Kornimate/medical-research-clean huggingface dataset:
application of large volume acute normovolemic hemodilution in cardiac surgery

Conditions: Cardiac Surgery; Acute Normovolemic Hemodilution

Summary: the application of acute normovolemic hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.for the application of acute normovolemic hemodilution in heart surgery, we still face an urgent problem: to what extent can acute normovolemic hemodilution achieve better "blood saving effect", that is, whether a large number of acute normovolemic hemodilution can reduce perioperative blood transfusion to a greater extent


Eligibility criteria:
inclusion criteria: * （1）18-75years old;（2）elective cardiac surgery under cardiopulmonary bypass; （3）preoperative hemoglobin (hb) ≥ 12g/dl; (4) transfusion risk understanding scoring tool (trust) ≥ 2 (possibility of blood transfusion ≥40%). exclusion criteria: * （1）congenital heart disease、cardiac tumor、aortic dissection、heart transplantation（2）low body weight（\ 70%;severe aortic stenosis (area \ 70% or with symptoms);（7） kidney failure (blood creatinine level \>442 mmol/l) or dialysis treatment;（8） serum albumin level (alb) is less than 25 g/l.（9） international standardized ratio (inr) \>1.5 or platelet count \<100 103/mm3;（10）inherited/acquired coagulation function defect;（11）contagious or infectious diseases;（12） patient or family members refused to participate in research;（13）refused to infusion of autologous blood or allogeneic blood products
the isthmus logic post market clinical follow-up study

Conditions: Peripheral Arterial Disease

Summary: isthmus logic carbostent™ is a ce-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease. the aim of this post-market retrospective study protocl p22202 is to collect clinical data of patients treated with isthmus logic for the treatment of peripheral iliac artery disease in routine clinical practice. in order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.

the objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device isthmus logic in the daily clinical practice in an unselected population treated within the intended use. data will be collected via medical chart review in anonymous form to assess the safety and efficacy of isthmus logic. the isthmus logic carbostent™ stent is made of cobalt chromium alloy and is coated with icarbofilm™, a thin carbon film with a high-density turbostratic structure substantially identical with that of the pyrolitic carbon used for mechanical cardiac valve discs. coating the substrate provides it with the bio- and haemocompatible characteristics of pyrolitic carbon, without affecting the physical and structural properties of the substrate itself. two radio-opaque platinum markers at either end of the stent allow for accurate positioning over the lesion to be treated.

Eligibility criteria:
inclusion criteria: * patient has been implanted with at least one isthmus logic stent according to the indications described in the instructions for use (ifu). * study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection. exclusion criteria: * patients treated less than 12 months prior to study start
clinical evaluation of surrounding electroacupuncture in the treatment of acute lateral ankle sprain

Conditions: Electroacupuncture

Summary: comparison and evaluation of the difference in clinical efficacy of electroacupuncture combined with surrounding acupuncture and sham electroacupuncture groups and control group (ice compress combined with brake rest group) in the treatment of alas by means of musculoskeletal ultrasound technique.

1. to evaluate the efficacy and safety of electroacupuncture combined with surrounding acupuncture in the treatment of alas,and compare its differences and advantages with traditional therapy. 2. to investigate the effect of electroacupuncture combined with surrounding acupuncture on the physiological and biochemical changes of the affected nerve,muscle and ligament, as well as its mechanism and pathway. 3. to investigate the influence of treatment time,frequency,intensity,stimulation point and other factors on the therapeutic effect and mechanism,further optimize the treatment plan and improve the therapeutic effect and efficiency. 4. to demonstrate the unique advantages and value of acupuncture analgesia,strengthen the concept and practice of integrated chinese and western medicine,and make contributions to promoting the application and development of acupuncture analgesia in the field of orthopedics and traumatology.

