Kornimate/medical-research-clean huggingface dataset:
semi-sitting versus supine position in endoscopic skull base surgery

Conditions: Pituitary Adenoma

Summary: this study is to prospectively compare the standard supine (control group) and the semi-sitting position (head elevation of 30°; intervention group) in endoscopic endonasal pituitary surgery.

the endonasal endoscopic approach (eea) for pituitary surgery is standardly performed with the patient in supine position (sp). the semi-sitting position (ssp) is routinely used for the traditional microscopic transsphenoidal approach and also for posterior fossa surgery. the ssp results in lower intracranial pressure when compared to the supine position due to decreased venous congestion. as a result, intraoperative bleeding may be reduced, potentially leading to decreased surgical morbidity and improved surgical workflow. studies during endoscopic sinus surgery have shown a significant reduction of blood loss when the patient is placed in a reverse trendelenburg position with a head elevation of 30°. this study is to prospectively compare the standard supine (control group) and the semi-sitting position (head elevation of 30°; intervention group) in endoscopic endonasal pituitary surgery.

Eligibility criteria:
inclusion criteria: * patients with a presumed pituitary pathologies who are suitable for endoscopic endonasal surgical resection exclusion criteria: * patients with known hemorrhagic or thrombophilic disorders * patients with conditions associated with high central venous pressure: congestive heart failure, pulmonary hypertension, chronic obstructive pulmonary disease (copd), interstitial lung disease, pregnancy * patients with poor cardiopulmonary condition (unable to perform 4 metabolic equivalents without stopping (climb a flight of stairs))

Keywords: endoscopic endonasal pituitary surgery endoscopic skull base surgery intracranial venous pressure venous air embolism
vaccination with peptides from anti-apoptotic proteins in relapsed multiple myeloma

Conditions: Relapsed Multiple Myeloma

Summary: anti-apoptotic proteins from the bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the bcl-2 family in combination with an immunostimulatory adjuvant. the vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple myeloma * tissue type of hla-a1, hla-a2 or hla-a3 * performance status \< 2 * adequate bone marrow - renal and liver function * written informed concent exclusion criteria: * candidate for bone marrow transplantation * other malignancies than multiple myeloma * other significant medical disease (heart-, lung or liver disease or diabetes) * allergy * active autoimmune disease * treatment with immunosuppressive drugs * treatment with other experimental drugs * uncontrolled hypercalcemia

Keywords: multiple myeloma vaccination antiapoptotic proteins proteasome inhibition
study of pomella™ extract to treat prostate cancer

Conditions: Prostate Cancer

Summary: this is a randomized, two-arm, placebo controlled trial to evaluate benefit of treatment using pomella™ extract on mechanisms known to drive prostate cancer. this research allows provision for biochemical and histological comparisons to be made between pomella™ treated and placebo treated prostate tissues removed from men with organ confined prostate cancer.


Eligibility criteria:
inclusion criteria: * men 18 years or older (19 years in bc) with a histologic diagnosis of clinically localized prostate cancer prior to radical prostatectomy as defined by: 1. clinical state t1-t2 2. psa \<20 3. gleason score ≤ 7 * ecog performance status of 0-1. * life expectancy greater than 10 years. * able to understand and give informed consent. * laboratory values must be as follows: 1. white blood cell count: ≥ 3,000/mm\^3 2. absolute granulocyte count: ≥ 1,500/mm\^3 3. platelets: ≥ 100,000/mm\^3 4. hemoglobin: ≥ 12g/dl 5. serum creatinine: ≤ 1.5 x uln 6. ast: ≤ 2 x uln 7. alt: ≤ 2 x uln 8. serum calcium: ≤ uln 9. total bilirubin: ≤ 1.5 x uln exclusion criteria: * patients who are receiving any other investigational therapy. * patients who have received or are receiving any other treatment for their prostate cancer. * patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. * dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. * histologic evidence of small cell carcinoma of the prostate. * patients who are currently receiving active therapy for other neoplastic disorders will not be eligible for study. * patients who are receiving any androgens, estrogens or progestational agents. * patients with a known hypersensitivity to pomegranates or composites of the capsules/placebo: hydroxypropyl methylcellulose, silicon dioxide or aerosol. * patients who are taking any drugs or natural health products which might impact biochemical tests (some examples include: spironolactone, aprepitant, bexarotene, clarithromycin, itraconazole, ketoconazole, st. john's wort). a washout period of 30 days prior to commencing the study would be necessary for these compounds if required. * patients who have chronic active hepatitis. * medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.

