Kornimate/medical-research-clean huggingface dataset:
long-term lifestyle change and testosterone replacement

Conditions: Hypogonadism; Aging; Overweight and Obesity

Summary: older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. this study will determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults.

background: there are studies on long-term testosterone replacement in older adults with hypogonadism showing benefits on body composition, sexual function and mood but not on testosterone replacement therapy in combination with lifestyle change (diet-induced weight loss and exercise) in the specific population of older adults with both obesity and hypogonadism. purpose: to determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults . design: overweight/obese older veteran patients with obesity and hypogonadism who are being followed at the endocrine clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body composition testing.

Eligibility criteria:
inclusion criteria: * overweight/obese (bmi = or \> 27 kg/m2) * older (65-85 yr) * male veteran patients being seen at the pi's endocrine clinic and receiving standard of care consisting of diet and regular exercise counseling * diagnosed with hypogonadism on current or previous testosterone replacement at the pi's endocrine clinic * willing to provide informed consent exclusion criteria: * failure to provide informed consent * unstable cardiopulmonary disease (e.g. recent mi, unstable angina, stroke) or unstable disease (class iii or iv congestive heart failure).
prevalence of covid-19 infection among hcw in a french university hospital

Conditions: Sars-CoV2

Summary: the objective of this study is to determine the prevalence of sars-cov2 infection among health care workers exposed of lille university hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.


Eligibility criteria:
inclusion criteria: - health care workers with or without symptoms suggestive of a covid-19 infection exclusion criteria: * hcw working off-site at the chu de lille * hcw on sick leave. * hcw outside the lille university hospital temporarily coming as reinforcements in the context of the epidemic.

Keywords: prevalence health care workers occupational exposure environmental exposure serological testing rt-pcr
application of brachial plexus block in patients undergoing cerebral aneurysm embolization via transradial approach

Conditions: Intracranial Aneurysm; Transradial Access(TRA)

Summary: the aim of this study was toinvestigate the effect of bpb on outcome of upper extremity arteries in patients undergoing interventional embolization of intracranial aneurysms via tra. a multicenter prospective clinical trial was designed. the study subjects were patients undergoing cerebral aneurysm embolization with tra. bpb was given in the bpb group patients and no bpb in the control group.the incidence of radial artery spasm (ras) diagnosed by intraoperative angiography and the occurrence of the unfavorable ra for repeated trans-radial interventions (tri) diagnosed by vascular ultrasound 1 month after surgery， perioperative changes of blood flow parameters in upper limb vessels,postoperative inflammatory factors and complications were observed in the two groups.

the aim of this study was to investigate the effect of bpb on outcome of upper extremity arteries in patients undergoing interventional embolization of intracranial aneurysms via tra. a multicenter prospective clinical trial was designed, and the study subjects were patients undergoing cerebral aneurysm embolization with tra. participants were randomly assigned to receive ultrasound-guided bpb with 0.15% ropivacaine 20ml (bpb group) or normal saline 20ml (control group) in 1:1ratio.the primary outcomes measured were the incidence of ras diagnosed by intraoperative angiography and the occurrence of the unfavorable ra for repeated trans-radial interventions (tri) diagnosed by vascular ultrasound 1 month after surgery.secondary outcomes included the severity of ras, components of unfavorable ra for repeated tri, intraoperative nitroglycerin use, intraoperative hypotension, surgeon satisfaction scores.

Eligibility criteria:
inclusion criteria: * 18-75 years old, bmi\<28kg/m2 * asa physical status ⅰ-ⅲ * elective interventional surgery for intracranial aneurysms via tra * willing to sign informed consent exclusion criteria: * patients allergic to local anesthetics * neck infection on the surgical side * preoperative upper extremity ultrasound or dsa showed radial artery occlusion and arteriovenous fistula * the diameter of radial artery was still less than 2mm after brachial plexus block * axillary artery occlusion and other vascular anatomical abnormalities may affect the operation * radial artery patency: barbeau type d * the history of hand trauma may affect the establishment of radial artery; access, or the use of radial artery as a bypass or dialysis vessel * patients with incomplete block effect after nerve block were detected; * the patient refused to participate in the study or cooperate with the follow-up
efficacy and safety of etx-018810 in subjects with lumbosacral radicular pain

Conditions: Lumbosacral Radiculopathy

Summary: efficacy and safety of etx 018810 in subjects with lumbosacral radicular pain

a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of etx 018810 in subjects with lumbosacral radicular pain

