Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of elagolix in pre-menopausal women with heavy uterine bleeding and uterine fibroids

Conditions: Heavy Uterine Bleeding; Uterine Fibroids

Summary: the purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.


Eligibility criteria:
inclusion criteria: * subject is a pre-menopausal female 20 to 49 years of age. * subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria: * at least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound. * only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary). * ultrasound procedures were performed during the screening period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements. * subject has a history of regular menstrual cycles between 24 to 35 days. * subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss \> 80 ml during 2 screening menstrual cycles, measured by the alkaline hematin method. exclusion criteria: * subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation. * subject has a history of osteoporosis or other metabolic bone disease. * subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. * subject has a history of clinically significant condition(s) including but not limited to: * endometriosis * epilepsy or seizures * type 1 diabetes * any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy

Keywords: uterine fibroids heavy uterine bleeding elagolix menorrhagia abt-620 leiomyomata elagolix sodium
pep flute-selfcare in covid-19

Conditions: COVID-19; SARS-CoV-2

Summary: most research on the coronavirus sars-cov-2 and covid-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. it is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. thus, there is a need of measures to help the sars-cov-2 infected individual at home to overcome the course of disease with less symptoms and strain. a positive expiratory pressure (pep) flute is feasible for home use and it is possible that regular use of pep flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with covid-19 disease. the primary objective of the study is to examine the effect of pep flute use among sars-cov-2 infected, non-hospitalized patients on self-reported change in copd assessment test (cat) score during 30 days of follow-up. the secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.

it is hypothesized that the pep flute has positive effects on sars-cov-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group. finally, potential subgroup effects by gender, age, comorbidity and bmi at study entry will be explored for all outcomes. based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. based on the present testing strategy and covid-19 incidence, current expectations are that two months should be enough to recruit 400 patients. the investigators will allow for recruitment to the end of december 2020, but will terminate enrolment at n = 400. link to detailed protocol paper will be added once published.

Eligibility criteria:
inclusion criteria: * positive sars-cov-2 * symptoms of sars-cov-2 infection e.g. fever, cough and shortness of breath. * access to use a smartphone * can reply to a questionnaire (sent on email, text messages or via telephone interview) in danish * given informed consent exclusion criteria: * age \< 18 years. * any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders. * hospitalised patients or citizens living in nursing homes

Keywords: covid-19 sars-cov-2 respiratory symptoms positive expiratory pressure positive expiratory pressure flute airway clearance techniques
a phase iii study of comparing paclitaxel plus 5-fluorouracil versus cisplatin plus 5-fluorouracil in chemoradiotherapy for locally advanced esophageal carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.

locally advanced esophageal squamous cell carcinoma. t2-4n0-1m0-1a,txn1m0-1a，txnxm1a （according to ajcc2002） scheme: eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (n0 or n1), then randomized to 2 arms at 1:1 ratio. arm cisplatin: chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles. arm paclitaxel: chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.

Eligibility criteria:
inclusion criteria: * joined the study voluntarily and signed informed consent form; * age 18-75 * both genders * esophageal squamous cell carcinoma confirmed by pathology * local advanced esophageal squamous cell carcinoma (t2n0m0-txnxm1a, ajcc 2002) * no radiotherapy, chemotherapy or other treatments prior to enrollment * ps ecog 0-2 * life expectancy of more than 3 months * hemoglobin（hb）≥9 g/dl * wbc≥3x109/l, neutrophils (anc )≥1.5x109/l * platelet count (pt) ≥100x 109/l * hepatic function: alat and asat \< 2.5 x uln, tbil\<1.5 x uln * renal function: creatinine \< 1.5 x uln * no immuno-deficiency * use of an effective contraceptive for adults to prevent pregnancy. exclusion criteria: * complete esophageal obstruction * deep esophageal ulcer * esophageal perforation * haematemesis * after surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * participation in other interventional clinical trials within 30 days * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * drug addiction * alcoholism or aids * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * patient who has metastasis such as lung, liver metastasis

Keywords: esophageal squamous cell carcinoma chemoradiotherapy
pencil beam proton therapy for recurrences in anal cancer patients previously treated with radiotherapy (dacg 5)

Conditions: Anal Cancer; Recurrent Anal Cancer

Summary: this protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). the over-all aim is to improve local tumor control with acceptable side effects.


