Kornimate/medical-research-clean huggingface dataset:
trans and non-binary prostate-specific antigen reference interval determination study

Conditions: Prostate CA

Summary: the prostate specific antigen (psa) blood test can help diagnose prostate problems, including cancer. the prostate is an organ in the pelvis. it is found in cisgender men, transgender (trans) women and some non-binary people. anyone with a prostate can get prostate cancer. the prostate remains after genital (lower) surgery. the hormones and surgeries that trans women and non-binary people might have can lower the psa. we do not have good data on the normal psa levels are for this group transpride is a research study that will help us find the normal levels of psa in trans women and non-binary people with prostates. researchers will ask 500 trans women and non-binary people with prostates to take part. they will need to be aged 40 or over. they will need to be on hormones or have had lower surgery. they will be called after 6 months to recheck their health. if a person has a high psa, they may be sent for more tests. knowing the normal psa level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.


Eligibility criteria:
inclusion criteria: * • aged \>40 * transgender or non-binary (identify with a gender other than the one assigned at birth) * with a prostate * fulfills at least one of the following 3 criteria with regards to gender-affirming medical care: * taking oestradiol for at least the last 3 months * taking anti-androgens for at least the last 3 months * ever had bilateral orchidectomy * eligible for national health service (nhs) treatment exclusion criteria: * • history of prostate cancer (prostate cancer) at any time * history of prostate surgery at any time * history of prostate radiotherapy at any time * history of benign prostatic hypertrophy (enlarged prostate) at any time * vaginoplasty within 12 months * orchidectomy or vulvoplasty within three months * sexually transmitted infection (sti) within 6 weeks of blood sample * active urinary infection or within 6 weeks of blood sample * prostatitis within 6 weeks of blood sample * urological intervention (e.g. prostate biopsy) within 6 weeks of blood sample * unwilling to give consent * lacking capacity to give consent * in the secure estate

Keywords: prostate cancer transwomen non-binary prostate
the effects of chronic otitis surgery on svv

Conditions: Chronic Otitis Media

Summary: inner ear trauma during chronic otitis surgery is one of the major concerns of otolaryngology. hearing thresholds or semicircular canals were investigated with this purpose. the investigator's aim is to test the utricle for surgical trauma.

all patients who will have surgery for ear will be tested before the operation and after the first day and the first week. virtual svv(interacoustics) will be used for testing. the deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.

Eligibility criteria:
inclusion criteria: * chronic otitis media * who had surgical treatment exclusion criteria: * a patient who had the vestibular disease before * neurologic disease * patients who had ear, brain and musculoskeletal surgery before
evaluation of an antihypertensive food supplement based on aqueous extract from annona muricata sheets

Conditions: Hypertension

Summary: the am-htn trial aim to investigate the effects of a tablet based on aqueous extracts of annona muricata as add-on therapy in a hypertensive population. patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign in a single arm, non randomly, open label clinical trial. the group will receive in addition to their dietary measures, daily, one tablet of 796 mg of aqueous extracts of annona muricata leaves. the objective of am-htn is to determine the antihypertensive and metabolic effects of am tablets in a population of african hypertensives. blood pressure profile, lipid profile, serum creatinine and transaminases profiles will be recorded and analysed at baseline and two months following enrolment.

the am-htn trial aim to investigate the effects of a tablet based on aqueous extracts of annona muricata as add-on therapy in a hypertensive population. patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign in a single arm, non randomly, open label clinical trial. the group will receive in addition to their dietary measures, daily, one tablet of 796 mg of aqueous extracts of annona muricata leaves. the objective of am-htn is to determine the antihypertensive and metabolic effects of am tablets in a population of african hypertensives. blood pressure profile, lipids profile, serum creatinine and transaminases profiles were will be recorded and analysed at baseline and two months following enrolment.

