Kornimate/medical-research-clean huggingface dataset:
the austrian spinal cord injury study

Conditions: Traumatic Spinal Cord Injury

Summary: traumatic spinal cord injury (tsci) is a debilitating disease that leads to neurological deficits and often has long-term effects including severe lifelong disability. given the devastating personal and economic consequences of sci, it is critical to collect high-quality, prospective data. sci has not been systemically assessed in austria, and data regarding the etiology, incidence and prevalence are missing or significantly limited. more importantly to the individuals suffering from sci, health care for sci patients in austria is not concentrated in specialized sci centers but fragmented, which might result in a less effective recovery and rehabilitation of patients. accordingly, the paracelsus medical university salzburg (pmu) and the austrian social insurance for occupational risks (auva) initiated the austrian spinal cord injury study (ascis) at the beginning of 2012. ascis is defined as an organized network that uses observational methods to collect uniform longitudinal clinical data that can provide insight into current patient care parameters and evaluates the outcome of sci patients. ascis was initiated with the aim to develop a registry for patients with tsci in austria as a base for addressing research questions, improving patient outcomes and establishing a platform for future clinical trials. furthermore, a major goal of ascis is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and bring new standardized assessment tools to the clinical setting. due to the involvement of acute trauma hospitals and rehabilitation centers, ascis is uniquely positioned to capture detailed hospital-related information on the (very)-acute, rehabilitation and chronic phases of tsci patients. additionally, ascis is cooperation partner of the european multi-center study about spinal cord injury (emsci).


Eligibility criteria:
inclusion criteria: * patients suffering from paresis or plegia after trauma * first ascis assessment possible within the first 3 days after incidence * patient capable and willing of giving written informed consent * no cognitive impairment which would preclude an informed consent (including severe traumatic brain injury) exclusion criteria: * nontraumatic paresis or plegia (e.g. disc-herniation, tumor, av-malformation, myelitis) * previously known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent * peripheral nerve lesion above the level of lesion (e.g. plexus brachialis impairment) * previously known polyneuropathy * severe craniocerebral injury

Keywords: spinal cord injury spine surgery patient registry trauma
frailty assessment of patients with gastrointestinal surgery

Conditions: Gastrointestinal Disease; Frail Elderly Syndrome

Summary: patients aged 65 or older under gastrointestinal surgery will be enrolled，the investigators will assess the frailty of these patients by frailty index scale and explore the correlation between the frailty and perioperative adverse events.

patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. after the assessment, the patients' frailty index was obtained. moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded. the main purposes of present study are to verify the feasibility of applying frailty index (fi) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty，find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty. the secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.

Eligibility criteria:
inclusion criteria: * patients whose age not less than 65 years; * undergoing operation in gastrointestinal surgery of west china hospital due to gastrointestinal disease. exclusion criteria: * those who did not undergo surgery for various reasons; * death before operation

Keywords: gastrointestinal surgery frailty elder patient complication
simulated-altitude to optimize aerobic exercise among breast cancer survivors with limited mobility

Conditions: Obesity; Breast Cancer

Summary: the study will evaluate the utility of hypoxic exercise training to improve cardiovascular and metabolic health among obese breast cancer survivors. while participants exercise, a lower fraction of inspired oxygen will be used to simulate a higher altitude. this approach removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which is believed to support exercise tolerance. participants are randomized to either the treatment (walking+simulated-altitude) or control (walking under normoxic conditions).

cancer survivors have a two-fold greater risk of having one or more functional limitations compared to those without a history of cancer. though exercise interventions in breast cancer survivors exist, a large portion of women (61%) exhibit some form of lower-body dysfunction that severely restricts participation in physical activity and exercise. both physical and emotional well-being are negatively affected by the combination of increased adiposity, orthopedic problems and muscle weakness, thus reinforcing a cycle of physical inactivity. for these reasons, obese breast cancer survivors with walking limitations are faced with a barrier that greatly increases the difficulty of meeting prescribed exercise guidelines (≥150 weekly minutes of moderate-to-vigorous intensity exercise). though previous investigations have demonstrated the safety and benefits of exercise+simulated altitude to improve body fat, physical endurance and insulin sensitivity, results have been limited to non-cancer participants only. given the comorbidities common to breast cancer survivors, specifically, heart disease risk, lower body joint problems, low aerobic capacity, and fatigue, further research is needed.

