Kornimate/medical-research-clean huggingface dataset:
cyclasol for the treatment of signs and symptoms of dry eye disease (ded)

Conditions: Dry Eye Disease

Summary: the objective of this study is to assess the efficacy, safety, and tolerability of cyclasol ophthalmic solution in comparison to vehicle for the treatment of the signs and symptoms of ded.

this phase 2b/3 study will assess the efficacy, safety and and tolerability of cyclasol ophthalmic solution as one drop twice daily versus vehicle.

Eligibility criteria:
inclusion criteria: * signed icf (informed consent form) and hipaa (health insurance portability and accountability act) * patient-reported history of ded in both eyes * current use of otc (over-the-counter) and/or artificial tears for dry eye symptoms * ability and willingness to follow instructions, including participation in all study assessments and visits exclusion criteria: * women who are pregnant, nursing or planning a pregnancy * unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * clinically significant slit-lamp findings or abnormal lid anatomy at screening * ocular/periocular malignancy * history of herpetic keratitis * active ocular allergies or ocular allergies that may become active during the study period * ongoing ocular or systemic infection at screening or baseline * wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study * history of no response to previous topical cyclosporine a and/or use of topical cyclosporine a or liftigrast within 2 months prior to screening * intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period * presence of uncontrolled systemic diseases * presence of known allergy and/or sensitivity to the study drug or its components
carbohydrate-based strategies to prevent exercise-induced hypoglycemia

Conditions: Type 1 Diabetes Mellitus

Summary: to prevent hypoglycemia during prolonged exercise (\>30 minutes), additional carbohydrate intake is frequently required. carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. in addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 14 years of old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. last (less than 3 months) hba1c ≤ 10%. 4. patients using multiple daily injections with basal-bolus insulin regimen. exclusion criteria: 1. clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. 2. recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 3. abnormal blood panel and/or anemia. 4. ongoing pregnancy. 5. severe hypoglycemic episode within two weeks of screening. 6. other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation). 7. treatment with csii (continuous subcutaneous insulin infusion) "insulin pump therapy".

Keywords: exercise hypoglycemia carbohydrates
study of the effects of fabrazyme treatment on lactation and infants

Conditions: Fabry Disease; Alpha Galactosidase A Deficiency

Summary: the study was planned for up to 2 years (24 months). planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full participation of mother and no infant participation was 6 months.


Eligibility criteria:
inclusion criteria: mothers that met the following criteria were enrolled in this study: * provided signed written informed consent to participate in this study, * be enrolled in the fabry registry and received fabrazyme while lactating, * agreed to adhere to the fabry registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and * agreed to adhere to the schedule of evaluations for this study. infants that met the following criteria were enrolled in this study: * had the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study, * born to a mother who was receiving fabrazyme during lactation, * received breast milk from the mother, and * had the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study. exclusion criteria: * the mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.

Keywords: alpha galactosidase a agal r-hagal fabry gl3 fabrazyme lysosomal storage disorder enzyme replacement therapy (ert)
prolonged exposure (pe) treatment for post traumatic stress disorder (ptsd) 20 minutes versus 40 minutes

Conditions: PTSD

Summary: comparing the efficacy of 40 minutes pe treatment to 20 minutes of the same treatment


Eligibility criteria:
inclusion criteria: * ptsd exclusion criteria: * psychotic symptoms * dissociation * drug or alcohol dependence

Keywords: post traumatic stress disorder
genetic test based risk prediction of early calcific aortic valve disease in patients with bicuspid aortic valve

Conditions: Bicuspid Aortic Valve

Summary: this study is to elucidate the impact of germline mutations and clonal hematopoiesis (chip) on the progression of early aortic valve calcification in patients with bicuspid aortic valves. the study will be conducted over a recruitment period of one year and a follow-up observation period of two years. considering a 2-year event rate and a 33% occurrence rate of clonal hematopoiesis, each group requires a minimum of 102 participants. accounting for a 15% dropout rate, a total of 120 participants are needed for each group (type i error (α) = 5%, type ii error (β) = 20%). therefore, the total study population, including patients with normal aortic valve function, is set at 240 participants.


