Kornimate/medical-research-clean huggingface dataset:
a study of retatrutide (ly3437943) in the maintenance of weight reduction in individuals with obesity

Conditions: Obesity

Summary: this is a study of retatrutide in participants with obesity. the main purpose is to learn more about how retatrutide maintains body weight loss. the study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. participation in the study will last around 125 weeks.


Eligibility criteria:
inclusion criteria: * have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight exclusion criteria: * have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening * have a prior or planned surgical treatment for obesity * have a prior or planned endoscopic procedure and/or device-based therapy for obesity * have type 1 diabetes, type 2 diabetes, or any other type of diabetes * have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * have had within the past 90 days before screening: * acute myocardial infarction * cerebrovascular accident (stroke) * hospitalization for unstable angina, or * hospitalization due to congestive heart failure * have new york heart association functional classification class iv congestive heart failure * have a history of chronic or acute pancreatitis * have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
prospective evaluation of volatile sedation after heart valve surgery

Conditions: Valve Heart Disease; Awakening Early

Summary: cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids. the study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.


Eligibility criteria:
inclusion criteria: * valve reconstruction or valve replacement * must be capable to giving written consent exclusion criteria: * intolerance to volatile anaesthetics (e.g. malignant hyperthermia) * severe obstructive pulmonary disease * extended aortic arch or ascending aorta surgery * age \<18 years
a clinical trial to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers

Conditions: Renal Impairment

Summary: the purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.


Eligibility criteria:
inclusion criteria: \ * age: 20-65 years * egfr: \< 30ml/min/1.73m\^2 * not on dialysis * body weight: greater than 55kg * written informed consent \ * age: 20-65 years * body weight: greater than 55kg * written informed consent exclusion criteria: * ast, alt \> 1.5 times of upper normal range * positive drug or alcohol screening

Keywords: fimasartan renal impairment hypertension
comparison study of doxorubicin versus epirubicin-induced cardiotoxicity in patients with dlbcl

Conditions: Lymphoma

Summary: the aim of this study is to compare chop versus ceop-induced cardiotoxicity in patients with aggressive b-cell lymphoma. the hypothesis is epirubicin is associated with less cardiotoxicity without compromising the efficacy.

the doxorucin-containing regimen (chop) and epirubicin-containing regimen (ceop) are both frequently used in patients with aggress b-cell lymphoma in out institution. according to a cochrane meta-analysis, epirubicin is less cardiotoxic than doxorubicin on a mg per mg basis. however, compared with 50mg/m2 of doxorubicin in chop, epirubicin was usually used at a higher dose (70mg/m2) to treat non-hodgkin's lymphoma (nhl). because of the correlation between cumulative dose and risk of cardiotoxicity, it is reasonable to speculate that ceop (70mg/m2) has less cardiotoxicity than chop (50mg/m2) when both regimens are administered with similar cycles.

Eligibility criteria:
inclusion criteria: * previously untreated aggressive b-cell lymphoma * age range 18-75 years old * ecog performance status 0-2 * life expectancy of more than 3 months * adequate organ function exclusion criteria: * previous serious cardiac disease * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * pregnant or lactating women * serious uncontrolled diseases and intercurrent infection

Keywords: b-cell lymphoma chop ceop cardiotoxicity
safety evaluation of ss-por11

Conditions: Acne

Summary: the goal of the present study is to assess the safety of a topical probiotic (probiotic strain; ss-por11) on acne prone-skin, and the impact of ss-por11 on the distribution of porphyrins, in subjects with mild-to-moderate acne \[investigator's global assessment (iga) 1-3\].


