Kornimate/medical-research-clean huggingface dataset:
a phase ii neoadjuvant study of darolutamide plus adt in men with localized prostate cancer

Conditions: Prostate Cancer

Summary: scientific rationale: high risk localized prostate cancer (pca) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and pca-specific death. novel hormone therapies(nht) have shown a significant survival advantage with respect to classical adt in later stages of pca and have already been investigated in neoadjuvant setting. purpose: to assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (rp + plnd) for high-risk localized prostate cancer patients.


Eligibility criteria:
inclusion criteria: 1. male ≥18 years of age. 2. able to sign informed consent form independently. 3. non-metastatic adenocarcinoma of the prostate. 4. subjects must have as least one of the following features according to nccn definition of high-risk: gleason score ≥8, or psa \>20ng/ml,or≥clinical t3a. 5. subjects with pelvic lymph node involvement(n1) can be included. 6. candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator. 7. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 8. subjects must have normal organ and marrow function as defined below: hemoglobin ≥ 9.0 g/dl;absolute neutrophil count (anc) ≥ 1,500/mcl; platelets ≥ 100,000/mcl, independent of transfusions/growth factors within 3 months of treatment start; serum potassium ≥ 3.5 mmol/l; serum total bilirubin ≤ 2.0 x upper limit of normal (uln) (except in subjects with gilbert's syndrome who have a total bilirubin \> 1.5 x uln, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x uln, subject may be eligible);aspartate aminotransferase (ast), alanine aminotransferase (alt) ≤ 2.5 x uln;serum albumin ≥ 3.0 g/dl;serum creatinine \< 2.0 x uln. exclusion criteria: 1. prostate cancer with neuroendocrine differentiation or small cell features 2. distant metastasis based on conventional imaging (clinical stage m1). nodal disease below the iliac bifurcation (clinical stage n1) is not an exclusion. 3. history of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer. 4. subjects who are planning bilateral orchidectomy during the treatment period of the study. 5. intolerable with darolutamide or adt treatment. 6. candidates of other clinical trials. 7. any prior malignancy within 5 years. 8. complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator. 9. any condition that in the opinion of the investigator would preclude participation in this study.
variability of impedance pneumography tidal breathing flow-volume curves during sleep in healthy children

Conditions: Healthy Subjects

Summary: this is an observational study for the assessment of normal overnight variation in small healthy children using the ventica lung function testing system. the study is carried out to establish reference ranges for overnight lung function variation using the ventica test, and to assess the impact of the demographic factors on the ventica results.


Eligibility criteria:
inclusion criteria: * 18 months-6 years, both sexes * healthy at the time of inclusion * laboratory analyses in the reference range or not clinically relevant according to the investigator judgement * lung function in the reference range with a negative bronchodilator test result * signed informed consent exclusion criteria: * preterm birth * chronic respiratory disorder of prematurity * recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia) * primary immunodeficiency * chronic rhinosinusitis, synonasal polyposis * nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing * acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion * personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy) * use of asthma rescue or maintenance medication within 4 weeks prior to inclusion * implanted or external active medical devices such as pacemakers
study to compare the effect of vytorin (simvastatin/ezetimibe) 10/20mg versus atorvastatin 20mg on apob/apoa1 ratio in subjects with diabetes

Conditions: Type 2 Diabetes Mellitus Without Insulin Treatment

Summary: a single center, open label, randomized, clinical trial comparing apob/apoa ratio of vytorin 10/20mg vs atorvastatin 20mg treatment. dm2 patients will be screened for inclusion criteria. patients (n=66 in each arm) will be randomized to either ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or tlc period. primary and secondary endpoints will be assessed at week 12. primary endpoint: 1) change of apob/apoa ratio at week 12. secondary endpoint: 1. change of lipid parameters (tc, ldl-c, hdl-c, tg, apob 48) at week 12. 2. change of hba1c at week 12. 3. change of homa index at week 12 - homa =\[fasting insulin (miu/l) × fasting glucose (mmol/l)\] / 22.5 4. change of hscrp at week 12 5. safety assessment hypotheses: * three months treatment of vytorin 10/20mg will be superior to atorvastatin 20mg in apob/apoa ratio. * in dm patients, ezetimibe/simvastatin combination will be well-tolerated.


