Kornimate/medical-research-clean huggingface dataset:
cd19 car-t cells for patients with relapse and refractory cd19+ b-all.

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of cd19-car-t cells in patients with relapsed or refractory acute b-cell lymphoblastic leukemia (r/r b-all).

in this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 cd19+ b-cell relapsed or refractory acute b-cell lymphoblastic leukemia (r/r b-all) patients will be enrolled. side effects of cd19 car t cells therapy will be monitored. the purpose of current study is to determine the clinical efficacy and safety of cd19 car t cells therapy in patients with r/r b-all.

Eligibility criteria:
inclusion criteria: 1. more than 1 year; 2. cd19 positive b-cell acute lymphoblastic leukemia; 3. important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ecg; blood oxygen saturation ≥90%; creatinine clearance calculated by cockcroft-gault formula ≥40ml/min; alt and ast≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / l. 4. expected to survive for more than 3 months; 5. informed consent is signed by a subject or his lineal relation. exclusion criteria: 1. recent or current use of glucocorticoid or other immunosuppressor; 2. uncontrolled active infection, hiv infection, syphilis serology reaction positive; 3. has a graft-versus-host response and requires the use of immunosuppressants； 4. drug uncontrollable central nervous system leukemia； 5. pregnant or lactating female； 6. the patient did not agree to use effective contraception during the treatment period and for the following 1 year； 7. a history of other malignant tumors; 8. the investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

Keywords: b-cell acute lymphoblastic leukemia cd19 car-t
testing implementation strategies to improve delivery of prep for pregnant and postpartum women in kenya

Conditions: Pre-Exposure Prophylaxis; HIV Infections; Pregnancy Related

Summary: this study tests strategies for improving prep implementation in maternal and child health clinics using an interrupted time series.

this study aims to improve integrated delivery of prep to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized prep delivery. strategies to be tested include three packages of strategies identified by stakeholders.

Eligibility criteria:
inclusion criteria: * women receiving maternal and child health (mch) services hcw participating in satisfaction surveys exclusion criteria: * unwilling or unable to provide informed consent
the influence of lutein supplements on age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: rationale: age-related macular degeneration is the most common cause of blindness in the industrialized world. macular pigment is hypothesized to protect against the vision loss in this disease. objective: 1. to study if the macular pigment optical density can be raised by lutein supplementation. 2. to study if lutein supplementation can stop or slow down the decrease in visual functions. study design: randomized, double blind, placebo controlled intervention study. study population: eighty patients with early signs of age-related macular degeneration intervention: the intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.


Eligibility criteria:
inclusion criteria: * amd grade 2 or 3 * visual acuity \> 0.5 * bmi \< 30 exclusion criteria: * using lutein supplements * smoking * diabetes * diseases that interfere with lipid absorption * other eye diseases

Keywords: macular pigment lutein age-related macular degeneration amd
the association between decreasing labor analgesia epidural infusion and forceps delivery

Conditions: Labor Pain; Pregnancy

Summary: the objective of this study will be to compare epidural infusion management, specifically looking at infusion rate changes, in patients who receive forceps deliveries versus normal spontaneous vaginal deliveries. we will match patients based on time and date of delivery, as well as parity, in order to eliminate these variables as potential con-founders. we hypothesize patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery.

the obstetrical anesthesia database will be queried for all forceps deliveries between the dates of january 2004-october 2005. to minimize the influence of different anesthetic and obstetric care providers, the control group consisted of parturients who has spontaneous vaginal deliveries (svd) in the same 24 hour period who were case-matched for gravidity and parity. parturients with twin deliveries and fetal demise were not selected for either group. the database will be queried for the following: maternal age, parity, gestational age, type of analgesia, changes in epidural infusion rate and/or concentration, and supplemental bolus doses of local anesthesia. the data will be stripped of identification by the database manager and entered into a secured computer which is password protected and maintained in the department of anesthesiology. the primary endpoint is to evaluate if decreasing the epidural infusion rate was associated with a forceps delivery.

Eligibility criteria:
inclusion criteria: * singletons * viable fetal vaginal deliveries between january 2004-october 2005 exclusion criteria: * outside specified time frame * multiparity * fetal demise

Keywords: labor epidural analgesia delivery vacuum extraction obstetrical forceps
postoperative sensitivity following placement with different restorative materials in vital posterior teeth

Conditions: Sensitivity, Tooth

Summary: there is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class i cavities or examined post-operative sensitivity in non-caries cervical lesions. the purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration


Eligibility criteria:
inclusion criteria: either gender minimum age 18 years, maximum age 40 years. class i \& ii cavity on maxillary and mandibular 1st and 2nd molars. vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth. exclusion criteria: irreversible pulpitis diagnosed clinically and radiographically. class i \& class ii cavity of premolars and third molars patients taking analgesic prior to treatment. history of allergic reaction to any dental material used in the study. history of parafunctional habits (bruxism and/or clenching) malocclusion
identification of non-gal, non-hla antigens in patients implanted with xenogenic material