Eligibility criteria:
inclusion criteria: * participant's first language of french or english, given the written language of the icf * participants willing to sign the icf upon entering the study * participant must be willing and able (in the pi's opinion) to comply with all study requirements * participant must be aged 18-40 years * participant must have a screening and baseline iga score of 1 (rare blemishes/clear skin) or 2-3 (mild to moderate facial acne vulgaris) * participant must agree to appear on all evaluation days and conform to all study-related instructions * participant must agree not to undergo any topical treatments in the areas under investigation during the study period exclusion criteria: * participants under the age of 18 years or over the age of 40 * refusal to sign the icf * participants has any injuries or tumors in the areas under investigation * participant has a recent (i.e., 3 months) surgery or invasive treatment in the areas under investigation * use of oral antibiotics within 4 weeks prior to start of study * use of oral or topical "probiotic" products within one month prior to start of study * prior (3 months) or planned use of chemical peels, microdermabrasion, microneedling, or exfoliants during the course of the study * participant is using or has used within 3 months drugs such as corticosteroids, immunosuppressants, or others collagen-production inhibitors * participant is pregnant or lactating or wishes to get pregnant within the next 3 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential) * participant has active herpes simplex in the investigated areas or a history of herpes labialis with four or more outbreaks in the 12 months prior to baseline * participant has immunocompromising diseases; any known allergy or hypersensitivity to any of the ingredients of the investigational product * participants possessing any of the contraindications for use of ss-por11 * participant has tattoos, piercings, excessive scarring (e.g., hypertrophic or keloid scars) in the areas under investigation * current or prior (3 months) change in the use of retinoids; initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; and any other criteria that at the discretion of the investigator, could interfere with study assessments or expose the subject to undue risk by study participation.
efficacy of the hypothermic compression bandage in the surgical wound of cardiac devices

Conditions: Pocket Hematoma

Summary: the aim of this study is to evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging, for the prevention of surgical wound hematoma of cardiac implementable electronic devices in patients undergoing chronic oral anticoagulant therapy and/or oral antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * patients under oral anticoagulation and/or antiplatelet treatment who were going to undergo implantation of an implanted device cardiac stimulation or generator replacement due to battery depletion exclusion criteria: * insertion of drainage in the wound, * non-compliance with the pre-surgical antithrombotic protocol * inr in a high therapeutic range (\>3.5) * do not follow-up in the same hospital * coagulation and hemostasis disorders * replacement of devices due to alterations in the operation unrelated to the battery.

Keywords: cardiac devices surgical wound oral anticoagulation therapy oral antiplatelet therapy compression bandage hypothermic therapy
utility of icd electrograms during ventricular tachycardia ablation

Conditions: Sustained Monomorphic Ventricular Tachycardia

Summary: with the increasing use of implantable cardioverter defibrillators (icd) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (vt) after an icd is in place and the only documentation of the clinical arrhythmia will be the icd electrogram (eg). the absence of a 12-lead ecg in patients with an icd and sustained monomorphic vt represents a limitation when performing treatment with radiofrequency (rf) ablation. the analysis of icd-eg during a rf ablation procedure is expected to provide a reference "model" of vt with clinical expression consisting of the electrical signal of the icd during vt (which otherwise is not generally possible to obtain in icd patients). this will allow for a more targeted approach to the substrate of the vt with clinical expression because: 1) if vt is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if vt is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of icd-eg. these approaches will result in improved outcomes of the ablation procedure.


Eligibility criteria:
inclusion criteria: * age 18 years or older * clinical indication for rf catheter ablation * presence of an implanted icd * at least 1 episode of spontaneous sustained monomorphic vt documented with icd electrogram * presence of structural heart disease * able to obtain signed informed consent and willing to comply with study activity requirements exclusion criteria: * it is anticipated that data can not be obtained during follow-up * unwilling or unable to provide informed consent * women who are or may potentially be pregnant * patients who are participating in another clinical trial
berotralstat treatment in children with hereditary angioedema

Conditions: Hereditary Angioedema; Pediatric

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) and safety of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to \< 12 years old for prophylactic treatment to prevent attacks of hereditary angioedema (hae).

this is a single-arm, open-label study designed to evaluate the pk and safety of berotralstat weight-based treatment for the prevention of hereditary angioedema attacks in pediatric participants 2 to \< 12 years of age. this study will consist of two treatment periods: a 12-week standard-of-care (soc) treatment period followed by an open-label berotralstat treatment period lasting up to 144 weeks. participants will be enrolled into 4 dose cohorts; participant weight will be used to determine assignment to each cohort with the higher weight cohorts (cohorts 1 and 2) enrolling first and in parallel. safety assessments and pk modelling from all available pk data will then be used to confirm the weight bands for sequentially enrolling cohorts 3 and 4.the effectiveness of berotralstat in this population will be summarized using descriptive statistical methods.

