Kornimate/medical-research-clean huggingface dataset:
dose finding trial with a new treatment (degarelix) for prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. the patients participating in the trial were treated with degarelix every month for a year. during the treatment the patients had to visit the clinic for investigations. blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and prostate specific antigen were taken and analysed throughout the trial.

degarelix was not fda regulated at the time of the trial. after completion of the trial degarelix has been approved by the fda and is thus an fda regulated intervention.

Eligibility criteria:
inclusion criteria: * written informed consent prior to any study related procedures * proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising psa further to prostatectomy or radiotherapy * ecog score to be equal to or above 2 * testosterone level within age-specific normal range * psa value equal to or above 2 ng/ml * life expectancy of at least 6 months exclusion criteria: * previous or current hormonal treatment of prostate cancer * recent or current treatment with any drugs modifying the testosterone level * candidate for curative treatment such as prostatectomy or radiotherapy * history of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or quincke's oedema * hypersensitivity towards any component of degarelix or mannitol * cancer disease within the last 5 years except for prostate cancer and some skin cancers * signs of liver impairment shown as elevated serum alt or serum bilirubin * known hepatic disease * other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results * clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator * mental incapacity or language barrier precluding adequate understanding or cooperation * having received an investigational product within the last 12 weeks preceding the trial * previous participation in this trial
to evaluate iol position, clinical outcome of panoptix in high myopic cataract patients

Conditions: Cataract; High Myopia

Summary: to evaluate iol position, clinical outcome of panoptix in high myopic cataract patients

a prospective, single center study to evaluate iol position, clinical outcome of panoptix in high myopic cataract patients. the objective of this study to investigate the refractive and visual performance of panoptix and explore their correlation with elp change, capsular bending formation, iol tilt/decentration in high myopic cataract patients. panoptix iol provides good refractive outcomes and visual quality because of few elp change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * 26 ≤axial length\<30mm, iol power ≥6d (panoptix iol power is available +6d-+30d ) * eyes with corneal astigmatism less than 1.0d (iolmaster 700, carl zeiss meditec ag) * eyes with pupil diameter between 3 and 5.5 mm (itrace, tracey technology, houston, texas, usa) * eyes with angle kappa and angle alpha ≤0.50 mm (itrace); * eyes with corneal spherical aberration ≤ 0.50 (pentacam). exclusion criteria: * irregular corneal astigmatism * serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment * moderate-severe dry eye, corneal scarring, amblyopia * patients who can't cooperate with post-op 3 months follow-up.

Keywords: panoptix iol high myopic cataract patients
antimicrobial prophylaxis for skin colonization with propionibacterium acnes in primary open shoulder surgery

Conditions: Propionibacterium Infection

Summary: iness antibiotic prophylaxis in orthopedic guide recommends the use of cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. with the increasing rate of identified p. acnes shoulder surgery infection despite the use of recommended skin preparation and preoperative prophylactic antibiotics, a question arises; is cefazolin the most effective prophylactic antibiotic for shoulder surgery? the objective of this study is to determine if ceftriaxone is superior to cefazolin as a prophylactic antibiotic for skin colonization with p. acnes in primary shoulder surgery

this is a double blinded randomized clinical trial comparing two different prophylactic antibiotics used for primary open shoulder surgery. the participants are volunteer patients scheduled for a primary open elective or trauma shoulder surgery. patients with positive mrsa screening test will be excluded from the randomised study as they will receive vancomycin for prophylaxis. if they accept to participate, they will be included in the observational mrsa+ arm. the investigators will take from the participants the same data as the randomised patients and the investigators will take biopsies. 4 equals group will be form: female-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order female-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order male-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order male-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order the surgeons, anesthesiologist, patients and laboratory technician, microbiologist will be blinded to the antibiotics received by the patient.

