Kornimate/medical-research-clean huggingface dataset:
phase 1 pediatric pharmacokinetics/pharmacodynamics (pk/pd) study

Conditions: Deep Vein Thrombosis; Venous Thromboembolism

Summary: this is the first evaluation of edoxaban in pediatric subjects. in this phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

phase 1, open-label, multiple-center study in pediatric patients from 0 to \< 18 years of age. patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the 60 mg (high dose) exposure in adults. exact doses will be selected during the study on the basis of pk modeling of emerging data. if unanticipated exposures are observed, the target doses may be modified to best match expected exposure response relationships observed in adults. enrollment in the study will start with the low dose, highest age group (adolescents) and will continue from low to high dose in each age group and from higher to lower age groups. enrollment in the next dose/age cohort will begin after 50% of the subjects have completed the previous dose/age cohort. age cohorts and dose groups: (6 participants each in low and high dose groups, for a total of 12 participants per age cohort) * 12 to \< 18 years of age * 6 to \<12 years of age * 2 to \<6 years of age * 6 months to \<2 years of age * 0 to \<6 months of age

Eligibility criteria:
inclusion criteria: * is a pediatric subject requiring anticoagulant therapy * will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours prior to edoxaban dose until after the last pk sample is collected * will follow food and concomitant medication restrictions exclusion criteria: * any major or clinically relevant unexplained bleeding during prior anticoagulant therapy * history of abnormal bleeding or coagulation within last 6 months prior to study drug administration * renal function with glomerular filtration rate (gfr) less than 50% of normal for age and size * malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome) * hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk, alanine transaminase (alt) \> 5 times the upper limit of normal (uln) or total bilirubin \> 2 times the uln with direct bilirubin \> 20% of the total

Keywords: pediatric pharmacokinetics (pk) pharmacodynamics (pdy) anticoagulant safety
the effect of treatment of emphysema with endobronchial valves on the diaphragm mobility

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema or COPD

Summary: in some patients with chronic obstructive pulmonary disease (copd) the breathlessness is caused by hyperinflation of the lungs. this causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. the diaphragm is the muscle used for breathing between the chest and the stomach. some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness. the goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. the main questions it aims to answer are: * if the movement of the diaphragm improves after treatment with endobronchial valves. * if there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability. * if ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment. participants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.

when emphysema is present in copd-patients, the impaired expiratory ventilation causes lung hyperinflation. this results in a change in the respiratory mechanisms of the thorax and thereby impairment of the movement capacity of the muscles. the most important respiratory muscle, the diaphragm, is caudally displaced and flattened, hence, the capacity and mobility of the muscle decreases. some patients with copd fulfill the criteria for treatment with endobronchial valves (ebv) where one-way valves can be inserted in the bronchial system. the mechanism behind the effect of ebv is believed to be formation of an atelectasis of the designated lobe and thereby reduction of hyperinflation and hence reduction of symptoms and increase in pulmonary function in this study the aim is to assess: 1. if the movement of the diaphragm improves after insertion of endobronchial valves in patients with severe emphysema. 2. if there is a correlation between improvement of diaphragm function and improvement of symptoms, lung function examinations and physical ability after insertion of endobronchial valves. 3. if immediate post-procedural ultrasound evaluation of diaphragm function predicts the development of atelectasis and hence clinical outcome

Eligibility criteria:
inclusion criteria: 1. patients selected to receive treatment with endobronchial valves 2. signed informed consent exclusion criteria: 1. neuromuscular disease interfering with diaphragm function 2. pleural effusion at time of preoperative or 90-days postoperative ultrasound

Keywords: ultrasound diaphragm endobronchial valves endobronchial lung volume reduction
one-year patient reported outcomes following hospitalization for trauma

Conditions: Wounds and Injuries

Summary: this study evaluates the three, six, and twelve month patient reported outcomes of people admitted two trauma centres in western canada over a four month period. participants are evaluated using the trauma outcome profile and a custom survey instrument.