Eligibility criteria:
inclusion criteria: * male and non-pregnant, non-lactating females 2 to \< 12 years of age * body weight ≥ 12 kg * clinical diagnosis of hae * in the opinion of the investigator, the participant would benefit from long term oral hae prophylaxis exclusion criteria: * concurrent diagnosis of any other type of recurrent angioedema * known family history of sudden cardiac death * creatinine clearance using the modified schwartz formula of ≤ 30 ml/min/1.73 m2 * aspartate aminotransferase or alanine aminotransferase value ≥ 3 × the upper limit of the age-appropriate normal reference range value * clinically significant abnormal ecg including but not limited to, a corrected qt interval calculated using fridericia's correction \> 450 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping * current participation in any other investigational drug study or received another investigational drug within 30 days of enrollment

Keywords: berotralstat bcx7353 orladeyo® once a day hereditary angioedema (hae) pediatric oral once a day dosing kallikrein inhibitor
comparison of the management of post-prandial hyperglycemia by multiple bolus calculators

Conditions: Diabetes Mellitus Type 1

Summary: this prospective, non-randomized, non-controlled, interventional study will determine whether the roche automated bolus caclulator (abc) reduces post-meal hyperglycemia better than the competitor's abc without causing significant hypoglycemia.


Eligibility criteria:
inclusion criteria: * subjects \>/= 18 years at screening * type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit * subjects have to use a fast acting analog insulin * hba1c = 9% (measured with dca 2000) * willing to perform periods of intensive blood glucose (bg) monitoring for up to 21 days prior to the study (\~10 tests per day) with skipped meals and testmeals * willing to use the 3 different bolus calculators during the course of the study * willing to undergo planned hyperglycemia * willing to perform high frequency bg monitoring (\> 20 / day) during the experiment exclusion criteria: * type 2 diabetes * manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy) * current addiction to alcohol or substances of abuse * pregnant or lactating women * any known life-threatening disease
changes of intra abdominal pressure during surgeries in prone position as a marker of renal damage

Conditions: Intraabdominal Hypertension; Prone Postion; Spine Surgery

Summary: background: patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone. purpose of study: intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications. methodology: electronic device able to measure intra abdominal pressure is connected between a foley catheter and a urinary collecting bag. during the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. the numbers representing the pressure in mmhg are assessed and recorded. discussion: possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.


Eligibility criteria:
inclusion criteria: * consent to participate in the study * patients qualified for surgical stabilization of the spine in prone position exclusion criteria: * no consent to participate in the study or inability to obtain consent * the inability to insert a urinary catheter * no indication for urinary catheter * patients undergoing palliative treatment * patients with advanced liver and kidney disease
international cdkl5 registry

Conditions: CDKL5 Deficiency Disorder (CDD)

Summary: owing to the recent classification of cdkl5 deficiency disorder (cdd) as a unique disorder, there is a limited understanding of overall disease natural history and meaningful outcome measures. an international patient registry aimed at collecting both patient/caregiver and clinician-entered demographic, patient-reported outcome (pro) and treatment data would benefit both the scientific and patient communities. this cdd registry will follow up to 500 patients diagnosed with cdd over several years through both the patients/caregivers and their clinicians. initial data will be collected upon enrollment in the registry, followed by the collection of additional cdd-specific data on a bi-annual/ annual basis. no procedures will be performed as part of this registry. clinician-entered data will be collected following standard of care visits conducted as part of patients' ongoing clinical care. ultimately, the goal is to create a contact registry to allow patients/families to be alerted about relevant clinical trials and to collect valuable information that is accessible to the patient and scientific communities, thereby aiding and encouraging research in cdd.


