Kornimate/medical-research-clean huggingface dataset:
propact: retrospective prophylaxis patient case collection

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this study is conducted in europe and north and south america. the primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor vii. the secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor vii when used as prevention. the study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.


Eligibility criteria:
inclusion criteria: * haemophilia a or b with inhibitors * prescribed use of activated recombinant human factor vii for any type of prophylaxis with a duration of at least 30 days exclusion criteria: * prophylaxis prescribed post-surgery * one or more coagulation disorders in addition to haemophilia
haemocertm application in breast cancer surgery

Conditions: Breast Neoplasm Female; Mastectomy, Segmental

Summary: haemocer is a hemostatic agent to control bleedings during surgical procedures by accelerating natural hemostasis and is frequently applied during breast conserving surgery in women with breast cancer. there is however no adequate data available on the efficacy of haemocer regarding seroma formation or drainage output. the objective of this study is to investigate whether the intraoperative application of haemostatic powder (haemocer) in breast-conserving surgery in breast cancer patients reduces the postoperative drainage output and number of days until drain removal (number of hospitalization days).


Eligibility criteria:
inclusion criteria: * patients with breast cancer undergoing breast-conserving surgery * no previous breast-conserving surgery on the same site * ≥ 18 years age * no current pregnancy * informed consent exclusion criteria: patients with previous breast-conserving surgery on the same site -
parenting support intervention for families coping with metastatic or locally recurrent solid tumor diagnosis

Conditions: Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm

Summary: this clinical trial examines the acceptability and effect of a parenting support intervention for families coping with solid tumor that has spread to other places in the body (metastatic) or has come back (recurrent). parenting support program may help to reduce common parenting concerns, improve communication between parents and children about cancer, and improve the overall psychological wellbeing of parents.

primary objectives: i. examine the acceptability a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers. (trial 1) ii. examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers. (trial 2) iii. evaluate the initial evidence for intervention efficacy relative to waitlist control (wlc) group regarding patient and spousal caregiver psychological symptoms (primary outcome) and parenting concerns and parenting efficacy (secondary outcomes) and patient end of life (eol) healthcare utilization (exploratory outcome). (trial 2) iv. understand the patients and caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research. (trial 2) outline: trial 1: participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. caregivers attend 2 additional weekly intervention sessions over 45 minutes each. trial 2: participants are randomized to 1 of 2 groups. group i: participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. caregivers attend 2 additional weekly intervention sessions over 45 minutes each. group ii: participants receive standard of care. after completion of study, participants in trial 1 are followed up at 6 and 12 weeks and participants in trial 2 are followed up at 12 weeks.

Eligibility criteria:
inclusion criteria: * participants must (1) be diagnosed with a metastatic or locally recurrent solid malignant tumor and on active treatment; (2) be at least 18 years old; (3) have at least one dependent child between the ages of 4 and 16 and currently living with the parent; (4) be able to provide informed consent and (5) have a spousal caregiver over the age of 18 who co-parents the child(ren) (i.e. share custody) and is willing and able to consent to participate.\* exclusion criteria: * participants and caregivers who do not read and speak english and who do not have access to the internet.
a 3-month study to assess the safety of ons-5010 in subjects with visual impairment due to retinal disorders

Conditions: Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration; Wet Macular Degeneration; BRVO - Branch Retinal Vein Occlusion; Diabetic Macular Edema

Summary: the study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * active clinical diagnosis and oct confirmation of one of the following retinal disorders: exudative age-related macular degeneration (amd), diabetic macular edema (dme), or branch retinal vein occlusion (brvo) and, in the opinion of the investigator, requires treatment with an anti-vegf therapy exclusion criteria: * previous use of approved anti-vegf or avastin® within 4 weeks preceding randomization * macular edema due to something other than exudative amd, dme or brvo, in the study eye * history of inadequate response to previous intravitreal anti-vegf therapy * history of any intraocular or periocular corticosteroid injection or implant, in the study eye * laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization * any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period * active intraocular inflammation in the study eye * current vitreous hemorrhage in the study eye * polypoidal choroidal vasculopathy (pcv) in the study eye * history of idiopathic, infectious or autoimmune-associated uveitis in either eye * current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmhg despite treatment with anti-glaucoma medication) * premenopausal women not using adequate contraception * current treatment for active systemic infection * known allergy to any component of the study drug , not amenable to treatment
study evaluating safety and efficacy of ucart123v1.2 in patients with relapsed/refractory acute myeloid leukemia

