Kornimate/medical-research-clean huggingface dataset:
collection of anonymized samples

Conditions: Healthy; Respiratory Disease; Gastrointestinal Disease

Summary: this is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. subjects will be recruited from biofire diagnostics employees and from the general community. subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. no other identifying information will be collected and the samples will be kept anonymous.the samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.


Eligibility criteria:
inclusion criteria: * consenting adult exclusion criteria: * weigh less that 110 lb for blood collection
open-label extension study of trofinetide for rett syndrome

Conditions: Rett Syndrome

Summary: to investigate the safety and tolerability of continued long-term treatment with oral trofinetide in girls and women with rett syndrome


Eligibility criteria:
inclusion criteria: 1. has completed the eot visit of the antecedent trofinetide study acp-2566-004 (i.e., has completed 40 weeks) 2. may benefit from continued treatment with open-label trofinetide in the judgment of the investigator 3. can still swallow the study medication provided as a liquid solution or can take it by gastrostomy tube 4. the subject's caregiver is english-speaking and has sufficient language skills to complete the caregiver assessments childbearing potential 5. subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter. if a subject is sexually active or becomes sexually active during the study, she must use 2 clinically acceptable methods of contraception (e.g., oral, intrauterine device \[iud\], diaphragm plus spermicide, injectable, transdermal or implantable contraception) for the duration of the study and for at least 30 days thereafter. subject must not be pregnant or breastfeeding. exclusion criteria: 1. began treatment with growth hormone during the antecedent study 2. began treatment with igf-1 during the antecedent study 3. began treatment with insulin during the antecedent study 4. has developed a clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus), renal, hepatic, respiratory, or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) 5. subject is judged by the investigator or the medical monitor to be inappropriate for the study due to aes, medical condition, or noncompliance with investigational product or study procedures in the antecedent study 6. has a clinically significant abnormality in vital signs at baseline 7. has an average qtcf interval of \>450 ms on the baseline ecg performed before the first dose of trofinetide is given in the present study (i.e., the ecg performed at the eot visit of the antecedent study) 8. has developed a clinically significant ecg finding during the antecedent study additional inclusion/exclusion criteria apply. patients will be evaluated at baseline to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
effect of bronchodilation on cycle vs treadmill exercise endurance time in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with copd. the hypothesis of the study is that patients with copd will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.

the study is a randomized trial with crossover of consecutively recruited patients with symptomatic copd. each patient will participate in seven visits over a 3-4 week period. at the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. at visits 2 and 3 patients will inhale 2 puffs of albuterol hfa mdi, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak vo2 on the same exercise mode. at visits 4 - 7, patients will perform pfts at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.

Eligibility criteria:
inclusion criteria: * male or female patient 50 years of age or older; diagnosis of copd; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of \< 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator fev1 \< 80% predicted; a post-bronchodilator fev1/fvc ratio \< 70%; and clinically stable condition. exclusion criteria: * any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing

Keywords: exercise; treadmill; cycle ergometer; breathlessness; leg discomfort
impact of anesthesia, positive pressure ventilation and modality of imaging on the echocardiographic assessment of the severity of aortic regurgitation

Conditions: Aortic Regurgitation Disease; Aortic Insufficiency

Summary: the goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (tte) vs trans-esophageal echo (tee)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency. patients scheduled for cardiac surgery and in whom a tee is going to be performed intra-operatively will be enrolled. the grading of the aortic insufficiency will be compared between a tte performed immediately before the induction of general anesthesia end the tee performed after induction of general anesthesia.


