Kornimate/medical-research-clean huggingface dataset:
defocused shock wave therapy for chronic wounds

Conditions: Wounds

Summary: chronic soft tissue wounds of the lower limbs are painful and debilitating condition that significantly reduce the quality of life of the patient. they often do not respond to conservative treatments or advanced wound managements. focused and defocused extracorporeal shock wave therapy can be a viable alternative therapeutic strategy. the purpose of the study was to examine the effects of defocused extracorporeal shock wave treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound healing and pain control.


Eligibility criteria:
inclusion criteria: * chronic post-traumatic, venous, arterial, diabetic, or mixed wound of the lower limb * wound persisting for longer than three months * a wound surface bigger than 0,5 cm2 * a wound diameter between 0.5 and 5 cm * unresponsiveness to conservative treatments and advanced wound managements in the 3 months prior to enrollment * no changes in wound managements during the study. exclusion criteria: * an ankle brachial index (abpi)\<0.7 and tcpo2\<40 mmhg * arrhythmias, presence of pacemaker, or coagulation disorders * use of anticoagulant drugs * neoplasia * pregnancy * soft tissue wound infections and/or osteomyelitis * patients with full-thickness loss of soft tissue and extension into muscle, bone, tendon, or joint capsule.

Keywords: shock waves
study of tislelizumab in participants with resectable esophageal squamous cell carcinoma

Conditions: Resectable Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the pathological complete response (pcr) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.


Eligibility criteria:
key inclusion criteria: * eastern cooperative oncology group performance status of 0 or 1. * histologically confirmed esophageal squamous cell carcinoma (escc). * stage ct1-2n+m0 and ct3nanym0 (per the american joint committee on cancer 8th edition). * evaluation by the investigator to confirm eligibility for an r0 resection with curative intent. * adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose. key exclusion criteria: * ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy. * any prior therapy for current escc, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways. * history of fistula due to primary tumor invasion. * participants with high risk of fistula or sign of perforation evaluated by investigator. * any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose. \* adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted. * active autoimmune diseases or history of autoimmune diseases that may relapse. \* controlled type i diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases. * with infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection. * severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. * receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: tislelizumab pet chemotherapy chemoradiotherapy
ocular biomarkers for successful premium trifocal intra-ocular lenses implantation

Conditions: Presbyopia; Low Vision

Summary: the purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral at lisa try 839mp (carl zeiss meditec ag) implantation to achieve satisfactory post-post-operativly spectacle-free vision. social, biometric and patient reported outcomes will be evaluated.

pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including, corneal topography, and aberrometry (pentacam), biometry (iolmaster 700, carl zeiss meditec ag, jena, germany), specular microscopy (cem 539, nidek co ltd.), and macular and papillary optical coherence tomography (cirrus 4000 hd oct, carl zeiss meditec ag). all surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag iol placement. patients had both eyes operated within a week. patients were assessed at day 1, 6, and month 3 after surgery. six months post-operatively, refraction and slit-lamp examination was performed, and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction, spectacle independence and dysphoptsia like-symptoms.

Eligibility criteria:
inclusion criteria: * age ≥ 45 years old with clinical identified bilateral cataracts * patients that want to have good vision most of the time without glasses at all distances * highest limit of mesopic pupil of 6 mm * corneal total higher-order aberration (hoa) ≤ 0.5 μm * angle kappa ≤ 0.58 mm * absence of cornea ectasia diagnostic criteria. exclusion criteria: * patients with moderate or severe dry eye syndrome * ocular comorbidities such as corneal, retinal or optic nerve disease * previous ocular surgeries * patients with unreal post-surgical visual expectations * patients with known mild cognitive impairment or dementia.

