Kornimate/medical-research-clean huggingface dataset:
mycobacterial lung diseases in virginia: sequencing and clinical determinants of relapse and outcome

Conditions: Nontuberculous Mycobacterial Lung Disease

Summary: mycobacterial lung diseases in virginia: sequencing and clinical determinants of relapse and outcome

nontuberculous mycobacterial (ntm) lung diseases, primarily due to m. avium complex (mac), are an increasing clinical problem nationwide and now overtake domestic tb in terms of morbidity and mortality. it is also harder to treat and results in poorer outcomes despite longer drug regimens. in this project we utilize a state-wide clinical cohort of ntm lung disease patients to understand what features of the organism (such as the species or subtype or drug resistance profile), the host (such as antibiotic drug absorption), and the environment (such as household exposure to ntm) are most important in predicting clinical outcome. the sum of this research will direct future therapies and management algorithms for this difficult disease. first, we will perform whole genome sequencing of ntm isolates to discern relapse versus reinfection and the environmental sources of acquisition. second, we will utilize a state-wide cohort of new and prior diagnosed ntm lung disease patients, starting initial therapy to correlate clinical outcomes with ntm species, drug susceptibility, other bacterial in vitro assays, and serum drug levels.

Eligibility criteria:
inclusion criteria: * all subjects: * race/ethnicity: any * subject has no history of active tuberculosis in the last 2 years. * ntm culture positive from respiratory specimen (sputum or bronchial lavage fluid) * subject must have an available sputum sample that was taken in the last 2 years. if a sample is not available, the subject must be willing and able to provide a sputum sample. * meets the following infectious diseases society of america (idsa) criteria for ntm lung disease: * 2 or more sputum (or 1 bronchoscopy/biopsy) cultures positive for "mycobacterium avium complex" or "mycobacterium abscessus) within the last 2 years. * nodules, cavities, and/or bronchiectasis on ct scan within the past 2 years * if if the above data are not available, but a patient's infectious disease or pulmonary physician has documented the diagnosis of ntm lung disease in their notes, this will suffice pk subjects: * newly diagnosed with ntm lung disease and beginning antibiotics for ntm within the last 3 months from enrollment. * prior diagnosis of ntm lung disease, and starting initial therapy within the last 3 months prior to enrollment. * consent to pharmacokinetic testing within one month of enrollment and at six months of therapy exclusion criteria: * list the criteria for exclusion all subjects: * age \< 18 years * subject has cystic fibrosis or other inherited disorders of airway ciliary dysfunction (eg, primary ciliary dyskinesia) * unable to participate in follow-up requirements by phone or clinic visit pk subjects: • unable to have blood drawn for pharmacokinetic testing
ebv-specific anti-pd1 tcr-t cells in the treatment of ebv-positive nhscc

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: epstein-barr virus (ebv) infections is known to be a high-risk factor to induce nasopharyngeal cancers. to date, ebv-related head and neck squamous cell carcinoma (hnscc) is still a major concern in east asia, especially in china. concurrent therapies for hnscc have limited response rate and high chance of relapse. however, ebv-induced cancers provided an ideal target for t cell-based immunotherapy due to the non-self origins. engineered t cells bearing a tcr (tcr-t) that can specifically recognize the presented ebv antigen become a viable approach to treat this type of cancer. though engineered t therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. one key mechanism of tumor-elicited suppression is the pdl1-pd1 interaction which induces t cell exhaustion. therefore, tcr-t cells armed with a pd1 antagonist could further enhance the efficacy of tcr-t in solid cancers.


Eligibility criteria:
inclusion criteria: * expected to live longer than 12 weeks * ps 0-2 * pathology confirmed as ebv positive hnscc, either metastatic or recurrent disease * creatinine \<2.5mg/dl * alt/ast is lower than three times uln. * no contraindications of leukocyte collection * before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion. * understand this trial and have signed an informed consent exclusion criteria: * patients with symptomatic brain metastasis * with other uncontrolled malignant tumors. * hepatitis b or hepatitis c activity period, hiv infected patients * any other uncontrolled disease that interferes with the trial * patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage * untreated hypertension or hypertensive patients * a person with a history of mental illness that is difficult to control * researchers do not consider it appropriate to participate in this trial * patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids * subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment * an illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements
does meloxicam provide as much pain relief as opioids after shoulder surgery?

