Kornimate/medical-research-clean huggingface dataset:
safety and performance evaluation of a biological matrix used for rectal prolapse repair by ventral rectopexy

Conditions: Rectal Prolapse

Summary: the general objective of the study is to confirm the medium/long-term safety and clinical performance of the cellis rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material. the present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. the study will be conducted in france in 3 investigational centres.

the study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of cellis rectopexy used in rectal prolapse repair by ventral rectopexy. all evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure. the study will be conducted in france in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse. each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. patients will return for ambulatory visits at day 30 (+/- 7 days), month 6 (+/- 2 weeks), month 12 (+/- 2 weeks) and month 24 (+/-2 weeks). the surgical technique used to repair rectal prolapse will be either laparoscopic ventral rectopexy (lvr) or a robotic assisted rectopexy with the use of the da vinci surgical system (intuitive surgical, inc., sunnyvale, ca).

Eligibility criteria:
inclusion criteria: * patient aged ≥18 years, * patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse), * patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access, * patient being informed of the porcine origin of the device in advance of the procedure. exclusion criteria: * patient with known hypersensitivity to porcine materials, * patient with an existing infection not appropriately treated, * patient who are pregnant, * patient having refused to participate to the study, * patient refusing to come back to the follow-up visits.

Keywords: ventral rectopexy biological mesh
immunotherapy using autologous t cell-engineered with cd19-specific chimeric antigen receptor for the treatment of recurrent /refractory b cell leukemia

Conditions: Recurrent B-Cell Tumor; Refractory B-Cell Tumor

Summary: objectives: the purpose of this study is to evaluate the safety and prognosis of new cluster of differentiation antigen 19-chimeric antigen receptor t (ncar19-t) cells in the treatment of recurrent/refractory b-cell tumor and the optimal dosage of ncar19-t cell therapy. methods: this study designs a novel therapy using ncar19-t. 20 patients will be enrolled. cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); ncar19-t transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). according to the national cancer institute (nci) standard (ctcae), they will be observed 24 weeks long. follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.

a total of 20 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, male or female 2. karnofsky≥60% 3. at least 2 courses of chemotherapy were performed 4. creatinine is less than 2.5mg/dl;alanine aminotransferase (alt) / aspartate aminotransferase(ast) less than 3 times of the normal bilirubin is less than 3mg/dl 5. adequate venous access, isolation, and white blood cell production without other taboos 6. signed informed consent 7. patients with fertility are willing to use contraceptive method. 8. at least two months after infusion of t cells exclusion criteria: 1. need to use glucocorticoid therapy 2. need immunotherapy 3. creatinine \> 2.5mg/dl; alt / ast \> 5 times of the normal; bilirubin \> 3mg/dl 4. forced expiratory volume at one second (fev1)\<2 l,diffusing capacity of the lung for carbon monoxide (dlco)\<40% 5. congestive cardiac failure (iii or iv, nyha); significant hypotension; coronary heart disease can not be controlled; dlco\<40% 6. human immunodeficiency virus (hiv), hepatitis b virus (hbv),hepatitis c virus (hcv) patients 7. had received gene therapy 8. significant encephalopathy / new focal neurologic impairment 9. blood culture positive or radiographic evidence of infection 10. other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month 11. the history of allergic reactions in cell therapy and cetuximab similar compounds.

Keywords: recurrent b-cell tumor refractory b-cell tumor new cluster of differentiation antigen 19-chimeric antigen receptor t cells safety prognosis
the effect of exercises on young adults

Conditions: Exercise; Young Adults; Quality of Life; Pain; Depressive Symptoms

Summary: the aim of this study was to assess the treatment effect of plates and conventional exercises on health related quality of life, pain, functional level, psychological state in young adults. randomised controlled study. participants were randomly divided into 3 groups: a plates exercise group (n = 29), a therapeutic exercise group (n = 21), and a control group (n = 35). the therapeutic and plates groups underwent related training programs for 3 month, while the controls had no specific training. after demographic knowledge were collected the investigators carried out the following assessments on all participants: the visual analog scale (vas), waist/ hip ratio (whr), beck depression inventory (bdi), oswestry disability index (odi), notthingham health profile (nhp). all subjects were evaluated at baseline and post-training.


