Kornimate/medical-research-clean huggingface dataset:
comparison of slx-4090 combined with statin therapy versus statin alone in reducing ldl-c in patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: the purpose of this study is to determine whether slx-4090 in combination with statin therapy will reduce ldl-c in patients with hyperlipidemia more effectively than statin therapy alone.

1. ldl-c after 12 weeks of treatment 2. safety and tolerability 3. plasma levels of slx-4090

Eligibility criteria:
inclusion criteria: * ldl-c \> or = 100 mg/dl * on stable statin therapy for at least 6 weeks exclusion criteria: * coronary heart disease or risk factors for chd
studying dna in blood and bone marrow samples from young patients with acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how well patients will respond to treatment. purpose: this research study is looking at dna in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.

objectives: * to manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (all). * to provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects. * to facilitate research for childhood all using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of all, and risk of all subtypes (e.g., tel/aml1, bcr/abl, t-cell). * to provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood all. outline: this is a multicenter study. dna from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping. genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.

Eligibility criteria:
disease characteristics: * diagnosis of acute lymphoblastic leukemia (all) * previously enrolled in cog-9900, cog-c1991, cog-aall03b1, cog-aall05b1, cog-aall08p1, or other current cog or legacy trials for all and consented to submit blood and marrow samples for biological research studies * meets ≥ 1 of the following criteria: * germline dna that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after day 28 of remission indication therapy, or is known to come from a sample that contained \< 10% leukemic blasts * all blast dna that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained \> 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of all diagnosis patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: untreated childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia
the impact of renal impairment on the pharmacokinetic and pharmacodynamic of leo 27847

Conditions: Renal Impairment

Summary: the study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of leo 27847. volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.


Eligibility criteria:
main inclusion criteria: * male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months) * bmi ≥18.0 and ≤ 42 kg/m2 * patients with stable concomitant medical conditions * healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of cockcroft and gault within the range of: * ≥ 50 to ≤ 80 ml/min (mild group: 8 subjects), * ≥ 30 to \< 50 ml/min (moderate group: 8 subjects), * \< 30 ml/min (severe group: 8 subjects). main exclusion criteria: * patients with renal transplants or currently on haemodialysis or peritoneal dialysis * clinically significant illness or surgery within 4 weeks prior to dosing * clinically significant ecg abnormalities or vital sign abnormalities at screening * history of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft * clinically significant history or presence of any gastrointestinal pathology * use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for: * multivitamins or vitamin d taken on a regular basis * topical products without systemic absorption * hemoglobin ≤ 90 g/l * serum total calcium (adjusted for albumin) level \< 2.25 mmol/l * clinically significant history of congestive heart failure, cardiac dysfunction or liver disease
hypertrophic cardiomyopathy pilot study

Conditions: Hypertrophic Cardiomyopathy; Coronary Artery Disease

Summary: this study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate


Eligibility criteria:
inclusion criteria: * diagnosed hcm * documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest * maximal left ventricular wall thickness of \> 30mm * extensive fibrosis on cardiac mri (\>15% of total myocardial volume) * \>7.5%/5-year risk of sudden cardiac death as determined by hcm risk-scd exclusion criteria: * age \< 18 years * pregnancy * atrial fibrillation
physiotherapy in the treatment of breastfeeding difficulties

Conditions: Breastfeeding; Ankyloglossia; Lactation Disorders

Summary: the objective of this randomized, single-blind clinical trial is to compare the efficacy of two treatments (myofunctional therapy and breastfeeding sessions) in infants who have difficulty breastfeeding during the first week of life. the main questions to be answered are: * is breastfeeding improved with this type of intervention? * what type of intervention is better? * after carrying out these interventions, does the baby need to undergo surgery if it presents a sublingual frenulum? participants must be infants who are one week old and who have been diagnosed with ankyloglossia through the hazelbaker scale. they will be randomly distributed into the two intervention groups and after one month of treatment, they will be assessed again using the same scale. the researchers will compare the results between these two groups in order to verify the best intervention.

infants who met the inclusion and exclusion criteria, respectively, were accepted to participate in the study. the randomization of the sample was performed by a statistician, who had no prior contact with either the infants or the parents. the online randomizer (www.randomizer.org) program was used to randomly generate 200 sets of numbers, each containing two numbers ranging from 1 to 2 in random order. after signing the consent, a code was randomly chosen for each patient, thus ensuring that the 200 patients were equally distributed into two groups according to the group number of each code: group 1 (myofunctional therapy group) and group 2 (group sessions lactation). infants who met the inclusion criteria were referred to the rehabilitation and physiotherapy service. a physical therapist outside the study was in charge of evaluating the measurements of all infants during the first week of life through all the scales detailed below (pre-test). after randomly assigning the infants, another physiotherapist was responsible for applying the intervention once a week for 30 minutes for a period of 30 days. once the intervention was finished, all the infants (both intervention groups) were reassessed by the physiotherapist outside the study using the same baseline scales (post-test).