Conditions: Shoulder Pain

Summary: the opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. studies evaluating these practices found that opioids are overprescribed, even for common procedures. patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. the purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * scheduled for arthroscopic labrum repair of the shoulder exclusion criteria: * history of opioid, acetaminophen, nsaid or local anesthetic allergy or intolerance, or contraindications to these medications. * currently on long-term preoperative narcotics * scheduled for revision arthroscopic repairs of the shoulder * unable/unwilling to consent for enrollment * unable to complete postoperative surveys * history of chronic pain syndromes (fibromyalgia, chronic diffuse msk pain, etc) * patients under the age of 18 * pregnant or breastfeeding women * scheduled for concurrent procedures
safety of tetanus, diphtheria, acellular pertussis with 5 acellular pertussis components (tdap5) vaccination during pregnancy

Conditions: Pertussis (Whooping Cough)

Summary: the purpose of this study is to evaluate the safety of adacel vaccine among pregnant individuals exposed to adacel at any point between the 1st day of the 27th week of gestation up to the end of pregnancy and their offspring (ie, adacel-exposed cohort), in comparison with pregnant individuals not vaccinated with any tdap vaccines during pregnancy and their offspring (ie, tdap-unvaccinated comparator cohort). the primary objectives are to estimate incidence rates and relative risks for each prespecified pregnancy outcome in adacel-exposed and tdap-unvaccinated comparator cohorts and for each prespecified adverse birth outcome in the offspring of both cohorts. the secondary objectives are to estimate incidence rates and relative risks for each prespecified adverse fetal and neonatal outcome in the offspring of adacel-exposed and tdap unvaccinated comparator cohorts and for each prespecified adverse outcome for pregnant individuals in both cohorts.

study outcomes to be assessed in electronic medical records between january 2016 to december 2025.

Eligibility criteria:
inclusion criteria: * for pregnant individuals: * continuous enrollment, with no more than a 1-month administrative gap from 90 days prior to their last menstrual period (lmp) * continuous enrollment for the duration of their pregnancy through delivery or termination of pregnancy (or 6 weeks postpartum for preeclampsia/eclampsia and 28 days for pph) unless censored at death in order to capture study outcomes * at least 1 prenatal visit prior to 27 weeks of gestation during pregnancy * for offspring: * infants delivered by pregnant individuals who meet all the inclusion criteria above * with gestational age as calculated based on date of birth recorded in the emr exclusion criteria: * for pregnant individuals: * loss of pregnancy or with delivery before 27 weeks of gestation * vaccinated with boostrix® (tdap vaccine, gsk), or with an unknown brand of tdap vaccine, or td (tetanus, diphtheria) vaccine during pregnancy * vaccinated with any tdap vaccine prior to the acip recommended optimal timeframe of ≥ 270/7 weeks of gestation * received more than one tdap vaccine during pregnancy * vaccinated with one or more live vaccines during pregnancy * pregnant individuals with multiple gestation pregnancies (eg, twins, triplets) * for offspring: * infants delivered by pregnant individuals who meet any of the exclusion criteria above
fenretinide/lxs oral powder plus ketoconazole in recurrent ovarian cancer

Conditions: Ovarian Cancer; Cancer of Ovary; Cancer of the Ovary; Ovary Neoplasms; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to determine the effectiveness of fenretinide (4-hpr/lxs) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. in addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-hpr/lxs) is most effective alone.

in this study, an initial phase i component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-hpr) given together with ketoconazole

Eligibility criteria:
inclusion criteria: * recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant * swog performance status 0-2 * previously received a platinum and paclitaxel containing regimen * projected life expectancy of at least 3 months * adequate bone marrow function * adequate organ function * must have received at least 1 prior salvage regimen for recurrent ovarian cancer * recovery from acute toxicities from surgery, radiation or chemotherapy * at least 3 weeks from last therapy exclusion criteria: * prior fenretinide oral capsule use allowed. if prior iv fenretinide use, must contact study chair for eligibility * second malignancy within last 5 years * use of concomitant antioxidants, such as vitamin c or e * untreated or symptomatic brain metastases * history of hypertriglyceride levels \> 200 mg/dl; triglyceride levels \< 200 and receiving treatment are okay. * use of certain medications is prohibited - contact study coordinator for information

