Kornimate/medical-research-clean huggingface dataset:
evaluating a primary-care group-based mindfulness program

Conditions: Anxiety; Depression; Sleep Initiation and Maintenance Disorders; Social Isolation

Summary: the study evaluates the effectiveness of a group-based mindfulness program conducted in a primary care setting. this study also aims to identify any scale-up and implementation considerations for the program.

a primary care group-based mindfulness program was developed by community physicians and co-op and public health students in ajax, ontario. the program was started in january 2018 and is run through the ajax harwood clinic, which is a clinic housing a family health organization (fho) comprising of 5 physicians and approximately 6,500 patients. the purposes of the program are: 1. to teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions, 2. to promote an integrative concept of health, which treats the whole person 3. to promote community building and positive relationships 4. to capitalize on the power of groups to: 1. foster peer-to-peer learning and support when it comes to coping with life challenges 2. combat isolation 3. increase efficiency, quality, and timeliness of care this study evaluates the 8-week rolling admission mindfulness program, by first doing a retrospective chart review to identify effect sizes and then conducting a before-after study evaluation of the effect of the mindfulness program on key mental health outcome measures.

Eligibility criteria:
inclusion criteria: * be enrolled in mindfulness-based program through ajax harwood clinic * age of 18 * english-speaking ability to participate in program * able to provide informed consent exclusion criteria: * no formal exclusion criteria

Keywords: generalized anxiety disorder mental health mindfulness group-based therapy
use of celecoxib in patients with intraductal papillary mucinous neoplasms (ipmns)

Conditions: Pancreas Neoplasms

Summary: the purpose of the study is to find out whether the drug celecoxib has beneficial effects on people with pre-cancerous lesions of the pancreas.

efforts at finding a successful chemotherapy for pancreatic cancer have been disappointing. some patients are at increased risk of pancreatic cancer or may have pre-malignant pancreatic lesions which predispose them to later pancreatic cancer development. in these individuals, chemopreventative measures may block future development of pancreatic cancer. human tissue studies, cell culture and animal models of pancreatic cancer strongly suggests that cyclooxygenase-2 (cox-2) may be a successful target for chemoprevention. cox-2 is overexpressed in human pancreatic cancers. elevated cox-2 expression correlates with progression of premalignant precursors of pancreatic cancer in development models of hamster pancreatic cancer. human tissue studies confirm increases in cox-2 expression with progression of premalignant precursors called intraductal papillary mucinous neoplasms (ipmns) and pancreatic intraepithelial neoplasms (panins). moreover, cox-2 inhibitors appear to have chemopreventative efficacy in the pc-1 homograft model of hamster pancreatic cancer. demographic studies have suggested cox-2 inhibitors may confer protection from pancreatic cancer. we propose to conduct a pilot/phase ii trial to determine the chemopreventative effects of the cox-2 inhibitor celecoxib in patients with premalignant pancreatic lesions. patients registered to the study will take celecoxib twice daily for 6-8 weeks prior to surgery (if patient decides to have surgery for his/her condition). if subject is not a surgical candidate or puts off surgical treatment, subject will take celecoxib for 6 months.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ipmn * ecog performance status of 0, 1, or 2 * adequate liver function, bilirubin \< 1.5 times uln, alt or ast \< 2.5 times uln * adequate renal function: creatinine \< 1.8 * must be at least 18 exclusion criteria: * use of cox-2 selective inhibitors within the last month * more than occasional use of nsaids in last month (occasional use defined as up to twice weekly dosing) * ca19-9 levels 1.5 times the uln * active pancreatitis * taking sulphonylureas, fluconazole or lithium concomitantly

Keywords: celecoxib for pancreas lesions
mixed chimeric transplantation for primary amyloidosis

Conditions: Amyloidosis

Summary: to evaluate the role of nonmyeloablative allogeneic transplantation in amyloidosis.


Eligibility criteria:
inclusion criteria: * primary amyloidosis * adequate organ function * matched sibling donor exclusion criteria: * evidence of multiple myeloma * hiv positive

Keywords: amyloidosis nonmyeloablative hematopoietic cell transplantation
autoimmune cytopenia and bcr inhibitors

Conditions: Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia

Summary: efficacy of bcr inhibitors in the treatment of autoimmune cytopenias associated with chronic lymphocytic leukemia (cll): a retrospective analysis of the french innovative leukemia organization (filo)

the investigators of the study propose a card of data collection, validated by the scientific council of the group filo. the data to be collected are entered on an e-crf made available to the investigators on a secure site. the main data collected are as follows * anonymized demographic data * clinical and biological data of cll at diagnosis * previous treatments of llc and cai * clinical and laboratory data at the time of initiation of bcri treatment * response to treatment with bcri * tolerance to bcri treatment * progression under treatment with bcri * recent news

