Kornimate/medical-research-clean huggingface dataset:
the nintedanib in progressive pneumoconiosis study (nipps): a collaborative nsw treatment trial

Conditions: Pneumoconiosis Coal; Asbestosis; Silicosis

Summary: prospective clinical pilot study for subjects diagnosed with occupational progressive pneumoconiosis. subjects will be treated with nintedanib 150mg twice daily for 3 years.

100 patients with asbestosis, silicosis, coal workers pneumoconiosis and diffuse dust fibrosis will be included. patients will have an fvc ≥45% predicted (no upper threshold), and a diffusion capacity of the lung for carbon monoxide (tlco) above 30% predicted. patients will be randomised to receive nintedanib 150 mg twice daily, with the dose of the study drug reduced to 100 mg twice daily or interrupted temporarily in the case of adverse events (aes).the primary end point will be the annual decline in fvc, measured in millilitres per year, calculated from serial measurements over 36 months. lung function testing will be performed at baseline; 2, 4, 6, 12, 18, 24, 30, 36, 44 and 52 weeks, and every 4 months thereafter until study cessation or withdrawal at a maximum of 36 months. in patients who show clinical benefit as per the end points specified access to nintedanib treatment will be continued.

Eligibility criteria:
inclusion criteria: * pneumoconiosis diagnosis confirmed at the occupational mdt (occ-mdt) * diffuse fibrosing lung disease of extent \>10% on hrct with protocol criteria for progression * asbestosis, silicosis, coal worker's pneumoconiosis and diffuse dust fibrosis * fvc ≥45% predicted and tlco above 30% predicted exclusion criteria: * idiopathic pulmonary fibrosis (ipf) and non-occupational progressive pulmonary fibrosis * ild due to connective tissues disorders, hypersensitivity pneumonitis, non-occupational interstitial pneumonia, non-occupational sarcoidosis * contraindications to nintedanib (forthcoming surgery, use of anticoagulants, high cvd risk, liver function abnormalities)
cardiovascular risk markers in patients with rheumatoid arthritis: effect of rituximab therapy

Conditions: Endothelial Function; Rheumatoid Arthritis; Inflammation

Summary: the purpose of this investigation is to determine the effects of rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function


Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent and comply with the requirements of the study protocol * negative serum pregnancy test (for women of child bearing age) * men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment. * igg \& igm levels within normal limits * adequate renal function as indicated by serum creatinine measurements. * no previous biological use (investigational or approved) except for the three approved anti-tnf alpha therapies * patients who have been treated with anti-tnf alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry * no use of phosphodiesterase type 5 inhibitors (pde5) (i.e. sildenafil, tadalafil, and vardenafil) 1 week prior to the study and during the course of the study. * sbp ≤ 140/90 for two months prior to study enrollment exclusion criteria: * prior history of mi, cva, cabg, ptca, or peripheral vascular disease * any serious concomitant medical condition that could interfere with the study. * patients with insulin dependent diabetes * failure to provide written consent. * individuals with hiv infections * sbp \> 140/90 at two months prior to study enrollment

Keywords: endothelial function rheumatoid arthritis cardiovascular risk rituxan therapy
invasive arterio-venous fistula blood pressure monitoring & fluid dynamics study

Conditions: Arterio-venous Fistula

Summary: the surgical formation of an avf offers a unique example of vascular remodelling and adaption. yet, the specific factors which elicit remodelling events which determine successful maturation or failure have not been unambiguously determined. computational fluid dynamic (cfd) simulations are increasingly been employed to investigate the interaction between local haemodynamics and remodelling and can potentially be used to assist in clinical risk assessment of maturation or failure. however, these simulations are inextricably linked to their prescribed boundary conditions and are reliant on in vivo measurements of flow and pressure to ensure their validity. this study will compare in vivo measurements of the pressure distribution across an avf against a representative numerical model.

most patients with end stage renal disease (esrd) will require haemodialysis. several studies have recognized a well-functioning arterio-venous fistula (avf) as the best modality for access in patients with esrd undergoing haemodialysis. a mature avf has lower incidence of thrombosis and stenosis compared to the other two available modalities of the arterio-venous graft (avg) and central venous catheter (cvc). this translates into prolonged patency rates and lower risk of infection. the use of avf's are also associated with lower mortality, and costs. however, significant numbers of avfs \[20% to 60 %\] are known to fail to mature into functioning fistulas. issues such as impaired vein remodelling, intimal hyperplasia, technical problems, unrecognized stenosis within the outflow vein, inflow problems, or steal syndromes can all lead to failure of achieving a mature avf. the aim of the study is to examine the relationship between the pressure gradient within the surgically formed avf and its' maturation and functioning status.