this study intends to assess patient reported outcomes following discharge from trauma services at the foothills medical centre (fmc) and vancouver general hospital (vgh). the investigators will survey participants with pen-and-paper surveys at three, six and twelve months following discharge from hospital. the survey instrument being used is the trauma outcomes profile, which has been previously validated in this population, supplemented by a supplemental survey to help further describe resources this population has access to in their recovery. the results of these surveys will be compared with pre-injury health status, injury types, mechanisms, and discharge medications and treatments. the investigators anticipate enrolling 500 participants starting in october 2016. at the conclusion of the study the investigators will have a better understanding of patient reported functional outcomes after trauma and will be better positioned to design trauma rehabilitation systems to service this population.

Eligibility criteria:
inclusion criteria: * admitted to the trauma service at vgh or fmc * age 18 or older * resident of canada exclusion criteria: * english language literacy * impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey * no fixed address

Keywords: patient outcome assessment
effect of tpn171h on spermatogenesis

Conditions: Erectile Dysfunction

Summary: this study is a phaseⅰstudy to determine the acute effects of tpn171h on semen function in healthy male subjects.

safety study in male subjects

Eligibility criteria:
inclusion criteria: 1. male aged 18\~40years (included) 2. body mass index of 19 to 28 kg/m2; body weight no less than 50 kg; 3. sperm concentration ≥15\*10\^6/ml, sperm motility(a+b(%))≥32%, semen volume ≥1.5 ml, liquefaction time≤60 min 4. sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence. 5. take reliable contraceptive measures 6. physical examination, vital signs examination, laboratory examination, ecg were normal or abnormal without clinical significance; 7. be able to understand and willing to sign the informed consent form; exclusion criteria: 1. people with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease 2. people with vasectomy and ligation 3. people who have a history of hypersensitivity to other pde5 inhibitors or tpn171h; 4. there are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in b-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension; 5. blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (naion), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration; 6. a history of fainting needles or fainting blood; 7. blood loss or blood donation of 400 ml or more within 3 months before administration; 8. those who have taken any prescription drugs, over-the-counter drugs, chinese herbal medicines or health care products within 2 weeks before administration 9. those who have participated in other drug clinical trials and received trial drugs within 3 months before 10. positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 ml of beer or 45 ml of 40% spirits or 150 ml wine); 11. urine drug screening positive； 12. smoking more than 10 cigarettes per day ； 13. those who are positive for hepatitis b surface antigen (hbsag), hcv antibody, syphilis antibody and hiv antibody; 14. he investigator believes that there are other factors that are not suitable for participating in this trial.
metabolic consequences of cross-sex hormonal treatment

Conditions: Gender Dysphoria

Summary: retrospective study in a single academic regional transgender referral center. analyse vat, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls


Eligibility criteria:
inclusion criteria (retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. all measurements were made at the time of the routine follow-up visits) * age \>= 16 years (tanner stage iv) and \<= 50 years at the initiation of gender-affirming hormone therapy; * bmi \< 28 kg/m2 at the initiation of cross-sex hormonal treatment. exclusion criteria: * hormonal contraception * previous gender-affirming hormonal treatment * previous gender-affirming surgery * recognized syndrome or chromosomal defect, known metabolic or inflammatory disease, skeletal dysplasia, or chronic corticosteroid treatment.
down syndrome autonomic nervous system induction bradycardia

Conditions: Down Syndrome; Bradycardia

Summary: children with down syndrome (ds) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-ds patients. given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population. historically, individuals with ds were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. fortunately, today individuals with ds live into adulthood and surgical correction of anomalies is universally offered. thus, increasing numbers of children with ds are exposed to anesthesia and at risk for this hemodynamic catastrophe. it is medically unacceptable and an autonomic nervous system mechanism will be sought.


