Kornimate/medical-research-clean huggingface dataset:
ft819 in subjects with b-cell malignancies

Conditions: Lymphoma, B-Cell; Chronic Lymphocytic Leukemia; Precursor B-Cell Acute Lymphoblastic Leukemia

Summary: this is a phase i dose-finding study of ft819 as monotherapy and in combination with il-2 in subjects with relapsed/refractory b-cell lymphoma, chronic lymphocytic leukemia and precursor b-cell acute lymphoblastic leukemia. the study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility criteria:
key inclusion criteria: diagnosis of b-cell lymphoma, cll or b-all as described below: b-cell lymphoma: * histologically documented lymphomas expected to express cd19 * relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy chronic lymphocytic leukemia (cll): * diagnosis of cll per iwcll guidelines * relapsed/refractory disease following at least two prior systemic treatment regimens precursor b-cell acute lymphocytic leukemia (b-all): * diagnosis of b-all by flow cytometry, bone marrow histology, and/or cytogenetics * relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. for subjects with philadelphia-chromosome positive (ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen all subjects: * capable of giving signed informed consent * age ≥ 18 years old * stated willingness to comply with study procedures and duration * contraceptive use for women and men as defined in the protocol key exclusion criteria: all subjects: * females who are pregnant or breastfeeding * eastern cooperative oncology group (ecog) performance status ≥2 * body weight \<50 kg * evidence of insufficient organ function * receipt of therapy within 2 weeks prior to day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to day 1 * currently receiving or likely to require systemic immunosuppressive therapy * ongoing requirement for systemic gvhd therapy following prior allogeneic hematopoietic stem cell transplant (hsct) or allogeneic car-t * receipt of an allograft organ transplant * known active central nervous system (cns) involvement by malignancy * non-malignant cns disease such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease * clinically significant cardiovascular disease * positive serologic test results for hiv infection * positive serologic and polymerase chain reaction (pcr) test results for hepatitis b (hbv) infection * positive serologic and pcr test results for hepatitis c (hcv) infection * live vaccine \<6 weeks prior to start of lympho-conditioning * known allergy to albumin (human) or dmso

Keywords: lymphoma leukemia bcl cll b-all car-t cellular therapy
effect of a botanical ingredient in healthy subjects with anxiety and poor sleep quality

Conditions: Poor Quality Sleep

Summary: randomized, controlled, double-blind, single-center clinical trial with two parallel arms depending on the product consumed (experimental product and placebo product) to analyze the efficacy of a botanical extract in reducing anxiety and improving sleep quality.

subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose or placebo, depending on the group to which they have been assigned). the product to be consumed is a botanical extract. participants will consume the product for 90 days. they should consume one capsule one hour before going to sleep. they will make a total of five visits to the research laboratory and the tests preestablished in the protocol will be performed. subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Eligibility criteria:
inclusion criteria: * healthy adults. * moderate levels of anxiety by stai. * low sleep quality by psqi. * volunteers able to understand the clinical study and willing to comply with its procedures and requirements. exclusion criteria: * serious or terminal illness. * subjects with body mass index above 32 kg/m2. pregnant or lactating women. * participation in another study involving blood draws or dietary intervention. * organic dementias such as alzheimer's, huntington's disease, parkinson's and senile dementia. * hypersensitivity to the components of the formula. * use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs. * subjects with known allergy to some of the study components. * inability to understand the informed consent.

Keywords: botanic extract
a phase 2 randomised controlled trial to evaluate efficacy and safety of anaprazole in patients with duodenal ulcers.

Conditions: Duodenal Ulcer，DU

Summary: a phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of anaprazole 20mg qd, 40mg qd compared with rabeprazole 10mg qd in patients with duodenal ulcers.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, male and female 2. has endoscopic diagnosis of active duodenal ulcer(s) (a1 or a2 stage) within 7 days prior to randomization 3. 1 or 2 ulcers, 3-15 mm in diameter. 4. signed informed concent form exclusion criteria: 1. has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer, esophageal erosion and ulcer, reflux esophagitis, zollinger-ellison syndrome. 2. has esophageal and gastric varices； 3. with severe compliaction, such as pyloric obstruction, bleeding (forrest i, iia and iib) or perforation, and etc； 4. has other gastrointestinal disease (e.g.gastric ulcer), or has history of inflammatory bowel disease (such as crohn's disease or ulcerative colitis)； 5. has undergone surgical resection or partly resection of esophageal, stomach or duodenum； 6. has used proton pump inhibitors(ppis) within 5 days prior to randomization, or continuous more than 3 days of use of proton pump inhibitors within 2 weeks prior to randomization； 7. has been treated with triple or quandruple helicobacter pylori eradication therapy included ppis within 28 days prior to randomization； 8. current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding or continuous more than 3 days of use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior to randomization； 9. laboratory tests performed in screning stage revealed alanine aminotransferase (alt) or aspartate aminotransferase (ast): \> 1.5 upper limit of normal (uln); 10. laboratory tests performed in screning stage revealed thyroid stimulating hormone (tsh)； 11. woman in pregnancy or lactation period； 12. plan for pregancy or not willing to contracept with reliable contraception method during study period and within 90 days after the final time of investigational drug administratio； 13. have alcohol abuse or drug abuse 1 years prior to screening； 14. has hypersensitivity or allergy to investigatory drug, comparatory drug or related supplements； 15. has participated or been participating other clinical trials(non-interventional study is excluded)； 16. has an uncotroled disease, such as has a history of significant central nervous system (cns), cardiovascular, pulmonary, hepatic, renal, or mental or psychological disorders with drug treatment that,in the opinion of the investigator, would not be suitable for participating this clinical trial. 17. in the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.
topical use of difinsa53™ to prevent radiation dermatitis