Conditions: Valve Heart Disease

Summary: this study involves collecting serum samples from patients presenting for aortic valve replacement at mayo clinic, rochester, mn. serum samples will be collected pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and between 12-18 months post-operatively. the patients antibodies in these serum samples will be used to capture proteins from the same type of tissue their replacement heart valves are made from (i.e., bovine/porcine pericardium - a non-human tissue which is currently used to make glutaraldehyde-fixed heart valves). the captured proteins will be identified, and compared over time (i.e., 0, 1, 3 and 12 months) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.

protein g hp spintrap columns will be used to capture igg antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant. these antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie native bovine/porcine pericardium) will be deglycosylated and run through the column. antigenic proteins will be trapped and non-antigenic proteins will be washed through the column. these antigenic proteins will be eluted off the column and identified using lc-ms/ms. the proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens. success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.

Eligibility criteria:
inclusion criteria: * patients who will receive either a biological or mechanical heart valve exclusion criteria: * currently receiving therapy for cancer requiring treatment with concurrent radiotherapy and/or chemotherapy * cancer in remission for less than 5 years if previously treated with radiotherapy and/or chemotherapy * previous tissue valve implants * current pregnancy
the hombre trial: comparing two innovative approaches to reduce chronic disease risk among latino men

Conditions: Obesity; Metabolic Syndrome; Lifestyle Intervention; Pre Diabetes

Summary: the purpose of this study is to test a flexible lifestyle program designed to help latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. the program is called hombre (hombres con opciones para mejorar el bienestar y bajar el riesgo de enfermedades crónicas; english translation: men with choices to improve well being and decrease chronic disease risk).

this study is a comparative effectiveness trial where obese latino men will receive, by random assignment, the hombre intervention or a minimal intensity intervention. the study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. if proven successful, this study has the potential to significantly impact health outcomes that matter to latino men through the innovative design of lifestyle interventions to prevent chronic disease.

Eligibility criteria:
inclusion criteria: * latino of any race * bmi \>27 kg/m2 * one or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low hdl cholesterol) * primary care physician approval of patient study contact * able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the electronic health record. exclusion criteria: medical exclusions: * previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin a1c levels obtained through study screening; * diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years; * inability to walk without the assistance of another person; * severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class iii or greater heart failure, unstable coronary artery disease, liver or renal failure; * diagnosis of a terminal illness and/or in hospice care; * diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication * initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (the patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.) * have had or plan to undergo bariatric surgery during the study period other exclusions: * having no reliable telephone service * plan to move out of the area during the study period * family/household member of another study participant or of a study staff member * investigator discretion for clinical safety or protocol adherence reasons

Keywords: latino male
effects of platelet rich plasma on endometrium

Conditions: Asherman Syndrome

Summary: intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. the endometrial thickness will be assessed under ultrasound and hormone replacement will be started. as the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.

intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. in the second menstrual period following the prp injection, the endometrial thickness will be assessed under ultrasound and hormone replacement will be started. as the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed. pregnancy test results will be recorded and followed.

Eligibility criteria:
inclusion criteria: * women in whom cycle was cancelled due to an endometrial thickness \<7 mm when progesterone start was planned in patients undergoing frozen embryo transfer with hormone replacement therapy * women with a history of asherman syndrome, but no obvious intrauterine adhesion in the last hysteroscopic procedure; * women who have at least 2 frozen good-quality embryos. exclusion criteria: * women with any other known cause of implantation failure, such as poor embryo quality, or congenital uterine anomalies, endometrial polyp or fibroid, * previous diagnosis of any malignancy, * anticoagulant use for which plasma infusion is contraindicated,
the effectiveness of recombinant coagulation factor ix with recombinant albumin (rix-fp) in severe hemophilia b patients

Conditions: Hemophilia

Summary: the pivotal clinical data support prolonged dosing intervals of up to 14 days for routine prophylaxis in hemophilia b patients. the majority of adult and pediatric patients using idelvion for routine prophylaxis had a median annualized spontaneous bleeding rate (asbr) of 0.00. the majority (99%) of bleeding episodes were managed successfully with one or two infusions, and 94% of bleeds were controlled with only one infusion regardless of the cause or location. the rationale for this study is to collect the effectiveness and safety data of severe hemophilia b patients treated with idelvion following institutional standard of care. it is the aim of this study to extend the results of the clinical trial program to a broader hemophilia b population, and to compare with current alternative factor ix treatments in taiwan.