Eligibility criteria:
inclusion criteria: * patient with cll * active autoimmune cytopenia * initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia. exclusion criteria: * other lymphoid hemopathy b * absence of documentation of the autoimmunity of cytopenia

Keywords: chronic lymphocytic leukemia autoimmune cytopenias bcr inhibitors
the efficacy of hypertonic dextrose injection to anterior talofibular ligament sprain

Conditions: Ankle Sprains

Summary: anterior talofibular ligament is the most injured ligament in ankle sprain. investigators will include ankle sprain patients who have ankle pain or instability more than 3 months. ultrasonography will be done for confirm ligament injury. participants will be randomized into two groups. participants in dextrose injection group will accept dextrose 15% injection to tendon and enthesis. in the other hand, subcutaneous sham injection to control group. pain condition, stability test and function test, will be evaluated in 1 week, 4 weeks and 12 weeks after injection.

background: sprains constitute most of ankle injury and 85% ankle sprain is inversion injury. the conventional treatment includes medication, physical therapy, bracing and steroid injection. anterior talofibular ligament is the most injured ligament in ankle sprain. although the response of acute ligament sprain is usually quickly, treatment of chronic ligament sprain is difficult. chronic pain and ankle instability is the most common symptom in chronic ankle sprain. dextrose prolotherapies been used for treating soft tissue injury such as osteoarthritis, tendinopathy and ligament sprain. however, there is not randomized control trial for hypertonic dextrose injection to chronic ankle sprain. methods: investigators will include 40 ankle sprain patients who have ankle pain or instability sensation more than 3 months. ultrasonography will be done for confirm ligament injury. participants will be randomized into two groups. dextrose injection group will accept dextrose 15% injection to tendon and enthesis. otherwise, investigators will do subcutaneous sham injection to control group. investigators will measure pain threshold and peak pressure by algometer, the degree of ankle instability by ultrasound, the proprioception by single leg standing, and foot and ankle questionnaire. the examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.to our hypothesis, investigators suggest dextrose prolotherapy injection could decrease pain and improved proprioception.

Eligibility criteria:
inclusion criteria: 1. 20-70 age 2. chronic ankle sprain more than 3months with chronic ankle pain or instability sensation 3. ultrasound diagnosed anterior talofibular ligament sprain exclusion criteria: 1. acute ankle sprain less than 3 months 2. lower limb fracture history 3. cognitive impairment 4. other neurological or muscular disorders 5. sever pain could not tolerate examination
accuracy of the pima™ cd4 test for enumeration of cd4+ t-cell counts

Conditions: HIV Infection; AIDS; HIV Infections

Summary: this is a multi-center study designed to assess the accuracy of pima™ cd4 test to enumerate cd4+ t-cells in whole blood over the measurement range expected for the intended population. the pima cd4 test consists of the pima™ cd4 cartridge and pima™ analyzer to identify and determine the absolute counts of mature helper (cd3+/cd4+) t-lymphocytes in whole blood.

blood samples will be collected from hiv infected adolescents and adult men and women presenting to a physician's office or outpatient clinic. capillary whole blood samples will be obtained by fingerstick in duplicate from all subjects in the study for immediate measurement of cd4+ t-cell count on the pima cd4 test by a trained healthcare professional. venous whole blood samples from all subjects in the study will also be collected and transported to the clinical laboratory of each study site for concurrent testing on the reference method by a trained laboratory professional. venous samples from all subjects in the study will also be measured on the pima cd4 test at the study site. hematocrit will also be measured for all subjects.

Eligibility criteria:
inclusion criteria: 1. 12 years of age or older 2. confirmed hiv infection, hiv-1 or hiv-2 according to medical history (this inclusion will be waived for healthy non-hiv infected individuals who may need to be enrolled in order to fill the high end of the cd4+ t-cell measurement range of the pima cd4 test. 3. subject agrees to complete all aspects of the study exclusion criteria: 1. subject has already participated in this study at a previous date 2. subject is enrolled in a study to evaluate a new drug 3. patient unable or unwilling to provide informed consent 4. vulnerable populations as deemed inappropriate for study by site principal investigator.

