Kornimate/medical-research-clean huggingface dataset:
lung transplantation in respiratory failure patients

Conditions: Respiratory Failure

Summary: survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. the objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ecmo) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .

the one-year survival rate and postoperative pulmonary functional results will be reported in this study.

Eligibility criteria:
inclusion criteria: * respiratory patients depended on ventilator supports prior to lung transplant exclusion criteria: * non-cardaveric lung transplant

Keywords: lung transplantation respiratory failure ecmo lung transplants in respiratory failure patients
in.pact flexion, investigating the performance of the in.pact admiral deb for popliteal lesions

Conditions: Peripheral Arterial Disease

Summary: the objective of this study is to evaluate the performance of the in.pact admiral deb for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal lesions


Eligibility criteria:
inclusion criteria: * - de novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement * patient presenting a score from 2 to 5 following rutherford classification * patient is willing to comply with specified follow-up evaluations at the specified times * patient is \>18 years old * patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * prior to enrollment, the guidewire has crossed target lesion * patient is eligible for treatment with the in.pact admiral drug-eluting balloon * the target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type a or b lesion according the tasc ii guidelines * the target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation * target vessel diameter visually estimated is \>3.5mm and \<7.5 mm * there is angiographic evidence of at least one vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention. exclusion criteria: * - presence of another stent in the target vessel that was placed during a previous procedure * presence of an aortic thrombosis or significant common femoral ipsilateral stenosis * previous by-pass surgery in the same limb * patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated * patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site * perforation at the angioplasty site evidenced by extravasation of contrast medium * patients with known hypersensitivity to nickel-titanium * patients with uncorrected bleeding disorders * aneurysm located at the level of the sfa and/or popliteal artery * female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * life expectancy of less than twelve months * ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure * use of thrombectomy, atherectomy or laser devices during procedure * any patient considered to be hemodynamically unstable at onset of procedure * patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
optical detection of malignancy during percutaneous interventions

Conditions: Pulmonary Coin Lesion; Colon Cancer Liver Metastasis; Breast Cancer

Summary: investigation of application possibilities of optical spectroscopy within the field of oncology. optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. the hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. the purpose is to improve and speed up the diagnostics and therapy of the malignancies.

primary objective: in this observational study the investigators aim to evaluate whether optical spectroscopy can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous interventions in lung, liver, and breast. secondary objective: during the measurement procedure, possible improvements of the measurement hardware will be recorded. analysis of this documentation will provide information for possible alterations of hardware design for improved clinical applicability in the future. special attention will be paid to observe how the procedure fits in the standard workflow of the radiologist.

Eligibility criteria:
inclusion criteria: * patients with a suspicious lesion in lung or liver who are scheduled for a standard core biopsy procedure * patient planned for percutaneous rfa of colorectal liver metastasis * written informed consent * patients ≥ 18 years old * breast patients with a birads score 4 or 5 general exclusion criteria: * patients who have higher risk of bleeding * patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy breast specific exclusion criteria: * patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy * patients who have breast implants * patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)

Keywords: spectroscopy tumour biopsy malignancy
gadofosveset for axillary staging in breast cancer patients

Conditions: Breast Neoplasms

Summary: the aim of this pilot-study is to examine the accuracy of gadofosveset enhanced mri compared to current nodal staging methods. the accuracy of mrl will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. the pathologic examination of the snlb or alnd will be regarded as the golden standard for nodal involvement.


Eligibility criteria:
inclusion criteria: 1. patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging. 2. tumor must be a t2 according the tnm 6-classification. 3. the ultrasound of the axilla must be suspect for nodal metastases. 4. willing and able to undergo all study procedures 5. has personally provided written informed consent. exclusion criteria: 1. age \<18 2. history of prior chemotherapy 3. history of prior radiotherapy of the surrounding areas of the axilla. 4. pregnancy 5. contra indications for mri such as pacemaker, aneurysm clips or severe claustrophobia. 6. allergy to any of the ingredients of gadofosveset (vasovist® /ablavar®) 7. being unable to give informed consent in person 8. acute or chronic severe renal insufficiency (glomerular filtration rate \<30 ml/min/1.73m2). 9. acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

Keywords: mri lymph node metastases breast cancer gadofosveset
pediatric concussion outcomes

Conditions: Concussion Post Syndrome; Headaches Posttraumatic; Mild Traumatic Brain Injury

Summary: this is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. at the end of 4 weeks the study will be unblinded. it is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.