Keywords: clinically localized prostate cancer low and intermediate risk for relapse candidates for radical prostatectomy
a randomized trial to study combined pulsed dye laser and rapamycin treatment of port wine stain birthmarks.

Conditions: Port Wine Stain

Summary: the researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. this single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the beckman laser institute and medical clinic, university of california, irvine.

the study will offer two different approaches to the treatment of port wine stain birthmarks. study group number 1: port wine stain treated by the pulsed dye laser alone, which is the current standard of care: 20 subjects. study group number 2: port wine stain treated by combined pulsed dye laser and rapamycin: 20 subjects. the researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. twenty subjects will have their entire port wine stain birthmark treated by pulsed dye laser alone. twenty subjects will have their entire port wine stain birthmark treated by combined pulsed dye laser and rapamycin, which is a drug that prevents the formation of blood vessels in the skin. safety will be evaluated by searching for any local effects such as injury to the skin or systemic effects such as abnormal blood and/or urine studies. efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for the two study groups.

Eligibility criteria:
inclusion criteria: * port wine stain suitable for comparison testing. * age \> 13 years of age or older; minor will be accompanied in the room by parents or guardians during laser treatment. * apparent good health as documented by medical history. * ability to understand and carry out subject instructions. * women of childbearing potential must have a negative urinary pregnancy test prior to being started on rapamycin. * women of child bearing potential must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of rapamycin. exclusion criteria: * inability to understand and carry out instructions. * pregnancy. * abnormal blood or urine tests * history of cancer. * history of high cholesterol, lipids or liver disease. * allergy to macrolide drugs (e.g., erythromycin). * any therapy within the previous two months to the proposed port wine stain treatment sites. * current participation in any other investigational drug evaluation. * concurrent use of known photosensitizing drugs. * concurrent use of immunosuppressive drugs or steroids. * concurrent use of any of the following medications: antifungals, antiepileptics, protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapetine, troleandomycin, or verapamil.

Keywords: port wine stain
safety and efficacy of prp for treatment of disc pain

Conditions: Discogenic Pain

Summary: this is a multi-center, randomized, controlled, double-blind clinical trial comparing hemocyte autograft (platelet rich plasma) to control injection (placebo) in subjects with reported cervical, thoracic or lumbar pain for at least 3 months with pfirrmann grade changes at 7 or less and who are being considered for discography in order to identify pain generator discs in evaluation of potential surgical candidates.

the study will recruit 180 subjects: 60 suffering from lumbar discogenic pain, 60 suffering from thoracic discogenic pain and 60 suffering from cervical discogenic pain. in each arm 40 study subjects will be randomized to receive hemocyte autograft, while 20 will be randomized to receive contrast as the control group. all subjects will have blood drawn (50 cc) from any access site and have it prepared for hemocyte autograft. using a 20 gauge introducer and 25 gauge disc needle, subjects randomized to active condition will have exactly 3 cc of hemocyte autograft placed in a 3 cc syringe while subjects randomized to placebo will have exactly 3 cc of saline placed in a 3 cc syringe. the syringe barrels and tubing will be completely covered with opaque tape so that the injector is blinded to the contents. for both conditions, 1-2 cc of designated injectant (prp for active, saline for placebo) will be injected into the nucleus pulposus of each identified treatment level disc for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical. primary endpoint will be at 8 weeks after injection. after 8 weeks subjects who received placebo are eligible for crossover to treatment arm with hemocyte autograft, and subject who received treatment arm are eligible for surgery if not improved.

Eligibility criteria:
inclusion criteria: 1. male or female at least 18 years of age. 2. clinically suspected discogenic pain in the cervical, thoracic or lumbar spine. 3. bring considered for discography in order to identify source of pain in the evaluation of potential surgical candidates. 4. history of neck pain or mid or low back pain for at least 3 months. 5. failed to respond to conservative therapies that include physical therapy and analgesics. 6. documented pfirrmann grade changes of 7 or less at each treatment level as represented by an mri no more than 12 months old (extravasation not excluded). exclusion criteria: 1. unresolved neck or back pain from a previous cervical, thoracic or lumbar surgery at any level. 2. any contraindication for discography or surgery 3. significant signs or symptoms of root or cord compression at treatment levels. 4. any diagnosis of a concurrent pain disorder or other concurrent cause of disability. 5. daily opioid requirements of greater than180 mg oral morphine equivalent (ome) per day. 6. current active systemic infection, or history of disc infection. 7. untreated disabling thought or mood disorder. 8. inability to provide informed consent including subjects in a socially compromised condition such as prisoners.

