Kornimate/medical-research-clean huggingface dataset:
a study in healthy people to test whether different doses of bi 1015550 have potential to induce heart rhythm abnormalities

Conditions: Healthy

Summary: the main objective of this trial is to evaluate the effects of a single therapeutic and a single supra-therapeutic dose of bi 1015550 following oral administration on cardiac safety parameters in healthy male and female volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs - blood pressure (bp) and pulse rate (pr), 12-lead electrocardiogram (ecg), and clinical laboratory tests without any clinically significant abnormalities 2. age of 18 to 50 years (inclusive) 3. body mass index of 18.5 to 32 kg/m\^2 (inclusive) 4. signed and dated written informed consent in accordance with international conference of harmonization-good clinical practice (ich-gcp) and local legislation prior to admission to the trial 5. either male subjects, or female subjects meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 37 days after the last administration of the study drug: * male participants must use condom plus their partner, if identified as a women of childbearing potential (wocbp), must use an oral contraceptive or highly effective contraception * female participants must be using highly effective contraception and in addition their male partner must use a condom if they are using an oral contraceptive exclusion criteria: 1. any finding in the medical examination (including bp, heart rate (hr) or ecg) deviating from normal and assessed as clinically relevant by the investigator 2. repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or heart rate outside the range of 50 to 90 beats per minute (bpm) 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase, aspartate transaminase, total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal 4. any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator 6. cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behaviour 8. history of clinically relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.
visualizing beta cells after islet transplantation

Conditions: Type 1 Diabetes Mellitus

Summary: in patients with type 1 diabetes (t1d) that have undergone islet of langerhans transplantation or are on the waiting list for transplantation, ga-68-exendin pet imaging is performed to study the visualization of transplanted islet grafts in patients.

detecting damage to islets with a reliable imaging technique could be important for improving islet survival after transplantation. this could lead to better patient outcomes which would be of great interest for the treatment of type 1 diabetes. in order to assess the possibility of visualizing transplanted islet grafts with ga-68-nodaga-exendin-4 pet, a proof-of -concept study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet transplantation with biochemically proven functional islet grafts and 5 patients with type 1 diabetes who are on the waiting list for islet transplantation. the investigators propose to determine the uptake of the radiolabeled tracer and compare it to functionality of the islet grafts. these highly relevant data will provide us with more information on the suitability of glp-1 receptor imaging for monitoring of transplanted islet mass.

Eligibility criteria:
inclusion criteria tx-group: * \>18 years old * t1d patient undergone islet transplantation * clinically proven functional islet graft * signed informed consent control group: * \>18 years old * t1d patients who are on the waiting list for islet transplantation * signed informed consent exclusion criteria: * treatment with synthetic exendin or dipeptidyl-peptidase iv inhibitors within the last 3 months * breast feeding * pregnancy or the wish to become pregnant within 6 months * kidney disease * liver disease * age \<18 years * no signed informed consent exclusion criteria for mr: * fragments, clips or devices in brain, eyes, spinal canal * implantable defibrillator or pacemaker (wires) * mandibular magnetic implants * neurostimulator, bladder stimulator, non-removable insulin pump * metal tissue-expander in chest * cochlear implant * ossicular replacement prosthesis
a study to evaluate the long-term safety of topical administration of fmx103 in the treatment of moderate to severe papulopustular rosacea

Conditions: Papulopustular Rosacea

Summary: the primary objective is to show that open-label extended treatment with fmx103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.

this is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of fmx103 1.5% topical foam in the treatment of moderate-to-severe facial papulopustular rosacea. subjects entering this study will have recently participated in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (fx2016-11 and fx2016-12 - nct03142451). subjects must demonstrate that they are eligible to continue into study fx2016-13 based on safety evaluations and iga score performed at final visit of one of the previous double-blind studies. at the completion of the final visit in study fx2016-11 or study fx2016-12, subjects may be invited to continue into this open-label study for an additional 40 weeks of open-label treatment. a minimum of 400 subjects will be enrolled into from studies fx2016-11 and fx2016-12. subjects who elect to continue into this open-label study will receive supplies of active fmx103 1.5% minocycline foam.

Eligibility criteria:
inclusion criteria: 1. have completed 12 weeks of treatment in either study fx2016-11 or study fx2016-12. 2. have not had a worsening of disease, determined by the investigator's global assessment (iga), at visit 5/week 12 (final visit) relative to the day 0/baseline assessment in study fx2016-11 or study fx2016-12. exclusion criteria: 1. have a new systemic disease or condition, including an ongoing ae that might interfere with the conduct of the study or the interpretation of results. 2. have developed a condition that would have been exclusionary for study fx2016-11 or study fx2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.
serum and semen vitamin d level with semen parameters

