Kornimate/medical-research-clean huggingface dataset:
cellular and molecular events during treatment of actinic keratosis with imiquimod 5% cream

Conditions: Actinic Keratosis

Summary: treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. some of the drug induced changes in skin cells should also be visible using a special microscope. this study examines both types of changes.

the primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (ak) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. secondary objectives were to assess the utility of confocal microscopy (cm) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with ak on the balding scalp.

Eligibility criteria:
inclusion criteria: * have actinic keratoses on balding scalp * discontinuation of tanning bed use * discontinuation of moisturizers * avoidance of retinol products exclusion criteria: * uncontrolled, clinically significant medical condition * dermatologic disease other than actinic keratosis in treatment area

Keywords: actinic keratosis ak imiquimod confocal microscopy gene microarray
treatment of multiple attacks of acute migraine (0462-025)

Conditions: Migraine Headache

Summary: a study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.


Eligibility criteria:
inclusion criteria: * patient had at least a 6-month history of migraine, with or without aura * patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions. * patient was judged to be in good health, apart from migraine exclusion criteria: * patient was pregnant or a nursing mother. * patient had abused drugs or alcohol within 12 months prior to entering the study * patient had a history of cardiovascular disease * patient had clinically significant ecg abnormality * patient had a resting systolic blood pressure of greater than 145 mm hg or diastolic of less than 95 mm hg at screening * patient received treatment with an investigational device or compound within 30 days of the study start * patient typically suffered from less then 1 or more than 8 attacks of migraine per month * patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches * patient had prior exposure to rizatriptan
opie in the thin interventricular septum

Conditions: Hypertrophic Cardiomyopathy

Summary: this is a follow up investigation to our previous study entitled "on-pump intraoperative echocardiography (opie)" (clinicaltrials.gov nct03094325) whereby we determined that left ventricular septal thickness as measured by the opie technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. opie may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. we therefore propose a study in which opie is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. subjects will receive the same perioperative care regardless of their involvement in the study. patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.


Eligibility criteria:
inclusion criteria: * all hypertrophic cardiomyopathy patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy with a preoperative transthoracic echocardiograph suggesting an interventricular septal width of less than 2.0 cm. exclusion criteria: * those hypertrophic cardiomyopathy patients who are scheduled to receive a septal myectomy who are less than 18 years old or whose preoperative transthoracic echocardiograph suggests an interventricular septal width of greater than 2.0 cm.
assessment of anaemia attributable to schistosomiasis in school children in kenya: mechanisms and effect of treatment

Conditions: Anaemia; Schistosomiasis Infection; Malaria; Iron Deficiency

Summary: the purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

the study will be carried out in an area around lake victoria in kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the lake. depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. the children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.

Eligibility criteria:
inclusion criteria: * school children between 9 to 12 year

Keywords: schistosomiasis anaemia malaria iron deficiency
safety and efficacy study of intravesical instillation of tara-002 in adults with high-grade non-muscle invasive bladder cancer

Conditions: Non-muscle Invasive Bladder Cancer

Summary: tara-002-101-ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of tara-002 in adults 18 years of age or older with high-grade cis nmibc (± ta/t1). the purpose of this phase 2 study (tara-002-101-ph2) is to further assess the safety and anti-tumor activity of tara-002 at the rp2d which has been established in the phase 1a dose finding study (tara-002-101-ph1a). this phase 2 study includes participants with cis nmibc (± ta/t1) with active disease (defined as disease present at last tumor evaluation prior to signing icf). participants will be enrolled into one of 2 cohorts: cohort a: * participants with cis (± ta/t1) who are bcg naive, or * participants with cis (± ta/t1) who are bcg exposed and have not received intravesical bcg for at least 24 months prior to the most recent cis diagnosis cohort b: * participants with persistent or recurrent cis (± ta/t1) who are bcg unresponsive within 12 months of completion of adequate bcg therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)


