Kornimate/medical-research-clean huggingface dataset:
revascularization rates and clinical outcomes with dabra laser. a long-term 2-year study

Conditions: Peripheral Artery Disease

Summary: this is an observational study of the dabra laser system and other medical devices intended for endovascular treatment of peripheral artery disease.

this is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the dabra laser system and other medical devices intended for endovascular treatment of peripheral artery disease. this study covers the use of endovascular devices including the dabra laser system and other devices commercially used in the united states for the treatment of lower extremity pad.

Eligibility criteria:
inclusion criteria: * participant's age ≥ 22 years. * participant presents with a rutherford category of 2 to 6. * participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with dabra laser system. * participant is able and willing to be anti-coagulated. * ability and willingness of participant to give written informed consent and comply with follow-up. exclusion criteria: * pregnant, breastfeeding, planning to become pregnant - if women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. subject must agree to use effective birth control measures for duration of study. pregnancy during study must be reported immediately. * endovascular interventions within 90 days prior to study enrollment (on leg to be treated). * participation in another cardiovascular or peripheral vascular study that might, in the judgement of the investigator, affect the results of the study. * disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast. * inability or unwillingness of the patient to comply with study examinations. * necrosis necessitating major amputation. * subject has an anticipated life span of less than one (1) year. * medically non-compliant subjects, based on investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels). * no run-off vessel is present when treating above the knee. a run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.

Keywords: lower extremity pad
efficacy and safety of atomoxetine in children with recent diagnosis of attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of adhd. patients will be randomized to atomoxetine or placebo arm (2:1). the double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered. a gatekeeper strategy will be employed for sequentially testing the secondary objectives.


Eligibility criteria:
inclusion criteria: 1. child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to visit 1, when informed consent is obtained. 2. patients must meet the diagnostic and statistical manual for mental disorders, fourth edition text revision (dsm-iv-tr) diagnostic criteria for adhd. for the purposes of this study the diagnosis of adhd will be confirmed during visit 1 by administering the k-sads-pl. patients must also have an adhdrs-iv-parent:inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both visit 1 and visit 2. in addition, they must have a cgi-adhd-s score 4 at both visit 1 and visit 2. 3. patients must have a newly diagnosed case of adhd. newly diagnosed case of adhd means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed adhd (according dsm-iv-tr or international statistical classification of diseases and related health problems \[world health organisation; 10th revision\] \[icd 10\] criteria) within 3 months prior to visit 1. exclusion criteria: 1. patients with history of adhd diagnosis longer than 3 months prior to visit 1. diagnosis of adhd means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed adhd (according dsm-iv-tr or icd 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis. 2. patients who weigh less than 20 kg at study entry (visit 1). if a patient's weight changes after visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
pharmacoscintigraphic investigation of nn9924 in healthy male subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate whether the volume of water administered with nn9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.


Eligibility criteria:
inclusion criteria: * good general health * body mass index (bmi) of 18.5-30.0 kg/m\^2 (both inclusive) exclusion criteria: * males who are not willing to use two acceptable forms of highly effective contraception * participation in another clinical trial within 90 days * any chronic disorder or severe disease * use of glp-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing * subjects who are smokers * subjects who have donated any blood or plasma in the past month or in excess of 500 ml within the 12 weeks preceding screening
a study to investigate the safety of opct-001 in adults who have primary photoreceptor disease (clarico)

Conditions: Primary Photoreceptor Disease; Retinitis Pigmentosa (RP); Usher Syndrome; Cone-Rod Dystrophy; Inherited Retinal Disease (IRD); Rod-Cone Dystrophy; Rod-Cone Disease; Cone-Rod Disease; Retinal Degeneration

Summary: study opct-001-101 is a phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of opct-001 in up to approximately 54 adults with primary photoreceptor (pr) disease. phase 1 will focus on safety and features a dose-escalation design. phase 2 is designed to gather additional safety data and assess the effect of opct-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.

phase 1 will include 4 planned dose levels to be administered across 4 cohorts (cohorts 1 through 4). participants will be assigned to receive opct-001. dose escalation in phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (\~3 to 6 per cohort) will receive opct-001. phase 2 is planned to enroll a maximum of 15 participants per cohort in 2 cohorts (cohorts 5 and 6) to evaluate 2 dose levels of opct-001 that will be selected based on phase 1 safety and tolerability data. phase 2 participants will be randomized 1:1 to either cohort 5 or cohort 6. phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to opct-001 dose assignments.

