Kornimate/medical-research-clean huggingface dataset:
a microneurography (mng) study of vx-150 in healthy participants

Conditions: Pain

Summary: the purpose of this study is to determine if c fiber conduction is impacted by nav1.8 modulation.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 30.0 kilogram per meter square (kg/m\^2) * a total body weight \>50 kg key exclusion criteria: * participants who have any 1 of the following criteria in the foot/ankle in which mng will be performed: * injection of local anesthetics or steroids within 35 days prior to randomization * unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot/ankle) * infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments * history of febrile illness within 14 days before study drug dosing * any condition possibly affecting drug absorption * participants with type 1 or type 2 diabetes mellitus * any dermatological (generalized) or autoimmune disease that may affect c-nociceptor excitability other protocol defined inclusion/exclusion criteria may apply.
left atrial appendage closure in patients with non-valvular atrial fibrillation and end-stage chronic kidney disease

Conditions: Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent

Summary: in the proposed event driven trial, laa closure devices will be compared in a 1:1 randomization to best medical care in af patients at high risk of stroke and bleeding with eskd. the trial will allow the use of the ce marked and clinically used laa device amplatzer cardiac plug and/or amulet and all approved medical therapies in af patients with eskd including vitamin-k antagonists (vka), noacs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.

the purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (laa) closure in patients with non-valvular atrial fibrillation (nvaf) and end-stage renal failure.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ability to give informed consent * documented nvaf (paroxysmal, persistent, or permanent) * cha2ds2vasc risk score ≥2 * chronic kidney disease kdoqi stage 5 (egfr \<15 ml/min/1.73m2) with or without hemodialysis exclusion criteria: * absolute contraindication to aspirin and/or clopidogrel * comorbidities other than af requiring chronic (n)oac therapy e.g. mechanical heart valve prosthesis * present laa thrombus * mobile aortic atheroma * age ≤18 years * patients presenting with pregnancy * patients without informed consent * participation in another trial * expected life expectancy \<2 years
zimberelimab plus metformin for recurrent ovarian clear cell carcinoma

Conditions: Ovarian Clear Cell Carcinoma

Summary: this study aims to evaluate the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

ovarian clear cell carcinoma (occc) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. previous studies indicate that pd-1 inhibitors may have clinical benefits for occc patients. this single-arm, single-center, pilot study evaluates the safety and effectiveness of zimberelimab combined with metformin in treating relapsed/persistent ovarian clear cell carcinoma.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years to ≤ 75 years * pathologic confirmed ovarian clear cell carcinoma * patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy * according to the definition of recist1.1, the patient must have measurable lesions * pd-l1 combined positive score ≥ 1 * ecog performance status of 0 to 2 * adequate bone marrow, liver, and renal function to receive combined immunotherapy * written informed consent exclusion criteria: * histological evidence of non-ovarian clear cell carcinoma * lack of tumor samples (archived and/or recently obtained) * previous administration of immunotherapy * patients have been vaccinated with the live vaccine or received anti-tumor treatment within 4 weeks before the first administration * an active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) within 2 years before the first administration * synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity) symptomatic or uncontrolled visceral metastases that require simultaneous treatment * patients are known to be allergic to the active ingredients or excipients of zimberelimab or metformin * known human immunodeficiency virus (hiv) infection history (hiv 1/2 antibody positive). * untreated active hepatitis b (defined as hbsag positive and the number of copies of hbv-dna detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center) * contraindications to metformin: kidney dysfunction or abnormal creatinine from any cause; acute or metabolic acidosis

Keywords: ovarian clear cell carcinoma immune checkpoint inhibitor metformin
investigation of chronic intestinal ischemia

Conditions: Chronic Mesenteric Ischemia

Summary: patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser doppler flowmeter and visible light spectroscopy.

patients with suspected chronic mesenteric ischemia (included median arcuate ligament syndrome/truncus coeliacus compression syndrome) referred to the vascular surgery department for investigation of splanchnic and mesenteric circulation shall be included in this study. in addition to ct angiography, patients shall be investigated 1. with gastroscopy-assisted laser doppler flowmetry and light spectroscopy (gals) before and after the surgical or endovascular treatment 2. endoscopic ultrasound before and after the surgical or endovascular treatment 3. transserosal laser doppler flowmetry and light spectroscopy during the surgical treatment 4. plasma ischemia bio-markers, before and after the surgical or endovascular treatment 5. health related quality of life assessed with eq5d and sf36 before and after the treatment 6. clinical outcomes of the treatment (early and late results).

