Kornimate/medical-research-clean huggingface dataset:
melphalan and filgrastim to stimulate peripheral stem cells in patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood. purpose: phase ii trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.

objectives: * determine the safety and efficacy of melphalan when used with filgrastim (g-csf) for stem cell mobilization in patients with multiple myeloma. * analyze how this mobilization regimen affects parameters of stem cell (cd34+) mobilization and collection in these patients. * determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients. outline: patients undergo peripheral blood stem cell (pbsc) mobilization consisting of melphalan iv on day 1 and filgrastim (g-csf) subcutaneously beginning on day 2 and continuing until pbsc collection is complete. patients are followed at 1 month. projected accrual: a total of 11-32 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * diagnosis of multiple myeloma * must have received induction therapy within the past 3 months * chemoresponsive disease * greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory * no symptomatic pleural effusions * eligible for stem cell transplantation patient characteristics: age: * 18 and over performance status: * ecog 0-3 (ecog 3 allowed only if due to bone disease or neuropathy) life expectancy: * not specified hematopoietic: * platelet count at least 150,000/mm\^3 hepatic: * bilirubin no greater than 2.5 mg/dl renal: * creatinine no greater than 2.5 mg/dl or * creatinine clearance greater than 51 ml/min cardiovascular: * no symptomatic cardiomyopathy * no medically documented symptomatic cardiac arrhythmias within the past 60 days * no new york heart association class iii congestive heart failure * no myocardial infarction within the past 6 months other: * no other concurrent medical conditions that would preclude study * no uncontrolled infections * no other active malignancy within the past 5 years except for non-melanoma skin cancer * not pregnant * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior stem cell mobilization or transplantation chemotherapy: * see disease characteristics * no more than 200 mg prior oral melphalan endocrine therapy: * not specified radiotherapy: * no more than 3000 cgy of prior radiotherapy for myeloma surgery: * not specified

Keywords: stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
effect of carbamazepine and oxcarbazepine on serum neuron-specific enolase and s100b in focal seizures

Conditions: Seizures, Focal

Summary: the present study has been planned to assess the level of serum neuron-specific enolase (nse) in focal seizures and its changes after antiepileptic therapy.

epileptic seizures can cause neuronal cell death, enhanced neurogenesis, axonal sprouting, dendritic changes, and reactive gliosis. histopathological analyses have suggested that the initial insult and recurrent seizures contribute to the neuronal damage. activation of mesial temporal structures is more likely to cause damage than that of other areas of brain; therefore, one of the consequences of prolonged seizures is selective neuronal loss in the hippocampus. the excitotoxic damage is considered the most important mechanism of injury but there is also evidence that programmed cell death contributes to neuronal damage. various biomarkers of brain damage have been studied in the context of epilepsy and brain damage but most widely investigated biochemical biomarker is neuron-specific enolase (nse). nse is γγ-isoenzyme of enolase involved in glycolysis pathway. nse originates predominantly from the cytoplasm of neurons and neuroendocrine cells. neuronal damage and impairment of blood brain barrier integrity can be detected by the release of nse into cerebrospinal fluid (csf) and eventually into blood. nse is therefore regarded as a marker of neuronal damage and prognosis in various disorders associated with cell damage in the central or peripheral nervous system. csf and serum nse levels obtained within first 48 hours were found to be elevated and correlated well with the duration of epilepsy and outcome of patients. some studies have shown elevated nse levels in temporal lobe epilepsy, after single tonic-clonic seizures, and status epilepticus. literature review reveals that there is lack of data on serum nse in focal seizures and there is no study on the effect of antiepileptic drugs on the level of serum nse. so the present study has been planned to assess the level of serum nse in focal seizures and its changes after antiepileptic therapy.