Eligibility criteria:
key inclusion criteria: * genetically confirmed diagnosis of primary photoreceptor (pr) disease * bcva at screening for phase 1: logmar 3.9 to logmar 1.0. bcva at screening for phase 2: etdrs letter score 20 and 60. * retinal structure examination in the study eye (se) demonstrating regions suitable for cell administration. key exclusion criteria: * history of/currently active clinically relevant, ocular inflammation or infection * glaucoma or other significant optic neuropathy * diabetic macular edema or diabetic retinopathy * clinically significant cystoid macular edema * spherical equivalent refractive error of greater than 8.00 diopters myopia * ocular surgery ≤3 months before screening * monocular vision (ie, no light perception in the fellow eye) * presence of clinically significant anti-opct-001 hla antibodies at screening * currently active malignancy, or history of malignancy within 5 years before opct-001 administration. exception: basal cell carcinoma that has been definitively treated. * any current infection (bacterial/viral/fungal) that could put the participant at risk from immunosuppression * history of any cell therapy, gene therapy, or retinal implant at any time * previously received a bone marrow or solid organ transplant

Keywords: primary photoreceptor disease clarico photoreceptor cells inherited retinal disease cell therapy cellular therapy usher syndrome cone-rod disease rod-cone disease retinitis pigmentosa
combination of sorafenib and vorinostat in poor-risk acute myelogenous leukemia (aml) and high risk myelodysplastic syndrome (mds)

Conditions: Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute; Myelodysplastic Syndromes

Summary: the purpose of this study is to test the safety of sorafenib and vorinostat when given together to see what effects (good and bad) it has on the patient and their acute myeloid leukemia (aml) or myelodysplastic syndrome (mds). this study is also being done to find the highest dose of sorafenib and vorinostat that can be given together without causing severe side effects.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of aml (\> 20% myeloid blasts in the peripheral blood or bone marrow) or mds with \> 10% myeloid blasts in the bone marrow. patients with acute promyelocytic leukemia (apl) must be refractory to all-trans retinoic acid (atra) and arsenic trioxide. * the patients must have one of the following criteria: * age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities * age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference * age of 70 years or older with relapsed or refractory disease * the patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy. * patients must have an ecog (zubrod) performance status of 0-2 * patients must be able to take and tolerate oral medications * patients must have adequate organ function as specified in the protocol. * patients not on anti-coagulation must have an inr \< 1.5 and a ptt within normal limits. exclusion criteria: * pregnant women or nursing mothers are not eligible for this trial. * patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial. * patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. see protocol for listing. * patients with known central nervous system (cns) leukemia by spinal fluid cytology, flow cytometry or imaging * patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
stick2prep cisgender women and trans individuals

Conditions: HIV Prevention; Pre-exposure Prophylaxis

Summary: taking a daily anti-hiv pill can protect people from hiv infection. this is called preexposure prophylaxis \[prep\]. many cisgender women and trans individuals do not know this medication is available; others struggle to take the pill every day. it is important to understand attitudes and preferences about hiv prevention options, especially as new options become available. this study plans to evaluate preferences over time among cisgender women and trans individuals who are taking medication to prevent hiv, and among cisgender women and trans individuals who are not taking medication but are at risk of hiv. the investigators enroll up to 175 participants who visit the hiv prevention clinic, and the investigators will ask participants to complete questionnaires at regular follow up visits and between visits. this study may help the investigators understand how best to prevent hiv among people at risk.

participants will receive online questionnaires about demographic characteristics, social determinants of health, and preferences regarding prep modalities. qualitative, in-depth surveys will be conducted with 12 cwti who decide not to start prep and 12 cwti who decide to discontinue prep to explore the drivers behind those decisions. participants who are taking prep will be offered the option of providing dried blood spot samples at clinic visits to measure prep levels and will receive an online questionnaire addressing their preferences regarding different modalities of measuring prep levels. the purpose of the hemaspot™ kit is to understand the subjects' perceptions of using this kit for self-testing prep levels; this will inform future strategies regarding prep monitoring. participants taking prep will also receive questionnaires regarding self-reported weekly prep adherence; they will then receive individualized text-message or email feedback based on their self-reported adherence in addition to standard-of-care retention/adherence counseling. participants on prep can also elect to receive or emails messages to remind them to take prep and attend follow up appointments.