Eligibility criteria:
inclusion criteria: clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome exclusion criteria: patients unable to go through gastroscopy
can methylprednisoloneacetate prevent seroma after mastectomy for primary breast cancer

Conditions: Breast Cancer

Summary: a randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.

after mastectomy, up to 90 % of patients develops seroma in the cavity. the treatment is puncture, which is a small operation, but many patients have to come several times, and there is a risk of infection. in some cases further treatment can be postponed. preventing seroma to develop would be an improvement in the treatment of breast cancer patients operated with mastectomy. an earlier study found that the seroma production was significant lower in the group who had prednison injected directly into the cavity. in this study the patient are divided into two groups: patients who have mastectomy and axillary dissection and patients who have mastectomy and sentinel node operation. each group are examined separately. using prednison in patients after operation could be a potential risk, but correct injection into the cavity will seldom give systemic side effects.

Eligibility criteria:
inclusion criteria: * women with primary breast cancer or ductal carcinoma in situ, mastectomy plus either sentinel node or axillary dissection, signed consent form exclusion criteria: * dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if the patient don't speak danish, allergy towards steroid, other medical conditions which the investigator find contradict participating

Keywords: breast cancer mastectomy methylprednisoloneacetate seroma numbers of punctures
study of inactivated poliovirus vaccine given at an earlier schedule with shorter intervals

Conditions: Level of Immunity Against Poliovirus Infection

Summary: the purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. the effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.

after polio eradication, access to live polioviruses will be highly restricted, and oral poliovirus vaccine (opv) use must be discontinued. opv-using countries must decide whether to switch to inactivated poliovirus vaccine (ipv) or stop polio vaccination. because only limited data are available on ipv immunogenicity in tropical developing countries, we conducted a randomized controlled trial of ipv in cuba. the objectives of this study were to assess the humoral and mucosal immunogenicity conferred by ipv administered at the who-epi schedule (6,10,14 wks of age) vs. placebo. a third arm was added to evaluate the immunogenicity of ipv administered at 2 and 4 months of age. antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm. target sample size was 100 children in each arm. mucosal (intestinal immunity) was measured indirectly through assessing poliovirus excretion in each group after a "natural challenge" of trivalent oral polio vaccine (opv)recieved by study participants through their participation in the annual opv mass campaigns approximately 1 month after their last dose of vaccine.

Eligibility criteria:
inclusion criteria: infants born 18 - 20 weeks prior to the first round of the 2002 national immunization days in cuba (in march 2002). born healthy at one of the 4 designated maternity hospitals in cuba exclusion criteria: serious congenital defect/disease at birth -

Keywords: inactived polio vaccine cuba trial randomized eradication
study to evaluate the feasibility of integrating the point-of-care testing for sexually transmitted infections and hiv into community-based clinics for msm and tgw in thailand

Conditions: Men Who Have Sex With Men and Transgender Women

Summary: this will be a prospective study that will enroll up to 2000 msm and tg from community-based clinics in bangkok, chonburi, chiang mai, and songkhla.

eligible participants will be followed up until the completion of a 12-month period. all participants will be followed up every 3 months. an additional follow up visit at month 1 will be made for participants who prep is initiated at entry visit (those who already received prep prior to the study will not need the additional visit). study sites the study will take place at the following community-based clinics: 1. swing dic, bangkok, thailand 2. rsat dic, bangkok, thailand 3. swing dic, chonburi, thailand 4. sisters dic, chonburi, thailand 5. mplus dic, chiang mai, thailand 6. rsat dic, songkhla, thailand

