Kornimate/medical-research-clean huggingface dataset:
fha: characterization of metabolic status, brain circuitry, and stress-reactivity

Conditions: Anovulation; FHA; Eumenorrhea; Polycystic Ovary Syndrome

Summary: functional hypothalamic amenorrhea (fha), the spontaneous cessation of the menstrual cycle for at least 6 months after menstrual cyclicity has been established, is a common and reversible form of anovulation not due to discernible organic causes. whereas animal studies suggest an interaction of metabolic and psychosocial stress in the genesis of fha, the distinct central mechanisms in humans are not clear. on a behavioral level, fha appears to depend on a complex interplay between individual stress susceptibility, stressful life events, and enduring metabolic challenge due to inappropriate attitudes towards eating and body image. we will use a comparison group of ovulatory, eumenorrheic women (ew) and a contrast group of lean women with polycystic ovary syndrome (pcos). although women with fha and pcos present with anovulation, each condition differs markedly in pathobiology (and health burden). contrasting women with fha to those with pcos will afford an opportunity to understand more about the interaction between metabolism, stress, and reproduction and to determine the extent to which differences between fha and ew are attributable to reproductive compromise (anovulation) per se versus specific to the pathogenesis of fha or pcos. we have used this approach to great advantage in the past to show that hypercortisolemia was confined to fha and not pcos (berga 1997) and that dysfunctional (unrealistic) attitudes and decreased coping skills were reported more often in fha than in pcos and more in pcos than ew. further, this approach of comparing 3 groups will allow us to improve therapeutic approaches for two principle causes of anovulatory infertility in women. to accomplish this, we will study women with fha, pcos, and normal ovulatory women. the study will take place over 2 months and women will make 4-5 outpatient visits to the clinical integration network center and will have one overnight stay for frequent blood sampling.


Eligibility criteria:
inclusion criteria: * inclusion criteria for participation are a gynecological age (age since menarche) \> 5 and \ 18 years, within 90-110% of ideal body weight as determined by the 1983 metropolitan height and weight table for women, and exercise \< 10 h/wk and run \< 10 mi/wk, day-awake/night-asleep schedule. * women in the fha and pcos groups have to fulfill the diagnostic criteria of fha or pcos and to have all other causes of amenorrhea and anovulation excluded. exclusion criteria: * exclusion criteria are smoking, medications, including psychotropic or illicit drugs, medical, neurological, or ophthalmologic disease except acuity problems, a weight loss or gain of \> 10 lb within a year preceding or since the onset of amenorrhea, a major axis i disorder other than depression, parturition in the last 12 months and/or lactating in the last 6 months.
a phase 2, double-blind, multiple-dose escalation study to evaluate nktr-118 (oral peg-naloxol) in patients with opioid-induced constipation (oic)

Conditions: Opioid Induced Constipation (OIC)

Summary: study (07-in-nx003) is a phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. it is designed to investigate the safety, efficacy and tolerability of nktr-118 (peg-naloxol) in patients with opioid-induced constipation (oic) and other clinical manifestations of opioid-induced bowel dysfunction (obd). the objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of nktr-118 at 4 different doses.


Eligibility criteria:
main inclusion criteria: * 18 years of age or older, male or female * receiving a stable opioid regimen * documented opioid-induced constipation * willingness to stop all laxatives and other bowel regimens. the use of constipation rescue medication will be allowed during the study. main exclusion criteria: * life expectancy less than 6 months * active substance abuse * fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea or intermittent loose stools or constipation * pregnant or breast-feeding * any receipt of an investigational medication within 30 days of screening * history or presence of specific cardiac, neurologic, endocrine and/or psychiatric conditions

Keywords: nktr, constipation, opioid, induced, bowel, dysfunction, naloxol, naloxone, narcan, peg naloxol, oic, obd, nektar
effect of androgen blockade therapy on thymus function in older patients who have undergone radical prostatectomy for localized prostate cancer

Conditions: Prostate Cancer

Summary: rationale: studying changes in thymus function in patients who have been undergoing androgen blockade therapy for prostate cancer may help doctors learn more about how well patients will respond to treatment, may help in planning cancer treatment, and may help the study of cancer in the future. purpose: this clinical trial is studying the effect of androgen blockade therapy on thymus function in older patients who have undergone radical prostatectomy for localized prostate cancer.

