Kornimate/medical-research-clean huggingface dataset:
barrow ruptured aneurysm trial

Conditions: Ruptured Cerebral Aneurysm; Subarachnoid Hemorrhage (SAH)

Summary: with evolving endovascular technologies there is a growing debate centered on the relative safety and efficacy of the currently accepted alternatives for the treatment of ruptured cerebral aneurysms in the face of acute subarachnoid hemorrhage (sah). the purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.

the planned trial enrolled 250 subjects per arm. subjects are followed postoperatively and outcome endpoints will be assessed at discharge, 6 months, 1 year, 3 years, and 6 years. one hundred (100) subjects will participate in neuropsychological testing at 1 year; after the 100th subject an interim data analysis will be performed and the viability of future neuropsychological testing will be determined. subjects will receive preoperative, intraoperative or postoperative, 3 year follow up, and 6 year follow up angiograms. in this fashion immediate clinical outcome, including peri-procedural morbidity and mortality, will be assessed as will long term outcome, both clinical and angiographic.

Eligibility criteria:
inclusion criteria: * acute subarachnoid hemorrhage (sah) * confirmed by ct scan or lumbar puncture * age 18-80 years * ability to give informed consent (subject or legally authorized representative) * no anatomic inclusions exclusion criteria: * traumatic subarachnoid hemorrhage * presents to hospital \>14 days post-bleed * sah caused by other primary disease * no anatomic exclusions

Keywords: intracranial aneurysm subarachnoid hemorrhage randomized trial coil embolization clip occlusion vascular disorders
aneurysmorrhaphy of vascular access for haemodialysis

Conditions: Patients With an Aneurysm of Native Vascular Access Indicated for Surgical Treatment

Summary: in patients with chronic renal failure, a well-functioning vascular access is essential for hemodialysis treatment. native arteriovenous fistula (avf) is the first-choice of vascular access, due to a lower incidence of complications and better long-term patency as compared to prosthetic arteriovenous fistula. with the incidence ranging between 6-60%, avf aneurysm (aavf) is a common complication of native avf. according to kidney disease outcomes quality initiative (k/doqi) guidelines, asymptomatic aneurysms are indicated for conservative treatment, but precise recommendations when and how to intervene in available guidelines are missing. several surgical (remodeling, resection and substitution, ligation) and endovascular techniques have been described in the aavf treatment, but there is currently no prospective randomized study comparing these techniques. in 2008, our team published the first experience with a new surgical method of aavf treatment - aneurysmorrhaphy with external porous prosthesis (provena©, bbraun). this therapy was validated in several studies and has shown a good long-term patency and a minimal incidence of complications. aavf aneurysmorrhaphy can be performed with or without an external porous prosthesis (provena©, bbraun). the use of external prostheses reduces venous wall shear stress, turbulent flow, endothelial damage, and thrombus formation, which should improve vascular patency and reduce the risk of avf re-aneurysm. so far, there is no prospective randomized study comparing the effect of external porous prosthesis on avf patency and the incidence of postoperative complications.


Eligibility criteria:
inclusion criteria: 1. signature of informed consent. 2. a male or female subject aged 18 or older. 3. a subject with a naive vascular access aneurysm indicated for surgical treatment. exclusion criteria: 1. patients with pseudoaneurysm of prosthetic vascular access 2. patients with a vascular access infection
the effect of real time continuous glucose monitoring in subjects with pre-diabetes

Conditions: Pre-diabetes; Impaired Glucose Tolerance

Summary: this study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.

the protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (rt-cgm) combined with diet and lifestyle education to those who have diet and lifestyle education alone. during a "wash-in" phase both groups will wear a masked cgm for 1 week at baseline and again after 12 weeks. those randomized to the rt-cgm will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and bmi. at the end of this period, they will wear a masked cgm for 1 week.