Eligibility criteria:
inclusion criteria: * cisgender women and trans individuals who have an indication for prep and have 1) decided to take prep, 2) decided not to take prep, or 3) decided to discontinue prep exclusion criteria: * cannot provide informed consent * living with hiv
high flow nasal cannula and aerobic capacity training

Conditions: COPD

Summary: the aim of this study is to compare exercise capacity in chronic obstructive pulmonary disease (copd) patients before and after an 8 week pulmonary rehabilitation program. patients will be randomised in two groups, one arm will received oxygen through high flow nasal cannula (hfnc) and the other group by the venturi mask (vm)

design: randomized, single blind, controlled trial. the main goal of this study is to compare the exercise tolerance in copd patients after an 8 week pulmonary rehabilitation program using high flow nasal cannula or the venturi mask. the exercise tolerance will be measured in seconds in a constant load treadmill test (ctlt).

Eligibility criteria:
inclusion criteria: 1. long term oxygen therapy (ltot) or oxygen needs during exercise. 2. clinically stable defined as four weeks without exacerbation exclusion criteria: 1. refusal to participate 2. any neuromuscular, cardiovascular or any other condition that limits test performance. 3. contraindication for exercise

Keywords: pulmonary rehabilitation high flow nasal cannula the venturi mask exercise capacity aerobic capacity hfnc
adherence to hu and hrqol in patients with sickle cell disease: an intervention study using hu-go app

Conditions: Sickle Cell Disease; Sickle B+ Thalassemia; Sickle Beta Zero Thalassemia; Sickle Cell Hemoglobin C

Summary: this project addresses three important research questions. first, adolescents and young adults (aya) with sickle cell disease (scd) and their parents/caregivers will be engaged to inform the (1) domains of health-related quality of life (hrqol) most important to them, (2) frequency at which they are willing to complete them, and (3) other procedures related to the use, uptake and effect of the hu-go app as a tool to improve hydroxyurea (hu) adherence. second, this study seeks to utilize novel modern mobile technology using a multi-functional personalized platform to improve adherence to hu and measure hrqol in youth with scd, using nih-endorsed promis® measures, based on a conceptual model with predefined behavioral targets and mediators. third, we plan to assess hrqol changes and identify modifiable behavioral strategies that could serve as surrogates or predictors for hu adherence. this real-time feedback might empower self-directed changes in behavior that could improve adherence to hu.

aim 1: identify the needs, desires, concerns, and expectations of aya patients with scd and their parents/caregivers that will guide implementation of a mhealth tool, hu-go, designed to improve adherence to hu. we will conduct semi-structured interviews with patients and their parents/caregivers. transcripts will be independently coded and thematic analysis will be conducted. hypothesis 1: aya patients with scd and their parents/caregivers will identify specific features, content, and usability requirements of hu-go. aim 2: assess the longitudinal relationship of hu adherence to hrqol domains, including fatigue and depression. hu adherence will be measured using electronic pill bottles, self-report measures, laboratory markers, and medication possession ratio (mpr). hrqol will be assessed using promis® measures. hypothesis 2: low hu adherence is associated with impairment of hrqol domains. aim 3: conduct a single-arm, pilot study to determine the effect size associated with improvement in hu adherence after using hu-go for 12 weeks. adherence will be measured using self-report measures, laboratory markers and mpr. hypothesis 3: hu-go will improve hu adherence by at least 20%.

Eligibility criteria:
inclusion criteria: * at least 12 years old at the time of study enrollment * diagnosis of sickle cell disease (hemoglobin ss or sc or s/b 0 thalassemia) confirmed by hemoglobin electrophoresis * on hydroxyurea * own or have access to a smartphone * be able to speak and read english exclusion criteria: * chronic monthly transfusion support * any hemoglobinopathy other than sickle cell disease
exparel use in peripheral nerve blocks and local infiltration for foot and ankle surgery: a randomized controlled trial

Conditions: Pain, Postoperative; Pain, Acute Postoperative; Ankle Fractures; Ankle Injuries and Disorders

