Kornimate/medical-research-clean huggingface dataset:
phase i study of jwcar029 in subjects with r/r cll/sll

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: this is a phase i, open-label, single-arm, single center study to assess the safety and efficacy of jwcar029 in subjects with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

upon the successful product generation of relmacabtagene autoleucel, subjects will enter the treatment phase of the study. treatment will include lymphodepleting chemotherapy followed by relmacabtagene autoleucel administration. subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, and survival. long-term follow-up will continue under a separate long-term follow-up protocol, currently up to 15 years after the last relmacabtagene autoleucel administration.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old and ≤ 75 years old; * sign on the informed consent; * diagnosis of: 1. cll with an indication for treatment based on iwcll 2018 and measurable disease, or 2. sll (lymphadenopathy and/or splenomegaly and \< 5×10\^9 cd19+ cd5+ clonal b lymphocytes/l \[\< 5000/µl\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven sll); * relapsed/refractory patients, subjects must have received and failed bruton tyrosine kinase inhibitor (btki) treatment or have been deemed ineligible for btki therapy; * eastern cooperative oncology group (ecog) performance status of 0 or 1; * expected survival is greater than 12 weeks; * adequate organ function; * adequate vascular access for leukapheresis procedure; * women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of jwcar029; males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of jwcar029. exclusion criteria: * central nervous system (cns) only involvement by malignancy or primary cns lymphoma; * history of another primary malignancy that has not been in remission for at least 2 years; * subjects has hbv, hcv, hiv or syphilis infection at the time of screening; * deep venous thrombosis (dvt)/pulmonary embolism (pe), or dvt/pe requires anti-coagulation within 3 months prior to signing the icf; * subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * presence of acute or chronic graft-versus-host disease (gvhd); * history of any serious cardiovascular disease or presence of clinically relevant cns pathology; * pregnant or nursing women; * subjects using of any chemotherapy, corticosteriod, experiment agents, gvhd therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * received allo-hematopoietic stem cell transplantation therapy previously. * uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * received car t-cell or other genetically-modified t-cell therapy previously.
cinacalcet study for peritoneal dialysis patients in double arm on the lowing effect of ipth level

Conditions: Secondary Hyperparathyroidism

Summary: this study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (shpt) and ca, p control. this study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin d and phosphate binders) for achieving the stringent national kidney foundation kidney disease outcomes quality initiative (kdoqi) targets for dialysis patients.


Eligibility criteria:
inclusion criteria: * peritoneal dialysis patients with secondary hpt(ipth \> 300 pg/ml) * \> 18 yr of age, \< 70 * had receive pd for \> 3 mo, * intact pth level \> 300 pg/ml and \<1000 pg/ml * albumin corrected ca level \>= 9.0 mg/dl exclusion criteria: * pregnant or breast-feeding, * had undergone parathyroidectomy within previous 3 mo, * are involved in other clinical trial within 30 d * had received cinacalcet therapy previously.

Keywords: peritoneal dialysis
visual perception intervention programmes impact on down syndrome affiliate children's fine motor and visual perception.

Conditions: Down Syndrome

Summary: a second copy of chromosome 21 results in trisomy 21, a genetic disorder commonly referred to as down syndrome. in addition to physical traits like low muscular tone, upward-slanting eyes, and a flat facial profile, this extra genetic material causes intellectual and developmental difficulties. even though people with down syndrome may experience a range of health problems, they can lead happy, fulfilling lives if they receive the right support and care. individual differences in the illness's severity are significant. there will be a randomized control trial. people with down syndrome who are five to nine years old will be screened for this study. adults with down syndrome and severe id will not be eligible to participate in this study. participants will be selected using

conventional physical therapy will be administered to the participants in both groups. visual perception interventions will be administered to the intervention group, and then standard treatment will follow. for six weeks, there will be three 45-minute treatment sessions per week. using outcome measure instruments, data will be gathered twice: once at the beginning of the study and again at the end of the six-week course of treatment.

Eligibility criteria:
inclusion criteria: * age ranged between 6-9 years. * iq level mild to moderate (below 40) exclusion criteria: * heart, * git problems, * respiratory problems * and hearing loss.

Keywords: down syndrome visual motor skills fine motor skills postural instability
evaluating the topical herbal solution on the treatment of male pattern hair loss and comparison with minoxidil 5%

Conditions: Androgenetic Alopecia

Summary: the purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of androgenetic alopecia.

this study will be done on male subjects with androgenetic alopecia(aga). the patients will be selected by volunteers attending the dermatology department of sina hospital, and eligible individuals will be selected among them. subjects were randomized to use either topical herbal solution or topical minoxidil 5% for 36 weeks. to our knowledge, this herbal solution for the first time covers all four major causes of aga, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting dermal papilla and hair cell apoptosis processes. therefore it acts with the quadruple mechanism. the application of this new herbal solution for the treatment of aga should be recommended.

