Kornimate/medical-research-clean huggingface dataset:
effects of malnutrition on respiratory and renal functions in patients undergoing peroral endoscopic myotomy (poem)

Conditions: Esophageal Achalasia

Summary: the hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing poem surgery.

the primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and must score in achalasia patients planned for poem operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications. the secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after poem procedure.

Eligibility criteria:
inclusion criteria: * criteria for inclusion in the study: * patients diagnosed with achalasia and suitable for poem treatment by gastroenterology physicians * asa 1-3 * between the ages of 18-80 exclusion criteria: * criteria for exclusion from the study: * those with a known history of active lung infection, advanced copd, or respiratory failure * patients with ef below 40%, severe ischemic heart failure, presence of valve disease * those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand) * severe kidney dysfunction * in the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both * pre-existing increased intracranial pressure * having a bmi \>30 * severe uncorrected hypovolemiahistory of radiotherapy to the esophagus * history of mucosal resection or ablation in the area where poem will be applied * presence of cirrhosis and portal hypertension.

Keywords: peroral endoscopic myotomy anesthesia esophageal achalasia
effect of the mediterranean diet in patients affected by cadasil and cerebral amyloid angiopathy.

Conditions: Cerebral Amyloid Angiopathy; CAA - Cerebral Amyloid Angiopathy

Summary: the study is divided into two phases: phase 1 (observational) and phase 2 (dietary intervention). the goal of phase 1 is to assess the nutritional status and dietary habits of two cohorts of patients with cadasil and caa. a specific aim is to evaluate adherence to the mediterranean diet. the objectives include analyzing patients' nutritional status, lean and fat mass, basal metabolism, and total energy expenditure. it also aims to assess the relationship between adherence to the mediterranean diet and the onset of stroke and cognitive decline, as well as examine stroke severity (ischemic or hemorrhagic) and its association with mediterranean diet adherence (medas questionnaire). additionally, the study will explore the link between diet adherence and cognitive deficits, and measure changes in biological and anthropometric parameters as a result of adopting the mediterranean diet. phase 2 is an interventional dietary study designed to evaluate the effects of the mediterranean diet, enriched with either extra virgin olive oil or walnuts, on stroke incidence and cognitive decline in patients with caa and cadasil.


Eligibility criteria:
inclusion criteria: * the study will include individuals of both sexes aged 18 years or older with a diagnosis of cadasil (confirmed genetically by the presence of the notch3 gene mutation) or possible/probable caa (defined according to the boston 2.0 criteria). all participants must provide informed consent for the use of demographic, clinical, and nutritional data for scientific purposes in an anonymous form exclusion criteria: * na

Keywords: cadasil caa mediterranean diet nutritional status cognitive decline stroke incidence
long-term outcomes associated with juvenile-onset mycosis fungoides and lymphomatoid papulosis

Conditions: Lymphomatoid Papulosis; Mycosis Fungoides

Summary: to follow up with all our participants with juvenile-onset mycosis fungoides, check on their status, and ask them or their parents about long term outcomes associated with their condition.

primary objective -to characterize the long-term outcomes associated with juvenile-onset mycosis fungoides (jmf) and lymphomatoid papulosis (lyp). the study will consider metrics such as 5-year and 10-year overall survival, and overall disease activity. secondary objective -to characterize treatments and associated comorbidities.

Eligibility criteria:
inclusion criteria: -to be eligible, participants had to be diagnosed with jmf or lyp before age 20. in the case of participants below the age of 18, parents and not the children will be contacted for participation (children are exempt from participation as their parents may answer our study questions). exclusion criteria: -participants older than 20 years of age at diagnosis
pediatric enhanced recovery after cardiac surgery

Conditions: ERAS; Pediatric ALL; Congenital Heart Disease

Summary: identify our institution's current perioperative management strategies for pediatric cardiac surgery patients. identify predictive factors for receiving perioperative care following p-eracs strategies. compare outcomes between p-eracs and non-p-eracs patients

study aims to 1) assess our institution's current perioperative management strategies for pediatric cardiac surgery patients, 2) identify which patient population would be appropriate for inclusion in a pediatric eracs (p-eracs) program, and 3) compare the outcomes of patients whose perioperative care followed general consensus p-eracs strategies (p-eracs patients) and those whose perioperative care did not (non-p-eracs patients). results from this study will inform current efforts to establish a local p-eracs protocol, and facilitate the initiation of a clinical trial to assess adherence to a p-eracs pathway as well as the impact of such a pathway on patient outcomes.