Eligibility criteria:
inclusion criteria: • they were apparently healthy and had no systematic diseases or any problem preventing their participation in any exercise program. exclusion criteria: * having a systemic pathology, including inflammatory, rheumatologic, or metabolic diseases * having any musculoskeletal injury, pathology, or structural deformity related to the spine or extremities * having any active intervention including corticosteroid or any medication in the previous 3 months.
virtual reality for the mitigation of anxiety during intrathecal administration in participants with spinal muscular atrophy

Conditions: Spinal Muscular Atrophy (SMA)

Summary: the primary objective of the study is to evaluate anxiety level during intrathecal administration (it) under standard of care (soc) and virtual reality (vr) conditions using a reliable self-rating scale.


Eligibility criteria:
key inclusion criteria: * participants aged 7 years and greater * genetically documented spinal muscular atrophy linked to chromosome 5q (5q-sma) * loading nusinersen dose period is completed, and ongoing treatment with nusinersen * ability of the candidate and/or their legally authorized representatives (e.g., parent, spouse, or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations * signed written informed consent from adult participants, or from legal authorized representatives for minors key exclusion criteria: * history of any clinically significant abnormalities that would render the candidate unsuitable for vr (e.g., visual or hearing impairment, presence of eye, face or sclap injuries) or for inclusion (e.g. cognitive impairment), as determined by the investigator * conditions that could be exacerbated by the vr environment, such as: (i) current symptomatic nausea, vomiting, dizziness, migraine; (ii) history of psychosis, hallucinations, epilepsy * ongoing medical conditions or treatments that according to the investigator would interfere with the conduct and assessments of the study (e.g. general anesthesia) * participants wearing a pacemaker and pregnant woman note: other protocol defined inclusion/exclusion criteria may apply.
vascular ultrasound versus intravascular ultrasound for diagnosing iliac vein obstruction

Conditions: Iliac Vein Obstruction; May-Thurner Syndrome; Cockett Syndrome

Summary: * determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct and indirect ultrasonographic signs, in the obstructive diseases of iliac venous segment, in patients with advanced chronic venous insufficiency (ceap 3-6), considering the intravascular ultrasound (ivus) as the gold standard for this diagnosis. * develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in the iliac segment in patients with advanced chronic venous insufficiency (ceap 3-6).


Eligibility criteria:
inclusion criteria: * advanced chronic venous insufficiency (ceap 3-6) submitted to clinical treatment for at least 1 year with no response. * subject must be \> 18 and \< 80 years of age * willing to participate in and able to understand, read and sign the informed consent document before the planned procedure * on duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg exclusion criteria: * subject cannot or will not provide written informed consent * previous venous stent implantation involving the study leg or inferior vena cava * previous venovenous bypass surgery involving the study leg * known reaction or sensitivity to iodinated contrast that cannot be managed with premedication * subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment * acute deep venous thrombosis involving either leg * known history of chronic total occlusion of the common femoral vein of the study leg. * known history of thrombophilia (e.g., protein c or s deficiency, anti-thrombin iii deficiency, presence of lupus anticoagulant, etc.) * venous compression caused by tumor encasement * venous outflow obstruction caused by tumor thrombus * life expectancy of less than 6 months * lower extremity arterial insufficiency * elevated baseline blood creatinine (value greater than the upper limit of the normal range) * any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.

Keywords: iliac vein obstruction may-thurner syndrome cockett syndrome vascular ultrasound ivus
preoperative correction of vitamin d deficiency in total joint arthroplasty (tja)

Conditions: Osteoarthritis; Vitamin D Deficiency

Summary: the purpose of this study is being conducted to determine whether correcting low levels of vitamin d with a single high-dose supplement reduces complications after the participant's primary tja.


