Kornimate/medical-research-clean huggingface dataset:
nerve grafting technique to preserve erectile function in patients undergoing robotic assisted radical prostatectomy

Conditions: Prostate Cancer; Erectile Dysfunction

Summary: the investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing nerve restoring (nr) robotically assisted laparoscopic radical prostatectomy (ralp). during this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, nr-ralp, which incorporates a genitofemoral (gfn) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure

patients will have baseline evaluation with international index of erectile function-5 (iief-5) questionnaire and the short form mcgill pain questionnaire (sf-mpq)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Eligibility criteria:
inclusion criteria: 1. patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of: 1. gleason grade ≥8 2. psa ≥20 3. \>pt2 on preoperative mri imaging 2. patients must have preoperative erectile function with a baseline iief score of ≥17 exclusion criteria: 1. patients with previous pelvic surgery 2. patients with previous pelvic radiotherapy 3. patient with previous focal therapy for prostate cancer 4. patients aged \< 18 years at diagnosis 5. legally incapable patients 6. patients who are unable to complete questionnaires and have no companion to help complete them 7. patients undergoing a concomitant cancer surgery 8. patients with pre-existing neurologic disease
an investigational surgical procedure (vascularized lymph node transfer) in reducing the risk of lymphedema in patients with breast cancer undergoing breast reconstruction

Conditions: Breast Carcinoma

Summary: this trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. patients who undergo breast reconstruction are often at high risk of developing lymphedema. vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.

primary objective: i. determine incidence of patients who develop lymphedema following autologous breast reconstruction. secondary objectives: i. determine the overall complications of prophylactic vascularized lymph node transfers. ii. compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer. outline: patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery. after completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.

Eligibility criteria:
inclusion criteria: * patients who have undergone treatment (mastectomy, axillary lymph node dissection \[alnd\], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction exclusion criteria: * patients that are known to be pregnant at the time of surgery * patients with a known hypersensitivity to indocyanine green (icg) and/or isosulfan blue (lymphazurin)
safety and immune response to an investigational vaccine against respiratory syncytial virus in healthy adults

Conditions: Respiratory Syncytial Virus Infections

Summary: this study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (rsv). the investigational vaccine (mv-012-968) is administered as drops in the nose. this study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.


Eligibility criteria:
key inclusion criteria: * adult 18-40 years of age * in good health based on review of the medical record, history, and physical examination, without evidence of chronic disease * rsv 'sero-low' from a pre-vaccination serum sample * signed informed consent form exclusion criteria: * occupational or household exposure to children \< 5 years of age, or to immunocompromised individuals * prior receipt of an investigational rsv vaccine * women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination * any other reason the investigator considers exclusionary

Keywords: vaccine live attenuated safety immunogenicity viral shedding phase 1 clinical trial
177lu-psma-i&t prior to radical prostatectomy for locally advanced disease

Conditions: Prostate Cancer

Summary: despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. drug therapy before surgery has the potential to improve treatment success by lowering tumor volume in the prostate and treating small metastases. pet psma is an advanced imaging technique that allows the identification of areas involved by the tumor in the prostate or in the pelvis. this technique is based on the protein psma (prostate-specific membrane antigen) which is located on the tumor cells. the presence of psma on tumor cells has been recently used for treatment purposes. a chemical element (lutetium) that binds to psma and emits local radiation can destroy tumors cells. this treatment has been used in patients with advanced metastatic disease and showed promising results. the investigators hypothesized that using these particles can improve long term results in patients who undergo surgery for prostate cancer which has not extensively spread. the investigators will assess both the immediate and long-term impact of this novel treatment.


Eligibility criteria:
inclusion criteria: * 1. male aged 18 years and older. 2. patients were diagnosed with high risk localized prostate cancer (ct3/4 and/or gleason score ≥8 and/or prostate biopsy or psa ≥ 20 ng/dl) or loco-regional prostate cancer (pelvic lymphadenopathy of ≥2 cm on axial imaging). 3. high psma expression was confirmed. pet psma with tracer uptake greater than normal liver (maximal standardized uptake value ≥1.5 of liver). in addition, no pet fdg positive sites without high psma expression. 4. patients should have an eastern cooperative oncology group (ecog) performance status score5 of 1 or lower and life expectancy of \> 10 years. exclusion criteria: * 1. clinically significant impaired bone marrow defined by platelet count lower than 150×103/µl, white blood cells count lower than 4×103/µl, hemoglobin concentration lower than 12mg/dl. 2. impaired liver function defined by albumin concentration lower than 3.5 gr/dl. 3. impaired kidney function defined by glomerular filtration rate (gfr) lower than 40 ml/min. 4. recent radiotherapy (within two months) 5. concomitant usage of nephrotoxic drugs 6. evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone metastases).
cp4acs - delphi study to determine appropriateness of stemi quality indicators in belgium