Conditions: Radiodermatitis

Summary: phase ii trial of the silibin containing cream, difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

the proposed study seeks to evaluate the efficacy of difinisa53™, a safe silibin-based skin cream, on preventing radiation dermatitis (rd) when compared to an over the counter ointment, aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. presently there is no known fully effective topical protectant from rd and there is no consensus among radiation oncologists on how best to treat rd. this study seeks to identify a more effective option for patients receiving radiation therapy. each participant will apply the difinisa53™ cream to one area of the treated skin and aquaphor to another area of treated skin. skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Eligibility criteria:
inclusion criteria: * female patients 18 years and older * pathologic diagnosis of breast cancer requiring radiation therapy to whole breast * able to apply lotion to treatment area at least twice daily during radiation course * all surgical sites healed * no evidence of infection * no history of sensitivity to any component in aquaphor or difensa53 exclusion criteria: * prior history of radiation therapy (rt) to that site * known dermatologic conditions affecting skin in radiation port * concurrent chemotherapy * skin infection in radiation port * history of sensitivity to aquaphor or difensa53 component

Keywords: breast cancer radiation dermatitis
long-term safety study of vildagliptin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. vildagliptin is an oral antidiabetic agent. this 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * patients who have been placed on diet and exercise therapy without achieving target blood glucose levels * outpatients exclusion criteria: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * significant cardiovascular complications as defined by the protocol * significant diabetic complications as defined by the protocol other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hba1c
dexmedetomidine vs fentanyl for bmt

Conditions: Otitis

Summary: a randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing bmt.


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following inclusion criteria to be eligible for participation: 1. the subject is 6 months to 6 years of age 2. the subject's american society of anesthesiologists (asa) physical status is asa 1 or 2 (see appendix 1) 3. the subject is scheduled for elective bilateral myringotomy with tube placement 4. the subject's parent/legally authorized guardian has given written informed consent to participate exclusion criteria: * subjects will be excluded from study participation if any of the following exclusion criteria exists: 1. the subject has a history or a family (parent or sibling) history of malignant hyperthermia 2. the subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests 3. the subject has a known or suspected allergy to opioid analgesics or dexmedetomidine 4. the subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. down's syndrome, dysrhythmias, conditions where hypotension is to be avoided) 5. the subject has know central nervous system disease or neurological impairment 6. the subject is an asa classification of 3 or greater (see appendix 1) 7. the subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux) 8. the subject refuses inhalation induction 9. the subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

Keywords: dexmedetomidine, transmucosal, myringotomy,
functional digestive disorders observatory

Conditions: Irritable Bowel Syndrome; Dyspepsia; Functional Constipation; Faecal Incontinence

Summary: functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. these diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. the objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. this collection could identify diagnostic or prognostic markers of the therapeutic response.

functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. these diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. the objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. this collection could identify diagnostic or prognostic markers of the therapeutic response. the investigators hope that a better knowledge of the pathophysiology of digestive functional diseases will improve the therapeutic management by making a therapeutic choice based on the observed pathophysiological abnormalities.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age; * patients with functional digestive disorder for more of 3 months; * patients assessed as part of routine care; * patients affiliated to the social security ; * patients not opposed to participation in the centre exclusion criteria: * person deprived of liberty by administrative or judicial decision or major protected subject (under guardianship or curatorship); * patients unable for any reason to read, understand, respond questionnaires (visual, psychiatric, cognitive, etc.)
imjudo & imfinzi pms

Conditions: Hepatocellular Carcinoma

Summary: based on the re-review of new drugs article, korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(imjudo \& imfinzi) in a real world setting in patients who treated according to the approved indications in korea.

primary objective: to assess safety of the study drugs for patients treated with the study drugs under the approved indication in korea secondary objective: to assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in korea exploratory objective: to assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in korea

Eligibility criteria:
inclusion criteria: 1. patients eligible for the study drugs according to the approved label in korea 2. provision of signed and dated written informed consent by the patient or legally acceptable representative exclusion criteria: 1. other off-label indications according to the approved label in south korea 2. current participation in any interventional trial
mito-6: capecitabine in platinum resistant ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.

ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are frequent and 5-year survival is only 20%. current therapies for second line treatment of recurrence in patients who have platinum refractory (who experienced progression of the disease during first line platinum based therapy) or platinum resistant (who experienced a recurrence of the disease within 6 months of completing platinum based therapy)ovarian cancer are limited. capecitabine, an oral chemotherapy already used in colon and breast cancers, has shown some promise in early clinical trials for treating recurrent ovarian cancer. patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14 every 21 days for up to 6 cycles, depending on response.

