Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of crizanlizumab in sickle cell disease related priapism

Conditions: Priapism

Summary: the goal of the study was to evaluate the efficacy and safety of crizanlizumab in sickle cell disease (scd) patients with priapism.

before participating in this study, information to determine key eligibility criteria was collected as a part of a 14-week pre-screening period. the study included a 12-week screening period and a 52-week (1 year) treatment period. eligible participants received crizanlizumab 5 mg/kg by intravenous infusion (iv). study treatment was received at clinic visits on week 1 day 1, week 3 day 1, and then on day 1 of every 4-week cycle. efficacy assessments included evaluation of priapic and vaso-occlusive (voc) events. safety assessments included laboratory tests, electrocardiograms (ecgs), vital signs and physical examinations. participants had a safety follow-up for up to 15 weeks after the last dose.

Eligibility criteria:
inclusion criteria * male patients aged 12 years and above * confirmed diagnosis of scd by hemoglobin electrophoresis or high-performance liquid chromatography. all scd genotypes were eligible (hbss, hbsβ0, hbsc, hbsβ+, and others) * experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation * experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12-week screening period with at least 1 event occurring within 4 weeks prior to the first treatment * if receiving hydroxyurea/hydroxycarbamide or l-glutamine or erythropoietin stimulating agent or voxelotor, must have been receiving the drug for at least 14 weeks prior to screening and planned to continue taking the drug at the same dose and schedule during the trial * if receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and planned to continue taking the drug at the same dose and schedule during the trial * written informed consent (or assent/parental consent for minor participants) prior to any screening procedures exclusion criteria: * had penile prosthetic implants or shunts or any other surgical procedure on the penis performed within 12 months prior to consenting was not allowed * took drugs/medications that may induce priapism over the 14 weeks preceding study entry * received leuprolide acetate (lupron) or any other gonadotropin releasing hormone receptor agonist agent within 3 months before pre-screening * had an erection lasting more than 12 hours over the 14 weeks preceding study entry * had an erection lasting more than 12 hours during the 12 weeks of the screening period

Keywords: priapism sickle cell disease scd crizanlizumab p-selectin seg101 monoclonal antibody prolonged erection painful erection
targeting cd5 car-t cells in the treatment of r/r cd5+ t-all

Conditions: T-Acute Lymphoblastic Leukemia

Summary: a clinical study on the safety and effectiveness of targeting cd5 car-t cells in the treatment of r/r cd5+ t-all

in this study, 30 patients with relapsed refractory t-all were proposed to undergo cd5 car-t cells therapy. under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of cd5 car-t cells therapy for relapsed refractory t-all; at the same time, on the basis of expanding the sample size, more safety data on cd5 car-t cells treatment for relapsed refractory t-all were accumulated.

Eligibility criteria:
inclusion criteria: * 1. according to the national comprehensive cancer network (nccn) clinical practice guidelines for acute lymphocytic leukemia (2020. v1), patients diagnosed as cd5+t-all; * 2. consistent with r/r cd5+t-all diagnosis, including any of the following conditions: 1. no cr after standard chemotherapy; 2. the first induction reaches cr, but cr ≤ 12 months; 3. patients with r/r cd5+t-all have not responded to the first or multiple remedial treatments; c.multiple recurrences. * 3. cd5 expression rate was \>90%; * 4. number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry); * 5. total bilirubin ≤51 (mol/l), alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/l); * 6. echocardiography showed left ventricular ejection fraction (lvef) ≥50%; * 7.refers to the pulse oxygen saturation 92% or higher oxygen (state); * 8.estimated life expectancy of minimum of 12 weeks; * 9.ecog 0-2; * 10.pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 11. those who voluntarily participated in this trial and provided informed consent; exclusion criteria: * 1.patients with the history of epilepsy or other cns disease; * 2. patients with prolonged qt interval time or severe heart disease; * 3. active infection of hepatitis b virus, c virus or hepatitis e virus; * 4. active infection with no cure; * 5. before using any gene therapy products; * 6. received anti-tumor therapy before infusion, should meet the following any one should be ruled out: 1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug); 2. received within 72 hours of small molecule targeted therapy; 3. 2 weeks received systemic chemotherapy except (pretreatment); 4. four weeks received radiotherapy; * 7. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; * 8. any unsuitable to participate in this trial judged by the investigator; * 9. any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Keywords: cd5 car-t
implementation of nutrition education videos for patients undergoing radical cystectomy