Conditions: Relapsed/Refractory Acute Myeloid Leukemia

Summary: phase i, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of universal chimeric antigen receptor t-cell (ucart) targeting the cluster of differentiation 123 (cd123) in patients with relapsed/refractory acute myeloid leukemia (aml). the purpose of this study is to evaluate the safety and clinical activity of universal chimeric antigen receptor t-cells targeting cd123 (ucart123v1.2) and determine the maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d).


Eligibility criteria:
main inclusion criteria: * patients with relapsed or primary refractory aml (as defined in world health organization \[who\] criteria) with ≥5% bone marrow blasts * patients with cd123+ blast cells (verified by flow cytometry) * eastern cooperative oncology group performance status (ecog-ps) of ≤1 * adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period * (dose-escalation) identified donor and transplant strategy prior to lymphodepletion (ld) * other criteria may apply main exclusion criteria: * patients with acute promyelocytic leukemia (apl) or central nervous system (cns) leukemia * previous investigation gene or cell therapy (including car) * \> 1 prior allogeneic stem cell transplantations (scts) * prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-cd20) therapy within 3 months * any known active or uncontrolled infection * other criteria may apply

Keywords: acute myeloid leukemia relapsed/refractory acute myeloid leukemia chimeric antigen receptor t-cell (car-t) therapy allogeneic transcription activator-like effector nuclease (talen)
the efficacy of using volunteers to implement a cognitive stimulation program in two long-term care homes

Conditions: Impaired Cognition; Geriatric Disorder; Learning Disorders; Age-Related Memory Disorders; Impairment of Attention

Summary: many volunteers visiting seniors make socially-based "friendly visits". this study investigated the efficacy of volunteers making visits focused on stimulating cognition. participants were randomly assigned to either a "friendly visit" control group or a cognitive stimulation group. seniors receiving stimulation visits made statistically significant improvement in memory abilities.

older adults who maintain their cognitive skills and abilities are able to live more independently than those whose skills have deteriorated. the costs (money, time, personnel) associated with providing cognitive stimulation programs to residents in long-term care homes often prohibit the delivery of these programs. the present study explored the efficacy of using volunteers to administer a stimulation program in two long-term care homes. the program focused on stimulating reasoning, attention, and memory abilities using uncomplicated, pen-and-paper exercises. thirty-six resident participants and 16 volunteer participants were randomly assigned to one of two parallel groups, either the control or stimulation group. for eight weeks, three times each week, control group participants met for standard "friendly visits" (casual conversation between a resident and volunteer) and stimulation group participants met to work through a variety of exercises meant to stimulate the cognitive abilities of residents. results were analyzed using a 2-way anova and indicated statistically significant group x time interactions for verbal memory (f(1, 33) = 7.92, p = .008), non-verbal memory (f(1, 33) = 6.8, p = .014), learning (f(1, 33) = 5.27, p = .028), and verbal fluency (f (1, 33) = 5.56, p = .024). volunteers completed a post-study questionnaire which indicated that the volunteers in the stimulation group found their skills-based interactions more stimulating for residents. given this showing of improved resident abilities, it is reasonable to assert that the study does demonstrate that a volunteer-administered, cognitive stimulation program can provide measurable gains in the cognitive abilities of older adults. further studies concerning the role of volunteers in the maintenance of the cognitive abilities of older adults are recommended.

Eligibility criteria:
inclusion criteria: * 65 years and over * living in a long-term care home * normal or corrected visual and auditory acuity * english proficiency * not currently using de-stabilizing, psychotropic medication known to impair cognition * ability and willingness to actively listen to and accurately follow 2-step instructions for at least 20 consecutive minutes
psychology of crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether emotional processing and somatic dissociation influence ibs-like symptoms in crohn's disease patients.


