Kornimate/medical-research-clean huggingface dataset:
evaluate the efficacy and safety of dwp05195 in subjects with post-herpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: the purpose of this study is to evaluate efficacy, safety of administered dwp05195 in postherpetic neuralgia.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 20 to 80 years * subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(phn). * subjects must have pain present for \> 3 months after healing of the acute herpes zoster skin rash. exclusion criteria: * other severe pain that may potentially confound pain assessment. * subjects with symptoms of neuropathic pain applied medical equipment * within 2 years: subjects were diagnosed with cancer
a pilot study of spinal cord stimulation in heart failure patients with depressed left ventricular function

Conditions: Heart Failure; Systolic Dysfunction

Summary: a randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.

patients will be randomized (1:1) for spinal cord stimulation as an addition to optimal guidelines-driven management or to control group on optimal management only. spinal cord stimulation will be performed for 30 days, and outcome measures will be testes before stimulation, after 30 days stimulation and after 30 days of further follow-up. the control group will be studied at baseline and after 30 days only.

Eligibility criteria:
inclusion criteria: 1. patients with chronic heart failure ii-iii class (nyha); 2. age 18-70 years; 3. left ventricle ejection fraction ≤35%; 4. optimal heart failure management according to the guidelines; 5. signed informed consent exclusion criteria: 1. heart transplant list; 2. acute conditions, including systemic infection; 3. reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc); 4. planned elective heart surgery or intervention; 5. recent (3 months) myocardial infarction, coronary intervention; 6. heart failure decompensation; 7. implanted cardiac resynchronization device \< 6 months ago; 8. contraindications for lumbal puncture or placement of a spinal cord pacing electrode; 9. permanent atrial fibrillation; 10. stroke or tia \< 6 months ago; 11. pulmonary thromboembolist \< 3 months ago; 12. hypertrophic cardiomyopathy with obstruction; 13. angina iii-iv class, or congestive heart failure iv class; 14. participation in any other clinical trial; 15. women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.

Keywords: spinal cord stimulation heart failure autonomic regulation bnp left ventricle systolic dysfunction
treatment of pressure ulcers using biological skin substitutes

Conditions: Pressure Sore

Summary: pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. this study aims to evaluate the efficacy of two treatment modalities: type-i collagen-based skin substitute (hptc) vs. dehydrated human amnion/chorion membrane (dhcam)

pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. they are prevalent in individuals with limited mobility, such as the elderly and those with spinal cord injuries, particularly in long-term care settings. effective management of pressure ulcers is crucial to prevent complications and improve patient outcomes, includes pressure relief, wound care, and advanced therapies such as bioengineered skin substitutes. management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. this study aims to evaluate the efficacy of two treatment modalities: type-i collagen-based skin substitute (hptc) vs. dehydrated human amnion/chorion membrane (dhcam) in promoting the healing of pressure ulcers. while both products are used in wound management, direct comparative studies evaluating their efficacy in treating pressure ulcers are limited.

Eligibility criteria:
inclusion criteria: 1. subjects must be at least 18 years of age or older 2. presence of a stage ii or stage iii pressure ulcer, as defined by the national pressure ulcer advisory panel 3. ulcer size between 5 cm² and 25 cm² 4. ulcer duration of at least 4 weeks prior to enrollment 5. the subject must agree to attend the twice-weekly/weekly study visits required by the protocol 6. the subject must be willing and able to participate in the informed consent process 7. adequate blood supply to the affected area, confirmed by clinical assessment exclusion criteria: 1. a subject known to have a life expectancy of \<6 months 2. presence of infection in the ulcer requiring systemic antibiotics. 3. known allergy to components of hptc or dhcam. 4. participation in another wound care study within the last 30 days. 5. a subject with autoimmune or connective tissue disorders. 6. women who are pregnant or considering becoming pregnant within the next 6 months and those who are breast feeding. 7. history of autoimmune disease, immunosuppressive therapy, malignancy, or uncontrolled diabetes (hba1c \>10%)

Keywords: pressure sore high purity type i collagen helicoll biological skin substitute dehydrated human amnion/chorion membrane
tolerance and pharmacokinetics with capecitabine 5 out of 7 days regimen