Eligibility criteria:
inclusion criteria: * serum 25(oh)d \< 30 ng/ml within 2 weeks of surgery. * able to provide informed consent. exclusion criteria: * follow-up duration \< 90 days anticipated. * acute hepatitis, cancer, organ transplant recipients, or dialysis patients. * extra vitamin d supplementation within 90 days post-surgery. * preoperative serum 25(oh)d ≥ 30 ng/ml. * adults unable to consent (excluded). * individuals under 18 (excluded). * pregnant women (excluded). * prisoners (excluded).
the effect of baseline bilateral uterine artery doppler velocimetry on obstetric outcomes in hrt-fet cycles

Conditions: Infertility

Summary: researchers aim to determine how baseline (pre-conceptional) uterine perfusion characteristics affect implantation rates and obstetric complications in women who underwent high-quality blastocyst transfer.

in hormonally prepared frozen embryo transfer cycles, basal bilateral uterine artery doppler velocimetry will be performed before treatment (pre-conceptional) in each patient. only patients who have high-quality blastocyst stage embryos will be included in the study. since the implantation potential of the specified embryos is high, possible embryo-induced implantation failure would be minimized. bilateral uterine artery doppler velocimetry will be performed during the basal ultrasonography (on the 2-5th day of menstruation). any uterine artery notch, absent diastolic or reverse flow also will be recorded. in addition, sub-endometrial (arcuate artery) blood flows will be evaluated by doppler ultrasonography. for endometrial preparation, estrogen replacement will be given for approximately 12-14 days as a routine in cases with endometrial thickness ≥7mm, progesterone treatment will be started and embryo transfer will be planned on the 6th day of the treatment. a pregnancy test will be performed 9 days after embryo transfer. pregnant patients will be called for ultrasonography control 3 weeks later to determine fetal heartbeat. additionally, the patients will be followed till labor and any obstetric complications will be recorded. uterine artery doppler ultrasonography findings in patients with and without pregnancy will be compared. additionally, in the group in which pregnancy was achieved, obstetric results including birth weight, small-large for gestational age, presence of hypertension, and preterm labor will be correlated with baseline (pre-conceptional) uterine artery doppler parameters.

Eligibility criteria:
inclusion criteria: * exogenous hormone preparation of the endometrial lining * high embryo quality ((≥2bb) according to alpha criteria * embryo transfer at the blastocyst stage exclusion criteria: * patients whose treatments were canceled for any reason before the embryo transfer procedure * patients who underwent embryo transfer in the cleavage stage * presence of low-quality (\<2bb) blastocysts * \>15% loss of viability of the embryo during embryo thawing, * patients with congenital uterine malformations, * patients in whom doppler velocimetry cannot be performed optimally

Keywords: uterine artery doppler velocimetry frozen - thawed embryo transfer
blood pressure lowering ability and safety of an olmesartan and amlodipine based treatment regimen in patients with stage i and stage ii hypertension

Conditions: Hypertension

Summary: this study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.


Eligibility criteria:
inclusion criteria: * males or females greater than or equal to 18 years of age * patients with a mean seated systolic blood pressure (mssbp) greater than or equal to 140 mm hg but less than or equal to 199 mm hg or a mean seated diastolic blood pressure (msdbp) greater than or equal to 90 mm hg and less than or equal to 109 mm hg, following a period of taking only placebo * patients with a mean daytime (8am-4pm) systolic blood pressure greater than or equal to 135 mm hg and less than or equal to 199 mm hg and a mean daytime diastolic blood pressure less than or equal to 109 mm hg as measured by an ambulatory blood pressure monitoring device (abpm), after a period of taking only placebo * if female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study exclusion criteria: * history of stroke or transient ischemic attack (tia) within the last one year * history of myocardial infarction, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months * patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or cushing's syndrome * type i diabetes. patients with type ii diabetes on stable treatment, with fasting glucose \<160 mg/dl may enroll * patients with hemodynamically significant cardiac valvular disease * patients with clinically significant cardiac conduction defects, including second or third degree av block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication

Keywords: hypertension angiotensin receptor blocker calcium channel blocker stage i and ii hypertension
perioperative magnesium sulphate as a cerebral protector in neurosurgical patients

Conditions: Seizures (Incl Subtypes); Brain Tumor

Summary: the purpose of this study is to determine the relationship between magnesium sulphate administration and levels of s100b protein in serum of patients undergoing supratentorial brain parenchymal resection.