Eligibility criteria:
inclusion criteria: * patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of down syndrome and children with down syndrome exclusion criteria: 1. contraindication to adhesive placement, eg, epidermolysis bullosa 2. patient or parent refusal 3. opioids 4. heart rate altering therapy such as beta blockers 5. during the study period, participants will abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for \[6 hours\] before the start of the anesthetic. 6. participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.
does a preoperative prophylactic antibiotic reduce surgical site infection following wire-localized lumpectomy

Conditions: Breast Cancer

Summary: background: data on the benefits of preoperative prophylactic antibiotics for breast surgery are conflicting and there is no guideline for their use for wire-localized lumpectomy. the aims of this study were to determine whether a single dose of pre-operative antibiotic reduces surgical site infection (ssi) for wire-localized lumpectomy and to identify risk factors for ssi. methods: this was a prospective randomized trial carried out from april 2018 to june 2019 at the "centre des maladies du sein du chu de québec - université laval", a tertiary center specialized in breast surgery. after informed consent, patients who underwent wire-localized lumpectomy were randomized to receive or not a pre-operative single dose of prophylactic antibiotic (cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy). data regarding demographics, comorbidities, perioperative details, and ssi were analyzed. ssi was considered if: 1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion) within 30 days after operation, in the absence of wound culture or in the presence of negative results. the patients and the investigator responsible for data collection were blind to grouping. all patients were called 30 days after surgery to be sure that they did not consult at another hospital for surgical wound infection.


Eligibility criteria:
inclusion criteria: * \>18 years of age * female * scheduled for a wire-localized lumpectomy exclusion criteria: * pregnant or breastfeeding women * incapacity to give informed consent * preoperative breast infection * patients known to be colonized with mrsa * immunocompromised patients * preoperative antibiotic prophylaxis needed for any concomitant condition.
sensenbrenner clinical study

Conditions: Sensenbrenner Syndrome

Summary: sensenbrenner syndrome, also known as cranioectodermal dysplasia (ced), is a rare autosomal-recessive disorder belonging to the ciliopathy group of diseases. it is characterized by a facial dysmorphism, abnormal bone development and ectodermal defects including dental anomalies. ced is a heterogeneous condition with significant phenotypic and molecular variability, whose spectrum may include cases of renal impairment, hepatic fibrosis, retinitis pigmentosa and/or brain anomalies. in many cases, patients develop chronic kidney disease (ckd) due to nephronophthisis between 2 and 6 years of age. the aim of this retrospective study is to better understand the characteristics of this syndrome and to find prognostic factors of ckd. we make the hypothesis that an early diagnosis of the syndrome would lead to a better global management of patients (quality of life, delayed onset of end-stage renal disease).


Eligibility criteria:
inclusion criteria: * boys and girls. * aged 3 to 18 years old. * subjects with a sensenbrenner's syndrome diagnosis and followed from 2005 * parents/ legal guardian must provide non opposition prior to participation in the study exclusion criteria: * patients whose parents / legal guardian have object to using the data usually collected for care

Keywords: sensenbrenner syndrome phenotypic analysis craniofacial characteristics
impact of home-based cardiac rehabilitation on outcomes after tavr

Conditions: Aortic Stenosis

Summary: to evaluate the effects of a home-based cardiac rehabilitation program for chinese patients after transcatheter aortic valve replacement (tavr).


Eligibility criteria:
inclusion criteria: * aortic stenosis accepted for tavr * participant able and willing to give written informed consent * participant able (in the investigator's opinion) and willing to comply with all study requirements exclusion criteria: subjects may not enter the study if any of the following apply * intervention deemed inappropriate due to co-morbidity or frailty * life expectancy less than one year due to co-morbidity * previous surgical aortic valve replacement (savr) or tavr * predominant aortic regurgitation
role of the stress in the development of the metabolic syndrome

Conditions: Anxiety Disorders; Depressive Disorders; Metabolic Syndrome; Stress Disorders

Summary: the purpose of this study is determine the incidence of metabolic syndrome (mets) in people of high risk, of 40 or more years and attended in the primary care. evaluating the association between anxiety, depression, quality of life and the vital stressful events, and the development of the metabolic syndrome in general population. our hypothesis is that population of the cohort with bigger degree of stress will develop earlier the metabolic syndrome. if our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing in a future interventions on these factors of risk to prevent or to decrease the incidence of this syndrome in the primary care.