Eligibility criteria:
inclusion criteria: * known aortic regurgitation of any grade * scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned. exclusion criteria: * non sinus rhythm * mitral regurgitation more than mild. * pre-operative critical state (according to the definition of the euroscore ii) * presence of a prosthetic aortic valve * contra-indication to trans-esophageal echo
68 ga-nodaga-e[c(rgdγk)]2: positron emission tomography tracer for imaging of angiogenesis in ischemic heart disease

Conditions: Chronic Ischemic Heart Disease

Summary: the aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.

ischemic heart disease is worldwide the single most frequent cause of death. the number of patients surviving acute myocardial injury is increasing due to improved acute treatment. however, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. this re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. ischemic heart disease is most commently caused by arteriosclerosis of the coronary artery. if chronic ischemic heart disease is left untreated, it will lead to symptoms to the patient. these symptons occur when the myocardiel oxygen demand exceeds the oxygen provided, due to coronary occlusion. if the heart suffers from ischemia, the tissue reacts strongly to the hypoxia. the body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. this is known as the biological process of angiogenesis. this complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia. integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. it facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. integrin αvβ3 is thus a key player in the angiogenic process. the integrin αvβ3 has a binding site for an rgd peptide (arg-gly-asp motif) and this can be targeted by pet tracers. rgd-based pet tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. the uptake before interventions may correlate to recovery of cardiac function and thus serve as a prognostic marker after intervention.

Eligibility criteria:
inclusion criteria: * age over 50 years * patient with known chornic ischemic heart disease admitted to rigshospitalet to either pci og cabg exclusion criteria: * no prior history of heart surgery * not treated with anti-angiogenic medicine * subject with pacemaker, cochlear implant or insulin pump * pregnancy * lactation * severe claustrophobia * severe obesity (weight above 140kg) * conversion from pci to cabg * if a subject is in the fertile age, a pregnancy test will be use prior to injection to the pet_tracer * if a subject is having a severe allergic reaction to the pet-tracer, the person will be excluded for the rest of the trial * if the pet-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨ * type i or ii diabetes

Keywords: positron emission tomography nuclear medicine prognosis
utilizing the michigan neuropathy screening instrument for early detection of diabetic neuropathy

Conditions: Diabetic Polyneuropathy

Summary: the study aims to compare the diagnostic accuracy of the michigan neuropathy screening instrument (mnsi) (using mns questionnaire, ,inspection, vibratory sensation, ankle reflexes exam, 10 g monofilament needle examination), routine ncs, and the u/s of the median, posterior tibial, and sural nerves in identifying diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * ü age: 30-55 y ü type of diabetes: type 2 ü duration of diabetes: within 1year of diagnosis of type 2 diabetes mellitus according to world health organization 1999 criteria exclusion criteria: * patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin b12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.
pilot study to evaluate the safety and preliminary efficacy of the peritec peritoneal lined stent and delivery system

Conditions: Vascular Disease, Peripheral

Summary: the occurrence of peripheral vascular disease has been increasing which includes the large artery in the upper leg called superficial femoral artery (sfa). the peritoneal lined stent has been developed as a new method for treating narrowed area in the sfa. this research study will determine the safety and effectiveness of the peritoneal lined stent in keeping th superficial femoral artery open and allowing blood to flow in the leg.


Eligibility criteria:
inclusion criteria: * patient with claudication or ischemic rest pain(rutherford categories 2-4) * the angiogram will need to have been performed confirming superficial femoral artery short segment occlusion(\ 50%)stenosis * patient has a signed and dated informed consent * patient has a resting abi \ 1.2) must have tbi \<0.8 * life expectancy greater than one year * the ability to comply with protocol follow up requirements and required testing * angiographic lesion requirements assessed at time of procedure * lesion of the superficial femoral artery with a short segment occlusion(\ 50%) stenosis * target lesion 1 cm below profunda/superficial femoral artery origin and 3cm above knee joint * angiographic evidence of a minimum of at least one tibial with continuous artery runoff to the ankle that does not require intervention * guidewire has successfully traversed lesion and is within the true lumen of the distal vessel, and successful placement of 9 french(fr) sheath exclusion criteria: * untreated iliac artery in-flow limiting lesion * significant proximal common femoral or superficial femoral artery disease above or below target lesion * any previously treated superficial femoral artery lesion * any previous stenting or surgery in the target vessel * femoral or popliteal aneurysm * non-atherosclerotic disease resulting in occlusion (e.g. embolism, vasculitis,etc) * serum creatinine \>2.5 mg/dl * any previously known coagulation disorder, including hypercoagulability * severe medical co-morbidities or other medical condition (for example untreated coronary heart disease and congestive heart failure, severe chronic obstructive pulmonary disease, metastasis malignance, etc.)
computed tomographic (ct) perfusion and ct angiography as screening tools for vasospasm following subarachnoid hemorrhage