Eligibility criteria:
inclusion criteria: * the subject has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s) * the subject reports at least moderate pain intensity at screening. * the subject's onset of leg pain due to lsrp is at least 3 months * the subject has a magnetic resonance imaging (mri) scan that is normal or shows incidental lesions * the subject has a calculated creatinine clearance ≥30 ml/min * the subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant. * body mass index (bmi) \<40 kg/m2. exclusion criteria: * the subject has previously undergone back surgery * the subject is unable to reliably delineate or assess pain by anatomical location/distribution on a body map. * the subject has a history of peripheral neuropathy, evidence of peripheral neuropathy, or evidence of mononeuropathy in the same limb of lsrp. * the subject has pain due to infection/abscess, hematoma, or malignancy or other pain that may interfere with the assessment of lsrp in the legs. * the subject has clinically significant and/or unstable renal, hepatic, hematologic, endocrine, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study * the subject has any neurological disease that could interfere with participation in the study (e.g., huntington's disease, parkinson's disease, alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke). * the subject has a history or current diagnosis of major psychiatric disorder(s) * the subject has a has a history of substance abuse or dependence * the subject has clinically significant abnormal electrocardiogram (ecg) findings * the subject has received nerve blocks and/or steroid injections for lsrp within the 3 months before screening * the subject is unwilling or unable to discontinue current medications for lsrp, including topical agents. * the subject is unable to refrain from using prohibited meds during the study, including: nsaid, antiepileptic drugs, steroids, cannabinoids, or major opioids, antidepressants, muscle relaxants, tramadol, or tapentadol. * the subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, within 30 days the study. * the subject is currently participating in another or the same clinical study or participated in another clinical study within 3 months before screening * the subject is pregnant or lactating or not practicing adequate birth control
in vivo depiction of bone vascularization with uhr-ct ct and deep learning algorithm reconstruction: a preliminary study

Conditions: Bone Vascular Tumor

Summary: to evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (uhr-ct) scanner using a deep learning reconstruction (dlr) and hybrid iterative reconstruction (hir) algorithms, compared to simulated conventional ct, using osteoid osteoma (oo) as a model.


Eligibility criteria:
inclusion criteria: * proven osteoid osteoma * ultra high resolution ct exclusion criteria: * none

Keywords: ct osteoid osteoma ultra high resolution ct
management of coccydynia: a prospective, observational study of coccygectomy

Conditions: Coccygodynia

Summary: the purpose of the study is to analyze the outcomes of patients with coccygodynia (pain in and around the coccyx region) treated with coccygectomy (a procedure during which the coccyx is removed) and to report on the rate of complications of the procedure. the study will also aim to find pre-operative clinical predictors of good outcomes after coccygectomy. the investigators hypothesize that coccygectomy will not improve scores on the short form-36 (sf-36), oswestry disability scale (odi), tolerable sitting time, or visual analog pain scale (vas). also, the investigators hypothesize that there are no independent variables associated with improved outcomes.

coccygodynia can be a functionally limiting and painful disease with conservative treatment providing mixed results. when proper surgical indications are met, results seem to be promising. however, there is a lack of data in the literature to support surgical treatment. the case series reports currently in the literature are small and retrospective with ill-defined selection criteria. to date there has been no study prospectively following patients undergoing coccygectomy. this type of study could accurately obtain data prospectively. this information will help better guide the clinician through treatment of this disease. all patients will be seen and enrolled through an outpatient spine specialty clinic of the senior author. patients that meet the inclusion criteria will be offered enrollment in the study by a third party (clinical research assistant). patients enrolled will then complete pre-treatment sf-36, oswestry disability scale and a pain visual analog scale. patients will be followed at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years after treatment. patients will complete the questionnaire containing the vas and tolerable sitting time at all visits with sf-36 and oswestry disability scale completed at one year post treatment.

Eligibility criteria:
inclusion criteria: * pain in the region of the coccyx * pain for greater than 2 months * tenderness to palpation over coccyx * radiographic abnormalities of the coccyx 1. hypermobility of greater than 25 degrees, posterior subluxation of a mobile segment, or a coccygeal spicule on sitting radiographs 2. post-traumatic coccygodynia * failure of conservative treatment methods: 4 weeks of nsaids, seat cushion, and rest * partial coccygectomy exclusion criteria: * coexisting low back pain * total previous coccyx surgery or previous lumbar fashion * under 18 years of age

Keywords: coccygodynia coccygectomy coccyx
adapted physical activity for children treated with cancer and insulin sensitivity

Conditions: Pediatric Cancer

Summary: the main objective of this study is to evaluate the evolution of the sensitivity to insulin, a hormone that acts on sugar in the body, as well as other metabolic, motor and nutritional elements of children with cancer, according to the practice of intense physical activities or stretching. in view of the scientific work on this subject, it is expect to observe that the practice of intense physical activities will improve the results of the children in the metabolic, motor and nutritional evaluations, compared to the stretching program.

the protocol consists of 6 months of intense physical activity and stretching programs for children with solid cancer or haematological disease, starting at diagnosis. evaluations will be performed at the first, third and sixth month of the programs and then six and eighteen months after they are stopped. the physical activity sessions will take place in the hospital during hospitalizations or by videoconference when the children are at home. the sessions are adapted to the needs, desires and abilities of the children and will take place two to three times a week. they will be mediated by various activities such as soccer, rugby, darts, muscle strengthening. inclusion lasts two years.