Keywords: cataract multifocal iol
does pulse-triggered vns autostimulation increase vns efficacy

Conditions: Epilepsy

Summary: this is a research study to investigate whether the use of an extra function of vagus nerve stimulator (vns) can give an improved effect against epilepsy. many epileptic seizures are accompanied by an increase in heart rate. one auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered. it has been shown that this can interrupt attacks that are about to develop. in this project the investigators will test how well that works for patients in daily life. the new type of stimulator has similar design and location as the old one. patients who have already been treated with vns and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate. the study is a randomized and blinded cross-over. the activation of the extra feature is done either in the first or the second treatment phase. which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started. the study period is 11 months. patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.


Eligibility criteria:
inclusion criteria: * subjects, 12 years of age or older, who have a vns without ecg-triggered auto stimulation implanted, have a positive effect and have a device replacement with model 106 or model 1000 due to low battery capacity,. * subjects, who have 2 or more seizure per month and not more than 28 days between seizures during the baseline. * subjects, who are on a stable regiment of antiepileptic drug treatment for at least 3 month prior to enrollment and maintain on this regimen throughout the study. * vns parameters have not been changed i the last 3 month prior to enrollment. * subjects which are using an off time of at least 1.8 min. (if the patient is on a duty cycle involving an off-time of 1.1 min. or less, and willing to participate in the study the duty cycle will have to be changed to fulfill the inclusion criteria as follows. the off-time will be changed to 1.8 min. and the on-time accordingly to achieve about the same duty cycle as the patient had before. if the duty cycle is above 30% the parameters will be changed to 60 sec./1.8 min., if the duty cycle is between 30% and 23% the parameters will be change to 30 sec./1,8 min., if the duty cycle is 20% the parameters will be change to 21 sec./1,8 min. and if the duty cycle is 15% the parameters will be change to 14 sec./1,8 min. after at periode of 3 month observation the patient can be included in the study.) * either the subjects or the legal guardian are able to agree to participate by signing the informed consent form. exclusion criteria: * subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease. * subjects or legal guardians who are unable to understand the study procedures.
comparison between two durations of antibiotherapy for non-surgically-treated diabetic foot osteomyelitis (chronos-2)

Conditions: Osteomyelitis - Foot

Summary: the aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.

the fight against multi-drug resistant bacteria is a global matter and a major health public issue. the excessive exposure of microorganisms to drugs increases their ability to develop survival mechanisms, causing an emerging threat and a health challenge. several recent studies showed that 18-35% of patients with diabetic foot infections harbored multiply drug-resistance to organisms (mdro), the most common is staphylococcus aureus (mrsa). hospitalization, surgical procedures and long antibiotic therapy induce the development of mdro or mrsa in diabetic foot, osteomyelitis (dfo) is a well recognize risk factor for major amputation and mortality rates that occurs in more than 20% of moderate infections and 50% to 60 % of severe infections. in this context, the aim of this study is to evaluated that reducing time of antibiotic administration (3 weeks) is not substantially worse than the current treatment guidelines (6 weeks) in dfo managed nonsurgically.

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * informed, written consent obtained from patient * patient having the rights to frenc social insurrance * for women of childbearing potential : any effective contraceptive is required * type 1 or 2 diabetic patients * diabetic patients treated non-surgically for an osteomyelitis of the forefoot affecting only one osteoarticular part/radial supported by adequate diagnostic imaging and bone biopsy performed through uninfected tissue. * two peripheral pulses or transcutaneous oxygen tension measurement (tcpo2 \> 30mmhg) or ankle brachial index (abi \> 0.9) * patient without antibiotherapy during 2 weeks before d1. * glycated hemoglobin (hba1c) \< 12% ( measured maximum 2 months before d1) * use of offloading boot for diabetic foot is feasible exclusion criteria: * bone fragmentation, articular destruction requiring bone resection or amputation. * gangrene * more than one osteoarticular part/radial affected * contraindication for the use of offloading boot * contraindication for bone biopsy * contraindication for the full course of antibiotics (allergy or based on rcp) * other drug-drug interaction that contraindicated the full course of antibiotics * charcot foot * patient undergoing radiotherapy of chimiotherapy for malignant neoplasms * hepatic insufficiency (asat and/or alat \> 3 times the normal level) * any disease or behaviour making impossible to follow the protocol or difficult to interpret the results * any disease or context making difficult to allow regular monitoring of the patient * participation in other interventional research during the study * curator or guardianship of patient placed under judicial protection * pregnancy or lactating women