Conditions: Cerebral Vasospasm; Cerebral Aneurysm; Subarachnoid Hemorrhage

Summary: cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction. the current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per procedure. computed tomographic perfusion imaging (ctp) and computed tomographic angiography (cta) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of embolic and thrombotic cerebral infarct. the investigators hypothesize that ctp and cta may be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid hemorrhage requiring treatment and provide prognostic information.


Eligibility criteria:
inclusion criteria: * subarachnoid hemorrhage after aneurysm rupture exclusion criteria: * renal insufficiency * pregnancy * contrast reaction

Keywords: cerebral aneurysm subarachnoid hemorrhage cerebral vasospasm computed tomographic perfusion computed tomographic angiography
observation or upfront cranial rt in oncogene mutated nsclc with asymptomatic bm: a phase iii rct

Conditions: Asymptomatic Brain Metastases; Driver Mutation Positive Non-small Cell Lung Cancer

Summary: tyrosine kinase inhibitors (tkis) especially higher generation tki have higher cns penetration rates and have shown favorable response rates in brain metastases. brain radiotherapy/surgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. no randomized trial has shown the superiority of early vs delayed cranial rt in asymptomatic bm of driver mutated nsclc.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients with ecog performance status of 0-2 3. patients with pathologically proven diagnosis of nsclc 4. patients with positive oncogene mutation status (egfr/alk) 5. patients with radiologically confirmed parenchymal brain metastases 6. patients with asymptomatic synchronous or metachronous brain metastases 7. patients willing for written informed consent and must be willing to comply with the specified follow-up schedule exclusion criteria: 1. patients with csf dissemination only without any parenchymal brain metastases 2. patients with brain metastases in the brain stem 3. patients with prior history of radiation therapy to the brain 4. patient not suitable for tki therapy as per the medical oncologist 5. pregnant or lactating females

Keywords: asymptomatic brain metastases egfr mutation whole brain radiotherapy stereotactic radiosurgery alk rearrangement
ovarian prp injections for improved embryo quality using embryo quality score

Conditions: Infertility; Poor Ovarian Reserve; Embryo Growth Disorder; in Vitro Fertilization

Summary: patients will have ovarian prp treatments and embryo development will be observed using time-lapse imaging and ai software.

. oprp treatment \& second ivf cycle (study cycle) * following the first ivf cycle, patients will undergo their first oprp injection: * timing: 1-2 weeks after the onset of the next menstrual cycle. * procedure: under iv sedation, a patient's autologous prp will be prepared and injected directly into both ovaries under transvaginal ultrasound guidance. * second ivf cycle (oprp study cycle) * the same ovarian stimulation protocol will be used for consistency. * a second oprp injection will be performed on stimulation days 2-5 to enhance folliculogenesis. * ovulation will be triggered at the same follicular size thresholds, and oocyte retrieval will follow identical protocols. * fertilization methodology will be identical to the first cycle unless no fertilization is identified in the first cycle. * embryo development analysis: up to 15 embryos will be cultured in the ai incubator, where time-lapse imaging will track their morphokinetics, and ai-based analysis will assess embryo viability and implantation potential.