Eligibility criteria:
inclusion criteria: * meets the diagnostic criteria for a grade i or ii injury; * onset time≤48h; * the patient aged between18 and 60, gender is not limited; * the skin of the ankle joint on the affected side is intact, without breakage or ulceration; exclusion criteria: * combined with ankle fracture; * grade iii injury or complete ligament rupture; * those who cannot comply with the treatment program. those with keloid, localized combination of other skin diseases, and those who are not suitable for electroacupuncture treatment; * those with serious cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system or systemic failure, connective tissue disease, hemophilia, diabetes mellitus, malignant tumors, and those who are prone to bleeding tendency.
generalized anxiety and seroquel

Conditions: Generalized Anxiety Disorder; Seroquel XR

Summary: the 12 week clinical trial of seroquel in generalized anxiety disorder (gad) patients will be combined with fmri experiments.

subjects will be recruited from clinic patients and known research subjects at mclean hospital, as well as by advertisements in the media, flyers, and word of mouth. an initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. subjects will be also screened for drug use. if no obvious health problems are present, subjects will be scheduled for an evaluation. upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. the research assistant will give subjects both verbal and written descriptions of the study procedures. after briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. when they are ready, subjects will be asked to sign the written informed consent form approved by the mclean institutional review board (irb). functional magnetic resonance imaging scans to examine brain functioning will be obtained from gad patients (n=30) at baseline and after 12 weeks. seroquel xr tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

Eligibility criteria:
inclusion criteria: * provision of written informed consent * fluency in english * a diagnosis of gad * no pregnancy * right-handedness * psychotropic medication-free at the start of the study exclusion criteria: * pregnancy or lactation * any current dsm-iv-tr axis i disorder * any mental retardation or cognitive impairment that precludes informed consent * known intolerance or lack of response to quetiapine fumarate * substance or alcohol dependence at enrollment * participation in another drug trial within 4 weeks prior enrollment * history of allergic reaction or hypersensitivity to seroquel or seroquel xr * history of prior seroquel or other antipsychotic agents use * contraindications to magnetic resonance imaging * treatment with an effective medication for gad

Keywords: seroquel generalized anxiety disorder fmri
phase 2: vvn461 ophthalmic solution for post -operative ocular inflammation after cataract surgery

Conditions: Inflammation

Summary: this is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the united states (us) in subjects undergoing routine unilateral cataract extraction and lens replacement (celr) surgery via phacoemulsification

this is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the us assessing the safety and ocular efficacy of vvn461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral celr surgery via phacoemulsification without surgical complication. approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. subjects will administer 1 eye drop in the study eye four times a day (qid) for 14 days.

Eligibility criteria:
inclusion criteria: * ≥21 years of age and in good general health at visit 1 (screening) * willing and able to provide informed consent and provide relevant privacy authorization(s) * willing and able to comply with study requirements and visit schedule * clear ocular media (other than cataract) in the study eye * planning to undergo routine unilateral cataract surgery via phacoemulsification extraction and implantation of an intraocular lens. exclusion criteria: * any ocular pain at visit 1 (screening) * recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs
a trial of nature-based post-stroke fatigue rehabilitation (nastru)

Conditions: Stroke

Summary: the aim of nastru was to examine whether ten weeks of nature-based rehabilitation, as add-on to standard management, could influence post-stroke fatigue (primary outcome), depression, work ability or functional outcome (secondary outcomes), compared to controls.

patients randomized to the intervention undergo a rehabilitation program in groups up to 8 patients in an especially designed garden at the swedish university of agricultural sciences, alnarp. the intervention is grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences. the enrollment of 101 patients (51 intervention; 50 control) was completed on august 2014. follow-up is on-going, with assessments by examiner blinded to treatment group, at end of intervention period, 8 months, and 14 months after randomization. a parallel study with qualitative in-depth interviews in a subset of patients, who were randomized to the intervention group, as well as the staff, is also ongoing.

