Kornimate/medical-research-clean huggingface dataset:
c-car011 treatment in subjects with all after hsct

Conditions: Acute Lymphoblastic Leukemia(ALL)

Summary: this is a single-center, prospective clinical study evaluating safety and efficacy of c-car011 treatment in subjects with all after hsct

a study evaluating safety and efficacy of cbm.cd19-targeted chimeric antigen receptor t cells (c-car011) treatment in subjects with acute lymphoblastic leukemia(all) after hematopoietic stem cell transplantation（hsct）. the amount of cells received：1.0-5.0×10\^6car+t cells/kg

Eligibility criteria:
inclusion criteria: * age 15-65 years old, male or female. * volunteered to participate in this study and signed informed consent. * meet the two populations above. * histologically diagnosed as cd19+b-all. * 100% t lymphocytes of donor. * treatment without chemotherapy and antibody therapy within 2 weeks prior to c-car011 therapy. * left ventricular ejection fraction (lvef) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias. * baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection. * expected survival ≧ 3 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * history of allergy to cellular products. * any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/l, alt, ast≧3×uln, serum creatinine≧2.0mg/ dl,platelets\<20×109/l. * the subjects had active agvhd with ii-iv degrees (glucksberg degrees) or active moderate to severe cgvhd. * severe uncontrolled infection (mycotic, bacterial, virus and so on). * any central nervous system leukemia(cns2, cns3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible. * the subjects were treated cart cells or dli after hsct. * bone marrow failure syndrome（bmf） after allogeneic hematopoietic stem cell transplantation. * any genetically modified t cell therapy. * history of heavy drinking, drug taking or mental disease. * participated in any other clinical trial within one month prior to enrollment. * women who are pregnant or lactating or have breeding intent in 6 months. * the investigators believe that any increase in the risk of the subject or interference with the results of the trial.

Keywords: acute lymphoblastic leukemia hematopoietic stem cell transplantation anti-cd19 chimeric antigen receptor t-cell
electronic intervention for hiv medication adherence

Conditions: HIV

Summary: the purpose of this study is to develop and examine the feasibility and initial efficacy of a computer-based intervention to improve medication adherence among people living with hiv.


Eligibility criteria:
inclusion criteria: * infected with hiv * over age 18 * currently prescribed a highly active antiretroviral therapy (haart) regimen * prescribed a regimen for the first time, changing regimens, or report adherence below 95% agree to brief follow-up interviews exclusion criteria: * physical impairment that would prevent them from successfully completing the computer-based program (e.g., blind, deaf, severe neuropsychological impairment) * actively psychotic * not fluent in english

Keywords: hiv medication adherence computer-based intervention
effects of different radiation dosimetry for anorectal function of patients with pelvic cancer

Conditions: Anorectal Cancer

Summary: in this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the score of anal incontinence in the radiation dose≤50gy group and \>50gy group. the study population includes 124 patients with anal canal cancer or rectal cancer who have received sphincter preservation treatments (including radiochemotherapy), aged from 18 to 75 years old undergoing sphincter preservation treatments at the sixth affiliated hospital, sun yat-sen university and nanfang hospital, southern medical university. the primary outcome is the average resting pressure of anal sphincter. the secondary outcomes are maximum anal sphincter contraction pressure and wexner continence score. evaluations will be carried out at the following stages: baseline (t1), after radiotherapy or chemotherapy (before surgery, t2), after surgery (before closing the temporary stoma, t3), and at follow-up visits (every 3 to 6 months, t4, t5......). follow-up for each patient will be at least 2 years.


Eligibility criteria:
inclusion criteria 18-75 years of age. anal cancer and rectal cancer with pathological diagnosis. patient will undergo sphincter-preserving therapies. eastern cooperative oncology group (ecog) score for performance status is 0-2. written informed consent. exclusion criteria patients who have undergone pelvic surgery, such as rectal cancer surgery and gynaecological procedures. patients who have received pelvic radiotherapy. patients with other active malignant tumors. patients with a history of prior peri-anal abscess, anorectal trauma, and inflammatory bowel disease (ibd). recently (less than 4 weeks) received surgery or patients with recent severe trauma. significant cardiac disease: congestive heart failure of new york heart association class ≥2; patients with recent (less than 12 months) active coronary artery disease (unstable angina or myocardial infarction). recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep vein thrombosis. patients with toxicity (common terminology criteria for adverse events (ctcae) grade ≥ 2) caused by previous treatment that has not subsided. women who suffered anal sphincter tear after vaginal delivery. pregnant or lactating women.
using nirs to evaluate splanchnic oxygenation during blood transfusion in preterm infant