Eligibility criteria:
inclusion criteria: * age of 19 or greater * outpatient with diagnosis of crohn's disease

Keywords: crohn's disease ibs dissociation emotional processing
analysis of immune responses to hiv vaccines

Conditions: Acquired Immunodeficiency Syndrome; HIV Infections

Summary: this study will evaluate a test designed to measure immune system responses to hiv and hiv vaccines.

assays for hiv-specific human cd4 and cd8 t cell immunity are needed in order to evaluate the immune response to hiv vaccines. such assays should be robust, reproducible, and amenable to high throughput analysis of clinical specimens. cytokine flow cytometry (cfc) assays can reliably and specifically detect human cd4 and cd8 t cell responses to aids-related opportunistic infections, including those caused by cytomegalovirus, mycobacterium tuberculosis, the mycobacterium avium complex, cryptococcus, and human papillomavirus. the purpose of this study is to devise and evaluate a similar cfc assay for the detection and quantitation of cd4 and cd8 t cell responses against hiv. this study will evaluate a "gag-ifng cfc" assay by comparing the results of this assay with results from other assays of immune phenotype and function in long-term nonprogressors, untreated patients with progressive hiv disease, and recipients of candidate hiv vaccines. the study will also examine hiv-specific immune responses in hiv infected individuals who appear to exhibit significant immune protection from hiv disease. participants in this study will be drawn from other studies currently underway. as a part of those studies, participants will have regular blood tests. blood samples from those studies will be used in this study. no participants will be directly enrolled in this study.

Eligibility criteria:
blood samples from 5 cohorts of hiv infected individuals and 2 cohorts of hiv uninfected individuals will be evaluated. varying stages of hiv disease are represented in these cohorts, including: * individuals who have been exposed but who have not seroconverted * individuals who have recently seroconverted * haart-treated patients who receive immune modulators such as il-2 and therapeutic immunization * haart-treated patients who undergo structured treatment interruptions * haart-treated patients who have durable suppression of viremia * haart-treated patients who experience incomplete suppression of viremia * haart-treated patients followed with careful drug adherence monitoring * long-term nonprogressors * untreated progressors

Keywords: hiv seronegativity hiv preventive vaccine hiv therapeutic vaccine
treatment of the metabolic syndrome in an interdisciplinary obesity clinic: a randomized controlled study

Conditions: Obesity; Metabolic Syndrome

Summary: this study is a randomized, controlled and opened trial designed to compare the effects of an interdisciplinary moderate-intensity lifestyle modification program vs. conventional treatment by primary care physicians. we want to show the benefits of coherent interdisciplinary care in the obesity clinic of chus (centre hospitalier universitaire de sherbrooke) in comparison to the conventional treatment in order to: * improve subjects' characteristic features of metabolic syndrome: weight, waist circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and hba1c; * improve our patients' nutritive practices; * decrease our patients' sedentary lifestyle; * improve our patients' motivation to lose weight, and to improve their quality of life; we also wish to define predictors of answer in order to better select the patients if necessary, and evaluate the costs incurred by the health system.

eligible participants recruited from patients, referred through the obesity clinic were separated into two groups. the interdisciplinary treatment group received interventions at our clinic for 6 months.. the intervention included a visit every 6 weeks including a nursing consultation (listening, psychological support, anthropometric measurements and blood pressure), an endocrinologist consultation, a nutritionist consultation (initial evaluation of food intake and counselling), a psychologist consultation if needed, an interactive group information session (to discuss the following: diet, psychological aspects associated with obesity, physical education, complications and pharmacological treatments of obesity), and a questionnaire on the individual costs of their visit. a control group was monitored during this 6 months by their family physician, as per usual. a biological assessment, questionnaires, and tests will be carried out in beginning and end of program: the questionnaires are to evaluate the physical activity (sallis, canada fitness survey); the quality of life (iwqol-lite, sf-36); the motivation (analogical visual scales); knowledge (pretest and post-test); and costs. tests to assess physical activity (6-minute walk test and accelerometer) will also be administered. after the first 6 months, both groups were followed at the obesity clinic for another 12 months.