Keywords: hiv aids cd4
verify: vedolizumab for the prevention of immune checkpoint inhibitor related diarrhea or colitis in patients with cancer

Conditions: Cancer; Cancer Metastatic

Summary: the purpose of this study is to assess the prevention of immune checkpoint inhibitors (icis) related diarrhea/colitis using vedolizumab in participants with unresectable stage iii or metastatic stage iv cancer, starting standard of care (soc) immunotherapy

after being informed about the study and potential risks, all patients giving written informed consent will undergo up to a 2-week screening period to confirm their eligibility. eligible patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to vedolizumab or placebo and given their first dose within 2 weeks of starting their soc immunotherapy. vedolizumab or placebo will be administered at weeks 0, 2, 6, 14, and 22.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to initiation of any study specific activities or procedures * diagnosed with unresectable advanced stage iii or metastatic stage iv malignancy * planned for initiation of soc immunotherapy and development of prognostic biomarker evidence that predisposes to ici diarrhea/colitis risk * ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously exclusion criteria: * condition(s) for which vedolizumab is contraindicated (e.g., hypersensitivity reaction, known allergic reaction to vedolizumab or its components) * current or prior use of vedolizumab or prior immunotherapy exposure for cancer * presence of inflammatory bowel disease (crohn's disease, ulcerative colitis), indeterminate colitis, or microscopic colitis * presence of ileostomy, colostomy, or short bowel syndrome * presence of known luminal gastrointestinal metastases at baseline * presence of significant pre-existing autoimmune disease (at investigator's discretion) * presence of severe infection(s) or opportunistic infection(s) * active enteric infection with viral, bacterial, or parasitic pathogens * presence of untreated latent or active tuberculosis, or untreated chronic hepatitis b virus * baseline ecog status grade ≥3 * pregnancy or lactation * treatment with another investigational product within 8 weeks of randomization * requirement for baseline anti-diarrheal treatment(s) (including but not limited to loperamide, diphenoxylate-atropine, octreotide, tincture of opium), anticholinergic drug(s), or opioid-based analgesic(s) used specifically for diarrhea control within 14 days of randomization * any condition or diagnosis, that could in the opinion of the qualified investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Keywords: immune checkpoint inhibitors
gait analysis and degenerative spine

Conditions: Spinal Disease

Summary: the goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. the main questions it aims to answer are: * what are the biomechanical variables affected by the disease * how they evolve with disease progression and treatment


Eligibility criteria:
inclusion criteria: * age between 50 and 85 years * diagnosis of spinal disease by clinical and imagiological criteria * more than 3 months duration of disease * ability to give consent * fluent portuguese speaker exclusion criteria: * previous spine surgery * spinal instability * neurological disease that might interfere with walking * known orthopedic conditions that causes significant gait impairment * dementia or development disorder with cognitive impairment * inability to give consent
a rollover safety study of lumacaftor/ivacaftor in subjects aged 2 years and older with cystic fibrosis, homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: a rollover safety study of lumacaftor/ivacaftor in subjects aged 2 years and older with cystic fibrosis, homozygous for f508del.


Eligibility criteria:
inclusion criteria: subjects entering the treatment cohort must meet the following criteria: * completed 24 weeks of lum/iva treatment and the safety follow-up visit in study vx15-809-115 part b (study 115b, nct02797132) * willing to remain on a stable cf medication regimen through the safety follow-up visit subjects entering the observational cohort must meet 1 of the following criteria: * completed 24 weeks of lum/iva treatment and the safety follow-up visit in study 115b, but do not want to enroll in the treatment cohort. * received at least 4 weeks of lum/iva treatment and completed visits up to week 24 and the safety follow-up visit, if required, of study 115b but are not taking lum/iva at the end of the study 115b treatment period (i.e., week 24) because of a drug interruption and either did not receive vertex approval to enroll in the treatment cohort or do not want to enroll in the treatment cohort. * permanently discontinued lum/iva in study 115b after receiving at least 4 weeks of treatment and remained in the study from the time of treatment discontinuation through the week 24 visit and safety follow-up visit, if required. exclusion criteria (treatment cohort only): * prematurely discontinued lum/iva treatment in study 115b. * history of any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering lum/iva to the subject * history of drug intolerance or other serious reactions to lum/iva in study 115b that would pose an additional risk to the subject in the opinion of investigator, and which should be discussed with the vertex medical monitor. * subjects with a history of allergy or hypersensitivity to lum/iva. * liver function test (lft) abnormality meeting criteria for lum/iva treatment interruption at the completion of study 115b, for which no convincing alternative etiology is identified. * qtc value at the completion of study 115b that would pose an additional risk to the subject in the opinion of investigator, and which should be discussed with the vertex medical monitor * history of poor compliance with lum/iva and/or procedures in study 115b as deemed by the investigator. * participation in an investigational drug trial (including studies investigating lum and/or iva) other than study 115b.
the clinical utility of bioep in diagnostic decision making in epilepsy