Conditions: Bladder Cancer

Summary: by doing this study the investigators hope to learn if educational videos focusing on nutrition for bladder cancer patients are a good and effective way to help people improve their nutrition and recovery after radical cystectomy (rc).

bladder cancer is the fifth most common cancer in the usa. the primary treatment for invasive bladder cancer is chemotherapy followed by rc. patients undergoing this surgery are at risk for complications. being malnourished can increase the risk of mortality by three times. the patients also suffer from taste alterations after chemotherapy and gastrointestinal disturbances such as diarrhea and constipation. these can lead to poor nutritional intake and malabsorption of nutrients. this study is being done to develop an educational video series for patients undergoing rc and assess their impact. the videos are created to address the nutritional needs of these patients and improve their outcomes after surgery.

Eligibility criteria:
inclusion criteria: * diagnosed with bladder cancer and scheduled to undergo a radical cystectomy or has undergone a radical cystectomy or be the caregiver of a patient diagnosed with bladder cancer who is scheduled to undergo a radical cystectomy or has undergone a radical cystectomy exclusion criteria: * 1. patients who are under 18 years old are not allowed to participate

Keywords: nutrition diet radical cystectomy
two electroacupuncture waveforms for different severity groups of bell palsy

Conditions: Bell Palsy

Summary: bell palsy (bp) is the most common cause of acute facial palsy, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. electroacupuncture (ea) received attention as an alternative and complementary treatment method. the low-frequency continuous wave ea and the intermittent wave ea have been used in the management of bp. the aim of this study is to compare the efficacy and safety of these two electroacupuncture waveforms for different severity groups of bp.

the investigators will recruit 60 patients with bp whose enog test indicate a mild to moderate facial nerve damage, as indicated by the ratio of amplitude of the compound muscle action potential (cmap) of the affected side comparing to normal side is 20% or higher. and the investigators will recruit 60 patients with bp whose enog test indicate a severe damage, as indicated by the ratio of amplitude of the cmap of the affected side comparing to normal side is less than 20%. both the two types of patients will be randomly divided into either the low-frequency continuous wave group, or the intermittent wave group, and receive 4 weeks treatment. the primary outcomes is change from baseline score of the facial nerve grading system 2.0. the secondary outcomes are change from baseline score of the sunnybrook grading scale, and change from baseline value of the amplitude of the cmap of the affected side in the enog test.

Eligibility criteria:
inclusion criteria: 1. diagnosed as bp by specialist. 2. the score of fngs 2.0 ≥ 15 at the day 21 since the onset of bp. 3. 18 years ≤ age ≤ 65 years. 4. received prednisolone within 72 hours since initial symptoms of bp, the prednisolone dose used was 60 mg per day for 5 days and then reduced by 10 mg per day. 5. signed informed consent and volunteered to participate in this study. exclusion criteria: 1. facial palsy caused by other diseases or injury. 2. ramsey-hunt syndrome. 3. bilateral facial palsy. 4. history of previous facial palsy. 5. manifesting facial spasm, facial synkinesis or contracture at day 21 since the onset of bp. 6. history of surgery on face. 7. combined with uncontrolled diabetes mellitus, uncontrolled hypertension, serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders. 8. installing pacemakers. 9. pregnant and lactating patients.

Keywords: bell palsy acupuncture treatment clinical study
the remote study: investigating the effects or online exercise on quality of life in men with prostate cancer

Conditions: Prostate Cancer

Summary: currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the covid-19 pandemic. however, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. the investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. as a result, the investigators have developed a remote/online exercise programme to explore this further. this study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. the study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. this project is open to men with prostate cancer on long term hormone therapy. the intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.