Eligibility criteria:
inclusion criteria: * recurrent anal cancer * bioptically verified (squamous cell carcinoma) * available dose plan from primary radiotherapy * previous rt (\>30gy eqd2) * evaluated in mdt-conferences (herlev, aarhus) * age\>18 years * ps 0-2 * adequate organ function * written informed consent exclusion criteria: * distant metastases deemed without curative intended treatment options (pet-ct) * unable to undergo mri, pet-ct * inability to attend full course radiotherapy and follow up in the outpatient clinic.
identification of anticancer drugs associated with cancer therapy-related cardiac dysfunction: a pharmacovigilance study

Conditions: Heart Failure; Cancer, Therapy-Related

Summary: therapeutic advances have significantly improved the survival of patients with cancer. however, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy. among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death. patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. it is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions. the explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction. using vigibase, the world health organization's (who) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs.


Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case reports to 29/02/2024 * patients treated with fda and/or ema approved cancer therapies (approval the 30th september 2023).
sildenafil and exercise capacity in hypertension

Conditions: Hypertension

Summary: hypertension (persistently elevated blood pressure) is a major risk factor for heart disease and stroke. hypertensive individuals show a reduced exercise capacity, which is present from a very early stage and contributes to their increased cardiovascular risk. sildenafil belongs to a class of drugs called phosphodiesterase type 5 (pde5) inhibitors, and it works by enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases blood flow. we hypothesize that sildenafil, because of its effect on nitric oxide and blood flow, will improve exercise capacity in hypertensive patients. therefore, the main aim of the study is to investigate the effects of pde5 inhibition on exercise capacity and vascular function in hypertension, and to compare these effects in hypertensive patients and healthy controls.


Eligibility criteria:
inclusion criteria: * male (age range: 18 - 70 years) * appropriate blood pressure range * hypertensive - systolic bp ≥140 mmhg and/or diastolic bp ≥90 mmhg * controls - systolic bp \<140 mmhg and diastolic bp \<90mmhg * written informed consent exclusion criteria: * female * history of coronary artery, cerebrovascular or peripheral vascular disease within the last 6 months * total cholesterol \>6.5 mmol/l * current alcohol abuse * diabetes mellitus * asthma * taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study * ecg evidence of clinically significant arrhythmia or cardiac ischaemia * clinically significant abnormality on screening blood test * contraindication to strenuous exercise * current involvement in other research projects * other clinically relevant conditions * lack of written informed consent

Keywords: hypertension exercise capacity pde5 inhibitors
validity and reliability of the sitting assessment scale in cerebral palsy

Conditions: Cerebral Palsy

Summary: the sitting assessment scale is a valid and reliable scale that evaluates sitting balance in cerebral palsy (cp). the validity and reliability study of the scale has been done, but it has not been adapted to turkish language. the aim of this study is to adapt the sitting evaluation scale, which evaluates sitting balance in cerebral palsy, into turkish and to examine the validity and reliability of the turkish version of the scale.

cerebral palsy will be participate the study between the ages of 2 and 18 years. children's classified with gmfcs and macs. evaluation will be applied to the volunteer participants after the translation steps of the sitting evaluation assessment are completed. the validity of the scale will be examined in terms of construct validity and content validity. all evaluations will be performed in the clinic with the specialist physiotherapist.

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy voluntary participation, * age between 2-18 years exclusion criteria: * not voluntary to participate in the research, * botox in the last 6 months, * hip or spine surgeries in the last 6 months

Keywords: cerebral palsy validity
impact of the prism-care multidisciplinary oncology program on secured drug intake of patients with kidney cancer

Conditions: Metastatic Renal Cell Carcinoma

Summary: the rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. the clinical consequences (reduced efficacy and potentialized toxicity) are all the more important that ambulatory monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings. adverse drug reactions are a major concern, as such, and because they involve prescription changes (dose reduction, treatment interruption). this results in a decrease in the dose taken and a risk of loss of efficacy. in the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher because the oral targeted therapies available in this indication have a safety profile marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce the treatment adherence (digestive and skin toxicities). in addition, these molecules are metabolized by the cyp3a4 hepatic cytochrome, which leads to avoid associating them with drugs inducing and / or inhibiting the cyp3a4, because of the risk of toxicity and / or loss of efficacy. the investigators propose to assess a program set up to secure drug taking by enhancing self-management of side effects and control of drug interactions by the patient. this program includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent pharmacist and liberal nurse) professionals. the hypothesis of the study is that the prism care program will improve self-management of side effects by the patient, resulting in a relative dose intensity of oral chemotherapy improved compared to usual care.