Conditions: STEMI; Quality Indicators

Summary: rand/ucla modified delphi study on quality indicators for stemi to determine the appropriateness of quality indicators retrieved from literature and guideline review. we aim to engage 20 cardiologists and 20 nurses with relevant experience in the care for stemi patients.


Eligibility criteria:
inclusion criteria: * cardiologist or cardio nurse with relevant experience in the care for stemi patients exclusion criteria: -

Keywords: quality improvement stemi belgium
switch to darunavir/r + maraviroc quaque die in patients with r5 tropism by viral dna genotyping (gusta)

Conditions: HIV Infection

Summary: objectives of the study: 1. to verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with r5 tropism by viral dna genotyping. 2. to collect relevant information about the safety, the immunologic and the economic impact of this strategy.


Eligibility criteria:
inclusion criteria: * patients treated with the same regimen including 3 haart from at least 4 months * aged 18 years or older * who gave informed consent to the participation to the study * with at least two viral load \< 50 copies/ml in two consecutive determinations at least 6 months apart (tolerance of two weeks) * with cd4 cell count \> 200 cells/μl and absence of any opportunistic infection or aids-related disease for at least one year prior to the screening. * with r5 tropism by viral dna genotyping (geno2pheno "clonal") * with cd4 cell count nadir\>50 cell/mmc or 100 cell/mmc if previous enfuvirtide or integrase inhibitors use exclusion criteria: * with at least one major or two minor mutation conferring resistance to darunavir reported in the update list of international aids society - usa , in previous resistance test * previous d/m or x4 viral tropism * previous major clinical toxicities (grade \>=3) to the proposed drugs of the study * pregnancy or breast feeding, desire of pregnancy in the short term * past exposure to chemokine receptor 5 antagonist * hbsag serostatus * liver cirrhosis of class c (child-pugh) * sulpha drug hypersensitivity * the presence of major non aids-defining diseases that, in the opinion of the investigator, may compromise the retention of the patient in the study for the necessary follow-up period. * estimated glomerular filtration \< 30 ml/min (cockroft-gaut; mdrd formula if black-african or african-american) at screening visit * hypertransaminasemia of grade iv (more than 10 times the upper normal limit) at screening visit

Keywords: hiv aids highly active antiretroviral therapy simplification maraviroc darunavir treatment experienced tropism
effect of probiotics on blood pressure management

Conditions: Hypertension

Summary: dysbiosis of gut microbiota has been reported to be involved in the development and progression of hypertension in both humans and animal models. probiotics have been reported to have ameliorative effects in murine models. however, whether probiotics could help alleviate hypertension in adults remain obscure.

probiotics are live microorganisms that have been associated with multiple health benefits. however, its protective role in adults has long been controversial. this study aims to examine the effect of 12-week probiotics supplementation on the prevention of hypertension in chinese adults. by understanding the mechanisms by which probiotics exert this beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.

Eligibility criteria:
inclusion criteria: * eligible subjects include men and women 18 to 75 years of age with pre-hypertension who has a systemic blood between 120 and 139 mmhg and/ or a diastolic blood pressure between 80 and 80 mmhg; * absence of any diet, dietary supplement and medications that might interfere with blood pressure and gut microbiota, especially antibiotics and probiotics. exclusion criteria: * any other systemic, metabolic and cardiovascular or cerebrovascular diseases; * type 1 diabetes, type 2 diabetes treated with insulin or other medications; * acute illness or current evidence of acute or chronic inflammatory or infective diseases; * participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment; * mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.

