Kornimate/medical-research-clean huggingface dataset:
pre- and postoperative cognitive behavior therapy for patients accepted for bariatric surgery

Conditions: Obesity, Morbid

Summary: the purpose of this study is to investigate the relationship between the potential predictive psychological variables and success after bariatric surgery. the investigators will also investigate the purpose of a pre- and postoperative psychological intervention.

bariatric surgery is the treatment of choice for morbid obesity, but it does not lead to equal results in every patients. research about personality factors involved in successful outcome after bariatric surgery has led to contrasting results. the existing literature about potential predictors of success after bariatric surgery is far from conclusive. the investigators want to evaluate preoperatively by standardized diagnostic interviews (mini, scid-ii) and rating scales and questionnaires to assess co-morbid psychopathology. the same evaluation will be done after 1,2 and 5 years. the investigators will look for a relationship between psychological variables and success after bariatric surgery, including amount of weight loss, psychiatric comorbidity, quality of life and employment. the investigators will also investigate the purpose of an pre- and postoperative psychological intervention. patients on a waiting list for bariatric surgery are randomised to an intervention- and a control group. the intervention is based on cognitive behavior therapy and mindfulness, 6 weeks preoperative and two weeks postoperative programme. outcome measures are amount of weight loss, psychiatric comorbidity, quality of life and employment.

Eligibility criteria:
inclusion criteria: * patients on a waiting list for bariatric surgery at haugesund hospital exclusion criteria: * patients with psychosis and suicidality * suicidal attempts the last two years * or suicidal thoughts or plans.

Keywords: comorbidity quality of life body weight changes
a study of ametumumab in combination with anti-pd-1 monoclonal antibody and folfiri in patients with ras wild-type advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: this is a multicenter, open-label, parallel-group, randomised, a phase iib clinical trial of efficacy and safety of ametumumab in combination with anti-pd-1 monoclonal antibody and folfiri versus ametumumab or cetuximab in combination with folfiri in patients with ras wild-type advanced colorectal cancer.

this is a multicenter, open-label, parallel-group, randomised, phase iib trial. this study is to evaluate and compare the efficacy and safety of ametumumab (anti-egfr monoclonal antibody) combined with anti-pd-1 monoclonal antibody in first-line treatment of ras wild-type colorectal cancer patients, as well as to assess the immunogenicity and pharmacokinetic profile and recommend dosing regimen for phase iii clinical trials.conditions and keywords.

Eligibility criteria:
inclusion criteria: voluntarily sign written informed consent; age 18 \~ 85 years (inclusive), male or female; •patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; histologically or cytologically confirmed adenocarcinoma of the colon or rectum; ras (kras, nras) gene is wild-type and no braf v600e mutation has been identified; presence of at least one measurable lesion (non-radiation field) confirmed by ct or mri that meets recist 1.1 criteria; performance status (ecog) score 0 or 1. exclusion criteria: previous chemotherapy for colorectal cancerprevious treatment with anti-egfr monoclonal antibodies received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose. radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy participation in other clinical trials within 4 weeks prior to enrollment; severe skin disease requiring systemic treatment. presence of serious clinical infection.\\ uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.
percutaneous closure of atrial septal defects in children: integration of 3d echocardiography and fluoroscopy imaging.

Conditions: Atrial Septal Defects

Summary: the interventional catheterization allows the percutaneous treatment of congenital heart diseases as the atrial septal defect (asd). the examination is guided by the x-rays with stochastic side effects worrying at the child's. the software "echonavigator" allows to merge the ultrasound image and fluoroscopic. this innovative software facilitates the procedures and reduce the irradiation time in some adult procedures. the aim of this study was to validate the image fusion in children.

the software "echonavigator" will be used after the introduction of the percutaneous closure of asd prosthesis. the image fusion on fluoroscopy will then be applied and the bias between the generated ultrasound image and the x-ray view of the prosthesis will be measured. the center marker visible prosthesis ultrasound and fluoroscopy used as a reference marker.