Eligibility criteria:
inclusion criteria: 1. thai nationality 2. age ≥ 18 years old 3. men or transgender women who have sex with men 4. have at least one of the following risks for hiv acquisition in the past 6 months: * any unprotected receptive anal sex * more than 5 sexual partners, regardless of condom use and serostatus * history of syphilis, chlamydia or gonorrhea diagnosed or treated * any stimulant drug use 5. have signed the consent form exclusion criteria: * none
remote mindfulness education plv

Conditions: Provoked Localized Vulvodynia

Summary: this is a study designed to learn more about the use of an online remote education and mindfulness practice program for the pain and anxiety associated with provoked localized vulvodynia.

the purpose of study is to evaluate the effectiveness of a remotely delivered mindfulness intervention combined with education for the treatment of the pain and distress associated with provoked localized vulvodynia (plv). women with plv will be randomized to either an app- based mindfulness program (headspace®) with online education or online education only. pain and sexual distress with be evaluated through a number of measures. the primary outcome of the study will be the change in distress relating to sexual activity over the 8-week intervention period, which will be measured by a change (reduction) in the female sexual distress scale (fsds). participants will additionally perform a weekly tampon test and fill out a weekly survey regarding their perceived pain as well as the frequency of use and completion of the weekly education materials

Eligibility criteria:
inclusion criteria: * reported dyspareunia for at least 3 months in non-pregnant, healthy women over aged 18 years old and estrogen replete with confirmed diagnosis of provoked localized vulvodynia (pvl) or positive q-tip test, meeting friedrich's criteria for plv. * ability to insert a regular tampax® tampon * phone access * cellular phone with ability to download applications * reliable internet access exclusion criteria: * pregnancy * active sexual counseling or mindfulness training (within 6 months of study) * any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc). * unable or unwilling to complete baseline assessments or agree to be randomized. * non-english speaking, as headspace® is not validated in other languages * actively engaged in a meditative practice

Keywords: mindfulness therapy vulvodynia vulvar pain
stiffness measurement of liver tumors and visceral parenchyma

Conditions: Hepatocellular Carcinoma

Summary: the investigators are measuring hepatocellular carcinoma(hcc)stiffness using acoustic radiation force impulse (arfi) technique to enhance the diagnostic accuracy for hcc stratifications and treatment efficacy.

regression modelings as well as validity testings including cut-off identification will be acquired by performing both qualitative and quantitative measurements of hcc using reference diagnostic modalities e.g. pathology grading, dynamic ct scanning, etc.

Eligibility criteria:
inclusion criteria: with hcc exclusion criteria: * subjects with liver cancer other than hcc * subjects with treated hcc * post major abdominal surgery * contraindications to liver tumor biopsy * contraindications to local percutaneous treatment of liver tumors * arfi measurement low quality

Keywords: hepatocellular carcinoma stiffness
assessment of ability related to vision

Conditions: Glaucoma

Summary: to determine the clinical usefulness of a refined third-generation instrument - the assessment of ability related to vision (aarv) in establishing the amount of disability, charting the detrimental effects of progressive disease and establishing the beneficial effects of treatment

this research study is designed to test the usefulness and repeatability of testing how much disability is caused by vision loss due to glaucoma. we are recruiting 100 patients with glaucoma and 20 healthy (have no eye disease) individuals to be enrolled in this study. the healthy study participants will be enrolled in order to describe how a healthy individual will perform on the test designed to assess one's performance when completing ten activities of daily living. clinical testing will be conducted by binocular and monocular visual fields, contrast sensitivity and visual acuity. the nei-vfq 15 quality of life questionnaire will be used to measure patients perception of how well they are doing.

Eligibility criteria:
inclusion criteria: * all patients 18 yrs of age and older * must understand and respond to spoken english and be fully literate. exclusion criteria: * patients with significant neurological problems (like parkinson's disease), motor problems (like arthritis) or other significant illnesses that may prevent them from completing the testing involved in the study (like advanced heart failure). * patients who have received training related to low vision.