Conditions: Breast Neoplasms; Chemotherapy

Summary: standard administration of capecitabine use a 14 days administration. routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). the second end point is to compare toxicity with either regimen. method : randomized study with two groups : one with standard administration , the second with 5/7 days regimen


Eligibility criteria:
inclusion criteria: * histologically proven breast adenocarcinoma * evaluable or measurable metastases * her-2 status 0 or 1 in immnohistochimy or negative in fish/cish * previously treated with anthracyclines and taxanes * age \> = 18 y * no more than two previous chemotherapy regimens for metastases * no nervous central system involvement * hormonal therapy must have been stopped two weeks before enrollment * adequate biologic function * performance status oms \< = 2 * signed informed consent exclusion criteria: * history of other malignancies, except basocellular cancer, in situ cervix carcinoma * gastro intestinal disease that might affect absorption of capecitabine * cardiac failure or angina pectoris uncontrolled * hypersensitivity for capecitabine, fluorouracil, or one of their excipient * known dihydropyrimidine dehydrogenase (dpd) deficiency * concomitant anticancer therapy (included hormonotherapy) * concomitant radiotherapy * treatment with sorivudine and analogs * pregnant or breast feeding patients. contraception methods excluding hormonal treatment is required. * inclusion in an experimental protocol within 30 days

Keywords: fluoropyrimidines metastases pharmacokinetics phase 1-2 study
oslo randomized laparoscopic versus open liver resection for colorectal metastases study

Conditions: Secondary Malignant Neoplasm of Liver; Colorectal Neoplasms

Summary: the purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. the study will include all non-anatomic liver resections in our institution. the primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.

full protocol is published open access in trialsjournal: http://www.trialsjournal.com/content/16/1/73

Eligibility criteria:
inclusion criteria: * patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation exclusion criteria: * inability to give written informed concent * patients with tumors that can't be resected without reconstruction of vessels or bile ducts * patients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation * patients with extrahepatic metastasis except resectable metastasis in lungs and adrenals * pre- and peroperative diagnosis of non radically treatable disease

Keywords: open liver resection laparoscopic liver resection colorectal cancer liver metastases
efficacy and safety of kw21052 compared to lyrica in the diabetic patients with neuropathic pain

Conditions: Diabetic Neuropathy

Summary: diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. this study is designed as a randomized controlled trial to demonstrate that the efficacy of kw21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (nrs) at the 8th week of intervention is inferior to that of lyrica.

patient reported outcomes (pro) using validated questionnaires and patient diaries will be assessed for efficacy analysis.

Eligibility criteria:
inclusion criteria: * type 1 and 2 diabetic patients * patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy * 40mm and more on vas * 4 and more on nrs * informed consented patients exclusion criteria: * participating in another clinical trial * pregnancy or lactating * sensitivity to pregabalin * significant underlying disease or disorders * prohibited concomitant medications * significant laboratory abnormalities

Keywords: diabetic neuropathy neuropathic pain pregabalin
breaking up sedentary time in rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Sedentary Behavior; Endothelial Dysfunction

Summary: this study will verify the effects of breaking up sitting time with short bouts of light intensity walking on vascular function in women with rheumatoid arthritis.

women diagnosed with rheumatoid arthritis will participate in this randomized crossover trial. in one of the experimental sessions, the participants will remain 4-h on uninterrupted sitting, and in another day they will perform 3-min light intensity walk every 30 min to break up the sitting position. vascular function will be assessed before and after each intervention using the following devices/techniques: a) transcranial doppler ultrasound to assess the middle cerebral artery blood flow velocity at baseline and in response to co2 breathing (5% co2 mixture for 3 min), and to repeated sit-to-stand transitions; b) a multi-frequency linear transducer (7-12 mhz) attached to a high-resolution ultrasound machine to assess femoral artery dilation after reactive hyperemia (i.e., flow-mediated dilation); c) a laser doppler probe attached to the skin surface of the right shin in order to quantify the laser doppler flux at baseline and during reactive hyperemia. additionally, healthy age- and body mass-matched women will be recruited and will only perform the pre-intervention tests.

