Kornimate/medical-research-clean huggingface dataset:
protamine sulfate during transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: transcatheter aortic valve implantation (tavi) is a new, rapidly emerging standard of care in inoperable and high-risk patients with severe, symptomatic aortic stenosis. information regarding reversal of unfractionated heparin with protamine sulfate in order to facilitate access site closure is scarce and based on expert consensus. clinical practice varies between centers. protamine sulphate may decrease the amount of bleeding complications related to the access-site. the impact on possible thromboembolic complications is unknown. both bleeding and thromboembolic complications increase mortality after tavi. a randomized trial is required in order to assess impact of protamine sulfate on prevalence and extent of bleeding and thromboembolic complications.

information regarding reversal of unfractionated heparin (ufh) with protamine sulfate (ps) is based on expert consensus from 2012, which recommends use of ufh in order to achieve activated clotting time (act) \> 300 seconds as well as ufh reversal with ps in case of tavi via transapical access as well as transfemoral access with the exception of cases with minimal bleeding risk. however, the clinical practice varies between centers - some use ps routinely, others - only in selected cases. the actual impact of ps on bleeding complications reduction is unknown. furthermore, a pro-thromboembolic effect of the ps cannot be excluded. both bleeding (major and life-threatening according to valve academic research consortium \[varc\] criteria) and thromboembolic complications increase mortality after tavi. the occurrence of these complications in international tavi registries in 30-day observation ranges from 9.7% in case of major bleeding, 4.7% in case of life-threatening bleeds and 5% in case of strokes. there are no randomized studies assessing impact of ps on frequency of bleeding and thromboembolic complications after tavi, its side-effects and influence on mortality. randomized trial is required in order to assess impact of protamine sulfate on prevalence of bleeding and thromboembolic complications.

Eligibility criteria:
inclusion criteria: * patients who underwent successful tavi * with any approved tavi device * via transfemoral access * with use of any of the approved vascular closure devices * provided written informed consent exclusion criteria: * no consent * periprocedural complications requiring continuation of heparin or administration of protamine sulfate * alergy to fish, protamine, protamine derivates, history of humulin n, novolin n, novolin nph, gensulin n, scilin n, nph iletin ii and isophane insulin intake
tobacco cessation field study for adults in recovery - 1

Conditions: Tobacco Use Disorder

Summary: the project's aim is to provide a targeted, computer-administered intervention to facilitate tobacco cessation for clients in alcohol treatment. the main focus of "on the air: a tobacco cessation program for adults in alcohol recovery" is to reduce tobacco use of clients in alcohol treatment. the program will be offered through inpatient, residential, and outpatient treatment programs to help those struggling with alcohol addiction to understand, reduce, and stop tobacco use. clients will develop a personalized tobacco cessation plan relevant to their readiness to quit tobacco use. based on the metaphor of a television network, this tobacco cessation program contains information on personal risks, peer stories, cravings and withdrawal, a variety of interactive activities and tools, and also motivational feedback and tips to assist in the quitting process. phase i was a proof of concept phase, in which we delivered a prototype cd-rom on tobacco cessation. phase ii will involve completing the development of a functional cd-rom tool which will be subjected to a clinical field trial with a group of adults (n=196) in treatment facilities for alcohol recovery. the clinical field study will involve finalizing the content, interface, and interactive features of the cd-rom. we will also gather satisfaction data from both clients and counselors in the various treatment facilities.


Eligibility criteria:
inclusion criteria: * carry a primary dsm-iv diagnosis of alcohol abuse or dependence * smoke at least one cigarette a day * be willing to sign informed consent and undergo initial assessment and follow-up * be willing to provide at least one collateral contact and collateral contact information

Keywords: tobacco
delayed-release bedtime caffeine and sleep inertia symptoms immediately upon awakening

Conditions: Sleep Inertia; Caffeine; Placebo

Summary: sleep inertia (sometimes also referred to as sleep drunkenness) is a disabling state of increased sleepiness, impaired mood and reduced vigilance immediately upon awakening. sleep inertia is highly prevalent in various neurological diseases, including neurodegenerative, affective and circadian sleep-wake rhythms disorders, as well as in frequent societal conditions such as chronic sleep restriction, jetlag and shiftwork. reactive countermeasures against sleep inertia, i.e., strategies implemented upon wake-up, are not sufficiently effective, yet current recommendations are limited to proactive strategies, including long enough sleep at optimal times of day. these recommendations are not always easy and sometimes impossible to apply. to address this unmet medical need, the investigators developed an innovative, time-controlled, pulsatile-release formulation of 160 mg caffeine targeting an efficacious dose briefly before planned awakening.

