Kornimate/medical-research-clean huggingface dataset:
elastographic and ultrasonographic evaluation of patients with breast cancer related lymphedema

Conditions: Lymphedema of Upper Arm; Stiffness of Hand, Not Elsewhere Classified; Evaluations, Diagnostic Self

Summary: the aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. the patients' demographic and clinical data were recorded. the thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with b-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. the lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. the patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. the patients' functionality and participation in daily life activities were evaluated with the quick dash and life impact index questionnaires. the relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Eligibility criteria:
inclusion criteria: for the patient group * between the ages of 18-75 * diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy * being stage 0-1-2 lymphedema according to isl staging for the control group * between the ages of 18-75 * no history of breast cancer exclusion criteria: * history of surgery in the assessment area * history of trauma at the assessment site * active infection in the assessment area * presence of congenital or acquired malformations at the assessment site * primary lymphedema * those with any medical condition that may cause edema, such as advanced heart or kidney failure
non-interventional treatment patterns study in chronic phase chronic myelogenous leukemia (cp-cml)

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to evaluate treatment patterns and associated outcomes for cp-cml patients who fail imatinib 400 mg daily in a real-world setting.

time perspective: retrospective and prospective

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * adult patients (18 years or older) in chronic phase cml patients who have been treated with imatinib 400 mg and have failed.
txi for the recognition of adenomas in colonoscopy

Conditions: Colorectal Polyp

Summary: this two parallel arms, randomized, multicenter trial is aimed at evaluating whether txi is superior to wli endoscopy in terms of adenoma detection. secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.


Eligibility criteria:
inclusion criteria: - all \>40 years-old patients undergoing a colonoscopy for primary screening, faecal immunochemical test (fit) +, post-polypectomy surveillance exclusion criteria: * patients with personal history of colorectal cancer (crc), or inflammatory bowel disease (ibd). * patients affected with lynch syndrome or familiar adenomatous polyposis. * patients with inadequate bowel preparation (defined as boston bowel preparation scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.
lumbar espb in hip replacement surgery

Conditions: Coxarthrosis; Pain, Postoperative; Pain, Acute; Pain, Chronic; Postoperative Pain, Chronic; Analgesia; Quality of Life; Anesthesia; Spinal

Summary: in this study, continuous erector spinae plane block (espb) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. moreover, chronic pain severity in months after the hospital discharge will be assessed.

this is a prospective trial in patients undergoing elective hip replacement surgery. written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the declaration of helsinki for medical research involving human subjects. before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed. each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (epidural) group and the continuous lumbar erector spinae plane block (espb) group. both regional techniques will be continued during the first day. investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (pca) pump. at several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (vas, 0-10), their quadriceps femoris muscle strength on the lovett scale (0-5), and their ability to sit, stand upright, and walk on the timed up and go test. moreover, the patient's recovery will be assessed through the quality of recovery 40 (qor-40) questionnaire on the first postoperative day. after the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview.

Eligibility criteria:
inclusion criteria: * primary hip replacement surgery due to coxarthrosis * anesthetized with spinal technique * able to use pca pump * having access to phone exclusion criteria: * patients taking painkillers not related to coxarthrosis; * having active cancer, * dementia or challenging contact with the patient; * suffering from depression or other psychiatric disorders that required antidepressant treatment; * consuming alcohol or recreational drug addiction; * contraindications to the regional block.

Keywords: erector spinae plane block epidural analgesia quality of recovery patient-controlled analgesia timed up and go test visual analog scale neuropathic pain symptom inventory lovett scale spinal anesthesia
women's opioid treatment follow-up study

Conditions: Opioid Use Disorder

Summary: the goal of this study is to examine the feasibility of a gender-specific digital intervention for women with opioid use disorder. in this study, women with opioid use disorder will be randomized to receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only. feasibility, satisfaction, and engagement with the intervention are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-up visits.

this study has two aims: (1) to demonstrate the feasibility of delivering a gender-specific digital intervention (gsdi) to women with opioid use disorder; (2) to collect preliminary estimates on the effect of the gsdi on engagement in medication treatment for opioid use disorder (moud). the investigators will conduct a pilot randomized controlled trial to achieve these aims. women (n=40) who have recently initiated moud (within 30 days) will be enrolled and randomized to receive either the gsdi+tau (gender-specific digital intervention + treatment as usual) or tau-only. feasibility, satisfaction, and engagement with the gsdi are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-ups. moud engagement will be assessed at two time-points: (1) 6-weeks and (2) 12-weeks post-enrollment to collect preliminary estimates on the effect of the gsdi on moud engagement.

Eligibility criteria:
inclusion criteria: * age 18 years of age or older * current opioid use disorder diagnosis * have a smartphone * initiated medication treatment for opioid use disorder in the past 30 days, * able to provide informed consent exclusion criteria: * an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures * admitted to their current treatment episode on an involuntary status
brentuximab vedotin with pembrolizumab in metastatic solid tumors

Conditions: Melanoma; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck

Summary: this trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. there will be several different types of cancer studied in the trial. the cancer must have spread to other parts of the body (metastatic). the study will also find out what side effects occur. a side effect is anything the treatment does besides treat cancer. this is a multi-cohort study.