Eligibility criteria:
inclusion criteria: * male or female participants 18 years of age or older at the time of signing informed consent * participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry * central histologic confirmation of high-grade non-muscle invasive cis (± ta/t1) with active disease * participants who are bcg naive, or participants who are bcg exposed and have not received intravesical bcg for at least 24 months prior to the most recent cis diagnosis (cohort a). participants with persistent or recurrent cis (± ta/t1) who are bcg unresponsive within 12 months of completion of adequate bcg therapy (cohort b). exclusion criteria: * penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory * predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review * concomitant prostatic or upper tract urothelial involvement per investigator's assessment * nodal and metastatic disease are excluded if they existed at any time (whether present or in the past) * any history of ≥ t2 bladder cancer that existed at any point in time in the participant's history for more information on eligibility criteria, please contact the sponsor

Keywords: non-muscle invasive bladder cancer bladder cancer high grade ta high grade nmibc carcinoma in situ
open-label dose-escalation study for crispr/cas13- rna targeting therapy for the treatment of neovascular age-related macular degeneration in phase i trial

Conditions: Neovascular Age-Related Macular Degeneration (nAMD)

Summary: age-related macular degeneration (amd) leads to severe and irreversible vision loss, while neovascular amd (namd) accounts for 80-90% of amd blindness. current anti-vegf therapies are the standard of care, but these therapies require life-long repeated intraocular injections. these frequent intravitreal injections increase the risk of complications, including submacular hemorrhage, intraocular hypertension, inflammation, and retinal detachment. therefore, repeated treatments for namd place a substantial burden on healthcare systems, patients, and their caregivers. additionally, approximately 25-35% of individuals with aggressive namd show suboptimal responses to the anti-vegf therapies, experience treatment-extended failure, or require intensive, frequent intraocular injections, and do not prevent irreversible vision loss. hg202 is a crispr/cas13 rna-editing therapy delivered through one single aav vector to partially knock down the expression of vegfa and thus inhibit cnv formation in amd. the long-term, stable delivery of hg202 following a one-time gene-editing therapy treatment for namd may potentially reduce the frequent injections and the potential risks of currently available anti-vegf therapies since it does not rely on the long-term expression of anti-vegf antibodies.


Eligibility criteria:
inclusion criteria: * males or females ≥ 50 and ≤ 85 years at the time of signing the icf; * active macular choroidal neovascularization (mnv) secondary to namd in the study eye; * sentinel (1st) subject for each dose cohort must have a bcva ≤ 20/63 and ≥ 20/400 (≤63 and ≥ 19 etdrs letters) in the study eye. following the sentinel subject evaluation, the rest of the subjects in the dose cohort must have a bcva between ≤ 20/40 and ≥ 20/400 (≤ 73 and ≥ 19 etdrs letters) in the study eye. * able to perform visual acuity and retinal function tests and able and willing to comply with study procedures for this clinical trial. exclusion criteria: * retinal or subretinal hemorrhage, scarring, or fibrosis of greater than 50% of the total lesion in the study eye; * other ocular diseases that may affect central vision in the study eye; * any other cause of cnv than namd in the study eye * uncontrolled glaucoma in the study eye; * history or presence of corneal transplant or corneal dystrophy in the study eye; * history of other intraocular surgery in the study eye within 3 months prior to baseline; * prior gene therapy or oligonucleotide therapy; * other conditions judged by the investigator as inappropriate for the study.

Keywords: macular degeneration namd wamd gene-editing crispr hg202
predicting the need for intubation in hospitalised covid-19 patients (pred icu covid19)

Conditions: COVID-19

Summary: one of the main challenges of the health crisis caused by the covid-19 epidemic is the availability of beds in intensive care units (icus) and, more importantly, the need for invasive mechanical ventilation (ivm) because the icus are currently reserved for intubated patients. the experiences of both china and italy indicate that a certain number of covid-19 patients will require mechanical ventilation. however, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. as a significant proportion about 5% to 10%, of patients initially admitted to hospital with covid-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units. the hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring covid-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation


Eligibility criteria:
inclusion criteria: * proven or expected covid-19 patients hospitalised in a non-intensive care unit for less than 24 hours, * patients requiring oxygen therapy, * age ≥ 18 years old. exclusion criteria: * patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect., * patients who can not be intubated for medical reasons, * pregnant women, parturient women or nursing mothers , * adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard), * adults person who is unable to give consent and who is not subject to a legal protection measure, * persons deprived of their liberty by a judicial or administrative decision, * persons subject to psychiatric care under duress.
comparison of standard fusion with "topping off"-system in lumbar spine

Conditions: Spondylolisthesis; Erosive Osteochondrosis in L2-S1

Summary: does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? does this device prevent the development of adjacent instability? does radiological adjacent instability correlate with clinical outcome?

primary efficacy endpoint: the baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the sf-36 (short-form-36)-measured outcome regarding the physical component summary (pcs). key secondary endpoint(s): 1. mental component summary (mcs) and individual dimensions and subscales of the sf-36 2. individual dimensions of the oswestry disability index (odi) 3. time until radiological adjacent instability and comparison to the clinical outcome 4. capacity of work at the time of surgery and after surgery, time until return to work assessment of safety: 1. treatment complication in control and intervention groups (sae-management) 2. a rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias

Eligibility criteria:
key inclusion criteria: 1. male or female \>30 years of age 2. lumbar spine pathology with indication for monosegmental plif 3. radiological signs of a degeneration of the adjacent segment without instability key exclusion criteria: 1. radiological signs of existing instability of the adjacent segment 2. normal endplates and no disc desiccation in mri in the adjacent seg-ment 3. previous surgery of the lumbar spine -

Keywords: lumbar spine fusion adjacent instability topping-off.
use of wearable tech to increase physical activity in inpatient rehabilitation for overweight and obese patients

Conditions: Obesity; Overweight

Summary: the aim of this project is to evaluate whether use of wearable tech increases physical activity in patients participating in inpatient rehabilitation for overweight and obesity.

obesity is a global epidemic with profound consequences for individuals and societies. physical exercise is important for weight reduction and weight loss maintenance. use of wearable tech might facilitate physical activity. here it will be evaluated whether use of wearable tech that gives feedback about the user's activity level, increases physical activity in people participating in inpatient rehabilitation for overweight and obesity. the control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level. the feedback application will give participants in the intervention group information about the number of pai they earn each week. pai is short for personal activity intelligence. one earns pai points every time heart rate increases: the higher heart rate, the faster one earns pai. previous research have shown that those who achieve 100 pai or more every week over time, live for an average of more than eight years longer than others. during the study all participants will take part in a traditional inpatient rehabilitation program (lifestyle modification program). the program consist of three periods at the rehabilitation center with time at home in-between. the study will take place during two periods at the center and one period at home. time spent on physical activity and number of earned pai's will be counted during the period at home.

Eligibility criteria:
inclusion criteria: * taking part in inpatient rehabilitation at unicare helefort rehabilitation center for overweight or obesity. * having been referred from a hospital outpatient obesity clinic. exclusion criteria: * not having a smartphone (will not be able to access the mobile application). * using a wheelchair (the technology will be not able to measure activity correctly)

Keywords: weight loss rehabilitation exercise biomedical technology
using higher cut-off values to diagnose acute myocardial infarction in patients with elevated hs-ctnt concentrations

Conditions: Acute Myocardial Infarction

Summary: high-sensitive cardiac troponin t (hs-ctnt) is a cornerstone for diagnosing acute myocardial infarction (ami). however, it is often challenging to diagnose ami in patients with elevated hs-ctnt before a rise or fall of hs-ctnt can be observed. the elevations of hs-ctnt are caused not only by ami, but also by other cardiac or even non-cardiac diseases. thresholds above the 99th percentile have been proposed to improve the specificity and to accelerate the rule in of myocardial infarction. this study aimed to find a more accurate cut-off value to rule in ami in patients with elevated hs-ctnt.