Eligibility criteria:
inclusion criteria: * have had an orchiectomy or; * are receiving a gnrh agonist/antagonist or; * are currently receiving abiraterone, enzalutamide, apalutamide or darolutamide * long-term retention is planned (intending to remain on the above stated treatments for at least the next 6 months). exclusion criteria: * patients who are currently classed as in active treatment i.e. are currently receiving chemotherapy/radiation therapy (note: patients that are included in the study but after inclusion are moved onto chemo/radiation therapy, will still be able to participate in the project). * patients who are stratified as high risk for having a cardiovascular event. * acute illness; or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put them at risk from exercising, as determined by screening and their clinician. * men with painful or unstable bony metastases.

Keywords: prostate cancer exercise online quality of life
reintegrating children living at landfills in burundi into society by means of a comprehensive family program addressing maltreatment and mental health symptoms

Conditions: Posttraumatic Stress Disorder; Aggressive Behaviour; Parental Maltreatment; Days Spent at the Landfill

Summary: children living at the landfills of bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. furthermore, they grow up in severe poverty. addressing trauma-related mental health issues and aggressive behaviour by narrative exposure therapy (fornet), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the burundian school system and improving familial relationships. the investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.


Eligibility criteria:
inclusion criteria: * spending days at the landfills of bujumbura exclusion criteria: * psychotic symptoms
comparative effectiveness of neuroprotectants on acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the primary objective of this study is to compare effectiveness of five different neuroprotectants, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke. the secondary objectives of the study are as follows: * to compare safety of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke. * to compare cost-effectiveness of five different neuroprotectents, including butylphthalide, edaravone, citicoline, cerebrolysin, and piracetam, among patients with acute ischemic stroke.

study population:the study population will consist of consenting patients who are on neuroprotectant injection for the treatment of acute is during hospitalization. hospitals may contribute differing numbers of patients to the total sample size. primary analyses will be conducted on the total sample size only. assessment of outcomes:the outcome measures in this study include effectiveness, safety and cost measures.

Eligibility criteria:
inclusion criteria: * at least 18 years old * ischemic stroke confirmed by brain ct or mri within 14 days of the index event * neuroprotectents administrated during hospitalization * direct admission based on physician evaluation or arrival through the emergency department * ability of patient or legally authorized representative (primarily spouse, parents, adult children, otherwise indicated) to provide informed consent.

Keywords: ginkgo leaves butylphthalide edaravone citicoline cerebrolysin piracetam neuroprotectants
danish vulva cancer recurrence study

Conditions: Vulva Cancer; Vulva Neoplasm; Vulvar Cancer; Vulva Disease; Vulvar Neoplasms; Vulvar Diseases; PROM; Circulating Tumor DNA; Survivorship

Summary: the overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (vc) to identify optimal treatment- and surveillance programs. davulvarec is a danish nationwide multicenter study with patient inclusion from aarhus university hospital and rigshospitalet, denmark. applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. furthermore, the investigators aim to examine if circulating tumor-dna (ctdna) can be detected in liquid biopsies from vc patients. all patients will be followed for two years or until recurrence. patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses. total number of patients to be included is 295 according to a power calculation. all patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from the danish gynecological cancer database. hence, the control group will consist of 1000 vc patients diagnosed between 2011-2022. hypotheses: * all patients with vc will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctdna at the time of diagnosis. * measurement of ctdna after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent vc. * proactive use of repeated prom assessments in combination with procedural actions during surveillance will allow early detection of recurrent vc and early identification of late effects after treatment.