Eligibility criteria:
inclusion criteria: * men 18 to 50 years old * written consent * normal general health status * men who have a presentation of androgenetic alopecia (norwood ii - v). exclusion criteria: * use of any topical product in the target region interfering with the study product in the last three months * within the past 6 months receiving of chemotherapy/cytotoxic agents * clinical diagnosis of alopecia areata or other non-aga forms of alopecia * uncontrolled hypertension * any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer * hormonal diseases such as thyroid disorders, diabetes and, ... * smokers * liver and kidney disease * history of hair transplants * history of surgical correction of hair loss on the scalp * subject having dyed, bleached hair or, with a permanent wave prior to study start. * no written consent

Keywords: androgenic alopecia hair diseases skin diseases baldness alopecia hair loss
safety, tolerability, and pharmacokinetics of lumateperone long-acting injectable formulations in patients with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia or Schizoaffective

Summary: study iti-007-037 is a phase 1b, open-label study to evaluate the safety, tolerability, and pk of lumateperone long-acting injectable (lai) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.


Eligibility criteria:
main inclusion criteria: * male or female patients between 18 and 55 years of age, inclusive; * clinical diagnosis of schizophrenia or schizoaffective disorder according to diagnostic and statistical manual of mental disorders (dsm-5); * clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to screening; * clinical global impression - severity (cgi-s) score ≤ 3 at screening and prior to dosing on day 1; * body mass index (bmi) between 18.0 and 38.0 kg/m2, inclusive at screening, and a minimum body weight of 50 kg at screening. main exclusion criteria: * history of psychiatric condition other than schizophrenia that, in the investigator's opinion, may be detrimental to participation in the study; * any suicidal ideation or wish to be dead within the past 6 months of screening, any suicide attempt within the past 2 years prior to screening, or any current concern for the patient's safety based on the columbia-suicide severity rating scale (c-ssrs) (excluding self-injurious, non-suicidal behavior), and/or investigator assessment that the patient is a safety risk to him/herself or others; * clinically significant abnormality within 2 years of screening that in the investigator's opinion may place the patient at risk or interfere with study outcome variables; * has a qt interval corrected for heart rate using fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ecg at screening.
levosimendan administration and outcome in cardiac surgery

Conditions: Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery

Summary: to assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery between 2006 and 2013 * levosimendan administration within 24 hours of postoperative icu admission exclusion criteria: * patients younger than 18
a novel patent platform of detection of circulating tumor cells to early detect colorectal cancer recurrence

Conditions: Colorectal Cancer (CRC)

Summary: the best strategy to prevent colorectal cancer (crc) death lies in early detection and early treatment at the local disease status of tumor. after curative resection of tumor, there are about 5\~10% of stage i, 20\~30% of stage ii and 40\~50% of stage iii patients suffering metastasis during subsequent follow-up periods. although carcinoembryonic antigen (cea) is the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic patients, it is difficult to use cea as biological marker to identify the population with high recurrent risk in patients with early-stage cancer because lower than half of patients with early-stage cancer do not have cea elevation. for improving the survival of patients with early-stage crc, we need effort to search more useful biological markers to predict the risk of tumor recurrence and to select out patients with high recurrent risk to receive preventive adjuvant therapy. circulating tumor cells (ctcs) in the blood play an essential role in cancer metastasis. hence, the detection of ctcs and subsequent analysis can potentially revolutionize the cancer care ranging from screening, diagnosis, monitoring, to drug selection and so on. in the past decade, many methods using magnetic beads (cellsearch), filtration (rarecelletc), or flow cytometry have been developed but all of them have the shortcomings from low sensitivity, low purity, to unable to retrieve cells for downstream molecular analysis and cell culture. recently, a biomimetic affinity based microfluidic platform has overcome abovementioned technical challenges. importantly, by using only 2 ml of peripheral blood, sinica's team has shown that the enumeration of ctcs increases with the crc disease progression, where the mean ctc counts are 3, 15, 29 and 60 per ml for the stages i, ii, iii and iv, respectively. the results imply that monitoring ctc enumeration serially may serve as a prediction marker to identify the crc patients with high probability of recurrence. the aims of this study are toestablishing ctc platform standard operation protocol (sop) that leads to certification of iso 13485 and to establish ctc criteria and evaluate its prediction power of early detection of colorectal cancer recurrence.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of colorectal cancer exclusion criteria: * age younger than 20 * pregnancy * inmates
clinical study of chondro-gide® for large chondral lesions in the knee

Conditions: Knee Injuries; Cartilage Injury; Cartilage Disease; Knee Discomfort

Summary: multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). treatment of large chondral lesions in the knee with microfracture plus the chondro-gide® acc is non-inferior to treatment of small chondral lesions treated with microfracture alone.