Keywords: probiotics prevention hypertension
viral kinetics of sars-cov-2 in patients with covid-19 in the intensive care unit undergoing dental procedures

Conditions: SARS-CoV2 Infection; Viral Load; Oral Diseases; Dental Treatment

Summary: the prevalence and clinical relevance of viremia in patients with covid-19 have not been well investigated. seeking to understand the need for dentistry to perform bloody procedures in critically ill patients with covid-19 admitted to the icu, the quantification of the magnitude of viral replication may play a fundamental role in this scenario. for this, it is necessary to study the viremia kinetics of sars-cov-2, seeking to assess whether there is any characteristic pattern that may be associated with a worse clinical outcome of the patient with covid-19 after undergoing bloody dental procedures, therefore, the objective of this research will be to investigate the occurrence of viral kinetics produced by dental procedures in patients with sars-cov-2 in intensive care units, where, in addition to analyzing the oral health condition, the viral kinetics of sars-cov-2 will also be investigated by means of reverse transcription polymerase chain reaction (rt-pcr) examination of blood samples from patients with covid-19 undergoing bloody dental treatment. this research is expected to identify risks and consequences regarding the possibility of performing bloody dental treatment in patients with covid-19 in serious condition, in addition to verifying the association of the impact of oral infection foci on this profile of patients.


Eligibility criteria:
inclusion criteria: patients between 16 and 90 years old who describe subgingival scaling of at least one dental sextant or a tooth extraction. exclusion criteria: patients who cannot perform clinical examination and/or open dental procedure.

Keywords: covid-19 viral load dental treatment intensive care unit
digoxin induced dissolution of ctc clusters

Conditions: Breast Cancer; Circulating Tumor Cells (CTCs)

Summary: this single arm therapeutic exploratory study of digoxin in patients with advanced or metastatic breast cancer investigates whether cardiac glycosides are able to disrupt ctc clusters in breast cancer patients.

circulating tumor cells (ctcs) are considered to be precursors of metastasis in various cancer types and are found in the blood of cancer patients as single ctcs and ctc clusters, with the latter featuring a higher ability to seed metastasis. ctc cluster share several properties that commonly feature stem cell biology which drive metastases formation. preclinical data shows that ctc clusters can be disaggregated into single cells by the treatment with cardiac glycosides such as digoxin. this single arm therapeutic exploratory study of digoxin in patients with advanced or metastatic breast cancer investigates whether cardiac glycosides are able to disrupt ctc clusters in breast cancer patients. patients with advanced or metastatic breast cancer in whom ctc clusters could be identified will receive an individualized daily maintenance dose of digoxin adapted to their kidney function. blood samples for analyses of digoxin serum level and mean ctc cluster size will be drawn at specified time points.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection, radiation therapy or systemic therapy with curative intent * adequate organ and marrow function exclusion criteria: * patients on treatment with digoxin or digitoxin * patients with atrial fibrillation or atrial flutter * ventricular fibrillation or ventricular tachycardia, * atrioventricular heart block 2nd or 3rd degree, sick sinus syndrome or sinus bradycardia, * wolff-parkinson-white syndrome * hypokalemia, hypercalcemia, hypomagnesemia, hypoxia, * hypertrophic cardiomyopathy, aortic aneurysm * simultaneous intravenous application of calcium salts * known hypersensitivity to digoxin, other cardiac glycosides or included compounds * known drug interactions of ongoing cancer therapy with digoxin * women who are pregnant or breast feeding, * intention to become pregnant during the course of the study, * lack of safe contraception * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease) * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * participation in another study with investigational drug within the 30 days preceding and during the present study, * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: cluster of circulating tumor cells (ctcs) cardiac glycosides digoxin
prospective study to validate the clinical accuracy of norbert device to measure body temperature

Conditions: Healthy; Febrile Illness

Summary: the study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the norbert device (nd).

the study design is based on the iso 80601-2-56, clause 201.102 for adjusted mode clinical thermometers. the study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the nd's temperature measurement compared to a standard fda 510(k)-cleared reference clinical thermometer (rct).

Eligibility criteria:
inclusion criteria: * male or female subjects over 22 years of age * ability to provide signed informed consent, and/or have a legally authorized representative (lar) willing to provide informed consent on behalf of the subject * esi score of 3-5 exclusion criteria: * use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure * recent immunization within seven days of the study procedure * pregnancy * esi score of 1-2

Keywords: medical device validation febrile thermometer body temperature norbert device norbert health
efficacy of topotecan and lapatinib in early recurrent ovarian or peritoneal cancer

Conditions: Cancer; Ovarian; Relapse; Chemotherapy

Summary: the objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.


