Kornimate/medical-research-clean huggingface dataset:
a multi-center, randomized, double-masked, parallel-group, vehicle-controlled, clinical trial of reproxalap to assess the safety and efficacy in subjects with dry eye disease

Conditions: Dry Eye

Summary: a multi-center, phase 2, randomized, double-masked, parallel-group, vehicle-controlled, clinical trial to assess the safety and efficacy of reproxalap ophthalmic solution (0.25% novel formulation) compared to vehicle in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race; * have a reported history of dry eye for at least 6 months prior to visit 1; * have a history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1 exclusion criteria: * have any clinically significant slit-lamp findings at visit 1, including active blepharitis; meibomian gland dysfunction (mgd); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle; * have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have used any eye drops within 2 hours of visit 1; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of visit 1; * have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; * have used temporary or permanent punctal plugs within 30 days prior to visit 1 or anticipate their use during the study period
a phase 2, baseline-controlled study evaluating the safety and efficacy of ptx-022 (sirolimus) topical gel 3.9% in the treatment of cutaneous venous malformations

Conditions: Cutaneous Venous Malformations

Summary: a phase 2, baseline-controlled study evaluating the safety and efficacy of ptx022 (sirolimus) topical gel 3.9% in the treatment of cutaneous venous malformations


Eligibility criteria:
inclusion criteria: the participant must have a clinically confirmed superficial/ cutaneous (visible on the skin) venous malformation (cvm), referred to as the treatment area. the treatment area may contain a minority (\<30%) lymphatic component (mixed venous / lymphatic malformation). - exclusion criteria: * the participant's treatment area is mainly in any wet mucosa or within the orbital rim. for clarification, no part of the venous malformation should be evaluated or treated if it in mucosa. external genital presentation is permitted. * the participant has a known pervasive extension of the lesion into mucosa, bone or tissue (as determined by diagnostic or the investigator) that would impair the ability of the investigator to evaluate the cutaneous components of the lesion.
evaluation of the effects of a novel dietary microalgae based ingredient on muscle recovery and endurance capacity

Conditions: Healthy

Summary: the purpose of this investigation is to examine the effects of consuming a new dietary microalgae based supplement vs. placebo on neuromuscular function, energy utilization, soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in healthy young men before and after an acute exercise-induced muscle damage protocol (downhill running), and influence on endurance capacity after prolonged consumption.


Eligibility criteria:
inclusion criteria: * male participants * healthy as assessed by medical and activity history questionnaire (mhq) * recreationally active according to american college of sports medicine guidelines * able to provide written and dated informed consent to participate in the study exclusion criteria: * untrained * any response of "yes" on the par-q+ * physical limitations preventing running, countermovement jump, and strength (peak isometric torque and peak isokinetic torque) assessments

Keywords: recovery muscle endurance exercise capacity microalgae inflammation
genetic evaluation of men (gem)

Conditions: Prostate Cancer

Summary: this is a prospective research registry and prospective genetic testing cohort study. the goal is to collect personal medical and cancer history data, family cancer data, exposure history, and biospecimens to support research focused on optimal genetic testing strategies for men with prostate cancer with the ultimate goal of informing national guidelines focused on genetic evaluation for prostate cancer.

objectives: 1. collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility. 2. collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process. 3. create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk. 4. perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk. 5. develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.

Eligibility criteria:
inclusion criteria: 1. men with a personal history of prostate cancer 2. unaffected males who are at higher risk for prostate cancer exclusion criteria: 1. age \< 18 years 2. mental or cognitive impairment that interferes with ability to provide informed consent 3. social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)
a covid-19 symptom, exposure and immune response registry

Conditions: COVID-19

Summary: this is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the covid-19 global pandemic. data collected will include participant medical histories, history of prior sars-cov-2 infection and exposure to known cases. on an ongoing basis data will be collected on new contacts with known cases, the presence of covid-19 symptoms, including severity and outcome, and information on the immune system response to sars-cov-2 infection.

this is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the covid-19 global pandemic. all data will be collected by participant entry into a mobile app designed for this study. upon entering the study, participants will be asked a series of questions about their prior exposure to the sars-cov-2 virus including reporting prior test results, and identification and description of contact with known or cases or other high risk encounters. participants will also provide a detailed medical history. on on ongoing basis, participants will be asked to report any symptoms associated with covid-19 that they develop, and any new contacts they experience with known cases. some participants will be sent an at-home sars-cov-2 antibody test and asked to report the results. in addition, participants will be asked to report the result of any other test they receive for covid-19 outside of the study.