Eligibility criteria:
criteria inclusion: * referred to the obesity clinic by a medical doctor; * bmi \> 27 kg/m²; (body mass index) * metabolic associated syndrome according to the definition of the ncep-atp iii * be able to give an inform consent criteria exclusion: * impossibility to be present at the visits * physical/motor incapacity (or other) making one unable and insecure to walk at a moderate to rapid speed for 6 min and more * use of an anti-obesity treatment the last 3 months * bariatric surgery in the past * planned pregnancy * pacemaker
study of inhaled iloprost for the treatment of pulmonary hypertension after repair of congenital heart disease

Conditions: Pulmonary Hypertension

Summary: the objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.

pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. iloprost is a prostacyclin analogue. when applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. no randomized controlled trials (rct) of iloprost have previously been performed in this indication. the investigators study is the first rct of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.

Eligibility criteria:
inclusion criteria: before corrective procedure for chd, two of bellow ten criteria should be met: * decreased respiratory infection \& decreased exercise tolerance * pulse sao2 \< 93% in left-right shunt chd case (in room air) * ekg: right ventricular hypertrophy, right atrial dilatation * chest x-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement * cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt * underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels * pp/ps \> 0.75 * qp/qs \<1.5 * pvr \> 9wu/m2 * rp/rs \> 0.5 exclusion criteria: * a body weight of \< 2 kg, * prematurity (birth 36 weeks postconceptual age) * renal dysfunction (creatinine \>= 1.5 mg/dl 48 hours before surgery) * plt \< 50,000\*109/l and obvious bleeding * lcos or hypotension on arrival to the intensive care unit after corrective procedure for chd: * deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation * severe arrhythmia led to low cardiac output

Keywords: pulmonary hypertension
pain control for anterior cruciate ligament reconstruction patients with adductor canal or femoral perineural infusions

Conditions: Pain, Postoperative; Anterior Cruciate Ligament Injury

Summary: nerve blocks are used to provide pain control after moderately painful orthopedic surgeries. anterior cruciate ligament (acl) reconstruction with patellar autograft is a painful orthopedic procedure performed after traumatic injury to the knee. many patients undergoing acl reconstruction receive a nerve block as part of their anesthetic care. these blocks can be performed in different locations along the femoral nerve, with advantages and disadvantages to each location. recently published evidence indicates that there is no short-term difference in pain control between the two commonly-targeted locations ("adductor canal" and "femoral"). however, studies involving patients undergoing total knee arthroplasty indicate that femoral blocks provide better pain control with movement than adductor canal blocks. as many patients undergoing acl reconstruction use continuous passive motion (cpm) machines as part of rehabilitation starting on post-operative day one, the investigators hypothesize that pain control and quality of recovery in the first 48 hours after surgery will be superior with a continuous femoral block than with a continuous adductor canal block. the investigators plan to study this by randomizing patients presenting for acl reconstruction to receive either a continuous femoral or continuous adductor canal block (both considered adequate means of pain control), and following them to 48 hours to determine the level of pain, quality of recovery score, opioid use, and cpm compliance.

covery score, opioid use, and cpm compliance.

Eligibility criteria:
inclusion criteria: * adult patients \>18 years * asa physical status i, ii, or iii * scheduled for acl reconstruction surgery with patellar autograft exclusion criteria: * pregnancy * incarceration * age \<18 * bmi \>35 * pre-operative opioid use \>15 mg morphine equivalents per day * inability to communicate with investigators by telephone * pre-existing neuropathy of the operative extremity
patient-derived xenograft models of tumor from patients with head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the investigators want to have a collection of fresh primary or recurrent tumor tissue for establishment of patients-derived xenografts in order to: generate a biobank of in vivo patient xenografts representing the different subgroups of tumors for head and neck cancer * perform genetic and transcriptional profiling of the primary, metastatic tumors and xenograft tumors * evaluate the efficacy of new targeted agents, whether or not in combination with standard treatment options * evaluate biomarkers of drug sensitivity * study primary and secondary (acquired) resistance in these models


Eligibility criteria:
inclusion criteria: * in the first phase, all patients with primary or recurrent/ metastatic disease of head and neck cancer can be included pre-operatively or before a tumor biopsy after obtaining informed consent * data on stage, grade, histology, adjuvant treatment, responses, relapse should be available * follow-up data should be available * patients with recurrent disease are allowed * written informed consent