objectives: * determine if inhibition of sex steroid action is associated with increased thymic size in older patients who have undergone radical prostatectomy for localized adenocarcinoma of the prostate. * determine if inhibition of sex steroid action is associated with an increase in the absolute number or percentage of circulating "naive" phenotype t cells, and/or an increase in the frequency of t-cell receptor excision circles in peripheral blood cells. outline: this is a nonrandomized, single-blind, cohort study. patients are stratified according to hormonal therapy after surgery (yes vs no). patients undergo ct scan of the thymus. blood samples are analyzed by flow cytometry to determine phenotype of t cells. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * underwent prior radical prostatectomy as local definitive therapy for prostate cancer * meets criteria for 1 of the following strata: * has received ≥ 9 months of androgen blockade therapy (either single-agent luteinizing hormone-releasing hormone or combined androgen blockade) for serologic progression after surgery * serologic progression defined as a rising prostate-specific antigen, which has risen serially on two determinations (from baseline) ≥ 1 week apart, and no objective evidence of metastatic disease * prior radiotherapy for serologic progression allowed * did not receive any form of androgen blockade therapy within the past 9 months * no metastatic disease by abdominal/pelvic ct scan and whole-body scan patient characteristics: * able to tolerate ct scanning in the supine position * no prior medical condition known to have effects on the thymus, including myasthenia gravis, lymphoma, hyperthyroidism, or cachexia * no autoimmune disorders * no acute illness, including active infection requiring antibiotics prior concurrent therapy: * see disease characteristics * no prior systemic chemotherapy * no prior immunological therapy * no prior single-agent antiandrogen (e.g., high-dose bicalutamide) * no prior or concurrent 5-alpha reductase inhibitors (e.g., finasteride), pc-spes, or estrogen-containing nutraceuticals * no concurrent systemic steroid therapy (topical steroids allowed)

Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
evaluation of three dimensional echocardiography in critical care medicine

Conditions: Shock

Summary: comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit.

prospective, observational study evaluating three dimensional echocardiography for measuring hemodynamic variables versus the current gold standard (pulmonary artery catheter). critically ill patients with a severly compromised circulation due to a shock state with an advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will be included. while performing an echocardiography study stroke volume measurements using the bolus method for thermodilution will concomittantly be measured. in case of insufficient image quality we are planning to use sonovue echo contrast. once the image quality has improved we will repeat the stroke volume measurements with the bolus thermodilution method while performing the echocardiography. the acquired echocardiography loops will then be analysed and measured offline once deferred consent has been obtained. we will then compare the echocardiographic measurements with the measurement obtained by the pulmonary artery catheter (bolus method) - since this is the current reference method.

Eligibility criteria:
inclusion criteria: * advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter in place * patient intubated or tracheostomy in place * clinical indication for performing an echocardiography * ongoing sedation requirement exclusion criteria: * heart rhythm other than sinus rhythm or paced atrial rhythm * known allergy to sulphur-hexafluoride (sonovue©) * artificial heart valves in place * any form of mechanical cardiac assist * contraindication to performing a transesophageal echocardiography * presence of significant cardiac valve regurgitation * presence of an intracardiac shunt

Keywords: measurement of cardiac output
vitamin deficiency in immigrants, a treatment study

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to determine the efficacy of different doses of vitamin d in persons, immigrated to sweden from middle east or africa, with decreased s vitamin d.

the participants in the study have taken part in a previous screening study. they are now asked to participate in this treatment study. at a screening visit blood samples for vitamin d3 and pth are collected. data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. the vitamin d value predict the treatment dose.

Eligibility criteria:
inclusion criteria: * serum- vitamin d below 75 nmol/l * men and female * 25-65 years of age * born in middle east or africa, living in umeå district exclusion criteria: * hypersensitive to cholecalciferol, cocos oil, palm kernel or rubber * serum d3 equal to or above75 nmol/l * hypercalcemia * renal insufficiency * history of kidney calculi * nephrocalcinosis * history of sarcoidosis and other granulomatous diseases * known malignancy * ongoing treatment with phenytoin, barbiturates, rifampicin, isoniazid * ongoing treatment with cardiac glycosides * ongoing treatment with thiazides * ongoing treatment with etalpha, rocaltrol, ergocalciferol, dygratal * ongoing treatment with drugs involving fat absorption; orlistat colestyramin * oral treatment with glucocorticoids * ongoing treatment with aluminum compounds drugs * ongoing treatment with omega -3, vitamin d and/or calcium * immobilisation * other medial reason not to participate according to the investigator * pregnancy (women with s-d3 below 25 nmol/) * breastfeeding

Keywords: vitamin d insufficiency cholecalciferol d3 parathyroid hormone 25-hydroxyvitamin d3 rda, recommended daily intake (nutrition policy) vitamin d hypovitaminosis-d pharmacologic treatment
clinical markers of panic and generalized anxiety disorder

