Kornimate/medical-research-clean huggingface dataset:
18f-fluoroestradiol (fes) pet/ct for breast cancer

Conditions: Breast Cancer

Summary: the standard of care imaging of breast cancer metastases recommended by the national comprehensive cancer network (nccn), ct of the chest/abdomen/pelvis and bone scan, may be suboptimal. 18f-fluoroestradiol (fes) is a novel pet tracer designed to detect estrogen receptors, which are often expressed in breast cancers. fes pet/ct may provide improved evaluation of metastases in patients with er-positive breast cancer.

this will be a phase ii clinical trial to assess the clinical value of fes for staging and detection of disease recurrence in patients with er-positive breast cancer, in direct comparison to the national comprehensive cancer network's (nccn) recommended standard-of-care using ct of the chest/abdomen/pelvis and bone scan \[2\]. two cohorts will be evaluated: 1. patients with advanced local breast cancer that will undergo standard of care imaging (ct + bone scan) to evaluate for unsuspected distant metastases. 2. patients with suspicion for breast cancer recurrence that will undergo standard of care imaging (ct + bone scan) to evaluate for disease recurrence. in both cohorts, fes pet/ct will be obtained, and compared with standard of care imaging. whether on standard of care imaging or the research fes pet/ct, lesions suspicious for unsuspected distant metastases (cohort 1) or the site of disease recurrence (cohort 2) will be selected for biopsy, as is clinically standard of care to confirm disease that would alter patient management. pathology will be used as the reference standard for confirming malignancy.

Eligibility criteria:
inclusion criteria: 1. female ≥ 18 years of age. 2. histologically confirmed er-positve breast cancer. any pathology from a primary or metastatic breast cancer site demonstrating er-positivity will be allowed. 3. ecog performance status 0 to 2 4. written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. 5. either: 1. for cohort 1: stage 2b-3c locally advanced disease and plan for ct/bone scan systemic staging or 2. for cohort 2: suspected recurrent disease and plan for ct/bone scan systemic staging exclusion criteria: 1. pregnant or breastfeeding 2. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. 3. patients who cannot undergo pet/ct scanning because of weight limits. pet/ct scanners may not be able to function with patients over 450 pounds. 4. selective er modulators (serms) such as tamoxifen and selective er degraders (serds) such as fulvestrant may reduce detection of er-positive lesions by fes. thus, exclusion criteria specify that patients must be withdrawn from selective er modifiers for at least 8 weeks and withdrawn from selective er degraders for for least 24 weeks prior to performance of the fes pet/ct.

Keywords: 18f-fluoroestradiol breast cancer pet/ct staging
a study of safety, tolerability and immunogenicity of a 1-dose regimen of mrkad5 hiv-1 gag vaccine versus the alvac_hiv vaccine (v520-019)

Conditions: HIV-1 Infection

Summary: this study is designed to determine whether patients previously primed with ad5 of mrkad5 hiv-1 gag vaccine respond better when boosted with alvac-hiv vaccine than when boosted with mkrad5 hiv-1 gag vaccine.


Eligibility criteria:
inclusion criteria: * subject was previously enrolled in merck hiv vaccine study v520 protocol 007 or 012, and received the complete 3-dose regimen during participation * subject is in good general health * subject is not infected with hiv * subject agrees not to donate blood during the first 52 weeks of the study * subject agrees not to donate sperm during the first 12 weeks of the study * subject who is of reproductive potential agrees to use an acceptable method of birth control through week 12 of the study exclusion criteria: * subject has been administered immune globulin or blood product 3 months prior to receiving study vaccination * subject has been vaccinated with a live virus vaccine in the past 30 days * subject has been vaccinated with an inactivated vaccine in the past 14 days * subject has an active medical disease * subject is taking daily required prescription drugs * female subject is pregnant, breastfeeding or expecting to conceive * subject is positive for hiv * subject has used injection drug within the past year * subject has a sexual partner that is infected with hiv * subject has a sexual partner that is an active injection drug user * subject has been treated for or diagnosed with a new sexually transmitted disease in the past 6 months * subject engaged in unprotected intercourse with more than 2 persons in the previous 6 months * subject engaged in protected intercourse with more than 4 persons in the previous 6 months * subject has previously participated in an hiv vaccine clinical trial (other than merck v520 protocols 007 and 012) * subject weighs less than 110 lbs. * subject has a recent history of alcohol abuse * subject intends to donate blood in the first 52 weeks of the trial
post market clinical follow up to "patient reported outcome" using a titanised polypropylene mesh (tiloop® bra pocket)