Keywords: lumbar spine thoracic spine cervical spine
prospective analysis of the use of n-acetylcysteine and vitamins in the treatment of tbi in geriatric patients

Conditions: Traumatic Brain Injury

Summary: this study will evaluate the administration of n-acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (\>60 years of age) who have experienced a traumatic brain injury.

this study aims to determine the effect of supplemental n-acetyl cysteine and additional multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms as determined by the rivermeade post-concussion questionnaire (rpq) within 24 hours of admission, post injury day 7, and post injury day 30. the rpq questionnaires will be given to patients older than 60 years, who have been evaluated by the honorhealth john c. lincoln medical center or deer valley medical center trauma service within 3 hours of sustaining a traumatic brain injury (tbi).

Eligibility criteria:
inclusion criteria: * 60 years or older * present to emergency department within 3 hours of documented tbi exclusion criteria: * patients without tbi * patients with a history of tbi greater than 3 hours prior to presentation * patients under the age of 60 * currently enrolled in an ongoing research study * patients who at baseline prior to the tbi, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to tbi) * patients who are unable to tolerate po medications within 3 hours of sustaining tbi.
ino as salvage treatment of hypoxemia after taad surgery

Conditions: Type A Aortic Dissection

Summary: the purpose of this study was to clarify the possible mechanism of hypoxemia after surgical treatment of type a acute aortic dissection and the possible mechanism of the treatment role of inhaled nitric oxide in refractory hypoxemia.

the investigators' previous study has stressed that inhaled nitric oxide therapy might play an ameliorative role in patients with refractory hypoxemia after surgical treatment of type a acute aortic dissection. the possible reason might be the decreasing of intrapulmonary shunt because previous studies showed that inhaled nitric oxide could decrease intrapulmonary shunt by selectively dilating the pulmonary vessels in ventilated areas. as a result, the investigators designed this observational study to calculate the intrapulmonary shunt before and after inhaled nitric oxide therapy. intrapulmonary shunt was calculated from oxygen content (co2) of different sites ( artery, mixed venous, alveolar capillary) by fick equation:(cao2-cco2)/(cvo2-cco2). a fio2 of 1.0 and tidal volume of 6\~8 ml/kg were chosen. oxygen content was calculated from hemoglobin (hb), oxygen saturation (so2) and oxygen partial pressure (po2) by the following equation: co2 = 1.34\*hb\*so2 + 0,0031\*po2. pao2, sao2, pvo2 and svo2 were measured from arterial and mixed venous blood samples taken from the radial arterial catheter and from the pulmonary artery catheter. sco2 was estimated to be 1.0 with a fio2 of 100%. pco2 was considered to be the same as pao2 (partial pressure of oxygen in the alveoli), and was calculated from the alveolar gas equation with pao2 = \[(atmospheric pressure - 47) \* (fio2)\] - paco2/0.8.other variables such as hemodynamic variables from pulmonary artery catheter were also collected.

Eligibility criteria:
inclusion criteria: * adult * type a aortic dissection; * after surgery; * p/f ratio ≤ 200mmhg exclusion criteria: * intracardiac shunt; * contradiction of pac; * chronic pulmonary diseases before surgery; * ecmo; * anticipation of death within 48 hours after operation;

Keywords: hypoxemia type a acute aortic dissection inhaled nitric oxide
internal fixation of lateral humeral condyle fractures with absorbable screws in children

Conditions: Humeral Fractures

Summary: lateral humeral condyle fractures are the second most common elbow fractures in children. displaced and rotated fractures require stabilization and reduction. kirschner wires (k-wires) are most commonly used for fracture fixation. here, the investigators introduce a new fixation method involving absorbable screws. the investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. k-wire fixation.

methods: between may 2007 and september 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. all participants had been diagnosed with lateral condyle fractures classified as jacobs type ii (unstable) or iii. closed reduction failed in all participants. therefore, open reduction was performed under general anesthesia. one absorbable screw was used for fixation in the experimental group, while two 1.8-mm k-wires were used in the control group. at 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.