Conditions: Vitamin D Deficiency

Summary: vitamin d may have multiple functions, one of them is modulating reproductive processes and the reproductive role of vitamin d is highlighted by expression of the vitamin d receptors in testis, male reproductive tract and sperms

semen analysis is the corner stone of infertility evaluation as it provides information on the functional status of the seminiferous tubules, epididymis and accessory sex glands. the methods on how the semen should be evaluated are provided by the world health organization vitamin d is synthesized mainly in the skin, where ultraviolet ray b radiation converts 7-dehydrocholesterol to vitamin d3. then, vitamin d3 undergoes two hydroxylation processes first in the liver and second in the kidney serum 25(oh)d is the major circulating metabolite of vitamin d and reflects vitamin d inputs from cutaneous synthesis and dietary intake. the serum 25(oh)d level is the standard clinical measure of vitamin d status vitamin d deficiency has been linked to various health disorders including boneheallth, cardiovascular, infectious, oncologic, musculoskeletal, neuropsychologic and reproductive disorders, as well as to overall mortality

Eligibility criteria:
inclusion criteria * -males with different semen parameter finding * age: 20-50 years exclusion criteria: 1. varicocele. 2. genital tract infections. 3. primary and secondary hypogonadism 4. hormonal therapy. 5. calcium and vitamin d supplement. 6. hepatic or renal failure 7. diseases or drugs affecting vitamin d absorption -
denex, renal denervation therapy, in patients with hypertension on no or 1-3 antihypertensive medications

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases

Summary: the objective of this study is to show that the safety and efficacy of renal denervation using denex, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.

denex system developed by handok kalos medical inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. it was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Eligibility criteria:
inclusion criteria: * subject aged 19 to 75 years old * subject should maintain the 0 to 3 antihypertensive medications of different classes, ace-i, arb, beta blocker, ccb or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure * subject with 140 mmhg ≤ average office sbp \< 180 mmhg and 90 mmhg ≤ office dbp \< 120 mmhg at primary and secondary screening * subject with 135 mmhg ≤ average daytime ambulatory sbp \<170 mmhg and 85 mmhg ≤ average daytime ambulatory dbp \< 105 mmhg at secondary screening after the run-in period for at least 4 weeks exclusion criteria: * subject with the anatomical findings in kidney or renal artery which preclude renal denervation * subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus * subject with egfr less than 40ml/min/1.73㎡ * subject with a brachial circumference greater than 42 cm. * subject with secondary hypertension (except for sleep apnea patients) * subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment. * subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent. * subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea) * subject with primary pulmonary hypertension

Keywords: hypertension renal denervation uncontrolled hypertension
the effect of periarticular multi-drug regimen on pain after partial hip replacement

Conditions: Femoral Neck Fracture

Summary: this prospective randomized study aims to evaluate the effectiveness of periarticular multi-drug regimen injection on the relief of pain in patients undergoing partial hip replacement. total 258 patients will be randomized into one of two groups (groupc or groupi) based on excel number generation. patients in group c will receive no medication intraoperatively, and patients in group i will receive oral oxycodone and celecoxib preoperatively and a periarticular injection of multi-drug regimen during operation. visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (fpb) of a patient-controlled analgesia system will be recorded at 1, 4, 7 postoperative day.

patients in group i will receive oxycodone sr 10 mg, and celecoxib 200 mg with 10 ml of water 1 hour before surgery. and patients in group i will receive periarticular injection of 50 ml solution which contains ropivacaine 15 mg, epinephrine 0.3 mg, cefmetazole 1000mg, ketorolac 30 mg and morphine hcl 10mg before closure of surgical wound. patients in group c will receive no medication.

Eligibility criteria:
inclusion criteria: * femoral neck fracture * partial hip replacement exclusion criteria: * r/o infection * reoperation * mental change

Keywords: pain preemptive postoperative delirium
mri/ultrasound fusion guided laser ablation of prostate cancer

Conditions: Neoplasms Prostate; Cancer of the Prostate

Summary: this serves as a registration trial. it aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. outcomes will be categorized as: 1- procedure related, 2- perioperative - adverse events that may occur within 90 days, 3-oncologic: recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- functional: sexual and urinary function following treatment

clinical registry observation nature this serves as a registration trial evaluating short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. the primary outcome measure is 1-year oncological control of the targeted ablated area. the following secondary aims are sought: procedure related: tolerability, feasibility, pain during this office-based procedure. perioperative: adverse events (aes) and series aes profile during the initial 90 days after the procedure. oncologic - in addition to primary aim, determine risk and rate of emergence of de-novo tumors (so called outfield recurrence) at the 1 year fusion biopsy mark and overtime. will also observe rate of progression locally and systemically. conversion to whole gland treatment - surgery extraction, radiation or whole gland cryoablation is of particular interest as is the initiation of androgen suppression (castration). moreover, the investigators will evaluate the impact of mri in assessing tumor locations and of software registration guiding the location and extent of ablation of the laser ablation over fixed time intervals. finally, incidence of metastatic disease - non castrate and castrate - as well as cancer specific and overall survival at 5, 10 and 15 years post procedure. functional outcomes - determine urinary function and sexual function including incidence of ejaculation, and climacturia at months 3, 6 and 12. these outcomes will then measured yearly for the extent of the study