Eligibility criteria:
inclusion criteria: 1. type 2 dm 2. hypercholesterolemia (baseline screening ldl-c \> 100 mg/dl) 3. in case of medication, stable doses of oral hypoglycemic agents for at least three months 4. hba1c \<8.5% 5. age: 20-80 exclusion criteria: 1. chronic renal failure: creatinine \> 3.0 mg/dl 2. serious liver disease (\> x3 lft unl) 3. congestive heart failure 4. stroke or mi/coronary intervention during the preceding 3 months. 5. ck \> x 2.5 unl 6. unstable hypo/hyperthyroidism 7. pregnant/lactating woman, or woman intending to become pregnant 8. subject with any clinically significant condition or situation, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Keywords: diabetes mellitus
the heat study: 2 year lifestyle intervention in overweight women to encourage weight management

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: the purpose of this trial is to determine the most cost effective programme for overweight and obese individuals to maintain weight loss over a 2 year period.

although short term weight loss is often achievable in overweight individuals, long term maintenance is generally poor. the researchers urgently need new information regarding the most cost effective programme(s) for maintenance of weight loss. this study will recruit 200 women and compare two approaches for providing support: one with intensive health professional support, the other peer group support facilitated by a research nurse with frequent 'weigh- ins'. the researchers will also compare two different diets one a high carbohydrate, high fibre, low glycaemic index diet versus one relatively high in monounsaturated fat and protein and low in glycaemic load.

Eligibility criteria:
inclusion criteria: * female participants * aged 25 to 70 * those who have intentionally lost more than or equal to 5% of initial body weight in the previous 6 months will be recruited * objective evidence that volunteers were overweight or obese and have lost weight will be obtained from doctors records exclusion criteria: * presence of major illness including cancers * established cardiovascular disease or stroke * diabetes * gestational diabetes * renal disease * malabsorption disorders * thyroid disorders * major psychiatric disorders * taking weight loss medication or medications known to cause weight gain * planning a pregnancy in the next 2 years * those who do not intend to be in the area for the next 2 years

Keywords: weight diet exercise maintenance
triage survey for cardiovascular, obesity, and related endocrine trial eligibility

Conditions: Cardiovascular Diseases; Obesity; PreDiabetes; Diabetes Type 2; Metabolic Syndrome

Summary: swift-core-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials. a physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, comorbidities, and current symptoms. site staff may collect vital signs, urine drug screens, blood draws, and urine pregnancy tests. a doctor will review medical history with the participant to determine study suitability via clinical interview. the doctor may reach out to the patient's current treating physicians and pharmacies to determine eligibility for clinical trials.


Eligibility criteria:
inclusion criteria: 1. participant or legally authorized representative has signed an icf prior to study-specific procedures being performed. 2. participant is at least 18 years old. exclusion criteria: 1. participant is pregnant, breast-feeding, or planning to become pregnant. 2. history of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results. 3. moderate or severe substance use disorder within 90 days prior to screen 4. any condition that in the investigator's opinion makes a participant unsuitable for the study. 5. currently employed by swift clinical research group, inc. or any of its subsidiaries, including brooklyn clinical research, or a first-degree relative of an employee.
host genetic susceptibility to avian influenza a/h5n1

Conditions: Influenza A Virus/H5N1 Subtype

Summary: the identification and characterization of susceptibility loci for h5n1 infection in humans could have profound implications. the detection of host genetic factors may shed light on key pathogenic interactions between h5n1 and human cells, assisting in identifying the viral characteristics determining pandemic potential. in addition, the identification and verification of susceptibility loci would be followed by functional studies which might point the way to new therapeutic and preventive options. the objective of this study is to investigate if host genetic factors are associated with susceptibility to influenza h5n1 illness

this is primarily an hypothesis screening exercise and while guesses based on biological plausibility are possible, a comprehensive analysis of genetic susceptibility can only be achieved by a whole genome approach. therefore we will test for genetic linkage and association using a large number of single nucleotide polymorphisms (snps) spanning the whole genome. principal investigators have access to information on all surviving and deceased laboratory confirmed h5n1 cases. these cases will form the study base. the epidemiologist will attempt to make telephone contact with either the recovered patient or,if the patient died, the closest relative of the deceased patient. the proposed study will be explained and permission will be sought for the epidemiologist and a study nurse to visit the household to explain the study in greater detail, to offer an opportunity for questions and, if the subject agrees, to obtain informed consent for participation. if the epidemiologist has difficulty in making contact with the case or their family the local public authorities will be asked to assist in making contact. eligible family members of h5n1 cases will be identified by face-to-face interviews with the surviving confirmed cases or close family members of deceased cases.

