Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of kh631 gene therapy in subjects with neovascular age-related macular degeneration (namd)

Conditions: Age-Related Macular Degeneration

Summary: kh631 is a adeno-associated virus (aav) vector-based gene therapy for subretinal injection. the long-term, stable therapeutic protein after one time injection for namd could potentially reduce the treatment burden and maintain vision.


Eligibility criteria:
inclusion criteria: * 1.are willing and able to sign the study written informed consent form (icf); 2. men and women ≥ 50 and ≤85 years of age, diagnosed with namd at the screening visit; 3. subjects must be under active anti-vegf treatment for namd and received a minimum of 3 injections within 6 months prior to screening; 4. response to anti-vegf therapy(response is defined as reduction in crt≥50μm or at least 30% reduction in fluid by oct compared to disease at the worst); 5. bcva between ≤20/63 and ≥20/400(≤63 and ≥19 early treatment diabetic retinopathy study \[etdrs\] letters) for the first patient in each cohort followed by bcva between ≤20/40 and ≥20/400(≤73 and ≥19 etdrs letters) for the rest of the cohort; 6. must be pseudophakic(at least 3 months after intraocular lens implantation) in the study eye; 7.female subjects must have been postmenopausal for at least 1 year. exclusion criteria: * 1.any other cause of cnv, including pathologic myopia, etc, or other diseases except namd have an influence on the test of macular or affect the central visual acuity; 2.presence of an implant, refractive media opacity affects fundus examination or narrow pupil of the study eye; 3.active or history of retinal detachment in the study eye; 4.uncontrolled glaucoma or ocular hypertension; 5.have taken the drug known to have retinal toxicity; 6.history of intraocular surgery; 7.uncontrolled hypertension despite medication at the screening visit.
efficacy of preparation in self-hypnosis by anchoring versus conversational hypnosis, used alone or combined, in patients undergoing breast macrobiopsies

Conditions: Breast Neoplasm Female

Summary: the incidence of breast cancer and its mortality are reduced thanks in particular to early detection. often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. this anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act. faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination. investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management. however, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.


Eligibility criteria:
inclusion criteria: * aged 18 or over, * referred to the medical imaging department of saint-joseph hospital for breast macrobiopsy, * naive of any hypnosis, * having given free, informed and written consent, * being affiliated to a social security scheme or beneficiary of such scheme exclusion criteria: * having a major hearing loss, * suffering from identified mental or psychotic disorders, * not understanding the french language, * having already had hypnosis practices, * having an ongoing pregnancy, * being the subject of a safeguard measure
movement pattern in patients with hip dysplasia

Conditions: Hip Dysplasia

Summary: the purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for periacetabular osteotomy (pao). secondary to examine the movement pattern in patients compared to healthy controls and historical data.

congenital hip dysplasia is a disease characterised by pathological changes in the hip joint. hip dysplasia is a normal disease with a prevalence of 4.3% in men and 3.6 in woman. untreated hip dysplasia is a known cause of developing osteoarthritis early in life and symptoms as pain, hip instability together with a changed gait pattern are normal. symptomatic hip dysplasia is seen in patients between 15 and 55 years and can be unilateral as well as bilateral. causes of hip dysplasia are described as genetic, mechanic or hormonal. today patients with hip dysplasia are offered a hip conserving surgery before the osteoarthritis has developed. in 2003 a minimally invasive approach for periacetabular osteotomy (pao) was introduced at aarhus university hospital. an advantage of minimally invasive approach compared to the classical bernese periacetabular osteotomy is minimal impact of the soft tissues in the hip region. hip pain and activity limitations highly affect quality of life and physical function. the gait distance is reduced and patients have to compensate to relieve the pressure on the hip joint. knowledge about the dynamics of the gait and running pattern in patients with dysplasia is important to understand the consequences of the dysplastic hip joint. furthermore knowledge about gait compensations is relevant for the clinicians in the management and treatment of patients with hip dysplasia. today, gait and running compensation is unknown after minimally invasive approach the purpose of this study is, therefore, to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for peri-acetabular osteotomy (pao). secondary to examine the movement pattern in patients compared to healthy controls and historical data.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hip dysplasia * patients in the age of 18-60 years * patients, who can speak, understand and read danish exclusion criteria: * persons with hip dysplasia secondary to other hip conditions such as calvé perthes and epiphysiolysis. * persons who have had alloplastic surgery in the hip, knee or ankle. * persons with diseases that affect the gait pattern. * persons with serious hip, knee, ankle or back pain.

Keywords: movement capture system movement analysis hip dysplasia hip pain quality of life physical function
cardiac rehabilitation for young people

Conditions: Congenital Heart Disease; Cardiomyopathies; Cardiac Arrythmias; Heart Failure; Cerebrovascular Event; Heart Valve Diseases

Summary: heart problems are amongst the most common physical illnesses in children and young people (cyp). they can be present from birth or develop as cyp get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life. while adults are offered exercise classes and lifestyle advice after a heart problem, cyp with heart problems are not. improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes). approximately 1 in 3 cyp with heart problems have anxiety and/or depression so it is also important to support their mental health. one way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (cr) consisting of exercise with mental health support for cyp. the aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for cyp.


