Kornimate/medical-research-clean huggingface dataset:
cryolipolisis for abdomen and flank fat reduction

Conditions: Subcutaneous Fat Disorder

Summary: sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: conventional cryolipolysis, contrast cryolipolysis or recovery reperfusion cryolipolysis. the region will be treated according to the individual need, in the region of abdomen and flanks. assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.


Eligibility criteria:
inclusion criteria: * healthy subjects * body mass index \> 29.9 kg/m2 exclusion criteria: * pregnancy * diabetes * cancer * vascular diseases * heart diseases * liposuction or other surgical procedures for body contouring * active infection * wounds * paroxysmal cold hemoglobinuria * cold urticaria * significant weight changes in the past 3 months or during treatment
efficacy of bnc210 in acute, as-needed treatment of anxiety in social anxiety disorder - 1

Conditions: Social Anxiety Disorder

Summary: the purpose of the study is to evaluate the effect of a single, acute dose of bnc210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the subjective units of distress scale (suds) in adult patients with social anxiety disorder.

this is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. participants will attend a screening visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. randomized participants will receive a single dose of their allocated study medication (225 mg bnc210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. after 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Eligibility criteria:
inclusion criteria: * a current diagnosis of social anxiety disorder as defined in the dsm-5. * a liebowitz social anxiety scale total score of ≥60. * suitable contraception use in line with protocol requirements. * ability to swallow tablets. exclusion criteria: * history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, ptsd, autism-spectrum disorder or obsessive-compulsive disorder, or any other axis i or ii disorder which is currently the primary focus of treatment over social anxiety disorder. * hamilton rating scale for depression score of ≥18. * moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months. * use of psychotropic medications within 30 days of screening. daily use of benzodiazepines within 90 days of screening. * any clinically significant medical history or findings as determined by the investigator that could interfere with the objectives of the study or put the participant at risk.
the effectiveness of mindfulness-based relapse prevention

Conditions: Substance Use Disorder

Summary: this study developed a mindfulness-based relapse prevention targeting craving. based on the randomized controlled trial design, 600 adult usd females and 600 adult usd males with methamphetamine, heroin, or ketamine in intervention group(mbi) , the matched 250 subjects in control group and 250 healthy matched controls (hc) participated in this study, 1200 adult usd subjects of intervention group received the 8-week group mindfulness intervention performed by psychiatrists. sud patients were assessed three times, before, during(1-2 weeks after the mbi began), and after the intervention by a variety of clinical variables, cognitive task(reginal segmental task),fmri and blood test to verify the effectiveness of the intervention method, attempting to expand the model of addiction and mindfulness.

the group mindfulness-based intervention adhered to structured formal procedures, conducted by psychiatrists, and was scheduled once a week, where each session spans for two hours, interspersed with a 10-minute break. starting from the second intervention, the previous intervention's contents and home practice were reviewed at the beginning of each subsequent intervention. based on the randomized controlled trial design, the evaluation time nodes for clinical variables, cognitive task(reginal segmental task),fmri and blood test were baseline (before intervention), 1-2 weeks after intervention began, and after intervention. all clinical variable scales were presented in paper form, the questions were clearly explained by researchers.

Eligibility criteria:
inclusion criteria: 1. meets the diagnostic criteria for dsm-5 of substance use disorders; 2. the duration of using the addictive substance shall not be less than 1 year; 3. prohibit addictive substances for at least 48 hours before conducting magnetic resonance imaging scans; 4. han nationality, junior high school or above education level, aged 18-57 years old; 5. informed and agreed to participate in this study, with the consent of the ethics committee. exclusion criteria: 1. have a history of mental illness before taking drugs; 2. other substance use disorders (excluding nicotine); 3. brain organic diseases, history of craniocerebral injury, history of coma; 4. individuals with mental disorders who meet the dsm-5 diagnostic criteria within two generations; 5. history of endocrine diseases; those with abnormal function in blood, heart, liver, and kidney after examination; 6. intelligence impairment iq.

Keywords: addiction mindfulness-based relapse prevention anxiety depression subliminal perception
preoperative prehabilitation for sarcopenic patients prior to pancreatic surgery for cancer

Conditions: Sarcopenia; Pancreatic Cancer

Summary: major digestive surgery is associated with a significant rate of postoperative complications. to improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. however, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. sarcopenia is a condition characterized by loss of skeletal muscle mass and function. also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes. the hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.


Eligibility criteria:
inclusion criteria: * patients undergoing pancreaticoduodenectomy for cancer * sarcopenic status exclusion criteria: * age younger than 18 years * medical contraindications including cardiovascular disease or clinically significant vascular disease * physical inability to exercise * emergent surgery

Keywords: morbimortality prehabilitaion pancreatic surgery cephalic duodenopancreatectomy
application of a positive psychology program for the development of emotional skills in prison

Conditions: Borderline Personality Disorder

Summary: studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? the investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care. the main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of kotsou, i. et al (2011) for its implementation in remand homes.

the expected secondary outcome is the identification of the interest of emotional skills development program (in prison) regarding : * therapeutic support for patients meeting the criteria for borderline personality disorder * participant satisfaction * the development of emotional skills

Eligibility criteria:
inclusion criteria: * meet the criteria for borderline personality disorder (dsm-v), * interest in the issue of emotional skills development, * comprehension and use of the french language adapted to the study, * disposition to group practice, * attentive disposition allowing to participate in a therapeutic activity for 3 hours. * psychological/psychiatrical follow-up at the health unit of the villeneuve-lès-maguelone prison exclusion criteria: * minor patients * releasable before july 2021, * decompensated psychiatric disorders, * patient in withdrawal syndrome.

Keywords: borderline
observational retrospective study to assess the use of ribociclib in patients with hr+, her2- metastatic breast cancer treated with chemotherapy

Conditions: Metastatic Breast Cancer

Summary: eileen was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in turkey. group i cohort of the study was based on secondary use of data of postmenopausal hormone receptor-positive (hr+), human epidermal growth factor receptor 2-negative (her2-) metastatic breast cancer (mbc) patients treated with ribociclib in combination with letrozole (let) or fulvestrant (ful) after june 2020. group ii cohort of the study was a parallel, comprehensive chart review for detecting all postmenopausal hr+, her2- mbc patients who were eligible for cyclin-dependent kinase inhibitors (cdkis) but received chemotherapy. the study used secondary data which was retrieved from electronic or paper medical records or clinical databases available at the sites. regular follow up with close monitorization was used for the effective management of patients with breast cancer. data sources included information about diagnosis, treatment and monitorization of patients at an individual level. the study used medical patient records at hospitals e.g. hospital discharge files, primary clinical records and electronic medical records.


Eligibility criteria:
inclusion criteria: group i: postmenopausal female patients who had histologically or cytologically confirmed hr-positive (10% or more er+), her2-negative, metastatic breast cancer and initiated ribociclib combinations per local label. * treated with ribociclib plus letrozole relapsed after 12 months completing adjuvant treatment or without any prior endocrine treatment for metastatic disease, 1 line or less chemotherapy was allowed. * treated with ribociclib plus fulvestrant, clinical and/or radiological disease progression after at least 6 months and at least 1 aromatase inhibitor treatment for metastatic disease or relapsed after 12 months adjuvant aromatase inhibitor treatment and/or relapsed within 12 months completing adjuvant aromatase inhibitor, 2 lines or less prior treatments and 1 line or less prior chemotherapy at metastatic setting were allowed. * had first treatment response rate assessment within 6 months after ribociclib initiation. * initiated ribociclib in combination with letrozole/fulvestrant after mbc diagnosis after local approval of ribociclib in june 2020. group ii: postmenopausal female patients who had histologically or cytologically confirmed hr-positive (10% or more er+), her2-negative, metastatic breast cancer eligible for cyclin-dependent kinase (cdk) inhibitors according to local label but started chemotherapy. exclusion criteria: * pre- or perimenopausal women. * enrollment in an interventional clinical trial for mbc during the study observation period. * evidence of prior treatment with any cdk4/6 inhibitor in the adjuvant setting. * evidence of another primary cancer within 3 years prior to the initial line containing ribociclib.
effect of different infusion volume on perioperative bladder and blood volume in patients undergoing daytime surgery.

Conditions: Cholecystolithiasis and Thyroid Nodule

Summary: the objective of the trial was to explore the effect of different infusion volume on perioperative bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound and transthoracic echocardiography.

the objective of the trial was to evaluate the effects of different infusion volume of ringer's solution acetate (2 ml/kg,8ml/kg, 16ml/kg) on bladder volume, hemodynamics,transthoracic echocardiography and vascular ultrasound including the inferior vena cava(ivc) and the right subclavian vein(scv) diameter and the ivc and scv collapsibility index in patients undergoing daytime surgery through a randomized controlled clinical study, so as to provide better guidance for clinical transfusion avoiding bladder catheterization . the patients in this trial were visited before induction and discharge from the postanaesthesia .we also collected the first time and times of micturition and whether the patients have the dysuria.

Eligibility criteria:
inclusion criteria: * 1. ethnic chinese; * 2. age, 18 to 65 years old; * 3. american society of anaesthesiologists (asa) physical status i or ii; * 4. daytime patients scheduled for general anesthesia exclusion criteria: * patients unwilling to cooperate with the experiment * body mass index exceeding 30 kg/m2; * patients with a history of heart ,liver and renal failure ,hypertension,diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study. * patients with the urinary diseases, such as kidney, ureteral calculi and tumors, prostatic hypertrophy.
the prevalence of "wearing-off" in patients with parkinson's disease in shanghai

Conditions: Wearing Off Effect; Parkinson Disease

Summary: the study would be designed as a multi-center cross-sectional investigation on the prevalence of wearing-off in parkinson's patients in shanghai as well as related influencing factors.

pd patients would be randomly recruited into this investigation from around thirty hospital covering the 16 districts of shanghai. the wearing off would be defined by two methods: the doctors' judgement or the woq-9 questionnaire which was a patient-determining tool. the investigation also includes the medicine, the severity of pd symptoms, the demographic factors. the study would be designed with the purpose of clarifying the prevalence of the "wearing-off" and its related influencing factors.

Eligibility criteria:
inclusion criteria: * have been clinical diagnosed with parkinson's disease * have received stable anti-parkinson's treatment before being recruited to the study. exclusion criteria: * being suspicious of atypical parkinson syndrome or secondary parkinson syndromes * have not received anti parkinsonian treatment. * being combined with serious cognitive dysfunction or psychiatric symptoms * unable to complete the investigations.

Keywords: wearing off wearing-off 9 questionnaire prevalence sensitivity specificity
intra-operative evaluation of the glenoid implant position with structured light

Conditions: Shoulder Arthropathy Associated With Other Conditions

Summary: positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. prosthesis longevity and functional outcomes are considered highly dependent on accurate positioning. currently, there are no adequate means to verify the position of the glenoid component during surgery which is a significant impediment to accurate positioning. we propose a non-interventional study to validate a novel technology for verifying the position of the glenoid component during shoulder replacement surgery.

positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. in this study, we are testing a new method of checking the glenoid component position using an optical light 3d scanner for both total and reverse total shoulder replacements. currently, the position of the glenoid component is verified by the operating surgeon visually and there is no routine imaging to verify the position of the glenoid component during surgery. participants in this study will have a 3d optical image of their glenoid bone taken during the surgical procedure. taking this image will require less than 3 minutes and the image will only include their surgical wound (no facial features or other identifying features will be taken in the images). two to six weeks after the surgery, the study participants will have ct scan of their replaced shoulder. this will allow the researchers to measure the accuracy of the new imaging system. it is anticipated that about 14 people will participate in this study at sunnybrook. the length of this study for participants is 6 weeks. the entire study is expected to take about 1 year to complete and the results should be known 6 months after study completion.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age. * scheduled to undergo total shoulder arthroplasty surgery. * scheduled pre-operative ct imaging of the shoulder and the surgical plan includes open exposure of the glenoid. exclusion criteria: * previous shoulder surgery involving the glenoid. * no clinically indicated pre-operative ct imaging. * pregnancy (current or planned). * current or planned participation in other research, or having a clinical condition that would result in cumulative annual radiation exposure exceeding the regulatory limit (30 msv) from all sources.
nitrites in acute myocardial infarction

Conditions: Acute ST Elevation Myocardial Infarction

Summary: the research question to be addressed is "does a 2.5 - 5 minute systemic intravenous injection of sodium nitrite administered immediately before opening of the infarct related artery result in significant reduction of ischaemia reperfusion injury in patients with first acute st elevation myocardial infarction (mi)?"