participants are randomly assigned to one of two treatment groups. the experimental group receives standard headache treatment including tylenol, nsaids 2-3x/week, vestibular pt and daily nortriptyline 10mg oral. the control group also receives the standard headache treatment, but will instead be given a placebo, which will look physically identical to the nortriptyline capsule and be comprised of non-active pharmaceutical grade excipient.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. participants aged 13-21 years old 4. in good general health as evidenced by medical history and diagnosed with recent head trauma meeting ichd-3 criteria for acute posttraumatic headache with symptom onset \< 7 days from trauma 5. ability to take oral medication and be willing to adhere to the medication regimen 6. no loss of consciousness or loss of consciousness \<30 minutes 7. headache symptoms persisting ≥4 weeks post trauma 8. pcshe score for headache + pressure in head + neck pain must be \> 3 9. after week 4 post-concussion at time of enrollment 10. not currently receiving pharmacologic treatment for concussion asid from nsaids and acetaminophen exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. focal neurological deficits following injury 2. any acute abnormality on computed tomography (if obtained) 3. history of known seizure disorder or moderate or severe tbi 4. current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion). 5. current suicidal ideation as screened for on phq on intake 6. a personal history of brugada syndrome 7. known allergic reaction to nortriptyline 8. current pregnancy 9. positive covid-19 test in prior 14 days

Keywords: concussion headache mild tbi post concussion
a dose selection trial of ckd-330 in patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the efficacy and safety of candesartan/amlodipine combined or alone and select better dose of ckd-330 in essential hypertension patients.


Eligibility criteria:
inclusion criteria: * age of 18 or above * essential hypertension with 90mmhg ≤ mean sitdbp ≤ 115mmhg on target arm at visit 3 * ability to provide written informed consent exclusion criteria: * nean sitdbp ≥ 116mmhg or mean sitsbp ≥ 200mmhg at visit 1, visit 2, visit 3 * the change of mean sitdbp ≥ 10mmhg or mean sitsbp ≥ 20mmhg on target arm at visit 1 * known or suspected stage 2 hypertension (aortic coarctation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) * patients with congestive heart failure(nyha class iii\~iv), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft * history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months * type i diabets mellitus, type ii diabetes mellitus with hba1c \> 8% * history of severe or malignant retinopathy * ast/alt \> unl \* 2, serum creatinine \> unl \* 1.5, k \> 5.5meq/l * patients with acute or chronic inflammatory status, autoimmune disease * patients who need to take antihypertensive drug besides investigational products * patients must be treated with medications prohibited for concomitant use during study period * hypersensitive to candesartan/amlodipine or other dihydropyridine drugs * hereditary angioedema or history of angioedema related to ace inhibitor or angiotensin ii receptor blockers * history of malignant tumor within 5 years * patients who are dependent on drugs or alcohol * history of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, gi bleeding, obstructions of urinary tract * patients treated with other investigational product within 4 weeks at the time concents are obtained * women with pregnant, breast-feeding * not eligible to participate for study at the discretion of investigator
the effect of personalized shoe insole on the gait of parkinson's disease subjects

Conditions: Parkinson Disease

Summary: this study aims to assess the efficacy of custom-made shoe insoles, for subjects with parkinson's disease (pd). to do that, a sample of pd subjects has been randomly assigned to an intervention group that will receive the custom-made insoles or a control group that will receive a sham insole without any specific manufacturing. both groups will receive physiotherapy and occupational therapy according to pd rehabilitation guidelines. the principal outcome will be the time up\&go test time, secondary outcomes 10 meters walking test speed, berg balance scale score, sf12 score, and orthesis liking.


Eligibility criteria:
inclusion criteria: * subjects with idiopathic parkinson's disease; * age \> 18 years; * subjects should be in a positive therapeutic window or in the on phase during the evaluations; * subjects must be able to walk at least 10 meters independently with or without any walking aid. exclusion criteria: * not clinical stable subjects; * subjects in off phase during the evaluations; * other neurological conditions (e.g. stroke, peripheral neuropathies, etc.); * other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Keywords: parkinson disease foot orthoses randomized controlled trial
preoperative prediction of difficult laryngoscopy in diabetic patients: importance of the palm print test

Conditions: Difficult Laryngoscopy; Diabetes; Preoperative Period

Summary: the investigators assessed upper airway management at the pre-anaesthetic consultation using the usual clinical criteria. on the day before surgery, diabetic patients were assessed for the palm print sign to predict difficult laryngoscopy. after induction of anesthesia, laryngoscopy was performed with a macintosh metal laryngoscope blade. at this stage of the study, patients were categorized into two groups: difficult and easy laryngoscopy.

during pre-anesthesia consultation, all participants were assessed for airway conditions using usual clinical tests (mallampati classification, thyromental distance, mouth-opening test, upper lip biting test (ulbt), head extension and prayer sign). demographic characteristics, diabetes duration, blood glucose regulation and diabetes-related complications were also recorded. on the day before surgery, patients were assessed for the palm print sign during preoperative evaluation rounds. on the day of surgery, after an intravenous line (iv) and complete monitoring, induction of anesthesia was initiated, and a muscle relaxant was used to facilitate intubation. laryngoscopy was performed with a macintosh metal laryngoscope blade by an anesthesiologist who had more than 2 years of intubation experience. mcgrath® videolaryngoscope, mccoy laryngoscope, lma fastrack®, or i-gel® airway were kept ready for emergency situations. at this stage of the study, patients were categorized into two groups: difficult and easy laryngoscopy.