Eligibility criteria:
inclusion criteria: 1. physician's medical clearance for participation 2. english-speaking women 3. 18-70 years of age with a history of stage 0-iii breast cancer 4. preferred walking speed of less than 2.9 mph as measured by a timed 10 meter walk test (to be performed on-site after consent during preliminary screening) "or" the inability to complete a 6-minute walk without stopping (to be performed on-site after consent during preliminary screening) 5. body mass index between 30-45 kg/m2 6. ≥1 year post-treatment and not currently receiving or planning to receive chemo/radiation therapies 7. not participating in a structured exercise routine 8. in the previous 6 months, not engaging in (on average) ≥60 minutes of moderate or ≥30 minutes of vigorous physical activity per week. exclusion criteria: 1. males 2. dementia 3. medical, psychological, and/or social characteristics that may interfere with the ability to fully participate in the proposed study activities/assessments (e.g., psychosis, schizophrenia) 4. contraindication to participate in regular exercise training 5. unwilling to complete prescribed exercise 6. inability to walk 7. pregnant 8. resting oxygen saturation via pulse oximetry below 90% 9. using home oxygen therapy

Keywords: exercise cancer obesity
recombinant subunit herpes zoster vaccine in vzv-seronegative organ transplant recipients

Conditions: Varicella Zoster Vaccine

Summary: the investigators plan to study the immunogenicity of the vaccine in vzv-seronegative solid organ transplant recipients. vzv-seronegative patients will be enrolled after organ transplantation. the investigators hypothesize that the recombinant subunit herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in vzv-seronegative patients.

solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary vzv infection (chickenpox) and vzv reactivation (shingles). a non-live, recombinant subunit herpes zoster vaccine (shingrix; gsk vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. as both components of the immune system are important for protection against vzv, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in vzv-seronegative patients. indeed, the current live vzv vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to vzv-seronegative transplant patients.

Eligibility criteria:
inclusion criteria: * solid organ transplant recipient. * age ≥18 years * vzv-seronegative at time of transplant * ≥90 days post-transplant * able to provide informed consent exclusion criteria: * has already received the recombinant subunit herpes zoster vaccine in the past * ongoing cmv viremia \> 200 iu/ml * hiv infection * diagnosis of malignancy (e.g. ptld) * history of a severe allergic reaction (anaphylactic reaction) after any vaccine * documented chickenpox or shingles after transplantation * congenital immunodeficiency (e.g., cvid) * treatment for rejection in the past 30 days * immunoglobulin in the past 30 days or anticipated to receive immunoglobulin * anti-cd20 monoclonal antibody in the past 6 months or anticipated to receive anti-cd20 monoclonal antibody * plasmapheresis in the past 30 days or anticipated to receive plasmapheresis * febrile illness in the past one week * unable to comply with the study protocol
baba robotic thyroidectomy without gas is safe enough as that use a gas

Conditions: Thyroidectomy; Thyroid Diseases

Summary: in this study, a randomized controlled study was conducted between two groups of 14 classic recipients of carbon dioxide insufflation during baba robotic-thyroidectomy and 14 recipients of gasless method during baba robotic-thyroidectomy. this is a study to see if there is any difference in hemodynamic and metabolic changes and pain .


Eligibility criteria:
inclusion criteria: * subject who will have thyroid surgery exclusion criteria: * subject who underwent thyroid surgery * subject who underwent any radiotherapy on neck * subject who need to neck dissection * subject under 18 years or over 70 years * bad general condition * high american society of anesthesiologists(asa) score (over 3) * breast feeder or pregnancy * subject who disagree to do this trial

Keywords: gasless bilateral axillo-breast approach da vinci robot-assisted thyroid surgery
the effect of postoperative modified trendelenburg position to decrease shoulder pain after laparoscopic hysterectomy: a randomized controlled trial