Eligibility criteria:
all participants meeting the following inclusion criteria and aged between 11-16 years old will be eligible: inclusion criteria: 1. fluent in english 2. consent to participate 3. diagnosed with at least one of the following: * congenital heart disease (all subtypes) * cardiomyopathy * cardiac arrhythmia * heart failure * post-cerebrovascular event * post-heart valve repair/replacement exclusion criteria: 1. significant risk or safeguarding concerns (i.e., suicidal ideation) 2. head injury/organic impairment 3. significant social and/or communication difficulties those with a formal diagnosis or under assessment for any above exclusion criteria will be excluded.

Keywords: cardiac rehabilitation metacognitive therapy mental health feasibility congenital heart disease
adapting daily activity performance through strategy training

Conditions: Strategy Training; Attention Control

Summary: individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. the proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. we predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.


Eligibility criteria:
inclusion criteria: * primary diagnosis of acute stroke * admission to acute inpatient rehabilitation * impairment in higher order cognitive functions (exit-14 ≥ 3) exclusion criteria: * pre-stroke diagnosis of dementia in the medical record * inability to follow two- step commands 80% of the time * severe aphasia (bdae ≤ 1) * current major depressive, bipolar, or psychotic disorder * drug or alcohol abuse within 3 months

Keywords: stroke rehabilitation cognition disability
a multicenter, randomized, double-blind, placebo-controlled phase iv clinical trial to evaluate the immunogenicity and safety of a live attenuated herpes zoster vaccine in adults aged 40 years and older

Conditions: Prevention of Herpes Zoster

Summary: to evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine. to evaluate the safety of the live attenuated herpes zoster vaccine.


Eligibility criteria:
inclusion criteria: 1. age ≥40 years on enrollment day； 2. the informed consent of the subject can be obtained and signed； 3. the subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol； 4. armpit body temperature ≤37.0℃ on the day of enrollment. exclusion criteria: 1. people who are immune deficient or immunosuppressed due to certain diseases or treatments. causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as aids or other diseases caused by viral infection; leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; being treated for immunosuppression; being treated with radiation/chemotherapy for a tumor； 2. do not use in persons with a history of allergic reaction to any of the components contained in this product； 3. those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product； 4. premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months； 5. if this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days； 6. treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination； 7. received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study； 8. taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid； 9. patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmhg and/or diastolic blood pressure ≥100mmhg)； 10. previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)； 11. any situation that the investigator considers likely to affect the evaluation of the trial。

Keywords: iv clinical trial herpes zoster vaccine, live herpes zoster prevention of herpes zoster
a study to assess the safety of pf-06342674 in adults with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of pf-06342674. several dose levels will be evaluated.


Eligibility criteria:
inclusion criteria: * women and men age 18 and older. * diagnosis of type 1 diabetes within 2 years of randomization. * peak stimulated c-peptide levels ≥ 0.15 ng/ml. exclusion criteria: * anticipated ongoing use of diabetes medications other than insulin. * evidence or history of diabetic complications with significant end-organ damage. * episode of severe hypoglycemia within 60 days of randomization. * multiple hospitalizations for diabetic ketoacidosis.

Keywords: phase 1 rn168 adults type 1 diabetes t1d
peripheral neurostimulation for nerve block placement

Conditions: Pain Syndrome

Summary: peripheral nerve blocks are routinely used and highly successful for intra-operative anesthesia and post-operative pain management. nerve blocks are guided using either neurostimulation as a means to localize the right nerve or by ultrasound guidance or combining the 2 methods. the purpose of this study is to assess whether electrical stimulation improves nerve block quality, beyond its simple purpose of nerve localization.

the investigators wish to understand how electrical stimulation can affect local anesthetic disposition when performing a peripheral nerve block. by studying this subject, the investigators open possibilities for improvement on many levels: increasing the efficacy of the nerve block allows for a reduced onset time, reduced incidence of incomplete block and prolonged duration of the local anesthetics. this allows for patients to fully benefit from the analgesic properties of the nerve block, allows for a decrease in delays for the operating room readiness, and a decrease in the amount of medication needed for a successful nerve block. this will decrease side effects and risks of the nerve blocks. overall better post-surgical pain control may decrease risks for developing chronic post-operative pain, a major post-operative complication. the results of this study will open the door to novel approaches to manage acute post-operative pain.

Eligibility criteria:
inclusion criteria: * undergoing elective upper limb surgery with a planned brachial plexus nerve block exclusion criteria: * under 18 years old * asa score above iii * chronic pain condition with daily milligrams of morphine equivalent \> 30 * poorly controlled psychiatric condition * coagulopathy * active infection * moderate, severe or progressing neuropathy * copd/chronic oxygen user * pregnancy * incarceration * unable to consent

Keywords: peripheral nerve block neurostimulation
staphylococcus haemolyticus in the neonatal intensive care unit of chsd in 2023: analysis and trends

Conditions: Staphylococcus Haemolyticus; Staphylococcal Infections; Sepsis; Catheter-Related Infections; Infant, Newborn; Intensive Care Units, Neonatal; Cross Infection; Drug Resistance, Bacterial

Summary: this study looks at cases of staphylococcus haemolyticus infections in newborns hospitalized in the neonatal intensive care unit (nicu) at the saint-denis hospital in 2023. researchers reviewed the medical records of 28 infants who had this bacteria found in their blood or catheter cultures. the goal is to understand whether these infections have increased and how they affected the babies' health.