Keywords: chemotherapy
a study of tirzepatide (ly3298176) in participants with type 2 diabetes during ramadan

Conditions: Type 2 Diabetes

Summary: the main purpose of the study is to investigate whether tirzepatide can be effectively started before ramadan and used per label in participants with type 2 diabetes during the fasting month.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of uncontrolled type 2 diabetes based on the world health organization classification or other locally applicable diagnostic standards, and who intend to fast during ramadan * have hba1c ≥7% within 30 days prior to screening * are glucagon-like peptide-1 receptor agonist (glp-1 ra) naïve * have had stable body weight self-reported change ≤5 kilograms (kg) during the 90 days prior to screening * have body mass index ≥25 kilograms per square meter (kg/m2) at screening exclusion criteria: * have type 1 diabetes or gestational diabetes * have a history of chronic or acute pancreatitis * have acute or chronic hepatitis * have evidence of a significant, uncontrolled endocrine abnormality * have a history of an active or untreated malignancy * have new york heart association functional classification iv congestive heart failure * have been treated with insulin within two weeks prior to screening

Keywords: ramadan fasting
post-atu study of nivolumab

Conditions: Melanoma

Summary: nivolumab obtained european marketing authorization in june 2015. before this date, a temporary authorization for use (atu) program in france for nivolumab was set up between september 2014 and august 2015. this program enrolled approximately 600 melanoma patients (unresectable or metastatic). it appears relevant to conduct a study on patients treated during the atu to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.

in order to reach goals of this study, collaboration had been established between bms and the ric-mel network (network for research and clinical investigational research on melanoma) (nct03315468). the ric-mel network has set up a national database in order to reference the active file of melanoma patients in france. the ric-mel database, supported by nantes university hospital, had been approved by french authorities (cctirs and cnil). the ric-mel network is coordinated by pr b. dreno (nantes university hospital) and pr c. lebbe (saint-louis hospital, ap-hp, paris). nowadays, 49 centres located all over the country are participating, with more than 19,000 melanoma patients included in the database. the ric-mel database is referred as one of the privileged access to any research program on melanoma by the cancerology group (gcc) of the french society of dermatology . based on this, bms and the ric-mel network had established a partnership to set up a study in order to estimate the overall survival of melanoma patients treated by nivolumab during the french atu program. data are collected in the ric-mel database by participating centres. information of centres, follow-up of activity, data reviewing and extractions are realized by the ric-mel network. data analysis is performed by bms following a developed statistical protocol. patients included in the study were patients with unresectable or advanced metastatic melanoma, which received at least one of nivolumab, dispensed during the french atu program.

Eligibility criteria:
inclusion criteria: * patients with unresectable or metastatic melanoma cared in participating sites, * patients included in french nivolumab atu program, * patients treated by at least one perfusion of nivolumab, * patients agreed to participate to the study. exclusion criteria: * patients with unresectable or metastatic melanoma not included in french nivolumab atu program, * patients having initiated nivolumab after the 31th december 2015, * patients disagreed to participate.

Keywords: unresectable melanoma metastatic melanoma immunotherapy nivolumab temporary auhorization for use (atu)
pattern and type of amputation and mortality rate associated with diabetic foot in jeddah, saudi arabia: a retrospective cohort study

Conditions: Diabetic Foot; Amputation

Summary: this study explored the pattern and type of amputations performed on patients with diabetic foot who were admitted to our institution, as well as the 7-year mortality rate of patients with diabetic foot at the same institution. we believe that our study makes a significant contribution to the literature because it highlights the need for strengthening efforts to decrease the risk of amputation and mortality among patients with diabetic foot, especially in jeddah, saudi arabia.


Eligibility criteria:
inclusion criteria: * from the medical records of king abdulaziz university hospital (kauh). exclusion criteria: * none
a study to evaluate the safety and immune response of mrna-1345, a vaccine targeting respiratory syncytial virus (rsv), when co-administered with a fluzone hd, in adults ≥65 years of age

Conditions: Respiratory Syncytial Virus

Summary: the main purpose of this study is to evaluate the safety and immunogenicity of mrna-1345 rsv vaccine when coadministered with a high dose (hd) quadrivalent seasonal influenza vaccine (fluzone hd) in adults ≥65 years of age. the study will examine the impact of fluzone hd on the immune response to mrna-1345 against rsv-a and rsv-b, as well as the impact of mrna-1345 on the immune response to fluzone hd against 4 vaccine-matched influenza a and b strains.


