Kornimate/medical-research-clean huggingface dataset:
evaluation of ave5026 in the prevention of venous thromboembolism in acutely ill medical patients with restricted mobility

Conditions: Venous Thromboembolism

Summary: the primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of semuloparin sodium (ave5026) with q.d. s.c. injections of enoxaparin for the primary prevention of venous thromboembolic events \[vte\] in patients hospitalized for acute medical illness. the secondary objectives were to evaluate the safety of ave5026 and to document ave5026 exposure in this population.

randomization had to take place just prior to the first study drug injection. the total duration of observation per participant was 35-42 days from randomization broken down as follows: * 10 to 14-day double-blind treatment period; * 25 to 32-day follow-up period. mandatory bilateral compression ultrasound \[cus\] had to be performed between 10 to 15 days after randomization.

Eligibility criteria:
inclusion criteria: patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions: * congestive heart failure (new york heart association \[nyha\] class iii/iv); * acute respiratory failure (not requiring mechanical ventilation); * acute infection (without septic shock)\*; * acute rheumatic disorder\*; * acute episode of inflammatory bowel disease\*. * patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (vte) among the following: * age ≥ 75 years; * active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months); * previous vte; * obesity; * oral hormone therapy (antiandrogen or estrogen); * chronic heart failure; * chronic respiratory failure. exclusion criteria: * previous surgery with general anesthesia within 30 days before inclusion in the study; * patient requiring a curative anticoagulant or thrombolytic treatment; * patient at risk of bleeding; * stroke; * known hypersensitivity to heparin or enoxaparin sodium; * end stage renal disease or patient on dialysis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: venous thrombosis primary prevention
a multicentre pilot study of midline catheter's tip at a different position in antimicrobial therapy

Conditions: Infection

Summary: the research protocol was based on assigning patients to three different catheter tip groups and then observing the relationship between the tip and catheter-related complications when infusing antimicrobial agents.

a prospective case-control observation study method was adopted. the investigators of each center included patients who met the inclusion and exclusion criteria and were fully informed about the content of the study, possible benefits, and risks. after obtaining informed consent, the patients were included in the method of continuous sampling and convenient sampling. according to the method of random control, the patients were grouped. in the control group, the length of catheter insertion is measured from the pre-puncture point to the shoulder or armpit. in experimental group 1, the catheter insertion length is measured from the pre-puncture point to the midpoint of the clavicle, and in the experimental group, 2 catheter insertion length is measured from the pre-puncture point to the sternoclavicular joint. with a single-blind design, patients do not know the enrollment situation. the catheter was inserted by a full-time specialist nurse of intravenous therapy under ultrasound guidance combined with the modified seedinger technique. the catheter was inserted according to the length of different measurement methods in different groups. after the catheter was inserted, an x-ray examination was performed to determine the catheter tip position again. data collection and follow-up observation will be conducted by researchers who have been uniformly trained. record the baseline data of the patients in the group before catheterization, record the insertion status during catheterization, record the patient's catheter use and catheter sealing frequency every day during catheter placement, and evaluate catheter function and complications until extubation daily.

Eligibility criteria:
inclusion criteria: expected intravenous infusion time over 1 week in line with the indications for the use of medium-length catheters more than 18 years old full consciousness signed the study informed consent exclusion criteria: source of infection at the catheter insertion site history of radiation therapy, history of thrombosis, history of trauma or vascular surgery at the site of catheterization treatment requires input of irritating or hyperosmolar solutions patients who need to be discharged with a catheter

Keywords: infection nursing
mindfulness in pregnancy

Conditions: Anxiety; Depression; Mindfulness

Summary: this study aims to determine if a short audio clip about mindfulness implemented during nst appointments can lower pregnant women's levels of anxiety and depression. subjects will be placed into either the intervention group or a control group. the intervention group will be asked to listen to a short audio clip on mindfulness during their nst appointments, and the control group will receive the standard of care during nst appointments. subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.