Eligibility criteria:
inclusion criteria: * newborns in 2023 * hospitalized in the neonatal and neonatal resuscitation department of the saint-denis * at least one isolation of s. haemolyticus in blood cultures or catheter cultures exclusion criteria: - no exclusion criteria
antibiotic treatment trial directed against chlamydia pneumonia in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is an inflammatory, demyelinating disease which affects the central nervous system (cns). the etiology of ms is unknown, although the immune system appears to play a role. many different infectious agents have been proposed as potential causes for ms, including epstein-barr virus, human herpesvirus 6, and coronaviruses. recently dr. sriram at vanderbilt university has found evidence for active chlamydia pneumonia infection in the cns of ms patients. these findings have been replicated in part by other laboratories. the purpose of the current study is to test whether antibiotic treatment aimed at eradicating chlamydia infection will reduce the disease activity in ms. the primary outcome measure will be reduction in new enhancing ms lesions on brain mri. forty patients will be entered into the trial. to be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization mri scans. patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.


Eligibility criteria:
patients with unequivocal diagnosis of multiple sclerosis and have evidence of c. pneumoniae infection in the cerebral spinal fluid
study of intracranial pressure (icp) monitoring in critically ill

Conditions: Intracranial Pressure

Summary: the sim city study seeks to explore for the variance in practice that is associated with nursing and medical care of patients with brain pressure (icp) monitors. the underlying hypothesis is that there is not a consistent pattern of care throughout the u.s., rather, there is a wide range of practice patterns that are used to monitor and treat icp.


Eligibility criteria:
inclusion criteria: * adult (18 years of age or older) * admitted to an intensive care unit (icu) exclusion criteria: * prisoners

Keywords: intracranial pressure (icp) monitoring admission to intensive care unit (icu)
body cooling in hyperthermic males and females

Conditions: Cryotherapy Effect

Summary: exertional heat stroke (ehs) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. it is diagnosed when the rectal temperature is above 40°c with the presence of central nervous dysfunction (altered mental status). the gold standard method of care for ehs is immediate onsite whole body cooling using cold-water immersion (cooling rates \>0.15°c•min-1), which is reported to have the highest cooling rate. in the treatment of ehs, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°c to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. however, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. in this proposed study, we aim to compare the cooling rates of the polar breeze® (developed by polar breeze ®, clearwater, fl), cold-water immersion (the current gold standard for ehs treatment), and passive cooling in individuals with exercise-induced hyperthermia


Eligibility criteria:
inclusion criteria: * males and females between the ages of 18-35. * recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session) exclusion criteria: * chronic health problems * fever or current illness at the time of testing * history of cardiovascular, metabolic, or respiratory disease * current musculoskeletal injury that limits physical activity * history of exertional heat illness in the past three years
laryngomalacia no longer an ambiguity

Conditions: Laryngomalacia

Summary: the purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.

laryngomalacia is the most common congenital malformation of the larynx and it is a self-limited disorder. it is the most common cause of stridor in newborns and infants. it results from an abnormal prolapse of supraglottic structures during inspiration. despite its widespread prevalence, the etiology of laryngomalacia is unclear. most infants will squeaky but otherwise well. although affected patients do not exhibit much in the way of other physical symptoms, the unusual voice is worrisome to their parents.

Eligibility criteria:
inclusion criteria: * babies delivered with laryngomalacia with ≥ 37 weeks of gestation * delivered with birth weights ≥ 2.5 kg * no history of natal or post-natal complications * from the same community exclusion criteria: * pre-term babies * history of natal or post-natal complications

Keywords: laryngomalacia factors associated or predisposing
virtual reality based rehabilitation after ischemic stroke

Conditions: Ischemic Stroke

Summary: use the template below as a guide to write a brief study description in plain language. tailor the text that appears in brackets and yellow to your research study. to finalize, delete the text in italics. the goal of this single-arm study is to explore the use of early virtual reality-based rehabilitation as an adjunct to conventional physical/occupational therapy in adult patients with acute ischemic stroke. the main question it aims to answer is: feasibility and tolerability of using immersive virtual reality technology-based therapy for patients suffering from acute ischemic stroke in an inpatient hospital setting participants will receive 1 or 2 virtual reality therapy sessions and complete surveys at the end of each session.


Eligibility criteria:
inclusion criteria: * age \> 18 * mri or ct imaging confirmed ischemic stroke * able to follow multistep commands exclusion criteria: * plegia in both arms * previous reported history of vertigo or inner ear dysfunction * patients with epilepsy * patients who cannot begin therapy during admission * patients who are pregnant * patients with a pre-existing condition that interferes with virtual reality usage (e.g., visual impairment, limitation of either upper extremity or neck).

Keywords: virtual reality stroke rehabilitation quality of life upper extremity