Summary: liposomal bupivacaine (exparel) has been recently studied as the active agent utilized in various nerve block. due to its liposomal form allowing for extended delivery, exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. this study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without exparel in patients undergoing foot and ankle surgery.

three study groups: a - surgeon infiltrates with exparel on site of surgery; b - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); c - anesthesia provides a regional nerve block (popliteal/adductor) with exparel/bupivacaine mix. follow up occurs on postop day 4 via phone call to patient. measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution * english speaking * able to provide consent to surgery and study participation exclusion criteria: * non-elective or emergent foot and ankle surgery * non-english speaking * does not possess medical decision making capacity

Keywords: liposomal bupivacaine ankle surgery postoperative pain regional nerve block
gene polymorphism associated with macroangiopathy in type 2 diabetes patients

Conditions: Diabetic Angiopathies

Summary: to explore the possible implications of hla-drb1\*04 alleles in patients with type 2 dm and macroangiopathy

previous studies examining the molecular etiology of diabetes mellitus in china and abroad have mainly focused on the relationship between hla and type 1 diabetes mellitus (dm) (1-3). due to the complexity of type 2 dm heredity, few researchers have studied the correlation between type 2 dm and hla. in recent years, it has been suggested that the development of coronary heart disease (chd) in diabetic individuals is not merely a complication of diabetic macroangiopathy. chd and diabetic macroangiopathy share some genetic associations. previous studies have demonstrated that certain hla\*drb1\*04 subtypes are associated with an increased risk of cardiovascular disease. experimental methods: for genomic dna extraction, 3-5ml venous blood samples were collected from all patients. coagulation was prevented using edta. the procedure for pcr amplification was as follows: denaturing for 100s at 96°c, annealing for 60s at 63°c, 1 cycle; denaturing for 10s at 96°c, annealing for 60s at 63°c, 9 cycles; denaturing for 10 s at 96°c, annealing for 30 s at 59°c; extending for 30 s at 72°c, 20 cycles; maintaining at 4°c. analyzing pcr products stained by ethidium bromide on 2.5% agarose gel electrophoresis. bands were observed using an ultraviolet light and a biological imaging system. statistical method: the degree of agreement with hardy-weinberg equilibrium was determined using the χ2 test. a t-test was employed for comparison of crp levels (m ± s) and a χ2 test was performed to compare allelic frequencies. the relative risk rate (rr) was calculated as (number of patients with the gene×number of people in control group without the gene) divided by (number of people in control group with the gene×number of the patients without the gene). pc was calculated using fisher's method if χ2 \> 3.84.

Eligibility criteria:
inclusion criteria: * clinical chd (such as angina pectoris, myocardial infarction) diagnosed by dynamic electrocardiogram and ultrasonic cardiogram; * coronary atherosclerosis confirmed by coronary angiographic examination; * cerebral infarction diagnosed by cerebral ct; * common carotid artery intimal-media thickness (imt) ≥1.2 mm measured by doppler ultrasonic examination; * extensive irregular stenosis of a lower extremity artery (diameter \< 3mm) or segmentally obstructed. exclusion criteria: * age \< 20 years * age \> 60 years
niacin as secondary prevention of coronary artery disease (naspocad)

Conditions: Coronary Artery Disease

Summary: aim of the study is to show additional effects of the combined therapy of niacin and statins analyzing number and function of epcs and other stem cell populations and adiponectin as well as hscrp levels in patients with cad.


Eligibility criteria:
inclusion criteria: * be at least 18 years old, male or female * have stable coronary artery disease (i.e. no acute event like myocardial infarction or ptca less then 3 months ago) * ldl \> 100 mg/dl * hdl \< 50 mg/dl * triglycerides \< 400 mg/dl * no nicotine abuse for at least 3 months * statin-therapy for more than 4 weeks * give a written informed consent * have the ability to understand the requirements of the study, and agree and be able to return for the required assessments. exclusion criteria: * women of childbearing potential, pregnancy or being lactating * current participation in another clinical trial * have other severe concurrent illness (e.g., active infection, malignancy) * have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely. * have significant or unexplained liver dysfunction or chronic increased levels of transaminases (alt, ast) * suffer from myopathy, active peptic disease or arterial bleeding * have a known hypersensitivity against niacin or statins * are actually treated with any of itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone. * actual therapy with ezetimibe * diabetes mellitus type i