Kornimate/medical-research-clean huggingface dataset:
fim-nl - first-in-man study (netherlands part) with sirolimus coated modified bx velocity stent

Conditions: Coronary Artery Disease

Summary: the objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified bx velocity balloon-expandable stent mounted on the raptor over the wire (otw) stent delivery system (sds) in patients with de novo coronary artery lesions.

this is a single center, non-randomized study. patients who meet the eligibility criteria will be treated with the sirolimus coated modified bx velocity balloon-expandable stent mounted on the raptor otw sds. patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.

Eligibility criteria:
inclusion criteria: 1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs) or a positive ischemia study; 2. single de novo lesion requiring treatment in a major native coronary artery; 3. target lesion is \<=18mm in length (visual estimate); 4. target lesion is \>=3.0mm and \<=3.5mm in diameter (visual estimate); 5. target lesion stenosis is \>50% and \<100% (visual estimate); exclusion criteria: 1. a q-wave or non-q-wave myocardial infarction within the preceding 72 hours unless the ck and ck-mb enzymes are back to normal; 2. unprotected left main coronary disease with \>=50% stenosis; 3. have an ostial target lesion; 4. angiographic evidence of thrombus within target lesion; 5. calcified lesions which cannot be successfully predilated; 6. ejection fraction \<=30%; 7. target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch); 8. totally occluded vessel;
coronary bifurcations with ischaemia and flow assessment

Conditions: Coronary Bifurcation Lesions

Summary: the coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. if these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. narrowings are usually treated using metal scaffolds called drug eluting stents. however, in one in five cases where the narrowing occurs at a branching point, treating it with stents is more challenging and can cause complications. a possible alternative treatment is using a special type of balloon called a drug-coated balloon. this balloon is inflated in the blood vessel and releases medicine to help widen the blood vessel and the procedure is completed without leaving any metallic scaffold behind. this study aims to compare drug coated balloons with drug eluting stents to see which treatment works better for narrowing that occurs at branching points. we will used advanced imaging techniques to create computer models of blood flow in the vessels, and we will follow up with patients over tie to see how well the treatments work.


Eligibility criteria:
inclusion criteria: * age 18 or over * any bifurcation lesion amenable to a provisional main vessel treatment strategy * a main vessel diameter of 2.5mm or more and side branch diameter of \>2mm * any patient with stable angina, silent ischaemia, unstable angina or nstemi * able to give informed consent exclusion criteria: * cardiogenic shock * lvef \<30% * stemi (as unable to give informed consent) * egfr \<30 * severe asthma contraindicating use of adenosine * high degree av block on 12 lead ecg precluding the use of adenosine * pregnancy * inability to consent * left main stem coronary bifurcation lesions

Keywords: drug coated balloons coronary bifurcation lesions computational flow dynamics
personalizing exercise for parkinson disease

Conditions: Parkinson Disease

Summary: the overarching aim is to determine the benefits of parkinson-specific exercise programs and general exercise patterns on physical function and disease-related quality of life among people with parkinson disease (pd). the significance of this project is that millions of individuals experience adverse consequences of pd and there is strong evidence that structured exercise programs have beneficial effects on motor function and pd-related quality of life. participation in this study involves online surveys upon enrollment (i.e., baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years.

parkinson disease (pd) is a neurodegenerative disease that affects more than ten million people worldwide. in the united states, more than one million people are living with pd and more than 100,000 new cases are diagnosed each year. exercise to ease the burden of pd: exercise is an adjunct to pharmacologic therapy for pd that has been shown in many intensive research studies to help improve motor and non-motor symptoms in pd. a variety of parkinson-specific exercise programs have been developed to help improve balance, posture, mobility, strength, endurance, speech, and/or self-help skills. these classes include various modes of exercise and different intensity levels, tailored for patients' personal characteristics and functional abilities. current gaps in knowledge and aim: the benefits of pd-specific exercise programs on physical function and disease-related quality of life have not been evaluated. furthermore, many patients may not have access to pd-specific exercise programs. the proposed project addresses these gaps by exploring associations between pd-specific exercise programs and several metrics of physical function and quality of life among individuals with pd. in addition, the investigators are studying associations among overall exercise patterns, physical activity patterns, physical function, and quality of life among individuals with pd. study involvement: participation in this study involves online surveys completed upon enrollment (i.e., baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years. a family member, caregiver, or friend may help the participant complete the online surveys.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson disease * ability to provide informed consent exclusion criteria: * children (\<18 years of age)

Keywords: exercise physical activity
an observational exploration of clinical trials targeting traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: clinical study participation has historically been heavily biased toward specific demographics. several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. people with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with traumatic brain injury * patient has self-identified as planning to enroll in an observational clinical trial * patient is a minimum of 18 years or older exclusion criteria: * pregnant or nursing patients * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form

Keywords: traumatic brain injury
hh-120 nasal spray for post-exposure prevention of sars-cov-2

Conditions: COVID-19

Summary: this study will assess the efficacy of hh-120 nasal spray in participants for the post-exposure prevention of sars-cov-2.

during this study, participants will receive hh-120 nasal spray treatment for 7 consecutive days, the efficacy and safety of hh-120 nasal spray will be assessed throughout the study period mainly based on the incidence of symptomatic sars-cov-2 infection and adverse events, respectively.

Eligibility criteria:
inclusion criteria: * 12 to 85 years old. * participants with potential exposure to index patients (with known positive result of qrt-pcr or rapid antigen test \[rat\]). * participants will be randomized no longer than 48 hours from the onset of the covid-19 related symptom of the index patients. * participants with a negative rat result within 2 hours prior to randomization. * fertile participants must agree to use a highly effective method of contraception. * participants being able and willing to provide informed consent prior to any study-specific procedure. exclusion criteria: * those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators). * those comorbid with asthma. * those with a history of sars-cov-2 infection within 3 months prior to randomization. * those who has received any nasal spray or aerosol inhalation covid-19 vaccine within 3 months prior to randomization. * those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc. * known history of allergy or reaction to any component of the study drug formulation. * those who has received other treatment with anti-covid-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first). * participants with nasal disease that is inconvenient or intolerant of nasal spray administration. * other reasons considered by the investigator to be unsuitable for the study.

Keywords: severe acute respiratory syndrome coronavirus 2 coronavirus disease 2019
post-operative lower eyelid massage for prevention of the lower eyelid scare contracture after subciliary approach

Conditions: Zygomatic and Lefort II Fractures; Infraorbital Rim Fixation; Subciliary Approach Repair

Summary: patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. the massage group received post-operative instructions. data on demographics, injury profiles, lower eyelid scar contracture (graded by glesco criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up.

* the massage technique was executed with the patient in a fully open-eyed state, maintaining an upward gaze. the lateral aspect of the distal phalanx of the index finger was employed, exerting pressure on the lower eyelid to bring its margin into contact with the upper eyelid margin for a duration of 10 seconds per repetition. this procedure comprises 10 repetitions per set, administered once hourly, spanning 10 hours daily. the massage instruction was provided either by the authors or plastic surgery residents. * facial fracture surgeries were conducted by experienced plastic surgeons and/or proficient 4th and 5th year plastic surgery residents at chiang mai university hospital, utilizing the skin-muscle flap subciliary approach. all patients underwent surgery one week after injury to mitigate soft tissue swelling, which had subsided by that time. * consistent pre-operative, peri-operative, and post-operative care protocols were administered to both patient groups. stitches at the subciliary incision site were extracted on post-operative day 5. patients in the massage group were instructed to commence lower eyelid massage on the day when stitches were removed. * the follow-up assessments were occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively. evaluation criteria include the grading of lower eyelid scar contracture (glesco). additionally, grading of lower eyelid malpositioning, comfort scores, rate on a scale of 0-10, adapted from posas and verbal rating scale, wound infection, dehiscence, eyelid comfort, and management related to the subciliary incision will be assessed and documented by the plastic surgeon (author) and plastic surgery resident.

Eligibility criteria:
inclusion criteria: * patients diagnosed with zygomatic and lefort ii fractures necessitating infraorbital rim fixation following motorcycle accidents, and presenting without external lower eyelid wounds. exclusion criteria: * pre-existing lower eyelid retraction (from previous scar, neurogenic cause, myogenic cause or graves' disease), incision alteration, communication barriers, inability to perform daily activities or lower eyelid massage (ecog ≥ 2, pps adult suandok ≤ 60), inability to attend follow-up visits, and patient refusal.

Keywords: subciliary incision subciliary approach lower eyelid massage facial fracture scar contracture eyelid malposition ectropion
diagnostic performance and safety of 18f-naf-pet/ct in bone metastases compared with 99mtc⁃mdp-bs±spect

Conditions: Bone Metastases

Summary: the goal of this clinical trial was to assess the diagnostic performance and safety of sodium fluoride f-18 positron emission tomography / computed tomography (18f-naf-pet/ct) in bone metastases of malignant tumors compared with technetium\[99mtc\] methylenediphosphonate bone scintigraphy ± single photon emission computed tomography (99mtc-mdp-bs±spect). the enrolled subjects were randomly assigned to two sequences a and b at a ratio of 1:1. within 7 days, 18f-naf-pet/ct and 99mtc-mdp-bs±spect bone imaging were performed alternately. the sensitivity, specificity, positive and negative predictive value of 18f-naf-pet/ct and 99mtc-mdp-bs±spect were calculated respectively based on the diagnostic data of standard of truth.


Eligibility criteria:
1. male or female, age 18 to 75 years, inclusive. 2. it is confirmed to be lung cancer, prostate cancer or breast cancer by combining medical history, imaging and pathological examination, and radionuclide bone imaging is required, and any one of the following is required: 1. bone imaging within 3 months before the signing the icf cannot exclude bone metastasis. 2. associated with clinical manifestations related to bone metastasis, including bone pain, activity disorder, pathological fracture, spinal cord or spinal nerve compression symptoms, alkaline phosphatase elevation, hypercalcemia or prostate specific antigen (psa) \>10 ng / ml. 3. those with definite metastasis outside the primary tumor focus. 4. patients with a history of bone metastasis. 5. patients who need to confirm the status of bone metastasis for tumor staging. 3. according to the standard of the eastern cooperative oncology group (ecog), the score was 0-1. 4. the expected survival of the patients was \> 6 months.