Conditions: Epilepsy

Summary: neuronostics plan a prospective multisite trial to determine the clinical utility of bioep in the context of diagnostic decision making. neuronostics will use findings from the trial to improve user experience of the neuronostics platform (the tool which clinicians use to obtain a bioep score from eeg and the aligned report). the data coming from the trial will also enable neuronostics to iterate the bioep algorithms and so improve future performance.

neuronostics will conduct a two-arm randomised control trial with two groups: (i) usual care, (ii) usual care + bioep score and report. in this context, usual care involves clinical/ patient history, eye-witness accounts and any standard tests ordered (electroencephalogram (eeg), magnetic resonance imaging (mri), blood tests etc.). investigators will recruit adults attending first seizure clinics where there is a suspicion that epilepsy is the causing symptoms and so a first eeg is recommended. participants will be sourced from 10 sites. the trial duration will be 1 year recruitment, and 2 year follow up period. randomisation: consenting individual patients will be randomly assigned to either usual care or usual care + bioep in a 1:1 ratio. randomisation will be stratified by centre, with eligible and consenting participants allocated in random blocks. the allocation schedule will be generated by the trial statistician, and concealed from the clinicians assessing eligibility and recruiting patients.

Eligibility criteria:
inclusion criteria: * adult (age 18 and above) presenting with first suspected seizure(s) * able to give informed consent * patient receives eeg following clinicians' decision to refer for an eeg based on clinical history and seizure description taken during first seizure clinic. exclusion criteria: * participants unable to tolerate an eeg test so no eeg data were gathered * participants with a known hepatic/renal encephalopathy * participants that upon history taking have a clear clinical diagnosis of a physical condition other than epilepsy (e.g. vasovagal syncope)
effects of water and food intake on the pharmacokinetics and pharmacodynamics of oral salmon calcitonin in healthy postmenopausal women

Conditions: Postmenopausal Osteoporosis

Summary: this is a phase i study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (smc021) and salmon calcitonin nasal spray in post-menopausal women.


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women exclusion criteria: * previous treatment with other osteoporosis medication other protocol defined inclusion/exclusion criteria may apply.

Keywords: postmenopausal osteoporosis pharmacokinetics/dynamics calcitonin
long term study to evaluate safety and efficacy of m518101 in subjects with plaque psoriasis

Conditions: Psoriasis

Summary: this study is to evaluate the efficacy and safety for long term use of m518101 in subjects with plaque psoriasis.


Eligibility criteria:
inclusion criteria: * who are able and willing to give signed informed consent * who are male or females aged 18 years or older with plaque psoriasis confirmed by the investigator. * who have up to 20% of body surface area (bsa) afflicted with plaques * who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. exclusion criteria: * who have a history of allergy to vitamin d3 derivative preparations or a history of relevant drug hypersensitivity. * who are pregnant or lactating. * who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. * who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. * who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study. * whose serum calcium levels exceed the upper limit of reference range * who have used any investigational medicinal product and/or participated in any clinical study within 60 days of treatment. * who have been treated with systemic therapy within 30days of treatment. * who have treated with biologics within 5 half-lives of the biologics before the day of treatment * who have been treated with topical therapy within 14days before the day of treatment.
demonstrate the value of using hypnosis in chimiotherapy- induced chronic neuropathies

Conditions: Chemotherapy-induced Neuropathy

Summary: chimiotherapy produces neuropathies injuries to 30% to 70% cases. a third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected. hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them. the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies. the aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.


Eligibility criteria:
inclusion criteria: * minimum age :18 years * chemiotherapy- induced chronic neuropathies for at least 2 months with a dn4 score \>4 * failure of classic treatment used to relief neuropathic * having stopped chemotherapy treatment and being in complete or partial response or in tumoral stability * without any planed chemiotherapy during the study * having signed a written informed consent. * french efficient understanding * with health insurance coverage * availability during all the study * with efficient contraception for women of childbearing age exclusion criteria: * no participation to another study at the same time * suffering from neuropathy before having chemotherapy * other disease that may cause neuropathy * deafness * any medicine that could cause neuropathy * neurological or psychiatrical disease past or present * mental retardation * allergy to emg's electrodes * unable to consent, under tutelage or curatorship or judiciary safeguard * pregnant or nursing woman