Eligibility criteria:
inclusion criteria: * age superior or equal 18 years * primitive ovarian adenocarcinoma histologically confirmed * or peritoneal or fallopian tube adenocarcinoma histologically confirmed * progression or relapse within 12 months after the end of first line of platin based chemotherapy * association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib). * intra-peritoneal chemotherapy in first line is possible * no previous treatment with her inhibitors (ex : gefitinib) * her status not necessary * measurable lesions (recist criteria). and/or ca125 value higher than 2 fold the normal value or ca125 higher than 2 fold nadir value (if no normalized) proved by two samples distant of 1 month * oms inferior or equal 2. * biological parameters as follow: creatininemia ≤ 150 µmol/l or clearance ≥ 50 ml/min,bilirubin ≤ 1,5 lns,transaminases and or alcalin phosphatases ≤ 2 lns without hepatic metastasis or ≤ 3 lns if hepatic metastasis,neutrophils ≥ 1,5.109/l,plaquettes ≥ 100.109/l. * normal fev * no previous treatment by chemotherapy, hormonotherapy, immunotherapy or radiotherapy within 4 weeks before inclusion * no concomitant treatment forbidden with lapatinib. * no previous treatment by amiodarone in 6 months before inclusion * signed informed consent exclusion criteria: * previous treatment with : * intensive chemotherapy with autograft * two lignes of chemotherapy * previous total abdominal irradiation * previous chemotherapy with anti-her treatment * history of brain or meningitis metastasis uncontrolled. * malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer. * uncontrolled infectious pathology * uncontrolled cardiovascular disease * patients with an active intestinal occlusion not permit oral treatment * known hypersensibility to topotecan and its excipients * woman of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period * individual deprived of liberty

Keywords: ovarian - cancer - relapse - topotecan - lapatinib
curcumin in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to examine the safety and tolerability of curcumin, and to determine its effect on patients with mild to moderate alzheimer's disease (ad).

curcumin, a yellow substance found in the spice turmeric, has antioxidant, non-steroidal anti-inflammatory (nsaid), and cholesterol-lowering properties, all of which make it a good candidate in the prevention and treatment of ad. the study will examine the safety and tolerability of 2 different doses of curcumin c3 complex. blood and cerebrospinal fluid (csf) tests will be used to examine how the curcumin is absorbed in the body, and whether it has an effect on inflammation, oxidative damage, and cholesterol levels. participants will also be tested to determine the potential effect of curcumin on cognition, behavior, and daily function in patients with mild to moderate ad. participants will be randomly assigned to receive one of two doses of curcumin, or a placebo, for the initial 6 months of the trial. for the final 6 months, those receiving a placebo will be switched to one of the two doses of the drug. the 33 participants will make 7 visits to the study site over a 12-month period. these visits may include a physical and neurological examination, routine laboratory tests, lumbar puncture, and neuropsychological (mood and memory) evaluations.

Eligibility criteria:
inclusion criteria: * male or female at least 50 years old * diagnosis of probable ad * no history of significant psychiatric or non-ad neurological disease * proficient in english to be able to perform cognitive testing * caregiver available to monitor and administer medication and to accompany patient to every clinical visit * on stable doses of cholinesterase inhibitors and memantine (alzheimer's medications) for 3 months prior to enrollment * on stable doses of all other allowed medications for at least one month prior to starting the study medication exclusion criteria: * current or recent major psychiatric illness (i.e. bipolar disorder, schizophrenia) * significant, uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure) * recent history of gastrointestinal bleeding or ulceration * alcoholism or substance abuse within the past year * familial, autosomal dominant alzheimer's disease due to a mutation in a known gene (presenilin-1, presenilin-2, or amyloid precursor protein) * nsaids (e.g. ibuprofen, naproxen, etc.) taken on a regular basis (more than 3 times per week) * aspirin at doses more than 325 mg per day * coumadin, heparin, other anticoagulants * antioxidants or other supplements including gingko biloba, coenzyme q10, alpha-lipoic acid * vitamin e at doses more than 2,000 iu per day * vitamin c at doses more than 500 mg per day

Keywords: curcumin turmeric curry nsaid anti-inflammatory cholesterol anti-oxidant