Eligibility criteria:
inclusion criteria: 1. patients undergoing avf formation surgical procedure or avf intervention surgery. 2. willing and capable of signing an informed consent form. exclusion criteria: 1. patients unable to provide informed consent. 2. patients under the age of 18 3. patients who are deemed unsuitable due to any circumstances as deemed appropriate by the p.i.
effect of periodontal therapy in the systemic status of individuals with chronic periodontitis and diabetes type 2

Conditions: Chronic Periodontitis; Diabetes Type 2

Summary: this study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.


Eligibility criteria:
inclusion criteria: periodontitis group: * minimum of 15 teeh; * at least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with cal ≥ 3 mm; age ≥30 years; control group: * systemically healthy; * 20 teeth; * probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing. exclusion criteria: * periodontal treatment in the last six months; * continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months; * systemic diseases that interfere with periodontal condition, except for diabetes for the test group (hiv, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity \[bmi 40 kg / m2\] or underweight \[evil nourished bmi \<18.5 kg / m2\], etc.); pregnant or lactating; smoking; age \<30 years; indigenous groups.
efficacy and safety of propionibacterium extract gel versus 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure: a randomised controlled trial

Conditions: Anal Fissure Chronic; Anal Fissure

Summary: the study compares the efficacy and safety of a propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

patients were randomly allocated to a peg or gtn group and medication was taken every 12 hours for 40 days. primary outcome was the success rate as measured by a decrease in the realise score at 10, 20 and 40 days after starting either treatment. the secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Eligibility criteria:
inclusion criteria: * consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years exclusion criteria: * fecal incontinence * inflammatory bowel disease * previous history of anal surgery * previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment * current pregnancy or breastfeeding * known allergy to one of the agents contained into the evaluating drugs
a study of how mk-0736 affects arterial plaque (0736-006)(terminated)

Conditions: Peripheral Vascular Diseases

Summary: a 12-week efficacy study in participants with peripheral arterial disease. the primary hypothesis is that mk-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).


Eligibility criteria:
inclusion criteria: * participants with peripheral arterial disease * participants must be 18 to 85 years of age * females must be postmenopausal or sterile exclusion criteria: * participans with hepatic, hiv, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension
stay healthy in nature everyday: family nature outings in a low income population

Conditions: Stress, Psychological; Social Isolation; Physical Activity

Summary: the shine study is a randomized controlled study of the effect of a park-based family support group on multiple outcomes (including stress and physical activity) in a low income population.

despite mounting evidence that nature matters for human health, we are not aware of any prospective intervention trials looking at the use of nature as a health intervention. like other protective factors, such as the presence of a caring adult, safe play places, greater stimulation, the presence of green-space in a child's life has been empirically linked to greater resilience. nature has been proposed as a buffer to stress through several pathways: by providing a space for friends and families to gather (thereby increasing social support and improving family relationships), by increasing opportunities for physical activity, and by improving cognition. research to date suggests that participation in outdoor activities facilitates a sense of connectedness to place. this sense of attachment may also provide a form of social support. families served by children's hospital oakland primary care clinic experience high levels of stress. as a safety-net clinic, the primary care clinic serves a diverse set of patients, with a common thread of poverty. the stay healthy in nature program was developed to encourage stress management skills through play and physical activity in parks. the program uses a combination of facilitated and independent outings into local parks to encourage sustained behavior change and measurable health benefits.

Eligibility criteria:
inclusion criteria: * child must be 4 years and older, a patient in our clinic, physically able, available for follow up, able to answer questionnaire * caregiver must be 18 or older, legal guardian, physically able, able for follow up, able to answer questionnaire exclusion criteria: * enrolled in a weight loss program, unable to be physically active, unable to give informed consent, unable to follow up for study duration.

Keywords: parks well-being stress physical activity nature greenspace
efficacy and safety of intravitreal injection of bevacizumab with and without oral curcumin

Conditions: Diabetic Macular Edema; Macular Edema; Retinal Neovascularization

Summary: the purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema. a blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. the patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo). the evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.


