Kornimate/medical-research-clean huggingface dataset:
effectiveness and safety study on different timing of preventive ileostomy closure after surgery for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer. to evaluate the effectiveness and safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical resection of rectal carcinoma). this study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

a temporary stoma may, in fact, result in reduced quality of life because of feelings of physical and mental restriction, debilitating nuisance, among other problems. skin irritation, prolapse, and retractionare quite common after ileostomy. a high incidence of parastomal hernia, ileus, and increased salt and fluid loss has been reported, which may also contribute to greater willingness of both the surgeon and patient to close the temporary stoma as soon as possible. currently, it remains unclear whether stoma closure should be performed after the end of chemotherapy or during chemotherapy (12 weeks or 24 weeks after radical resection of rectal carcinoma). the aim of this study is to assess the possible impact of stoma closure timing on postoperative results and to evaluate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

Eligibility criteria:
inclusion criteria: * sign the informed consent * postoperative pathology is rectal adenocarcinoma * primary middle and low rectal cancer patients (tumor distance from the anal margin is less than 10 cm) * underwent total mesorectal excision for rectal cancer with preventive loop ileostomy exclusion criteria: * postoperative pathology is not rectal adenocarcinoma (rectal neuroendocrine tumor, lymphoma, etc.) * postoperative pathologic staging of rectal cancer is i phase, ii phase * underwent total mesorectal excision for rectal cancer without preventive loop ileostomy * emergency operation for rectal cancer * disease progression (local recurrence or distant metastasis, etc.) * anastomotic stenosis * serious system disease, including heart dysfunction, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases * participate in other clinical trial * pregnancy or perinatal woman * combined with other malignant tumor * with a history of neurological and psychiatric disorders * patients with abnormal bone marrow suppression after chemotherapy
relationship between maternal awareness about vitamin d for under- five years children and their health status outcomes

Conditions: Maternal Care Patterns; Child Nutrition Disorders; Vitamin D Deficiency

Summary: the observational study aims to identify the relationship between maternal awareness about vitamin d for under-five-year-old children and their health status outcomes. the research question is : is there a relationship between maternal awareness about vitamin d for under-five years children and their health status outcomes? mothers of children under five will be interviewed about their knowledge and practices regarding vitamin d and their children's health status. each child will be observed for the manifestation of vitamin d deficiency and to measure their weight and height.

the observational study aims to identify the relationship between maternal awareness about vitamin d for under-five-year-old children and their health status outcomes. the research question is : is there a relationship between maternal awareness about vitamin d for under-five-year-old children and their health status outcomes? this study will be conducted in the outpatient and inpatient departments of smouha children's university hospital (scuh) at alexandria and matrouh general hospital and specialized children's hospital at matrouh city. mothers of children under five will be interviewed about their knowledge and practices regarding vitamin d and their children's health status. each child will be observed for the manifestation of vitamin d deficiency and to measure their weight and height. written informed consent for participation will be obtained from a under five years mothers after an explanation of the aim of the study, their voluntary participation, and the right to withdraw from the study at any time.

Eligibility criteria:
inclusion criteria: * under-five years exclusion criteria: * any associated neurological and chronic disorders

Keywords: vitamin d maternal awareness under-five children health status outcomes
study on the consistency evaluation of organoids used in the clinical treatment of ovarian cancer with anti-tumor drugs

Conditions: Ovarian Cancer; Organoid

Summary: this is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. the purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the clinical efficacy of anti-cancer drugs


Eligibility criteria:
inclusion criteria: - patients with ovarian cancer who are diagnosed as ovarian cancer by tissue and/or cytology and need neoadjuvant, adjuvant or standard treatment age 18-75 years old (including 18 years old and 75 years old) it is clear that there are measurable lesions (according to recist1.1) exclusion criteria: - patients with concurrent radiotherapy and chemotherapy, less than half a year of radiotherapy, or patients undergoing radiotherapy during the study period during the study period, patients need other tumor treatment methods such as surgery, intervention, radiofrequency ablation, etc. immune deficiency or severe bone marrow suppression the patient has severe liver and kidney disease, cardiovascular disease, blood disease, etc. illegal use of drugs or chronic alcohol abuse or total daily alcohol intake\> 50 g/d lack of autonomy, unable to walk, or unable to participate in the 6-month follow-up
single dose of 9-cis-retinoic acid in hepatic patients

Conditions: Hepatic Insufficiency

Summary: to test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.


Eligibility criteria:
inclusion criteria: 1. have biopsy verified hepatic insufficiency 2. medically stable. 3. ultra sonic examination of lever within the past 3 months 4. no pregnancy documented in women. use of anticonception during study and 1 month after exclusion criteria: 1. odd blood counts and samples not related to hepatic disease 2. encephalopathy (\> grad ii) 3. concomitant treatment with pharmaca that is metabolized by cyp3a4 in the liver. 4. cardiac disease 5. kidney disease 6. epilepsia 7. stroke 8. esophagal bleeding 9. severe ascites 10. hiv-positivity 11. psychiatric disorder 12. cancer 13. pregnancy or lactating women.