Eligibility criteria:
inclusion criteria: * person of any age, living or deceased; * be a patient or the legal guardian (parent or caregiver) of a patient with a diagnosis of cdd (diagnoses must be confirmed by a clinician or genetic test); * have the ability to understand and complete an informed consent process where applicable per local regulations or have a legal guardian to provide consent on the patient's behalf if the patient is under the legal age, per local regulations, or otherwise unable to provide consent. exclusion criteria: * patient with a diagnosis of cdd who is under the legal age, per local regulations, enrolling without a legal guardian; * legal guardian of a patient who is 1) over the legal age, per local regulations, and 2) is able to read and provide consent and enter data. (we require that patients over the legal age who are capable of reading and understanding and informed consent provide data directly.)

Keywords: cdkl5 cdd cdkl5 disorder cdkl5 deficiency pediatric epilepsy epilepsy cdkl5 registry cdkl5 patient registry cdd registry cdd patient registry
source of human milk fortifier and intestinal oxygenation in preterm infants <30 weeks gestation

Conditions: Feeding; Difficult, Newborn

Summary: preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. standard volumes of human milk alone do not offer sufficient nourishment to these infants. there are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (b-hmf) or human sources (h-hmf). fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (nec), though it could potentially affect feeding tolerance. changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. research indicates that feeding a mother's own milk (mom) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (b-hmf) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives. the goal of this clinical trial is to compare the effect of h-hmf and b-hmf on splanchnic oxygenation in infants less than 30 weeks.

the fortification of human milk has been proven to enhance growth without raising the risk of necrotizing enterocolitis, although it may affect feeding tolerance. non-invasive techniques like doppler ultrasonography of the superior mesenteric artery (sma) and near-infrared spectroscopy (nirs) have been utilized to evaluate mesenteric blood flow and intestinal oxygenation in preterm infants. numerous studies have investigated the relationship between sma flow and feeding intolerance. findings indicate a significant correlation between increased mean superior mesenteric artery blood flow velocity and early tolerance of enteral feeding. moreover, research suggests a higher incidence of necrotizing enterocolitis (nec) in preterm infants exhibiting increased resistance patterns of sma blood flow velocity on the first day. non-invasive monitoring methods offer the ability to assess the impact of various fortification products on intestinal perfusion and oxygenation. this could aid in determining the most suitable fortification product to minimize episodes of feeding intolerance.

Eligibility criteria:
inclusion criteria: 1. preterm infants born \<30 weeks' gestation age and less than 1500g of weight. 2. admitted in neonatal intensive care unit at foothills medical center 3. reached full fortified enteral feed and at least 21 days of chronological age. exclusion criteria: 1. chromosomal or major congenital anomalies 2. infants diagnosed with nec.

Keywords: feed intolerance human milk fortifier bovine based human milk fortifier human milk based human milk fortifier preterm infants
immune biomarker study for cisplatin-ineligible patients receiving chemoradiotherapy with docetaxel

Conditions: Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of the Hypopharynx; Larynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

Summary: analysis of tumor tissue (which is already available in pathology) and collection of saliva/stool and blood samples, which are obtained as part of a routine collection. these will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.


Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated * patients who are cisplatin-unfit for chemotherapy, defined as: * ecog 2 * organ dysfunction ≥ 2 according to national cancer institute common toxicity criteria (nci ctc) version 4.0, such as hearing loss or tinnitus or neurological diseases * calculated creatinine clearance of ≤50ml/min * impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \< 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension * poor nutritional status bmi \< 16kg/m² * concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses. * willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes * age ≥ 18 years * sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it exclusion criteria: * distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion * malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri) * carcinomas in which no sample collection is possible or likely without compromising the pathological assessment * persistent drug or medication abuse * patients who are unwilling or unable to comply with the protocol and receive treatment * patients who are unsuitable for participation in the study due to a language barrier