Eligibility criteria:
inclusion criteria: * age 18 or older * newly diagnosed with pre-diabetes (within the previous 6 months) with a fpg of \> or = 110-125mg/dl or an a1c \> or = 6% - 6.4% * able to independently measure and read finger stick blood glucose levels * willing to wear the cgm device for up to 12 weeks during the study period * willing to test blood sugar by fingerstick twice per day while wearing the cgm * deers eligible exclusion criteria: * using medication for pre-diabetes * women who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method; all female subjects will undergo pregnancy testing via a serum hcg with their initial blood testing. * subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study. * active duty service members likely to be deployed during the 18-month study period.
efficacy and safety evaluating study of ct-p6 in her2 positive early breast cancer

Conditions: HER2-positive Carcinoma of Breast

Summary: this study will determine whether ct-p6 and herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant ct-p6 or herceptin. patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.


Eligibility criteria:
inclusion criteria: * patient who has histologically confirmed and newly diagnosed breast cancer * patient who has clinical stage i, ii, or iiia operable breast cancer according to ajcc (american joint committee on cancer) breast cancer staging 7th edition * patient who has her2-positive status confirmed locally, defined as 3+ score by ihc (immuno-histochemistry). exclusion criteria: * patient who has bilateral breast cancer * patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.
a study to evaluate the safety and immunogenicity of gsk biologicals' candidate vaccines rts,s/as02d (0.5 ml dose) and rts,s/as02a (0.25 ml dose) administered im according to a 0, 1, 2 month vaccination schedule in children aged 3 to 5 years living in a malaria-endemic region of mozambique.

Conditions: Malaria

Summary: gsk biologicals is developing in partnership with the malaria vaccine initiative at path a candidate malaria vaccine rts,s/as02 for the routine immunization of infants and children living in malaria endemic areas. the vaccine would offer protection against malaria disease due to the parasite plasmodium falciparum and also would provide protection against infection with hepatitis b virus. studies conducted using the formulation rts,s/as02a (0.25 ml dose) in children and adults have shown to be safe. currently all intramuscular vaccines in the epi schedule are administered at a dose volume of 0.5 ml and in this context, a new variant of rts,s/as02d (0.5 ml dose) formulation has been composed which has the same active constituents in the same quantities as in a 0.25 ml dose of rts,s/as02a. in this study, rts,s/as02d (0.5 ml dose) was compared to the existing formulation, rts,s/as02a (0.25 ml dose).

children participating in this study will either receive rts,s/as02d (0.5 ml dose) or rts,s/as02a (0.25 ml dose) intramuscularly according to 0, 1, 2 months schedule. the children will be followed-up throughout the study period to record safety events. blood samples will be collected at defined time points to assess the subject's immune response to the relevant immunological indicators.

Eligibility criteria:
inclusion criteria: healthy children of both sexes between the ages of 3 to 5 years (up to but not including 6th birthday) who had not previously been immunized with hepatitis b vaccine, whose parents or guardians the investigator believed could and would comply with the requirements of the protocol, whose parents or guardians would give written or oral, signed or thumb printed and witnessed informed consent, who were free of obvious health problems as established by medical history and clinical examination before entering into the study and who were available for the foreseen duration of the immunization and follow-up period. exclusion criteria: if the child was found to have major congenital defects or serious chronic illness; history of surgical splenectomy; a diagnosis or clinical suspicion of an immunosuppressive or immunodeficient condition; family history of congenital or hereditary immunodeficiency; history of allergic disease or reactions likely to be exacerbated by any component of the vaccine; previous vaccination with hepatitis b vaccines or with an experimental vaccine; or if the child is simultaneously participating in any other clinical trial, then the child would be excluded from the study.
motor plasticity, intermittent hypoxia and sleep apnea

Conditions: Sleep Apnea, Obstructive; Spinal Cord Injuries; Hypoxia

Summary: the purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.