Keywords: lung cancer breast cancer prostate cancer
preoperative evaluation of lymph nodes of cholangiocarcinoma

Conditions: Hilar Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma; Common Bile Duct Neoplasms; Cholangiocarcinoma; Adenocarcinoma

Summary: the goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pcca), intrahepatic (icca) or mid-common bile duct (cbd) cholangiocarcinoma. the main questions it aims to answer is: 1. the number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition 2. characteristics during endoscopic ultrasound of lymph nodes associated with malignancy


Eligibility criteria:
inclusion criteria: * presumed resectable pcca or * presumed resectable icca or * presumed resectable mid-common bile duct cca or * presumed unresectable pcca worked-up for liver transplantation and * written informed consent must be given according to international council on harmonisation/good clinical practice guidelines, and national/local regulations and * age \> 18 years. exclusion criteria: * patients with a history of treated cca * patients with cca for which a pancreatoduodenectomy is indicated, based on cross-sectional imaging * patients with a history of treated liver malignancy * patients with a contra-indication for eus-tissue acquisition (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice

Keywords: endoscopic ultrasound fine needle aspiration fine needle biopsy lymph node adenocarcinoma
testing new method of analyzing mr images

Conditions: Breast Abnormalities

Summary: preliminary imaging study to test for future use of this mri-imaging for evaluating anti-angiogenesis treatment.

the purpose of this study is to develop and evaluate new mr imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. this feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing mr for clinical purposes. the specific objective of this research study is to develop and validate both mri and functional mri data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results. the information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.

Eligibility criteria:
inclusion criteria: * females * age 18 years or greater * undergoing breast mri exam exclusion criteria: * pregnancy * contraindication for mri on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia) * history/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality

Keywords: mr scanning
trial to optimally show the pharmacological action of z-100

Conditions: Cervical Cancer

Summary: the objective of this clinical trial is to evaluate the change of the immunological parameter levels in figo stage iiib cervical cancer subjects by administration of z-100


Eligibility criteria:
inclusion criteria: 1. figo stage (2008): iiib, cervical cancer 2. pathologically confirmed squamous cell carcinoma of the cervix 3. subjects with treatment-naive cervical cancer 4. subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node 5. subjects ≥21, ≤79 years of age at informed consent 6. subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy 7. subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy 8. eastern cooperative oncology group performance status: 0-2 9. subjects with the following organ functions; (1) wbc ≥3,000/mm3 (2) platelet count ≥100,000/mm3 (3) hemoglobin ≥9.5 g/dl (correction by medication, e.g. blood transfusion, iron compounds, is allowed) (4) total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (5) ast, alt ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (6) creatinine clearance: ≥50 ml/min 10. subjects who are willing to give informed consent exclusion criteria: 1. subjects who have a double cancer or are being treated for that 2. subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent 3. subjects with cancer of the cervical stump which is judged by the investigator 4. subjects who have a history of being diagnosed of autoimmune disease 5. subjects who have a history of radiotherapy in the pelvis 6. subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum 7. subjects complicated with a serious drug allergy 8. subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid) 9. pregnant women, nursing mothers or subjects who desire pregnancy during the trial period 10. subjects who have ongoing infection of human immunodeficiency virus (hiv), active hepatitis b virus (hbv), hepatitis c virus (hcv) 11. subjects with symptomatic tuberculosis at the date of obtaining consent 12. subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent 13. other subjects considered inappropriate to participate in the trial by the investigator
reliable hypertension diagnosis based on 24 abpm

Conditions: Arterial Hypertension

Summary: 24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements

hypertension is a common condition in modern society. as blood pressure fluctuates with time, a single blood pressure measurement is useless to diagnose hypertension. nevertheless, a questionable not well-defined number of measurements still is often used for this purpose. diagnosis and therapeutic control of hypertension are therefore suboptimal. this study's objective is to determine the number and timing of measurements needed to give a trustworthy approximation of an individual's average blood pressure. therefore, 24 h ambulatory blood pressure measurements were retrospectively analyzed.

Eligibility criteria:
inclusion criteria: * 70 per cent of valid measurements exclusion criteria: * none
a study of gw685698x for the treatment of perennial allergic rhinitis in adolescents and adults

Conditions: Rhinitis, Allergic, Perennial

Summary: the purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (hpa) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. this study can last up to 6 weeks and you will come to the clinic up to 7 times. clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ecgs and allergy skin testing. you will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.

a randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of gw685698x aqueous nasal spray 100mcg qd on the hypothalamic pituitary adrenocortical (hpa) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (par).

Eligibility criteria:
inclusion criteria: * diagnosis and history of perennial allergic rhinitis. * must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours. * must comply with all study procedures and be literate. exclusion criteria: * use of tobacco products. * work a rotating shift. * significant concurrent medical conditions. * certain medications such as corticosteroids and allergy medications.

Keywords: perennial allergic rhinitis intranasal corticosteroid hpa axis function gw685698x