Eligibility criteria:
inclusion criteria: * all pediatric patients (\&lt;18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (cpb) exclusion criteria: * emergency procedures and transplantation (heart, lung, heart and lung)
preoperative educational videos reduce maternal anxiety whose children received congenital heart disease surgery

Conditions: Educational Videos; Maternal Anxiety; Surgery; Congenital Heart Disease in Children; Maternal Depression

Summary: to examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. compared to only routine education, adding digital video disk could decrease mothers' anxiety more after education, and until the day of discharge. compared to only routine education, adding digital video disk could decrease mothers' anxiety more on the discharge day if their child had surgical or post-surgical complications.

aims and objectives: to examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. background: mothers experience anxiety and depression if their children undergo conditions mentioned above. design: a randomized control-group pretest-posttest design. the consort checklist is used. methods: in a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. between groups, mothers' anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on anxiety and depression at discharge day was evaluated.

Eligibility criteria:
inclusion criteria: * mothers, whose children underwent first elective cardiac surgery for congenital heart disease * mothers should have been the primary caregivers * mothers able to communicate effectively, either orally or in writing exclusion criteria: * mothers of children with genetic disorders * mothers of children with non-cardiac congenital anomalies * mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and \* \* mothers of children with chronic lung diseases
candesartan cilexetil in heart failure assessment of reduction in mortality and morbidity (charm preserved)

Conditions: Congestive Heart Failure

Summary: a study to evaluate the effect of atacand on patients with heart failure with preserved left ventricular function


Eligibility criteria:
inclusion criteria: * male or female aged 18 or above * congestive heart failure with symptoms for more than 4 weeks before starting study * provision of informed consent exclusion criteria: * current low blood pressure with symptoms * liver disease considered significant by the study doctor * pregnant or lactating females

Keywords: congestive heart failure atacand candesartan
the relationship between arterial stiffness and hemodynamic responses in patients with spinal anesthesia

Conditions: Arterial Stiffness; Hypertension; Spinal Anaesthesia

Summary: the aim of this study is to investigate the importance of pulse wave velocity, an indicator of arterial stiffness, in predicting hemodynamic changes in normotensive and hypertensive patients undergoing spinal anesthesia.

the prospective cross-sectional study will be carried out between september 1, 2021 and september 1, 2022 at aydin adnan menderes university faculty of medicine. patients aged eighteen and over who will undergo lower extremity surgery under spinal anesthesia will be included in the study. during the preoperative evaluation, the patient will be asked about age, weight, height, smoking and alcohol use history. at the same time, hypertension disease (if any, drugs used), diabetes (if any, drugs used), hyperlipidemia (if any, drugs used) and other diseases and drugs used will be recorded. before surgery, hemodynamic data (systolic arterial blood pressure, diastolic arterial blood pressure, mean arterial blood pressure, heart rate and oxygen saturation), arterial stiffness measurement (pulse wave velocity) will be evaluated in the patient preparation room. arterial stiffness measurement will be made with the oscillometric mobil-o-graph device in the anesthesia department. hemodynamic data is recorded by the anesthesia device 1.,3.,5.,10.,20. minutes during surgery. intraoperative hypotension is accepted as a 20% reduction in systolic arterial blood pressure evaluated before anesthesia. using this data recorded on the monitor, reductions of 20% or more in systolic arterial blood pressure will be recorded as hypotension.