Eligibility criteria:
inclusion criteria: 1. age 18 or older, 2. chronic (≥ 1-year post-injury), non-progressive sci, 3. asia impairment scale (ais) c or d, 4. resting saturated oxygen (sao2) ≥ 95%, 5. cervical injury (c5-c8) exclusion criteria: 1. currently hospitalized, 2. resting heart rate ≥120 beats per minute (bpm), 3. resting systolic blood pressure \>180 mmhg, 4. resting diastolic blood pressure \>100 mmhg, 5. self-reported history of unstable angina or myocardial infarction within the previous month, 6. osa that is being treated with positive airway pressure therapy, 7. women who know or suspect they may be pregnant or who may become pregnant, 8. known underlying lung disease, 9. pregnant women, 10. prisoners, 11. unable to consent

Keywords: neuroplasticity respiratory function motor function
effect of intrapulmonary recombinant human activated protein c (apc) on coagulation and inflammation after lipopolysaccharide (lps)

Conditions: Pneumonia; Lipopolysaccharides

Summary: recombinant human activated protein c (rhapc) has been shown to reduce the mortality of patients with severe sepsis. the biological effects of apc are pleiotropic, and can be roughly divided in anticoagulant and cytoprotective effects. lung infection and inflammation are associated with reduced bronchoalveolar levels of endogenous apc. recent evidence derived from animal studies indicates that local administration of rapc into the lungs exerts local anti-inflammatory and anticoagulant effects. in this study we propose to study the potential of locally administered apc, within a lung subsegment, to inhibit lipopolysaccharide (lps) induced lung inflammation and coagulation in humans.


Eligibility criteria:
inclusion criteria: * male, 18-35 years of age * no clinically significant findings during physical examination and hematological and biochemical screening * normal spirometry and ecg * able to communicate well with the investigator and to comply with the requirements of the study * no medication * written informed consent * no smoking exclusion criteria: * known diseases * a history of smoking within the last six months, or regular consumption of greater than three units of alcohol per day * administration of any investigational drug within 30 days of study initiation * donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation * history of enhanced bleeding tendency * history of heparin-induced thrombocytopenia * history of serious drug-related reactions, including hypersensitivity

Keywords: activated protein c lipopolysaccharides inflammation, pulmonary
the impact of changing gloves during cesarean section on post-operative wound complication

Conditions: Decreasing Wound Infection

Summary: the investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing caesarean section. the primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are postoperative fever: defined as greater than 38 degrees celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or combined wound complications and endometritis.

the investigators conduct a prospective randomized study at department of obstetrics and gynecology, afhsr since april 2019 till october 2019, after approval of the study protocol by the local ethical committee. patients undergoing both elective and emergency cesarean sections and patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. all patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated. the patients (600) are divided into two groups, group a (300) during cs the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in group b (300) no intervention

Eligibility criteria:
inclusion criteria: 1. both elective and emergency cesarean sections. 2. patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. exclusion criteria: 1. women with active infection during the procedure. 2. women did not receive the standard preoperative antibiotic prophylaxis. 3. women with diagnosis of chorioamnionitis.
does cognitive status affect pulmonary rehabilitation gains?

Conditions: Cognitive Impairment; Pulmonary Rehabilitation

Summary: pulmonary rehabilitation program with aerobic and strengthening trainings for 3 months will be applied to the candidates for lung transplantation. the program will be designed to be 2 days supervised weekly and 3 day home program. after completion of the program, patients will be divided into two groups according to their cognitive status (group 1: those with poor cognition; group 2: those with good cognition). the pr gains of the groups will be compared.

the fact that cognition is not always included in the assessment routine makes it difficult to clarify which patient group or severity of illness is more affected by this issue. the effect of exercise on cognitive functions is a remarkable issue in recent years. it can also be predicted that cognitive function may be effective on program adaptation in patients who are given home program without supervision. the aim of the investigator's study was to investigate the effect of cognitive status to pulmonary rehabilitation gains in lung transplant candidates. lung transplantation candidates who refered from lung transplantation surgery team will receive the pulmonary rehabilitation program for 3-months (2 days at hospital, 3 days at home). exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components. patient will evaluate at the beginning and end of the program. demographic information, diagnosis distributions, educational status of patients will be recorded. exercise capacities are determined by 6 min walk test. the medical research council dyspnea scale is used in determining the dispense levels. montreal cognitive function assessment (moca) is used to determine cognitive functions. cognitive functions and exercise capacities of the patients before and after the program will be evaluated.