Conditions: Breast Reconstruction After Mastectomy; Breast Neoplasm; Breast Cancer; Breast Diseases

Summary: "pro-pocket" - international prospective multicentre post market clinical follow up to "patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (tiloop® bra pocket)

this international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on tiloop® bra pocket surgical meshes for a period of up to two years. in particular, on patient reported satisfaction (breastqtm), cosmetic outcome and the rate of complications. the objective of the clinical investigation is to establish the efficacy and safety of the tiloop® bra pocket. the investigation will be performed in ten clinical centres in germany and austria.

Eligibility criteria:
inclusion criteria: age \[≥ 18\] indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (dcis, lcis), mutation carrier with increased breast cancer risk, strong family history (lifetime risk \> 15%) the patient is capable to realise the nature, aims and possible consequences of the clinical trial (mpg §20.2.1) patient information has been provided and all written consents of the patient are available exclusion criteria: metastatic breast cancer patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use patient is kept in an institution under judicial or official orders (mpg §20.3) participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial

Keywords: breast reconstruction surgical mesh synthetic mesh patient reported outcome breast cancer mesh
the prognostic value of pet/ct for tumor progression in patients with metastatic hormone-sensitive prostate cancer

Conditions: Prostate Cancer Metastatic Disease; PET / CT

Summary: investigators retrospectively collected data from consecutive patients treated at the first affiliated hospital, sun yat-sen university, guangzhou, china, from october 2020 to march 2024. the inclusion criteria were as follows: (1) patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by psa levels, radiographic tests and pathological information; (2) patients who underwent fdg and psma pet/ct prior to the initiation of medical treatment. the exclusion criteria were as follows: (1) patients who received novel hormone therapy or a prostate biopsy prior to pet/ct; (2) patients with other malignancies; (3) patients received hormone therapy without nht; (4) patients received chemotherapy or radiotherapy prior to or during novel hormone therapy; (5) absence of follow-up data at the hospital.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by psa levels, radiographic tests and pathological information * patients who underwent fdg and psma pet/ct prior to the initiation of medical treatment exclusion criteria: * patients who received novel hormone therapy or a prostate biopsy prior to pet/ct * patients with other malignancies * patients received hormone therapy without novel hormone therapy * patients received chemotherapy or radiotherapy prior to or during novel hormone therapy * absence of follow-up data at our institution
imc-f106c regimen versus nivolumab regimens in previously untreated advanced melanoma (prism-mel-301)

Conditions: Advanced Melanoma

Summary: this is a phase 3, randomized, controlled study of brenetafusp (imc-f106c) plus nivolumab compared to standard nivolumab regimens in hla-a\*02:01-positive participants with previously untreated advanced melanoma.


Eligibility criteria:
inclusion criteria: * participants must be hla-a\*02:01-positive * participants must have histologically confirmed stage iv or unresectable stage iii melanoma * archived or fresh tumor tissue sample that must be confirmed as adequate * participants must have measurable disease per recist 1.1 * participant must have braf v600 mutation status determined * participants must have an eastern cooperative oncology group (ecog) performance status score of 0 or 1 * male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention exclusion criteria: * participants with a history of a malignant disease other than those being treated in this study * participants with untreated, active, or symptomatic central nervous system (cns) metastases or carcinomatous meningitis * hypersensitivity to imc-f106c, nivolumab, relatlimab, or any associated excipients * participants with clinically significant pulmonary disease or impaired lung function * participants with clinically significant cardiac disease or impaired cardiac function * participants with active autoimmune disease requiring immunosuppressive treatment * participants with any medical condition that is poorly controlled or that would, in the investigator's or sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results * participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma * participants with a history of a life-threatening ae related to prior anti-pd-(l)1 or anti-lag-3
adjuvant use of colchicine with the standard therapy in moderate and severe corona virus disease-19 infection

Conditions: COVID-19 Pandemic

Summary: the study included 2 arms colchicine group: colchicine + standard therapy of covid-19 control group: standard therapy of covid-19

this study will be a randomized controlled trial with 2 arms study trial 1:1 allocation. the sample size was calculated and we need a total of 160 patients (80 colchicine add on group and 80 controls)