Eligibility criteria:
inclusion criteria: * the individual had a clinically compatible illness (defined as respiratory symptoms and an abnormal chest x-ray or encephalitis), and * influenza a/h5 rna identified in a clinical sample by reverse transcription-polymerase chain reaction \[rt-pcr\], or * influenza a/h5 cultured from a clinical sample, or * high titres (1:80 or higher) of anti-h5 antibodies by microneutralization in convalescent samples of patients who had a compatible illness but no or negative rt-pcr, and * the patient survived or if they died an archived biological specimen is available for potential dna extraction, and * valid, written consent is obtained. * the biological parents and biological siblings of all the cases and any other family members linking two cases, and * valid, written consent is obtained.

Keywords: influenza a/h5n1 host genetic susceptibility genotyping
a study to assess the safety and efficacy of vatiquinone in participants with friedreich ataxia

Conditions: Friedreich Ataxia

Summary: the primary objective of this study is to assess the long-term safety of vatiquinone in participants with friedreich ataxia (fa) previously exposed to vatiquinone.

this long-term, open-label study will serve as a continued access study for participants with fa who have previously participated in a vatiquinone study. the purpose of this study is to assess continued safety and efficacy of vatiquinone dosing in previously treated participants. this study addresses the medical need for participants to continue vatiquinone with a planned study duration of 3 years.

Eligibility criteria:
inclusion criteria: * participants with fa who completed and directly rolled over from a previous vatiquinone clinical study. * males and females of childbearing potential must be willing to use an effective method of contraception (for example, implants, injectables, transdermal patches, combined oral contraceptives, barrier methods, and intrauterine devices) from the time consent is signed until 30 days after the last dose of study drug or early termination visit. exclusion criteria: * current participation in any other interventional study * pregnancy or breastfeeding
effects of cultura yoghurt in relation to transit time and digestive discomfort in healthy women and men

Conditions: Constipation

Summary: the aim of this study is to determine the effect of cultura yoghurt on transit time and digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women and men.

transit time is the time it takes for a substance to pass through the gut. the major part of the transit is spent in the large bowel is therefore mainly a colonic event. it has been observed that slow transit time is associated with high prevalence of large bowel disorders. the objectives of this study is to: * determine the effect on mean transit time after 2 weeks intake of a investigational products using radio-opaque sulphate impregnated polyethylene pellets as markers. * determine effect of investigational products on total symptom score according to bristol stool form (bsf) * determine effect of investigational products in gastrointestinal symptoms * determine safety of intake of the investigational products

Eligibility criteria:
inclusion criteria: * female and males * healthy * bmi 19-29 at visit 1 * age 18 and 60 years at visit 1 * defecation 3-4 times per week or every second to third day (bristol stool form) during the run-in * transit time 35 and 72 hours calculated from the abdominal x-ray at visit 3 * signed written informed consent exclusion criteria: * use of probiotics food or supplements during the study * past history of digestive disease * previous complicated gi surgery * oral use of antimicrobial medication or antimicrobial prophylaxis 4 weeks prior to screening visit * use of laxatives (medication or dietary supplements) during the study. * pregnant or lactating or wish to become pregnant during the period of the study * lack of suitability for participation in the trial, for any reason, as judged by the personnel at kpl good food practice ab

Keywords: transit time constipation gut regularity defecation frequency colonic transit time
improving germline testing in at-risk patients with prostate cancer

Conditions: Prostate Cancer

Summary: a quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.

this is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.

Eligibility criteria:
inclusion criteria: 1. men, age greater than or equal to 18 years of age. 2. diagnosis of prostate cancer of any histology. 3. must meet nccn guidelines for germline testing exclusion criteria: 1. have had prior germline testing. 2. have somatic genetic testing that is positive for a possible germline variant.

Keywords: prostate cancer germline testing education video
dimenydrinate vs ondansetron for ponv (donv)

Conditions: PONV in Laparoscopic Cholocystectomies

Summary: this study will investigate the impact of dimenydrinate (h1-receptor antagonist) versus ondansetron (ht3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the los in pacu and/or the overall los.

dimenydrinate has been extensively used for motion sickness. however, as far as postoperative nausea and vomiting is concerned the results are still conflicting. this study will investigate the impact of dimenydrinate (h1-receptor antagonist) versus ondansetron (ht3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the los in pacu and/or the overall los.