Eligibility criteria:
inclusion criteria: * male and females older than 18 years. * undergoing supratentorial parenchyma resection surgery. * capable of collaborate on probes and explorations included in the study. * signature the written informed consent form. exclusion criteria: * life expectancy less than 12 months due to the suspected histological type of tumour. * hypothalamic-pituitary axis illness. * presence of melanoma previously. * glomerular filtration rate less than 60 ml/min. * thyroid or parathyroid glands pathology. * myasthenia gravis. * respiratory depression. * pregnancy or breastfeeding.
treatment of peripheral arterial hemorrhage with lava les (the lava study)

Conditions: Peripheral Arterial Hemorrhage

Summary: to evaluate the safety and effectiveness of the lava les for the embolic treatment of arterial hemorrhage in the peripheral vasculature.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * active arterial bleeding in the peripheral vasculature, documented on a suitable imaging study; * subject or subject's legally authorized representative is able and authorized to provide written informed consent for the procedure and the study; * subject is willing and able to comply with the specified follow-up evaluation schedule; * life expectancy \>30 days; * no prior embolization in the target territory. exclusion criteria: * pregnancy or breast feeding. a woman who, in the investigator's opinion, is of child-bearing potential must have a negative pregnancy test within 7 days before the index procedure; * coexisting signs of peritonitis or other active infection; * participation in an investigational study of a new drug, biologic or device that has not reached its primary endpoint at the time of study screening; * uncorrectable coagulopathies such as thrombocytopenia \ 2.0; * contraindication to angiography or catheterization, including untreatable allergy to iodinated contrast media; * anatomic arterial unsuitability such that, in the investigator's opinion, the delivery catheter cannot gain access to the selected position for safe and intended embolization; * known allergy or other contraindication to any components of lava les including dimethyl sulfoxide (dmso); * more than 4 target lesions will require embolization, in the investigator's opinion after performance of diagnostic angiography or another suitable imaging study.

Keywords: peripheral arterial hemorrhage embolic treatment
brain-controlled spinal stimulation walking therapy after incomplete spinal cord injury (sci)

Conditions: Spinal Cord Injuries

Summary: the purpose of this research is to test the effectiveness of a new therapy, called brain-computer interface (bci)-transcutaneous spinal cord stimulation (tscs), for improving walking in people with an incomplete spinal cord injury (sci).


Eligibility criteria:
inclusion criteria: 1. at least 18 years old and no older than 70 years old at the time of enrollment. 2. traumatic incomplete spinal cord injury (neurological level at or above t10 spinal cord level; abbreviated injury scale (ais) c or d impairment grade for group 1, 3 and 4 and ais b, c or d impairment grade for group 2), who are more than 6 months post-injury. 3. has detectable motor function in at least 2 muscles per side confirmed by voluntary electromyography (emg) or detectable tibialis anterior (ta) muscle motor evoked potentials (meps) at the baseline assessment. 4. able to commit to intensive training and assessment sessions over a maximum total duration of 6 months. 5. could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by dual-energy x-ray absorptiometry (dxa) scan. exclusion criteria: 1. has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking. 2. has severe spasticity that could prevent stepping and walking function determined by the investigator. 3. has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities. 4. has other contra-indications for transcranial magnetic stimulation (tms) or transcutaneous spinal cord stimulation (tscs). 5. has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by tms or tscs. 6. has a history of prior intracranial surgery or known lesions that would limit tms assessments and brain-computer interface (bci) recordings. 7. individuals with metal implants in their head and other implantable devices in the body that could be affected by tms or tscs. 8. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.). 9. has urinary tract infection, unhealed fracture, contracture, and pressure sore (braden scale). 10. has breakdown in skin area that will come into contact with electrodes. 11. individuals who require therapy or other care that could interfere with participation in the study. 12. individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function. 13. individuals with substance disorders, including alcoholism and drug abuse. 14. individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study. 15. in the opinion of the investigators, the study is not safe or appropriate for the participant.
an open-label phase 3 study of lutetium (177lu) oxodotreotide injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.

Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor

Summary: the study is being conducted to evaluate the efficacy, and safety of lutetium (177lu) oxodotreotide injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. 18\~75 years old,male or female； 3. ecog performance status 0 or 1 4. unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors ( gep-nets ) of low and medium grade ( g1 or g2 ) confirmed by histopathology ; exclusion criteria: 1. central nervous system metastasis is known. patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks. 2. there are clinical symptoms or diseases of the heart that are not well controlled. 3. diabetes ( fasting blood glucose \> 2 × uln ) that cannot be well controlled after optimal medical support treatment. 4. severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason