Kornimate/medical-research-clean huggingface dataset:
intravitreal ranibizumab for the treatment of choroidal neovascularization in ocular histoplasmosis syndrome

Conditions: Ocular Histoplasmosis Syndrome

Summary: the purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.

patients will be evaluated monthly for one year. participants will be assigned to one of two groups: group a will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study group b will receive injections of ranibizumab on an as needed basis throughout the study you cannot take part in this study if: 1. you are pregnant or intending to become pregnant in the next 12 months or are nursing an infant 2. you are under the age of 18

Eligibility criteria:
inclusion criteria: * age 18 or over * active choroidal neovascularization secondary to ocular histoplasmosis * visual acuity between 20/25 and 20/400 exclusion criteria: * pregnancy or intent to become pregnant within the next 12 months * nursing an infant * premenopausal women not using contraception * prior treatment with subfoveal thermal laser * allergy to sodium fluorescein simultaneous participation in another investigation or trial

Keywords: histoplasmosis lucentis ranibizumab ohs
the research about acute compartment syndrome

Conditions: Acute Compartment Syndrome

Summary: acute compartment syndrome (acs) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. threre is the controversy in diagnosing, treating acs. it was found that there was no criterion about the acs, and result unnecessary osteotomy. the presence of clinical assessment (5p) always means the necrosis of muscles and was the most serious or irreversible stage of acs. besides pressure methods, the threshold of pressure identifying acs was also controversial.


Eligibility criteria:
inclusion criteria: * fracture patients with schatzker v and vi, * who were older than eighteen years. exclusion criteria: * the exclusion criteria were pathologic, extra-articular proximal tibial fracture, * patients who was eighteen years or younger. * patients treated with other implant, * underwent conservative management were also excluded.

Keywords: acs tibial plateau fractures tibial shaft fractures
maintenance therapy with subcutaneous bortezomib

Conditions: Multiple Myeloma

Summary: this is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.


Eligibility criteria:
inclusion criteria: 1. patient is of a legally consenting age as defined by local regulations. 2. patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements. 3. patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 4. female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (highly effective methods: intrauterine device -iud-; hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; additional effective methods: latex condom; diaphragm; cervical cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy. 5. male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of bortezomib therapy. 6. patient was previously diagnosed with multiple myeloma based on standard criteria. 7. patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease. 8. patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease. 9. patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing bortezomib. 10. before the salvage treatment with bortezomib-based regimens, patient must have measurable disease exclusion criteria: 1. any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk. 2. pregnant or lactating females 3. known positive for hiv or active infectious hepatitis type a, b or c 4. peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by national cancer institute common toxicity criteria (nci ctc) 4.0 5. infiltrative pulmonary disease.

Keywords: multiple myeloma refractory relapsed
non-drug treatment study in parkinson's disease patients and healthy volunteers to collect biological samples in order to assess ex vivo the activity of candidate therapies and develop novel analytical methods for biomarkers

Conditions: Parkinson Disease

Summary: this is a non-drug study in patients with parkinson's disease (pd) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (csf) samples ex vivo, or outside of their body, to further develop researchers knowledge on lrrk2 biomarkers. participants were enrolled either in cohort a or in cohort b. a blood sample was collected in each participant within a maximum of two study visits within 14 days, and an option to complete both visits on the same day.

this study will allow researchers to assess the potency of investigational lrrk2 inhibitors, outside of participant bodies. it will enroll parkinson's disease patients (lrrk2 g2019s symptomatic carriers and idiopathic) and healthy volunteers meeting eligibility criteria. the study will consist of a maximum of two study visits, a selection visit to check eligibility criteria, and a sample collection visit. the two visits can take place on the same day or can occur within 14 days of each other. participants will be assigned to cohort a or cohort b, each include a blood sample collection, and an optional cerebrospinal fluid (csf) collection in cohort a. no investigational product, study drug, will be administered to study participants.

Eligibility criteria:
inclusion criteria: * women of childbearing potential (wocbp) must have a negative pregnancy test * parkinson's disease (pd) patients must be at least 40 years old * healthy volunteers must be at least 30 years old * pd patients must have a pd diagnosis, according to the 2015 movement disorder society criteria, with bradykinesia, and at least one of the following: muscular rigidity, or resting tremor with no other suspected cause of parkinsonism * the lrrk2 g2019s symptomatic carrier pd patients must have a documented g2019s mutation on the leucine-rich repeat kinase 2 gene (lrrk2) exclusion criteria: * pregnant or lactating women * have participated in an investigational drug trial within 30 days * are sars-cov-2, covid-19, positive within 15 days prior to blood sample collection * have another active disease that the investigator believes could interfere with study results
meaning-centered pain coping skills training