Eligibility criteria:
inclusion criteria: * open to any adult individuals (18 years of age or older) permanently residing in the united states * have regular access to smartphone and internet sufficient to support registry demands * willing and able to follow the procedures of the study * willing and able to provide informed consent exclusion criteria: * participants unable to understand the study protocol or provide informed consent * participants unable or unwilling to perform all requested study tasks
comparison of clinical and radiological results of using only screws and plate use in latarjet operation in shoulder instability

Conditions: Shoulder Dislocation

Summary: randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability

randomized controlled comparison of the clinical and radiological results of using only screws and plate use in latarjet surgery in shoulder instability 2 groups will be determined in the study, while the first group will include the group in which corocoid fixation with cannulated screws was performed, while the second group will include the group that underwent osteosynthesis with plate and screw the results will be evaluated statistically based on clinical scores (constant, vas) and radiological findings (a angle).

Eligibility criteria:
inclusion criteria: - recurrent shoulder dislocation; 18-65 age \>%10 glenoid loss or hill sacs lesion exclusion criteria: - \<18 age \<%10 glenoid loss shoulder dislocation due to epilepsy dislocations associated with other upper extremity injuries
preparatory work to assess adherence to oral chemotherapy

Conditions: Chronic Myeloid Leukemia

Summary: this study to find out more about how patients take their anticancer medications and challenges related to taking cancer medications.

120 patients with chronic myeloid leukemia (cml) who are currently prescribed an oral anti-cancer agent from up to 6 ccdr ncorp sites to complete a brief interviewer administered survey to assess medication adherence and related factors.

Eligibility criteria:
inclusion criteria: * patient is diagnosed with chronic myeloid leukemia (cml) and is receiving care for cml at a participating ccdr ncorp practice, * patient had been prescribed one of the following oral anticancer agents for cml for ≥30 days (imatinib, nilotinib, dasatinib, bosutinib, ponatinib). prior use of any of these medications is allowed, as long as they have been on a stable regimen for at least 30 days prior to enrollment. * patient is 18 years of age or older exclusion criteria: * patient does not speak english or requires an interpreter for medical visits * patient is cognitively impaired, as determined by the referring provider
covid-19 pandemic and parents of disabled children

Conditions: COVID-19; Disabilities Multiple; Cerebral Palsy; Muscular Dystrophies

Summary: pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents. in this research, it is aimed to determine the positive and negative effects of pandemic on parents and disabled children and to provide an insight for future solutions.

to determine the effect of covid-19 pandemic and the possible difficulties experienced by the parents of disabled children, a questionnaire was prepared. it takes approximately 10-15 minutes to complete the survey. questionnaire is loaded to qualtrics program and sent to the families by e-mail or social media accounts.

Eligibility criteria:
inclusion criteria: * having disabled child/children * having ability and facility to use internet * having ability to read and write * having enough cognitive capacity to answer the questionnaire * to accept to participate the research exclusion criteria: * not having disabled child/children * not having ability and facility to use internet * not having ability to read and write * not having enough cognitive capacity to answer the questionnaire * not to accept to participate the research

Keywords: cerebral palsy covid-19 pandemic disability
training-induced muscle strength and its role in interface pressure in inelastic compression

Conditions: Resistance Training

Summary: the present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression?

this phase i two-armed randomized clinical trial including participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in resistance exercise programs will be conducted at the ativas gym, xanxere/sc, brazil. participants will perform exercises during the strength-training protocol intervention, while individuals in the control group will not be offered the exercise program in the three months before data collection and during the entire period corresponding to the 12-week intervention. in addition, we will monitor their eating and physical activity habits throughout the data collection period. the study was designed in accordance with the consort statement.

