Kornimate/medical-research-clean huggingface dataset:
dissemination and implementation field trial of dialectical behavior therapy for adolescents with bipolar disorder

Conditions: Bipolar Disorder

Summary: the overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy dbt for adolescents with bipolar disorder in an outpatient mental health clinic. in collaboration with the university of pittsburgh, this study will measure study therapists' knowledge of the dbt model, adherence to the treatment model, and satisfaction with the treatment model.

this study proposes to implement dialectical behavior therapy (dbt) for adolescents with bipolar disorder (bd) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. in collaboration with the university of pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. this study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level. aim 1: to examine the short- and longer-term feasibility and acceptability of a training program in dbt for adolescents with bd through clinician satisfaction ratings. aim 2: to examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.

Eligibility criteria:
inclusion criteria: * english-speaking * age 13 years, 0 months to 19 years, 11 months * meet diagnostic criteria for bd by ksads-pl * engaged in, or willing to proceed with, a pharmacotherapy regimen * at least one parent/guardian with whom the patient lives or regularly interacts (\>5 hours per week) is willing to participate in skills training * able and willing to give informed consent/assent to participate. exclusion criteria: * evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the k-sads-pl, parent report, medical history, or school records * a life-threatening medical condition requiring immediate treatment * current victim of sexual or physical abuse.

Keywords: dialectical behavior therapy
the effect of wound problems wound dressing in patients with colorectal cancer surgery

Conditions: Colorectal Cancer; Surgery; Surgery--Complications; Surgical Site Infection; Wound Complication

Summary: this study was conducted as a randomized controlled trial in order to determine the effect of prophylactic negative pressure wound therapy for the prevention of surgical site complications in high-risk colorectal cancer surgery. hypothesis: prophylactic negative pressure wound therapy applied after open colorectal cancer surgery to high-risk patients affects surgical wound complications. pnbyt group: the study was completed with a total of 50 patients, 24 of intervention group anda 26 of the control group, who met the inclusion criteria at the surgical oncology service of a university hospital. the data were collected using patient identification form, surgical procedure form, wound follow-up chart and asepsi̇s wound scoring system. ethics committee approval and written informed consent of the individuals was taken in the research. the data were analyzed in spss statistics 24.0 program using shapiro wilk test and q-q graphs, independent sample t test, mann whitney u test, chi-square, cochran's q and friedman test. the value of p\<0.05 was accepted for the statistical significance level. it was determined that the groups were similar in terms of identification and surgical procedure characteristics.

the effects of negative pressure wound treatment applied to high-risk patients after open colorectal cancer surgery on four swcs, including surgical site infections, hematoma, seroma, and wound dehiscence, were studied. the study started before surgery and lasted up to one month after surgery. preoperatively, patients fasted for eight hours before the operation and were required to take a shower with 2% chlorhexidine gluconate at night. the patients who required surgical hair removal were shaved with a clipper in the operating room before the operation. also, patients received 1g of ampicillin + sulbactam/cefazolin within 60 minutes before the incision.

Eligibility criteria:
inclusion criteria: patients undergoing open colorectal cancer surgery, clean-contaminated (class-ii) or contaminated (class-iii) wounds, asa 2, 3, or 4, and fulfilling at least one of the following criteria were included: * 75 years old and above, * chronic disease such as diabetes (dm), chronic obstructive pulmonary disease (copd), heart failure (ejection fraction ≤ 40%), preoperative anemia (hb≤10mg/dl), * nutritional problems (bmi 30 kg / m2 and over, malnutrition (nrs 2002 score 3 and over or albumin≤3 mg/dl), * regular steroids or anticoagulants, * neoadjuvant chemotherapy and radiotherapy. exclusion criteria: -

Keywords: colorectal cancer colorectal surgery surgical site infection surgical wound complication negative pressure wound therapy
hormone changes in women with stage iiib or stage iv non-small cell lung cancer receiving erlotinib

Conditions: Advanced Nonsmall Cell Lung Cancer

Summary: studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels. this clinical trial is looking at hormone changes in women with stage iiib or stage iv non-small cell lung cancer receiving erlotinib.

patients undergo a dermatology evaluation and complete the polycystic ovarian syndrome (pcos) research study questionnaire once. blood samples are collected after an overnight fast. samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.