Eligibility criteria:
inclusion criteria: * 18 years or older * english as primary language * less than 36 weeks gestational age * at least 28 weeks gestational age exclusion criteria: * use of psychoactive medications * any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features * history of suicide attempt or current suicidal ideations * uncontrolled substance abuse in the last 6 months * patients with hearing loss * more than three no-shows to nst appointments

Keywords: pregnancy mindfulness anxiety depression nst non-stress test
intragastric injections of botox for the treatment of obesity

Conditions: Obesity, Morbid

Summary: one possible angle for treating obesity could be slowing down the gastric emptying time. by prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. if such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run. there are now several pilot studies documenting that intragastric treatment with botulinum toxin a (bta) can be effective, although the treatment perspective is short and do not include repeated injections. however, they demonstrate that bta-injections are safe for the patient. the treatment is administered by endoscopy.


Eligibility criteria:
inclusion criteria: * bmi \> 35 exclusion criteria: * known hypersensitivity to medication * neuro muscular disease * dysphagia * tendency for aspiration * ulcus * use of aminoglycoside antibiotics and/or spectinomycin lately * previous side effects of botox injections * previous bariatric surgery * previous cancer in gi-tract * other obesity treatment last 12 months * severe eating disorder * hypothyroidism * pregnancy/brest feeding * reduced competence to consent

Keywords: botulinum toxin endoscopy satiation diet weight loss
outcomes of transcatheter aortic valve implantation in oncology patients with severe aortic stenosis

Conditions: Aortic Valve Stenosis; Malignancy

Summary: as for today, transcatheter aortic valve implantation (tavi) is indicated only in symptomatic patients with severe aortic stenosis (as) at high surgical risk. as cancer therapy improves, some as patients suffering active malignancy (including advanced metastatic diseases) may be more endangered by their untreated valvular disease than their oncological disease. among these patients, tavi may be indicated before cancer related surgery or cardiotoxic anti-cancer therapy in order to achieve better anti-cancer therapy outcomes. individualized life expectancy assumptions should be evaluated by the heart team in the clinical decision-making process as an essential factor in weighing the risk-benefit ratio for oncologic patients undergoing tavi. a multicenter, international tavi in oncology patients with as (top-as) registry was designed to collect data on patients with an active malignancy and severe as undergoing tavi. the aim of the study is to evaluate the outcomes, benefits and risks of oncology patients undergoing tavi, mainly the patients' survival and cause of death and also the interactions between the valvular and the oncologic conditions.

the tavi program was initiated in rabin medical center in 2008 and the institutional review board approved the prospective collection of our tavi database (i.e. record tavi). during these years, several oncology patients were treated with tavi. also, in daily practice a few asymptomatic as patients in whom tavi was indicated before cancer related surgery / cardiotoxic anti-cancer therapy underwent tavi. this study will initiate a multicenter, international registry designed to collect data on tavi in cancer patients in correspondence to medical records within each center. data will be collected retrospectively for cases performed before registry initiation and prospectively thereafter. all inconsistencies regarding data collection will be resolved directly with local investigators and on-site data monitoring. patients' inclusion approval is by a local ethics committee in each center. saving data: data will be recorded in excel table; each center and patient will receive a unique code so the data file will be anonymous.

Eligibility criteria:
inclusion criteria: * patients with active malignancy (all types excluding non-melanoma skin ca) * severe aortic stenosis undergoing native valve tavi (any transcatheter heart valve type). exclusion criteria: * tavi for conditions other than severe as. * valve in valve tavi patient. * patients cured /in remission from cancer during the index tavi.

Keywords: aortic valve stenosis transcatheter aortic valve implantation cancer malignancy
the effects of ropinirole on mood or mild depression in patients with moderate to severe restless legs syndrome

Conditions: Restless Legs Syndrome; Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)

