Kornimate/medical-research-clean huggingface dataset:
study of rad001 for treatment of nf2-related vestibular schwannoma

Conditions: Neurofibromatosis Type 2; Neuroma, Acoustic

Summary: the purpose of the study is to determine if rad001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in neurofibromatosis 2 (nf2) patients. secondary objectives include determining if rad001 treatment will improve hearing ability in nf2 patients. rad001 is an oral drug that is approved by food and drug administration (fda) for other types of tumors, it is not approved by the fda for treatment of nf2 related tumors.

this protocol is a phase ii, open-label, efficacy and safety study of single-agent rad001 in patients with nf2. during the study, subjects will receive continuous daily oral treatment with rad001 for up to 1 year or until tumor progression. primary objective: to determine whether rad001 has an effect on the vs growth in patients with nf2 at a rate sufficient to submit the drug for further testing. secondary objectives: to determine whether rad001 has an effect on the volume of other intracranial tumors, and to assess the effect of rad001 on hearing function in patients with nf2 (when applicable).

Eligibility criteria:
inclusion criteria: * diagnosis of nf2 by national institutes of health (nih) criteria * age ≥ 16 years * progressive vs growth during the previous 12 months. * who performance status \> or = 2 * adequate bone marrow, liver and renal function. * for women of childbearing potential, no pregnancy or breast-feeding * willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. * willingness to provide informed consent exclusion criteria: * inability to tolerate periodic mri scans or gadolinium contrast. * inability to tolerate periodic audiologic testing or to understand a language with established scoring for word recognition testing. * inability to adequately perform volumetric measurement of at least 1 target lesionnote: patients with cochlear or auditory brainstem implants may participate if a target lesion can be accurately assessed. * radiation therapy for the target lesion in the 60 months preceding inclusion in the study. * patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug. * immunization with attenuated live vaccines within one week of study entry or during study period. * presence of a fungal infection requiring systemic antifungal treatment at enrollment * other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. * patients who have any severe and/or uncontrolled medical conditions. * patients with a known hypersensitivity to everolimus or other types of rapamycin or to its excipients. * patients unwilling to or unable to comply with the protocol

Keywords: neurofibromatosis type 2 vestibular schwannoma hearing
phosphodiesterase-5 (pde5) inhibition and pulmonary hypertension in diastolic heart failure

Conditions: Pulmonary Hypertension; Diastolic Heart Failure

Summary: prevalence of heart failure (hf) with left ventricular (lv) diastolic dysfunction and preserved ejection fraction (ef) (hfpef) is increasing. prognosis worsens with development of pulmonary vasoconstriction and hypertension (ph) and right ventricular (rv) failure. the investigators aimed at modulating pulmonary vascular tone and rv burden in hfpef due to high blood pressure (hbp), by using the phosphodiesterase-5 (pde5) inhibitor sildenafil.

heart failure (hf) with preserved left ventricular (lv) ejection fraction (ef) (hfpef) is a public health problem and a major topic in clinical cardiology. its prevalence, in fact, is increasing and the outcome seems to be similar to that of hf with lv systolic dysfunction (lvsd). pulmonary hypertension (ph) in hfpef is highly prevalent and often severe and, like in lvsd (3), is a predictor of morbidity and mortality (4). because of the thin wall and the distensibility, the right ventricle (rv) is much more vulnerable by an excessive afterload than by preload. the pulmonary circulation is a central determinant of rv afterload, and an increase in impendance to rv ejection, like occurring in lv dysfunction, can easily result in rv failure, tricuspid regurgitation, central venous pressure (cvp) rise. development of rv failure is unanimously viewed as a predictor of poor prognosis but the underlying mechanisms have not been extensively investigated. because of the prevalence and clinical significance of ph secondary to hf, attenuation of the pulmonary vascular tone and of the rv hemodynamic burden has been suggested as a goal to be achieved with hf therapy. attempts with endothelin receptor antagonists, or prostacyclin analogues, were basically unsuccessful. experimental models and human studies, showing that in hf nitric oxide (no) - dependent pulmonary vasodilatation is impaired and pulmonary vascular resistance elevation is at least in part due to pulmonary endothelial dysfunction, have suggested therapeutic strategies with agents that increase no activity, like nitrates or phosphodiesterase - 5 (pde5) inhibitors (12-14). the latter agents offer the double advantage of selectively dilating the pulmonary vessels and not producing tachyphylaxis. in this 1-year duration study, the primary end-point was to probe whether pulmonary hemodynamics and rv performance in hfpef with ph may be targets of pde5 inhibition with sildenafil.