Eligibility criteria:
inclusion criteria: all participants had been diagnosed with lateral condyle fractures classified as jacobs type ii (unstable) or iii exclusion criteria: participants had not been diagnosed with lateral condyle fractures classified as jacobs type ii (unstable) or iii

Keywords: absorbable screw internal fixation children
the relationship between right-to-left shunt and brain white matter lesions in patients with migraine

Conditions: White Matter Disease; Right-to-left Shunt; Migraine Disorders

Summary: the purpose of the study is to evaluate the prevalence of white matter lesions in chinese migraineurs with and without right-to-left shunt. the aim is to study the relationship among right-to-left shunt, migraine and white matter lesions.

this is a prospective multicenter study of chinese population. participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (tcd and migraine diagnosis). for all the participants, brain mri and c-tcd are required. up to 10-15 study sites nationwide will be needed to recruit the planned participant population during a 1-year period. the information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, and headache impact test-6 (hit-6) questionnaire.

Eligibility criteria:
inclusion criteria: * patients who fulfilled the criteria for migraine according to the international classification of headache disorders iii-beta were included. healthy volunteers without a history of migraine were included as controls. exclusion criteria: * subjects were excluded from the study if they had severe arterial stenosis, an insufficient temporal window, inadequate cubital venous access, and/or were unable to perform the valsalva manoeuvre (vm) because of severe heart or lung disease.

Keywords: right-to-left shunt brain white matter lesions migraine
evaluation the effectiveness of the risk minimisation activities in the treatment of stroke prevention in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the key focus of this survey will be to collect data on physicians awareness of the content of the pradaxa® prescriber guide and the extent to which risk awareness is communicated to patients. the data collected with atrial fibrillation patients will show if and how well this information is received and understood.

purpose:

Eligibility criteria:
inclusion criteria: * pradaxa® prescribers (cardiologists and primary care physicians) * patients with atrial fibrillation treated with pradaxa® exclusion criteria: as defined in summary of product characteristics for patients treated with pradaxa®
comparative study between ivi of ranibizumab with and without prior acp in patients with dme using oct-a

Conditions: Diabetic Macular Edema

Summary: the goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present . the main question\[s\]it aims to answer are: •\[is there any effect of post intra-vitreal injection iop spikes on retinal microvasculature?\] •\[is there any effect of prior anterior chamber paracentesis?\] participants in group a will be subjected to an identified approved treatment( intra-vitreal injection)\& participants in group b will be subjected to a prior acp with the intra-vitreal injection . \]


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type ii. * patients with visual acuity \> 0.1, able to fixate and with clear visual media. * patients with eyes with non ischemic diffuse center involving dme were randomly assigned to receive ivi of ranibizumab either without (group a) or with (group b) acp. exclusion criteria: * age under 40 years. * poorly controlled diabetics (hba1c greater than 9.0%) * proliferative diabetic retinopathy. * oct-angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion) * neovascular amd in the study eye. * history of glaucoma. * tilted disc and optic disc anomalies. * one-eyed patients. * usage of systemic or topical corticosteroids. * patients with a history of intraocular surgery other than cataract surgery. * systemc diseases rather than hypertension and diabetes mellitus. * corneal opacities that might hinder acquisition of good quality oct images.
comparison of non-invasive methods of lung ventilation in patients with respiratory failure after cardiac surgery

Conditions: Respiratory Failure

Summary: comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery

the study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. it assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.the study will be randomized, single-center, prospective.

Eligibility criteria:
inclusion criteria: 1. age from 30 years to 60 years inclusive 2. decreased oxygenation function of the lungs (spo2 less than 90%, pao2/fio2 less than 300, bh less than 25 per minute) 3. by data ct/x-ray examination of hypoventilation zones (pneumonia, atelectasis) 4. consent the patient to participate in this study exclusion criteria: 1. tracheal intubation, absence of independent breathing 2. unstable hemodynamics or hemodynamically significant rhythm disturbances 3. acute violation of the cerebral blood supply 4. shocks of various etiologies 5. impossibility provide respiratory protection , high risk of aspiration 6. lack of productive contact with the patient 7. patient's refusal to participate in this study