Kornimate/medical-research-clean huggingface dataset:
bpx-501 t cells infused post stem cell transplant in pediatrics with non-malignant disorders ineligible for bpu004 study

Conditions: Hurler Syndrome; Inherited Metabolic Disorder; Lysosomal Storage Disorder; Metachromatic Leukodystrophy; Inborn Errors of Metabolism

Summary: providing access of bpx-501 gene modified t cells and rimiducid to pediatric patients who do not meet the eligibility criteria of the bp-u-004 study.

this is an expanded access protocol of bpx-501 t cells infused after t cell-depleted hsct in pediatric patients with non-malignant hematologic disorders eligible for treatment on the bp-u-004 study. the purpose of this protocol is to provide access to the caspacide system combination product (bpx-501 gene modified t cells and rimiducid) to patients on a case by case basis who do not meet the bp-u-004 protocol eligibility criteria. bpx-501 infusion can enhance immune reconstitution with the potential for reducing the severity and duration of severe acute gvhd.

Eligibility criteria:
inclusion criteria: 1. males or females 2. age \ 3 months 3. life expectancy \> 10 weeks 4. patients deemed eligible for allogeneic stem cell transplantation. 5. non-malignant disorders including: 1. inherited metabolic disorders such as adrenal leukodystrophy; 2. lysosomal storage disorders such as hurler syndrome or metachromatic leukodystrophy 3. other inborn errors of metabolism 6. lack of suitable conventional donor (hla identical sibling or hla phenotypically identical relative evaluated using high resolution molecular typing). 7. a minimum genotypic identical match of 5/10 is required. 8. the donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: hla-a, hla-b, hla-cw, and hla- drb1. 9. lansky/karnofsky score \> 50 10. signed written informed consent 3.2 subject exclusion criteria 1. age \ 21 years 2. patients with non-malignant disorders eligible for treatment on the bp-u-004 study: 1. primary immune deficiencies, 2. severe aplastic anemia not responding to immune suppressive therapy, 3. osteopetrosis, 4. selected cases of hemoglobinopathies and 5. congenital/hereditary cytopenia, including fanconi anemia before any clonal malignant evolution (mds, aml) 3. greater than grade ii acute gvhd or chronic extensive gvhd due to a previous allograft at the time of inclusion 4. patient receiving an immunosuppressive treatment for gvhd treatment due to a previous allograft at the time of inclusion 5. dysfunction of liver (alt/ast \> 5 times normal value, or bilirubin \> 3 times normal value), or of renal function (creatinine clearance \< 30 ml / min) 6. severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \< 40%) 7. current active infectious disease (including positive hiv serology or viral rna) 8. serious concurrent uncontrolled medical disorder 9. pregnant or breast feeding female patient 10. lack of parents'/guardian's informed consent. -
better sleep in psychiatric care - depression, anxiety and trauma, pilot study

Conditions: Anxiety Disorders; Affective Disorders; PTSD; Insomnia Chronic

Summary: between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. in addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. according to international guidelines, cognitive behavioral therapy for insomnia (cbt-i) should be used as the first choice for treatment of insomnia. in practice, however, it is very uncommon for psychiatric patients to be offered cbt-i, instead most are treated with sleep medications. there is also a lack of research studies evaluating cbt-i in regular clinical practice. this pilot study investigated the feasibility of a group treatment with cbt-i at a psychiatric outpatient clinic in stockholm for patients with depression, bipolar disorder ii, anxiety syndrome and ptsd. changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated. patients with self-perceived sleep problems were offered a six-session group treatment based on cbt-i. the primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed. secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.