Eligibility criteria:
inclusion criteria: * all patients with the clinical diagnosis of localization related epilepsy/focal seizure (international league against epilepsy 2010) with a history of an episode of seizure within 48 hours of presentation * treatment naïve patients or patients who had not taken any treatment for at least 3 weeks before inclusion. exclusion criteria: * history of any recent traumatic brain injury, cerebral ischemia/transient ischemic attack/stroke * patients with neuroendocrinal tumours * history of any invasive neurosurgical /non-invasive neuropsychiatric procedure. * patients who are already under treatment for the presenting conditions. * medication history of psychoactive or central nervous system depressant drugs * pregnant and nursing women

Keywords: neuron-specific enolase (nse) carbamazepine oxcarbazepine
haemodynamic stability of ketamine/propofol admixture "ketofol" in patient undergoing endoscopic retrograde cholangio pancreatography

Conditions: Pancreatitis; Cholangitis

Summary: the investigators aim to evaluate the effect of ketamine/propofol admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during endoscopic retrograde cholangiopancreatography.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists ( i ,ii ) exclusion criteria: 1. presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity. 2. history of substance abuse or dependence. 3. history of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs. 4. pregnancy.
safety and efficacy study of gamaline+hipericin in pms

Conditions: Edema; Depression; Hot Flashes; Anxiety; Irritability

Summary: gamaline is already register for pms and hipericin as antidepressive drug. both plant extracts. the investigators will try the mixture and see if the vasomotor symptoms will disappear. the investigators expect that together all symptoms will be covered better than gamaline alone. the investigators will run for 180 days measuring at t0, t1 and t6 (starting point, 30 days and 180 days).

this protocol wants to show the advantages for the mixture gamaline 900mg+hipericin 300mg - 2 herbal extracts for pms treatment against the individual use of gamaline

Eligibility criteria:
inclusion criteria: * climacteric pre-menopausal women between 45 e 55 anos * women between 25 e 44 anos exclusion criteria: * age inferior 25 anos or superior 55 anos and/or decline invitation. * patients pos-menopause * under hormone therapy * thyroid disease * under psychiatric therapy or medication * history for allergies and hypersensitivity to one or both extracts * breast feeding or pregnancy * no knowledge for writing and/or reading

Keywords: pms, climacteric, depression
investigating pompe prevalence in neuromuscular medicine academic practices

Conditions: Pompe Disease

Summary: the incidence of type ii glycogen-storage disease (pompe disease) varies depending on ethnicity and geographic region. as of 2010, nine studies have been published documenting the incidence of pompe disease. it is most common within the african american population, with an incidence of 1 in 14,000. in the u.s. more broadly speaking, the combined incidence of all three variants of the disease is 1 in 40,000. these estimates relied on the frequencies of three mutations in the gene acid alpha-glucosidase (gaa), leading to variants of the disease. criteria for inclusion in the studies were often non-selective; in many cases, molecular genetic screening was done at birth. with such a high prevalence of pompe disease reported, it is expected that large university medical centers specializing in neuromuscular diseases would see a higher incidence of pompe disease among their patients. from a comparable italian multicenter study, it appears that pompe disease accounts for 3% of all patients presenting with proximal weakness with or without ck elevation. this study will measure the incidence of pompe disease based on manifest laboratory abnormality, namely low gaa enzyme activity. analysis of gaa enzyme activity will be determined through a blood sample of 4 ml. the study seeks to measure the epidemiology of pompe disease by symptomatically screening all patients who present with symptoms of hitherto undiagnosed proximal weakness with or without elevation of the muscle enzyme, creatinine kinase (ck), or elevation of ck alone, at thirteen academic tertiary neuromuscular practices throughout the united states and canada. total recruitment is expected to be \~1,500 participants. it is anticipated that the number of incident pompe cases in this cohort would be between 3-5%, i.e. 45-75 newly diagnosed cases of pompe disease.


Eligibility criteria:
inclusion criteria: * age 8 years or older. * geographically accessible to one of the sites. * one of these following three clinical situations: complaint of proximal muscle weakness with or without elevation in creatinine kinase (ck); neck muscle weakness (either flexor or extensor) with or without elevation in ck; or elevation of ck in isolation. * capable and willing to provide informed consent or assent and follow study procedures. exclusion criteria: * less than 8 years of age. * subjects with an alternative neuromuscular diagnosis that is responsible for subject's symptoms * incapable or unwilling to provide informed consent and to follow research procedures.
sedation influence on delirium and post-traumatic stress-disorder as a result of hospitalization in intensive care