Conditions: Post Operative Pain; Shoulder Pain; Gynecologic Disease

Summary: laparoscopic surgery is commonly used procedure in diagnostic and treatment including hysterectomy. post laparoscopic shoulder pain is common side effect mostly occur after surgery. postoperative trendelenburg position might decrease pain by reducing the mechanical pressure of co2 on the diaphragm. maintaining the patient in trendelenburg for 6 hours postoperatively will decrease postoperative shoulder pain.

after laparoscopic hysterectomy surgery, patients in intervention group were positioned in a modified trendelenburg position (20 °) postoperative for 6 hours because of the limitation of this study cannot positioned in trendelenburg position. a modified trendelenburg position is head and trunk of patient were in neutral position while hips and lower extrimities were raised at 20 degree. in control group were in neutral position. all patients were asked shoulder pain score at ward, 6 , 12, 24 hours after postoperative modified trendelenburg position for 6 hours

Eligibility criteria:
inclusion criteria: * female patient age between 30-65 years * american society of anesthesiologist (asa) physical status i or ii * scheduled for operative laparoscopic hysterectomy with abdominal incisions measuring less than 1 cm in size * can speak and understand thai language exclusion criteria: * pregnant women * conversion procedure to open abdominal surgery * patients with postoperative abdominal drainage * surgery duration more than 3 hours * gynecologic malignancy surgery * patients with history of chronic shoulder pain * patients with history of previous shoulder surgery * inability to accurately express pain * patients with history of gastroesophageal reflux disease or chronic gastritis * patients with history of cardiovascular or pulmonary disease * patients with history of venous thrombosis * morbid obesity bmi \> 40 kg/m2 * patients with history of increase intracranial pressure * patients with history of increase intraocular pressure * patients with liver and/or kidney disease * nsaids and/or paracetamol and/or morphine allergy * current corticosteroid use * patients who use current analgesic drugs and don't want to quit while stay in the hospital * psychiatric disorder * intellectual disorder * postoperative length in hospital less than 24 hours

Keywords: modified trendelenburg, shoulder pain, laparoscopic hysterectomy
drains and surgical site infections

Conditions: Surgical Site Infection

Summary: this prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

surgical site infections (ssi) represent the most common type of nosocomial infection amongst surgical patients. they cause morbidity and mortality. surgical drains are commonly inserted at the end of many surgical procedures. in contrast to potential benefits, drains are also thought to potentially serve as a conduit of bacteria into the wound and hence may increase the risk of ssi. patterns of use of drains vary widely across surgical disciplines and individual practices. there are no uniform guidelines and standards are often rather based on tradition than on evidence. the aim of this large prospective study was to examine the association of presence, duration, type, number and location of drains with the risk of ssi in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

Eligibility criteria:
inclusion criteria: * inpatients * age 18 years or older * general, orthopedic trauma and vascular procedures * surgical antimicrobial prophylaxis exclusion criteria: * outpatient surgery * presence of a contraindication for cefuroxime and/or metronidazole * preexisting antibiotic therapy within 14 days prior to surgery * cognitive impairment * combined operations including other than the above specified surgical divisions * emergency procedures with planned incision within 2 hours after indicating the procedure.

Keywords: surgical site infection surgical drains
study of the safety, pharmacodynamics and efficacy of anb-002 in patients with hemophilia b (safran)

Conditions: Hemophilia B

Summary: the goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of anb-002 in subjects with hemophilia в. the study will have a dose-escalation design with elements of phase i/ii seamless adaptive design.

the study design includes anb-002 dose escalation in at three cohorts. in cohort 1, the subject is treated with a single dose of anb-002 (dose 1) administered as an intravenous infusion. follow-up for the assessment of dose-limiting toxicity (dlt) will be carried out for 28 days. if no dlt events are observed in the subject of cohort 1, the following subjects will be included in cohort 1. in cohort 2, the subjects are treated with a single dose of anb-002 (dose 2). in cohort 3, the subject are treated with a single dose of anb-002 (dose 3). the decision to continue enrolling in cohorts will be made at the independent data monitoring committee (idmc) meeting. after the idmc makes a decision regarding the dosing subjects, further enrolment to the cohort will be carried out. based on the data from the follow-up period of subjects included in сohorts 1-3, a potential therapeutic dose for further study will be determined and additional patients will be included to recieve this dose. in exploratory cohort 4 patients with anti-aav5 antibodies and/or hepatitis b in anamnesis will be included. these subjects will recieve the dose 3 of anb-002. the total duration of participation of one subjects in the study will be 5 years.