Eligibility criteria:
inclusion criteria: 1. patients with confirmed bicuspid aortic valves based on cardiac imaging (echocardiography, ct, mri) or surgical findings. 2. early aortic valve calcification group: patients aged 20-80 with moderate or greater aortic valve stenosis/regurgitation. 3. normal functioning aortic valve group: patients aged 20-80 with mild or less aortic valve stenosis/regurgitation. 4. patients who understand the purpose of the study and voluntarily consent to participate. exclusion criteria: 1. patients with malignant neoplastic diseases or other conditions, such as cerebrovascular accidents, which predict survival of less than 6 months. 2. patients with unclear presence of bicuspid aortic valves. 3. patients with stage 3 or higher chronic kidney disease. 4. patients with other inherited cardiac conditions. 5. patients with cognitive impairment or hemodynamically unstable patients who have difficulty understanding the study content.
med study to evaluate the safety, tolerability and pharmacokinetics of intravenous wck 5222 (zidebactam and cefepime) in healthy volunteers

Conditions: Serious Gram-negative Infections

Summary: study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous wck 5222 (zidebactam and cefepime) in healthy adult human subjects.


Eligibility criteria:
inclusion criteria: 1. have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2). 2. resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmhg and a resting pulse rate of 40 to 100 beats per minute. 3. calculated creatinine clearance ≥80 ml/min (cockcroft-gault method). 4. all values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the principal investigator. exclusion criteria: 1. participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before investigational product administration in this study. 2. history/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the principal investigator would confound the subject's participation and follow-up in the study. 3. history of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs. 4. history of clostridium difficile induced diarrhea or infection within 1 year before screening. 5. prior exposure to zidebactam.
optimization of nutritional state on the outcome of patients with acute exacerbation of bronchiectasis

Conditions: Bronchiectasis Adult

Summary: bronchiectasis is a chronic respiratory condition characterized by the abnormal and permanent dilation of the bronchi, leading to recurrent respiratory infections, chronic cough, and significant morbidity. the disease has gained increasing recognition due to its rising prevalence and the substantial burden it places on healthcare systems . recent studies have highlighted the importance of nutritional status in managing chronic respiratory diseases, including bronchiectasis. malnutrition is prevalent among patients with bronchiectasis, particularly those experiencing frequent exacerbations. it has been shown that underweight patients have lower lung function and may face worse clinical outcomes compared to those with normal weight . specifically, a study found that underweight individuals had a significantly lower forced expiratory volume in one second (fev1) compared to their normal-weight counterparts, indicating a direct correlation between nutritional status and respiratory function .

to evaluate the effects of nutritional optimization on clinical outcomes in patients experiencing an acute exacerbation of bronchiectasis. specifically, the study seeks to: * assess the relationship between nutritional status and clinical outcomes\*: to investigate how improvements in nutritional status, measured through dietary intake, body weight, and biochemical markers, correlate with clinical outcomes such as length of hospital stay, frequency of exacerbations, and overall recovery. * \*evaluate the effectiveness of nutritional interventions\*: to determine the impact of specific nutritional interventions (e.g., high-protein diets, caloric supplementation, and micronutrient support) on the health status and recovery of patients during acute exacerbations.

