Kornimate/medical-research-clean huggingface dataset:
evaluation of a mri-based prostate cancer screening program

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (pca) in a screening program based on bpmri of the prostate.

informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. according to european guidelines we will include men \> 50 years of age and men \>45 years of age and a family history of pca as well as african-americans \>45 years of age. in this study, bpmri will be used for opportunistic prostate cancer screening. the indication for prostate biopsy is based solely on the results of bpmri. in case of detection of lesions suspicious for prostate cancer ( pirads 3), targeted mri-trus fusion biopsy with 3 biopsies per lesion will be performed. in case no lesions suspicious for pca ( pirads 3) are detected, sb will performed if psa exceeds 10ng/ml and/or dre is suspicious for pca.

Eligibility criteria:
inclusion criteria: * well-informed men with the wish for prostate cancer screening * prostate biopsy naïve * life expectancy \> 10 years * men \> 50 years of age * men \> 45 years of age with a family history of prostate cancer * african-americans \> 45 years of age exclusion criteria: * prostate biopsy performed prior to study * life expectancy \< 10 years * acute urinary tract infection * nih-cpsi score 19 (leads to initiation of urologic diagnostics and treatment) * ipss score 20 (leads to initiation of urologic diagnostics and treatment) contraindications for mri: * heart pacemaker * artificial heart valves (some types are eligible) * cochlea implant * icd * metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.) * severe claustrophobia
the snack study: the feasibility of changing night-time food choices to improve glucose tolerance in pregnancy

Conditions: Glucose Intolerance; Obesity

Summary: obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. furthermore, few studies have proved to be efficacious among low income african american women who have high risk for the transmission of obesity to future generations. the purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child.

obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. furthermore, few studies have proved to be efficacious among low income african american women who have high risk for the transmission of obesity to future generations. the purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child. we hypothesize that women who replace their usual night-time foods and drinks with lower glycemic load options will have more stable night-time glucose and lower glucose following an oral glucose load. this intervention will be assessed in a cohort of african american women of low income, who were obese at their first prenatal care visit.

Eligibility criteria:
inclusion criteria: * african american race * healthy, singleton pregnancy * ≤ 28 weeks' gestation at enrollment * bmi of 30.0 - 45.9 kg/m2 at first prenatal visit * reports regular food consumption after 8pm at night that is not attributable to work schedule or other constraints. exclusion criteria: * pre-gestation or gestational diabetes * current smoker * presence of any medical condition or the use of any medication known to affect fetal growth * previous delivery of a small-for-gestational age infant (\<10th percentile) * previous delivery of a pre-term infant (\<36.0 weeks' gestation) * inability to communicate in both verbal and written english * unwilling or unable to consume study-provided foods.

Keywords: nutrition
a 1-year safety study of oto-104 in subjects with unilateral meniere's disease located in united kingdom

Conditions: Meniere's Disease

Summary: this is a 2-part study of oto-104 in subjects with unilateral meniere's disease in the united kingdom. the first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of oto-104 or placebo spaced 3 months apart. the second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of oto-104 spaced 3 months apart. each subject will participate on the study for a total of 1 year.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject has a diagnosis of definite unilateral meniere's disease. * subject agrees to maintain their current standard of care treatments for meniere's disease while on-study. exclusion criteria includes, but is not limited to: * subject is pregnant or lactating. * subject has a history of immunodeficiency disease. * subject has a history of previous endolymphatic sac surgery. * subject has a history of previous use of intratympanic gentamicin in the affected ear. * subject has a history of drop attacks. * subject has experienced an adverse reaction to intratympanic injection of steroids.
mindfulness meditation for cognition and mood

Conditions: Stress, Psychological

Summary: the purpose of this pilot study is to collect feasibility and acceptability of an internet mindfulness meditation intervention for older adults and to collect preliminary data on mood and cognition changes from before to after the intervention. up to 32 older adults will be randomized to receive a mindfulness meditation intervention or a time and attention control, both delivered over the internet (16 completers). participants will have a one-hour session weekly for six weeks with daily home practice between sessions. participants will complete the sessions online with a study ipad. their home practice will also be installed on the study ipad as well as an objective adherence monitoring program that the investigators developed to track actual home practice between sessions. the feasibility and acceptability measures are enrollment rate, completion rate, and participant satisfaction. self-report mood questionnaires and cognitive tasks will be measured before and after the intervention period and data used to conduct power analyses and sample size estimation for a larger clinical trial.