Eligibility criteria:
inclusion criteria: * adult women diagnosed with ra * from the rheumatology clinic at the liverpool university hospitals nhs foundation trust * aged 18-60 yr * non-smoker for at least 6months * able to provide written informed consent. exclusion criteria: * cannot readily read and understand english. * currently smoking or within last 6 months. * alcohol consumption \>14units per week. * symptoms of or established cardiovascular disease (except hypertension) * previous stroke or myocardial infarction. * history of diabetes or respiratory disease or chronic kidney disease. * musculoskeletal impairment/disability precluding physical activity * unstable medication (change in medication within the 3 months) * aged \ 60 yr * currently pregnant

Keywords: physical activity rheumatic diseases vascular function
a feasibility study in combat athletes with mild traumatic brain injury

Conditions: Mild Traumatic Brain Injury (mTBI); Brain Injury; Concussion

Summary: the use of hyberbaric oxygen therapy (hbot) would be a new treatment plan rather than conventional rest. if effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mtbi) patients. the use of a point of care glial fibrillary acidic protein (gfap) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mtbi. the innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. there are no published randomized controlled studies using hbot to treat concussed athletes within one week of injury. there are no published studies using gfap levels to predict post concussive symptoms (pcs).


Eligibility criteria:
inclusion criteria: * 18 years or older * male unarmed combat athlete * 30-day suspension (head injury without technical knockout or incapacitation) * 60-day suspension (head injury with technical knockout or incapacitation) * 90-day suspension (head injury with loss of consciousness) exclusion criteria: * prisoner status * female * suspension group injury severity would not include moderate to severe gcs \<13 these suspension groups are not based on gcs; therefore, gcs is not part of the inclusion criteria. this group will be divided into randomized groups, patients who will be treated with hbot and patients who will receive the standard of care, which is rest.

Keywords: brain injury concussion mild traumatic brain injury (mtbi)
ultrasonic comparison of salivary glands in autoimmune diseases (cougar)

Conditions: Sjogren Syndrome; Dry Syndrome; Lupus; Scleroderma; Rheumatoid Arthritis

Summary: prospective multicenter cross-sectional study evaluating ultrasound of the main salivary glands (2 parotid and 2 submandibular) in patients with sjögren's disease compared with patients with other connective diseases (rheumatoid arthritis (ra), lupus, scleroderma) and control patients (patient with dry syndrome without the above-mentioned autoimmune disease).

this is a non-interventional study involving patients who are routinely monitored for their disease, and who typically benefit from ultrasound of the parotid and submandibular salivary glands as part of their dry mouth syndrome. recruitment will be facilitated by the fact that these will be "general population" patients with sjögren's disease, lupus, ra, scleroderma with dry syndrome, and control patient. the study will be conducted over a single visit, including a clinical examination and an ultrasound scan. ultrasound will not be blinded to the clinic, so we will need only one examiner per center. this is a study in routine care, with no additional costs and no expected constraints. the examination will be carried out as part of their routine follow-up.

Eligibility criteria:
inclusion criteria: * major patients * patients fulfilling sjogren criteria (2012 and 2016 american-european criteria) or lupus according to acr 2019 criteria or ra according to acr/eular 2010 criteria or scleroderma according to acr-eular 2013 classification criteria or control patient (patient with dry syndrome felt without pre-cited autoimmune disease). exclusion criteria: * uncooperative patient who has refused to participate in the study. * patients unable to understand the protocol, under guardianship or curatorship. * patients not affiliated to the french social security system.
mindfulness-based intervention for caregivers of frail older chinese adults

Conditions: Frailty; Caregiver Burnout

Summary: this is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.

the proposed study is a multi-site, three-arm randomized controlled trial of a mindfulness-based intervention for chinese family caregivers in hong kong. effects of the intervention will be compared with those of an evidence-based psychoeducation program, and treatment-as-usual. 240 caregivers of frail elderly with moderate to severe levels of frailty, will be recruited and randomly assigned to mindfulness-based intervention, psychoeducation, and treatment-as-usual experimental conditions. overall program effectiveness will be analyzed on measures of caregiver burden, depression, anxiety, positive caregiving experience, spirituality, family conflict, and the biomarker of heart rate variability. measures on coping styles, experiential avoidance, and self-efficacy will be explored to see if they mediate the changes to participant improvements in outcomes. 6-month follow-up will be included to investigate the maintenance effects.