Conditions: Advanced Solid Tumor; Pain

Summary: this study is a randomized clinical trial of a psychosocial pain management intervention called, meaning-centered pain coping skills training (mcpc). patients with advanced solid tumor cancer and at least moderate pain will be randomized to mcpc or a standard care control condition. patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. the first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test mcpc. the second aim is to characterize mcpc's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. the third aim is to describe participants' experiences of mcpc using semi-structured qualitative interviews. the risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

many patients with advanced cancer describe pain as their most feared and distressing symptom. in this population, higher pain levels often predict worse physical, emotional, and existential/spiritual well-being. psychosocial interventions show promise for improving cancer-related pain; however, no interventions address existential concerns (e.g., a loss of meaning in life) that are common among those facing pain from advanced illness. to address this need, an intervention called meaning-centered pain coping skills training (mcpc) was developed. mcpc seeks to teach patients cognitive and behavioral skills for managing pain (e.g., guided imagery) in order to help them engage with what gives their life a sense of meaning, purpose, and significance. this pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of mcpc for improving patients' pain and pain-related outcomes.

Eligibility criteria:
inclusion criteria: * stage iv solid tumor cancer diagnosis; or stage iii pancreatic or lung cancer diagnosis * at least moderate pain (worst pain in past week \>/= 4 out of 10) at screening * eastern cooperative oncology group (ecog) performance status \</= 2 at screening * ability to speak and read english exclusion criteria: * brain tumor diagnosis * significant cognitive impairment * untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia) * previous engagement in pain coping skills training or meaning-centered psychotherapy * enrollment in hospice

Keywords: solid tumor cancer pain meaning-centered psychotherapy pain coping skills training meaning-centered pain coping advanced cancer
effect of commute traffic on vascular function

Conditions: Cardiovascular Diseases

Summary: the investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.

in this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives. one day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition. subjects will be unaware of the filtration conditions of the commute on that day. each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days. the two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the seattle area. before subjects begin the commute trials, they will go through the consent process and a series of screening tests. the study investigators will assess a series of measures regarding vascular function before and after each drive.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * asthma, * high blood pressure, * diabetes, * high cholesterol, * other chronic conditions requiring ongoing medical care.

Keywords: air pollution traffic vascular function gasoline exhaust diesel exhaust
nitazoxanide as a new local adjunctive to nonsurgical treatment of moderate periodontitis

Conditions: Periodontitis

Summary: the aim of the study was to assess the effect of nitazoxanide delivered subgingivally as thermosensitive hydrogel on the clinical and biochemical outcomes of srp in patients with moderate periodontitis.

a randomized, controlled clinical trial in a split-mouth design was conducted on forty patients equally divided between two groups: a control group treated with full mouth scaling and root planing (srp) and a test group treated with srp combined with subgingivally delivered 0.01% ntz sustained release poloxamer 407/hyaluronic acid thermosensitive hydrogel.

Eligibility criteria:
inclusion criteria: * patients having probing depth (pd) ≥5 mm. * patients having bleeding on probing (bop) in proximal tooth surface. * patients who could maintain an o'leary plaque index ≤10 proceeded into the study. exclusion criteria: * patients having any systemic disease that may affect the treatment outcomes. * smokers. * pregnant females. * patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.
ffr or oct guidance to revascularize intermediate coronary stenosis using angioplasty

Conditions: Ischemic Heart Disease

Summary: whether to revascularize patients with angiographically-intermediate coronary lesions (aicl) is a major clinical issue. intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. among these,fractional flow reserve (ffr) provides validated functional insights while optical coherence tomography (oct) provides high resolution anatomic imaging. both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with aicl and to optimize the result of percutaneous coronary intervention (pci). we aim to compare the clinical and the economical impact of ffr versus oct guidance in the percutaneous management of patients with aicl.


Eligibility criteria:
inclusion criteria: * single vessel disease with an intermediate coronary artery stenosis * multivessel disease with multiple intermediate coronary artery stenosis only * multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis exclusion criteria: * age \<18 years or impossibility to give informed consent, * female sex with child-bearing potential, * life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc), * poor cardiac function as defined by left ventricular global ejection fraction ≤ 30% * recent (\< 7 days) st-segment elevation myocardial infarction * recent (\< 48 hours) non st-segment elevation myocardial infarction * prior st-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation * severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ecg sokolow's criteria fulfilled) * severe valvular heart disease * significant platelet count alteration (\ 700,000 cells/mm3) * gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks * history of clotting pathology * known hypersensitivity to aspirin, heparin, contrast dye * advance renal failure with glomerular filtration rate \< 30 ml/min * lesions in coronary artery bypass grafts * multivessel disease requiring coronary aortic bypass graft intervention

Keywords: ffr, oct, seattle angina questionnaire
acute heart failure with preserved ejection fraction - congestion discharge evaluation

Conditions: Acute Heart Failure

Summary: the ahf-code preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure. the main objective of the ahf-code preserved study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.