Summary: ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of restless legs syndrome. up to 40% of rls patients suffer from mild depression, therefore it would be important for decisions no therapy to know whether a drug could improve both depressive and rls symptoms.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic restless legs syndrome, confirmed by a score of at least 11 on the rls diagnostic index * certain severity of symptoms (at least score of 15 on the international restless legs score (irls) * have had rls symptoms for at least 15 nights in the last four weeks. * \< 6 hours of sleep in nights with rls symptoms * madrs (depression rating scale) score of at least 12 (= borderline to depression) at baseline exclusion criteria: * any other sleep disorder that might interfere with the rls symptoms or sleep (e.g. sleep apnea disorder, narcolepsy) * secondary rls due to diagnosis of renal insufficiency, polyneuropathy, pregnancy (see below), iron deficiency anemia * any significant psychiatric disorders (e.g. schizophrenia, bipolar disorder); depression which by judgement of the investigator is caused by rls, is not an exclusion criterion. * current or past suicidality * medication known to trigger/aggravate/ cause or interfere with rls symptoms (e.g. most antidepressants, lithium, neuroleptics, opioids, carbidopa, clonidine, antihistamines, anticonvulsants etc.). * daytime rls symptoms which require treatment (daytime: 10 a.m. until 6 p.m.). * concomitant movement disorders (e.g. parkinson's disease, dyskinesia, dystonia). * medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, rheumatoid arthritis, fibromyalgia syndrome, cancer etc.). * subjects taking any medication known to induce drowsiness or to affect sleep. * subjects who are pregnant, lactating or of childbearing potential. women of childbearing potential must use adequate contraception * clinically significant or unstable medical conditions (e.g. severe heart disease, severe liver or kidney disease etc.). * pain syndromes, caused by other disorders than rls * excessive caffeine intake * diastolic blood pressure \>110mmhg or \ 180mmhg or \<90mmhg at baseline. * withdrawal, introduction, or change in dose of hormone replacement therapy (hrt) or the oral contraceptive pill (ocp) and/or certain drugs which are known to interact with ropinirole (e.g. ciprofloxacin, cimetidine, tobacco, omeprazole).

Keywords: randomised ropinirole depression rls placebo mood double-blind restless legs syndrome germany
evaluation of 11c-acetate pet imaging as a novel approach to detecting pathology in pulmonary tb

Conditions: Tuberculosis, Pulmonary

Summary: imaging using 11c-acetate pet (positron emission tomography) in patients with tuberculosis (tb) may be able to detect non-replicating persister bacilli. this may permit identification of those patients at risk of relapse following completion of tb treatment. the main aim of this pilot study is to assess the ability of 11c-acetate pet to detect pulmonary lesions in individuals with active pulmonary tb.

novel biomarkers for detecting pulmonary tb and response to treatment are sorely needed. pet in conjunction with either ct (computed tomography) or mri (magnetic resonance imaging) scanning allows assessment of the metabolic activity of lesions as well as the structural anatomy of the lung. the standard radiolabelled tracer for pet is 18f-fluorodeoxyglucose (fdg) which labels metabolically active cells. however, one of the main limitations of fdg is the non-specific uptake leading to difficulty differentiating between tumours, infection and inflammatory pathologies. 11c-acetate is a pet ligand used currently to image various conditions but has not been used to identify tb lesions previously. 11c-acetate may be taken up by the lipid bodies in the dormant bacteria in tb, enabling visualization of this sub-population of bacteria. using the 11c-acetate ligand for imaging pulmonary tb may add to the utility of pet scanning, potentially allowing monitoring of drug activity against the persister population and identification of those patients who may be at risk of relapse following drug therapy. this pilot study will compare 11c-acetate to the standard ligand, fdg, using pet/ct and pet/mri. the target population for this study is those individuals with confirmed pulmonary tb who have a high chance of demonstrable bacillary burden who are therefore likely to have populations of persister bacteria in the lungs.

Eligibility criteria:
inclusion criteria: 1. age 21 years and above 2. willing to comply with the study visits and procedures 3. willing and able to provide written informed consent 4. clinical diagnosis of pulmonary tb with characteristic symptoms and compatible x-ray findings plus microbiological confirmation with one or more of (i) acid-fast bacilli (afb) smear-positive or (ii) molecular test positive or (iii) tb culture positive. tests done at any time during the current episode of tb are acceptable for diagnostic purposes 5. not on tb treatment or have completed less than 8 weeks of tb treatment exclusion criteria: 1. diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate pet scanning 2. cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for mri 3. known chronic kidney disease 4. occupation involving substantial exposure to radiation 5. history of medical procedures in the last year involving substantial exposure to radiation (\>2msv) 6. malignancy requiring chemotherapy or radiation 7. women who are currently pregnant or breastfeeding
agreement between rolimeter and lachmeter in patients with acl injury