Eligibility criteria:
inclusion criteria: * 1. patients with age above 18 years and of any gender 2. definite diagnosis of covid-19 according to the who classification criteria 3. patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases 4. understands and agrees to comply with planned study procedures. exclusion criteria: 1. patients refuse to enrol in the study 2. patients with hypersensitivity to colchicine 3. patients with chronic diseases: renal failure with egfr\ 3x normal).; decompensated heart failure, long qt syndrome (qtc \>450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and metastatic cancer 4. pregnancy and breast feeding 5. medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.
adaptive individualized high-dose radiotherapy analysis-rectum-1 (aida-re-1)

Conditions: Rectal Cancer; Radiotherapy; Neoadjuvant Treatment

Summary: aim of the study is to evaluate achievement of complete pathologic response (pcr) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy

aida-re-1 is an interventional prospective trial for the treatment of locally advanced high-risk rectal cancer. in neoadjuvant setting, patients are treated with standard chemotherapy plus experimental radiotherapy. the total dose to clinical target volume (ctv, rectum and locoregional lymph nodes) is 45 gy, with a concomitant boost of 5 gy to gross tumor volume (gtv), delivered with imrt-sib (intensity modulated radiotherapy-simultaneous integrated boost) technique in 25 fractions. after 2 weeks of treatment, patients are evaluated with 18 fdg-pet and sequential boost of 5 gy (in 2 fractions) is planned.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of locally advanced rectal cancer (ct3n+, ct4nx, local relapse, ct3n0); ct2n+ is acceptable if low rectum is involved * m0 * ecog 0-2 exclusion criteria: * m1 * familial adenomatous polyposis (fap), non-polyposis hereditary colorectal cancer, inflammatory bowel disease * severe cardiopathy * previous pelvic rt

Keywords: rectal cancer neoadjuvant chemoradiation imrt-sib adaptive radiotherapy
observational follow-up to st-001 calciphylaxis pain treatment with intravenous sodium thiosulfate

Conditions: Calciphylaxis

Summary: this is an 8-week observational follow-up study of patients who participated in the st-001 calista study (a phase 3, intravenous sodium thiosulfate for acute calciphylaxis treatment: a multicenter, randomized, double-blind, placebo-controlled clinical trial).

this is an 8-week observational follow-up study of patients who participated in the st-001 calista study. in this st-003 (of-calista) study, the occurrence of delayed adverse events, standard of care treatments for calciphylaxis (medications \[including sodium thiosulfate injection and pain medication\], wound debridement, amputation, hyperbaric oxygen therapy, and surgical parathyroidectomy), and calciphylaxis-related complications (new or worsening skin lesions, ulceration, infection, sepsis and hospitalizations) will be recorded during an 8-week observation period following patient participation in the st-001 calista study (a phase 3, intravenous sodium thiosulfate for acute calciphylaxis treatment: a multicenter, randomized, double-blind, placebo-controlled clinical trial).

Eligibility criteria:
inclusion criteria: * previously enrolled as a patient in st-001 calista study * willing to provide written informed consent * willing and able to adhere to all study-related procedures * willing to authorize release of medical records * willing to authorize collection of medical data from health care providers * provide email, home address and phone number where he/she can be reached exclusion criteria: • patient did not participate in st-001 calista study

Keywords: calciphylaxis, calcific uremic arteriolopathy, calcium metabolism disorders metabolic diseases sodium thiosulfate
measurement of extravascular lung water to detect and predict primary graft dysfunction following lung transplant