Eligibility criteria:
* histologically confirmed non-small cell lung cancer * stage iiib (effusion) or stage iv disease * must be receiving daily erlotinib hydrochloride for more than 3 months * must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess

Keywords: advanced nonsmall cell lung cancer
askb589 in combination with capox and pd-1 inhibitor in patients with advanced or metastatic gc/gej adenocarcinoma

Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Summary: this study is a multicenter, randomized, double-blind, standard-of-care controlled phase iii clinical study conducted in china. the purpose of this study is to evaluate the efficacy of askb589 plus capox and pd-1 inhibitor compared with placebo plus capox and pd-1 inhibitor (as first-line treatment) as measured by progression free survival (pfs).

this study is a multicenter, randomized, double-blind, standard-of-care controlled phase iii clinical study conducted in china. the purpose of this study is to evaluate the efficacy of askb589 plus capox and pd-1 inhibitor compared with placebo plus capox and pd-1 inhibitor (as first-line treatment) as measured by progression free survival (pfs). this study will also evaluate efficacy, physical function, safety, and tolerability of askb589, as well as its effects on quality of life. pharmacokinetics (pk) of askb589 and the immunogenicity profile of askb589 will be evaluated as well.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of gastric and gastroesophageal junction 2. advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization 3. suitable for chemotherapy combined with pd-1 inhibitor 4. not suitable for anti-her2 therapy 5. have at least one measurable lesion according to recist1.1 assessed by site investigator within 28 days prior to randomization 6. cldn 18.2 positive exclusion criteria: 1. patients with active central nervous system (cns) metastases or suspected carcinomatous meningitis 2. participants have significant gastric bleeding 3. the presence of clinically uncontrollable third interspace fluid 4. received anti-cldn18.2 antibody at any time in the past 5. suspected complete or partial obstruction of gastroesophageal access

Keywords: cldn 18.2 gastric adenocarcinoma gastroesophageal junction adenocarcinoma askb589
safety and effectiveness of buprenorphine transdermal system in elderly subjects with chronic pain: pilot study.

Conditions: Chronic Pain

Summary: this pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. the treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility criteria:
inclusion criteria: * residing in a nursing home, assisted living environment, or any type of supervised living situation in which the principal investigator maintained primary responsibility for the analgesic management of the resident. * chronic pain of musculoskeletal origin who had been managed with short-acting opioids. exclusion criteria: * taking \>90 mg oral morphine sulfate per day (during any single day) or \>50 mcg/hr of transdermal fentanyl or its equivalent. * activity restricted totally to bed rest. * have cancer-related pain. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: chronic pain elderly supervised living opioid transdermal
serratus plane block for breast reduction surgery

Conditions: Pain Management

Summary: serratus plane block was first described in 2013 by blanco and designed to primarily block the thoracic intercostal nerves. and this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.increased use of ultrasound guidance for regional anesthesia in recent years has led to definition of thoracic wall pecs blocks by blanco. the serratus plain block (spb), providing wider analgesia, with easier application and less adverse effects than neuroaxial blocks, has been defined after these blocks and has taken its place in the literature.in spite of the insufficient randomized clinical trials in the literature, spb has been reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections, and the results are promising. the aim of this study is to determine effectiveness of ultrasound guided bilateral serratus plane block in patients undergoing breast reduction surgery. main outcome measures: the primary endpoint is postoperative opioid consumption. secondary endpoints are visual analogue pain scores, opioid related side effects.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients undergoing breast reduction surgery exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases

Keywords: postoperative analgesia ultrasound guided serratus plane block
case management - active telephone support to patients with cold

Conditions: COLD

Summary: to investigate the effects of patient counseling by telephone on quality of life and the use of health care system.

by analyzing patient data, patients with risk of high consumption of the health system are identified. these patients are invited to take part in the study. if the patient accept the invitation, oral and written information of the study is given. if the patient give informed consent to participate, the inclusion and exclusion criteria and the patient record are examined. if the patient meet the criteria the patient is randomized to active treatment or control 1:1. patient in the intervention group have a in depth interview of health and social status and possible interventions are planned. following that, the patient is contacted by telephone on weekly intervals for 6 to 9 months. patients in both groups fill out questionaire short-form health survey-36 (sf-36) and copd assessment test (copd) and the consumption of health care is monitored.