Eligibility criteria:
inclusion criteria: * cytologic or histologic diagnosis of relapsed ovarian cancer * refractory or resistant to platinum salts disease * age \< 75 years * at least one measurable lesion (³ 20 mm with conventional techniques or ³ 10 mm with spiral ct scan) * life expectancy of at least 3 months * written informed consent exclusion criteria: * previous or concomitant malignant neoplasia within 5 years prior to basal evaluation (excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix). * performance status (ecog) ³ 3 * previous chemotherapy treatment with capecitabine * more than 3 lines of chemotherapy * heart disease (heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia) * leukocytes \< 4000/mm3, platelets \< 100000/mm3 * modifications of renal function (creatinine ³ 1.25 times the upper normal limit) or liver function (sgot or sgpt ³ 1.25 times the upper normal limit) * present or suspected haemorrhagic syndromes * uncooperative and/or unreliable patients * patients' inability to access the centre

Keywords: oral chemotherapy platinum resistant platinum refractory second line
capecitabine versus bolus 5-fu associated to radiotherapy as neoadjuvant treatment for rectal cancer.

Conditions: Rectal Neoplasm Malignant

Summary: a randomized two-arm study comparing preoperative crt using oral capecitabine versus bolus 5-fu/lv concomitant to external beam radiation (50.5 gy/28 fractions) for locally advanced rectal cancer. main outcome was clinical response assessed using mri and endorectal us 6-8 weeks after crt. secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, os and dfs.

patients harbouring rectal adenocarcinoma t3-4 or n\>0 m0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolus intravenous 5-fu/lv 350mg/m2/20 mg/m2 d1-d5 on the first and fifth weeks, both combined to pelvic radiotherapy, total dose 50.4 gy in 28 fractions. clinical stage before and after crt was determined using pelvic magnetic resonance imaging (mri), endorectal ultrasonography (erus) and chest, abdominal and pelvic computer tomography. surgery was planned 6 to 8 weeks after crt. sphincter preservation was always considered when negative margins were possible. pathological assessment included stage (tnm 7th ed.) and mandard's tumor regression grade (trg). qol questionnaires qlq-c30 and cr38 were completed by patients before and after crt, after surgery and during follow-up.

Eligibility criteria:
inclusion criteria: patients with histologically proven locally advanced rectal cancer (ct3-4 or positive regional lymph node) on endorectal ultrasonography (eus) or pelvic magnetic resonance imaging (mri) were qualified for this study. distance from anal verge (av) should not exceed 10 cm measured with rigid proctoscopy. thorax and abdominal computer tomography (ct) exams were taken to rule out distant metastasis. performance status ecog 0-1. exclusion criteria: previous treatment for rectal cancer (rt, chemotherapy or surgical resection). previous diagnosis of other cancers except nonmelanoma skin cancer. uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. hepatic insufficiency and renal failure. pregnancy. serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent. -
rhomboid intercostal and subserratus plane block

Conditions: Cholecystectomy; Postoperative Pain; Nerve Block

Summary: laparoscopic surgery is frequently used today for abdominal region operations. laparoscopy has become the preferred treatment for cholecystectomy. patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. for this type of surgery, many different field blocks have been used for postoperative analgesia.

in this study, the analgesic efficacy of unilateral rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology physical status i and ii and who gave consent for the blocks were included in the study exclusion criteria: * bleeding disorders, * mental incapacity, * known allergy to the local anesthetics, * body mass index ≥35 kg/m2
the effect of neuromuscular electrical stimulation (nmes) on the renal function and renal blood flow

Conditions: Renal Injury

Summary: a randomized prospective controlled study aims to evaluate the effect of neuromuscular electrical stimulation on the renal function and renal blood flow of post partum women with acute kidney injury.


Eligibility criteria:
inclusion criteria: * patients aged 18 or old and hemodynamically stable. * post-partum women who developed aki. exclusion criteria: * pregnant women . * patients who required any emergency or elective surgery during the study; those who presented acute heart or lung disease, skin rashes, tumors, infections, diabetes mellitus or hypoesthesia in the region that the neuromuscular electrical stimulation would be applied. * patients with a pacemaker. * epileptic patients. * patients with recent effects of stroke (less than 3 months). * uncontrolled hypertension (systolic blood pressure \> 230 mm hg and diastolic blood pressure \> 120 mm hg).

Keywords: neuromuscular electrical stimulation renal function renal blood flow acute kidney injury
novel predictors of post spinal hypotension in cesarean sections: evaluating jugular vein collapsibility index and shock indices

Conditions: Cesarean Section Complications; Regional Anesthesia Morbidity; Hemodynamic Instability; Shock

Summary: jugular vein collapsibility index and shock indices (shock index, modified shock index, diastolic shock index) may be useful in estimating post spinal hypotension in cesarean section operations. evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. the main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.


Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia exclusion criteria: * patients with preeclampsia, eclampsia, hellp syndrome