sleep inertia is a disabling state of grogginess and impaired vigilance immediately upon awakening. the adenosine receptor antagonist, caffeine, is widely used to reduce sleep inertia symptoms, yet the initial, most severe impairments are hardly alleviated by post-awakening caffeine intake. to ameliorate this disabling state more potently, the investigators developed an innovative, delayed, pulsatile-release caffeine formulation targeting an efficacious dose briefly before planned awakening. the investigators comprehensively test this formulation in two placebo-controlled, double-blind, cross-over studies. first, the investigators establish the in vivo caffeine release profile in young men. subsequently, they investigate the formulation's ability to improve sleep inertia in sleep-restricted volunteers. following oral administration of 160 mg caffeine at habitual bedtime \[22:30\], the investigators keep the participants awake until 03:00, to increase sleep inertia symptoms upon scheduled awakening \[at 07:00\]. immediately upon awakening, the investigators quantify subjective state, psychomotor vigilance, cognitive performance, and the cortisol awakening response. they also record polysomnography during nocturnal sleep and a 1-hour nap opportunity at 08:00.

Eligibility criteria:
inclusion criteria: * male sex in order to avoid the potential impact of menstrual cycle on sleep physiology or hpa axis activity, * age within the range of 18 to 34 years, * a body-mass-index below 25, * an epworth sleepiness score (ess) below 10, * habitual sleep onset latency below 20 minutes, * regular sleep-wake rhythm with bedtime between 11 pm and 1 am, * absence of any somatic or psychiatric disorders, * no acute or chronic medication intake, * non-smoking, * no history of drug abuse (lifetime use \> 5 occasions, except occasional cannabis use) * caffeine consumption of less than 4 units per day (coffee, tea, chocolate, cola, energy drinks) exclusion criteria: - failure to meet inclusion criteria

Keywords: sleep restriction proactive countermeasure
the relation between bss solution temperature and endothelial cells and post phaco discomfort

Conditions: Corneal Diseases

Summary: patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs

patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs

Eligibility criteria:
inclusion criteria: * patients with cataract * more than 40 years * no glaucoma * no retinal abnormalities * no retinal abnormalities exclusion criteria: patients with corneal diseases patients less than 40 patients with previous eye surgery

Keywords: cornea, cataract
decreasing antibiotic duration for skin and soft tissue infection using behavioral economics in primary care

Conditions: Cellulitis; Abscess; Drain Abscess; Impetigo; Skin Infection; Antibiotic Duration; Behavioral Economics

Summary: study the efficacy of a package of behavioral economics strategies (versus an education-only control condition) in altering clinician behavior regarding antibiotic prescription duration for skin and soft tissue infection (ssti).

the investigators propose a prospective, cluster randomized trial of epic order panels in the 14 nationwide children's hospital (nch) primary care clinics. investigators have designed user-friendly epic order panels from which providers may select guideline concordant antibiotics by simply typing in a diagnosis (cellulitis) or antibiotic name. these order panels are prepopulated with the default, short-course (guideline-concordant) antibiotic duration, saving clinicians several clicks within the electronic medical record (emr). if a provider changes the prescribed duration from the one defaulted, a free text box will appear for them to write an acknowledgement reason (accountable justification). all 14 clinics will receive baseline education (control condition) about common infections and local and national guidelines for antibiotic choice and duration of treatment. clinician prescribers will also be instructed about the presence of a basic order panel. the full functionality of the default \[short/desired\] duration order panel will only be released to intervention clinics. the order panels will be restricted in epic to clinics randomized to the intervention. the investigators hypothesize that clinics with the intervention will have higher rates of short course antibiotics for ssti versus control clinics.

Eligibility criteria:
inclusion criteria: * diagnosis codes a46 (cellulitis), l03 (cellulitis and acute lymphangitis), j34 or l02 (abscess, furuncle), or l01 (impetigo) and * those who received a prescription for an enteral antibiotic * patient's treated in nationwide children's hospital primary care clinics exclusion criteria: * patients less than 3 months of age * animal bite * human bite * foreign body * diagnosis of hidradenitis suppurativa * immunocompromising conditions (primary immune deficiency, chemotherapy, etc) * burns
atsn-201 gene therapy in rs1-associated x-linked retinoschisis

Conditions: X-linked Retinoschisis

Summary: this study will evaluate the safety and tolerability of atsn-201 in male subjects ≥ 6 years of age with rs1-associated x-linked retinoschisis (xlrs).