Eligibility criteria:
inclusion criteria: * age 18-75 years old * asa ps i-iii * undergoing laparoscopic general surgery operations or laparoscopic gynecological operations exclusion criteria: * refused to participate * age other than 18-75 years old * pregnant patients * non-elective operations * patients that are not able to receive p.os agents * medical history of brugada sdr or brugada-like/related ecg abnormalities * long-qt sdr or concurrent use of medications that may cause long-qt ecg abnormalities * medical or family history of psychosis * allergy in dimenydrinate or in dimenydrinate drug versions * perioperative use of dexamethasone
adjacent level anterior cervical fusion: seaspine shoreline versus removal of previously implanted plate and replating

Conditions: Degenerative Disc Disease; Disc Herniation

Summary: the purpose of this study is to evaluate the efficacy of seaspine shoreline device in surgery of the cervical spine.

this is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the seaspine shoreline device. patients will be identified by the investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria.

Eligibility criteria:
inclusion criteria: 1. appropriate patient, as determined by the investigator, scheduled for an elective cervical spine fusion to treat adjacent level cervical disc herniation or degeneration resulting in cervical radiculopathy or myelopathy 2. at least 18 years of age 3. failure of nonoperative care 4. previous anterior cervical plating 5. psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements exclusion criteria: 1. pregnancy or anticipated to become pregnant during the course of the study 2. no previous cervical spine surgery 3. non-instrumented cervical fusion 4. cervical fusion with separate plate fixation 5. unwilling or unable to sign consent 6. patient has any condition, that in the opinion of the investigator, would prohibit the patient from complying with the protocol 7. currently a prisoner
efficacy of rice bran extract in mildly to moderately depressed adults

Conditions: Depression

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks.

a previous animal study has indicated that rice bran extract provided inhibition of mao-b enzyme activity and ros formation in a corticosterone-induced depression-like animal model. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of rice bran extract on depressive symptoms and related biomarkers in mildly to moderately depressed patients for 8 weeks; the safety of the compound is also evaluated. the investigators examine the korean version of the hamilton depression rating scale, the korean version of the beck-ii depression inventory, the korean version of the patient health questionnaire-9, the perceived stress scale, the korean version of the beck anxiety inventory and biomarkers at baseline and after 8 weeks of intervention. one hundred adults were administered either 1,000 mg of rice bran extract or a placebo each day for 8 weeks.

Eligibility criteria:
inclusion criteria: - the korean version of the hamilton depression rating scale score between 7-24 exclusion criteria: * no depressive symptom (k-hrsd ≤ 6) or severely depressed (k-hrsd ≥ 25) * those are taking hormone therapy such as estrogen within the past 6 months * those are taking the following drugs within the last 1 month or need to take them during the study period (sleep aids, antidepressants, selective estrogen receptor modulators, etc.) * those with a history of treatment for depression * abnormal liver or renal function (more than twice the normal upper limit of the research institute) * uncontrolled diabetes mellitus (\>160 mg/dl of fasting blood sugar) * uncontrolled hypertension (\>160/100 mmhg) * uncontrolled thyroid diseases. * those who are taking drugs, functional foods, herbs, etc. that may affect depression * alcohol abuser * allergic reaction to this test food * those who participated in other drug clinical trials within 1 month from the screening date. * severe gastrointestinal symptoms such as heartburn and indigestion * those who are pregnant, lactating, or plan to become pregnant during the clinical trial * those who are judged to be unsuitable by the pi for other reasons
effects on mortality and clinical course of a patient's choice model for opioid maintenance treatment for opioid dependence - evaluation of a system enabling a large expansion of treatment providers and treatment access

Conditions: Opioid Dependence; Overdose

Summary: opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications, social problems and crime. opioid maintenance treatment (omt) has proven effective in opioid dependence. in 2014, a patient's choice reform in skåne county, sweden, was introduced and led to a vast extension of omt in the region, including a large number of treatment providers and high access to treatment. still, opioid-related mortality in the region remains high. while patients' access to treatment has been increased, the content and nature of treatment in the present system has been questioned. the present system, which dramatically altered treatment conditions and access for omt in this region, has never been formally evaluated in any large-scale study. this study aims to assess clinical course of patients receiving omt before and during the patient choice reform system, and effects on the extent and nature of opioid-related mortality in the region.


Eligibility criteria:
inclusion criteria: * patients included in opioid maintenance treatment in skåne region. exclusion criteria: * none.

Keywords: opioid dependence opioid maintenance treatment methadone buprenorphine