Conditions: Delirium; Stress Disorders, Post-Traumatic

Summary: the aim of this study is to investigate if sedation of intensive care unit (icu) patients influences the development of delirium during their icu stay and if incidences of delirium have an impact on the development of post-traumatic stress-disorder (ptsd). hypothesis 1: patients who are minimally sedated, remember staying in icu and experiences fewer episodes of delirium than patients that are heavily sedated hypothesis 2: former delirious patients are more likely to develop ptsd hypothesis 3: delirium decreases health-related quality (hrqol) of life after discharge

background: it is known that icu patients that experience delirium have longer hospital stay, higher mortality and morbidity. other studies indicate that ptsd, dementia or depression may emerge after discharge from hospital. methods according to hypothesis 1: during icu stay: measure sedation level \& delirium. first follow-up 1-2 weeks after icu: memories analyses: data will be analyzed descriptive via epidata and stata delirium is endpoint, defined as cam-icu positive. sedation level is exposure variable. confounders: priory antipsychotic treatment or hypertension,glasses or hearing aids,alcohol and tobacco abuse,degree of illness,age and sex. correlation between sedation level and memories will be calculated. methods according to hypothesis 2: screening for: ptsd, depression, anxiety analyses: ptsd is endpoint, and delirium is the exposure variable. main confounders: anxiety and depression mean of ptsd will be calculated with confidence interval to test any difference between experienced delirium or not. methods according to hypothesis 3: method:health-related quality of life is endpoint, activities of daily living (adl), memories, and a script test (only after 2 month) analyses: mean of hrqol will be calculated with confidence interval to test any difference between experienced delirium or not. confounders: diary and/or follow up

Eligibility criteria:
inclusion criteria: * icu-stay \> 48 hours exclusion criteria: * severe brain trauma * non-danish-speaking * age \< 18 years * death (only hypothesis 2 and 3 in the study)

Keywords: sedation delirium ptsd depression anxiety hrqol cam-icu rass sf-36 icu-memory tool antipsychotic agents mobilization icu-nursing icu intensive care critical care critical care nursing
china atopic dermatitis registry study

Conditions: Dermatitis, Atopic

Summary: this regestry study is aimed to characterize the medical care and drug treatment under real-life conditions among chinese patients with moderate to severe atopic dermatitis who are not well controlled by topical therapies.

atopic dermatitis (ad) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. a survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland china has shown that the incidence of ad in outpatients (7.8%) has been raised in recent years. among topical therapy of ad, corticosteroids are first line therapy. in patients with extensive and severe dermatitis, topical therapy may be insufficient. such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. there is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. there is not clear recommendation grade for these therapy in chinese ad guideline and no published data to demonstrate current treatment situation in real clinical practise. the goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. this study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among ad patients in china.

Eligibility criteria:
inclusion criteria: * age≥12; * ad according to williams diagnosis criteria (see appendix 1); * moderate to severe ad that inadequately controlled by topical therapy * moderate-to-severe: scorad score≥25; or * inadequately controlled by topic therapies: determined by physicians. exclusion criteria: * no.
the public private partnership addressing literacy-numeracy to improve diabetes care

Conditions: Type 2 Diabetes

Summary: the primary hypotheses are that the intervention will improve a1c, blood pressure, lipids, weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24 months follow-up.


Eligibility criteria:
inclusion criteria: * patient has a clinical diagnosis of type 2 diabetes * age 18-85 years * english or spanish speaking * most recent a1c ≥ 7.5% * patient agrees to participate in the study for the full two years duration. exclusion criteria: * poor visual acuity (vision worse than 20/50 using rosenbaum pocket screener) -- significant dementia or psychosis (by health provider report or chart review) * terminal illness with anticipated life expectancy \< 2 years (per health provider or patient report).

Keywords: diabetes
morphine-sparing efficacy of parecoxib in pain treatment after radical prostatectomy

Conditions: Pain, Postoperative

Summary: the primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.

the study was terminated due to lack of recruitment due to competing alternative operation methods on 13september 2010. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * the patient's asa physical status is 1 or 2 and he has a low risk (i.e.,\<10%) of developing an acute coronary event within the next 10 years according to the procam risk assessment calculator. * the patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia. exclusion criteria: * the patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the investigator's opinion, would contraindicate study participation or confound interpretation of the results * the patient has a history or current presence of congestive heart failure (nyha ii-iv), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
the value of 68ga-fapi pet/ct in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery

Conditions: Thyroid Cancer

Summary: this study aims to investigate the value of 68ga-fapi pet/ct in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery.

the investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. all participants will undergo a 68ga-fapi pet/ct when recurrence or metastasis is suspected. the imaging response measurements will be compared with follow-up results or histopathological findings as the gold standard.