Eligibility criteria:
inclusion criteria: * blood pressure between 130/85 mmhg and 159/99 mmhg * no antihypertensive therapy (determined by the investigator), except the hygiene dietetic measures, for at least 3 months * no history of hepatic or renal insufficiency * before any study-specific procedure, the appropriate written informed consent must be obtained. exclusion criteria: * side effects affecting life quality of patients (determined by the data safety and monitoring board). * out of sight. * withdrawal of consent

Keywords: annona muricata hypertension sub saharan africa
evaluation of efficacy and safety of omacor, co-administered with atorvastatin, in subjects with hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the efficacy and safety of omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-hdl-c) in hypertriglyceridemic subjects.

randomized, double-blind, placebo-controlled, parallel-group study design with eleven clinic visits (one screening visit, three lead-in/baseline visits, and seven treatment visits) after a 4-week diet only lead-in period, subjects with a triglyceride (tg) level in the high to very high range and with non-hdl-c level above ncep atpiii goals will be randomized to receive either open-label atorvastatin 10 mg per day plus double-blinded lovaza 4g (4 x 1g capsules) per day or open-label atorvastatin 10 mg per day plus a double-blinded matching placebo (4 corn oil capsules per day) for 8 weeks after the initial 8-week treatment period, the dose of open-label atorvastatin will be titrated to 20 mg per day (with the lovaza or matching placebo corn oil doses remaining at 4 capsules per day) for an additional 4 weeks at week 12, a second open-label titration to 40 mg of open-label atorvastatin per day will be maintained for an additional 4 weeks (again with the lovaza or matching placebo corn oil doses remaining at 4 capsules per day)

Eligibility criteria:
inclusion criteria: * men and women, ages 18-79 years, inclusive * fasting, untreated non-high-density lipoprotein cholesterol (non-hdl-c) level above ncep atpiii goals * fasting, untreated triglyceride (tg) level in the high to very high range * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * pregnancy * use of lipid-altering drugs which cannot be stopped * history of certain cardiovascular conditions or cardiac surgery within prior 6 months * body mass index above 40 kg per square meter * allergy or sensitivity to omega-3 fatty acids or to statin drugs * poorly-controlled conditions including diabetes, hypertension, or thyroid disease * certain muscle, liver, kidney, lung, or gastrointestinal conditions * certain medications * active cancers treated within prior 2 years (except non-melanoma skin cancer)

Keywords: lovaza hyperlipidemias triglycerides lipids omega-3 fatty acids hypercholesterolemia hypertriglyceridemia omega-3-acid ethyl esters omacor dyslipidemias
investigating genetic risk for type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Summary: the objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for these children to be enrolled into a phase ii b primary prevention trial.

this is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. this study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old). women will be approached by research staff in the second or third trimester of pregnancy (≥18 weeks gestation) when attending for antenatal care. at this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. if they agree to participate, a qualified member of the research team will take written informed consent. this consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing. the punch from the blood sample will analysed for the child's risk of type 1 diabetes. if found to be at high risk (\>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase ii prevention trial.

Eligibility criteria:
inclusion criteria: * parent/guardian of participant is willing and able to give informed consent for participation in the study. * participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing. exclusion criteria: * parent/legal guardian unwilling or unable to give written informed consent to participate in the study * unable to understand written or verbal english which would preclude them from understanding the study

Keywords: type 1 diabetes infants ingr1d
mindfulness-based stress reduction in helping participants with metastatic breast cancer

Conditions: Stage IV Breast Cancer

Summary: this randomized trial studies how well a mindfulness-based stress reduction program helps participants with breast cancer that has spread to other places in the body. a cancer diagnosis is a life-changing and highly stressful event for most people, often resulting in marked declines in quality of life both during and after treatment. there are approximately 3 million women living with a history of invasive breast cancer in the u.s., with at least 150,000 living with metastatic disease. patient preferences suggest a high need for complementary and alternative medicine interventions to address these chronic symptoms. mindfulness-based stress reduction programs may help women living with metastatic breast cancer manage symptoms related to cancer treatment and improve quality of life.

primary objectives: i. to develop a novel online mindfulness-based stress reduction (mbsr) treatment for distressed metastatic breast cancer patients in the hope of reaching patients otherwise unable to participate in traditional interventions due to high symptom burden. ii. determine the impact of the intervention on both patient self-report and biological symptom measures. outline: participants are randomized to 1 of 2 arms. intervention arm: participants receive online group sessions over 60 minutes for 6 weeks, including 15 minutes of practice on that session's topic and daily meditation or yoga for 45 minutes. at the conclusion of the study period participants participate in mindfulness meditation over 3 hours. participants also receive a content manual and relaxation compact disc (cd). control arm: participants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.