Eligibility criteria:
key inclusion criteria: * participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: * absence of changes in medical therapy within 60 days of day 1 due to treatment failure or toxicity, * absence of serious or significant medical events within 30 days of day 1, and * absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, would make completion of the protocol unlikely. * a participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential. key exclusion criteria: * close contact with someone with laboratory-confirmed influenza and/or rsv infection or with someone who has been treated with antiviral therapies for influenza (for example, tamiflu®) within the past 5 days prior to day 1. * reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections. * participant has tested positive for influenza or rsv by local health authority-approved testing methods ≤6 months prior to day 1. * participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (day 1 and day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections. * participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to day 1. * participant has received any rsv vaccine (authorized/approved by local health agency or investigational) prior to day 1. note: other protocol-defined inclusion and/or exclusion criteria may apply.

Keywords: viral diseases messenger rna moderna mrna-1345 respiratory syncytial virus vaccines rsv vaccine
multimedia information for patients with renal biopsy

Conditions: Pain; Anxiety; Hematuria

Summary: this study takes place in the divisions of nephrology. patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. the control group received routine care, and the multimedia information intervention group received a multimedia information. after the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. this study used questionnaires that including general self-efficacy scale, pain visual analogy scale, visual analogue scale for anxiety, and positive and negative affective scale.

this study takes place in the divisions of nephrology at chang gung memorial hospitals. patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. the control group received routine care, and the multimedia information intervention group received a multimedia information. multimedia information intervention is based on self-efficacy theory. the multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies. in addition, the investigator also provide face-to-face consultations on answers and clarifications for the content of the videos and telephone consultations to understand the self-care situation of patients on the third day after discharge. after the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. this study used questionnaires that including general self-efficacy scale, pain visual analogy scale, visual analogue scale for anxiety, and positive and negative affective scale. generalized estimating equations (gees) will be used to o analyze data.

Eligibility criteria:
inclusion criteria: 1. patients are at least 20 years old 2. patients need to undergo a renal biopsy 3. patients can communicate in chinese or taiwanese 4. patients agree to participate in the research and sign the consent form 5. patients have family members accompanying exclusion criteria: 1. patients have undergone renal biopsy before 2. patients have history of mental disorder 3. patients use anticoagulants

Keywords: multimedia information renal biopsy self-efficacy pain anxiety positive and negative affective hematuria
a comparative study of two endoscopic operations for lacrimal duct obstruction

Conditions: Lacrimal Duct Obstruction

Summary: to compare the clinical effects between the silicone nasolacrimal intubation under nasoendoscopy and dacryocystorhinostomy on patients with lacrimal duct obstruction.

lacrimal duct obstruction is common among patients with epiphora,which is seriously affect the quality of life. the treatment principle is to restore or rebuild the lacrimal duct drainage channel. the classic operation type is dacryocystorhinostomy(dcr), which is complex for face-section particularly. however, with the development of endoscopy, the investigators prefer to the silicone nasolacrimal intubation under nasal endoscopy, which is more simple and efficient. with endoscopy, the investigators can see anatomical structures clearly and then can perform the operation much more perfectly.compare to the classic one called dcr, its short and long term therapeutic effects are equal and even better.therefore,the latter type does do good to both doctors and patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of nasolacrimal duct obstruction based on a clinical of epiphora and purulent secretion, another punctiform orifices with reflux in subsequent flushing in lacrimal passage irrigation; * must be able to withstand surgery * at least 18 years old * no lacrimal tumor and acute inflammation * nasolacrimal duct obstruction in digital subtraction dacryocystography * a sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up; * accepted informed consent verbally and in writing exclusion criteria: * the poor health * be allergic to anesthetics * lacrimal duct abnormalities * lacrimal tumor and acute inflammation * children * the same surgery failure before exit criteria * postoperative infection and persistent inflammation * operation failure.

Keywords: silicone nasolacrimal intubation dacryocystorhinostomy