Conditions: Splanchnic Oxygenation; NIRS; PreTerm Neonate; Enteral Feeds

Summary: to evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.

using nirs to evaluate splanchnic oxygenation

Eligibility criteria:
inclusion criteria: * infant with gestational age \< 37 weeks * planned to receive blood transfusion * had received minimum 25 ml/kg/day enteral feeding * in stable condition exclusion criteria: * infant with multiple congenital anomalies * infant with suspected/confirmed genetic anomalies * parents or family did not sign the informed consent

Keywords: transfusion nirs splanchnic oxygenation preterm neonate enteral feeds
study of recombinant interleukin 21 in combination with sorafenib for metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: the purpose of the study is to evaluate whether recombinant il-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (rcc).

this is a phase 1/2 open-label dose-escalation study of ril-21 given in combination with sorafenib to patients with metastatic rcc. the phase 1 part of this study will estimate the maximum tolerated dose of ril-21 given for 1 treatment course (consisting of two 5-day cycles of ril-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. increasing doses of ril-21 will be studied sequentially in different groups of patients. the phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of ril-21 at the dose recommended from phase 1 in combination with sorafenib. patients will be evaluated for safety over the course of the study. disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. patients with stable disease or better at this evaluation may go on to receive additional treatment courses. patients may be in the study for 2 to 7 months.

Eligibility criteria:
inclusion criteria: * diagnosis of rcc of predominantly clear cell histology * either no prior treatment or a maximum of 2 prior treatment regimens for metastatic rcc that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (vegf) pathway (phase 1 only) * at least 1 but no more than 2 prior systemic therapies for metastatic rcc that included no more than 1 therapy targeting the vegf pathway (phase 2 only) * disease measurable per the response evaluation criteria in solid tumors (recist) (phase 2 only) exclusion criteria: * presence of acute infection or other significant systemic illness * central nervous system involvement by malignancy * history of other cancer within 5 years * previously received ril-21 or sorafenib

Keywords: carcinoma, renal cell interleukin-21 sorafenib immunotherapy
eating disorder prevention programs

Conditions: Eating Disorders

Summary: this study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns.

adolescent girls with body dissatisfaction (n=481; sd=1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive-writing control condition, or assessment-only control condition. dissonance participants showed significantly greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, and lower risk for eating pathology onset through 2-3 year follow-up than assessment-only controls. dissonance participants showed greater decreases in thin-ideal internalization, body dissatisfaction, and psychosocial impairment than expressive-writing controls. healthy weight participants showed greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, less increases in weight, and lower risk for eating pathology and obesity onset through 2-3 year follow-up than assessment-only controls. healthy weight participants showed greater decreases in thin-ideal internalization and weight than expressive writing controls. dissonance participants showed a 60% reduction in risk for eating pathology onset and healthy weight participants showed a 61% reduction in risk for eating pathology onset and a 55% reduction in risk for obesity onset relative to assessment-only controls through 3-year follow-up, implying that the effects are clinically important and enduring.

Eligibility criteria:
inclusion criteria: * self-reported body image concerns

Keywords: adolescence prevention and control bulimia
triheptanoin for children with primary-specific pyruvate dehydrogenase complex (pdc) deficiency

Conditions: Pyruvate Dehydrogenase Complex Deficiency

Summary: this is a medical research study to test a medication in patients with a disease called pyruvate dehydrogenase complex (pdc) deficiency. the medication is triheptanoin, which is currently fda approved for the treatment of long-chain fatty acid oxidation disorders. previous research suggests that triheptanoin may also be effective in the treatment pdc deficiency. this study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with pdc deficiency.

participation in the study will require the patient to participate in up to 10 visits over a two-year period. five of those visits must be done at the upmc children's hospital of pittsburgh (chp). other visits can take place at chp or remotely. all of these visits will include blood draws. triheptanoin will be added to the patients' diet and administered at least 4 times per day. the target dose will be 1.2-3.9 g of triheptanoin per kg body weight with a max goal dose of about 4 g/kg per day. the triheptanoin will be provided to the patients at no cost. all other costs will be billed to the patients' insurance.