Conditions: Anterior Cruciate Ligament Injuries; Laxity of Ligament

Summary: the study is a quality assurance study, aiming to determine the agreement between two different measurement instruments for assessing knee joint laxity in patients with acl injuries. the study aims to include 60 patients with previous acl injury, recruited in an outpatient clinic at aarhus university hospital from september 2022 to march 2023. for patients who consent to participate in the study, their knee joint laxity in both the injured and the non-injured knee is assessed using both a rolimeter and a lachmeter. subsequently, the collected data are examined to determined the agreement between the two measurement instruments.

methods: in connection with their visit at either the orthopaedic or physiotherapy outpatient clinic, patients are invited to participate in the study. patients consenting to participate will undergo knee joint laxity tests with both the rolimeter and the lachmeter, and in addition health-related and demographic data are collected. the two tests are performed in random order for each patient, and the same physiotherapist conducts the two tests in each individual patient. the physiotherapist performing the two tests reads and notes the score on the first test, while a different physiotherapist, blinded to the score of the first test, reads and notes the score on the second test. agreement between the two scores are investigated using a bland-altman plot, with calculation of bias and upper and lower limits of agreements with 95% cis. a priori, an acceptable difference between the two methods is set at 1 millimeter.

Eligibility criteria:
inclusion criteria: * patients with acl injury awaiting potential acl-surgery * patients with previous acl-surgery exclusion criteria: * multiligament injury * pcl injury
a phase i, first in human study of cba-1535, t cell engager(5t4/cd3/5t4) in patients with advanced solid tumors.

Conditions: Solid Tumors; Refractory Cancer

Summary: this is a first in human muticenter, non-randomized, open-label phase i dose-escalation study of cba-1535. the study will have 2 parts (part 1 and part 2). part 1 is the dose-escalation cohorts of cba-1535 single agent theapy. part 2 is the dose-escalation cohorts of cba-1535 in combination with pembrlizumab. this study will evaluate the safety, tolerability, pk, biomarker profiles and preliminary efficacy of cba-1535.

to evaluate safety and efficacy of cba-1535 in the following two parts in a stepwise manner: part 1 - in part 1, the primary objective is to evaluate the safety and tolerability of cba-1535 in patients with solid tumors where no standard treatment is available, or who are intolerant to or non-responders to standard treatments. additionally, the pk, biomarker profiles, and preliminary efficacy will be evaluated. the initial dose for part 2 will also be determined. part 2 - in part 2, the primary objective is to evaluate the safety and tolerability of cba-1535 in combination with pembrolizumab in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment. additionally, the pk, biomarker profiles, preliminary efficacy will be evaluated. the recommended phase 2 dose (r2pd) will also be determined.

Eligibility criteria:
inclusion criteria: * patients who provide voluntary written informed consent to participate in the study * ecog performance status: \<= 1 * patients with 3 months or longer life expectancy * patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy exclusion criteria: * patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment * patients who received anti-cancer drug within 14 days prior to enrollment * patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (chinese hamster ovary cell-derived drugs) or any component of the study drug

Keywords: cba-1535 5t4 cd3 t cell engager trophoblast glycoprotein tribody solid tumors
linguistically-tailored mobile intervention for the improvement of follow up for abnormal pap test results

Conditions: Cervical Carcinoma

Summary: this clinical trial evaluates the feasibility of a linguistically-tailored mobile intervention, called cervixchat in improving the follow-up of patients with abnormal papanicolaou (pap) test results. a text messaging program, such as cervixchat may support patients who need a colposcopy.

primary objective: i. to evaluate the feasibility of cervixchat intervention in a mix method design, through participants consent rate and the study completion rate. secondary objective: i. to evaluate the acceptability of cervixchat intervention using a validated likert-scale participant satisfaction questionnaire, as well as participant's interview data. exploratory objective: i. to evaluate the preliminary impact of cervixchat intervention, by comparing the colposcopy appointment adherence rate in the study cohort against a 1:1 matched control sample selected based on matching age, race and ethnicity, from participants at jefferson obstetrics and gynecology (ob-gyn) department scheduled for a colposcopy in 2019. outline: patients receive text messages for 1-2 months before scheduled appointment. patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy. after completion of study, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * female, aged 21 to 65 years of age * had received an abnormal pap smear result * scheduled colposcopy * able to communicate with ease in english or spanish * have a cell phone with text (txt) ability * competent to give consent exclusion criteria: * are pregnant at the time of recruitment * display current evidence of positive invasive carcinoma of the cervix