Eligibility criteria:
inclusion criteria: * men between 50 and 65 years of age with a clinical diagnosis of prostate cancer with low or intermediate risk prostate cancer, and \<50% positive core rate by prostate lobe * men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe * absence of extra-capsular extension * absence of seminal vesicle invasion * absence of regional or distant metastatic disease * multiparametric mri of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy * treated with cryotherapy of the prostate * treatment based on co-registration between mp-mri and prostate ultrasound exclusion criteria: * prior treatment of prostate cancer in the form of surgery. * performance status greater than 0 based on ecog criteria * mental status impairment

Keywords: prostate psa fusion ultrasound mri cancer laser outcomes recurrence qol, quality of life urinary function sexual function
68ga-fapi pet/ct for the detection of adenoid cystic carcinoma(acc)

Conditions: 68Ga-FAPI PET/CT; Metastatic Adenoid Cystic Carcinoma

Summary: this study was used to study the diagnostic value of 68ga-fapi, a novel fibroblast activating inhibitor, in metastatic adenoid cystic carcinoma（acc）

68ga-fapi is a positron labeled inhibitor of fibroblast activating protein, which has been widely used in malignant tumor imaging in recent years. adenoid cystic carcinoma (acc) is a rare epithelial malignant tumor, which usually originates from salivary glands. its typical characteristics are long clinical course and high rate of distant metastasis. the purpose of this study was to investigate the clinical value of 68ga fapi pet/ct in metastatic adenoid cystic carcinoma.

Eligibility criteria:
inclusion criteria: * patients with acc suspected metastatic tumor,and being able to provide basic information and sign the written informed consent form exclusion criteria: * claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study

Keywords: 68ga-fapi pet/ct adenoid cystic carcinoma
genetic profile of alpha thalassemia children at sohag university hospital .

Conditions: Alpha-Thalassemia

Summary: genetic profile of alpha thalassemia children at sohag university hospital ,the aim to determine the prevelance , molecular character of the disorder, characterized by decreased synthesis of alpha -globin recent work to provide mechanisms for phenotypic heterogeneity .


Eligibility criteria:
inclusion criteria: * acase suspecteed of alpha thalassemia * age between 0-18years * micocytic hypochromic anemia not iron deficiency anemia or beta thalassemia exclusion criteria: * age more than 18 years * healthy children free from any chronic hematological disease * micocytic hypochromic anemia either iron deficiency anemia or beta thalassemia
collecting information from patients and family members with hereditary colorectal cancer syndromes or who are at high risk of developing colorectal cancer

Conditions: Colorectal Cancer; Hereditary Non-polyposis Colon Cancer; Precancerous Condition

Summary: rationale: gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer. purpose: this research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

objectives: primary * to identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer. secondary * to establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes. outline: data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. the information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research. registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. tissue samples from a previous biopsy may also be obtained. samples will be stored for future research studies.

Eligibility criteria:
disease characteristics: * meets any of the following criteria: * patients and family members with a known hereditary colorectal cancer or polyposis syndrome * patients who meet amsterdam i, ii, or bethesda criteria * patients with a family history suggestive of a hereditary colorectal or polyposis syndrome * patients diagnosed with colorectal cancer at \< 50 years old * patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the vanderbilit tumor registry patient characteristics: * see disease characteristics prior concurrent therapy: * not specified

Keywords: colon cancer hereditary non-polyposis colon cancer rectal cancer familial adenomatous polyposis
predicting covid-19 patients' clinical outcomes using icu mobility scale and mrc sum score

Conditions: COVID-19

Summary: the investigators hypothesize that early mobility condition and muscle power may be the predictive factors for coronavirus disease 2019(covid-19) patients' activity prognosis and hospitalization days. to prove our hypothesis, the investigators proposed a retrospective cohort study to see if icu mobility scale(icums) and medical research council sum score(mrcss) can predicted the patients' barthel index after discharge and hospitalization days.

the investigators hypothesize that early mobility condition and muscle power may be the predictive factors for covid-19 patients' activity prognosis and hospitalization days. to prove our hypothesis, the investigators checked the patient's baseline icums and mrcss upon admission. also, blood test results were also obtained. subsequently, the investigators measured their outcomes by barthel index and hospitalization length, and divided them into two groups. the icums, mrcss and the blood test results differences between two groups were checked. for those factors that showed significant difference between two groups, the investigators recruited them into regression model. last, receiver operating curve of those factors were plotted to find the appropriate cutoff points for identifying two groups of outcomes.

Eligibility criteria:
inclusion criteria: * covid-19 patients diagnosed by positive polymerase chain reaction(pcr) exclusion criteria: * impaired baseline activities, such as stroke, fracture, neurodegenerative disease * baseline barthel index score less than 100 * lost follow-up

Keywords: covid-19 activities of daily living muscle strength