Conditions: Primary Graft Dysfunction

Summary: primary graft dysfunction (pgd) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (elwi) and impaired graft function. pgd has many features in common with acute respiratory distress syndrome (ards). pgd may be life-threatening and can also lead to impaired long term lung function. in ards, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of elwi that accumulates in the setting of pgd are lacking. using transpulmonary thermodilution to estimate elwi and the pulmonary permeability index (ppi) represents a novel approach to fluid management, which has been used in patients with ards, but to date not in the transplant setting. to determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of pgd, and whether they may be useful for predicting outcomes. aim 1: the investigators will evaluate the correlation between elwi and current surrogates of pulmonary edema in lung transplant patients with and without primary graft dysfunction (pgd) aim 2: the investigators will correlate the use of elwi and ppi to determine the presence and severity of pgd. aim 3: a) the investigators will determine whether early measurements of elwi and ppi can predict the onset of pgd. b) across different strata of pgd, the investigators will determine whether elwi and ppi have a differential effect on duration of mechanical ventilation. the results of the study will be used for the following: 1. provide the rationale for routine monitoring of elwi to detect pgd if found to be more discriminatory and have a stronger association with outcome compared to the current gold standard. 2. provide the means of early identification of those as risk of developing pgd in order to guide management decisions or future therapeutic interventions aimed at preventing or treating pgd. 3. provide the requisite groundwork for a clinical trial comparing the effects of an elwi-driven protocol versus usual care on icu outcomes in lung transplant recipients.


Eligibility criteria:
inclusion criteria: * all consecutive bilateral lung transplant recipients exclusion criteria: * immediate need for extracorporeal life support following transplant (those requiring ecls four hours after intensive care admission can be included as the investigators would have obtained some elwi measurements) * contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)

Keywords: extravascular lung water transpulmonary thermodilution primary graft dysfunction ischemia reperfusion injury
robotic utility for surgical treatment of umbilical hernias

Conditions: Hernia, Umbilical

Summary: the purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic assisted surgery for the treatment of incisional hernia's of 40 patients treated in maria middelares in laparoscopic rtarup technique.

minimally invasive hernia repair by laparoscopy is the standard treatment in adult patients with an umbilical hernia larger than 2 cm in maria middelares, ghent. as previously described in a chapter in a surgical guide and in a review article on the surgical fixation technique for laparoscopic umbilical hernia repair, the used technique has been proven feasible end safe. robot-assisted laparoscopic surgery has become standard in urology for resection of the prostate carcinoma. in general abdominal surgery, a large group of surgeons are currently working on the introduction of robotic-assisted surgery for resection of colon and rectal cancer in their daily practice. the third generation robot (davinci xi), has extended the applicability of this technology within the field of general surgery. for the surgical treatment of hernia's and other abdominal wall defects (umbilical or/and incisional hernia's), currently only surgeons in the us have experiences in structured treatment programs. from september 1, 2016 maria middelares hospital will introduce robot-assisted surgery, including the laparoscopic tarup umbilical hernia repair. main obstacles to the introduction of robot technology in abdominal wall surgery are prolonged preparation time in the operating room required for installation of the robot, and higher material costs related to the robot-assisted surgery. however, there are few precise data available on the exact size of extra time or increased costs related to the introduction of robotic assisted surgery in a program for abdominal surgery. the purpose of this study is the measurement of the evolution of the operation time during the start-up phase of robotic-assisted surgery for the treatment of umbilical hernias by 40 patients in maria middelares hospital.

Eligibility criteria:
inclusion criteria: * 40 patients selected and operated by the pi. exclusion criteria: * patients under the age of 18 * pregnancy * no informed consent
repeat of: a study to evaluate efficacy and safety of sublingual tnx-102 sl tablet taken at bedtime in patients with fibromyalgia

Conditions: Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases; Musculoskeletal Diseases

Summary: the present trial is designed to assess the safety and efficacy of tnx-102 sl 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. the use of low-dose sublingual formulation of cyclobenzaprine (tnx-102 sl) dosed nightly for fibromyalgia is supported by the results of tnx-cy-f202 phase 2b study -- the results provide strong evidence that tnx-102 sl 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other fm symptomatology.


Eligibility criteria:
inclusion criteria: * diagnosis of primary fibromyalgia (2010 acr criteria) * male or female 18-75 years old * patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame. * willing and able to withdraw specific therapies (ask pi) * if female, medically acceptable form of contraception or not of child bearing potential. * provide written informed consent to participate. * willing and able to comply with all protocol specified requirement. exclusion criteria: * arthritis, lupus and other systemic auto-immune diseases * regional or persistent pain that could interfere with assessment of fibromyalgia pain * bipolar and psychotic disorders * increased risk of suicide * significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities. * inability to wash-out specific medications (ask pi) * known hypersensitivity to cyclobenzaprine * others: seizure disorders, severe/untreated sleep apnea, bmi\>45

Keywords: pain sleep fibromyalgia fm