Conditions: Generalized Anxiety Disorder; Panic Disorder; Duration of Untreated Illness

Summary: the goal of this observational study is to compare socio-demographic and clinical features in patients affected by generalized anxiety disorder (gad) and by panic disorder (pd). the main questions it aims to answer are: * which socio-demographic/clinical markers are associated to gad or pd diagnosis? * which factors are associated with a longer duration of untreated illness (dui) in gad and in pd? participants will signed a written informed consent and socio-demographic/clinical variables will be retrospectively collected. researchers will compare gad and pd groups in terms of socio-demographic and clinical features, including dui, to better characterize the two disorders and to investigate factors associated to a longer dui.


Eligibility criteria:
inclusion criteria: * age 18-65 years; * ability and willing to give informed consent; * fluency in italian language; * diagnosis of gad or pd according to the criteria of the diagnostic and statistical manual of mental disorder, 5th edition. exclusion criteria: * intellectual disability; * lack of clinical and socio-demographic information; * patients treated for less than three months in the outpatient clinics for the impossibility of a comprehensive collection of clinical variables.
clinical study of z-213 in subjects with iron-deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: to confirm the safety and efficacy of z-213 until 12 weeks after start of z-213 administration in patients with iron deficiency anemia


Eligibility criteria:
inclusion criteria: * patients with iron deficiency anemia exclusion criteria: * patients with anemia caused by conditions other than iron deficiency * patients with abnormal laboratory test values at screening for serum phosphorus, aspartate aminotransferase, alanine aminotransferase * patients with liver, kidney or circulatory system disease * patients with a history or present illness that is a malignant tumor or autoimmune disease * patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening * patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
addition of pyridostigmine to conventional management of postdural puncture headache

Conditions: Postdural Puncture Headache

Summary: postdural puncture headache (pdph) is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent dural puncture during epidural anesthesia. the presence of pyridostigmine in csf would be expected to increase the level of acetylcholine in csf and subsequently in the brain through inhibition of cholinesterase. the increased level of acetylcholine would produce cerebral vasoconstriction.


Eligibility criteria:
inclusion criteria: * patients american society of anesthesiologists' physical status (asa) ii because of pregnancy. * patients diagnosed with postdural puncture headache following intrathecal spinal anesthesia for elective caesarean delivery. exclusion criteria: 1. patients with pdph and a visual analog scale (vas) score \<5. 2. patients with history of chronic headache, cluster headache, migraine, convulsions. 3. patients with history of cerebrovascular accident, previous neurological diseases. 4. patients with preeclampsia, eclampsia, coagulopathy. 5. patients with severe bleeding (\>20% of blood volume). 6. patients undergoing treatment with vasopressors. 7. patients with bronchial asthma. 8. patients with arrhythmia, and any type of heart block.
developing lung cancer screening in hodgkin lymphoma survivors: a qualitative study

Conditions: Hodgkin Lymphoma

Summary: to explore the topic of lung cancer screening following treatment for hodgkin lymphoma from the perspective of survivors

explore survivors' attitudes towards lung cancer and lung cancer screening explore survivors' understanding of cancer screening as a concept and the benefits of screening and early detection explore survivors' level of awareness of and attitudes towards their lung cancer risk explore survivors' views on the barriers and motivating factors that would impact their decision to attend a lung cancer screening test

Eligibility criteria:
inclusion criteria: * details held in the adapt database at the christie nhs foundation trust * responded to most recent adapt study questionnaire (april - august 2019) * aged 18-80 * previously treated for hodgkin lymphoma without evidence of relapse for at least 5 years * able to provide informed consent * treated with radiotherapy (with lung tissue in the radiotherapy field) and/or alkylating agent containing chemotherapy. exclusion criteria: * previous or current diagnosis of lung cancer * stated within 2019 health questionnaire that they did not wish to be contacted * have participated in lung cancer screening through the manchester lung health checks
revascularisation or medical therapy in elderly patients with acute anginal syndromes

Conditions: Acute Coronary Syndromes

Summary: for octogenarian patients with nstemi (non-st segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.