Eligibility criteria:
inclusion criteria: * lvef \>50% * sinus rhythm and stable clinical condition defined as no changes in therapeutic regimen, or hospitalization in the 6 months preceding recruitment. * pulmonary artery systolic pressure \> 40 mm hg, exclusion criteria: * patients receiving nitrates * a history of pulmonary disease * alternative causes of ph other than cardiac-related * renal failure (creatinine \> 2mg/dl) * anemia * pericardial disease * cardiac amyloidosis

Keywords: diastolic heart failure pulmonary hypertension
comparing g6pd tests using capillary blood versus venous blood

Conditions: Glucose-6 Phosphate Dehydrogenase Deficiency

Summary: in this study we propose to determine the correlation in glucose-6phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. as secondary endpoints we will seek to correlate phenotype as determined by quantitative and qualitative g6pd test, genotype as determined by pcr and dna sequencing with flow cytometry. the secondary endpoints are critical for the design of g6pd diagnostic test evaluation studies.

in this study we propose to determine the correlation in glucose-6 phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. we will also compare results of different g6pd tests with known g6pd genetic profiles. the results of the study will inform design of future g6pd diagnostic development \& evaluations. this research will be conducted in maesot thailand, where g6pd deficiency has a high prevalence. study participants will be recruited into three groups of 50 volunteers per group: 50 g6pd-deficient individuals, 50 g6pd-normal individuals, and 50 g6pd-intermediate individuals. following a written informed consent, participants will donate about 3 ml of venous blood and about 4 drops of capillary blood (fingerstick). there will be no direct benefit to research participants.

Eligibility criteria:
inclusion criteria: * previous g6pd test at smru clinic * patient willing to participate and sign informed consent form * patient willing to allow donated sample to be used in future research * subjects 18 years of age or older exclusion criteria: * patients with severe malaria or other severe illness * patients who received a blood transfusion in the last 3 months * patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)

Keywords: glucose-6 phosphate dehydrogenase deficiency capillary venous genotype phenotype correlation
an early intervention to increase maternal self-efficacy after preterm birth

Conditions: Posttraumatic Stress Disorder; Stress; Anxiety; Depression

Summary: this study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. participants will be followed up at one month and six months. it is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.


Eligibility criteria:
inclusion criteria: * mothers of very preterm infants born between 28 and 32 weeks of gestation * infant aged up to 8 weeks exclusion criteria: * do not speak french sufficiently well to participate in assessments * have established intellectual disability or psychotic illness * infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)

Keywords: maternal parenting self-efficacy parental stress maternal sensitivity mother-infant bond
progesterone vs placebo therapy for women with epilepsy

Conditions: Epilepsy

Summary: the purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.

this is a 6-month study. the first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. the second 3 months will assess the effects of treatment on these parameters.

Eligibility criteria:
inclusion: 1. subject must be between the ages of 13 and 45. 2. subject must have a history of seizures (documented by eeg). 3. subject must have had at least 2 seizures or auras per month during the past 3 months. 4. subject must be on stable antiepileptic drug therapy for at least 2 months. 5. subject must have cycle intervals between 21 and 35 days during 6 months prior to entry. exclusion: 1. subject that is pregnant or lactating. 2. subject that is on major tranquilizers, antidepressant medications, or reproductive hormones. 3. subject that is unable to document seizures. 4. subject that has progressive neurological or systemic disorder or \> 2-fold elevation in liver enzyme levels

Keywords: epilepsy seizure hormone progesterone catamenial
extracorporeal life support and modification of hemostasis

Conditions: Bleeding Disorder; Extra Corporeal Life Support; Thrombosis

Summary: to evaluate change in coagulation tests during a 48-h period after initiation vv-ecmo and va-ecmo. (ecmo= extra corporeal membrane oxygenator) assessment of bleeding during veno-venous extracoporeal membrane oxygenator (vv-ecmo) and veno-arterial extracoporeal membrane oxygenator (va-ecmo).