Eligibility criteria:
inclusion criteria: 1. age 1 year to \<18 years of age 2. subjects with pdcd would need to have a metabolic physician following their clinical care needs prior to their enrollment in the study 3. diagnosis of pdcd by molecular genetic confirmation of pdha1, pdhb, dlat, pdhx, or pdp1 mutation 4. not pregnant or lactating 5. parental permission and assent of minor and willingness to comply with study procedures 6. not participating in any interventional treatment clinical trials 7. not a recipient of gene therapy, organ transplant, or bone-marrow transplantation 8. if currently on any investigational drugs or therapies, must complete a 30-day washout period prior to intake \& dosing (day 1). 9. negative pregnancy test for all female patients of childbearing age. individuals of childbearing potential must agree to use a highly effective method of contraception, and males must agree not to father a child or donate sperm. true abstinence for the duration of the study will also be accepted. 10. subjects are following some form or type of ketogenic diet at the time of the screening visit. exclusion criteria: 1. diagnosis of medium-chain acyl-coa dehydrogenase (mcad) 2. use of alcohol or drugs of abuse 3. evidence of liver disease as defined by elevations of ast or alt \>2x uln in the past 6 months 4. pregnant, breastfeeding, or lactating females 5. on any investigational product research study (and not completed the required 30-day washout period prior to intake \& dosing) or recipient of gene therapy or organ or bone-marrow transplantation

Keywords: pyruvate dehydrogenase complex deficiency
peri-operative morbidity and quality of life after coronary artery bypass graft (cabg)

Conditions: Coronary Artery Bypass Graft Surgery

Summary: it is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.

the objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.

Eligibility criteria:
inclusion criteria: 1. patients had to be undergoing elective cabg, without concomitant valve or other cardiac surgery. 2. patients also had to be able to perform the neuropsychologic tests, and to provide informed consent. exclusion criteria: 1. patients who refused to participate in the study. 2. patients who live too far away from nyc to be able to come back for follow up at six months post-operatively. 3. patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery. 4. patients who were unable to complete the neuropsychologic test. 5. patient who were part of another cabg study.

Keywords: coronary artery bypass graft surgery perioperative complications neurocognitive function quality of life blood pressure
ragus trial by postoperative patients

Conditions: Vasoplegic Syndrome; Sirs Due to Noninfectious Process Without Organ Dysfunction; Orthostatic Hypotension

Summary: vasoplegic syndrome is characterized clinically by reduced systemic vascular resistance and normal or increased cardiac output. it is principally observed in cardiovascular and orthopedic interventions and is characterized by a systemic inflammatory response with the inability of the vascular endothelial muscles to contract and a resistance to the action of vasoactive drugs. this event extends the length of stay in the critical care area due to the need of vasoactive drugs. the investigators aim to assess the standardized application of midodrine in postoperative patients without sepsis and need of vasoactive drugs in order to reduce the length of stay in critical care area and for extension in hospital.

midodrine is an alpha 1 receptor agonist used usually in cases of hypotension helping to increase blood pressure. the main indication is orthostatic hypotension but there are other clinical conditions where this medicament is often used like hypotension by dialysis, hepatorenal syndrome and after carotid artery stenting. vasoplegic syndrome coul be interpreted as a variant of orthostatic hypotension that happens usually after surgical interventions. it produces a loss of systemic vascular resistance due to inflammatory reaction without any signs of infection. the investigators aim to conduct a randomized, double-blind, single-center, placebo-controlled study of midodrine in patients who present postoperative vasoplegia with no active signs of sepsis but need of vasoactive drugs (noradrenalin).

Eligibility criteria:
inclusion criteria: * over 18 years of age * need of vasoactive drugs after three hours from arrival and adequate volume recovery. exclusion criteria: * signs of infection (anamnesis or pro-calcitonin \> 0.2 with leukocytosis, crp and/or fever) * serum lactate \> 2mmol/l * mechanical ventilation * therapeutic restrictions or comfort measures at arrival * "de novo" or acute on chronic heart failure (reduction of known ejection fraction for more than 20 percent, signs of acute lung edema) * pregnant * patients with digoxin treatment or history of glaucoma. * history of midodrine allergy, pheochromocytoma, thyrotoxicosis, tachyarrhythmias or ventricular fibrillation.

Keywords: midodrine vasoplegic syndrome noradrenaline sirs
tacrolimus and mycophenolate mofetil (mmf) in gvhd prophylactic regimen compared to tacrolimus and methotrexate (mtx

Conditions: Mucositis; Graft-versus-host Disease

Summary: a comparative trial where all patients will receive daily doses of tacrolimus (tac) until day +60 when tapering will begin, in the absence of graft-versus-host disease (gvhd), and discontinued by day +180. in addition patients will be randomized to methotrexate (mtx) or mycophenolate mofetil (mmf) and again, in the absence of gvhd, a tapering schedule will begin on day +240 and be completed on day +360. doses will be adjusted to maintain blood levels.

the randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on mcc-14178, by busulfan auc level. all patients will receive daily doses of tac beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (hct)) and will be given until day +60 when tapering will begin in the absence of gvhd. provided no gvhd develops, tac should be discontinued by day +180. doses will be adjusted to maintain blood levels. in addition to tac, patients will be randomized to one of the following additional anti-gvhd medications: mtx or mmf beginning day 0 at least 2 hours after the end of the hct. in the absence of gvhd a tapering schedule will begin on day +240 and be completed on day +360. study participants will be extensively monitored as inpatients and then weekly as outpatients. some tests will be conducted at least twice weekly (blood tests, toxicity data, gvhd and physical exams) one-month post-transplant and during the tapering off periods for up to 2 years.