Eligibility criteria:
inclusion criteria: * no none contraindications to ivf or prp treatment * adequate ovarian reserves and amh level * willingness to undergo two ivf cycles and oprp treatment exclusion criteria: * anovulation due to menopause or perimenopause * any health conditions that are contraindicated for ivf or oprp treatment
cervical morphological changes on pregnancy outcome

Conditions: Pregnancy Outcome

Summary: this study aims to assess how the proportion of the cervical volume/length removed during treatment for cervical intraepithelial neoplasia (cin) varies and whether this correlates to the pregnancy duration at delivery

the high peak age of the cervical intraepithelial neoplasia (cin)patients was from 25 to 35 years old, which is the best women of childbearing age, standard treatment for cin is called loop electrosurgical excision procedure (leep),but the inappropriate conization may damage the cervical function leading to infertility, abortion, preterm delivery and dystocia. therefore, reasonable and standard conization is very important for treating and preventing the complication. the international federation of cervical pathology and colposcopy(ifcpc) advocates the length of cervical conization should be decided by the type of cervical transformation zone, however, the cervical lengths in female are different leading to the same cervical conization lengths cause the diverse influences on the cervical function.therefore, individualized cervical conization therapies are very needed，at present, there are still lack of objective data about cervical morphology of women at childbearing age,besides the effects of cervical morphological changes caused by leep on pregnancy and childbirth has not been reported. our hypothesis is that the proportion of the cervical tissue removed is likely to influence both cervical healing and the cervical volume following surgery and as a result the risk of prematurity in subsequent pregnancies. the present prospective study investigates the variation in the proportion of the cervix removed during excisional treatment and provides pilot data on pregnancy outcomes in a sample population for which the dimensions and proportions of the cervical tissue excised are assessed at the time of treatment.

Eligibility criteria:
inclusion criteria: having fertility requirements,antecedent biopsy read as 1. cervical intraepithelial neoplasia (cin) grade 2 or 3 or microinvasive cancer 2. adenocarcinoma in situ 3. persistent cin 1 4. antecedent pap read as 5. high grade squamous intraepithelial lesion 6. atypical glandular cells 7. persistent low grade squamous intraepithelial lesion exclusion criteria: 1. anatomy unsuitable for safe office loop excision based on operator judgement 2. inability to tolerate procedure under local anesthesia 3. pregnancy 4. age less than 21 years 5. refusal of consent 6. prisoner 7. mental incapacity 8. anticoagulant or antiplatelet therapy, or known bleeding diathesis 9. use of analgesics other than over the counter medications(otc meds include nsaids or tylenol) within 7 days of scheduled leep.

Keywords: leep loop electrosurgical excision procedure cervical intraepithelial neoplasia pregnancy outcome
mobile health application for family and behavioral health provider communication

Conditions: Posttraumatic Stress Disorder; Anger

Summary: the purpose of this study is to examine feasibility, tolerability, utilization, and effectiveness of using the supportteam mobile application in the context of cognitive behavioral therapy (cbt) for veterans with ptsd.

purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the supportteam mobile application in the context of cognitive behavioral therapy (cbt) for veterans with ptsd. participants: (n=100) 50 veterans who have served in the military since october 2001 and have ptsd with anger problems; and 50 collateral family members/close friends above the age of 18. procedures (methods): all veterans with ptsd will receive a 12 session standard cbt for anger. veterans in the intervention group will additionally receive instructions for using supportteam with a family member or friend that will provide data for the cbt clinician. veterans in the control group will receive the cbt sessions, but will not receive the supportteam mobile application.

Eligibility criteria:
inclusion criteria: for veteran: * age 18 or older * served in a branch of the us military since october, 2001 * meets dsm-5 criteria for current ptsd as measured by the clinician-administered ptsd scale for dsm-5 (caps-5); * reports at least one episode of anger or irritability in the past week; * has and regularly uses an ios (iphone 5s or higher with ios 8 or higher) or android (with 4g network and android 4.1 or higher) smartphone with a data plan; * has a family member or friend who also has and uses a smartphone with a data plan and agrees to participate in the study. * is able and willing to attend 12 weekly sessions at duke psychiatry offices within normal business hours (m-f 8:00-5:00) for collateral: * 18 years old or older * has and regularly uses an ios (iphone 5s or higher with ios 8 or higher) or android (with 4g network and android 4.1 or higher) smartphone with a data plan; * has a family member or friend who meets the veteran inclusion criteria and agrees to participate in the study. exclusion criteria, veteran: - is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.

Keywords: veterans posttraumatic stress disorder anger behavioral health mobile health technology