Eligibility criteria:
inclusion criteria: 1. patients with thyroid cancer who have undergone surgery and are suspected of recurrence or metastasis during clinical evaluation. 2. signed and dated informed consent form. 3. commitment to comply with research procedures and co-operation in the implementation of the full research process. 4. aged 18-80 years old. exclusion criteria: 1. patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc. 2. intestinal perforation, complete intestinal obstruction. 3. pregnant women and women who may be pregnant, women who are breastfeeding. 4. non-compliant person.

Keywords: thyroid cancer 68ga-fapi pet/ct
the effect of exercise on ovarian reserve

Conditions: Physical Exercise

Summary: the purpose of this study is to examine how different levels of physical activity impact the ovarian reserve during the pre-menopausal period

two groups are included: 1. the study group: women between 20-35 years of age who practice high level of physical activity, as defined by international physical activity questionnaire , for the past 3 years 2. the control group: women between 20-35 years of age who practice low level of physical activity, as defined by international physical activity questionnaire , for the past 3 years women who meet the criteria for inclusion for will be recruited to the study after signing a consent form. recruitment will be done through sport centers. the control group will include women being examined in gynecologic emergency department, after signing a consent form, if they meet the control group's inclusion criteria. these women will be asked to fulfill the international physical activity questionnaire and additional questionnaire regarding relevant demographic and medical information (see below). blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. ultrasound will be performed to measure antral follicular count and ovarian blood flow. data collection: 1. demographic information on age, weight, height, bmi, marital status 2. medical information regarding chronic diseases and medications 3. obstetrical history 4. information regarding physical activities in the version of international physical activity questionnaire . 5. information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5 pads). 6. hormonal profile - follicle-stimulating hormone , luteinizing hormone , progesterone, estradiol, thyroid-stimulating hormone . 7. antral follicle count, anti-mullerian hormone 8. leptin levels -reflecting metabolic changes.

Eligibility criteria:
inclusion criteria: study group: 1. women between 20-35 years of age who practice high level of physical activity, as defined by international physical activity questionnaire, for the past 3 years 2. bmi 18-25 3. regular menstruation control group: 1. women between 20-35 years of age who practice low level of physical activity, as defined by international physical activity questionnaire, for the past 3 years 2. bmi 18-25 3. regular menstruation exclusion criteria: 1. polycystic ovary syndrome 2. endometriosis 3. diabetes 4. hyper/hypothyroidism 5. bmi\>25, bmi\<18 6. active or past eating disorder -
stem cells and secretomes for infertility therapy in polycystic ovary syndrome (pcos) patients with insulin resistance.

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to investigating the effect of umbilical cord mesenchymal stem cell (uc-mscs) and secretomes to insulin resistance in polycystic ovary syndrome (pcos) patients. this study has 4 arms namely uc-mscs treatment, secretomes treatment, uc-mscs and secretomes treatment, and control.

the investigator hypothesized that pcos patients with insulin resistance given combination of uc-mscs and secretomes can improve their clinical and laboratory insulin resistance, haid ovulatory cycle and fertility. all group will be observed every 1,3, and 6 months after injection.

Eligibility criteria:
inclusion criteria: * pcos patients with insulin resistance based on rotterdam consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea) * patients must have hiperandrogenemia clinical and laboratory proof (ferriman gallwey score \>8) * patients with free androgen index (fai) \>4 and ovary polycystic from usg transvaginal * patients with homeostatic (homa) ir score ≥ 1.7 exclusion criteria: * patients who are allergic to component of wj-msc or secretome. * patients who are not currently on hormon treatment of other resistance treatment. * refusing or not participating in part / all of the research process. * patients with positive diagnosis of hepatitis a,b,c, and hiv

Keywords: umbilical cord mesenchymal stem cell secretome