Eligibility criteria:
inclusion criteria: - patient must be going through a t cell-replete allogeneic transplant exclusion criteria: - a contraindication to the use of tacrolimus, mycophenolate, or methotrexate

Keywords: tacrolimus methotrexate mycophenolate mofetil mucositis acute graft-versus-host disease (agvhd) engraftment hemolytic/uremic syndrome (hus) thrombotic thrombocytopenic purpura (ttp)
estrogen and platelet rich plasma in treatment of atrophic vaginitis

Conditions: Atrophic Vaginitis; Postmenopausal Atrophic Vaginitis

Summary: this study is designed to compare the efficacy, acceptability, and safety of vaginal estrogen cream and platelet-rich plasma in pt. complaining of atrophic vaginitis.

oestrogen deficiency affects many organs such as the genitourinary system. genitourinary involvement causes untoward symptoms of atrophic vaginitis including dryness, burning, dyspareunia, vulvar pruritus, and discharge for this reason, many investigations have been performed to find out effective, safe, and acceptable therapeutic methods for atrophic vaginitis. although systemic administration of estrogen can improve the localized symptoms of atrophic vaginitis, women are often reluctant to use systemic hormone replacement therapy and prefer local administration of estrogen. vaginal application of estrogen has been considered an effective treatment of atrophic vaginitis. the effects of prp treatment have been evaluated in many clinical conditions, including wound healing, hair repair, skin regeneration \[9\], vulvar lichen sclerosis, stress urinary incontinence, episiotomy scars, and lubrication aging in the vagina. it can take at least 12 weeks to determine the final effects of treatment with prp population of study it includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt methodology in detail: patients of the first group will receive vaginal estrogen cream one tube every night for 14 nights; then, one tube 2 nights in 1 week (two tubes every week) for 10 weeks. the second group will receive prp injection every 3 weeks for 4 times. prp will be administered to the anterior vaginal wall using 27-g needles once every 3 weeks for 4 times and prp is mainly injected into the clitoris or the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

Eligibility criteria:
inclusion criteria: * postmenopausal women aged 50-70 years old * with a clinical diagnosis of vaginal atrophy who will not need systemic estrogen therapy for the treatment of vasomotor symptoms or prophylaxis of osteoporosis * any parity. exclusion criteria: * women with any history of carcinoma of the breast or endometrium, * abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disorders associated with previous estrogen use, * or current urinary. * in addition, women who underwent hormone replacement therapy, treated with systemic or vaginal estrogen within 6 months prior to the study, * or had any contraindication for estrogen therapy will be excluded from the study.

Keywords: atrophic vaginitis platelet rich plasma postmenopausal symptoms
a pilot investigation of clinician-guided internet-delivered cognitive behavioural therapy for depressed patients

Conditions: Depressive Symptoms

Summary: this study aims to explore the efficacy and acceptability of a clinician-guided internet-based cognitive behavioural therapy (icbt) programme for patients with depression, in singapore.

all outpatients, from the institute of mental health, singapore, who are diagnosed with a primary diagosis of mild to moderate depression and were referred to the psychology department for therapy were invited to take part in this research. participants were randomised into two groups: icbt intervention group and delayed waitlist-control group. the four-week icbt programme comprised of three face to face 30-minute sessions with a clinician and six online modules).the treatment group is hypothesised to exhibit pre-post improvements in depressive symptoms, compared to the control group.

Eligibility criteria:
inclusion criteria: * 21 to 65 years old * not currently seeing a therapist for any form of invidual or group therapy * diagnosed with a primary diagnosis of depression by imh psychiatrist * a total score of above 9 on the patient health questionnaire (phq-9; kroenke et al., 2001), indicating at least mild symptoms * if using medication for depression then on a stable dose for at least 1 month, * provides informed consent * able to read and speak at least primary 6 level english * adequate it skills to operate icbt programme exclusion criteria: * severe depression (i.e. score = 23 on phq-9) * strong suicidal ideation (i.e. score \> 2 on question 9 of the phq-9) * current active suicidal intention or plan * presenting problem is not depression * does not meet the minimum english language requirements stated above * participants who are concurrently attending other forms of group/individual psychotherapy