Eligibility criteria:
inclusion criteria: * age 65 - 90 years old * baseline perceived stress scale1 score ≥ 9 * stable on medications six weeks prior to and during study * willing to learn and use study technology * can hear and understand instructions * willing to accept randomization scheme and agrees to follow the study protocol exclusion criteria: * cognitive impairment limiting ability to give consent or follow the protocol (≤26 on the mtics)2 * significant acute medical illness that would decrease likelihood of study completion (self-report). * significant, untreated depression, as assessed by cesd-5 \>16 during screening. * current daily meditation practice (≥5 min/day daily for at least 30 days in the last 6 months. past practice not exclusionary but will be recorded)

Keywords: meditation education stress, psychological aged
home-based aids care project

Conditions: HIV Infections

Summary: the home-based aids care program pilot project delivers and monitors antiretroviral (arv) and tuberculosis (tb) medications at the homes of 1,000 people with hiv living in a rural area of uganda. this study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. this study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and cd4 cell count measurements.

in uganda, the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide. the home-based aids care program (hbac) pilot project was designed to deliver and monitor arv and tuberculosis (tb) medications at the homes of 1,000 people with hiv living in a rural area of uganda. in addition, the cost and complexity of frequent laboratory monitoring of viral load and cd4 cell counts is a major impediment to widespread use of arv therapies in uganda and other resource-limited settings. nested within the home-based aids care (hbac) project, is a randomized study of strategies for monitoring arv therapy that involves 3 arms: 1) quarterly cd4 cell counts, viral loads and home visits by trained lay persons; 2) quarterly cd4 cell counts and home visits; and 3) home visits alone.

Eligibility criteria:
inclusion criteria: * hiv infection * cd4 cell count \<250 or symptomatic aids * age \>13 years * karnofsky score \>40% * ast or alt \< 5 times normal values * creatinine clearance \>25 ml/min

Keywords: antiretroviral therapy hiv adherence viral load opportunistic illness
a phase 2 study of tcp-25 gel in patients with epidermolysis bullosa, step-study

Conditions: Epidermolysis Bullosa (EB)

Summary: this is a phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied tcp-25 gel in patients with confirmed deb or jeb. the study will implement intrasubject randomization, ie, pairs of matching index wounds will be randomly assigned to be treated with a local application of either tcp 25 gel or vehicle gel.

the study will include a screening period, a treatment period (days 1 to 56, with study visits conducted every 2 weeks, including the baseline \[day 1\], day 14, day 28, day 42, and day 56 visits) and a safety follow-up conducted via a telephone/video call at approximately 14 days after the last dose of the imp. patients will undergo efficacy, safety, tolerability, and pk assessments at scheduled visits. for evaluation of the primary efficacy endpoint, a trained clinician will take the images of the index wounds at all scheduled visits from baseline through day 56 (visit 6) using 3d digital photography and software for wound measurement.

Eligibility criteria:
inclusion criteria: * male or female patients with documented diagnosis of deb or jeb, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping. * patients ≥4 years old. note: initially, patients ≥12 years will be enrolled. enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a dmc reviews and provides a positive opinion regarding the safety and tolerability of the imp in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of imp use. exclusion criteria: * the patient has any subtype of eb other than deb or jeb. * the patient is currently being treated or planned to be treated with systemic antibiotics. note: use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the baseline visit) is permitted. use of topical antibiotics on the index wounds within 7 days before the baseline visit is prohibited. • use of systemic corticosteroids \&gt;0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the screening visit. note: corticosteroids for inhalation, ophthalmic, or intranasal use are permitted. • the patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.
evaluate the efficacy and safety of shr-1918 in patients with homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: this is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (ldl-c) by shr-1918 in patients with homozygous familial hypercholesterolemia (hofh).


Eligibility criteria:
inclusion criteria: 1. diagnosis of functional hofh by either genetic or clinical criteria as defined in the protocol 2. ldl-c ≥2.6mmol/l at the screening visit 3. body weight ≥40 kg 4. receiving stable lipid-lowering therapy for at least 28 days before enrollment. exclusion criteria: 1. previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (hba1c \> 8.5%) 2. egfr \<30ml/min/1.73m2 at the screening visit 3. ck \>5times uln at the screening visit
relational development in children with cleft lips and palates: influence of the waiting period prior to the first surgical intervention and the parents' psychological perception of the abnormality

Conditions: Cleft Palate

Summary: the treatment of patients suffering from cleft lip(s) with or without a cleft palate (cl/p) is multidisciplinary. the careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. yet the birth of a child affected by cl/p is a particularly stressing and traumatising event for the parents. the investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by cl/p over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. the time of the first surgical intervention varies amongst the treatment centres. the investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. the results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the cl/p through embryo diagnosis and those who found out at their child's birth. the mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).