Eligibility criteria:
inclusion criteria * participants must have * metastatic squamous or nonsquamous non-small cell lung cancer (nsclc) (without known targetable egfr, alk, ros1, or braf mutations) who either * a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti pd-1/pd-l1 or * b) are relapsed/refractory with progression on anti pd-1/pd therapy. * relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a pd-1 inhibitor * metastatic head and neck squamous cell carcinoma (hnscc) who have not yet received frontline therapy for metastatic disease and without prior exposure to a pd-1/pd-l1 inhibitor. * cohorts 1-4 only: melanoma participants must be currently on pd-1 checkpoint inhibitor (cpi) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of pd-1 cpi containing therapy as the last previous line of therapy within 90 days prior to enrollment; pd-1 cpi therapy must be the immediate prior line of treatment. * cohorts 1-4 only: participants must have progressed on treatment with an anti-pd-1 monoclonal antibody (mab) administered either as monotherapy, or in combination with other cpis or other therapies. pd-1 treatment progression is defined by meeting all of the following criteria. * have received at least 2 doses of an approved pd-1 inhibitor. * have demonstrated disease progression (pd) after a pd-1 inhibitor as defined by recist v1.1. * progressive disease has been documented within 90 days from the last dose of pd-1 inhibitor. * participants with melanoma will need irecist confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease * nsclc participants on pd-1 inhibitor containing therapy for less than 90 days will need irecist confirmation of progression at least 4 weeks after the initial date of progressive disease * tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained. * an eastern cooperative oncology group (ecog) performance status score of equal or less than 1 exclusion criteria * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * prior immunosuppressive chemotherapy, any immunotherapy other than a pd-1 inhibitor within 4 weeks of first study drug dose. * history of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.

Keywords: seattle genetics
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy

Conditions: Node-positive Breast Cancer

Summary: evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy

targeted axillary dissection (tad) is a novel technique in the field of surgical oncology. during tad, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (slnd). compared to sentinel lymph node dissection (slnd), axillary lymph node dissection \[alnd\] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. patients undergoing slnd have fewer infections and a better quality of life, so axillary dissection has been largely replaced by slnd in early-stage breast cancer. targeted axillary dissection (tad) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of slnd. breast cancer patients suitable for neoadjuvant systemic therapy \[nast\] with node-positive disease (n1,n2) were assessed by the multi-disciplinary team and if potentially eligible for tad, a metallic marker\[clip\] is inserted in the suspicious node prior to neoadjuvant therapy. the procedure is performed together with slnd using a single-tracer technique. towards the end of nast, a progress ultrasound and mammogram are performed to assess the breast and axillary response, clip position within node is confirmed. a standard surgical approach for sentinel lymph node dissection \[slnd\] is used for tad, patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. any residual sentinel nodes or palpable abnormal nodes are excised and examined separately.

Eligibility criteria:
inclusion criteria: 1. females with invasive breast cancer with axillary metastasis, staging of n1: n2 2. complete axillary response to neoadjuvant therapy by clinical examination and imaging exclusion criteria: * 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour \[not breast cancer\]
faslodex specific clinical experience investigation

Conditions: Breast Cancer

Summary: the purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of faslodex for long term treatment in daily clinical practice.

mc md

Eligibility criteria:
inclusion criteria: * patients treated with faslodex for the first time due to postmenopausal breast cancer exclusion criteria: * none

Keywords: postmenopausal breast cancer faslodex cohort
phonosurgical augmentation after laser resection of early glottic carcinoma

Conditions: Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Voice Disorders; Laryngeal Cancer

Summary: objectives: transoral laser microsurgery (tlm) is widely used in for treating t1/t2 glottic cancers. hyaluronic acid (ha) is a safe and commonly-used injectable in vocal cord augmentation. we report on the results of our single-blinded, randomized-controlled trial (rct) investigating the impact of intra-operative ha injection on voice outcomes in early glottic cancer. methods: patients with t1/t2 glottic cancers were randomized to the treatment group (n=14) receiving ha injection to the unaffected cord during tlm; or the control group, receiving no injection (n=16). all patients had a voice handicap index-10 (vhi-10) questionnaire and a maximum phonation time (mpt) measurement preoperatively and at 3, 12 and 24 months post-operatively. mean change in vhi-10 and mpt, between pre-operative and post-operative time points, and between the time points, were compared. survival estimates were also calculated.


Eligibility criteria:
inclusion criteria: * males and females * 18 years of age or older with a biopsy-proven t1a, t1b or t2 glottic scc * lesion amenable to co2 tlm resection. exclusion criteria: * previous radiotherapy to the head and neck. * palpable, or radiographic, pathological lymphadenopathy. * allergy, or sensitivity, to ha or components of the injectable. * neurological disorder affecting phonation, such as multiple sclerosis or stroke.
feasibility assessment of cardiovascular endurance training for the symptomatic improvement of irritable bowel syndrome patients with a sedentary and non-active lifestyle.

