patients with hyperkalemia detected in the emergency department 4. patients willing to participate in the study and who sign the consent form exclusion criteria: 1. patients under 18 years old 2. patients who do not wish to participate in the study 3. patients without chronic kidney damage 4. patients without detected hyperkalemia 5. patients needing cardiopulmonary resuscitation due to hyperkalemia

Keywords: echocardiography ecg chronic kidney disease hyperkalemia
intracameral gas sf6 (sulfur hexafluoride) injection for acute hydrops in keratoconus

Conditions: Hydrops in Keratoconus

Summary: intracameral gas sf6 (sulfur hexafluoride) injection for acute hydrops in keratoconus


Eligibility criteria:
inclusion criteria: * hydrops exclusion criteria: * age \< 18 years old
resolving the burden of low back pain in military service members and veterans: a pragmatic clinical trial

Conditions: Low Back Pain

Summary: the resolve trial will provide a pragmatic approach to evaluate whether physical therapy clinical practice guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the departments of defense and veterans affairs healthcare systems.

physical therapy (pt) is frequently used for the management of low back pain (lbp) within the u.s. departments of defense (dod) and veterans affairs (va). however, variations in pt practice patterns and utilization of ineffective interventions lower the quality and increase the cost of care. although, adherence to the clinical practice guidelines (cpgs) can improve outcomes and cost effectiveness of lbp care, pt cpg adherence rates remain below 50%. the resolve trial will evaluate the effectiveness of an active pt cpg implementation strategy using an education/audit/feedback model for reducing pain, disability, medication use and cost of lbp care within the dod and va healthcare systems. the resolve trial will include 3300 to 7260 patients with lbp from five dod and va medical facilities, using a stepped-wedge study design. an education/audit/feedback model will be used to encourage the physical therapists to better adhere to the pt cpg recommendations. the primary outcomes of disability and pain intensity will be measured with the oswestry disability index and the defense and veterans pain rating scale. secondary outcomes will include the lbp-related medical resource utilization and biopsychosocial predictors of pt outcomes. statistical analyses will be based on intention to treat principles and will use linear mixed models to compare treatment conditions, and examine the interactions between treatment and sub-grouping status. the resolve trial will provide a pragmatic approach to evaluate whether pt cpg adherence can reduce pain, disability and downstream healthcare utilization for lbp within the dod and va healthcare systems.

Eligibility criteria:
inclusion criteria: * receiving physical therapy care for low back pain in an outpatient physical therapy setting
aromasin vs arimidex study as initial hormonal therapy in postmenopausal women with advanced/recurrent breast cancer

Conditions: Breast Neoplasms

Summary: to verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (ttp), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed breast cancer at original diagnosis. at study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer. exclusion criteria: * having received any hormonal therapy (e.g., tamoxifen, lhrh-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer
comparison of two methods to estimate the lung recruitment

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury

Summary: in this study the investigators aim to compare two common methods to estimate the lung recruitment in ali/ards patients.


Eligibility criteria:
inclusion criteria: * ali/ards exclusion criteria: * barotrauma
pulmonary nodule localization prospective validation

Conditions: Video-assisted Thoracic Surgery; Pulmonary Nodules

Summary: localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. however, the criteria is still unclear. the investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.

excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. the procedure of mark placement (localization) could probably cause damages to the patients. however, the criteria for patient selection is still not clear. through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.

Eligibility criteria:
inclusion criteria: * age ≧ 20 years * lung nodule size ≦2cm on the pre-operative computed tomography (ct) * nodulectomy is performed under thoracoscopy exclusion criteria: * age \< 20 years * lung nodule size \> 2cm on ct or in the final pathology report * open surgery for nodulectomy

Keywords: video-assisted thoracic surgery thoracoscopy localization pulmonary nodules
evaluation of a peer coach-led intervention to improve pain symptoms

Conditions: Chronic Pain

Summary: to maximize implementation potential of pain self-management in the va, alternative delivery methods are needed to provide veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. a novel and promising approach is a peer coaching model, in which veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other veterans with pain.

the investigators' goal is to test the effectiveness of a peer coaching model among veterans. the investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation. aim 1 (primary aim): to compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function). hypothesis 1: veterans in the peer support arm will experience reduced overall pain compared to controls. aim 2 (secondary aim): to compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization. hypothesis 2: veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls. aim 3 (pre-implementation aim): to explore facilitators and barriers to implementation of peer support for chronic pain, intervention costs, and fidelity to the model.

Eligibility criteria:
inclusion criteria: * have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for 3 months * have at least moderate pain severity, defined by pain 5 on a 0 (no pain) to 10 (worst pain imaginable) scale * indicate willingness to engage in phone or in-person contact on a regular basis with another veteran exclusion criteria: * if the electronic medical record indicates a diagnosis of a psychotic disorder (e.g., international classification of diseases (icd) icd-9 codes 295-295.9 for schizophrenia) * current substance dependence (e.g., icd-9 codes 304-304.9) * severe medical conditions precluding participation (e.g., new york heart association class iii or iv heart failure, icd-9 codes 428-428.9 ) * if the eligibility screener given to prospective participants reveals active suicidal ideation severe hearing or speech impairment * pending surgery for a musculoskeletal condition (e.g., back surgery)

Keywords: self-management peer support social support
a phase 2/ 3 trial to evaluate the efficacy and safety of bay86-6150