Eligibility criteria:
inclusion criteria: * caregivers of frail elderly based on a professional's assessment of clinical frailty scale with a score of 6, indicating a moderate level of frailty or above (rockwood et al., 2005) * caregivers being adult children or children in-law of the elder care receiver * caregivers who are experiencing caregiver burden at the time of study, with scores of 8 or above in zarit burden interview-4 exclusion criteria: * impairment, which may present difficulties in comprehending the content of the program * spouses, siblings, or friends will be excluded * caregivers of elders with moderate to severe dementia will be excluded and the clinical dementia rating scale will be administered * caregivers who had participated in an eight week mindfulness-based stress reduction or equivalent
efficacy, safety and tolerability of bym338 in patients with sporadic inclusion body myositis

Conditions: Sporadic Inclusion Body Myositis

Summary: this study will assess the efficacy, safety and tolerability of bym338 in patients with sporadic inclusion body myositis


Eligibility criteria:
inclusion criteria: - males and females aged 40-80 with a confirmed diagnosis of sporadic inclusion body myositis exclusion criteria: * unable to walk at least 3 meters without assistance from another person * use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months * patients with a history or presence of renal impairment and/or liver disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: sporadic inclusion body myositis
salvage hifu for local recurrence in the prostatic bed after prostatectomy and external beam radiation therapy : preliminary results

Conditions: Prostatic Cancer

Summary: retrospective monocentric analysis performed on patients treated with salvage hifu for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant ebrt. the oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence will be evaluated.


Eligibility criteria:
inclusion criteria: * patient treated by s-hifu for a single recurrence within the prostatic bed after an initial rp with curative intent with or without lymphadenectomy followed by salvage or adjuvant ebrt (with or without pelvic lymph node irradiation) combined or not with adt; * life expectancy of ≥10 years; * histological local recurrence (positive biopsy), * negative metastatic evaluation (all patients underwent multiparametric mri (mpmri) to confirm the relapse in the prostatic bed and choline pet/ct to exclude metastasis (lymph node, visceral or bone metastasis). * the use of adt at bf after s-ebrt was not an exclusion criterion (adt was introduced by the centre referring the patient). * no limits were placed on prostate cancer characteristics, psa (value, doubling time (psa-dt)), gleason score and location of suspected recurrence in relation to the sphincter. exclusion criteria: * patients who do not meet the inclusion criteria
correlation between eye rubbing and keratoconus severity in a treatment-naive keratoconic population

Conditions: Keratoconus

Summary: determination if, within a keratoconic population, strong eye rubbing was correlated with visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry, keratometry, and tomography classification determinating keratoconus stage.

a retrospective study was performed between november 2014 and october 2015 in the metz hospital center. were included 33 patients presenting with treatment-naive keratoconus. patients responded to a questionnaire that assessed eye rubbing habits, family history of keratoconus, history of atopy. 2 groups were separated: group 1 constituted by 15 eyes with no eye rubbing, and group 2 constituted by 18 eyes with moderate or severe eye rubbing. the following informations were collected: best visual corrected acuity (bcva), spherical equivalent value (sev), corneal opacities or vogt striae. for each eye were performed an anterior segment oct (as-oct) to determine the oct stage for keratoconus (fourrier domain oct classification, 2013), and a scheimpflug camera imaging to determine the maximal keratometry (kmax) and the minimal corneal thickness (mct).

Eligibility criteria:
inclusion criteria: * patients presenting with treatment-naive keratoconus. exclusion criteria: -
optimization of pk/pd target attainment for ceftriaxone in critically ill patients with community-acquired pneumonia.

Conditions: Pharmacokinetics; Critical Illness

Summary: wp2.1. pk/pd target attainment plasma exposure elf exposure wp2.2. predictive dosing algorithm wp2.3. ecmo subset

first, the investigators will document exposure to ceftriaxone in plasma and epithelial lining fluid. second, the investigators will try to identify risk factors for not attaining pk/pd target. based on significant predictors for target non attainment a predictive dosing algorithm will be constructed. finally in a small subset of ecmo patients pk exposure will be explored.

Eligibility criteria:
inclusion criteria: * pneumonia * admitted to an icu ward * treated with ceftriaxone exclusion criteria: * pregnancy * dnr code 2-3 * renal replacement therapy

Keywords: pharmacokinetics ceftriaxone critical illness capillary leak hypoalbuminemia