Eligibility criteria:
inclusion criteria: * diabetes mellitus * aged more than 18 years * undergoing surgery under general anesthesia with endotracheal intubation. exclusion criteria: * physical or intellectual disabilities preventing cooperation * malformations, trauma, tumors, or infections of the maxillofacial region and upper airways, * a history of burns or cervicofacial irradiation * neurosurgical conditions causing temporomandibular pseudoankylosis. * hand joint stiffness (e.g., carpal tunnel syndrome, dupuytren's disease, scleroderma, rheumatoid arthritis) * restricted cervical mobility (due to osteoarthritis, ankylosing spondylitis, or cervical trauma), * a history of difficult intubation * pregnancy (including up to six weeks postpartum)
safety and efficacy of sofosbuvir based antiviral regimen for treating hepatitis c in patients with moderate to advanced chronic kidney disease and patients receiving renal replacement therapy

Conditions: CKD With Hepatitis C

Summary: all patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with hcv infection attending nephrology and hepatology opd or getting outpatient dialysis at the dialysis unit of ilbs.


Eligibility criteria:
inclusion criteria: 1. patients with moderate to severe renal dysfunction (ckd stage 3, 4, 5) and chronic dialysis patients 2. patients consented for the study protocol by signing the informed consent. exclusion criteria: 1. age less than 18 years 2. confirmed pregnancy 3. hcv-hiv co infection 4. hbv-hcv co infection
native hawaiian diabetes intervention program

Conditions: Diabetes Mellitus, Type 2

Summary: the native hawaiian diabetes intervention program is a project focused on determining whether a cultural-based, healthy lifestyles program with family support will have a positive effect on lifestyle behaviors and psychosocial and clinical outcomes. a culturally sensitive, lifestyle intervention program was administered via community peer educators to a population of native hawaiians with or at risk for diabetes. the effect of this intervention program on selected outcomes is being compared to a ''standard'' program given to a similar population in a second native hawaiian community.


Eligibility criteria:
inclusion criteria: * participant must be a native hawaiian adult 30 years of age or older residing in the research community and have diabetes or at-risk for diabetes. * family support member must be 18 years or older and live in the study community and be willing to go through the entire program with the participant as their support person. * physician clearance to participate in the program. exclusion criteria: * pregnancy

Keywords: native hawaiian diabetes mellitus lifestyle intervention family support diabetes mellitus, at-risk
the effect of lubricating gel on patient comfort during speculum insertion.

Conditions: Examination, Gynecological; Examination, Pelvic; Examination, Vaginal

Summary: the purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.

the outcome measure is patient discomfort as measured by a visual analogue scale.

Eligibility criteria:
inclusion criteria: * women undergoing vaginal speculum examination between the ages of 18 and 50. exclusion criteria: * pregnancy. * non-english speaking. * using hormone therapy. * active vulvar or vaginal lesion, infection or complaint. * undergoing vaginal or vulvar procedure or biopsy. * history of chronic pelvic pain, interstitial cystitis or vulvar vestibulitis. * history of prior vulvar or vaginal surgical procedures.

Keywords: lubricating gel speculum pain, pelvic examination, gynecological
effectiveness of a digital health application for people with insomnia disorder (somnovia)

Conditions: Insomnia Disorder

Summary: the trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., care-as-usual \[cau\]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use cau. the primary outcome measure is the score of the insomnia severity index (isi), collected at three months post-baseline.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic insomnia * impaired quality of sleep (insomnia severity index score ≥ 10) exclusion criteria: * none
comparison of software-assisted implantation of elastic spine pad (tm) with respect to postoperative change in neck disability index (ndi) with the conventional disc spacer squale (tm) after anterior cervical discectomy for cervical disc prolapse

Conditions: Intervertebral Disc Displacement

Summary: this is an investigator-initiated study. the primary goal is to evaluate the efficacy of two different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative change in neck disability index. the evaluation will include clinical and radiological parameters.


Eligibility criteria:
inclusion criteria: * indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis exclusion criteria: * radiologic signs of extensive bone degeneration in the affected segment * necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the vertaplan (tm) software * transversal spine cord lesion * cervical myelopathy * preceding surgery on the cervical spine * traumatic lesions of the cervical spine * radiographic instability in the affected segment: flexion / extension: shift sagittal plane\> 3.5 mm or 20% and rotation in the sagittal plane \> 20 °, or in static x-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation \> 11º * signs of instability (olisthesis) in another segment of the cervical spine * active systemic infection * diseases of the rheumatic type and all autoimmune diseases * bone metabolic diseases (for example, paget's disease) * skeletal metastases * infections in the cervical spine * neurological seizure disorders or other serious neurological disease with risk of falls * severe heart failure (nyha iii-iv) * bleeding disorders or clopidogrel / coumarins - treatment * systemic use of corticosteroids for more than a month in the last 12 months * pregnancy * legally incompetent patient * lactation * deformity, anomalies, not fully developed skeleton * local tumor disease * pre-existing neurologic abnormalities or other shortcomings, such as a parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy * drug / drug or alcohol dependence