Kornimate/medical-research-clean huggingface dataset:
post-marketing study to collect safety data in heart transplant patients receiving everolimus

Conditions: Coronary Heart Disease

Summary: the purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants. primary outcome measures: incidence of acute rejection episodes secondary outcomes: safety


Eligibility criteria:
inclusion criteria: * cardiac transplant recipients * discharged alive from hospital * must be receiving everolimus exclusion criteria: * patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant other inclusion/exclusion criteria may apply.

Keywords: transplantation, heart organ transplant
analysis of the inflammatory response and the development of humoral and cellular immunity in patients with covid-19

Conditions: SARS-CoV-2

Summary: the sars-cov-2 infection in the airway epithelium induces cytopathic effects and the cessation of ciliary movement. increased cytokines and chemokines have been reported to be associated with the severity of the disease. however, most of the molecular and cellular aspects of the inflammatory response and the processes of development of humoral and cellular immunity in these patients are unknown. the aim of this study is characterizing inflammatory processes, seeking to expand the knowledge of the cellular and molecular pathophysiology of covid-19 that could help in the decision-making of treating health personnel. mainly, the study is focused on analyzing the inflammatory response by determining cytokines and chemokines. also, the viral load of the patients with covid-19 will be determined and will be correlated with the antibody titers. on the other hand, cells will be immunophenotyped to search the cellular depletion profile. finally, an epidemiological analysis of the patients will be carried out.


Eligibility criteria:
inclusion criteria: * patients over 16 years old with positive molecular diagnosis of covid-19, in the laboratory of imss exclusion criteria: * patients with immunosuppressive diseases: hiv +, hepatitis c virus, primary immunodeficiencies, rheumatoid arthritis, lupus erythematosus and patients under treatment with immunosuppressants
locking plates for distal femur fractures - a multicenter case review

Conditions: Distal Femur Fracture

Summary: in order to assess the rate and mode of failure cases observed in patients with distal femur fractures treated with a distal femur plates, anonymized radiographs from those patients will be collected retrospectively. all available images will reviewed by an expert review board in regards to fracture classification, implant and surgery details, quality of initial reduction and plate positioning as well as the occurrence of mechanical complications and the outcome in terms of fracture healing (if available). additionally, age and gender as basic demographical data will be collected in a de-identified way..

severely comminuted distal femur fractures can be challenging injuries and usually require surgical treatment with lateral distal plate osteosynthesis. anatomically pre-contoured locking plates are commonly used. in 2012, the 4.5mm va-lcp curved condylar plate for distal femur fractures (va-lcp df, synthes) was introduced offering the option of axis variation of the locking screws. recently, a report highlighted cases of implant failure with this implant, cautioning practicing surgeons against the use of this implant in certain type of ao/ota fracture and dislocation classification 33 fractures (ao/ota classification). based on this report, the current study was designed to perform a retrospective in-depth radiological analysis of all cases distal femur fractures of 4 participating sites in which the va-lcp df, the lcp distal femur plate (lcp df, synthes) or the 'less invasive stabilization system' for distal femur fractures (liss df, synthes) were used for fracture stabilization. the radiological in-depth analysis will be done by an expert review board with the aim to identify potential causes and risk factors for the failure cases among all cases collected. this evaluation will contribute to a better understanding of the mechanical performance of distal femur fracture plates and the causes and risk factors for failures.

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of a distal femur fracture type ota/ao classification 33-a, -b, -c * uni- or bilateral * low or high energy trauma * open or closed fractures * surgical treatment with the va-lcp df, liss df, lcp df * available radiographical documentation, beginning with the injury radiographs, ending with the documented healing or any documented failure with or without revision surgery (up to a maximum follow-up of 1 year

Keywords: va-lcp df lcp df liss df various angle locking plate
prospective study evaluating the effect of repository corticotropin in the treatment of various nephrotic syndromes

Conditions: Nephrotic Syndromes

Summary: to determine if h.p. acthar gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic acth analogue in europe.

synthetic acth (synacthen depot) has been used in the treatment of nephrotic syndrome in europe. it has been proven effective in treating idiopathic membranous nephropathy and other various diagnoses involving the kidneys. however, synacthen is not available in the united states. the only preparation available is the h.p. acthar gel (repository corticotrophin) which has been widely used in the treatment of infantile spasms and has been available longer than synacthen. therefore, we are conducting this study to determine if h.p. acthar gel (repository corticotrophin) is as effective in reducing protein in the urine as seen in synthetic acth in europe.