Eligibility criteria:
inclusion criteria: * full-term infants exclusively breastfed * born both by normal delivery and by cesarean section * who presented difficulty in breastfeeding exclusion criteria: * preterm newborns * with low birth weight (less than 2,500 kg) * mothers with flat or inverted nipples * patients who did not wish and did not authorize to participate in the study.

Keywords: breastfeeding ankyloglossia physiotherapy myofunctional therapy breastfeeding session
protocol for the esreflujo study: epidemiological study of heartburn and gastroesophageal reflux in community pharmacy

Conditions: Reflux

Summary: introduction: symptoms as heartburn and/or reflux is frequent consultations in community pharmacies, the characterization of them is crucial to provide appropriate patient counseling. to facilitate the assistance work of the community pharmacist and its coordination between different levels of care, a group of experts in community pharmacy, primary care, and gastroenterology has recently worked on an algorithm to manage these symptoms. objective: analyse the epidemiological characteristics of patients who consult for symptoms of heartburn and/or reflux in spanish community pharmacies, and evaluate the clinical and humanistic results of the protocolization of a professional pharmaceutical service in said patients. methods and analysis: the study design consists of a cross-sectional descriptive part, in which the clinical and sociodemographic characteristics of the patients who come to the community pharmacy will be evaluated for consultation derived from heartburn and/or reflux symptoms and a before-after descriptive study in which will evaluate the clinical and humanistic results in patients who come to the pharmacy after receiving pharmaceutical care.


Eligibility criteria:
inclusion criteria: * population´s age ≥ 18 years * patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it. exclusion criteria: * subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person * women with high-risk pregnancies

Keywords: heartburn, dyspepsia, reflux, pharmacy
a phase ii study of hmpl-504 in lung sarcomatoid carcinoma and other non-small cell lung cancer

Conditions: Lung Sarcomatoid Carcinoma

Summary: this is a phase ii, open-label, multicenter study of savolitinib administered orally once per day(qd) to locally advanced/metastatic psc patients and other nsclc patients with met exon 14 mutation. the targeted population is the patients with met exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.

savolitinib will be administrated 600mg or 400mg once per day (qd). the treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. a cycle of study treatment will be defined as 21 days of continuous dosing.

Eligibility criteria:
inclusion criteria: * 1.fully understood the study and voluntarily signed informed consent form * 2.age \> 18 years * 3.histologically or cytologically documented locally advanced or metastatic pulmonary sarcomatoid carcinoma (psc) patients and other non-small cell lung cancer（nsclc） with met exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy * 4.patient should have measurable disease per recist1.1 * 5.ecog performance status of 0, or 1 * 6.expected survival \> 12 weeks exclusion criteria: * 1.co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ. * 2.any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received tki (for ex. egfr-tki) treatment within 2 week prior to initiation of study treatment * 3.palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment * 4.herbal therapy within 1 week prior to the initiation of study treatment * 5. has egfr, alk or ros 1 positive mutation
evaluation of 2 resection strategies of synchronous colorectal cancer metastases

Conditions: Colorectal Cancer; Hepatic Metastases

Summary: the surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. the purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. endpoints include the rate of severe complications and survival.

in france, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. it is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. the aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. the primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.