Eligibility criteria:
inclusion criteria: * 18 years and older * male or female * presenting normal skin on the shoulder aria exclusion criteria: * used antibiotics or treated their skin with antibiotic gel, alcohol gel or cream or acne treatment in the last three months * active infection at the surgical site or anywhere * affected shoulder previously received radiotherapy * allergic to one of the antimicrobial prophylaxis used * open fracture * life threatening or a limb threatening pathology * liver or kidney failure
evaluating the impact of adjuvant use of beta blockers on clinical outcomes in patients with traumatic brain injury

Conditions: TBI Traumatic Brain Injury

Summary: propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. the receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in tbi. therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.


Eligibility criteria:
inclusion criteria: 1. patients with moderate \& severe tbi detected on admission by ct scan and gcs score of ≤ 13 who either do not have any other injuries or only have associated minor injuries. minor injuries are defined as presence of any of the following: 1. mild intraperitoneal free fluid (ipff) observed through abdominal ultrasound. 2. mild lung contusion detected in the chest ct scan. 3. hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress. 4. simple limb fractures. exclusion criteria: 1. patients on pre-injury beta-blocker therapy. 2. patients with any bronchospastic conditions. 3. patients with active acute coronary syndrome. 4. tbi with gcs ≤ 13 with associated major injuries defined as the presence of any of the following: 1. moderate \& marked ipff requiring surgical intervention ( laparotomy ). 2. moderate \& marked lung contusion, pneumothorax \& hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation. 3. compound fracture in the upper or lower limb. 4. open faciomaxillary trauma. 5. patients with persistent shock (systemic blood pressure \ 4, or oliguria , hr \ one week of admission.
long-term outcomes of conservative management in patients with moyamoya disease and their first-degree relatives (lamora)

Conditions: Moyamoya Disease

Summary: the purpose of this study is to investigate the long-term outcomes of conservative management in patients with moyamoya disease and their first-degree relatives, and provide potential pathogenesis of moyamoya disease.

moyamoya disease (mmd) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. it is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. the specific pathogenesis of mmd is still unclear. the treatment modalities of revascularization and conservative management have been used in patients with mmd. however, the long-term outcomes of mmd with conservative management remain unknown. also, some first-degree relatives who are carriers of genetic variants occasionally manifest with intracranial arterial stenosis. therefore, it is significant to detect the long-term outcomes of conservative treatment in mmd patients and their first-degree relatives, and thus provide potential pathogenesis of mmd.

Eligibility criteria:
inclusion criteria: 1. patients with age between 2-60 years; 2. a clinical diagnosis of moyamoya disease, including unilateral and bilateral disease. 3. patients are medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation. 4. capable of understanding the purpose and risk of the study and has signed the informed consent. if the participant is not capable of this at the time of enrollment, a legally authorized representative will provide written informed consent in accordance with all regulations. 5. ability to comply with study follow-up. exclusion criteria: 1. concomitant other diseases, including systemic vasculitis, neurofibroma, meningitis, sickle cell disease, down's syndrome, and previous basilar radiotherapy. 2. patients with cardiogenic embolism, including a history of atrial fibrillation, valvular disease or cardiac valve replacement. 3. patients are allergic to the contrast agents. 4. patients are treated with direct, indirect, or combined revascularization depending on the presentation. 5. physical or subjective failure to cooperate with the examination or serious comorbid diseases. 6. patients are unable or unlikely to return for follow-up visits. 7. any other reasons that, in the opinion of the investigators, make the participant unsuitable for enrollment.

Keywords: moyamoya disease conservative management long-term follow-up first-degree relatives
comparison of high versus low bicarbonate hemodialysis

Conditions: Chronic Kidney Disease; End-stage Renal Disease; Metabolic Acidosis

Summary: this study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.

this study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. these parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. they will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. the study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.

Eligibility criteria:
inclusion criteria: * age \>18 * receiving chronic thrice-weekly conventional hemodialysis for at least 6 months exclusion criteria: * use of oral alkali within the previous month * hospitalization within the previous month * inability to provide written informed consent * plans for kidney transplant in the next 2 months * planned change in phosphate binder therapy within the next month * pregnancy, or planned pregnancy in the next 2 months

Keywords: hemodialysis dialysis acidosis bicarbonate
evaluation of the effectiveness of cannabidiol in treating severe behavioural problems in children and adolescents with intellectual disability

Conditions: Intellectual Disability; Child Behavior Problem

Summary: this is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (cbd) with placebo in reducing severe behavioral problems (sbp) at 8 weeks in children aged 6 - 18 years with intellectual disability (id). eligible participants will be randomized 1:1 to receive either cbd or placebo.