Eligibility criteria:
inclusion criteria: * being a patient at a specialist outpatient clinic treating these patient groups * insomnia disorder or sleep problems of insomnia type * over 10 points on the insomnia severity index (isi) * adequate skills in written and spoken swedish * no practical barriers to participate in the group treatment exclusion criteria: * night shift work * ongoing alcohol or drug abuse that required treatment at a specialised unit

Keywords: cbt-i
role of uterine artery embolization in adenomyosis

Conditions: Adenomyosis

Summary: management of symptomatizing women diagnosed with uterine adenomyosis, by uterine artery angioembolization as a minimally invasive replacement for hysterectomy. this is followed by assessment of the symptoms and mri of the pelvis after 3 months.

adenomyosis is defined by the abnormal location of endometrial tissue within the myometrium associated with hypertrophy or hyperplasia of the myometrial stroma. although pathogenesis and etiology of adenomyosis remain unknown, two main theories have been proposed: invagination of the endometrial basal layer and metaplasia of embryonic stem cells. despite the absence of specific (pathognomonic) diagnostic features for uterine adenomyosis, typical symptoms include menorrhagia, chronic pelvic pain, and dysmenorrhea. for more than a century, diagnosis was dependent on histopathologic examination of post-hysterectomy specimens till the introduction of noninvasive ultrasound and mr techniques. since then, several studies have illustrated high sensitivities and specificities for both two-dimensional transvaginal sonography (tvs) and magnetic resonance imaging (mri). current treatment options for symptomatic adenomyosis include hysterectomy, medication, conservative surgery, or minimally invasive techniques including uterine artery embolization. to date, hysterectomy remains the definitive treatment. this is mainly due to difficult diagnosis, the diffuse nature of the disease, and little evidence-based literature needed to standardize treatments. this consequently results in a management dilemma, particularly in symptomatic patients who wish to preserve their uterus. uterine artery embolization is the use of transarterial catheters aiming to induce more than 34% necrosis within adenomyotic tissues. vascular access is gained through a femoral or radial artery puncture using 4-6-french (f) arterial sheath for femoral and 4-f sheath for radial access. under fluoroscopic guidance, aortography is followed by selective and super selective arteriography using 4-5-f catheters for the internal iliac and 2-3-f microcatheters for the uterine artery and its branches respectively. embolization is usually performed using variable-sized permanent particulate agents.

Eligibility criteria:
inclusion criteria: * symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy. exclusion criteria: * women who desire further child bearing (not completed their family yet). * impaired coagulation profile. * hypersensitivity to intravenous contrast media. * decompensated congestive heart failure. * hypertensive crisis. * stroke or cva. * renal failure.
an observational study of avastin (bevacizumab) in patients with her2-metastatic or locally advanced breast cancer

Conditions: Breast Cancer

Summary: this observational study will evaluate the safety and efficacy of triple negative or hr+ patients with her2-metastatic or locally advanced breast cancer treated with avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * her2-metastatic breast cancer or locally advanced breast cancer * patients with avastin as first line therapy administered for at least 12 months * patients without disease progression after the beginning of avastin treatment for at least 12 months exclusion criteria: * patients not willing to give informed consent
phone-based based walk with ease program for adults with arthritis

Conditions: Arthritis; Gout; Fibromyalgia; Rheumatoid Arthritis; Osteoarthritis; Lupus Erythematosus, Systemic

Summary: the objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of walk with ease intervention.

participants will be randomized to either start the 6-week program immediately or after one year. our walk with ease by telephone (wwe-t) program is adapted from the original 6-week community-based group walking program developed by the arthritis foundation for adults with arthritis. the phone-based program will include 2 phone calls each week with a trained walk with ease leader for 6 weeks. assessments will be completed before at the start of the study, 6 weeks, 6 months and at 12 months.

Eligibility criteria:
inclusion criteria: * told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia * able to read and write in english * plan to live in the columbia, sc region for next year * willing to be randomized to either group * complete all baseline measure exclusion criteria: * contraindications to exercise (besides arthritis) * are pregnant, breastfeeding, or planning to become pregnant in the next year * have a serious cognitive impairment

Keywords: arthritis physical activity intervention
borderline of cme/d3 dissection for local advanced right-sided colon cancer

Conditions: Colon Cancer

Summary: the study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing smv and sma left resection, with the aim of resolving the controversy over the left resection boundary of cme/d3 lymph node dissection through this study, and to clarify whether sma left resection is superior to smv left resection.