Eligibility criteria:
inclusion criteria: * weight higher than or equal to 20 kg * presence of an ostium secundum atrial septal defect diagnosed by transthoracic echocardiography and associated with a shunt from left to right evidenced by the significant dilation of the right cavities liable to a closure * the asd should have an anatomy allowing percutaneous closure according to international recommendations exclusion criteria: * children with contraindication to transesophageal ultrasound according to international recommendations * ads with minor shunt without indication of closure * refusal to participate in the study expressed by parental authority

Keywords: atrial septal defects (asd) percutaneous closure
posaconazole tablet as primary prophylaxis of hsct patients with gastrointestinal gvhd

Conditions: Invasive Fungal Disease; Graft Versus Host Disease; Hematopoietic Stem Cell Transplantation

Summary: this is a prospective investigation using a nonrandomized, single-arm design. posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive hsct as the primary prophylaxis of ifd, after which the posaconazole plasma concentration on day 5 will be examined.

this is a prospective investigation using a nonrandomized, single-arm design. posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive hsct as the primary prophylaxis of ifd, after which the posaconazole plasma concentration on day 5 will be examined. once patients developed gi gvhd, first line therapy and second line treatment will be reviewed according to the condition, besides which the posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of gi gvhd symptoms to monitor the impact of gi gvhd on the posaconazole plasma concentration. the primary endpoint was the incidence of breakthrough fungal infection (bfi) including proven, probable and possible fungal infection

Eligibility criteria:
inclusion criteria: 1. patients with hematologic diseases who undergoes hematopoietic stem cell transplantation. 2. patients who receive posaconazole tablet as primary prophylaxis of invasive fungal disease. 3. patients developing or developed acute gastrointestinal gvhd which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors. gastrointestinal gvhd grades (i-iv) were recorded according to the glucksberg criteria. 4. patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent exclusion criteria: 1. refuse to enroll 2. patients have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used. 3. pregnant or lactating females 4. take drugs known to interfere with azole antifungal agents, including terfenadine, cisapride and ebastine, within 24h before posaconazole application; astemizole at enrollment or within 10 days before posaconazole application; or cimetidine, rifampin, carbamazepine, phenytoin, rifamycin, barbiturates, isoniazid, catharanthine and anthracyclines within 24 h before posaconazole application 5. have an ecg with a prolonged qtc interval (qtc greater than 500 ms); 6. have severe renal insufficiency, alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin levels more than two-times the upper limit of normal; 7. patients are expected to survive no more than 72 h; 8. those with evidence of active fungal infection within 3 weeks prior to enrollment

Keywords: hematopoietic stem cell transplantation graft versus host disease invasive fungal disease primary prophylaxis
improving surgical patient outcomes through implementation of a semistructured intraoperative anesthesia handoff tool

Conditions: Post-operative Complications

Summary: the purpose of this study is to assess the impact of a semi-structured intraoperative anesthesia handoff tool on patient outcomes and to assess the validity of the 5-factor perceived shared mental model scale (5-psmms) in a healthcare setting and whether the perception of shared mental model (smm) mediates the effect of the intraoperative handoff tool on postoperative outcomes


Eligibility criteria:
inclusion criteria: * undergoing non-cardiac surgery in the main operating rooms (e.g. not the endoscopy suite or labor and delivery ward) * undergoing at least one permanent (e.g. end of shift) anesthesia clinician handoff exclusion criteria: * american society of anesthesiologists (asa) physical status 6 (organ donors)

Keywords: intraoperative anesthesia handoffs
clinical description of a bronchoscopic approach to ablate lung nodules using the emprint™ ablation catheter

Conditions: Cancer, Lung; Cancer, Metastatic to Lung

Summary: the purpose of this investigation is to characterize the safety and performance of the emprint™ ablation catheter kit with thermosphere™ technology in clinical use. this is a prospective, single-arm, multicenter, non-randomized study. up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. the study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the emprint™ ablation catheter kit with thermosphere™ technology.

the primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the emprint™ ablation catheter kit with thermosphere™ technology device in subjects undergoing lung ablation procedures. the primary endpoint is the composite rate of adverse events related to the emprint™ ablation catheter kit with thermosphere™ technology through 1-month follow-up. the following secondary endpoints will be evaluated: * composite rate of serious adverse events related to the emprint™ ablation catheter kit with thermosphere™ technology through 1-month follow-up. * composite rate of all adverse events related to the procedure or study devices through 1-month follow-up. * composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up. * patient satisfaction and pain (bronchoscopic ablation patient pain and satisfaction survey) * quality of life (eq-5d scale) * technical success * technique efficacy

Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years of age 2. subject has provided informed consent 3. subject is able and willing to comply with the study follow-up schedule 4. subject has a definitive diagnosis of cancer in the lung 5. target nodule is ≤ 30mm in maximum diameter 6. there is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure 7. subject is a candidate for an elective electromagnetic navigation bronchoscopy (enb) procedure 8. subject is a candidate for an elective lung ablation procedure according to standard of care and product instructions for use 9. subject is not a candidate for lung surgery or refuses lung surgery 10. subject is not a candidate for stereotactic body radiation therapy (sbrt) or refuses sbrt exclusion criteria: 1. target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea 2. patients currently diagnosed with global initiative for chronic obstructive lung disease (gold) stage iv emphysema 3. female subjects who are pregnant or nursing as determined by standard site practices 4. subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study 5. the investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Keywords: lung nodule bronchoscopy ablation, microwave
ketamine enhances analgesia and mood in chronic pain patients

Conditions: Mood Disorder; Opioid; Mood Insomnia

Summary: most chronic pain patients have mood disorders. the mood disorders may improve with better analgesia produced by ketamine injections. a prospective study of patients undergoing interventional pain therapy using ketamine injections. pre-injection and post-injection patient data is collected. pain is measured using numeric pain rating scale, and change in pain score by 2-points is considered significant. sleep is measured using likert sleep scale, and change in sleep score by 2-points is considered significant. anxiety is measured using general anxiety disorder (gad-7) scale, and change in anxiety score by 4-points is considered significant. depression is measured using patient health questionnaire (phq-9), and change in depression score by 5-points is considered significant.

chronic pain is usually associated with psychological and mood disorders. many chronic pain patients have various forms of mood abnormalities; and these mood issues may improve with better analgesia produced by ketamine injections. this is a prospective observational study of consenting adult patients who are undergoing interventional pain management. the patients undergo routine interventional pain therapy using ketamine injections. pre-injection and post-injection patient data is collected using validated tools. data collection includes patients' age, psychiatric diagnosis, pain score, sleep score, anxiety score and depression score. pain score is measured using the numeric pain rating scale, and a change in the pain score by 2-points is considered significant. sleep score is measured using the likert sleep scale, and a change in the sleep score by 2-points is considered significant. anxiety is measured using the general anxiety disorder (gad-7) scale, and a change in the anxiety score by 4-points is considered significant. depression is measured using the patient health questionnaire (phq-9) scale, and a change in the depression score by 5-points is considered significant. data is analyzed with ibm® spss® statistics 25; using student's t-test, anova, pearson chi-square test, and regression analysis. p-value \<0.05 is considered significant.

Eligibility criteria:
inclusion criteria: * adult chronic pain patients * associated mood disorder * good treatment compliance * associated chronic insomnia * regular ketamine pain therapy injection * consent for clinical record quality assurance review exclusion criteria: * severe cognitive disorder * inability to provide consent * major neuropsychiatric disorder * cannabis use * stimulant use * substance abuse * poor treatment compliance * lack of ketamine pain therapy injection

Keywords: mood therapy
an open-label trial of clevidipine for controlled hypotension during spinal fusion

Conditions: Neuromuscular Scoliosis

Summary: the current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. as the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.

this would basically be an observational study without a significant change in our current practice. there would be no change in the standard and usual anesthetic care including premedication, anesthetic induction, intraoperative anesthetic management, and intraoperative monitoring. our usual anesthetic routine includes: 1. intravenous or oral premedication with midazolam 2. inhalational or intravenous induction based on the preference of the patient 3. facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula 4. maintenance anesthesia to include desflurane titrated to maintain the bispectral index at 40-60, fentanyl 2-4 µg/kg followed by a remifentanil infusion to maintain the mean arterial pressure at 55-65 mmhg. 5. tranexamic acid to limit intraoperative bleeding 6. as needed, agent to control blood pressure to maintain the map at 55-65 mmhg if remifentanil in doses up to 0.3 µg/kg/min are ineffective. as needed, clevidipine will be started at 1 µg/kg/min and titrated up in 1 µg/kg/min every 1-2 minutes to achieve an map at 55-65mmhg. vital signs including heart rate will be recorded every 1 minute until the target map is achieved and then at 15 minute increments after that.