Keywords: diabetes mellitus antibiotic treatment
autologous stem cell transplant (asct) with intravenous busulfan and melphalan as conditioning regimen

Conditions: Multiple Myeloma

Summary: analyze the results of asct using intravenous busulfan and melphalan as conditioning regimen for patients with multiple myeloma.

primary efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100). secondary graft kinetics (time to neutrophil and platelet recovery after asct) 2.analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after asct

Eligibility criteria:
inclusion criteria: * symptomatic multiple myeloma * male or female subject age \>= 70 years * the subject has received at least one previous line of therapy including: * front-line treatment with vbmcp/vbad or vad or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide * the subject has given voluntary written informed consent exclusion criteria: * use of bortezomib, thalidomide or lenalidomide as front-line therapy * ecog satus \>=2 * left ventricular ejection fraction \<40% * dlco and fvc \<39% theoretical value * abnormal liver function(total bilirubin \> 2 mg/dl and/or alt or ast \> 3 x uln) * serum creatinine at transplant \>1.6 mg/dl and/or creatinine clearance \< 65 ml/minute * subject has an active systemic infection requiring treatment * subject had a myocardial infarction within 6 months of enrollment or has nyha class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias * subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol * subject is known to be immunodeficiency virus (hiv)-positive * subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment * if female, the subject is pregnant or breast-feeding. confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. pregnancy testing is not required for postmenopausal or surgically sterilized women

Keywords: autologous transplantation multiple myeloma intravenous busulfan
non-steroidal anti-inflammatory drugs in pleurodesis

Conditions: Non-steroidal Anti-inflammatory Drugs; Pleurodesis; Pneumothorax; Pain Management

Summary: non-steroidal anti-inflammatory drugs (nsaids) are recommended in a multimodal pain management to reduce pain intensity and to spare opioid use. however, there is a controversy in its use in pleurodesis surgery as it could block the process of pleurodesis in surgical pneumothorax. in addition, nsaids could increase the risk of pneumothorax recurrence. the investigators hypothesized that nsaids are safe during pleurodesis with a better pain management without increasing the risk of pneumothorax reccurence.


Eligibility criteria:
inclusion criteria: * age≥18-year-old * pneumothorax with an indication of pleurodesis * with or without minimal lung resection * via thoracotomy or thoracoscopy exclusion criteria: * minor patient * pregnant, parturient or breast-feeding patient * severe polytrauma (associated with the presence of a vittel criterion) * purulent pleurisy * hemopneumothorax * lactose hyper sensibility * contraindications to nsaid * contraindications to tramadol * contraindications to paracetamol * curative anticoagulation * patients under guardians or deprived of their liberty * patient refusal

Keywords: non-steroidal anti-inflammatory drugs pleurodesis pneumothorax pain management
modified ultrafiltration in cardiac surgery

Conditions: Coagulopathy; Rethoracotomy; Blood Loss; Transfusion Requirements

Summary: the purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.

the impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. in this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. primary hemostasis is assessed using multiple electrode aggregometry (multiplate) and secondary hemostasis is assessed performing thrombelastometry using the rotem device. patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.