acute myocardial infarction (ami) is a major cause of morbidity and mortality worldwide. in real clinical practice, early and accurate recognition of ami is crucial to accelerate effective reperfusion therapy. high-sensitivity cardiac troponin t (hs-ctnt) is an important protein that regulates cardiomyocytes excitability, which can be proliferated in cardiomyocytes and released into the blood after myocardial injury or infarction. according to the fourth universal definition of ami, a rise and/or fall of ctn values with at least one value above the 99th percentile url is the essential precondition for diagnosing ami. however, it is challenging for clinicians to diagnose ami in patients with elevated hs-ctnt levels before a rise and/or fall of hs-ctnt values can be observed, particularly for those who present atypical symptoms and non-significant changes in electrocardiograms (ecg). when the 99th percentile upper reference limit (url) is referred, it happens frequently that the elevations of hs-ctnt are not caused by ami, but by other cardiac or even non-cardiac diseases. therefore, thresholds above the 99th percentile have been proposed to improve the specificity and to accelerate the rule in of myocardial infarction. this study aimed to find a higher and more accurate cut-off value of hs-ctnt to rule in ami in a large volume of patients with elevated hs-ctnt.

Eligibility criteria:
inclusion criteria: * patients hospitalized from january 1,2015 to may 31,2023 in the first affiliated hospital of nanjing medical university with hs-ctnt concentrations over 14.0 ng/l were enrolled. exclusion criteria: * patients who underwent major cardiac surgeries during the hospitalization.

Keywords: acute myocardial infarction high sensitivity cardiac troponin t rule in
aspirin in the prevention of cardiovascular events in hemodialysis patients

Conditions: End-Stage Renal Disease

Summary: the study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients.


Eligibility criteria:
inclusion criteria: * patients with end-stage renal disease who are undergoing long-term hemodialysis. exclusion criteria: patients will be excluded if there is evidence of * a recent history of acute uremia, * previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema), * concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs, * high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or * life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer).

Keywords: aspirin aspirin resistance hemodialysis cardiovascular prevalence of aspirin resistance, cardiovascular events, and safety profile
performance output with haptics - evaluating athlete response and unrealized potential

Conditions: Muscle Strength; Muscle Weakness

Summary: this minimal risk, randomized, double-blind, placebo controlled institutional review board (irb)-approved observational study with functional measurements, will evaluate athletic performance after use of a drug- free, non-invasive patch (victory patch; the super patch company inc.); using kangatech, catapult and force plates along with crossover control of trials within the same subject group not receiving an 'active' patch.

emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. the victory patch (superpatch company, toronto, canada) that also incorporates this technology has shown anecdotal promise to improve athlete performance. with the tools currently in use at the university of arizona, team coaches and physicians can measure the true impact of neuromuscular changes suggested by the victory patch. this study will measure quadriceps and hamstring strength in isolation as well as peak output in jumping and speed testing within in season training programs with and without victory patch use. when combined with new methods of assessing individual muscle strength (kangatech) and force plate as well as catapult measurements of compound movements of the investigational muscles, the investigators can evaluate the true performance and changes in football athletes with the superpatch technology.

Eligibility criteria:
inclusion criteria: 1. adults 18 to 30, inclusive 2. able to provide written informed consent 3. have received a victory patch if in treatment group. 4. is an athlete on a university of arizona varsity athletic team 5. agree to having physical activity objectively measured for physical activity, as well as attendance, and participation in intervention. 6. agree to place an adhesive patch on their skin, as instructed, based on selection group. exclusion criteria: 1. use of drugs of abuse (illicit or prescription) 2. have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid. 3. any current medical or musculoskeletal injury that would prohibit athletic participation 4. any significant injuries in the last month prior to the intervention that may impact tested performance measures. 5. new injuries that occur during the course of study testing that may impact performance measures.

Keywords: muscle quadriceps hamstrings college athletes elite athletes haptic technology vibrotactile trigger technology vtt neuromuscular changes