Eligibility criteria:
inclusion criteria: 1. males and females aged 6 - 18 years of age; 2. dsm-5 diagnosis of intellectual disability (id): 1. full scale iq \< 70 on standardized cognitive assessment. testing results must be sighted by the investigators and performed within two years of enrollment. in the event that records of prior testing are unavailable or the assessment was more than 2 years prior, iq will be estimated using the wechsler abbreviated scale of intelligence-ii. 2. deficit in adaptive function (basis for severity rating of id in dsm-5) in at least one activity of life on the vineland adaptive behavior scales (derives scores in communication, daily living skills and socialization domains, and a global adaptive score). if records of prior testing are unavailable or the assessment was more than 2 years prior, this will be completed by the parent or guardian. 3. sbp: defined as scores of: 1. 18 or higher on the aberrant behavior checklist-irritability subscale (abc-i), and 2. moderate or higher on the clinical global impressions-severity scale; 4. no changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study; 5. written informed consent from parent or legal guardian; 6. participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator. exclusion criteria: 1. non-english speaking parents; 2. psychosis; 3. taking clobazam, mtor inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day.; 4. abnormal liver function tests: defined as alt \> twice uln; 5. abnormal renal function tests: defined as creatinine \> uln 6. current use of medicinal cannabis, or use in the 4 weeks prior to screening; 7. pregnant or intending to become pregnant during the study, or breastfeeding; 8. known allergy to cannabidiol or cannabis products

Keywords: pediatric intellectual disability severe behavior problems
a clinical trial to compare the safety and pharmacokinetic characteristics of combination of rosuvastatin and cs-866 and dwj1276

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and cs-866 and dwj1276 alone.


Eligibility criteria:
inclusion criteria: 1. healthy adult male volunteers aged 20 to 50 years 2. a subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints exclusion criteria: 1. a subject who had any allergic history to any drug. 2. a subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases 3. history or suspicion of current drug abuse 4. a subject who had received treatment with below listed drug within specified period prior to the first dose of study medication * within 1 month: drug known cyp inducer or inhibitor * within 2 weeks: prescribed or herbal medicine * within 1 weeks: otc medicine * within 2 days: consumption of caffeine 5. a subject who had participated in any other clinical study within the last 2 weeks 6. a subject from whom over 400ml of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
implant placement in mandibular molar xenograft versus prf

Conditions: Edentulous Alveolar Ridge

Summary: 20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use platelet-rich fibrin as space filling material.


Eligibility criteria:
inclusion criteria: 1. patients with non-restorable mandibular molars 2. both sexes - exclusion criteria: * • heavy smokers more than 20 cigarettes per day.5 * patients with in sufficient interseptal bone height and width * patients with systemic disease that may affect normal healing. * patients with completely resorbed buccal cortical plate.

Keywords: platelet rich fibrin,xenograft
exploration the effect of walking program in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: the aims of this four-year study are to 1. explore the relationships between fatigue and muscle strength (i.e., upper limbs and lower legs) 2. comparison with the effects of 8-week, 12-week moderate intensity of walking program on muscle strength and fatigue. 3. develop a clinical guidelines of home-based walking program for patients with colorectal cancer receiving active treatment and survivors in taiwan. 4. explore the relationships among the self-report fatigue intensity and metabolism.