Keywords: glaucoma quality of life daily living activities visual fields contrast sensitivity
laryngomicrosurgery under nidp general anesthesia supported by thrive

Conditions: Vocal Polyp

Summary: laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. after the procedure, patients need a long time to recover. in the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated deep paralysis (nidp) general anesthesia. in this case series study, the investigators will test the safety and feasibility of such a technique.


Eligibility criteria:
inclusion criteria: * elective polypectomy of unilateral vocal cord * age between 18 to 40 * be able to communicate * estimated operation time less than 15min * asa i-ii * agree to sign written informed consent exclusion criteria: * pregnancy or breastfeeding women * severe gastrointestinal reflex disease * neuromuscular disease * body mass index(bmi)\>30 * predictable difficult airway. * allergy to medicine would be used in the present study including propofol, remifentanil or sugammadex

Keywords: laryngomicrosurgery nonintubated deep paralysis transnasal humidified rapid-insufflation ventilatory exchange
segmental epidural anesthesia (sea) v/s general anesthesia for pcnl

Conditions: Success Rate Under Segmental Epidural; Post Operative Pain

Summary: management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (eswl) and percutaneous nephrolithotomy (pcnl). pcnl is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones resistant to eswl. anaesthesia for pcnl is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the possibility of fluid absorption, dilutional anaemia and blood loss. general anaesthesia is the gold standard for this surgery.the advent of new drugs has refined the technique of general anaesthesia. however there are several issues related to prone position still to be addressed like accidental extubation and difficult reintubation, nerve injuries and post operative respiratory complications. combined spinal epidural(cse) and only epidural anaesthesia (ea) is a well established technique of anaesthesia for upper abdomen and lower thoracic surgeries. it use has also been reported in pcnl surgeries.segmental epidural can selectively blocks pain fibres from the surgical site. this not only allows to limit the dose of the local anaesthetics, but also limit motor and sympathetic blockade. selective sympathetic block is associated with respiratory, cardiac, gastrointestinal and metabolic benefits. this formed the basis of our current study. in the present study the investigators aimed to evaluate the efficacy of segmental epidural for pcnl and compared it with standard technique i.e. ga.

to evaluate efficacy the investigators compared intraoperative haemodynamics, surgical clearance of stones, post operative pain, surgeon's and patient's satisfaction scores and postoperative complications and side effects in 60 asa i and ii patients undergoing pcnl surgery who received either general anesthesia or segmental epidural anesthesia.

Eligibility criteria:
inclusion criteria: * asa i/ii * age - 18 years to 60 years * either sex * bmi \< 30 exclusion criteria: * unwilling for consent * asa 3 * obesity with bmi \> 30. * contraindications for epidural anaesthesia * undilated pelvicalyceal system

Keywords: segmental epidural regional anesthesia for pcnl
evaluation of diagnostic value of 3-t magnetic resonance imaging (mri) in suspected prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of the study is to evaluate the usefulness of 3-t magnetic resonance imaging (mri) in the evaluation of suspected prostate cancer. men with suspected prostate cancer based on serum prostate-specific antigen antigen (psa) value are included. men are randomized to pre-biopsy mri or no mri groups in ratio 1:1. standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on mri evaluation. hypothesis is that more prostate cancers will be found after mri evaluation.


Eligibility criteria:
inclusion criteria: * informed consent * suspected prostate cancer based on psa value (total psa 2,5-10 ng/ml and psa free to total ratio \<=0.15, or total psa 10-20 ng/ml) * psa and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies * no evidence of psa increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis) exclusion criteria: * previous prostate biopsies * previous prostate surgery * contraindication for mri (such as pacemaker or inner ear implant) * claustrophobia * estimated glomerular filtration rate (egfr) \<40 ml/min * suspected clinical t3-t4 prostate cancer based on digital rectal examination * contraindication for transrectal ultrasound-guided prostate biopsies * body mass index \>30

Keywords: prostate cancer diagnosis magnetic resonance imaging prostate biopsy