Keywords: metabolisation of 9-cis-retinoic acid hepatic patients investigation of urine and blood samples
intraoperative approach with eventual clearance of common bile duct by spyglass discover vs sequential strategy in patients with acute calculus cholecystitis and intermediate/high risk of common bile duct stone

Conditions: Acute Calculous Cholecystitiis (ACC)

Summary: inaccessible trial is a randomized controlled study that compares two different strategies for the treatment of acute calculous cholecystitiis (acc) patients with high/intermediate risk of cbds, according to the score by khoury t (named israelian score, is). if a patient meets the inclusion and exclusion criteria, (s)he will be randomized to receive ercp + early laparoscopic cholecystectomy (elc) in two stage procedures (control group) or elc + spyglass cholangiography (study group). the follow-up will be performed after 30 days and 6 months from intervention with an outpatient medical examination


Eligibility criteria:
inclusion criteria: * have a diagnosis of acc as defined by 2018 tokyo guidelines criteria * have an israelian score (is) for the risk of main bile duct stones of 2 or 3 * be \>18 years old * onset of symptoms ≤7 days before emergency department (ed) admission * provide signed and dated informed consent form * be willing to comply with all study procedures and be available for the duration of the study. exclusion criteria: * pregnancy * patients unwilling to undergo follow-up assessments * patients diagnosed with concomitant cholangitis or pancreatitis * acute cholecystitis not related to a gallstone etiology * onset of symptoms \>7 days before ed admission * altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum * biliary peritonitis
the connection between areas in the brain of blind patients

Conditions: Blindness; Brain Mapping; Healthy

Summary: the purpose of this study is to test the belief that specific areas of the brain are connected differently in blind patients than patients with sight. in addition, the study will examine the different anatomical connections between brain areas of patients who became blind early in life versus patients who became blind later.

the purpose of this protocol is to test the hypothesis that the anatomical connectivity of occipital and somatosensory areas in early blind subjects differs from that in subjects who became blind later in life and from that in sighted volunteers.

Eligibility criteria:
inclusion criteria: subjects with late blindness. subjects with early blindness. sighted volunteers. age between 18 and 65 years. exclusion criteria: subjects with personal or family history of seizures or other neurological or demyelinating disorders. pregnant women tested after urine pregnancy test. subjects with metal in the cranium except mouth. subjects with intracardiac lines and implanted medication pumps. subjects with increased intracranial pressure as evaluated by clinical means. subjects with cardiac pacemakers. intake or neuroleptics. subjects with blindness secondary to degenerative cns diseases.

Keywords: plasticity magnetic stimulation pet blind braille transcranial magnetic stimulation
lenalidomide in combination with chop in patients with untreated ptcl

Conditions: PTCL, NOS; AITL; ALK- ALCL; Phase III-IV ALK+ ALCL; EATL

Summary: the prognosis of ptcl (except early stage alk+ alcl) is dismal. previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory ptcl. the investigators therefore design this phase ii study to investigate the safety and efficacy of lenalidomide in combination with chop in patients with treatment-naive ptcl.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed ptcl, nos, aitl, alk- alcl, phase iii-iv alk+ alcl, eatl according to who 2016 criteria. 2. ecog ps 0-2 3. age 18-70 years old 4. expected survival ≥ 12 weeks 5. a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm) 6. understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. 7. female subjects in childbearing age, their serum or urine pregnancy test must be negative. all patients must agree to take effective contraceptive measures during the trial measures exclusion criteria: 1. women who are pregnant or lactating. patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures 2. active hepatitis b or hepatitis c virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to hiv infected persons 3. patients known to have varicella or herpes zoster virus infection 4. previous exposure to any anti-tumor therapy 5. poor hepatic and/or renal function, defined as total bilirubin, alt, ast, cr more than two fold of upper normal level,ccr# 50 ml/min unless these abnormalities were related to the lymphoma 6. history of dvt or pe within past 12 months 7. poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/l or platelet count less than 75×109/l, unless caused by bone marrow infiltration 8. new york heart association class iii or iv cardiac failure; or ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia 9. cns or meningeal involvement 10. known sensitivity or allergy to investigational product 11. major surgery within three weeks 12. patients receiving organ transplantation 13. patients with secondary tumour, excluding cured (5 years without relapse) in situ non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, gastrointestinal intramucous carcinoma and breast cancer 14. presence of grade iii nervous toxicity within past two weeks 15. active and severe infectious diseases 16. any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment 17. in any conditions which investigator considered ineligible for this study.

Keywords: ptcl lenalidomide untreated chop
antimalarial treatments for clearing low density p. falciparum and its impact on malaria transmission

Conditions: Plasmodium Falciparum; Asymptomatic Parataemia; Sub Patent Parasitaemia

Summary: the malaria parasite plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. we are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern sudan.