Eligibility criteria:
inclusion criteria: * both genders, elderly than 40 years * subjects with 1 or 2 criteria of ncep-atpiii set for metabolic syndrome * abdominal waist \> 102 cm ( men ) or \>88 cm ( women ) * blood pressure ( \>130/85 mmhg ) ( or else pharmacologic treatment of hypertension ) * hypertriglyceridaemia ( \>150 mg/dl ) ( or else pharmacologic treatment ) * hdl-cholesterol \<40 mg/dl ( men ) or \<50 mg/dl ( women ) ( or else treatment ) * fasting glucose \> 110 mg/dl. exclusion criteria: * metabolic syndrome (ncep-atpiii defined)(3 criteria of above mentioned) * severe or terminal disease * severe mental disease that difficulties the follow-up

Keywords: anxiety disorders depressive disorders metabolic syndrome stress disorders primary care
hlx07+hlx10+chemotherapy or hlx07 monotherapy in patients with advanced metastatic gastric cancer

Conditions: Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Summary: this study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. this study includes two arms: a and b. arm a (patients with her2 negative and pd-l1 cps≥5 ) will receive hlx07 combination therapy with hlx10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. arm b will receive hlx07 monotherapy as third-line or above treatment. all of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, hlx10 treatment up to 2 years).


Eligibility criteria:
inclusion criteria: 1. volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (icf); be willing to follow and be able to complete all study procedures; 2. age ≥ 18 years and ≤ 75 years when icf is signed; 3. unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma; 4. arm a: never received systemic anti-tumor drug therapy before, with her2 negative and pd-l1 cps≥5; arm b: failed to prior systemic anti-tumor therapy (at least 2 lines); 5. measurable lesion according to recist v1.1 by irrc; 6. ecog score 0-1; 7. expected survival 12 weeks. exclusion criteria: 1. has other active malignancies within 5 years before the first administration of the study drug; 2. plan to or have previously received organ or bone marrow transplantation; 3. uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 4. arm a: previously received antibody drugs against immune checkpoints (such as pd-1, pd-l1, ctla4, etc.) and / or antibody drugs against egfr; arm b: previously received antibody drug treatment against egfr; 5. have received any research drugs within 14 days before the first use of the study drugs.
preoperative anxiety and preemptive analgesia on postoperative delirium in adenotonsillectomy surgery

Conditions: Preoperative Anxiety; Postoperative Delirium

Summary: the effects of preoperative anxiety and preemptive analgesia on paed in children undergoing adenotonsillectomy surgery.

it is known that the frequency of postoperative delirium increases in children with preoperative anxiety. the modified yale preoperative anxiety inventory (m-ypas) was developed as a tool to assess children's preoperative anxiety, and m-ypas≥30 was considered 'anxious'. post-anesthesia recovery agitation (paed) is a self-limiting condition seen in children upon awakening from anesthesia in the first 15-20 minutes. there are factors such as inhalation agents, preoperative anxiety and postoperative pain in its etiology.

Eligibility criteria:
inclusion criteria: * 2-10 years old, * asa i-ii risk group * those who will be operated under general anesthesia under elective conditions. * will undergo surgery for adenoidectomy and/or tonsillectomy * patients whose informed consent form was read to their parents and their consent was obtained exclusion criteria: * those whose families do not want to participate in the study, * asa iii -iv-v patients * having a history of drug allergy and drug interaction, * having a history of systemic disease such as heart, kidney, liver failure, * having a history of bleeding diathesis, * difficult intubation expected, * obese, * emergency patients, * mental-motor retarded, * having psychiatric and neurological diseases, * those with chronic drug use