Eligibility criteria:
inclusion criteria: * patients hospitalised for acute heart failure. * patient with preserved ejection fraction (fe ≥ 50%). * patients considered clinically discharging from hospitalisation for acute heart failure. * age ≥18 years * patients having received complete information regarding the study design and having signed their informed consent form. * patient affiliated to or beneficiary of a social security scheme. exclusion criteria: * comorbidity for which the life expectancy is ≤ 3 months * dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m² at inclusion. * history of lobectomy or pneumonectomy lung surgery * severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc. * pregnant woman, parturient or nursing mother * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * adult person who is unable to give consent * person deprived of liberty by a judicial or administrative decision, * person subject to psychiatric care pursuant to articles l. 3212-1 and l. 3213-1 of the public health code.
study of patients with allergic rhinitis and asthma

Conditions: Asthma

Summary: this study will last up to 6 weeks. subjects will visit the clinic up to 5 times. certain clinic visits will include a physical examination, medical history review, and lung function tests. all study related medications and medical examinations will be provided at no cost to the subject. the drugs used in this study are approved for the age group under study.

a multicenter, randomized, double-blind, triple-dummy, placebo-controlled, parallel group, four-week study assessing the efficacy of fluticasone propionate aqueous nasal spray 200mcg qd versus montelukast 10mg qd in adolescent and adult subjects with asthma and seasonal allergic rhinitis who are receiving advair diskus® 100/50mcg bid or placebo bid

Eligibility criteria:
inclusion criteria: * have asthma for at least 3 months prior to the study. * have been using an allowed pre-study asthma therapy for at least 3 months prior to study. * currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons. * have a positive allergy skin test. exclusion criteria: * have a history of life-threatening asthma. * been hospitalized for asthma within the 6 months prior to the study. * have certain conditions that would make study participation unsafe. the study doctor will evaluate other inclusion and exclusion criteria.

Keywords: asthma allergic rhinitis
comparing stainless steel crowns with prefabricated resin crowns in primary molar teeth

Conditions: Dental Caries

Summary: the main reason for this research study is to learn more about a new flexible white dental crown (bioflx) by comparing it to an existing flexible metal crown (stainless steel crown). it is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. a potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.


Eligibility criteria:
inclusion criteria: * cchmc pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any cchmc dental clinic location and then are found to need full mouth dental rehabilitation. * patients who speak the most common languages at cchmc will be able to be recruited for the study. o english, spanish, arabic, uzbek, nepali, chinese mandarin, russian, french. * these patients must qualify for treatment at the cchmc dental in-office general anesthesia (ioga) area or the procedure center (pc). ioga and the pc will be selected as a venue of treatment to control behavioral factors. this is not specific to the study and would occur due to their treatment needs. * participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch. * for example, tooth a \& j, b \& i, s \& l, or t \& k * for each participant, a minimum of one ssc or one prc will be randomly assigned via a split mouth design to be placed as part of the study. * need for full coverage and high caries risk will be defined by aapd best practice guidelines 2,16 o teeth with 1. extensive caries 2. cervical decalcification 3. developmental defects (e.g., hypoplasia, hypocalcification) 4. when failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism) 5. following pulpotomy or pulpectomy 6. for definitive restorative treatment for high caries-risk children as defined by the aapd 7. for patients who exhibit high caries risk and whose treatment is performed under sedation or general anesthesia. this would be normal and not specific to the study. * participants who consent to the study, and who can be available for follow-up recall appointments. * all participants will be asa i or asa ii as defined by the american society of anesthesiologists.15 exclusion criteria: * participants who do not meet inclusion criteria will be excluded. * participants whose teeth do not meet the inclusion criteria. * participants who do not wish to participate in the study. * patients who do not wish to or cannot reliably return for follow-up visits. * red dye allergy as patient will not be able to be plaque disclosed during follow-up visits. * participants who do not speak english, spanish, arabic, uzbek, nepali, chinese mandarin, russian, french.

Keywords: pediatric dentistry
exploratory study of respiratory bacterial infections or superinfections and colonizations in patients with spinal muscular atrophy under niv

Conditions: Non Invasive Ventilation; Spinal Muscular Atrophy; Respiratory Bacterial Infection

Summary: sma (spinal muscular atrophy) is a rare neuromuscular disease characterized by motoneuron damage. symptoms consist of respiratory involvement with numerous respiratory infections and eventually respiratory failure, for which niv (non invasive ventilation) is often used. ventilation machines are in close contact with the respiratory tract of patients. they contain heated water to humidify the circuit. these humid and warm environments are conducive to the development of bacteria such as pseudomonas aeruginosa. in this context, it is interesting to look for the presence or absence of bacteria, in comparison with the respiratory ecology of the patients. the aim is to highlight the microbiological role of niv on the occurrence of respiratory bacterial infections or secondary infections in patients with sma. to do this, samples are taken from the machines, and ecbcs are performed on patients during respiratory physiotherapy sessions.


Eligibility criteria:
inclusion criteria: * diagnosis of ams (previous diagnosis or new diagnosis during the inclusion period) * age from 0 to 12 years old * nusinersen treatment * benefiting from a niv * current monitoring at the university hospital of amiens exclusion criteria: * invasive ventilation on tracheotomy * no ventilation * other treatment than nusinersen or no treatment * parental refusal to participate in the study

Keywords: non invasive ventilation spinal muscular atrophy respiratory bacterial infection