Eligibility criteria:
inclusion criteria: * patient living in the zealand region. * a cold-related contact with hospital with-in 6 months. * predicted to be in high risk of new hospital admission. exclusion criteria: * dementia. * psychosis. * drug-addiction. * cancer with metastasis. * terminal illness. * language difficulties demanding translator.
new biomarkers in the intracystic liquid of inflammatory and non-inflammatory pancreatic cysts

Conditions: Pancreatic Cyst

Summary: due to the advances made in the field of the imaging techniques and their common use, pancreatic cysts are more and more incidentally found. pancreatic pseudocysts can be misdiagnosed as cystic neoplasms, in particular when there is no clinical history of acute or chronic pancreatitis. pancreatic cystic neoplasms on the other hand are rare, but are difficult to diagnose accurately. neutrophil gelatinase-associated lipocalin (ngal) , interleukin 1 beta (il1beta) and high mobility group at-hook 2 (hmga2) are molecules implicated in the process of inflammation and tumour development. the diagnostic value of their concentration in pancreatic cysts is not established yet. study aim to asses the significance of ngal,il1beta and hmga2 concentration in cystic fluid obtained by endoscopic ultrasound (eus) with eus-guided fine-needle aspiration (eus-fna) and serum level for discriminating between inflammatory and non-inflammatory pancreatic cyst.


Eligibility criteria:
inclusion criteria: * patients aged 18-90 years with an unclear specific diagnosis of pancreatic cysts * pancreatic cyst \>15mm on ct or mri * patients with pseudocysts with indication for drainage exclusion criteria: * refusal to participate * platelet level \ 1.5) * duodenal stenosis * severe chronic pancreatitis * history of pancreatic cancer or major upper abdominal surgery * congestive heart failure * the liquid sample \< 1ml;

Keywords: pancreatic cyst eus-fna intracystic fluid
evaluation of the autonomic nervous system in patients undergoing esophagectomy for cancer

Conditions: Esophageal Cancer

Summary: esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. the incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. a section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. the vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. the post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. the main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy.

the sympathomimetic balance was measured using a holter-ecg heart rate monitor. the parameters collected were used to calculate the variability of the heart rate, the high frequencies (hf, reflection of the parasympathetic system), the low frequencies (lf, reflection of the sympathetic system and the parasympathetic system) and the ratio // lf / hf (reflection of the sympathetic activity) thanks to fourier analysis and the use of hrvanalysis software. the measurements were taken at night, to overcome the great sympathomimetic variabilities due to external stimulations during the day: one night 3 month before surgery/before the first chemotherapy, one night between 2 and 4 weeks before hospitalization (remotely of possible chemotherapy), the night before the intervention (context of hospitalization and preoperative stress), one night between d7 and d10 (context of hospitalization, and distance from anesthetic drugs), one night at home between 4 and 8 weeks post-operative, and one night at home at 3 months post-operative. the measurements were therefore not carried out the first nights following the intervention to overcome the anesthetic drugs that affect the balance of the autonomic nervous system. a baroreflex measurement was carried out at the patient's entrance, the day before the intervention, during hospitalization, and the day of discharge. this measure was renewed at 3 months. a measurement of patient activity was carried out preoperatively by wearing an actimeter watch for 1 week then renewed at 3 months. a respiratory functional exploration associated with a stress test with calculation of the vo2max is systematically carried out before the esophageal surgery. a respiratory functional exploration was renewed 4 to 8 weeks after the intervention, and then at 3 months. the 6-minute walk test was performed at the same time.