Eligibility criteria:
inclusion criteria: * \*age\*: adults aged 18 years and older. * diagnosis\*: confirmed diagnosis of bronchiectasis, as established by clinical evaluation and imaging studies (e.g., chest ct scan). * acute exacerbation\*: patients presenting with acute exacerbation symptoms, such as increased sputum production, worsening dyspnea, or chest pain. * nutritional assessment\*: patients identified as malnourished or at risk of malnutrition based on the subjective global assessment (sga) or similar nutritional screening tools. exclusion criteria: * \*cognitive impairment\*: patients with cognitive impairments that affect their ability to participate in the study or adhere to nutritional recommendations. * current enteral feeding\*: patients receiving enteral nutrition or those with a feeding tube. recent nutritional interventions\*: patients who have recently undergone significant nutritional interventions (e.g., dietary changes, supplementation) within the past three months prior to enrollment. \*pregnancy or lactation\*: pregnant or lactating women, due to the need for specific nutritional considerations.
effectiveness of the eko digital stethoscope in capturing infant ecgs

Conditions: Tachyarrhythmia

Summary: when a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. in most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (cpr) classes. fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room.

tachyarrhythmias which would prompt an emergent call to the pediatric cardiologist following the child, along with simultaneous transportation towards the nearest, preferably pediatric, emergency room. in reality, parental caregivers may be blinded by their personal anxiety in caring for their child with a tachyarrhythmia, and their interpretation or ability to count their child's heart beats may not be accurate. this in turn, can result in unnecessary calls and visits to the emergency room which increase their utilization in addition to piling onto the already astounding cost of healthcare in the united states. fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. eko manufactures a digital stethoscope with 1-lead electrocardiogram (ecg), the duo, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. the application enables the clinician to visualize the sounds and electrical signals coming from the device in real time. currently, the duo is cleared for use on patients greater than or equal to 10 kg. this device may have additional clinical utility in pediatric patients \<10 kg when used by either a physician or a parent/caregiver at home for remote patient monitoring. the core 500 may also have clinical utility in this patient population.

Eligibility criteria:
inclusion criteria: * age \<1 year * no previous diagnosis of arrhythmia * parent/caregiver can provide informed consent * parent/caregiver can speak and understand simple english exclusion criteria: * age ≥ 1 year * patient has a pacemaker or implantable cardioverter defibrillator (icd) * parent/caregiver is unwilling or unable to provide informed consent * parent/caregiver is unable to speak and understand english

Keywords: infant tachyarrhythmia cardiac rhythm digital stethoscope
minoxidil 2% for eyebrow enhancement

Conditions: Hypotrichosis of Eyebrows; Thinning Eyebrows

Summary: the purpose of the study is to compare minoxidil 2% versus placebo in enhancement of eyebrows.


Eligibility criteria:
inclusion criteria: * male or female aged 18-40 years * hypotrichosis of eyebrows * healthy * informed consent obtained exclusion criteria: * no underlying diseases * no alopecia areata or trichotillomania * no thyroid diseases * no pregnancy or breast feeding * no previous eyebrow tattoo, trauma or accident. * no history of eyebrow or hair medications in 6 months * no history of minoxidil or its ingredient allergy * no history of eyebrow surgery.

Keywords: hypotrichosis of eyebrows thinning eyebrows minoxidil placebo randomized
comparative assessment of adjuvant effect of cultured epidermal autografts versus skin allografts on wound healing of burns treated with widely expanded skin autograft using meek micrografting technique meekadeau

Conditions: Burn Wounds

Summary: the investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to meek micrografting technique : cultured epidermal autografts and cryopreserved skin allografts.

10 patients presenting burn wounds over 50% of total body surface area, including at least 40 % of deep burns, will be enrolled.