Eligibility criteria:
inclusion criteria: * undergoing elective lower extremity surgery * 18 years and over * who agreed to participate in the study * asa i-ii exclusion criteria: * undergoing cardiovascular or neurological surgery within 6 months * unwilling to participate in the study * undergoing prosthetic valve surgery * vasculitis * peripheral artery disease * under the age of 18 * conditions in which spinal anesthesia is contraindicated
to determine the maximum tolerated dose (mtd) of bibf 1120 in patients with solid tumours

Conditions: Malignant Solid Tumour

Summary: the primary objective of this study was to determine the maximum tolerated dose (mtd) of bibf 1120 in patients with solid tumours by the monitoring of drug-related adverse events. secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment * evaluable tumour deposits by one or more techniques (x-ray, ct, mri, ultrasound) * age 18 years or older * life expectancy of at least three months * patients had to give written informed consent (which must be consistent with international conference on harmonization good clinical practice (ich-gcp) and local legislation) * eastern cooperative oncology group (ecog) performance score \< 2 * full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy exclusion criteria: * history of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing * pregnancy or breastfeeding * active infectious disease * brain metastases requiring therapy * absolute neutrophil count less than 1500 / mm3 * platelet count less than 100 000 / mm3 * bilirubin greater than 1.5 mg / dl (\> 26 μmol / l, international system of units (si unit) equivalent) * aspartate amino transferase (ast) and / or alanine amino transferase (alt) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) * serum creatinine greater than 1.5 mg / dl (\> 132 μmol / l, si unit equivalent) * uncontrolled, severe hypertension * gastrointestinal disorders anticipated to interfere with the resorption of the study drug * serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol * women and men who are sexually active and unwilling to use a medically acceptable method of contraception * treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) * patients unable to comply with the protocol * active alcohol or drug abuse
efficacy study of gemcitabine, paclitaxel, and irradiation in the treatment of pancreatic cancer

Conditions: Carcinoma, Pancreatic Ductal

Summary: the purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (gemzar) and paclitaxel (taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.

based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 gy, we are conducting this study incorporating the use of gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed adenocarcinoma of the pancreas. 2. patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability. 3. patients with residual disease after resection (r-1 or -2, micro and macroscopic residual) are eligible. 4. patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation. 5. all malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum). 6. all patients must have radiographically assessable disease. 7. electrocardiogram (ekg), chest x-ray, abdominal computed tomography (ct)/magnetic resonance imaging (mri) scan must be obtained within four weeks of study entry. 8. eastern cooperative oncology group (ecog) performance status 0-1. 9. required entry laboratory parameters: granulocytes \>/= 1,800/µl, platelet count \>/= 100,000/µl, bilirubin \< 2.0 mg/dl, alanine aminotransferase (alt) \< 3 x upper limit of normal, and creatinine \< 3.0 mg/dl. 10. signed study-specific consent form prior to study entry. exclusion criteria: 1. patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites. 2. previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (gemzar® or taxol®). 3. malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder. 4. patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.

Keywords: pancreatic cancer hyperfractionated radiation therapy gemcitabine paclitaxel carcinoma, pancreatic ductal
management of preoperative anxiety in children: could a lollipop be the solution?

Conditions: Anxiety, Preoperative

Summary: the aim of the study is to evaluate the effectiveness of distraction using a lollipop versus premedication with intranasal midazolam to manage preoperative anxiety in pediatric anesthesia.

participants were randomized into two groups to receive either intranasal midazolam at 0.3 mg/kg (group m) or distraction using a lollipop (group l) 15 minutes before entering the operating room. the anesthetic technique was standardized: a peripheral intravenous line, intravenous induction (propofol and fentanyl), airway management with an age-appropriate igel mask, and maintenance with sevoflurane. anxiety was assessed using the modified yale preoperative anxiety scale (mypas) before and after premedication. the investigators also evaluate the level of sedation upon entering the operating room, the quality of parent separation, acceptance of the facemask during induction, and emergence of agitation using the pediatric anesthesia emergence delirium scale (paeds).

Eligibility criteria:
inclusion criteria: * age \> 4 ans , asa 1 ou 2 exclusion criteria: * children who rejected premedication - the occurrence of perioperative complications

Keywords: anxiety children anesthesia distraction midazolam
a double-blinded, randomised, three-period crossover euglycaemic clamp trial investigating the pharmacokinetics, glucodynamics and safety of biochaperone human insulin, human insulin (huminsulin® normal) and insulin lispro (humalog®) in subjects with type 1 diabetes

Conditions: Diabetes Mellitus Type 1

Summary: the addition of biochaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection. the aim of the trial is to assess the efficacy and safety of biochaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 u/kg. this trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. each subject will be randomly allocated to a single dose of biochaperone human insulin 0.2 u/kg, a single dose of huminsulin® normal 0.2 u/kg and a single dose of humalog® 0.2 u/kg on 3 separate dosing visits.


