Kornimate/medical-research-clean huggingface dataset:
clinical trial of biolimus-coated intracranial balloon dilation catheter

Conditions: Intracranial Atherosclerotic Stenosis

Summary: this test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of biolimus coating. after completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.


Eligibility criteria:
inclusion criteria: * 18 to 80 years old; * symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70\~99%(wasid method); exclusion criteria: * target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover; * ischemic cerebral infarction occurred 3 weeks before surgery; * cerebral hemorrhage 3 months before operation;

Keywords: intracranial balloon stenosis
a study of cc-98633, bcma-targeted chimeric antigen receptor (car) t cells, in participants with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 1, multicenter, open-label study of cc-98633, bcma-targeted nex-t chimeric antigen receptor (car) t cells, in participants with relapsed and/or refractory multiple myeloma. the study will consist of 2 parts: dose-escalation (part a) and dose-expansion (part b). the dose-escalation part (part a) of the study is to evaluate the safety and tolerability of increasing dose levels of cc-98633 to establish a recommended phase 2 dose rp2d(s); and the dose-expansion part (part b) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of cc-98633 at the rp2d(s).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. signed written informed consent prior to any study procedure. 3. relapsed and/or refractory multiple myeloma (mm). 1. subjects must have documented progressive disease as per international myeloma working group (imwg) criteria during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. also, subjects with confirmed progressive disease within 6 months prior to start of screening and who are refractory (or non-responsive) to their most recent anti-myeloma treatment regimen afterwards will be also eligible. 2. part a and part b cohort a: subjects must have confirmed at least 3 prior antimyeloma treatment regimens. 3. part b cohort b only: subjects must have received at least 1 but no greater than 3 prior antimyeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent. 4. subjects must have previously received all of the following therapies: i) autologous stem cell transplant ii) a regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination iii) anti-cd38 (eg, daratumumab), either alone or combination subjects in cohort b do not require prior anti-cd38 antibody therapy. 4. measurable disease 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate organ function exclusion criteria: 1. known active or history of central nervous system (cns) involvement of mm 2. active or history of plasma cell leukemia, waldenstrom's macroglobulinemia, poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis 3. prior treatment with car t-cell or another genetically modified t-cell therapy 4. part a and part b cohort a only: prior treatment with investigational therapy directed at bcma 5. uncontrolled or active infection 6. active autoimmune disease requiring immunosuppressive therapy 7. history or presence of clinically significant cns pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Keywords: multiple myeloma myeloma myeloma multiple cc-98633 bcma car-t cart bcma cart bcma car-t
magnetic particle-icg lymph node mapping in colorectal cancer

Conditions: Colorectal Cancer

Summary: study to determine the feasibility of sentinel lymph node (sln) mapping using novel magnetic tracers (ferrotrace) and indocyanine green (icg) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (ferrotrace) and icg for colorectal cancer.

primary: 1. to determine the feasibility of sentinel lymph node (sln) mapping using novel magnetic tracers (ferrotrace) and indocyanine green (icg) for colorectal cancer. 2. to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (ferrotrace) and icg for colorectal cancer. secondary: 1. to determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the slns with detailed immunochemistry versus the normal h\&e staining pathology tests. primary end points: 1. feasibility: number of registered patients who complete all study procedures with at least one sentinel node identified. 2. safety: rate of any grade iii or greater toxicity attributable to ferrotrace injection, evaluated using the common terminology criteria for adverse events (ctcae) v. 5.0. adverse events according to general peri-operative complications. secondary endpoints: 1. the identification rate and number of ferrotrace-positive lymph nodes for each patient. 2. incidence of pathological upstaging of ln metastasis status by the addition of (non-routine) serial h\&e and immunohistochemistry in the pathological assessment of identified ferrotrace-positive lymph nodes.

Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * biopsy proven colon or rectal cancer * no distant metastases exclusion criteria: * serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team * previous pelvic radiotherapy or radiotherapy planned prior to surgery * allergy or intolerance to iron oxide compounds * iron overload disorder * allergy or intolerance to iodides * pregnant or lactating women\*
non-invasive neurostimulation as a tool for diagnostics and management for neurodegenerative diseases

Conditions: Alzheimer Disease; Frontotemporal Dementia; Dementia With Lewy Bodies

Summary: double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tacs) in neurodegenerative diseases. the investigators will evaluate whether a 4-times daily repeated stimulation with gamma tacs on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with lewy bodies, alzheimer's disease, idiopathic normal pressure hydrocephalus and frontotemporal dementia.

double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tacs) in neurodegenerative diseases. the investigators will evaluate whether a 4-times daily repeated stimulation with gamma tacs on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with lewy bodies, alzheimer's disease, idiopathic normal pressure hydrocephalus and frontotemporal dementia.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment due to alzheimer's disease * dementia with lewy bodies * frontotemporal dementia * idiopathic normal pressure hydrocephalus (inph) exclusion criteria: * history of seizures * pregnancy * metal implants in the head (except dental fillings) * electronic implants (i.e. pace-maker, implanted medical pump) * age \<18 years
the impact of outdoor sports practice on the well-being of disabled people

Conditions: Disability or Chronic Disease Leading to Disablement

Summary: survey of the members of the french handisports federation (ffh) practicing outdoor sports.

this is a national cross-sectional study to investigate the impact of outdoor sports practice on the well-being and self-esteem of people with disabilities. the study is based on a survey of ffh members practicing outdoor sports. the survey will be distributed between october and november 2023 via the federation's internal communication system. data will be collected on outdoor sports activity, psychological impact and barriers to practice. analyses will be made between able-bodied and disabled members, between types of disability, and between types of outdoor sport practiced (water, land and air). analysis will be based on anomysed data and will respect the mr004 methodology.

Eligibility criteria:
inclusion criteria: * being a member of the french handisport federation between september 2022 and august 2023 * practicing outdoor sports exclusion criteria: * persons who have objected to be contacted by e-mail

Keywords: physical activities, outdoor sports, disability
quality improvement initiative for enhancing early mobilization in intracerebral hemorrhage patients

Conditions: Primary Intracerebral Hemorrhage; Early Mobilization

Summary: primary intracerebral hemorrhage (ich) is a severe and life-threatening condition with a high mortality rate, reaching up to 50% within the first month. survivors are often at risk of long-term disability due to the extensive brain damage caused by the hemorrhage. unlike ischemic stroke patients, ich patients are typically younger, face longer hospital stays, and are more likely to experience acute complications. modern treatment approaches have shifted from focusing solely on reducing mortality to minimizing disability and enhancing functional outcomes through early rehabilitation. however, the optimal timing and intensity of early mobilization remain unclear, especially for patients with severe ich, where medical stability is a major concern. delays in initiating rehabilitation may limit neuroplasticity and hinder recovery, prompting the need for a structured, multidisciplinary approach to early mobilization in ich patients. objective : this quality improvement (qi) initiative aimed to enhance early mobilization in ich patients by implementing a structured clinical pathway in an academic stroke center. the goal was to integrate evidence-based early mobilization pathways to improve patient mobility outcomes while ensuring safety through standardized assessments of cardiovascular, respiratory, and neurological stability.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary ich * ich score from 0 to 4 * patients in line with the stroke center's standard criteria for early rehabilitation exclusion criteria: * patients with traumatic brain injury, hemorrhagic transformation of ischemic stroke, or hemorrhage related to underlying malignancy * patients placed in palliative care or those who died before initial hospital discharge

Keywords: intracerebral hemorrhage early mobilization stroke unit clinical pathway
superiorly based pharyngeal flap versus myomucosal resection and direct closure

Conditions: Velopharyngeal Insufficiency

Summary: patients were classified into two groups. group (a) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. group (b) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

patients were classified into two groups. group (a) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. group (b) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Eligibility criteria:
inclusion criteria: * - patients have velopharyngeal insufficiency. * age range 4-10 years exclusion criteria: * - syndromic patients.
a study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (mcl).

Conditions: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma

Summary: a study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (mcl) who are not candidates for transplantation and have achieved partial response (pr) or complete response (cr). this study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. a study design with the control arm of no active treatment was no longer appropriate. the termination of the trial was not based on any safety concerns in the study.