Eligibility criteria:
inclusion criteria: patients with center-involving macular edema with macular center thickness more than 300 microns in oct 2-patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months. 3- the amount of bcva should not be \<20/400. 4-consent to participate in the study exclusion criteria: 1. other retinal diseases except for dme and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and... 2. existence of proliferative diabetic retinopathy and patients with a history of vitrectomy 3. patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (armd) 4. media opacities that limit the interpretation of diagnostic tests 5. surgery or procedure 3 months before starting treatment 6. pregnancy or breastfeeding 7. history of allergy to curcumin 8. use of warfarin 9. changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease 10. change in the patient's general health condition 11. absence of patient referrals 12. lack of consent to continue treatment and follow-up

Keywords: macular edema diabetic macular edema central macular edema bevacizumab diabetic retinopathy retinal neovascularization
implementation of a combination intervention for sustainable blood pressure control

Conditions: Hypertension

Summary: this is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural south africa using community health workers (chws) in conjunction with in-home bp monitoring among adults.

we will conduct a trial using chws in conjunction with in-home bp monitoring among 774 adults ≥ 18 years old residing in umkhanyakude district in northern kwazulu-natal in an area that is served by a chw. eligible participants will be recruited from prior community-based hypertension screening programs, chw-led hypertension screening activities, and/or from trial clinics where they are accessing care. consenting participants will be randomized to one of the three study arms of hypertension care (258 participants per arm): 1) clinic-based standard of care model (soc); 2) community health worker-based blood pressure monitoring model (chw); 3) and enhanced community health worker-based model, including mobile health blood pressure monitoring model (echw+). independent of clinical care, all participants will be seen at enrollment and at 6 months for bp monitoring and data collection by study nurses for outcome assessments. the primary effectiveness outcome will be assessed in an intention-to-treat analysis and defined as the change in systolic blood pressure (sbp) 6 months after enrollment. the secondary effectiveness outcome will be the proportion of participants with controlled blood pressure, as defined by an sbp \<140 mmhg and a diastolic bp (dbp) \<90 mmhg 6 months after enrollment.

Eligibility criteria:
inclusion criteria: * age greater than 18 years old * residing in umkhanyakude district in northern kwazulu-natal in an area that is served by a chw. * elevated blood pressure (blood pressure \> 140/90 mmhg) on two measurements. exclusion criteria: * pregnant or breast-feeding women. * severe, symptomatic hypertension with a measured blood pressure \> 180/110 mmhg. * known, advanced chronic kidney disease. gfr \< 60 ml/min/1.73 m2. * current use of at least 3 different anti-hypertensive therapies at full dose. * planning to move within the next 24 months.
a clinical trial to evaluate the safety, efficacy, and pharmacokinetics of megalt injection for treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Conditions: Refractory Thrombocytopenia

Summary: a study to evaluate the safety, efficacy, and pharmacokinetics of megalt in treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

a single-center, open-label, dose-escalation study to assess the safety, efficacy, and pharmacokinetics of megalt for treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Eligibility criteria:
inclusion criteria: * age between 4 and 75 years (inclusive) at screening; gender is not restricted; * diagnosed with refractory thrombocytopenia following radiotherapy/chemotherapy or transplantation; * adequate organ function：alanine aminotransferase (alt) or aspartate aminotransferase (ast) \< 2.5\*upper limit of normal (uln); serum creatinine \< 1.5\* uln; total bilirubin level \< 1.5\* uln; coagulation function: international normalized ratio (inr) ≤ 1.5\* uln, activated partial thromboplastin time (aptt) ≤ 1.5\*uln; hemoglobin ≥ 60 g/l, or hemoglobin maintained at this level after transfusion; absolute neutrophil count (anc) ≥ 1.0×10\^9/l; * eastern cooperative oncology group (ecog) performance status of 0-2; * voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form. exclusion criteria: * patients with any malignant tumor relapse; * pregnant or breastfeeding women; * life expectancy less than 3 months; * severe infections or severe concurrent conditions such as heart, liver, lung, kidney, neurological, or metabolic diseases; * history of severe thrombotic events or known thrombotic risk factors. exceptions: participants for whom the potential benefits of the study, as determined by the investigator, outweigh the potential risks of thromboembolic events; * uncontrolled infectious or other serious diseases, including but not limited to infections (e.g., hiv positive), congestive heart failure, unstable angina, arrhythmias, psychiatric disorders, or conditions that limit the ability to meet study requirements or pose unpredictable risks as judged by the primary physician; * active hepatitis b or c infection; * refractory thrombocytopenia post-transplant with grade iii-iv acute graft-versus-host disease (gvhd) \[according to nih standards\] or severe chronic gvhd (nih 2014 standards); * history of organ transplantation or planned organ transplantation (excluding hematopoietic stem cell transplantation); * participation in another clinical study within 30 days prior to the baseline visit, involving any investigational drug or device; observational studies are allowed; * any other conditions deemed by the investigator to make the participant unsuitable for the clinical trial.