Eligibility criteria:
inclusion criteria: * a diagnosis of metastatic breast cancer within the past 5 years and treated at roswell park cancer institute (rpci) * ability to read and understand english * current distress score of 4+ on the national comprehensive cancer network (nccn) distress thermometer * access to an internet connection with own device (computer, tablet, smartphone, etc.) * patient not currently involved in an ongoing psychological intervention * if taking prescribed medication for mood or anxiety disorder, dosage has been consistent for prior 3 months exclusion criteria: * unable to speak and understand english * prior or current experience with mindfulness-based practice * diagnosis of a psychotic disorder, bipolar disorder, substance abuse disorder, or reported suicidality * current involvement in any other psychological treatment (excluding medication) during study duration * currently being treated for another cancer diagnosis other than metastatic breast cancer
investigation of acute effects of local vibration and whole-body vibration applications

Conditions: Ataxia

Summary: this study was designed as a single-blind, randomized and cross-over study to investigate and compare the acute effects of local vibration (lv) and whole-body vibration (wbv) applications on postural control in adult patients with ataxia. the study will be included in patients aged 18-50 years, including ataxia diagnosed by the neurologist and able to walk independently. patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months and other neurological diseases other than ataxia will not be included in the study. between the applications, a washout period of one week will be given to each patient to apply both local and whole body vibrations. the order of application will be decided by the coin toss randomization method. descriptive evaluations of the patients will be done with mini-bestest and trunk impairment scale. stability limits and postural sways (bertec balance check screenertm), gait time - distance characteristics (gaitrite), functional mobility skills (timed up and go test), and static balances (one leg stance test) before, 1 minute after the application and 60 minutes after the application.


Eligibility criteria:
inclusion criteria: * located in the 18-50 age range, diagnosed with ataxia by the neurologist, patients who can walk independently exclusion criteria: * patients with pregnancy status, epilepsy, spasticity, implant / endoprosthesis / pacemaker, benign paroxysmal positional vertigo, history of fracture in the last 6 months, and other neurological disorders other than ataxia

Keywords: local vibration, whole body vibration, postural control
a reliability and validity study of urdu version of knee outcome survey-activities of daily living scale

Conditions: Knee Pain

Summary: the purpose of this study is to translate knee outcome survey-activities of daily living scale into urdu language and to check the reliability and validity of the knee outcome survey-activities of daily living scale in urdu language for the general population of pakistan

approximately 150 participants will be included in the study on the basis of inclusion and exclusion criteria. the english version of the knee outcome survey-activities of daily living scale will be translated and culturally adapted as per as previous recommendations. in the general population with knee pain,urdu version of the knee outcome survey-activities of daily living scale will be distributed among general participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. to test inter and intra-observer reliability of the final urdu version of knee outcome survey-activities of daily living scale with knee osteoarthritis outcome survey and lysholm knee score will be filled within same day, by two observers and for the inter-observers assessment, with an interval of 30 minutes between the first and second application. third assessment will carry out after 7 days by observer-1(re-intra-observers assessment. data will be entered and analyzed by cronbach alpha value.test-retest reliability will be assessed using interclass correlation coefficient.

Eligibility criteria:
inclusion criteria: * ability to walk without assistive device * proficiency in the urdu language * pain level of at least 30% on the visual analog scale exclusion criteria: * other osteoarthropathies with a good history * if you have a heart condition or are having trouble with your nerves * a debilitating factor that lowers functional independence and activity levels * a lower-extremity fracture within the previous six months of the research * other joint diseases include ligament, menisci, or patellofemoral issues, as well as severe non-osteoarthritic knee effusion or arthroplasty

Keywords: knee outcome survey-activities of daily living scale general population cultural adaptation validity urdu version reliability knee osteoarthritis
feasibility of a smart-phone app for patients with advanced renal cell carcinoma undergoing combination immunotherapy

Conditions: Renal Cell Carcinoma Stage IV

Summary: the purpose of the study is to test and understand acceptability and preliminary effectiveness of a mobile educational app specifically customized to patients with advanced renal cell carcinoma (rcc) receiving therapy with combination immunotherapy.