this is a multi-center, prospective, pilot cohort study, performed in the intensive care units (icus) of the ghent university hospital, chu liège, university hospital brussels, and university hospital munster. each group will contain 20 subjects; in total there will be 40 subjects 2 groups of 20 patients group 1: vv-ecmo n = 20 group 2: va-ecmo n = 20 * demographics: age, sex, comorbidities, medication, reason for ecmo therapy * simplified acute physiology score (saps) 3 at time of icu admission. * components of the sequential organ failure assessment score daily (based on worst value of each component of the score) * ecmo characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations) * incidence and severity of bleeding, scored according to the gusto and barc scores * coagulation profile: at inclusion (before heparine infusion is started), 2h after start of therapy, 24h, and 48h, and at specific moments of clinical suspicion of profound altered hemostasis. we defined a coagulation profile as a set of tests that includes * prothrombin time (pt), international normalized ratio (inr) * activated partial thromboplastin time (aptt) and heparin ratio * the fibrinogen level * platelets * act (iact®, ...) * d-dimer * rotem (extem, intem, heptem) or teg (utrecht) * at iii * anti xa * temperature daily (h/l) (core) * patient characteristics that may influence coagulation or the results of coagulation tests: body weight, body mass index, drugs, c-reactive protein (as a marker for inflammation), hemoglobin level, ldh, unconjugated bilirubin, (or haptoglobine or plasma free haemoglobin, if tested) * heparin dose

Eligibility criteria:
inclusion criteria: * group 1: patients who will be initiated on vv-ecmo within a 12-h period * group 2: patients who will be initiated on va-ecmo within a 12-h period * ≥ 18 years * signed informed consent, signed by subject or authorized representative exclusion criteria: expected survival \<48-h known coagulopathy pregnancy
clinical and molecular staging of lung cancer stages i and iip

Conditions: Lung Cancer

Summary: the classification of lung cancer (lc) according to the degree of anatomical extension (tnm) allows the estimation of the prognosis of the patient, although its accuracy is limited. in fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. the incorporation of genetic, epigenetic and proteomic information to tnm staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.in this project a prospective cohort of 320 patients with lung cancer staged i-iip will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of tnm staging.this project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with spanish collaborative group in lung cancer.


Eligibility criteria:
inclusion criteria: * over 18 years old * able to understand and sign the informed consent exclusion criteria: * absence of mediastinal disease

Keywords: biomarkers, early detection
physician preference study of shuntcheck - madsen

Conditions: CSF Flow Through the Shunt of a Hydrocephalus Patient

Summary: shuntcheck can be used to detect csf flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction. secondarily, the shuntcheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)


Eligibility criteria:
inclusion criteria: 1. subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors 2. subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle. 3. subjects must be physically stable as determined by the physician. exclusion criteria: 1. subjects with the presence of an open wound at the shunt site that could interfere with the collection of shuntcheck data. 2. subjects unable to lie supine with head elevated 30 degrees or less 3. subjects who have had shunt surgery within two weeks. 4. inability or unwillingness of subject to endure the test. 5. other judgments of the investigator.
comparison of pilates and aerobic exercises on pain, anxiety and qol in pms

Conditions: Premenstrual Syndrome

Summary: the significance of this study is that it may improve the premenstrual symptoms like pain and anxiety in females with premenstrual syndrome and improve their quality of life. this study may add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy. therefore, the study will be done to compare the effects of pilate exercises and aerobic exercises on pain, anxiety and quality of life in females with premenstrual syndrome.


Eligibility criteria:
inclusion criteria: * unmarried * age between 18-30 years * patients with at least 5 of 11 symptoms on premenstrual syndrome questionnaire exclusion criteria: * patients suffering from any disability. * patients suffering from diabetes or hypertension or any other chronic illness. * spine fracture or history of any previous surgery.
effect of eplerenone in elderly hypertensive early stage chronic kidney disease (ckd) patients

Conditions: Hypertension; Chronic Kidney Disease.

Summary: the purpose of this study is to determine whether eplerenone is effective in the treatment of blood pressure, heart function, renal function in elderly hypertensive stage1 (egfr\>=90ml/min/1.73m2) and stage2 (egfr 60-89ml/min/1.73m2) chronic kidney disease (ckd) patients.