Keywords: refractory thrombocytopenia megakaryocyte
retinal vessel analysis (rga) at the patient bed in the context of non-traumatic subarachnoid haemorrhage

Conditions: Non-traumatic Subarachnoid Haemorrhage

Summary: a subarachnoid hemorrhage occurs in about 10 out of 100,000 people each year. this bleeding leads to irritation and constriction of blood vessels in the brain (vasospasm) in two out of three people affected within four to 21 days and thus to reduced blood flow. this can lead to a stroke and serious damage. in order to be able to diagnose and treat a constriction of the blood vessels at an early stage, there are various examination methods which, however, have various disadvantages such as radiation exposure of the patient, low sensitivity or high effort. therefore, the prediction and timely therapy of vascular constrictions is currently only successful in a few cases before the reduced blood flow has already led to irreversible damage. the aim of this study is to investigate whether the so-called retinal vascular analysis can be used in addition to previous standard examinations for the early detection of diseases of the cerebral blood circulation. this method has few side effects and has been successfully used for 50 years to examine the blood circulation in the eye.


Eligibility criteria:
inclusion criteria: * female or male patient, age ≥ 18 years * inpatient stay in the clinic * written informed consent for participation in the study prior to beginning of treatment * written consent for further evaluation of the images and for the scientific publication of the study results * non-traumatic subarachnoid haemorrhage confirmed by computer tomography or magnetic resonance tomography or cerebrospinal fluid puncture (collection of nerve water from the lower part of the lumbar spine exclusion criteria: * female or male patient \< 18 years * pregnancy, lactation * lack of written consent to participate in the study and to further evaluate the image material collected * known allergy to ms eye drops (active substance: phenylephrine/tropicamide * narrow chamber angle, narrow angle glaucoma, terson syndrome (if it makes retinal vascular imaging impossible * persons in a dependency or employment relationship with the investigator * persons who are accommodated in a facility by judicial or administrative order * receipt and intake of a study drug within the last 30 days * supine position in bed
predicting treatment failure in hsil patients with positive margins after conization via detection of pax1 methylation

Conditions: High-grade Squamous Intraepithelial Lesions (HSIL); Cervical Conization

Summary: the goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (pax1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (hsil). the main question it aims to answer is: can pax1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence/persistence in addition to existing methods? participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, pax1 gene methylation testing, will be added.

this study is a multicenter, prospective observational study that qualitatively assesses the methylation status of the pax1 gene in cervical exfoliated cells from patients with hsil and positive margins after conization. the aim is to evaluate the ability of pax1 gene methylation testing to predict treatment failure (lesion recurrence or persistence). the first follow-up occurs 6 months post-surgery, including high-risk human papillomavirus (hrhpv) testing and cytology, with referral for colposcopy, including biopsy and/or endocervical curettage (ecc), if necessary. subsequent management and follow-up are based on examination results, following clinical guidelines, and arranged at intervals of 6-12 months depending on the findings. the follow-up includes routine clinical examinations widely applied in practice, and pax1 testing will be completed at each follow-up visit. pax1 testing, like hrhpv testing and cytology, will be performed using cervical exfoliated cells.

Eligibility criteria:
inclusion criteria: * age greater than 25 years and less than 55 years; * first-time cervical conization (cold knife conization or loop electrosurgical excision procedure); * postoperative pathology showing hsil (cin2 or cin3); * positive margins for hsil (cin2 or cin3) in conization specimen. exclusion criteria: * the presence of other malignant tumors or precancerous lesions; * lack of willingness for follow-up; * pregnant or breastfeeding women; * unable or unwilling to complete follow-up examinations; * history of prior cervical disease treatment (surgical or physical therapy); * presence of immune system disorders.

Keywords: cervical intraepithelial neoplasia conization positive margins cervical cancer treatment failure residual/recurrent disease