Eligibility criteria:
inclusion criteria: * participants above 60 years of age who do not present any musculoskeletal limitations preventing their participation in strengthening exercise programs. exclusion criteria: * participants who present chronic venous insufficiency (ceap c3-6) evaluated through doppler ultrasonography, severe congestive heart failure (functional class iii and iv - nyha), and ankle/brachial index (abi) \< 0.8. we will also exclude elderly individuals who are unable to perform the required exercises due to physical limitations and those bedridden or wheelchair-bound.

Keywords: inelastic compression resistance exercise muscle hypertrophy chronic venous disease
genes, omega-3 fatty acids and cardiovascular disease risk factors

Conditions: Cardiovascular Disease

Summary: the main purpose of this study is to examine whether n-3 pufa-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors.

the main purpose of this study is to examine whether n-3 pufa-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors. to do so, the metabolic risk factor response to an n-e pufa supplementation will be compared in carriers and non-carriers of polymorphism within genes acting as fatty acids sensors.

Eligibility criteria:
inclusion criteria: * healthy men and women aged between 18 to 50 years; * having a bmi between 25 and 40kg/m2; * plasma triglycerides levels \<4.0 mmol/l; * non-smokers; * free of any thyroid or metabolic disorders requiring treatment such as diabetes, hypertension, severe dyslipidemia, and coronary heart disease. exclusion criteria: * subjects taking medication for hyperlipidemia, hypertension, diabetes or taking anticoagulant or n-3 pufa supplementation; * having a taste aversion for fish, fish allergy or regular alcohol drinker; * body mass index \> 40kg/m2; * pregnant or nursing women.

Keywords: omega-3 pufa fatty acids cardiovascular disease gene expression
effectiveness of the echos approach for patients with eating disorders and their carers

Conditions: Eating Disorders

Summary: family therapy is considered an empirically supported treatment approach for adolescents and adults with eating disorders. one family based approach, expert carers helping others (echo) is based on evidence that suggests family environment, e.g., carer criticism, can influence an individual's eating disorder symptoms. echo aims to improve carer coping, reduce expressed emotion and manage eating disorder symptoms, and has been associated with reduced carer distress, caregiver burden, and an increase in general well being. the current pilot study seeks to evaluate a new condensed version of the echo intervention that is delivered entirely in a 2 ½ hour self-help dvd format (echos). sixty patients and their carers will be recruited from the capital health eating disorders service and randomized into either a treatment as usual group (tau) or a tau+echos group. both carers and patients will be assessed along a variety of dimensions including psychiatric symptoms, family functioning, and carer and patient collaboration, at pre-intervention, four weeks later at post-intervention, and then three-months post-intervention. anovas will be used to compare the primary outcomes between the two groups over time. this pilot study will be the first evaluation of echos, which may ultimately boost the efficacy of current treatment for adults with eating disorders and reduce carer distress.


Eligibility criteria:
inclusion criteria: * patients with an ed (an, bn, ednos) according to dsm-v criteria (american psychiatric association, 2013) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist. * patients age of \>17y.o. * carers can include parents/partners/siblings/extended family who provide unpaid help and support. peers and roommates could also be included in circumstances within which they play a significant role in the person's life and meet the following criteria: * live with or have regular, current contact with the patient (at least 7 hours/week) throughout the duration of the trial (approximately 6months). * interact with the patient in some meaningful manner regarding their ed (e.g. provide support, eat meals together, discussions about behaviours). * consent from patient and at least one carer exclusion criteria: * ed comorbid with severe psychiatric or physical comorbidity: e.g. current psychotic illness (inc. bipolar disorder), severe alcohol/drug abuse, significant metabolic or gastrointestinal problems (i.e. treatment interfering) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist. * family in a concurrent treatment trial. * either patient or carer has insufficient knowledge of english.

Keywords: eating disorders carers
intranasal dexmedetomidine vs. standard of care for emergency department (ed) procedural sedation in the older adult

Conditions: Altered Mental Status

Summary: the purpose of the study is to determine if intranasal dexmedetomidine could be an alternative to the current standard of care (injectable benzodiazepines or antipsychotics) for sedation prior to computerized tomography (ct) or magnetic resonance imaging (mri) in those greater than or equal to 65 years of age (older adults) that are seen in the emergency department (ed).