Eligibility criteria:
inclusion criteria: * patients undergoing complex cardiac surgery procedures exclusion criteria: * none

Keywords: modified ultrafiltration cardiac surgery rotem multiple electrode aggregometry
bone geometry and muscle density changes in postmenopausal women and breast cancer patients prescribed anastrozole

Conditions: Breast Cancer

Summary: the primary objective of this study is to determine if trabecular or cortical volumetric bone mineral density (vbmd) change over time in postmenopausal breast cancer patients who are prescribed anastrozole, as measured by pqct at the proximal and distal radius and tibia.

in bone, where estrogen is required to maintain density, there is indication of increased turnover in patients prescribed aromatase inhibitors. however, there are no studies to date that prospectively quantify the impact of aromatase inhibitors on bone quality. furthermore, the actual effects and clinical significance of adjuvant chemotherapy and supportive medications on bone quality in women with breast carcinoma is unknown. the current study proposes to prospectively assess novel skeletal health outcomes, namely trabecular structure (connectivity, hole size) and bone geometry (bone area, cortical thickness) among women with breast cancer being treated with anastrozole. not only will the current study provide a better understanding of the changes in bone quality and muscle mass after anastrozole treatment, it will provide important information about the development of secondary skeletal complications in this population. therefore, the potential to collect data prospectively from a cohort of individuals with breast cancer being treated with anastrozole represents an important step to advance knowledge in this area. also, by examining bone quality and secondary complications in a diverse cohort of patients who vary with respect to radiation therapy, chemotherapy and additional medications, we can begin to identify patterns of musculoskeletal change and predictors of these changes.

Eligibility criteria:
inclusion criteria: group 1: treatment group * postmenopausal breast cancer patients (stage 1 and 2) * non-institutionalized * prescribed anastrozole within the preceding 1-2 weeks * ambulatory * ability to read and comprehend study protocol and informed consent group 2: control group * healthy, age-matched postmenopausal women * non-institutionalized * ambulatory * ability to read and comprehend study protocol and informed consent exclusion criteria: * prior tamoxifen or raloxifene therapy * known congenital metabolic bone disease (e.g., osteogenesis imperfecta) * concomitant treatment with corticosteroids * patients with a history of endocrine disorders or surgical parathyroidectomy * patients with disorders known to affect bone metabolism including diabetes mellitus, systemic lupus erythematosus, cushing's disease, hyperparathyroidism, chronic liver disease, chronic renal failure, paget's disease * conditions preventing pqct measurement (e.g., unable to lie flat or still for 15 minutes) * geographically inaccessible for follow-up

Keywords: breast cancer pqct anastrozole bone geometry
odense fallers and osteoporosis study

Conditions: Accidental Falls; Osteoporosis; Disability

Summary: osteoporosis and falls occur with increasing frequency among the elderly. osteoporosis and fall increases the risk of fracture. falls in the elderly are associated with a high morbidity and mortality with potentially life-threatening consequences of falls including fractures. besides fracture fall may cause long term problems such as disability fear of falling and loss of independence. today osteoporosis is diagnosed by bone scan of the hip and spine. the investigators want to investigate whether other more accessible and less expensive testing methods can be used to diagnose osteoporosis. additionally, the investigators will examine the incidence of osteoporosis among the elderly in the municipality of odense. finally, the investigators would like to investigate the association between factors that can lead to falls and to investigate the performance of older and whether there are changes in functional ability over time.

study objectives 1. to define the prevalence of osteoporosis in a falls clinic population, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers. 2. to evaluate the usefulness of peripheral bone scanning techniques in a falls clinic population. 3. to determine the prevalence of vertebral fractures in a falls clinic population and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers 4. to investigate functioning, disability, health related quality of life and perceived need for rehabilitation in a falls clinic population including variation in a one year period, and compare it with two aged matched control groups - fallers not attending the falls clinic and non-fallers.

Eligibility criteria:
inclusion criteria: * women aged 65 years or over attending the falls clinic \*(there will be no upper age limit to recruitment). * those capable of giving informed consent. exclusion criteria: * patients under the age of 65 years. * men. * patients unwilling to give informed consent. * cognitively impaired people who are not capable of giving consent. * patients who are not mobile enough to be helped onto a dxa scan table with help