Eligibility criteria:
inclusion criteria: * histologically-proven mantle cell non-hodgkin's lymphoma, * one of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) fludarabine containing regimen such as fc (fludarabine, cyclophosphamide) * achieved a pr or better response after the first-line induction chemotherapy regimen (assessed by 2007 revised response criteria for malignant lymphoma) * ecog performance status score of ≤ 2 * willing to follow pregnancy precaution exclusion criteria: * patients who have received more than 1 line of induction chemotherapy; * patients who have received less than 4 cycles of r-chop, r-chop-like, or r-fc are ineligible; * patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy; * any of the following laboratory abnormalities: * absolute neutrophil count (anc) \< 1,500 cells/mm3 (1.5\*10\^9/l) * platelet count \< 60,000/mm\^3 (60\*10\^9/l) * serum aspartate transaminase (ast/sgot) or alanine transaminase (alt/sgpt)) \> 3.0 times upper limit of normal (uln), except in patients with documented liver involvement by lymphoma * serum bilirubin \> 1.5 times uln, except in case of gilbert's syndrome and documented liver involvement by lymphoma * calculated creatinine clearance (i.e. cockcroft-gault formula) of \< 30 ml /min * active or any history of central nervous system (cns) lymphoma or leptomeningeal involvement by lymphoma * subjects at high risk for deep vein thrombosis (dvt) not willing to take dvt prophylaxis * known seropositive for or active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv)

Keywords: mantle cell lymphoma non-hodgkin's lymphoma cc-5013 revlimid lenalidomide
study assessing the efficacy of eductyl® for the treatment of patients with dyschesia

Conditions: Dyschesia

Summary: the purpose of this study is to assess the efficacy of eductyl versus placebo for treatment of patients with dyschesia.


Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 75 years old, * writing consent to take part in the study, * patient with a dyschesia according to rome iii criteria * an intensity of the inconfort using a vas (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm exclusion criteria: * patient suffering of neurologic affection, * rectal diseases including : * current anal ou peri-anal pain, * current organic injury of colon or rectum, * current anal injury, * current rectal prolapse, * current haemorrhoid, * colon inflammatory disease (ulcero haemorrhagic recto colitis, crohn disease...), * current ano-recto-colon stenosis (anastomosis, scarring ...) * patient undergone pain killers (who level ii (except dextropropoxyphen) and iii) during the last 8 days, * patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study, * patient with a constipation treatment except if this treatment is regular for at least 15 days and it won't be modified during the study * intolerance to eductyl® or to one of its components (potassium tartarate acid, sodium bicarbonate, solid hemisynthethic glycerides, soya lecithin, talc) * use of eductyl® during the previous 15 days (over 5 days in the last 15 days), * patient already included in clinical trial in the last month, * pregnant or breast feeding woman, * woman of childbearing potential without contraception, * patient unable to read and write.

Keywords: dyschesia treatment inconfort related to dyschesia quality of life bowel function index
ed diabetes screening and outpatient care

Conditions: Diabetes Mellitus; Non Insulin Dependent Diabetes Mellitus

Summary: this goal of this nih funded r01 study is to identify risk factors for not being able to follow-up for a new diagnosis of diabetes in the emergency department and improve linkage of these newly diagnosed patients to appropriate outpatient care. its three aims will be accomplished through 1) a retrospective chart review of emergency department (ed) patients screened for diabetes, 2) a series of prospective qualitative interviews among ed patients with newly diagnosed diabetes who fail to follow-up for outpatient care, and 3) a simple randomized controlled trial to test the efficacy of telehealth bridge visits to connect ed patients with newly diagnosed diabetes to outpatient primary care.