eligible patients who enroll in this study will receive a one-time subretinal injection of atsn-201 in one eye. safety and tolerability will be evaluated for 5 years.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 for cohorts 1 through 3, and age ≥ 6 years and \< 18 years for cohort 4. 2. male patients with clinical diagnosis of xlrs caused by mutations in rs1. 3. best corrected visual acuity (bcva) in study eye of 34 to 73 early treatment diabetic retinopathy study (etdrs) letters (corresponding to a snellen acuity of 20/200 to 20/40). exclusion criteria: 1. pre-existing eye conditions in the study eye that would contribute significantly to an increased risk of visual loss from a subretinal injection. 2. any intraocular surgery (including laser treatment) in the study eye within 6 months prior or any intraocular surgery anticipated in the study eye during the first 12 months of the study. 3. treatment in a prior ocular gene or cell therapy study.

Keywords: xlrs, rs1
anlotinib in combination with pd-1/l1 inhibitor as sequential therapy of thoracic radiotherapy after induction chemotherapy for extensive-stage small cell lung cancer:a single arm study

Conditions: NSCLC; Anlotinib; PD-1/L1 Inhibitor

Summary: anlotinib in combination with pd-1/l1 inhibitor as sequential therapy of thoracic radiotherapy after induction chemotherapy for extensive-stage small cell lung cancer:a single arm study


Eligibility criteria:
inclusion criteria: 1. the subjects volunteered to join the study and signed the informed consent form. they had good compliance and cooperated with the follow-up; 2. patients between 18-75 years old; 3. extensive small cell lung cancer confirmed by histopathology (according to veterans administration lung study group, valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide \[complete remission (cr), partial remission (pr) or stable (sd) according to recist1.1 standard\]; 4. the time interval between the first trt and the end of the last chemotherapy should be less than or equal to 6 weeks; 5. the life expectancy shall be at least 3 months; 6. ecog score: 0-1 exclusion criteria: 1. small cell lung cancer patients with other pathological types of tumor species; 2. patients with pathological fracture in bone metastasis of small cell lung cancer; 3. patients with central nervous system metastasis; 4. patients who have received chest radiotherapy before; 5. patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; 6. imaging (ct or mri) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
a phase 2 study of elx-02 in patients with nephropathic cystinosis

Conditions: Genetic Disease; Nonsense Mutation; Cystinosis

Summary: this is a phase 2 open label study to evaluate the safety, tolerability, pk, and pd of multiple dose levels of sc administered elx-02 in patients with cystinosis with nonsense mutation in at least one allele. six patients will be enrolled in the trial. the study will comprise of the following periods for each patient: * a screening period of up to 6 weeks * a total treatment period of 4 weeks * a safety follow-up period of 4 weeks after the last treatment each patient will receive three escalating doses as follows: * treatment period 1: elx-02 0.5 mg/kg sc daily for 7 days (total dose not to exceed 3.5 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 47.5 µg\*h/ml) * treatment period 2: elx-02 1.0 mg/kg sc daily for 7 days (total dose not to exceed 7.0 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 95 µg\*h/ml) * treatment period 3: elx-02 2.0 mg/kg sc daily for 14 days (total dose not to exceed 14 mg/kg for these two weeks; the daily dose will be individualized to achieve the target weekly exposure of about 190 µg\*h/ml)


Eligibility criteria:
patients must meet all of the following criteria to participate in this study: 1. male or female patients who, at the time of screening, are 18 years of age or older (cohort 1) or ≥12 years of age (cohort 2) 2. a diagnosis of nephropathic cystinosis and biallelic ctns mutations, including at least one nonsense mutation 3. patients should have a mild to moderate disease estimated glomerular filtration rate ≥40 ml/min/1.73m2 using the chronic kidney disease epidemiology collaboration ckd-epi formula 4. body mass index of 19.0 to 30.0 kg/m2. patients with a lower bmi may be entered into the study at the discretion of the investigator following consultation with the sponsor 5. renal transplant permitted with stable graft function (serum creatinine) for 3 months prior to screening patients with any of the following characteristics/conditions will not be included in the study: 1. participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study 2. concomitant use of cysteamine bitartrate from 7 days prior to baseline until 7 days following final administration elx-02 3. an average systolic blood pressure and/or diastolic blood pressure ≥95th percentile for sex, age, and height on 3 or more occasions during the screening period 4. patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides 5. known relevant allergy or hypersensitivity to aminoglycosides

Keywords: aminoglycoside translational read-through cystinosis nonsense mutation
chondromodulating effect of diacerein in osteoarthritis of the hip

Conditions: Hip Osteoarthritis

Summary: we carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to: * evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis * to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis this study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery


Eligibility criteria:
inclusion criteria: * outpatients fulfilling the american college of rheumatology criteria for the diagnosis of hip osteoarthritis. * lequesne algofunctional index of at list 3 points. * radiographic criterion for inclusion: joint space width (jsw) between 1 mm and 3 mm. if the jsw exceeded 3 mm, it had to be at least 0.5 mm thinner than jsw of the contra lateral hip, measured at its narrowest point. exclusion criteria: * intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study. * any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.