Eligibility criteria:
inclusion criteria: * age between 5 and 18 years old; * have a solid cancer or hematological disease; * be treated for the first time in pediatric oncology and hematology department; * have an estimated life expectancy at diagnosis of more than 6 months. exclusion criteria: * present a physical and/or psychological impossibility to follow an adapted physical activity program; * have a pre-existing heart disease that is not suitable for adapted physical activities; * have a known type 1 diabetes * have an obesity defined by a body mass index greater than or equal to the international obesity task force 25 threshold

Keywords: pediatric cancers exercise insulin sensibility metabolic syndrome
a study of ds-8201a in metastatic breast cancer previously treated with trastuzumab emtansine (t-dm1)

Conditions: Breast Cancer

Summary: some human epidermal growth factor receptor 2 (her-2) breast cancer patients do not respond or become resistant to current treatment. ds-8201a is a new experimental product that is a combination of an antibody and a drug. it has not yet been approved for use. ds-8201a may slow down tumor growth. this might improve outcomes for these patients.


Eligibility criteria:
inclusion criteria: * men or women the age of majority in their country * has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has her2 positive expression confirmed per protocol * has an adequate tumor sample * has at least one measurable lesion per response evaluation criteria in solid tumors (recist) version 1.1 * has protocol-defined adequate cardiac, renal and hepatic function * agrees to follow protocol-defined method(s) of contraception exclusion criteria: * has a medical history of myocardial infarction, symptomatic congestive heart failure (chf) (nyha classes ii-iv), unstable angina or serious cardiac arrhythmia * has a corrected qt interval (qtc) prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females * has a medical history of clinically significant lung disease * is suspected to have certain other protocol-defined diseases based on imaging at screening period * has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise: 1. safety or well-being of the participant or offspring 2. safety of study staff 3. analysis of results

Keywords: her-2 positive breast cancer metastatic or unresectable resistant or refractory to t-dm1 destiny - breast 01 trastuzumab deruxtecan t-dxd
use of dermal matrix in breast reconstruction

Conditions: Breast Cancer

Summary: we propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.

we propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

Eligibility criteria:
inclusion criteria: * all women who are candidates for breast reconstruction using tissue expanders after mastectomy exclusion criteria: * other forms of breast reconstruction after mastectomy
the impact of practicing active breathing exercises on elderly individuals living in the community

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore the impact of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants enrolled are required to undergo a continuous three-week (21 days) active breathing exercises, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

the investigators have designed a simple and user-friendly training method called "active breathing exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. the goal of this clinical trial is to explore the impact of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of active breathing exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants enrolled are required to undergo a continuous three-week (21 days) active breathing exercises, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility criteria:
inclusion criteria: * age over 60 years old. * no hospitalization within the past six months. * with clear consciousness and able to cooperate with questionnaires and training. * the elderly people who voluntarily participate and agree to adhere until the end of the study. exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * physical disability. * difficulty in mobility.
virtual reality during skin prick test

Conditions: Allergy

Summary: skin prick testing (spt) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. virtual reality (vr) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored. to evaluate the effectiveness of vr in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing spt.


Eligibility criteria:
inclusion criteria: * a confirmed history of allergic symptoms related to either environmental or food allergens * between 4 and 18 years of age exclusion criteria: * history of seizure disorders, * motion sickness, * severe developmental delay, * non-italian-speaking patients * participants who had used systemic antihistamines or corticosteroids within the past seven days

Keywords: virtual reality skin prick test pediatric allergy anxiety pain compliance
intra-operative adverse events during laparoscopic ventral mesh rectopexy

Conditions: Rectal Prolapse

Summary: outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. a multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. despite accepted lower rate of morbidity, these results come from four well equipped european centers by four surgeons practiced at least 200 lvmr.

multicenter pooled-analysis of lvmr for internal/external rectal prolapse. all events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the clavien-dindo classification.

Eligibility criteria:
inclusion criteria: * all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse exclusion criteria: * other condition than rectal prolapse

Keywords: rectal prolapse
discontinuation of postmenopausal hormone therapy: impact on the cardiovascular system and quality of life

Conditions: Menopause; Atherosclerosis; Cardiovascular Diseases; Estrogen Replacement Therapy

Summary: although the impact of postmenopausal hormone therapy (ht) on cardiovascular disease risk has been studied in several large randomized trials, little is known about the acute cardiovascular consequences of ht discontinuation. in this randomized, double-blind, placebo-controlled trial, the investigators will compare the cardiovascular consequences of abrupt and tapered modes of ht discontinuation in 150 finnish healthy postmenopausal women under age 60 years. the primary outcome is brachial artery flow-mediated dilatation. in addition, biochemical markers will be measured during the study period of 20 weeks. health-related quality of life, frequency of hot flush recurrence and other menopausal symptoms will be also assessed in these groups. the trial will provide new high-quality information about the cardiovascular safety as well as the correct timing and method of ht discontinuation.


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women * age ≤ 60 years * has used postmenopausal hormone therapy for at least 3 years exclusion criteria: * any clinically significant disease * use of regular medication * history of cardiovascular events * history of smoking * body mass index over 30 kg/m2 * thickness of endometrium over 6 millimeters

Keywords: randomized controlled trial menopause hormone therapy vasomotor symptoms quality of life cardiovascular diseases endothelium