Eligibility criteria:
inclusion criteria: * emergency patient receiving lab tests with an initial hba1c test result of ≥ 6.5% * residential address in new york city or long island * primary language is english or spanish * able to provide informed consent exclusion criteria: * no prior history of diabetes * no medical condition that would result in a spurious hba1c test (e.g., sickle cell, recent blood loss)
trial with telomerase peptide vaccine in combination with temozolomide in patients with advanced malignant melanoma

Conditions: Malignant Melanoma

Summary: primary objective: determination of safety and tolerability of gv1001 administration combined with temozolomide (based on blood samples and adverse events). feasibility of combining active immunisation with temozolomide treatment. determination of immunological response after administration of gv1001 and temozolomide as measured by presence of dth skin test reaction and specific t-cell responses. secondary: evaluation of objective tumour response the trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. however, the trial may also indicate the efficacy of the combination.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of malignant melanoma. * previously untreated and non-resectable disease * measurable or evaluable tumour. * age ≥ 18 and ≤ 75 years. * performance status ecog-who 0, 1 and 2 (appendix iii) * written informed consent (appendix ii) * adequate bone marrow liver, heart and renal function: * wbc count \>3.0 x 109/l and platelets count \>100 x 109/l. * asat, alat \<2 x upper normal laboratory value. * serum creatinine \<2 x upper normal laboratory value. exclusion criteria: * previous treatment with chemotherapy. * clinical signs of brain metastases. * severe cardiac insufficiency (nyha iii or iv) with uncontrolled and/or unstable cardiac or coronary artery disease. * severe active infections such as hiv or hepatitis b or hepatitis c. * medication for severe intercurrent disease which might affect immunocompetence (e.g. immunosuppressants, systemic corticosteroids). * pregnancy, breast-feeding or absence of adequate contraception for fertile patients. * simultaneously participation in other clinical studies. * any reason why, in the opinion of the investigator, the patient should not participate.

Keywords: non-resectable, advanced malignant melanoma.
the impact of surgical technique on circulating tumor dna in stage i-iii non-small cell lung cancer

Conditions: Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8

Summary: this clinical trial compares the effect of pulmonary vein-first surgical technique to pulmonary artery-first surgical technique in decreasing circulating tumor cell deoxyribonucleic acid (ctdna) in patients with stage i-iii non-small cell lung cancer. pulmonary vein first and pulmonary artery first surgical techniques are standard surgical techniques for the division of the blood vessels during lung resection surgery. pulmonary vein-first surgical technique may reduce the risk of shedding tumor cells during surgery and influence long term overall survival.

primary objective: i. to determine the association between sequence of surgical resection and postoperative ctdna levels at specified time points. secondary objective: i. to determine the associated between sequence of surgical resection and postoperative ctdna level and clinical oncologic outcomes. ii. to assess disease-free survival and the role of circulating tumor dna in disease recurrence in patients with resectable non-small cell lung cancer. outline: patients are randomized to 1 of 2 groups. group i: patients undergo pulmonary vein first approach surgical procedure on day of surgery. group ii: patients undergo pulmonary artery first approach surgical procedure on day of surgery. after completion of surgery, patients are followed up at day 1, day 7, days 7-28, 4 months, every 6 months for 2 years, then every 6 months for up to 5 years

Eligibility criteria:
inclusion criteria: * any patients 18 years of age or older with confirmed or suspected early-stage (stage i-iii) nsclc * eligible and scheduled for surgical anatomic lung resection (e.g. lobectomy or segmentectomy) as routine clinical care for their disease exclusion criteria: * previous cancer diagnosis within 5 years (except ductal carcinoma in situ \[dcis\] of the breast, superficial bladder cancer, non-melanoma skin primary, other malignancy that does not require treatment). * preoperative chemotherapy, immunotherapy, or radiation therapy * receipt of perioperative blood transfusion
rejection sensitivity and puberty in mental health vulnerability to social media experiences in early adolescent girls

Conditions: Rejection Sensitivity; Puberty; Psychopathology

Summary: this longitudinal study is designed to test bidirectional relationships between preteen girls' mental health and social media experiences. we will explore how pubertal development and experiences of rejection influence these relationships.


Eligibility criteria:
inclusion criteria: * female aged 10-11 years * engagement in social media use * proficient in the english language * family/personal device that can complete daily diaries exclusion criteria: * previously diagnosed chronic medical illness * autism spectrum disorder * significant developmental or speech delay * endocrine disorder * not assigned female at birth (afab)

Keywords: puberty rejection sensitivity psychopathology social media