Eligibility criteria:
inclusion criteria: * male subject with type 1 diabetes for at least 12 months * treated with multiple daily insulin injections or insulin pump (csii) for at least 12 months * body mass index: 18.5-28.0 kg bw·m-2 * hba1c: ≤ 9.0% exclusion criteria: * diabetes mellitus type 2 * receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial * clinically significant abnormalities as judged by the investigator * any systemic treatment with drugs known to interfere with glucose metabolism * history of alcoholism or drug/chemical abuse as per investigator's judgement * use of any tobacco or nicotine-contained product within one year prior to screening
orthopaedic conservative treatment in the time of covid-19 pandemic

Conditions: Ankle Fractures; Proximal Humeral Fracture; Wrist Fracture

Summary: this is a one centered retrospective study. tendency for surgical interventions in the pre-pandemic period was reduced to protect surgical team and patients. the investigators aimed to find out the answer to the following question: will conservative treatment be the shining star in the post pandemic period?

the researchers compared the treatments performed for fractures during the covid 19 pandemic period with the treatments performed in the prepandemic period. for this purpose, they tried to measure the effectiveness of the treatments according to clinical scoring by forming 2 groups.

Eligibility criteria:
inclusion criteria: * patients with extraarticular distal radius fracture, proximal humerus fracture and weber type b ankle fracture were treated conservatively during march 11, 2020 and 11 august, 2020 exclusion criteria: * surgically treated patients during march 11, 2020 and 11 august, 2020
prostar: a study evaluating cpi-1205 in patients with metastatic castration resistant prostate cancer

Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Summary: this is a two-arm, open label phase 1b/2 study with an oral administration of cpi-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with metastatic castration resistant prostate cancer. this study is designed to determine the maximum tolerated dose (mtd) and recommended phase ii dose (rp2d) based on safety, tolerability, pharmacokinetic, and efficacy profiles of cpi-1205 in combination with either enzalutamide or abiraterone/prednisone. following determination of mtd and rp2d will proceed to phase 2. patients in phase 2 will receive cpi-1205 at the rp2d in combination with either enzalutamide or abiraterone/prednisone vs either enzalutamide or abiraterone/prednisone as a control arm.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) * eastern cooperative oncology group (ecog) performance status 0-1 * life expectancy of at least 12 weeks * histologically or cytologically confirmed adenocarcinoma of the prostate * progressive disease in the setting of medical or surgical castration (i.e. crpc) * documented metastatic disease * must have undergone bilateral orchiectomy (surgical castration) or be willing to continue gonadotropin-releasing hormone (gnrh) analog or antagonist (medical castration) * serum testosterone \<50 ng/dl * receipt of prior line of second generation androgen inhibitor * demonstrate adequate organ function as defined below: * absolute neutrophil count (anc) ≥ 1,000/μl * platelet count ≥ 100,000/μl * hemoglobin (hgb) ≥ 8 g/dl * serum creatinine ≤ 2 × upper limit of normal (uln) or * creatinine clearance (crcl) ≥ 40 ml/min as estimated by the cockcroft and gault formula1 in subjects with creatinine \> 2 x uln * bilirubin ≤ 1.5 × uln unless evidence of gilbert's disease in which case \< 3 x uln * aspartate aminotransferase (ast) ≤ 2.5 × uln without liver metastases; must be ≤ 5 × uln with liver metastases * alanine aminotransferase (alt) ≤ 2.5 × uln without liver metastases; must be ≤ 5 × uln with liver metastases exclusion criteria: * known symptomatic brain metastases (note: patients with treated epidural disease are allowed) * treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of treatment: 1. first generation: ar antagonists (e.g., bicalutamide, nilutamide, flutamide) within 4 weeks 2. 5 alpha reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol \[des\]), or progesterones within 2 weeks 3. chemotherapy within 3 weeks 4. biologic therapy within 4 weeks 5. investigational therapy within 3 weeks (or within a time interval less than at least 5 half-lives of the investigational agent \[if known\], whichever is longer). 6. immunotherapy within 4 weeks 7. prior radionuclide therapy within 4 weeks

Keywords: phase 1/2 oncology ezh2 inhibitor