chronic kidney disease (ckd) was reported to be affecting 11% of the all population. this number is much higher in the elderly population and may be as high as 30%. ckd is an independent risk factor of cardiovascular disease (cvd). this is called "cardio-renal continuum". the renin-angiotensin-aldosterone system (ras) plays pivotal roles in both cardiovascular and renal functions. the increased oxidative stress by activated ras on vascular endothelium is one of important factor to development of cardio-renal continuum. the blockade of ras by angiotensin i converting enzyme inhibitors (aceis) and/or angiotensin receptor blockers (arbs) has been reported to ameliorate the renal disease and cvd; however,they do not completely suppress ras and may induce aldosterone breakthrough that plays important roles for the development of cvd. eplerenone, a selective aldosterone blocker, is effective against essential hypertension; however, little is known about the effects of eplerenone on heart and kidney functions in elderly hypertensive ckd patients. in this study, we assessed the efficacy of eplerenone on heart and kidney functions in elderly hypertensive early stage (stage1 (egfr\>=90ml/min/1.73m2) and stage2 (egfr 60-89ml/min/1.73m2)) ckd patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stage1(egfr\>=90ml/min/1.73m2) and stage2 (egfr 60- 89ml/min/1.73m2)chronic kidney disease * clinical diagnosis of hypertension (blood pressure \>=140/90mmhg) * elderly people(\>=65 years old) exclusion criteria: * the patients who are already taking eplerenone * stage3(egfr 30-60 ml/min/1.73m2),stage4(egfr 15-30 ml/min/1.73m2)and stage5 (egfr \<15 ml/min/1.73m2) ckd patients * the patients who are receiving hemodialysis or peritoneal dialysis * the patients who are taking itraconazole, ritonavir and nelfinavir * the patients who are taking potassium-sparing diuretics and potassium supplement * the patients who have hyperkalemia(\>=5.5meq/ml) * severe heart failure (\>=nyha class iii) * insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (\>=hba1c 9.0\&) * severe liver dysfunction (five folds increased ast or alt than standard values)

Keywords: elderly early stage chronic kidney disease hypertension eplerenone
the accuracy of endometrial ultrasound to predict implantation

Conditions: Infertility, Subfertility

Summary: to measure the accuracy of different ultrasound endometrial patterns to predict successful embryo implantation during assisted conception; in vitro fertilisation (ivf) or intracytoplasmic sperm injection (icsi).

ultrasound appearance of the endometrium may predict successful implantation in assisted conception, but studies have yielded conflicting results. the explanation may be different timing of, and classification systems for, the scan, different treatment protocols, and different definitions of success. also scan quality has improved over time. this is a prospective study looking at the endometrial pattern as a predictor of ivf/icsi outcome, adjusting for embryo quality, ease of transfer, and fresh or frozen cycles. the study will focus on good quality single embryo transfer at the blastocyst stage. other endometrial ultrasound parameters such as thickness, volume and doppler will also be measured. reliability studies will also be conducted to assess and account for inter- and intra-observer variation. 200 women will be recruited. they will include approximately 100 undergoing fresh and 100 undergoing frozen embryo transfer. there will be no change to routine clinical care. a single operator will analyse all ultrasound images to reduce inter-observer variation. when there is uncertainty about the pattern the chief investigator will be consulted to reach an agreement.

Eligibility criteria:
inclusion criteria: * female undergoing in vitro fertilisation or intracytoplasmic sperm injection (ivf/icsi) * own or donated eggs * informed consent exclusion criteria: * known pathology affecting the endometrial cavity (polyp, submucosal fibroid) * septate uterus or more complex uterine abnormality.

Keywords: in vitro fertilisation (ivf) intra cytoplasmic injection (icsi) endometrial pattern ultrasound
the effect of self-management support provided to hypertension patients affected by the earthquake via tele-nursing on patients' treatment compliance and self-care management

Conditions: With Tele-Nursing

Summary: this important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. this study will be carried out at fırat university hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. the sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. it has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study. . the results obtained within this framework may provide guidance in the development and implementation of turkey's health policies, and may also shed light on strategies for the management of other similar health problems. on the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the development plan, further emphasize the importance of this research. the success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into turkey's healthcare system and be an important step towards achieving strategic goals in this field.


Eligibility criteria:
inclusion criteria: * being followed for at least 6 months with the diagnosis of essential hypertension, * patients diagnosed with hypertension who suffered financial or moral loss after the earthquake * located in elazığ at the time of the february 6 earthquake * continuing to live in elazığ after the earthquake * using antihypertensive medication, * no change in antihypertensive drug treatment has been made in the last month, * computer/tablet/smartphone etc. to watch videos. having technological devices, * having internet access, * being over 40 years old, * education level must be at least primary education level exclusion criteria: * being pregnant or breastfeeding * presence of another accompanying chronic disease (diabetes mellitus, cancer, chronic renal failure, chronic obstructive pulmonary disease, heart failure, etc.), * having physical (speech, hearing impairment, etc.), neurological and psychological problems that prevent filling out research forms and participating in training.