Eligibility criteria:
inclusion criteria: * right side colon cancer(the primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon) * t3-4 and/or n1-2m0 * colonoscopy and pathological biopsy confirmed colon adenocarcinoma exclusion criteria: * t1-2n0m0 * cannot undergo curative resection * simultaneous multiple primary colorectal cancer or other diseases requiring segmental resection * distant metastasis * tumor invades surrounding organs, requiring joint organ resection * emergency surgery is required for complications such as intestinal obstruction, perforation, and bleeding * patients who have received neoadjuvant therapy before surgery * pregnant or lactating women * patients who are not suitable or unable to tolerate surgery

Keywords: right side colon cancer complete mesentery resection
reco flow restoration device versus solitaire fr with the intention for thrombectomy study

Conditions: Ischemic Stroke

Summary: endovascular therapy is increasingly used for patients with moderate-to-severe acute ischemic stroke.this study will compare the efficacy and safety of reco(a novel, self-expanding stent retriever) with solitaire fr within 8 hours of stroke onset caused by the large vessel occlusion.

reco is a novel, self-expanding stent retriever, designed to yield rapid flow restoration in acute cerebral ischaemia. the proposed study is a multicenter, randomized, prospective, parallel-group, open-label clinical trial with a blinded outcome, to test the reco(a novel, self-expanding stent retriever), as compared with solitaire fr stent retriever.

Eligibility criteria:
inclusion criteria: 1. age (18-80 years) 2. acute ischemic stroke 3. within 8 hours after symptom onset 4. a large-vessel confirmed by cta/mra (eg, internal carotid, middle cerebral m1 and/or m2 segments) 5. nihss(≥8 and ≤24) 6. patients or their legally authorised representatives provided signed, informed consent. exclusion criteria: 1. ct or mri evidence of intracranial haemorrhage/tumor 2. major ischaemic infarction (acute ischaemic change in more than a third of the middle cerebral artery territory) 3. nihss(≥25 and ≤7) 4. severe sustained hypertension (systolic blood pressure \>185 mm hg or diastolic blood pressure \>110 mm hg) 5. baseline glucose concentrations of less than 2·7 mmol/l or higher than 21.6 mmol/l 6. known haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with an international normalised ratio of more than 1.7 7. treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal, baseline platelet count of less than 100×10\^9/l 8. history of severe allergy (worse than rash) to contrast medium or nitinol 9. pregnancy

Keywords: acute ischemic stroke,endovascular recanalization mechanical thrombectomy
optimization of darunavir therapy and dosage recommendations

Conditions: Human Immunodeficiency Virus I Infection

Summary: this study will assess and characterize the variability observed in the response to darunavir therapy, an antiretroviral medication used against the human immunodeficiency virus (hiv). more specifically, it aims to quantify variations in the drug's blood concentrations and determine the sources of such variability, both genetic and non-genetic. in light of this information, current dosage guidelines will then be reviewed.

data will be used to create a population pharmacokinetic model. inter- and intra-individual pharmacokinetic variability will be quantified and linked to patient-specific covariates, both genetic and non-genetic in nature. pharmacokinetic-pharmacodynamic relationships will be established, linking drug exposure to efficacy (as measured by cd4 cell count and viral load reduction) and toxicity (as measured by frequency and degree of adverse events). simulations will be conducted for specific patient profiles and current dosage guidelines reviewed. pharmacokinetic design : combined sparse/intensive sampling * sparse sampling : one blood sample collected in each individual at a random post-intake time (during a routine visit to the hospital), up to three times over the course of the study period (months 1-18). * intensive sampling : eight blood samples collected over six hours in a subset of twelve individuals (during an additional observation period, months 19-22).

Eligibility criteria:
inclusion criteria: * capable of giving informed consent * hiv-positive * routinely followed at the cliniques universitaires saint-luc * treated with darunavir inclusion criteria (intensive sampling): - perfect adherence to treatment (as assessed by anamnesis and based on available pk data for each patient) exclusion criteria: - n/a
adenovirus keratoconjunctivitis and ophtalmology

Conditions: Adenoviral Keratoconjunctivitis

Summary: adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. it can leave corneal sequelae even several years after infection. the primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist. secondary aim are to describe administrative procedures (occupational disease declaration and sick leave),infections characteristics; and risk factors.

adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. it can leave corneal sequelae even several years after infection. the investigation tream create a nationwide anonymous retrospective questionnaire using the secure internet application redcap® to build and manage the questionnaire addressed to ophtalmologists (interns, graduates and retirees) and orthoptists. investigator collect several characteristics such as general characteristics (sex, age range, profession), administrative procedure declaration (occupational disease declaration, sick leave, cessation of surgery); infection characteristics (bilaterality, season, anteriority, sequels, current therapy, professional discomfort), risk factor (refractive surgery history, wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy). the primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist. secondary aim are to describe administrative procedures (occupational disease declaration and sick leave), infections characteristics; and risk factors such as a refractive surgery history, the wearing of eyeglasses or contact lenses, smoking, or corticosteroid therapy.

Eligibility criteria:
inclusion criteria: * ophtalmologist or orthoptist (interns, graduates and retirees) * french exclusion criteria: - foreign practitionner

Keywords: adenovirus epidemic keratoconjunctivitis subepithelial infiltrates occupational diseases ophtalmologists orthoptists epidemiology
timing of smoking intervention in alcohol treatment (nicotine patch)

Conditions: Alcoholism; Smoking

Summary: this study will attempt to determine the best time to begin a smoking cessation program in individuals who undergo intensive treatment for alcohol dependence. the goal of this trial is to determine whether a smoking cessation program is more effective if it occurs at the same time as or after treatment for alcohol dependence. the study also will attempt to determine the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol use disorder and other drug dependence. * complete first week of alcohol treatment program. * current cigarette smoker (more than 5 cigarettes/day, smoking more than 1 year). exclusion criteria: * lifetime diagnosis of an excluding psychiatric disorder: bipolar disorder, schizophrenia or other psychotic disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, eating disorder, post- traumatic stress disorder, antisocial personality disorder, or borderline personality disorder. * unable to participate in protocol due to functional deficits or severe depression. * suicidal or homicidal ideation. * current use of disulfiram (antabuse) or naltrexone (revia). * current use of pipes, cigars, or smokeless tobacco and unwillingness to stop. * lives more than 100 miles from alcohol treatment facility. * no telephone.
tms-evoked potentials during heat pain

Conditions: Heat; Pain; Electroencephalography; Transcranial Magnetic Stimulation

Summary: this study investigates the modification of the local-to-global connectivity pattern in response to experimental heat pain. transcranial magnetic stimulation (tms) will be applied to elicit electroencephalography (eeg) responses in healthy volunteers. the tms-evoked potentials (teps) will be recorded and serve as a reflection of cortical reactivity to tms. a thermal cutaneous heat stimulus will induce painful sensations.

abnormal connectivity patterns interfere with the normal function of a given neuronal network, thus leading to circuit dysfunction and, subsequently, chronic pain. in the last few years, neuroscience has been heavily influenced by network science. this synergistic association provided a new framework for understanding brain function in health and how dysfunction in specific neuronal brain circuits can lead to symptoms. a network comprises nodes (e.g., areas of the brain) and edges (functional connections between nodes). an effective network can process and share large amounts of information while maintaining specificity and not allowing noise to contaminate the flow of information across the circuits. the network approach to brain functioning has been able to integrate what has been known for several decades as spatial structural anatomy with the time-varying streaming of information (connectivity) in a dynamic perspective. in this context, symptoms of diseases are seen as being correlated with specific network abnormalities, and therapeutic interventions as being associated with the normalisation of these abnormal patterns of connection. this study will investigate the responses of specific neuronal brain circuits to experimental heat pain in healthy volunteers. it has been hypothesised that the local-to-global connectivity pattern obtained by the stimulation of different cortical hubs (e.g., the primary motor and dorsolateral prefrontal cortices) will be described by tms-eeg responses in healthy individuals, and the modification in cortical connectivity in experimental models will be described and compared it with a non-painful sensory stimulation of the same salience.

Eligibility criteria:
inclusion criteria: * healthy men and women * speak and understand english exclusion criteria: * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate * history of chronic pain or current acute pain * contraindications to rtms application (history of epilepsy, metal in the head or jaw etc.). * failure to pass the "tass questionnaire" (tass = transcranial magnetic stimulation adult safety screen)