Eligibility criteria:
inclusion criteria: * patient aged 18 years old or more * with metastatic renal cell carcinoma * with an initiation or change of oral targeted therapy, especially: tyrosine kinase inhibitor (sunitinib, sorafenib, pazopanib, axitinib) or mtor inhibitor (everolimus) * with ambulatory status (not hospitalized for the management and treatment of its metastatic renal cell carcinoma) * without either cognitive disorders or major psychiatric disorders * with a sufficient autonomy for the management of medication at home * having declared an outpatient doctor * having declared a usual pharmacy * having given his written consent to participate in the study exclusion criteria: * significant cognitive and psychiatric disorders * management of medication at home exclusively performed by the family caregiver * patient in an institution or under guardianship, major protected by law * patient refusing to participate in the study

Keywords: oral chemotherapy relative dose intensity health related program secured drug intake
prevena™ incision management system vs conventional management for wound healing

Conditions: Wound Healing; Prevena; Dirty Abdominal Surgery; Contaminated Abdominal Surgery; Emergency Abdominal Surgery; Negative-Pressure Wound Therapy

Summary: comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

all patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. the investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing. in the study group inpwt (prevena) is positioned immediately next surgery and dressed for six days. every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score. moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.

Eligibility criteria:
inclusion criteria: * abdominal surgery * open surgery * contaminated or dirty surgery exclusion criteria: * not abdominal surgery * mininvasive surgery * clean surgery
antipsychotic therapy and first episode

Conditions: Schizophrenia

Summary: for schizophrenic patients who remained in remission while on maintenance medication, there may come a point in time when the relative risk for relapse become so low that discontinuation of therapy can be considered. this study is to investigate whether that point in time is reached in 12 months following the first episode illness. moreover, it also aims to identify other predictors of relapse as well as to evaluate the costs and benefits of maintenance therapy.


Eligibility criteria:
inclusion criteria: * male or female patients, from 18 to 65 years of age at visit 1 * patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing. * patients must agree to cooperate with all tests and examinations required by the protocol. they must be willing to comply fully with treatment * patient must understand the nature of the study and must sign an informed consent document. * patients must be cantonese speaking han chinese * patients must be diagnosed, according to the scid for dsm-iv, with schizophrenia, schizoaffective disorder or schizophreniform psychosis. * patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in clinical global impression scale (cgi) severity of illness; a rating of 4 or below in improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (suspiciousness) of positive and negative syndrome scale (panss) for at least 8 weeks exclusion criteria: * female patients who are either pregnant or lactating. * patients previously on clozapine should be excluded from the study * significant medical illnesses including seizures. * dsm-iv substance (alcohol or other drugs) abuse or dependence within the past 3 months. * judged clinically to be at serious suicidal risk. * treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
a longitudinal observational cohort study of nsi-189, with out-patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: all subjects completing the randomized treatment period in protocol ns2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. the study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.

following completion of the ns2014-1 final study visit procedures, subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of nsi-189. the enrollment visit begins when informed consent is signed.the duration of the follow-up period will be up to 6 months, until the start of a new antidepressant treatment. subjects who provide consent will be seen for in-person visits every 8 weeks, with bi-monthly phone visits occurring between in-person visits. safety assessments and efficacy assessments will be performed at each visit. no study drug will be taken during the longitudinal observational cohort study.

Eligibility criteria:
inclusion criteria: 1. subject has the ability to understand the purpose, potential benefits and risks of the study and to provide signed and dated informed consent, authorizing the use of protected health information in accordance with national and local subject privacy regulations. 2. subject completed the 12-week randomized treatment period and final study visit for the ns2014-1 clinical study. exclusion criteria: 1. subjects taking excluded medications. 2. subject who, in the opinion of the site investigator, are unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study. 3. subject who, in the opinion of the site investigator, are unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up and improbability of completing the clinical study.

Keywords: depression major depressive disorder (mdd) major depressive disorder neurogenesis synaptogenesis nsi-189 neuralstem
observance of anticonvulsant treatments and quality of life of epileptic children

Conditions: Epilepsy; Children, Only; Quality of Life; Seizures; Patient Compliance

Summary: there is little epidemiological data in the literature on the therapeutic compliance of epileptic children. yet it is a fundamental issue in the therapeutic education and balance of this pathology. to obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). propose an evaluation of the quality of life of their children by a suitable self-questionnaire.


Eligibility criteria:
inclusion criteria: * • child aged 5 to 17 * child who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data * holder (s) of the parental authority present (s) having received the complete information on the organization of the research and not being opposed to the participation and the exploitation of the data of his child * epileptic child * follow-up at the neuro pediatric department of chru nancy exclusion criteria: * epileptic encephalopathy * multiply handicapped child

Keywords: epilepsy children seizures patient compliance quality of life