Eligibility criteria:
inclusion criteria: * nephrotic syndrome with a minimal of 3.5grams of protein per 24 hr period, measured via either 24hr urine collection or spot protein to creatinine ratio. * males and post-menopausal, surgically sterile, or non-lactating and non-pregnant females using adequate contraception * biopsy proven diagnosis of nephrotic syndrome due to lupus glomerulonephritis, membranous nephropathy, focal segmental glomerulosclerosis, minimal change disease, diabetic nephropathy (type 2)or iga nephropathy. * greater than 18 years of age * willing and able to give informed consent * diabetics are on insulin or willing to start insulin during the study exclusion criteria: * previous intolerance to native acth or proteins of porcine origin * history of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, primary adrenocortical insufficiency or adrenocortical hyperfunction. * expected to begin renal replacement therapy or receive a transplant within the next year. * recent cardiovascular event within 3 months of screening including: myocardial infarction, cva, tia, new york heart association functional class iii or iv failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy, second or third degree atrioventricular block not successfully treated with a pacemaker. * history of hiv * know peptic ulcer disease. * sbp\> 160 or dbp \> 100 at time of enrollment * new diagnosis of cancer or recurrent cancer within 2 years of screening * history of alcohol or drug abuse within 12 months of study entry. * receipt of any investigational drug within 30 days of enrollment. * anticipated major surgery during trial period * psychiatric disorder that interferes with the patient's ability to comply with the protocol. * inability to cooperate with study personnel or history of noncompliance to medical management * active infection within 1 month of screening * poorly controlled diabetes with an hba1c \> 10% * type 1 diabetes mellitus

Keywords: nephritis,nephropathy
intra-operative neuromodulation of the pelvic plexus

Conditions: Erectile Dysfunction; Prostate Cancer

Summary: the purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).

prostate cancer is the main cancer in men. however, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (rp), the gold standard treatment for non-metastatic cancers. unfortunately, despite providing optimal cancer control, rp often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. various erectile rehabilitation strategies have not been able to prove a beneficial action yet. however, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy. the primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. during standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded. the secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.

Eligibility criteria:
inclusion criteria: * scheduled for open radical prostatectomy procedure under total anesthesia. * age 40 to 75 years old. * able to read and understand patient information materials and willing to sign a written informed consent. exclusion criteria: * have been diagnosed with severe vasculogenic erectile dysfunction. * have a prior history of pelvic surgery, trauma or irradiation therapy. * have a penile prosthesis. * have been diagnosed with neurologic diseases that may negatively impact erectile functions. * currently having an active implantable device (such as a pacemaker). * posses any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study. * inability to provide a fully informed consent.

Keywords: erectile dysfunction prostate cancer neuromodulation
evaluation of the efficacy and safety of surgical device "lymphoblock" for prevention of lymphorrhea in patients with thoracoabdominal aorta repair.

Conditions: Aorta Abdominalis; Aneurysm; Aorta Thoracic; Aneurysm

Summary: randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. it is planned to recruit 138 clinical observations. efficacy will be evaluated based on clinical and laboratory data.

the study design will include patients with open surgical repair of the thoracoabdominal aorta who underwent thoracophrenolumbotomy with retroperitoneal exposure of the aorta. it is assumed the lymphoblock to reduce the incidence of postoperative lympho-/chylorrhea. patients will be divided based on randomization into groups that will receive a lymphoblock or a placebo. it is planned to recruit 138 patients, 69 patients in each group. the drug will be used right before wound closure. the solution will be applied to the surface of the wound with further exposure and draining. blood test and drainage discharge parameters (from the left pleural cavity and retroperitoneum) will be examined in postoperative period. the thoracic and abdominal ct and ultrasound will be performed to exclude presence of effusion and/or lymphocele.