Eligibility criteria:
inclusion criteria: * 65 years of age and older * patients in need of sedation prior to either a computerized tomography (ct) or magnetic resonance imaging (mri) exclusion criteria: * patients who weigh \< 50 kg * cardiac arrhythmias or qtc \>450 * intravenous access not standard of care or unable to obtain * patients with any allergies or contraindications to dexmedetomidine, haloperidol (i.e. patients diagnosed with parkinson's) or lorazepam * patients with low blood pressure, defined as a less than 100/60 mmhg * patients with bradycardia (heart rate \< 60 bpm) * patients presenting with chief complaint of respiratory distress/failure * intranasal administration contradictions: nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus or blood, and intranasal damage, recent use of nasally administered vasoconstrictors such as cocaine, oxymetazoline, and phenylephrine

Keywords: sedation
effects of tacs combined with cct for patients with mci

Conditions: Mild Cognitive Impairment

Summary: this goal of this study is to explore the effects of transcranial alternating current stimulation(tacs) combined with computerized cognitive training(cct) on improving cognition for patients with mild cognitive impairment(mci). the study will recruit 195 patients with mci. participants will undergo baseline cognitve assessment, eeg and structural and functional mri. participants will be randomized to active tacs+cct group, sham tacs+cct group and active tacs+sham cct group. at the end of the intervention, 3-month, 6-month and 12-month follow-up, all subjects will repeat the baseline assessments.

tacs is a non-invasive brain stimulation technique that uses a low-intensity alternating current (1 to 2 ma) to apply a sinusoidal current to the scalp, directly interacting with the oscillating cortical activity at a given frequency with a given stimulus intensity. studies have shown that simultaneous tacs on the left prefrontal lobe and left temporal lobe can significantly improve working memory in healthy older adults. the 40 hz tacs is gamma oscillation, and more and more studies have pointed out that gamma oscillation regulation disorder is associated with impaired working memory function.cct can improve the cognition in patients with mci. we hypothesized that tacs combined with cct can produce synergistic effects in sensitive brain areas.

Eligibility criteria:
inclusion criteria: * (1)age ≥ 60 years old with memory impairment; (2) the memory test scores are lower 1.5 sd than the normal control; (3) in addition to memory impairment, other cognitive functions remain relatively intact or only slightly impaired; (4) normal daily living ability; (5) can not reach the diagnostic criteria for dementia, clinical dementia rating (cdr) is 0.5 exclusion criteria: * (1) serious medical diseases such as hypertension, heart disease, severe liver disease, etc.; (2) central nervous system diseases such as cerebrovascular diseases, infectious encephalopathy, brain tumors, etc.; (3) severe depression, schizophrenia and patients who have taken psychotropic substances for a long time; (4) alzheimer's disease and vascular dementia; (5) history of alcohol dependence and other psychoactive substance abuse; (6) patients with contraindications for magnetic resonance imaging; (7) cannot complete the cognitive function tests for various conditions

Keywords: transcranial alternating current stimulation computerized cognitive training
outreach and choice in colorectal cancer screening

Conditions: Colorectal Cancer Screening

Summary: the primary objective of this clinical trial will be to compare overall colorectal cancer (crc) screening participation between an active choice (fecal immunochemical test \[fit\] or colonoscopy) and a sequential choice (fit offered first, then colonoscoscopy offered in those still unscreened) arm. secondarily, we will (1) compare the proportions of fit vs. colonoscopy per arm, (2) compare active choice vs fit only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding crc screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of crc, adenomas and ssls per arm, and the operational results of the outreach program across arms.


Eligibility criteria:
inclusion criteria: 1. adults 45-75 years of age not up to date with crc screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter). 2. the assessment of screening status will happen monthly, on a rolling basis. 3. definition of being up to date with crc screening includes any one of the following: i) fit or guaiac-fobt within 1 year, or ii) colonoscopy within 10 years, or iii) sigmoidoscopy within 5 years, or iv) ct colonography within 5 years, or v) cologuard within 3 years exclusion criteria: 1. age outside the 45-75 range. 2. history of precancerous polyps requiring colonoscopy surveillance. 3. already being up to date with crc screening, as defined above. 4. evidence of total removal of the colon which would eliminate the need for screening.