Eligibility criteria:
inclusion criteria: * male patients with age ≥ 20 years old * endogenous fix activity ≤1 iu/dl, * at least 50 exposure days (eds) with fix products, * no detectable inhibitor to fix or inhibitor history, * had a minimum of 2 nontrauma-induced bleeding episodes (any type or location) treated in the 6 months preceding study entry, * the patient or patient's parents or legal authorized representative, as applicable, are capable to understand the study objectives and procedure, and sign the written consent, * accept that the supply of idelvion might be stopped once the study is completed, * able to complete a diary during 12 months or 50 eds, whichever comes first. exclusion criteria: * currently participating in an interventional clinical trial, * known hypersensitivity to any fix product or hamster protein, * known inhibitor to fix or inhibitor history, * with other comorbidities which are not suitable for this study, at investigator's discretion, * not able to compliant with the prophylactic treatment, * lacking previous treatment and bleeding records.
s1 vs.pemetrexed plus carboplatin in patients with egfr wild type stage iiib or iv nonsquamous nsclc

Conditions: NSCLC

Summary: this study compared the efficacy and safety of s1 plus carboplatin (c) followed by s1 with pemetrexed plus carboplatin (c) followed by pemetrexed in patients with epidermal growth factor receptor (egfr) wild type advanced nonsquamous non-small-cell lung cancer (nsclc).patients with previously untreated egfr wild type stage iiib or iv nonsquamous nsclc and eastern cooperative oncology group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or s1（80-120 mg/d）combined with carboplatin area under the curve (auc) 5 every 3 weeks for up to four cycles. eligible patients received maintenance until disease progression: pemetrexed or s1. the primary end point of this non-inferiority study was progression free survival（pfs）


Eligibility criteria:
inclusion criteria: 1. chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous nsclc, classified as stage iiib not amenable to curative treatment or stage iv; egfr wild type. 2. at least one unidimensionally measurable lesion according to the response evaluation criteria in solid tumors 3. eastern cooperative oncology group performance status of 0 or 1 4. 18 \<age\<75 years 5. patients had adequate bone marrow reserve and organ function. 6. prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment and patients had fully recovered from its acute effects 7. written informed consent was obtained directly from every patient 8. estimated life expectancy of at least 12 weeks. 9. patient compliance and geographic proximity that allow adequate follow up. 10. male and female patients with reproductive potential must use an approved contraceptive method, if appropriate during and for 3 months after the study. women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. exclusion criteria: 1. brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments); 2. serious infections or other serious complications. 3. uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin b12, or corticosteroids 4. have a prior malignancy other than nsclc, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. 5. pregnant or breast feeding. 6. a distinct history of drug allergies
virtual reality rehabilitation in patients with acquired brain injury

Conditions: Acquired Brain Injury

Summary: the aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.


Eligibility criteria:
inclusion criteria: * acquired brain injury within 1 month before the recruitment; * score between 0 and 3 at the motor arm subscore of the italian version of the national institutes of health stroke scale (it-nihss); * score between 9 and 15 at the glasgow coma scale for the traumatic brain injury acquired brain injury. exclusion criteria: * denial of informed consent; * visual deficits that interfere with the virtual reality rehabilitation; * score under 18 at the mini mental state examination; * severe orthopedic deficit; * patients with pace maker; * patients with contraindication to undergo magnetic resonance; * pregnant women.

Keywords: virtual reality rehabilitation acquired brain injury
counteracting age-related loss of skeletal muscle mass

Conditions: Sarcopenia; Muscle Loss

Summary: up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects. upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (m/f) and 30s chair stand (\<16 or ≥16). the five groups are: heavy resistance training (n=30-35), light intensity training (n=30-35), protein whey (n=40-50), protein collagen (n=40-50) and carbohydrate (n=30-35). the individuals randomized into one of the supplementation groups (protein whey, protein collagen or carbohydrate) will be blinded to the supplement content. assessments will be performed at baseline (before intervention start), and after 6 and 12 months of intervention and again at 18 months (after 6 months of follow up). the primary outcome is change in quadriceps muscle cross sectional area from baseline to 12 months of intervention. the primary hypothesis is that by applying the intension-to-treat analysis, the light intensity training group will increase quadriceps muscle cross sectional area just as much as the heavy resistance training group. the two training groups will gain more muscle mass than the protein whey group, which will gain more than the protein collagen and the carbohydrate groups that will loose quadriceps muscle cross sectional areas.


Eligibility criteria:
inclusion criteria: * healthy, independently living * age at least 65 years exclusion criteria: * subjects dependent on help/nursing etc. * chronic medical diseases: diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia. * surgical diseases: bone, muscle, tendon or joint injuries compromising participation in exercise regimens. * implanted magnetic devices incompatible with mri-scanning. * weekly alcohol consumption \> 21 units (1 unit equals 4g of ethanol) for men and \> 14 for women. * medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ace-inhibitors, angiotensin ii blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics. * \>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.

Keywords: frailty ageing protein supplementation protein quality gut microbiota metabolome exercise training sarcopenia