Eligibility criteria:
inclusion criteria: 1. male with hemophilia b. 2. age ≥18 years. 3. fix activity at screening ≤2% without fix inhibitor. 4. ≥150 previous exposure days of treatment with fix concentrates. exclusion criteria: 1. previous gene therapy. 2. other blood or hematopoietic disorders. 3. positive anti-aav5 antibodies (for cohorts 1-3). 4. diagnosed hiv-infection, not controlled with anti-viral therapy. 5. hepatitis b (for cohorts 1-3), acute or chronic hepatitis c. 6. any active systemic infections or recurrent infections requiring systemic therapy at screening. 7. any other disorders associated with severe immunodeficiency. 8. significant hepatic disorders (liver cirrhosis, liver fibrosis, etc). 9. malignancies with remission \<5 years.
home-based virtual reality rehabilitation for children with cerebral palsy

Conditions: Cerebral Palsy

Summary: rationale: in a way, vr-based gaming shows some similarities to constraint-induced movement therapy. vr games are controlled unimanually or bimanually. when unimanually-controlled games are performed with the affected upper limb, movements of the unaffected hand are completely ineffective. this mimics the principle of forced use. to some degree, also bimanually-controlled games result in a forced use of the affected upper limb. additionally, vr could help in the engagement in rehabilitation programs, as virtual environments and gaming increases enjoyment and motivation, and therefore therapy adherence. accordingly, vr-based gaming may have the potential to improve upper limb functionality in children with cp. objective: this study aims to investigate the feasibility of a home-based vr intervention to improve upper limb functionality in children with cp. sub-objective: the validation of a self-developed upper limb assessment (upper limb reaching test). study population: children and adolescents with unilateral cp (age 10-18 years old). intervention: the intervention consists of vr-based rehabilitation with the oculus quest device. the training frequency and duration represents 2x15 minutes a day, five days a week, for a total of eight weeks. therefore, this rehabilitation intervention should represent a total amount of 20 hours of rehabilitation. however, the total dosage is variable as the intervention is self-managed. main study parameters/endpoints: logbook, system usability scale, melbourne assessment 2, wall arm reaching test, elbow and shoulder range of motion.


Eligibility criteria:
inclusion criteria: * cp children with a unilateral or severely asymmetric, bilateral spastic movement impairment. * age 10-18 years old. * manual ability classification system (macs) scores i, ii or iii. * house classification of 1, 2 or 3. exclusion criteria: * significant (persisting) motion sickness, or any other related adverse event in vr.

Keywords: home-based rehabilitation virtual reality upper limb
a study of the safety and pharmacology of gdc-0941 in combination with erlotinib in patients with advanced solid tumors

Conditions: Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers

Summary: this is an open-label, multicenter, phase ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (pk) of oral (po) gdc-0941 administered in combination with po erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (nsclc) who have failed at least one prior chemotherapy regimen.


Eligibility criteria:
inclusion criteria: * documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only) * documented locally advanced or metastatic nsclc in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only) * adequate organ function as assessed by laboratory tests * evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist) * agreement to use an effective form of contraception for the duration of the study exclusion criteria: * any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment * prior treatment with pi3k pathway-inhibiting agents (cohort-expansion stage only) * history of grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication * current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic) * history of clinically significant cardiac or pulmonary dysfunction * history of malabsorption syndrome or other condition that would interfere with enteral absorption * clinically significant history of liver disease * any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents * active autoimmune disease and/or need for corticosteroid therapy * known brain metastases that are untreated, symptomatic, or require therapy * pregnancy, lactation, or breastfeeding

Keywords: pi3k nsclc tarceva
de-111 ophthalmic solution in patients with open angle glaucoma or ocular hypertension

Conditions: Open Angle Glaucoma or Ocular Hypertension

Summary: safety and iop (intraocular pressure) lowering effect of de-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.


Eligibility criteria:
inclusion criteria: * diagnosed with open angle glaucoma or ocular hypertension * provided signed, written informed consent * 20 years of age and older * if a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * presence of any abnormality or significant illness that could be expected to interfere with the study.