Conditions: Hemophilia A, Hemophilia B

Summary: haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (fviii) is missing or not present in sufficient levels. in a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability. the current haemophilia standard of care is to maintain fviii activity level above 1%. sometimes, patients can develop antibodies (so called "inhibitors") against fviii and it is no longer effective at controlling bleeds. bleeds in these patients are currently treated using other proteins involved in the clotting process. the purpose of this study is to investigate how effectively bay86-6150 may stop acute bleeds in "inhibitor" patients. this study consists of two parts, a and b. the purpose of part a is to find the most effective yet tolerable out of four doses of bay86-6150 with regard to efficacy and safety (dose-finding part). part a is expected to last 9 - 29 months. the purpose of part b is to confirm efficacy and safety of the dose found in part a in all participating patients (confirmatory part). part b is expected to last 12-32 months. approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia a or b, with inhibitors to fviii or fix, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study. patient's bleeds will be treated with bay86-6150 and with a rescue medication if no response is made to bay86-6150. patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.


Eligibility criteria:
inclusion criteria: * male subjects * 12 to 62 years-of-age * history of moderate or severe congenital hemophilia a or b with inhibitors to fviii or fix * 4 or more bleeding episodes in the last 6 months before enrollment. exclusion criteria: * clinically relevant coagulation disorder other than congenital hemophilia a or b with inhibitors * history of coronary and/or peripheral atherosclerotic disease * disseminated intravascular coagulopathy, or stage 2 hypertension * angina pectoris * myocardial infarction * transient ischemic attack * stroke * congestive heart failure * thromboembolic event

Keywords: hemophilia, haemophilia, inhibitor, fviia, factor vii activated, bypassing
couple-based meditation for metastatic lung cancer patients and their partners

Conditions: Lung Cancer

Summary: objectives: our specific aims are to: aim 1: examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners. aim 2: establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes.


Eligibility criteria:
inclusion criteria: 1. all phases, patients only: diagnosed with stage iv non-small cell lung cancer (nsclc) 2. all phases, patients only: currently receiving treatment (e.g. radiotherapy, chemotherapy) at md anderson cancer center 3. all phases, patients only: eastern cooperative oncology group (ecog) performance status of less than or equal to 2 4. all phases, patients only: have a romantic partner with whom they have resided for a minimum of 6 months 5. all phases, patients and partners: must be at least 18 years old 6. all phases, patients and partners: able to read and speak english 7. all phases, patients and partners: able to provide consent. exclusion criteria: 1. all phases, patients and partners: not oriented to time, place, or person as deemed by the clinical team 2. all phases, patients and partners: regular (self-defined) participation in psychotherapy or a formal cancer support group 3. all phases, patients and partners: prior enrollment in a couple-based mind-body intervention research study (protocols 2011-1179, 2013-0496, 2014-0036) conducted by the principal investigator including phase 1 or phase 2 of the current study.

Keywords: non-small cell lung cancer nsclc couples-based meditation program couples-based cancer-related discussion program questionnaires surveys metastatic lung cancer quality of life qol
study of il2 in combination with zoledronic acid in patients with kidney cancer

Conditions: Kidney Cancer

Summary: this study is being done to see if we can improve the response of interleukin-2 by adding zoledronic acid. the effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. in particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of il-2 with zoledronic acid.

the purpose of this research is to evaluate the antitumor response of low-dose interleukin-2 in combination with zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of low-dose interleukin-2 in combination with zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine expression, antigen-specific t-cell immune responses, and peripheral gd t-cell frequency and function.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed renal cell carcinoma with metastasis. * must have measurable disease. * no prior cytokine, chemotherapy, hormonal, or other immuno-based therapies (including vaccine or cellular based) for their renal cancer is allowed. no prior use of bisphosphonates will be allowed. one prior experimental therapy will be permitted as long as \> 4 weeks have passed since last drug administration. * ecog performance status 0 or 1 * adequate cardiac function by history. * pulse-oximetry \> 92% on room air. exclusion criteria: * radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * known brain metastases * any history of an autoimmune disease (ie. psoriasis, inflammatory bowel disease, etc) must receive clearance by the investigator before being permitted on study due to the potential worsening of those disorders from il- * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. * history of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment. * history of prior malignancy (except basal cell carcinoma resected with curative intent) unless resected or treated with curative intent and disease free for \> 5 years. * any history of seizures given increased seizure risk with il-2. * organ allograft (transplant) recipients will be excluded given absolute contraindication with il-2 therapy. * pregnant women are excluded * patients on systemic steroids (oral or iv) will not be eligible for the study.

Keywords: renal cell cancer metastatic
treatment of post-poliomyelitis syndrome by intravenous immunoglobulin

Conditions: Post-Poliomyélitis Syndrom

Summary: our study evaluates the efficacy of igiv treatment in pps on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with ps at montpellier's hospital

patients are admitted to a multidisciplinary consultation (neurologist, pmk) to validate the indication of treatment with igiv. realization of a pre-therapeutic evaluation in the department of mpr on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of igiv. the patient is then re-admitted to a pmr service for post-treatment evaluation. collection of data retrospectively.

Eligibility criteria:
inclusion criteria: * diagnosis of pps * pre- and post-therapeutic evaluation carried out * data transcribed in the computerized patient file exclusion criteria: * no walking patient

Keywords: pre- and post-therapeutic evaluation carried out data transcribed in the computerized patient file post-poliomyelitis syndrome intravenous immunoglobulins walking test isokinetics