Eligibility criteria:
inclusion criteria: * patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access exclusion criteria: * refusal to participate in the study
perioperative oral vitamin d3 supplementation on implant osseointegration

Conditions: Implant Site Reaction

Summary: the number of patients treated in implantology at nantes university hospital is 400 per year. this pilot study aims to demonstrate the efficacy of a 6-month oral cholecalciferol supplementation on osseointegration in patients requiring dental implants and presenting with vitamin d deficiency, compared to french patients who have not undergone vitamin d screening

this study will be conducted on patients with vitamin d deficiency or insufficiency who visit the restorative and surgical dentistry department at the dental care center of nantes university hospital for implant surgery. the investigator will present the study to them and record their verbal non-opposition. clinical data from before the surgery (approximately 3 months prior), during the surgery, and postoperative visits up to 3 months afterward will be included in the osivid study.

Eligibility criteria:
inclusion criteria: * male or female patient ≥ 18 years old, candidate for dental implant placement. * with vitamin d deficiency or insufficiency: 25(oh)d \< 25 ng/l. * affiliated with a social security scheme. exclusion criteria: * with a local contraindication for implant placement. * under guardianship, curatorship, or legal protection * pregnant or breastfeeding women
clinical validation study for noninvasive cardiopulmonary management device

Conditions: Cardiopulmonary Disease

Summary: the adi at-home cpm (cardiopulmonary management) system is a non-invasive device that measures and trends a variety of biological parameters. this study will be conducted as a prospective non-randomized study with two study arms/cohorts - one of healthy adult patients, one of pathologic patients who fit into the intended use population of the cpm system.


Eligibility criteria:
inclusion criteria: i. healthy cohort: 1. adults over the age of 18 and who are willing and able to give informed consent. 2. willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the cpm wearable device. 3. volunteers of any race, any gender 4. range of physiques 5. healthy ii. pathologic cohort 1. adults over the age of 21 and who are willing and able to give informed consent 2. willing to participate in all activities related to this study, including wearing a capnography device, thoracic impedance reference device, and the cpm wearable device. 3. those who: 1. are taking diuretic medications 2. are living with heart failure 3. have chronic obstructive pulmonary disorder (copd) 4. are recovering from a coronary-artery disease-related event. 4. volunteers of any race, any gender-range of physiques. exclusion criteria: i. healthy cohort 1. injury or skin disturbance in the area of the test device 2. pregnant 3. currently smokes cigarettes 4. has known respiratory conditions such as: 1. flu 2. pneumonia/bronchitis 3. shortness of breath/respiratory distress 4. respiratory or lung surgery 5. emphysema, copd, lung disease 5. has self-reported heart or cardiovascular conditions such as chest pain, afib, chf, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function 6. has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask) ii. pathologic cohort: 1. under the age of 21 2. cognitive or physical impairment sufficient enough to interfere with informed consent or successful completion of the protocol. 3. injury or skin disturbance in the area of the test device. 4. pregnant. 5. have life-threatening arrhythmias which require hospital admission and constant monitoring. 6. has other self-reported health conditions that could interfere with wearing a capnography mask.
a post-marketing surveillance study on erbitux® (cetuximab) in patients with metastatic colorectal cancer refractory to irinotecan containing treatment

Conditions: Metastatic Colorectal Cancer

Summary: a post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (egfr) expressing, kras wild-type metastatic colorectal cancer treated with erbitux as final evaluable cases.