Keywords: diacerein hip osteoarthritis structure-modifying effect / chondromodulating effect double blind study
autism genomics sweden - genetic guidance and information trial

Conditions: Autism; Autism Spectrum Disorder; ADHD - Attention Deficit Disorder with Hyperactivity; Depression Anxiety Disorder; Depression - Major Depressive Disorder; Anxiety

Summary: this observational clinical trial aims to evaluate whether providing genetic information about the origins of autism and related psychiatric disorders enhances understanding, well-being, and empowerment in adolescents and young adults with autism. the study will compare the outcomes of two groups: one receiving a 1.5-hour genetic counseling session with a clinician and the other receiving general genetic information via leaflet. participants will be assessed using pre- and post-intervention questionnaires, including measures of understanding of their condition (mgcos-24) and mental health (gad-7 and phq-9). the study also explores whether mental health factors like anxiety and depression influence the effectiveness of the interventions.

the goal of this observational clinical study is to assess whether receiving genetic information about the origins of autism and related neuropsychiatric disorders, either at a population level or as individual information after genetic testing, can improve understanding of their condition, well-being, and empowerment in adolescents and young adults with autism spectrum condition (asc). the main questions to answer are: * does a genetic counseling session improve participants' understanding of autism and its origins, well-being, and empowerment as measured by the modified genetic counseling outcome scale (mgcos-24)? * is the outcome modified by mental health indicators such as anxiety and depression measures, and does the information improve these? * we will also assess how genetic knowledge and beliefs prior the genetic information session affect the main outcome mgcos-24 change. the comparsion will be made between the group receiving a 1.5-hour genetic counseling session with a clinician to a group receiving general genetic information via leaflet by email to see if the genetic information session by the clinician leads to greater improvements in understanding, empowerment, and well-being. participants will: * answer basic demographic questionnaire as well as a questionnaire about genetic knowledge and beliefs * be randomized to receive a 1-1.5 hour genetic counseling session in person or through online, or general genetic information via leaflet. * complete pre-and post-intervention questionnaires, including the mgcos-24, gad-7 and phq-9.

Eligibility criteria:
inclusion criteria: * participants aged 15 - 30 years of age. * living in sweden. * able to consent independently or with guardian consent if necessary. * understanding of swedish-language questions. * interest in receiving genetic counselling information on autism. exclusion criteria: * participants unwilling to complete pre- or post-intervention surveys. * participants unwilling to participate in either form of genetic counseling

Keywords: genetic information polygenic scores rare variants genetic counselling genetic knowledge
a trial on sbrt after incomplete tae or tace versus exclusive tae or tace for treatment of inoperable hcc

Conditions: Hepatocellular Carcinoma

Summary: the trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of sbrt versus standard tae/tace for the curative treatment of inoperable hcc treated with a tae/tace incomplete cycle.

in this phase iii study patients with inoperable hcc single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete tae or tace, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of tae or tace. a total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either sbrt or tae/tace. the follow-up period will be finished 1.5 years after the final patient is randomised.

Eligibility criteria:
inclusion criteria: * age \>18 years * karnofsky index \>70% * child-turgotte-pugh a or b liver score. * an initial diagnosis of primary hcc or recurrence. * a technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined. * hcc (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive easl criteria * baseline ct or mri and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease * hb \>10.5.0 g/%, wbc \>3.000 cells/mm3, platelets \>50.000 cells/mm3, bilirubin \<2 mg/dl, aspartate and alanine aminotransferase levels \<5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2; * serum creatinine \<1.7 mg/dl * previously incomplete tae or tace with radiologically defined residual disease. * informed consent exclusion criteria: * extrahepatic disease and refractory ascites. * previous abdominal radiation therapy (rt) * hemorrhage/bleeding event = grade 3 within 4 weeks of enrollment in the study. * pregnant or breastfeeding patients. * patients with uncontrolled infections or hiv seropositive patients. * mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.

Keywords: sbrt tace tae