there are estimated to be 125,000 acute myocardial infarctions (heart attacks) in the uk every year. although substantial progress has been made in reducing the infarct size by prompt opening of the infarct related artery (with thrombolytic therapy or percutaneous coronary intervention (pci)), effective therapy to further reduce the infarct size would substantially reduce the risk of the patient subsequently developing heart failure. there is a growing body of evidence from studies in animals that the use of nitrites may help in reducing the infarct size, although this has not been tested in man. in this phase 2/3 study, the investigators propose to investigate the effect of sodium nitrite injection on infarct size. eligible patients will be males aged 18 and over and females aged 55 and over, presenting within 12 hours of the onset of chest pain, who are suitable for treatment with percutaneous coronary intervention. those who give verbal agreement to take part will receive a 2.5-5 minute injection of sodium nitrite (or placebo) immediately prior to the blocked artery being opened with percutaneous coronary intervention.

Eligibility criteria:
men aged ≥18 years, women aged ≥55 years, and women \<55years who are sterilised, or have had a hysterectomy or have effective contraception and thus where there is no possibility of them being pregnant; presenting within 12 hours of the onset of chest pain who have st segment elevation of more than 1mm elevation in limb leads or 2mm elevation in two contiguous chest leads or new left bundle branch block (lbbb) and for whom the clinical decision has been made to treat with primary pci will be eligible for enrolment. occlusion of the culprit related artery (timi grade 0 or timi grade 1) will also be required for inclusion. eligible patients will be of north european descent. exclusion criteria * historical or ecg evidence of previous myocardial infarction * patients with prior coronary artery bypass grafting (cabg) * prior revascularization procedure where this procedure (pci) was performed in the same territory as the current infarct * known or suspected pregnancy * contra-indications to mri * patients with cardiac arrest or cardiogenic shock * patients with left main coronary occlusion * patients with known moderate to severe renal failure (estimated gfr \< 30mls/min), or liver failure * patients with prior thrombolysis for this event * patients with such left main disease which after pci of their culprit lesion (culprit lesions may be located in the lad or lcx or rca) are likely to require cabg within the time course of the study period (6 months).
assessment of early treatment response by diffusion and perfusion mri in patients with brain metastasis

Conditions: Brain Cancer

Summary: magnetic resonance imaging (mri) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. the purpose of this study is to determine if new imaging methods can help tumor evaluation in the brain. the extra images will be obtained using diffusion and perfusion mri techniques to assess early treatment response in patients with brain metastasis, and will be compared to methods currently being used.


Eligibility criteria:
inclusion criteria: * adults aged 18 and over. * patients/subjects able to give informed consent * patients/subjects whose weight does not exceed 275 lbs. * patient with metastatic brain tumors greater than or equal to 1.0 cm that will be treated with stereotactic radiosurgery and scheduled for an mri scan as part of their routine care exclusion criteria: * patients who are unwilling or unable to undergo mri including patients with contra-indications to mri such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.

Keywords: mri brain metastases 13-094
to compare efficacy and safety between ct-p10 and rituxan in patients with low tumour burden follicular lymphoma

Conditions: Follicular Lymphoma

Summary: to demonstrate that ct-p10 is similar to rituxan in terms of efficacy as determined by overall response rate at 7 months


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of low tumour burden, cd20+ follicular lymphoma * ann arbor stage ii, iii or iv exclusion criteria: * has receive rituximab * allergies or hypersensitivity to murine, chimeric, human or humanised proteins * previous treatment for nhl * any malignancy * current or recent treatment with any other investigational medicinal product or device * pregnant or lactating
study of aortic root reimplantation procedure

Conditions: Ascending Aortic Aneurism; Aortic Valve Insufficiency

Summary: authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.

a single blind prospective randomized superiority study is conducted. our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. if there is truly difference between groups (aortic root reimplantation procedure and aortic valve reimplantation procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the aortic root reimplantation procedure of 21.1%. the blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. the study was approved by institutional review board. depending on a type of the procedure, the patients are divided into two groups: aortic root reimplantation procedure group includes 32 patients and aortic valve reimplantation procedure group consists of 32 patients. randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.

Eligibility criteria:
inclusion criteria: * aortic insufficiency 2+ * ascending aorta or aortic root of greater than 4.5 cm (\> 4.0 cm in marfan syndrome) * good conditions of aortic cusps exclusion criteria: * aortic annulus more than 32 mm * aortic cusps destruction * critical aortic cusps elongation * aortic root dissection

Keywords: valve-sparing valve repair