Eligibility criteria:
inclusion criteria: * children with cleft lip with or without cleft palate and their parents exclusion criteria: * children with cleft palate without cleft lip * children born the 35th week of d'amenorrhea * children with a birth weight inferior to 1800 g * children put under care by court order * parents under administrative supervision * parents who are not familiar with the french language and/or illiterate

Keywords: cleft palate
risk factors and machine learning model for aminoglycines related acute kidney injury

Conditions: Aminoglycoside Toxicity; Acute Kidney Injury

Summary: drug-induced acute kidney injury (d-aki) can occur after treatment with aminoglycosides. predicting the risk of d-aki is important for a tailored prevention and palliation strategy. there are currently no studies to construct a model for predicting the risk of d-aki associated with aminoglycosides. therefore, the study aimed to develop a model to predict the risk of d-aki that could be used in clinical practice. clinical data of inpatients treated with aminoglycosides at the first affiliated hospital of shandong first medical university from january 2018 to december 2020, were collected. the primary endpoint was d-aki, defined according to the 2012 global outcomes for kidney disease improvement (kdigo). patient clinical information, including demographic information, admission and discharge information, disease history, medication information, and laboratory tests, was obtained through an in-hospital electronic medical record system. independent risk factors associated with d-aki will be screened by univariate and multifactorial analyses. covariates with significant differences (p \< 0.05) were included in logistic regression models. the models were evaluated by the area under the curve (auc) of the receiver operating characteristic curve (roc) obtained by ten-fold cross-validation. future studies are needed to test the application of this model in clinical practice to determine whether d-aki in this setting can be predicted and mitigated.


Eligibility criteria:
inclusion criteria: * all inpatients who used aminoglycosides during hospitalization * hospital stay ≥ 48h * age ≥18 years * there are two or more blood creatinine tests during hospitalization exclusion criteria: * hospital stay \< 48h * age \<18 years * glomerular filtration rate (gfr) \< 30ml/min/1.73m2 within 48 hours after admission * aki was diagnosed on admission * less than two scr test results during hospitalization * the scr values were always lower than 40 μmol/l during hospitalization * cases with incomplete medical history information

Keywords: aminoglycosides acute kidney injury pharmacoepidemiology miss diagnosis risk factors logic regression
increasing condom use in people at risk for hiv infection

Conditions: HIV Infections

Summary: this study will evaluate a new program designed to increase condom use in both women and men.

as heterosexual hiv transmission increases, effective behavioral interventions to increase condom use are needed. interventions should be low cost and accessible to large segments of the at-risk population. this study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. the intervention is computer-delivered and will be provided in health care settings. the study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the multifaceted model of hiv risk. participants will be recruited from four health clinic sites that serve local ethnic minority communities. the participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an hiv information comparison group. all participants will receive comparable group-specific informational materials at study entry and at months 2 and 4. participants in the intervention group will receive individualized feedback and specially-tailored manuals. participants in the hiv information comparison group will receive general hiv information feedback and the best-available informational manual. assessments for both groups will be conducted at study entry and at months 6, 12, and 18. at study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. there will also be computer question sessions at study entry and at months 2 and 4. participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (std) history, and personal relationships. telephone follow-ups at months 6, 12, and 18 will take approximately 20 to 30 minutes.

Eligibility criteria:
inclusion criteria * hiv uninfected * sexually active * at risk for hiv (as determined by study officials) * speaks english * seen at a participating clinic exclusion criteria * pregnant

Keywords: condom hiv seronegativity hiv prevention behavioral intervention
evaluation of dysfunction of the basal ganglia before a parkinsonian walking in the elderly: risk of falling and confusional state

Conditions: the Elderly

Summary: the strong relationship between falling and severity of cognitive impairment in the elderly is well established. the association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. the gait fortiori neurological are fall risk factors. dysfunctions underlying disorders as parkinson called march executive disorders are subcortical origin involving so the basal ganglia. this study is indeed based on the assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the contrast vision disorders. these gait exposed to falls and dysexecutive these disorders with cognitive impairment and greater susceptibility to confusional states. the executive disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye movements, impaired vision contrasts are well established in the degenerative parkinsonian syndromes. this study proposes a new approach to assessing gait disorders to define a high risk of falling in the presence of parkinsonian walking in the elderly over 75 years.


Eligibility criteria:
inclusion criteria: * age: 75 years, * man or woman, * diagnostic criteria for parkinson walking: at least 3 of the following symptoms: * loss of swinging arms, * decrease in stride walking slowly, * feet as glued to the ground, * trample, * piece u-turn, * kyphotic attitude, * tolerance screw physiotherapy screws exclusion criteria: * unrecovered delirium, * unable to walk for a distance of 6 meters in length without technical assistance, * traumatic fall phase of rehabilitation, * acute pathology, * unstabilized psychiatric pathology, * symptomatic orthostatic hypotension, * severe depressive syndrome untreated * subjects with a sufficient gap to explain the falls: * cerebellar syndrome, * a pyramidal syndrome with sequelae pyramidal deficit and cortical stroke * peripheral pathology, * rheumatic disease, * orthopedic pathology, * mini metam state examination \<18, * parkinsonism induced by neuroleptics, * not cured cancer, * psychotropic drugs (benzodiazepines and antipsychotics) with significant sedative effect inducing excessive daytime sleepiness namely psychotropic half long life, and high dose over 2 psychotropic * severe heart failure * severe respiratory failure, * associated diseases and treatments interfering

Keywords: parkinson march