Conditions: Irritable Bowel Syndrome

Summary: this exploratory study's primary objective is the changes of irritable bowel syndrome (ibs) symptom severity by cardiovascular endurance training (cet) in relation to the baseline sedentary or non-active lifestyle. secondary endpoints focus on the mechanisms associated with these changes. these mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. virtually all ibs guidelines mention lifestyle modifications as a management option. research on the role of physical activity remains underassessed as compared to the other interventions. therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of ibs patients. this study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.


Eligibility criteria:
inclusion criteria: * patients aged 18 - 60 years; * fulfilling the rome iv criteria for irritable bowel syndrome (ibs); * moderate symptom severity as defined by a ibs-symptom severity scale \> 175; * sedentary lifestyle defined as sit-q-7d \> 8h/day; * physically inactive defined as \< 150min/week on the ipaq score exclusion criteria: * cardiorespiratory disorder hampering participation in a program of physical exercise as evidenced by the sport + keuringsartsen (ska) questionnaire. * clinical suspicion of an organic disorder different from ibs (patients can be included when this disorder had been excluded); * known inflammatory bowel disorder; * known intestinal motility disorder; * alcohol (defined as more than 14 u per week) or other substance abuse; * active psychiatric disorder; * known systemic or auto-immune disorder with implication for the gi system; * prior abdominal surgery (with the exception of appendectomy or cholecystectomy more than 6 months ago); * any prior diagnosis of cancer other than basocellular carcinoma; * current chemotherapy; * history of gastro-enteritis in the past 8 weeks; * change in diet in the past 8 weeks; * dietary supplements unless taken at a stable dose for more than 8 weeks; * antibiotics, pre-, pro-, post-biotics or any combination during the past 8 weeks; * treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed); * treatment with spasmolytic agents, opioids, loperamide, gelatine tannate or mucoprotect-ants during the past 8 weeks.
comparative study of the link between the practice of gambling and money and materialism among problem gamblers and non-problem gamblers

Conditions: Gambling

Summary: the purpose of this study is to to explore the link between materialism and addiction to gambling and money


Eligibility criteria:
inclusion criteria: ( specific to problem gamblers) * subject having at least four diagnostic criteria in "trouble linked to gambling and money" dsm-5 (apa 2013) * subject who had written consent for participation in the evaladd cohort * subject who has started treatment for a problem with the practice of gambling and money in the addictology and psychiatric department ( specific to non-problem gamblers) * subject playing games of chance and money at least once a year * subject playing games of chance and money less than once per week or less than € 500 per year * subject having a score of 0-2 at icje questionnaire exclusion criteria: * subject having difficulty reading or writing of the french language * subject having parkinson's disease * subject under guardianship
effects of neuromodulation on verbal fluency in post-stroke aphasia

Conditions: Post-stroke Aphasia

Summary: this is a single site, open label study with a single arm designed to assess the feasibility of use of caloric vestibular stimulation (cvs) in patients with post-stroke aphasia. cvs is delivered via a portable, non-invasive device. both language and movement assessments are made.


Eligibility criteria:
inclusion criteria: * \>6 months post-stroke (ischemic or hemorrhagic) * receptive or expressive aphasia * little or no improvement in language ability in the preceding 3 months exclusion criteria: * persons under the age of 18 or over the age of 75 * patients with pure receptive aphasia * co-morbid cns disease * primary motor/oral apraxia * pregnant or nursing women * have a history of unstable mood disorder or unstable anxiety disorder or psychosis * use of a hearing aid * have a cochlear implant * have a diagnosed vestibular dysfunction * abuse alcohol or other drugs * have had eye surgery within the previous three months or ear surgery within the previous six months * have active ear infections or a perforated tympanic membrane * have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial * though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a cvs treatment. the investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation.

Keywords: aphasia stroke
a study of islatravir (isl) and ulonivirine (ulo) once weekly (qw) in virologically suppressed adults with human immunodeficiency virus type 1 (hiv-1) (mk-8591b-060)

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Summary: investigators are trying to find better treatments for people with hiv-1. in this clinical study, investigators want to see how well a new treatment called isl+ulo, taken once a week, works compared to an existing treatment called bic/ftc/taf, which is taken every day. investigators will check how many people still have a high level of the virus in their blood after 24 weeks. the investigators also want to understand if the new treatment, mk-8591b, is safe and how well people can handle it.


Eligibility criteria:
inclusion: the main inclusion criteria include but are not limited to the following: - has been receiving bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) therapy with documented viral suppression \[human immunodeficiency virus type 1 (hiv-1) ribonucleic acid (rna) \<50 copies/ml\] for ≥6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen. exclusion: the main exclusion criteria include but are not limited to the following: * has human immunodeficiency virus type 2 (hiv-2) infection. * has a diagnosis of an active acquired immune deficiency syndrome (aids)-defining opportunistic infection. * has active hepatitis c virus (hcv) coinfection. * has hepatitis b virus (hbv) coinfection. * has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous kaposi's sarcoma. * has prior exposure to islatravir (isl) or ulonivirine (ulo) for any duration any time prior to day 1.

Keywords: hiv-1