Eligibility criteria:
inclusion criteria: * all residents of the 8 villages exclusion criteria: * pregnancy * history of allergy to sulfa drugs
comparison of tolerability and clinical performance of two emulsion-type artificial tears

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the performance between two emulsion-type artificial tears.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and over inclusive. * males or females * patient is in generally good \& stable overall health. * patient likely to comply with study guidelines \& study visits. * informed consent signed. * osdi score \>18 or * tbut \<10 seconds exclusion criteria: * corneal refractive surgery or contact lens wear within 6 months of this study. * current use of restasis * intra-ocular surgery within 6 months or ocular laser surgery within 6 months. * pregnant or lactating women. * ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Keywords: artificial tears
the study of efficacy and safety of generic methylphenidate prolong-released comparison with original

Conditions: Adhd

Summary: this study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (pr-mph) in children with adhd who had received immediate-release methylphenidate treatment

this 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with adhd. they will be randomized to receive generic or original pr-mph for 4 weeks and then switch to another brand for 4 weeks. swanson, nolan and pelham parent rating scale is used to measure the primary outcome.

Eligibility criteria:
inclusion criteria: * ages 6 to 12 years * diagnosis of adhd according to dsm-5 of icd-10 * patient who receiving a stable dose of ir-mph for at least 4 weeks before screening * patient who has a stable clinical symptoms. * patients or their legal representatives provide informed consent prior to enrollment exclusion criteria: * patients who present of a serious obstructive gastrointestinal disease * patients cannot swallow the whole tablet * patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study * patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder * patients or patients' family have a history of poor compliance * patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days * patients who receiving pr-mph except stop taking more than 7 days * patients' parent has a family problem and currently treatment with family therapy or adjust medication
a study to evaluate efficacy and safety effects using mikelan® la ophthalmic solution (os) 2% versus timoptol® xe ophthalmic solution (os) 0.5% in ocular hypertension patients

Conditions: Glaucoma

Summary: the primary objective of the clinical study is to evaluate the efficacy and safety for mikelan la eye drops 2% (once per day) of intra-ocular pressure decreased.


Eligibility criteria:
inclusion criteria: 1. male or females outpatients with primary open-angle glaucoma or ocular hypertension; 2. subjects who have received latanoprost at least 4 weeks, and in the end of screening period, subject's intra-ocular pressure is ≧18mmhg (choice of one eyes is possible), or investigator judges the reduction of iop is insufficient of individual subject. 3. aged between ≧ 20 and ≦80 years old when giving informed consent to the study. exclusion criteria: 1. hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study; 2. patients wearing contact lenses; 3. patients with severe dry eyes; 4. patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start; 5. patients who had laser trabeculoplasty within 2 months before starting study; 6. patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study; 7. patients who had herpetic keratitis or corneal ulcer within 2 months before starting study; 8. patient who are receiving systemic administration of drugs that may have and effect on iop; 9. patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock; 10. patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof; 11. patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis; 12. patients with aortic stenosis, raynaud's syndrome, intermittent claudication, or pheochromocytoma; 13. patients with myasthenia gravis; 14. patients with severe hepatic or renal disorder judged by investigator; 15. patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period; 16. patients who have treatment with any investigational drug when giving informed consent; 17. patients with significant alcohol, drug or medication abuse as judged by investigator; 18. patients whom investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complication)
a post-marketing observational study of vyxeos™

Conditions: Acute Myeloid Leukemia With Myelodysplasia-Related Changes; Therapy-Related Acute Myeloid Leukemia

Summary: the purpose of this observational study is to provide data on the incidence and severity of infusion-related reactions during and immediately following each infusion of vyxeos during the first induction.


Eligibility criteria:
inclusion criteria: 1. the decision to prescribe vyxeos must have been made prior to enrollment in this study and based upon approved us indications and dosing: 44mg/m2 daunorubicin and cytarabine 100 mg/2 on days 1, 3, and 5. 2. ability to understand and voluntarily give informed consent and understand the requirements of the registry. 3. age ≥ 18 years. 4. initiating vyxeos therapy for the first time according to the current prescribing information. 5. initiating vyxeos therapy for the first time according to standard institutional practice. exclusion criteria: 1. prior treatment with vyxeos. 2. patients receiving any investigational agent other than vyxeos (e.g., any drug or biologic agent or medical device that has not received approval in the us) or receiving vyxeos for any indication not currently approved in the us.

Keywords: newly-diagnosed t-aml or aml-mrc
berlin deep brain stimulation depression study

Conditions: Treatment Resistant Depression

Summary: in this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. in addition, the stress axis, the cortical gabaergic system, neurotrophins and event-related potentials will be assessed.


Eligibility criteria:
inclusion criteria: * patient is diagnosed with a severe major depressive episode * patient is in a chronic current mde and/or has had a history of recurrent mdes * patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode. * patient has a score \> 20 on the hamd24 * patient is stable on current psychotropic medication for at least 6 weeks * patient is \>25 and \<80 years * global assessment of function (gaf) score of \< 45 exclusion criteria: * atypical depression (according to dsm iv) * other relevant psychiatric axis i or axis ii diseases * relevant neurological diseases * relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (asa score \> 3) * patient is currently enrolled in another investigational study not associated with the current study * patient has a history of, or evidence of, significant brain malformation or significant head injury * patient is likely to require a whole body mri after implantation