Eligibility criteria:
inclusion criteria: * age\>80 non-stemi - characteristic chest pain accompanied by * typical ischaemic ecg changes * a troponin rise suitable for conservative or invasive strategy exclusion criteria: * lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity * acute stemi * cardiogenic shock * platelet count =50 x 109/mm3 * patient life expectancy \< 1 year * known allergies to clopidogrel, aspirin, heparin, stainless steel, iv contrast or stent drug elutant * recent major gi haemorrhage (within 3 months) * any previous cerebral bleeding episode * participation in another investigational drug or device study * patient unable to give consent * clinical decision precluding the use of stents

Keywords: revascularisation, octogenarian,acute coronary syndromes
a study of avastin (bevacizumab) in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this study evaluated the efficacy and safety of avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.


Eligibility criteria:
inclusion criteria: * adult patients, 19-75 years of age * multiple myeloma. * progressive disease after at least 2 lines of prior therapy. exclusion criteria: * non-secretory myeloma. * history of malignancy, other than squamous cell cancer, basal cell cancer, or cancer in situ of the cervix within the last 5 years. * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start. * clinically significant cardiac disease.
effectiveness of delirium care protocol after cardiac surgery

Conditions: Delirium, Postoperative

Summary: this study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.

this study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. the research was conducted at antalya training and research hospital between 06.03.2023 and 22.05.2023. the sample of the study consisted of 64 patients who underwent cardiac surgery and met the inclusion criteria. within the scope of the study, patients were divided into two groups: control (32) and intervention (32). while the patients in the intervention group received care in line with the "postoperative delirium prevention, diagnosis and intervention protocol", the patients in the control group received routine nursing care for delirium. the data of the study were collected using the patient identification form, acute physiological and chronic health evaluation, glasgow coma scale, richmond agitation-sedation scale, confusion assessment scale in the intensive care unit, nurse diagnosis form, information assessment form for postoperative delirium (pretest-posttest) and postoperative delirium prevention, diagnosis and intervention protocol checklist. in the first stage of the study, which consisted of three stages, the incidence of delirium in the control group patients receiving routine nursing care and the delirium diagnosis status of the nurses were determined. in the second stage, nurses were given training on postoperative delirium prevention, diagnosis and intervention protocol, and a preliminary study of the protocol was conducted. in the third phase, which is the last phase, patients in the intervention group received care in line with the "postoperative delirium prevention, diagnosis and intervention protocol".

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * being 18 years or older, * ability to speak and communicate in turkish, * having undergone cardiac surgery and being on the first postoperative day, * richmond agitation and sedation scale (rass) score of -3 and above, * having a glasgow coma scale (gcs) score of 8 and above, * not having a serious psychiatric or neurological diagnosis, * no serious visual or auditory problems exclusion criteria: * undergoing surgeries other than cardiac surgery (such as abdominal endovascular aneurysm repair, thoracic endovascular aneurysm repair, deep vein thrombosis, peripheral artery disease, carotid endarterectomy), * previous cardiac surgery, * postponing or canceling the surgery, * no preoperative admission to the cardiovascular surgery service and no emergency surgery.

Keywords: delirium cardiac surgery nursing
prediction of response to kinase inhibitors based on protein phosphorylation profiles in tumor tissue from advanced renal cell cancer patients

Conditions: Renal Cell Cancer

Summary: the rapid development of agents blocking kinases has established the use of molecularly targeted therapy as the preferred treatment approach for patients with metastatic renal cell cancer (rcc). five kinase inhibitors (sunitinib, everolimus, temsirolimus, sorafenib and pazopanib) are now approved for clinical use. response rates differ among these agents, importantly depending on line of treatment. in first-line treatment sunitinib results in 47% objective response rates, where in second-line after cytokines 34% responds. thus far, it is unclear which patient with advanced renal cell cancer will respond to targeted therapy. in order to select patients for targeted therapies, several profiling approaches have been explored but to date no adequate and reliable test is available. it is assumed that responses to targeted agents depend on specific receptor and protein signalling activities in tumor tissues. therefore, we propose that protein phosphorylation profiling with phosphoproteomics may be a potential clinical diagnostic tool to predict for tumor response to targeted therapy.


Eligibility criteria:
inclusion criteria: * patients with advanced (unresectable and/or metastatic) renal cell cancer. * patients who will start treatment with sunitinib, pazopanib, sorafenib, axitinib or everolimus. * at least one tumor lesion should be accessible for biopsy. bone metastases are excluded as possible biopsy site. * age \>- 18 years. * patients must have at least one measurable lesion. lesions must be evaluated by ct-scan or mri according to response evaluation criteria in solid tumors (recist). * who performance status 0 - 2 * able to provide written informed consent exclusion criteria: * clinical findings associated with an unacceptably high tumor biopsy risk, according to the judgement of the investigator. * radiotherapy on target lesions during study or within 4 weeks of the start of drug. * any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.