the study evaluates the investigational treatment for treating large chondral lesions of the knee to the control treatment of microfracture alone for treating small lesions.eligible patients with a large lesion will be treated with microfracture plus the chondro-gide® acc and compared to patients with small lesions that are treated with microfracture alone. outcome measures to be assessed include patient reported outcomes and freedom from certain adverse events.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. one symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified mri or arthroscopy 3. between 18 and 55 years of age 4. subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, and the rehabilitation protocol exclusion criteria: 1. bmi ≥ 30 kg/m2 2. symptomatic contralateral knee 3. diagnosis of radiographic osteoarthritis with kellgren-lawrence grade 3 or more 4. prior surgical treatment of the cartilage using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to enrollment) 5. patella dysplasia 6. chronic inflammatory arthritis or infectious arthritis 7. history of autoimmune disease or immunodeficiency 8. history of connective tissue disease 9. intra-articular steroid use within the 3 months prior to enrollment 10. other intra-articular injections (e.g. hyaluronic acid) within 3 months prior to enrollment 11. the patient is currently being treated with radiation, chemotherapy, immunosuppression or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone 12. pregnancy or lack of adequate contraceptives if a female of child-bearing potential 13. enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study 14. active infection of the index knee 15. previous diagnosis of osteoporosis as diagnosed by dexa, bone densitometry or ct scan 16. any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions 17. history or current substance or alcohol abuse as defined by the dsm-v 18. any other medical condition that the investigator determines would interfere with the validity of the study 19. known allergy to porcine collagen 20. symptom duration greater than 36 months

Keywords: microfracture cartilage knee
a trial comparing the safety and efficacy of insulin degludec and insulin glargine, both with insulin aspart as mealtime insulin in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe and the united states of america (usa). the aim of the trial is to compare the safety and efficacy of insulin degludec (ideg) and insulin glargine (iglar), both with insulin aspart (iasp) as mealtime insulin in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: - subjects fulfilling at least one of the below criteria: a) experienced at least one severe hypo episode within the last year (according to the ada (american diabetes association) definition, april 2013) b) moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 ml/min/1.73 m\^2 per ckd-epi (chronic kidney disease epidemiology collaboration) c) hypoglycaemic symptom unawareness d) diabetes mellitus duration for more than 15 years e) recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dl \[below or equal to 3.9 mmol/l\])) within the last 12 weeks prior to visit 1 (screening) - male or female, age at least 18 years at the time of signing informed consent - type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to visit 1 - current treatment with a basal-bolus regimen consisting of neutral protamine hagedorn (nph) insulin od (once daily) / bid (twice daily) or insulin detemir (idet) od / bid plus 2-4 daily injections of any rapid acting meal time insulin or csii (with rapid acting insulin) for at least 26 weeks prior to visit 1 - hba1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis - bmi (body mass index) below or equal to 45 kg/m\^2 exclusion criteria: - treatment with iglar or ideg within the last 26 weeks prior to visit 1 (short term use \[less than or equal to 2 weeks\] is allowed, but not within 4 weeks prior to screening) - use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to visit 1
a randomized trial of effect of low-cost maintenance training on exercise capacity, quality of life and morbidity

Conditions: Chronic Heart Failure

Summary: the aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and qol in patients with chronic heart failure.

guidelines recommend physical training in the treatment of patients with chf. several studies have demonstrated that even short-term training programmes can increase maximal oxygen intake, improve muscular strength, reduce neurohumoral activity and result in other effects, which are of potential benefit. following 2-3 months training at 70 - 80% of maximal capacity, improved exercise capacity and oxygen uptake due to increased cardiac output and also better oxygen uptake in the peripheral muscles have been demonstrated. moreover, studies have indicated an improvement of the quality of life (qol). however, the effects of exercise training are rapidly lost without maintenance. thus the crucial question is to identify a method to sustain the physical activity outside an expensive, enthusiastic and highly motivating protocol. the aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and qol in patients with chronic heart failure. comparison: patients fulfilling specified criteria for chronic heart failure are randomised to either eight weeks with supervised group-based training (1.5 hrs.) twice a week followed by home-based training according to a specified protocol with supervised group-based training every 2 weeks (1,5 hrs), or to eight weeks with supervised training followed by usual care. during the whole period patients in both groups can contact the heart failure clinic when needed.

Eligibility criteria:
inclusion criteria: 1. nyha ii-iv 2. ejection fraction ≤45% assessed by echocardiography within the last 6 months 3. optimal medical treatment according to guidelines 4. informed consent - exclusion criteria: 1. hæmodynamically significant obstructive heart valve disease 2. hæmodynamically significant valve insufficiency 3. recent myocardial infarction (8 weeks) 4. significant arrythmia at exercise testing (nsvt, vt, vf or svt with ventricular action \>150) 5. significant ischaemia or angina at low strain(£ 50 w) 6. disabilities that render physical training impossible 7. dementia 8. serious other illness with expected shortened survival 9. participation in other scientific protocols that do not allow participation 10. lack of informed consent 11. if the patient cannot train in a team supervised by only one physiotherapist, e.g. due to poor balance, the patient can be excluded within the first two weeks of inclusion.
to evaluate the criteria for renewal of luteinizing hormone-releasing hormone (lhrh) analogue treatment in prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of the study, is to determine the percentage of patients for whom the initial lhrh prescription has been renewed


Eligibility criteria:
inclusion criteria: * adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month lhrh analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy * patients having provided written informed consent * patients mentally fit for completing a self-administrated questionnaire exclusion criteria: * patients participating in another clinical study at the time of inclusion * patients with another severe malignant disease * life expectancy of less than 12 months * patients already treated with a lhrh analogue within the last year