Eligibility criteria:
inclusion criteria: * to be listed for lung transplantation, * pulmonary rehabilitation exercise program planned to be taken, * volunteers who have agreed to participate in the work, * patients who can complete the 3-month pulmonary rehabilitation program. exclusion criteria: * failure to complete the planned exercise program for any reason, * not to be literate.

Keywords: cognitive impairment pulmonary rehabilitation exercise moca aerobic training
efficacy and safety study of a modified xelox regimen in first-line treatment of metastatic colorectal adenocarcinoma

Conditions: Colorectal Adenocarcinoma

Summary: this is an open-label, phase ii study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the first-line therapy.

primary endpoint: overall response rate secondary endpoint: time to progression, overall survival, safety data

Eligibility criteria:
inclusion criteria: * signed written informed consent; * patients with histologically or cytologically confirmed stage iv colorectal adenocarcinoma whose ecog performance status are 0-2; * presence of measurable disease by radiographic study (including ct or mri scan, or chest x-ray) or physical examination; * at least 3 weeks since last major surgery; * at least 12 months since last adjuvant chemotherapy; * at least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is not expected; * patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields; * patients with reproductive potential must use effective bc; * required screening laboratory criteria: * hemoglobin 90g/l * wbc 3.5 x 109/l * neutrophils 1.5 x 109/l * platelets 100 x 109/l * creatinine 133 umol/l and creatinine clearance 60 ml/min * a probable life expectancy of at least 6 months; exclusion criteria: * brain metastases; * female of childbearing potential, pregnancy test is positive; * concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer; * active infection; * concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk; * sexually active patients refusing to practice adequate contraception; * patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator; * history of grade 3 or 4 toxicity to fluoropyrimidines; * pre-existing neuropathy ≥ nci ctc grade 2.

Keywords: colorectal cancer adenocarcinoma xelox
mk0974 (telcagepant) for migraine prophylaxis in patients with episodic migraine (0974-049)

Conditions: Migraine

Summary: a study to assess the safety and efficacy of mk0974 for preventing migraines in patients with episodic migraine.


Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient has had a history of migraine with or without aura * patient is able to complete study questionnaire(s) and paper diary exclusion criteria: * patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study * patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions * patient was older than 50 years of age at migraine onset * history of gastric or small intestinal surgery or has a disease that causes malabsorption * patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study * currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study * currently participating in a study with mk-0974 or mk-3207
feasibility study of anatomical modeling for image guided thoracic surgery

Conditions: Lung Neoplasm

Summary: this clinical trial assesses the feasibility of creating a 3 dimensional (d) model of the lung and lung nodule(s) from computed tomography (ct) scan images performed during lung surgery. unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). this makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. a 3d model may help surgeons better predict where the location of the tumor(s) will be during surgery.

primary objective: i. to assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery. secondary objectives: i. develop a registration technique to register the tumor onto the 2d/3d optical image obtained during surgery. ii. determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2d/3d optical images obtained during surgery. outline: patients undergo 4 ct scans during standard of care surgery.

Eligibility criteria:
inclusion criteria: * patients must have previous ct images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive) * patient is scheduled for surgical resection in a room equipped with intraoperative ct * patient must sign informed consent, with risks and benefits of ct imaging explained * patients with lung tumors \>= 1cm to =\ 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators) exclusion criteria: * pediatric patients less than 18 years of age * patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively * patients who received neoadjuvant immunotherapy * women who are pregnant or nursing
diagnosis and treatment of foreign bodies outside pharynx and esophagus lumen

Conditions: Surgery

Summary: objective: to improve the success rate of the treatment of migrating foreign bodies in the upper aerodigestive tract. methods: the medical records of inpatients conforming to the diagnosis of migrating foreign bodies between 2020 and 2025 were reviewed. data regarding age, gender, time from onset to hospitalization, computed tomography (ct) and endoscopic scans, surgical procedures，and follow-up were collected.


Eligibility criteria:
inclusion criteria: * the foreign body of pharynx or esophagus was confirmed by surgical exploration exclusion criteria: * the foreign body is in the pharynx or esophagus or is not found during surgery.

Keywords: migrating foreign body; upper aerodigestive tract; neck; laryngoscopy endoscopy; positioning