Eligibility criteria:
inclusion criteria: * male and female adults over 18 years old * at least one adenocarcinoma of colon and/or rectum, histologically proven. * no local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion) * at least one hepatic metastasis which r0 resection is possible through a conventional simple resection * informed written consent. non inclusion criteria: * heart, respiratory or renal failure * physical or psychological dependence * chronic liver disease * extra-hepatic metastases exclusion criteria (at time of surgery) * localized or diffuse peritoneal carcinomatosis * non resectable lymph node metastases * colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver r0 resection impossible immediately * other hepatic lesions diagnosed with ultrasound making liver r0 resection impossible immediately

Keywords: colorectal cancer sequential or simultaneous surgery synchronous hepatic metastases
ultrasound crestal bone topography of edentulous ridges

Conditions: Ultrasonography

Summary: a successful implant surgery primarily relies on a prudent evaluation of oral anatomy and meticulous treatment planning. additionally, of paramount importance that dictates the types of procedures, material selection and ultimately success of implant surgery is the quality and quantity of the edentulous ridge. ultrasound imaging (us), another cross-sectional imaging modality, has been extensively used in the medical diagnostics field. the ability of ultrasound to image soft tissue-bone interface makes it particularly promising for studying bone ridge width and crestal bone topography. therefore, this retrospective human study aimed to compare bone width measurements between us and cbct. this study also investigated the possible correlation between the crestal bone surface quality imaged by us and cbct.


Eligibility criteria:
inclusion criteria: * patient records at the graduate periodontal clinic * with both us and cbct scans taking within 3 months between each other from jan 2016 to mar 2020 * these images had to include at least one edentulous ridge at the anterior, premolar or molar site. * multiple sites in a given patient may be included.
thyroid hormones in critically ill children

Conditions: Hypotension; Respiratory Failure

Summary: thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. we are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. we hope to get a better understanding of hormone levels and their effects on critically ill children to better help other children in the future.

we hypothesize that critically ill children that require vasoactive infusions and/or invasive mechanical ventilation have thyroid hormone alterations. we will measure tsh, tt3, ft3, rt3, tt4, ft4, adn tyrosine concentrations in critically ill children with hypotension and/or respiratory failure and correlate thyroid hormone alterations to severity of illness, intensity of therapeutic interventions, and associated morbidity and mortality by using clinical outcomes parameters.

Eligibility criteria:
inclusion criteria: * informed consent * age of less than 12 months and less than or equal to 18 * patient must weigh greater than 10 kgs. * patients must require vasoactive infusions and/or mechanical ventilation. * patients must be enrolled within 24 hours of meeting eligibility. exclusion criteria: * patient with known or presumed pre-existing thyroid disease will be excluded * patients who receive thyroid supplementation will be excluded * patients with known or presumed hypothalamic and/or pituitary dysfunction that have thyroid hormone concentration abnormalities not related to an acute illness. * patients who are intubated for airway protection only. * patients intubated for neuromuscular disease * pregnant patients. * patients receiving amiodarone supplementation * patients who received blood product transfusions equaling more than 1/2 of their blood volume.

Keywords: thyroid deficiency thyroid stimulating hormone
a study of hy209 in healthy male volunteers for sepsis

Conditions: Sepsis

Summary: a randomized, double-blind, placebo-controlled single dosing, dose escalation phase i clinical trial to investigate the safety/tolerability and pharmacokinetics of hy209 after intravenous administration in healthy male volunteers

hy209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of myeloid-derived suppressor cells (mdscs).

Eligibility criteria:
inclusion criteria: * healthy male aged from 19 to 45 at screening test * bmi 18 kg/m2 \~ 27 kg/m2 at screening test * subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ecg), and appropriate laboratory tests * those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion exclusion criteria: * those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing taurodeoxycholate component, aspirin, antibiotics, etc.) * those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher * those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases * those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug * those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening * patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit \[systolic blood pressure (sbp): \ 150 mmhg, diastolic blood pressure (dbp): \ 90 mmhg\] * those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug * those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month * those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening * those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date * those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (otc) within 1 week * caffeine overdose, alcohol overdose or oversmoker * those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial * other investigator judged to be unsuitable as clinical subject
quality of life and sexuality of patients over 65 years undergoing adjuvant treatment for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

evaluation of quality of life and sexual health will be assessed by the mean of validated self questionnaires after surgery for breast cancer, before and after adjuvant chemotherapy and one year after initial surgery

Eligibility criteria:
inclusion criteria: * women over 65 years of age * treatment by adjuvant therapy for breast cancer * ptxnxm0 * sexually active at least three months before inclusion * in couple or not exclusion criteria: * inflammatory breast cancer * not sexually active before breast cancer diagnosis * opposition to fill sel questionnaire and collection of the data

Keywords: sexual health quality of life adjuvant chemotherapy