Eligibility criteria:
inclusion criteria: * patients with stage iv renal cell carcinoma * within 3 weeks from starting combination immune checkpoint blockade with tyrosine kinase inhibitor or multikinase inhibitor * estimated survival of 6 months or more * able to read and speak english exclusion criteria: * unable to read or speak english * enrolled in another clinical trial

Keywords: kidney cancer
methotrexate versus triamcinilone acetonide in treatment of recalcitrant alopecia areata

Conditions: Alopecia Areata

Summary: alopecia areata is the second most common cause of hair loss following androgenic alopecia. it is affecting 2% of global population with an increasing prevalence. briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common. methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders. methotrexate has been recently proven to inhibit jak/stat pathway. triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.


Eligibility criteria:
inclusion criteria: * age groups: \> 12 years old. * sex: both sexes. * co-operative patients. * recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy. exclusion criteria: * patients \<12 years. * pregnant and lactating women. * patients with any underlying systemic disorders. * patients with hbv or hcv. * patient with active infection of t.b. * patients with bone marrow suppression (leukopenia, thrombocytopenia) * patients who had received any other modalities of treatment in last 3-6 months.

Keywords: alopecia areata methotrexate triamcinolone microneedling
liver transplantation for non-resectable intrahepatic cholangiocarcinoma (lirica)

Conditions: Intrahepatic Cholangiocarcinoma

Summary: lirica is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable icca after a downstaging/disease control protocol with standard of care chemotherapy, in terms of overall survival and quality of life. additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. finally, the study aims to investigate the role of preoperative pet-mr, especially in relation to lymph node locations, by correlating the results with histological examination after iliac lymphadenectomy.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of icca * first diagnosis of icca * recurrence after r0 hepatic resection, n0, m0 without macrovascular invasion * disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction * absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study * no evidence of extrahepatic metastatic disease after chest-abdomen-pelvis ct and pet-mr (or pet-ct) * at least six months have passed since the first diagnosis of icca (or recurrence) to the date of inclusion on the liver transplant waiting list * the patient has received at least six months of soc chemotherapy, achieving disease stability or partial response (according to recist version 1.1) at the time of listing for transplantation * hematochemical evaluation: hb ≥ 9 g/dl, leukocytes ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100,000/mm3 (≥ 10 x 109/l), total bilirubin ≤ 3 mg/dl (≤ 51 umol/l), ast or alt ≤ 5 times the upper limit of normal, serum creatinine and urea \< 1.5 times the upper limit of normal * ecog (eastern cooperative oncology group) performance status ≤ 1 * patient's bmi ≥ 18 and ≤ 30 kg/m2 * signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations exclusion criteria: * tumor involving nearby extrahepatic structures (including involvement of major hepatic vessels) by direct invasion (t4 per ajcc 8th edition) * tumor penetrating the visceral peritoneum (t3 per ajcc 8th edition) * previous extrahepatic metastatic disease * prior neoplasms, except those treated curatively for more than 5 years without recurrence * known history of human immunodeficiency virus (hiv) infection * known history of solid organ or bone marrow transplantation * substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes * pregnant or breastfeeding women * medical-surgical contraindications for liver transplantation * any reason for which, in the investigator's judgment, the patient should not participate in the study

Keywords: liver transplantation
open-label, multiple-dose, phase iii study of the population pharmacokinetics of i.v. synercid in 75 pediatric patients

Conditions: Gram-Positive Bacterial Infections

Summary: open-label, multicenter, multiple-dose, study of population pharmacokinetics of i.v. synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. the purpose is to assess the population pharmacokinetics of synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.


Eligibility criteria:
inclusion criteria: * serious, suspected or documented gram-positive infection exclusion criteria: -