Eligibility criteria:
inclusion criteria: * spinal fusion for neuromuscular scoliosis. exclusion criteria: * allergy to dihydropyridine calcium channel antagonists * allergy to soy or eggs * non-neuromuscular causes of scoliosis * disorders of lipid metabolism (clevidipine is in a lipid base)
a study to investigate the food effect on the pharmacokinetics of ensartinib capsules in chinese healthy volunteers.

Conditions: Non-Small Cell Lung Cancer

Summary: the main objective of this study is to evaluate the effect of food on the pharmacokinetics of ensartinib capsules.

the main objective of this study is to evaluate the effect of food on the pharmacokinetics of ensartinib capsules in chinese healthy volunteers. in addition, the safety of ensartinib capsules in chinese healthy volunteers who with high-fat meal or fasting state will also be evaluated.

Eligibility criteria:
inclusion criteria: * age: 20 - 45 years; * sex: male and female; * body weight: male ≥ 50 kg,female ≥ 45 kg, body mass index bmi (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border); * healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests; * written informed consent; exclusion criteria: * received any investigational drugs within 14 days before the screening test; * donated 200 ml of whole blood within 30 days before the screening test,or donated 200 ml of whole blood during the study or within 30 days after completion of the study; * females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period; * history of drug or food allergies; * abnormal blood pressure or pulse，abnormal laboratory tests; * participated in other clinical trials within 3 months before screening; * smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;positive for hbsag, hepatitis c virus (hcv) antibody, hiv antibody or syphilis antibody;clinically apparent disease/infection within 1 month before screening; * positive for hbsag, hepatitis c virus (hcv) antibody, hiv antibody or syphilis antibody; * clinically apparent disease/infection within 1 month before screening;
755nm alex laser for treatment of stretch marks

Conditions: Striae

Summary: evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm alexandrite laser.


Eligibility criteria:
inclusion criteria 1. is a healthy male or female between 18 and 85 years old. 2. has unwanted striae and wishes to undergo laser treatments to remove or improve them. 3. is willing to consent to participate in the study. 4. is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits. exclusion criteria 1. is hypersensitive to light exposure. 2. has active localized or systemic infection. 3. is taking medication(s) for which sunlight is a contraindication. 4. has a history of squamous cell carcinoma or melanoma. 5. has a history of keloid scarring. 6. has used oral isotretinoin (accutane®) within 12 months of initial treatment or plans on using during the course of the study. note: skin must regain its normal degree of moisture prior to treatment. 7. has a history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. 8. is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 9. is allergic to lidocaine, tetracaine or xylocaine with epinephrine. 10. has any other reason determined by the physician to be ineligible to participate in the study.
cross linking corneal biomechanical evaluation of cats tonometer prism

Conditions: Keratoconus

Summary: the purpose of this study is to determine if the device, cats tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (goldmann) before and after a corneal crosslinking procedure. this difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

this clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in tucson arizona1. the purpose of this study is to determine if the device, cats tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (goldmann) before and after a corneal crosslinking procedure. this difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Eligibility criteria:
inclusion criteria: * male and female patients, at least 18 years of age * subject has a clear understanding and agrees to all the conditions of the informed consent form exclusion criteria: * • subject has undergone ocular surgery within the last 3 months * uncontrolled systemic disease that in the opinion of the investigator would put the subject's heath at risk * pregnant or nursing women * those who have had corneal surgery including corneal laser surgery * microphthalmos * buphthalmos * severe dry eyes * lid squeezers - blepharospasm * nystagmus * corneal or conjunctival infection.