Eligibility criteria:
inclusion criteria: * primary or recurrent biopsy-verified squamous cell carcinoma of the vulva * ≥ 18 years of age * able to understand oral and written information in danish exclusion criteria: * active treatment for concurrent cancer and/or dissemination of concurrent cancer
prevalence of metabolic syndrome in atahualpa

Conditions: Metabolic Syndrome

Summary: a recent epidemiologic survey demonstrated a high prevalence of type 2 diabetes mellitus in atahualpa residents. now, the investigators attempt to evaluate the prevalence of the metabolic syndrome in adults aged 40 years or more living in this rural village of coastal ecuador.

several studies have shown that the occurrence of the metabolic syndrome is a risk factor for the development of cerebrovascular and ischemic heart disease. to evaluate the prevalence of the metabolic syndrome, we will invite all atahualpa residents aged 40 years or more to participate in this study. for the purposes of this study we will obtain the waist circumference of all individuals, will measure their blood pressure using a standard protocol, and will take a blood sample to determine fasting glucose levels, hdl cholesterol levels, triglyceride levels, and plasma insulin levels.

Eligibility criteria:
inclusion criteria: * atahualpa resident aged 40 years or more exclusion criteria: * non-consenting persons

Keywords: metabolic syndrome diabetes mellitus
liraglutide effect on beta-cell function in c-peptide positive type 1 diabetes

Conditions: Type 1 Diabetes

Summary: recent studies show that many type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. finding means to increase this production would be of tremendous interest, since residual c-peptide concentrations \>0.1 nmol/l previously have been shown to markedly lower hba1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. it also substantially reduces the risks of severe hypoglycemic events and late complications. liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells. the hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve c-peptide concentrations over time.


Eligibility criteria:
inclusion criteria: 1. written informed consent for participation of the study, given before undergoing any study-specific procedures. 2. 18-30 years of age (age interval inclusive of both the ends). both males and females are eligible for the study 3. clinical diagnose of t1d 4. five or more years duration of disease 5. hba1c between 45 and 75 mmol/mol 6. fasting plasma c-peptide concentration \>1.5 pmol/l. exclusion criteria: 1. inability to provide informed consent 2. mental incapacity 3. unwillingness or language barrier precluding adequate understanding or cooperation 4. ongoing or planned pregnancy within the next 12 months 5. inadequate or no use of contraceptives 6. ongoing breast feeding 7. known sight-threatening retinopathy 8. creatinine clearance \<60 ml/min 9. life-threatening cardiovascular disease 10. history of drug/alcohol abuse 11. known or suspected allergy to trial product or related product 12. recurrent assisted hypoglycemias 13. taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin 14. uncontrolled hypertension (180/105 mmhg or above) 15. history of acute or chronic pancreatitis 16. personal or family history of multiple endocrine neoplasia type 2 (men2) or familial medullary thyroid carcinoma (fmtc) 17. personal history of non-familial medullary thyroid carcinoma. 18. any condition that the investigator or sponsor feel would interfere with trial participation or evaluation of results
a study of methoxy polyethylene glycol-epoetin beta (mircera) in participants with chronic kidney disease (primavera)

Conditions: Kidney Disease, Chronic

Summary: this randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with mircera in participants with chronic kidney disease on renal disease progression. participants will be randomly assigned to receive 30 microgram (mcg) mircera as subcutaneous injection once monthly or matching placebo. depending on change of hemoglobin values, the dose of mircera can be adjusted to 50 mcg or 75 mcg once monthly. the anticipated time on study treatment is 24 months.


Eligibility criteria:
inclusion criteria: * for diabetic participants: type 2 diabetes mellitus with glycated hemoglobin (hba1c) greater than (\>) 7% or anti-diabetic treatment * for renal allograft recipients: status at least 6 months post transplantation * chronic kidney disease stage iii * urinary albumin-to-creatinine ratio less than (\<) 3000 milligram (mg)/gram (g) or total protein \<3000 mg/ 24 hour urine sample where applicable exclusion criteria: * hemoglobin-level \ 14 g/deciliter (dl) * average systolic blood pressure (sbp) \> 140 millimeter of mercury (mm hg) or average diastolic blood pressure (dbp) \> 90 mm hg * initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment * present and known iron deficiency * hba1c \>9%