Eligibility criteria:
inclusion criteria: * ischemic or haemorrhagic stroke * first ever or recurrence, about 3 months (group 1) or more than one year prior to screening (group 2) * age: 55-80 years exclusion criteria: * dementia * severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)
phase 2 nab® -paclitaxel (abraxane®) plus gemcitabine in subjects with locally advanced pancreatic cancer (lapc)

Conditions: Pancreatic Neoplasms

Summary: this clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. the study treats all subjects with nab-paclitaxel plus gemcitabine for approximately 6 months of treatment. subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

this is an international, non-randomized, open-label, multi-center, phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. all subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an investigator's choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery. safety assessments by laboratory testing and physical exams will be conducted through-out the study. efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months. subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.

Eligibility criteria:
inclusion criteria: * non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients * no prior anticancer therapy for pancreatic cancer •≥ 18 years of age with a performance status of 0 or 1•adequate complete blood counts, hepatic function, and renal function * signed informed consent exclusion criteria: * active bacterial, viral, or fungal infection * infection with hepatitis b or c, or history of human immunodeficiency virus (hiv) infection, or receiving immunosuppressive or myelosuppressive * subjects with sensory neuropathy, ascites, or plastic biliary stent. * serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders) * women who are pregnant or breast feeding

Keywords: pancreatic neoplasms pancreatic cancer locally advanced pacriatic cancer nab-paclitaxel abraxane gemcitabine abi-007
survey on itch in outpatients of a university clinic

Conditions: Itch

Summary: this study is to investigate the pruriception (i.e. the perception of the character and intensity of itch), the impact of itch on quality of life, the response to itch and the subjective efficacy and preferences of the different treatment options among patients with different skin diseases. better insights into these aspects might help to optimize itch treatment in clinical settings.


Eligibility criteria:
inclusion criteria: * outpatients suffering from itch exclusion criteria: * outpatients (suffering from itch) not willing or able to participate

Keywords: itchy skin diseases itch treatments pruriception
arthroscopic partial meniscectomy versus exercise therapy for meniscal injuries in older patients, a 5 year follow up.

Conditions: Meniscus Tear, Tibial; Osteoarthritis, Knee

Summary: arthroscopic partial meniscectomie (apm) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. it is suggested that apm is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients. with the 5 year follow-up of the escape trial we will investigate the longterm results of apm and physical therapy in patients with a meniscal tear over 45 years old.


Eligibility criteria:
inclusion criteria: * 45 to 70 years old mri confirmed, non-obstructive and symptomatic meniscal tear exclusion criteria: * knee locking or trauma leading to acute surgery; ▸ associated injuries on the index knee consisting of: * symptomatic partial or total tear of the anterior cruciate ligament (acl), * posterior cruciate ligament tear, * oa of the knee, grade 4 on the kellgren and lawrence grading scale, * an injury to the lateral or posterolateral ligament complex with significant laxity; * previous knee surgery on the index knee (with the exception of diagnostic arthroscopy); * tumour that is suspected of malignancy, detectable on mri; * obesity with a body mass index \>35; * american society of anesthesiologists (asa) class 4 or 5 patients; * general disease that effects physical function or systemic medication/abuse of steroids; * any other medical condition or treatment interfering with the completion or assessment of the trial, for example, contraindications to mri or surgery; * drugs or alcohol abuse; * patients unable to fill out the dutch questionnaires.
hpv vaccination in women with cystic fibrosis

Conditions: Human Papillomavirus Infection

Summary: the main risk factor for the development of cervical lesions is human papillomavirus (hpv) infection. vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical pathology. despite this, human papillomavirus vaccination coverage remains low in france. some women with cystic fibrosis might need a transplantation, which is a factor associated with increased risk of human papillomavirus carriage and cervical pathology. an over-risk of cervical pathology would also be present in non-transplanted women with cystic fibrosis. particular attention should therefore be paid to vaccination in this population. the objective is to estimate the frequency of human papillomavirus vaccination in young patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.


Eligibility criteria:
inclusion criteria: * girls with cystic fibrosis * followed in a pediatric or mixed cystic fibrosis center of the region auvergne rhône alpes (aura) * aged 11 years or older exclusion criteria: - refusal to respond to the questionnaire
efficacy and safety of aeye-ds software device for automated detection of diabetic retinopathy from digital funduscopic images

Conditions: Diabetes Mellitus; Diabetic Retinopathy

Summary: aeye-ds is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using ai-based software. this study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.