Eligibility criteria:
inclusion criteria: * esophagectomy for cancer * written and oral agreement exclusion criteria: * pregnant women, * patients with permanent atrial fibrillation, * patients with pace-maker * patients under guardianship/curatorship

Keywords: esophagectomy surgery holter-ecg
a clinical trial to evaluate the efficacy and safety of olmesartan/amlodipine/rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia

Conditions: Hypertension; Hyperlipidemias

Summary: a multi-center, randomized, double-blind, phase iii clinical trial to evaluate the efficacy and safety of olmesartan/amlodipine/rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia


Eligibility criteria:
inclusion criteria: * age 20 to 80 years * patients with hypertension and hyperlipidemias exclusion criteria: * orthostatic hypotension * history of ventricular tachycardia, atrial fibrillation * uncontrolled diabetes mellitus
randomized trial comparing robotic and open radical cystectomy

Conditions: Bladder Cancer

Summary: the purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. the removal of the bladder and lymph nodes will be done by a robotic or by an open technique. it may be a robotic-assisted radical cystectomy (rarc) and pelvic lymph node dissection. or it may be an open radical cystectomy (orc) and pelvic lymph node dissection.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * scheduled for radical cystectomy at mskcc exclusion criteria: * prior pelvic or abdominal radiation therapy; * prior extensive open abdominal surgery, defined by the discretion of the attending surgeon * any clinical contraindication for trendelenburg positioning

Keywords: bladder cystectomy robotic open radical 10-016
characterization of a clinical subpopulation with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.


Eligibility criteria:
inclusion criteria: * participants previously diagnosed with asd (dsm-5) supported by either autism diagnostic interview revised (adi-r) or autism diagnostic observation scale (ados-2) scores * available health records within the first 2 years of life * participants must have a parent or reliable caregiver who agrees to provide information about the participant exclusion criteria: * genetically identified asd (syndromic form of autism, e.g. fragile x) * episode of fever (i.e. ≥100.5 °f) or clinically significant illness without fever (as judged by the investigator), within 10 days before the study visit
supplementation of l-arginine in patients with non-resectable brain metastases

Conditions: Unresectable Multiple Brain Metastases

Summary: this study evaluates the nutritional supplement arginine as supportive measure for patients with unresectable metastatic brain tumors that receive radiation therapy with palliative intent

brain metastasis, the most common intracranial tumor, is associated with neurological disability and short survival time. for selected patients this outcome can be improved by achieving greater local control. virtually all cancer patients with brain metastases receive radiotherapy; a majority as part of their primary treatment while others in connection with surgery or palliation. agents that increase the sensitivity of cancer cells to radiation may improve the control of the disease. previous data indicates that arginine supplementation can modify the metabolism of cancer and immune cells making tumors more susceptible to standard treatments liked radiation. in this phase 1/2 comparative study the investigators will investigate whether 10 mg of arginine oral supplementation (compared to placebo administration) administered twice a day prior to the radiation therapy can modify tumor metabolism, immune response and effect of radiation. the primary end-points are safety and toxicity of arginine, quality-of-life and clinical response. the secondary end-points are imaging response and neurological progression-free survival. additional exploratory end-points include intensity of radiation administered, effects on tumor metabolism by magnetic resonance spectroscopy, immune response by cytokine pattern in serum, body composition and nutritional parameters , overall survival and progression free survival

Eligibility criteria:
patients with pathology-confirmed diagnostic of solid cancer and measurable brain metastases by ct scan and/or mri inclusion criteria: * unresectable criteria by neurosurgeon * recursive partitioning analysis (rpa) -radiation therapy oncology group (rtog) class ii (karnofsky's performance score ≥ 70 and extracranial metastases and/or non-controlled primary tumor) * measurable brain lesion/s by contrast-enhanced ct or mri * absolute granulocyte count more or equal than 2000/mm3 * hemoglobin more or equal than 9 g/l (patients with lower levels were transfused before the randomization) * normal renal laboratory (serum creatinine \ 60 ml/min) * normal hepatic function (aspartate aminotransferase and alanine aminotransferase \<2.5 times the upper limit of normal) * stable body weight and composition for at least one month prior enrollment exclusion criteria: * prior treatment for brain metastases and/or brain tumor. * primary brain tumor * hematologic malignancies * solid tumors of germinal origin * contraindication for external radiation therapy. * allergy to l-arginine.

Keywords: cancer brain arginine radiation