Eligibility criteria:
inclusion criteria: * patients with colorectal cancer in receiving active treatment or completed treatment within 5years. * patients in different stages. * aged above 18. exclusion criteria: * kps\<60

Keywords: colorectal cancer,fatigue,6-minute walking test
sugar challenge study

Conditions: Type 2 Diabetes; Pre-Diabetes; Healthy

Summary: this is a longitudinal study involving use of the january app which collects multiple data streams and employs machine learning techniques to offer personalized lifestyle recommendations and structured food and activity challenges.

the sugar challenge study is a real-world, longitudinal study aimed at understanding the impact of lifestyle (i.e. food choices, physical activity and sleep patterns), genetics and personalized lifestyle recommendations on blood glucose levels, blood pressure, immune system status, stress hormone levels and microbiome composition. the purpose of this 10-day observational study was to primarily elucidate the impact of food choices, physical activity, and sleep patterns on an individual's blood glucose. in addition, we probed if continuous and personalized feedback to participants would improve glycemic control acutely through better decision making. multiple investigations may be performed over an indefinite period of time to improve the understanding of these interconnected relationships. for example, we will perform studies to understand an individual's blood glucose response to an oral glucose load or mixed meal. we will also perform studies to determine the phenotype (clinical, metabolic, or immunologic) associated with a particular genotype. the data collected will be analyzed using proprietary machine learning methods.

Eligibility criteria:
inclusion criteria: * healthy, have pre-diabetes or metabolic syndrome or type 2 diabetes on metformin or glp-1 or sglt-2 therapy * have access to smart-phone with nfc reader * be willing to wear a continuous glucose monitor (cgm) and a smartwatch 24 hours/day for 10-14 consecutive days at a time * be willing to limit swimming to a maximum of 30 minutes per session while wearing cgm * available for two in-person or remote study visits (study orientation and close-out) * willing to provide weight at baseline and comprehensive logging of their activity, food and water consumption for 10-14 days * covered by health insurance plan * able and willing to give informed consent for study participation exclusion criteria: * use of vitamin c supplements in excess of 200% of the united states recommended daily allowance at least 14 days prior to starting the trial * allergy to skin adhesives used in the trial * women who are pregnant, lactating, have given birth in the past 6 months, or are planning to get pregnant in the next 6 months * individuals deemed unfit for participation by study physician * allergy to nuts * individuals who are taking any of the following medications: * insulin * progesterone * atypical antipsychotics * oral or injectable antidiabetic medications except for metformin or glucagon-like peptide-1 (glp-1) agonists or selective sodium-glucose transporter-2 (sglt-2) inhibitors * oral corticosteroid use * triphasic oral contraceptives * blood thinners
persistent pulmonary hypertension of the newborn

Conditions: Persistent Pulmonary Hypertension of the Newborn

Summary: the ac-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (pphn) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.


Eligibility criteria:
inclusion criteria: 1. signed informed consent by the parent(s) or the legal representative(s). 2. term and near term newborns (gestational age \> 34 weeks). 3. post natal age ≥ 12 hours and \< 7 days. 4. weight at birth ≥ 2,000 g. 5. idiopathic pphn or pphn due to parenchymal lung disease 6. documented diagnosis of pulmonary hypertension (ph) confirmed by echocardiography. 7. need for continued inhaled nitric oxide (ino) at a dose \> 10ppm after at least 4 hours of continuous ino treatment. 8. two oxygenation index (oi) values ≥ 12 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving ino treatment. 9. mechanical ventilation with fraction of inspired oxygen (fio2) ≥ 50% at randomization. exclusion criteria: 1. ph associated with conditions other than pphn. 2. immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ecmo). 3. lethal congenital anomalies. 4. congenital diaphragmatic hernia. 5. significant structural cardiac anomalies. 6. medically significant pneumothorax. 7. active seizures. 8. expected duration of mechanical ventilation of less than 48 hours. 9. mean systemic blood pressure \< 35 mmhg despite therapy with volume infusions and cardiotonic support. 10. hepatic failure or all conditions with alanine aminotransferase (alt) values \> 2 x upper limit of normal (uln). 11. renal function impairment such as serum creatinine \> 3 x uln or anuria. 12. known intracranial hemorrhage grade iii or iv. 13. either hemoglobin or hematocrit level \< 75% of the lower limit of normal (lln). 14. thrombocytopenia (platelet count \< 50,000 cells /µl). 15. leukopenia (wbc \< 2,500 cells/ µl). 16. any condition precluding the use of a nasogastric/orogastric tube. 17. administration of prohibited medication prior to randomization.

Keywords: persistent pulmonary hypertension, newborn pphn