Eligibility criteria:
inclusion criteria: 1. age ≥22 2. male or female 3. documented diagnosis of diabetes mellitus, meeting the criteria established by the american diabetes association (ada) and world health organization (who): 4. understand the study and volunteer to sign the informed consent exclusion criteria: 1. uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters. 2. diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion. 3. previously diagnosed with diabetic retinopathy. 4. history of laser treatment of the retina or injections into either eye, or any history of retinal surgery. 5. currently participating in another investigational eye study and actively receiving investigational product for dr or dme. 6. participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation). 7. participant is contraindicated for imaging by fundus imaging systems used in the study: 1. participant is hypersensitive to light 2. participant recently underwent photodynamic therapy (pdt) 3. participant is taking medication that causes photosensitivity 4. participant has a history of angle-closure glaucoma or narrow anterior chamber angles 8. subject is pregnant.
cognitive behavioral interventions for motivation, psychological distress and quality of life among individuals with smoking cessation: a randomized control trial

Conditions: Cognitive Behavior Intervention for Psychological Distress, Motivation and Quality of Life Among Individual With Smoking Cessation

Summary: the main purpose of this research is to find out how brief cognitive behavior intervention influences the motivation level, psychological distress, and quality of life among people with smoking cessation. another objective of this research is to examine the effectiveness of cognitive behavioral therapy (cbt) among smoking people, another objective of this study is to investigate how cognitive behavioral therapy helps to enhance the motivation level and quality of life and minimize psychological distress among people with smoking cessation

participants: this was basically pre and post study, initially 60 sixty research participants were recruited for pre-assessment, while 4 participants left due to some reasons (2 persons went out of the city for a job, 1 person met a severe road accident, and 1 person simply refused to participate in this study furthermore. finally, 55 research participants were recruited for post-assessment. these research participants belong to different residential areas (rural/urban) have varied family systems (nuclear/joint) have different birth order, education, socioeconomic status, education, occupation, marital status, and distant smoking duration. the data were analyzed with the help of spss-23 (statistical package for social sciences - 23) descriptive statistics, correlation analysis, and repeated measure anova were used to understand the association and differences among pre and post-assessment of smoking personals.

Eligibility criteria:
inclusion criteria: * if we talk about inclusion criteria, the individuals who were ready to change their lives were part of this study, furthermore, persons above 18 years and below 60 years old were recruited for this study, minimum duration for smoking personnel was not less than 6 months and not more than 5 years were part of this study. the individuals who have signed a written informed consent form were part of this study. moreover, only males who were easily comprehended and understood the instructions of the researcher were recruited in this study. on the other hand, if we talk about the exclusion criteria of the study exclusion criteria: * the individuals who were reluctant to participate, or had any kind of psychophysiological illness prior to the study were excluded from this research. further, the people below 18 and above 60 years were excluded. furthermore, the research participants who had any kind of trauma during this study were excluded and those who refused to become further part of this study were excluded from this research study.

Keywords: psychological distress, quality of life, motivation, cognitive behavior therapy, smoking cessation
in vitro assessment of a breath-synchronized vibrating mesh nebulizer during non invasive ventilation

Conditions: Respiratory Diseases; Lung Diseases; Cystic Fibrosis; COPD; Asthma

Summary: using an adult lung bench model of non invasive ventilation, the aim of the study is to compare an experimental system of breath-synchronized vibrating mesh nebulizer to a conventional vibrating mesh nebulizer during non invasive ventilation in terms of inhaled and lost doses.


Eligibility criteria:
inclusion criteria: * not applicable (in vitro study) exclusion criteria: * hypersensitivity (allergic) reactions to aminoglycosides

Keywords: aerosol delivery vibrating mesh nebulizer breath-actuated nebulizer non invasive ventilation bilevel ventilator single limb circuit ventilator amikacin