Eligibility criteria:
inclusion criteria: * egfr expressing, kras wild-type subjects with metastatic colorectal cancer, who are indicated for erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy) exclusion criteria: * subjects who are not eligible for erbitux treatment according to the indication in national label; or with hypersensitivity reactions (grade 3 or 4) to erbitux

Keywords: metastatic colorectal cancer mcrc post marketing surveillance erbitux cetuximab kras
vivistim registry for paired vns therapy (grasp)

Conditions: Upper Extremity Problem

Summary: the purpose of the vivistim registry for paired vns therapy (grasp) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering vivistim system treatment. before and after vivistim system implant, patient data will be collected and reported throughout the therapy process. physicians or sites will receive appropriate remuneration for the effort and cost involved in collecting and transmitting this data to microtransponder inc.

the registry is a data repository of information on patients considering implant of the vivistim system. the vivistim system is an fda approved (p210007) device used to help improve upper limb motor deficits after a stroke. most patients entered into the registry will go on to be implanted with the system although those who decide not to move forward with the implant procedure can still have data collected as a non-implant comparison group (as long as either or both fm-a / wmft assessments were collected). the primary purpose of the registry is to provide real-world usage and outcomes data on the vivistim system. the patient outcome registry will collect acute and long-term follow-up data on vivistim implanted patients treated with paired vagus nerve stimulation (paired vns™) post-fda approval. historical and implant information as well as quality of life information will be gathered on patients who consider implant of the vivistim® system. data will be collected at baseline, 3, 6, and 12 months after implantation, as well as yearly thereafter for up to three (3) years post-implant. patients who decide not to have the vivistim system implanted can continue to have data collected for comparison purposes. contributing sites and physicians will have access to their own site data and can have anonymized summary analyses on all aggregated data; sites will not have access to other sites' individual level data. physicians can then use the above information to facilitate patient selection and treatment. publication (oral or written) of data in the registry, other than individual site data, will not be permitted without the express written advance approval of microtransponder, inc. and the other physicians contributing to the dataset.

Eligibility criteria:
inclusion criteria: * patients implanted with the vivistim system for upper limb deficits associated with an ischemic stroke exclusion criteria: * not eligible for surgery

Keywords: ischemic stroke paired vagus nerve stimulation
sialendoscopy in treatment of submandibular gland sialolithiasis

Conditions: Lithiasis

Summary: salivary disorders are common reason for ent specialist consultation. sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland. the management of salivary obstruction has changed over the past 30 years. sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. moreover, many studies have shown the effectiveness of this procedure. classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. the main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.


Eligibility criteria:
inclusion criteria: * adult patient * patient treated in chr metz-thionville between 2013 and 2020 * with a pathological impairment (suspected or confirmed) of a salivary gland * with sialendoscopy indication for diagnosis and/or treatment exclusion criteria: * opposed to use data * without sialendoscopy indication * without lithiasis salivary gland disorder * with parotid gland lithiasis

Keywords: sialendoscopy submandibular gland classification
alxn1210 versus eculizumab in adult participants with paroxysmal nocturnal hemoglobinuria (pnh) currently treated with eculizumab

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with pnh who were clinically stable after having been treated with eculizumab for at least 6 months.

the study consisted of a 4-week screening period and a 26-week randomized treatment period (primary evaluation period). after completion of the primary evaluation period, all participants had the opportunity to enter the extension period, wherein participants will receive ravulizumab for up to 4 years.

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age. 2. treated with eculizumab for pnh for at least 6 months prior to day 1. 3. lactate dehydrogenase level ≤1.5 times the upper limit of normal (uln) at screening. 4. pnh diagnosis confirmed by documented by high-sensitivity flow cytometry. 5. documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment. 6. female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab. 7. willing and able to give written informed consent and comply with study visit schedule. exclusion criteria: 1. history of bone marrow transplantation. 2. body weight \<40 kilograms at screening. 3. history of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation. 4. unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleeding, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, or coexisting chronic anemia unrelated to pnh). 5. female participants who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or day 1. 6. participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study treatment on day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.