Eligibility criteria:
inclusion criteria: 1. males and females between 18 to 60 years of age 2. burns \> 50% total body surface area (tbsa), including deep burns \> 40% tbsa (deep partial thickness and full thickness burns). 3. patients presenting two 300 cm² (30x10cm) non adjacent burn wound areas, of similar depth assessed by laser doppler imaging, on body anterior side, functional areas excepted. 4. written informed consent, signed by patient or legal representative (if patient unable to sign). 5. negative pregnancy test exclusion criteria: 1. chemical or electric burns 2. short delay life threatening disease, by itself or when associated with burns. 3. chronic systemic steroïd intake, 4. pre-existing diseases interfering with wound healing : inherited connective tissue disorder (ehlers danlos syndrome, marfan syndrome), epidermolysis bullosa. medical treatment interfering with wound healing (retinoids..). 5. prisonners 6. pregnant women 7. patient under guardianship. 8. participation in another investigational trial within this trial
qishenyiqi for ventricular remodeling after myocardial infarction

Conditions: Chronic Stable Heart Failure

Summary: the effects of qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. this project aims to clarify the efficacy and safety of qishenyiqi in patients with chronic heart failure after myocardial infarction. patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with qishenyiqi dripping pills; the control group was given placebo treatment. after 12 months of follow-up, the effects of qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. the results are helpful to provide a new treatment strategy for chronic heart failure.


Eligibility criteria:
inclusion criteria: * 1) the history of acute myocardial infarction exceeds 3 months; * 2) symptoms and signs of heart failure have been stable for more than one month; * 3) 18 years old or more; * 4) nyha cardiac function classified as grade ii\~iv; * 5) lvef≤40%； * 6) nt-probnp≥450pg/ml； * 7) all subjects or their guardians must sign the subject consent before entering the trial. exclusion criteria: * 1) patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor; * 2) planned to undergo cardiac surgery within 12 months; * 3) mechanical complications of myocardial infarction; * 4) pregnant or nursing, or having the intention to give birth within one year; * 5) patients who participated in clinical research of other drugs within 3 months before being selected; * 6) patients with poor sound transmission windows are examined by transthoracic ultrasound.
contrast enhanced ultrasound medical imaging for identifying breast masses

Conditions: Breast Carcinoma

Summary: this clinical trial investigates the role of contrast enhanced ultrasound (ceus) in identifying cystic breast masses as benign or malignant. ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). ultrasounds are widely used to diagnose many diseases in the body. this trial may help researchers learn if using ceus will help in determining whether or not an ultrasound guided biopsy is necessary.

primary objectives: i. to examine and compare the distribution of ceus parameters in breast masses that were evaluated as breast imaging reporting and data system (bi-rads) 4a, 4b, 4c or 5 by conventional ultrasound (us) and were recommended for ultrasound guided biopsy, and to evaluate whether these parameters can be used to classify suspicious cystic-appearing breast masses as benign or malignant. ia. to develop a ceus-based radiomics workflow to extract radiomic metrics (\> 1600 features) in classifying breast mass malignancy (radiomics). ib. to develop a systematic and rigorous machine learning (ml)-based framework comprised of classification, cross-validation and statistical analyses to identify the best performing classifier for breast malignancy stratification based on ceus-derived radiomic metrics (time-intensity curve \[tic\] analysis and radiomics). ic. to assess the independent contribution of radiomics classifier and time-intensity curve classifier to the model accuracy in discriminating benign from malignant cases (tic analysis versus \[vs.\] radiomics). id. to assess the potential benefit of machine learning classifier in preventing unnecessary biopsy (tic analysis and radiomics). outline: patients receive a contrast agent (lumason or definity) intravenously (iv) and then undergo ceus scan over 60-90 minutes.

Eligibility criteria:
inclusion criteria: * newly diagnosed breast masses assigned as birads 4a, 4b, 4c or 5 by conventional us and recommended for ultrasound guided biopsy * age \>= 18 years * female exclusion criteria: * contraindications to microbubble contrast: patients who have a known pulmonary hypertension and any known hypersensitivity to us contrast agent * women who are pregnant, possibly pregnant, or lactating * women currently undergoing neoadjuvant chemotherapy * women \< 18 years of age * masses in the same breast that had prior lumpectomy for cancer * women with cancer in the same breast will be excluded however, women with cancer in the contralateral breast will be eligible to participate in the study * women with an allergy to perflutren * prior history of biopsy for that specific lesion