Kornimate/medical-research-clean huggingface dataset:
prospective observational study of filgotinib in participants with rheumatoid arthritis in france

Conditions: Rheumatoid Arthritis

Summary: an observational study to describe the effectiveness, safety, and patient-reported outcomes (pros) in participants with moderate to severe active rheumatoid arthritis (ra) in france receiving filgotinib in real-world setting.


Eligibility criteria:
inclusion criteria: * participants aged ≥18 years with a diagnosis of moderate to severe active ra being prescribed filgotinib in accordance with the local treatment practices and product label for the first time. * female participants of childbearing potential must agree to use contraception while taking filgotinib as per product label. * participants must be willing and able to use an electronic device to complete the study pros. * participant must sign and date the informed consent form (icf) before enrollment into the study. exclusion criteria: * participation in any interventional or non-interventional study without prior approval from the medical lead. this does not preclude inclusion of participants enrolled to national registries. * female participant is pregnant or intending to become pregnant while taking filgotinib.

Keywords: filgotinib safety effectiveness patient-reported outcome
high dose inhaled mannitol study

Conditions: Bronchiectasis

Summary: this study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.


Eligibility criteria:
inclusion criteria: * adult subjects with non-cf bronchiectasis * fev1 \> 50 % predicted and \> 1.0l exclusion criteria: * bronchiectasis due to cf or endobronchial lesion * respiratory infection requiring iv antibiotics in last 4 weeks * pregnancy * significant haemoptysis in last 6 months * active tb * end stage ild * contraindications as determined by investigator
research and engagement on substance use: harnessing awareness and personalized education (reshape) to improve well-being and self-efficacy

Conditions: Substance Use Disorder (SUD)

Summary: the goal of this study is to gather feedback on a potential program that collects and shares real-world information to help create products and services to support people who have substance use disorders.


Eligibility criteria:
inclusion criteria: * u.s. resident * speaks, read, and understands english * adults ≥ 21 years of age * self-reported substance use disorder or at risk for substance use disorder as defined by cannabis use, tobacco use, illegal drug use, or prescription medication use for nonmedical reasons on at least 2-3 times in the past year * self-reports at least one of the following health-related social needs as assessed by american academy of family physicians social needs screening tool: * housing instability * non-reliable transportation * food insecurity * utility needs * personal safety * willingness and availability to participate in a recorded online interview (phase 1a participants) exclusion criteria: * participation in phase 1a (among phase 1b participants), to be assessed using participation history

Keywords: substance abuse
a study to compare pharmacokinetic parameters and safety profiles between ad-109 and ad-1091

Conditions: Embolism and Thrombosis

Summary: primary endpoint of this study is to evaluate the pharmacokinetic characteristics of ad-109 in healthy male subjects.

the purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of ad-109 compared with ad-1091 in healthy male subjects.

Eligibility criteria:
inclusion criteria: * body weight equal to or greater than 50kg and body mass index (bmi) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy male volunteers at the time of screening visit exclusion criteria: * patients with medical history increasing the risk of bleeding
safety and efficacy of glumetinib combined with docetaxel for injection (albumin-bound) in patients with advanced gastric cancer/gastroesophageal junction adenocarcinoma and other solid tumors

Conditions: Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors

Summary: the trial consists of stage 1 (including dose escalation and dose expansion) and stage 2 (proof-of-concept study). among them, stage 2 adopts a randomized, controlled, open-label, and multicenter design.


Eligibility criteria:
inclusion criteria: * 1. patients who are able to understand and voluntarily sign the written icf; * 2. male or female patients aged ≥ 18 years (inclusive); * 3. patients with advanced solid tumors diagnosed by pathology or cytology; * 4. patients with a past medical history showing either negative or positive her-2 expression can be enrolled. for those with unknown her-2 expression, the her-2 status needs to be determined before enrollment. for patients with positive her-2 expression, their previous treatments should include anti-her-2 drug therapy. * 5. overexpression and/or amplification of met in tumor tissue specimens/blood samples confirmed by the central laboratory. * 6. there are measurable lesions or non-measurable but evaluable lesions according to recist v1.1. * 7. the eastern cooperative oncology group (ecog) performance status (ps) score is 0 or 1. * 8. the expected survival time is ≥ 3 months. * 9. the functions of major organs and bone marrow meet the criteria. exclusion criteria: * 1. patients with prior treatment with targeted met drugs; * 2. previous treatments included docetaxel; * 3. patients with meningeal metastases, spinal cord compression, symptomatic or progressive brain metastases are not eligible for enrollment. * 4. known hypersensitivity or intolerable conditions to any component of the drugs in the study protocol or their excipients. * 5. according to nci-ctcae 5.0, adverse events caused by previous anti-tumor treatment have not recovered to ≤ grade 1 (excluding toxicities such as grade 2 alopecia which are judged by the investigator to pose no safety risk). * 6. any severe and/or uncontrolled co-existing diseases that may prevent the patient from participating in the study. * 7. female patients who are lactating or pregnant; women of childbearing potential with a positive blood pregnancy test result within 7 days before trial enrollment. lactating women can participate in this study if they stop breastfeeding, but they must not resume breastfeeding during and after the completion of the study treatment. * 8. any male or female patient of childbearing potential who refuses to use a highly effective contraceptive method throughout the trial period and within 6 months after the last administration. * 9. those who are unwilling or unable to comply with the study procedures and requirements, or those who, in the judgment of the investigator, are not suitable for participating in this study.
comparison between vapocoolant spray and eutectic mixture of local anesthetics in reducing pain from spinal injection

Conditions: Adult Patient Undergoing Elective Surgery With Spinal Anesthesia

Summary: this study aimed to evaluate the effect of vapocoolant spray and emla in reducing pain from spinal injection

approval from ethical committee of faculty of medicine universitas indonesia was acquired prior conducting the study. subjects were given informed consent before enrolling the study and randomized into two groups (vapocoolant spray group and eutectic mixture local anesthetics (emla) group). intravenous (iv) cannulae with ringer acetate fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. vital signs were recorded. patients were positioned in sitting position and were instructed to flex their head and bend their back. identification of intervertebral space l4-5 were performed. asepsis and antisepsis procedure were performed. the vapocoolant spray group received vapocoolant spray at a distance of 10 cm for 2 seconds and we waited for 10 seconds. the emla group received emla cream which consisted of 2.5% lidocaine and 2.5 % prilocaine in 2 ml of water/oil emulsion and then they received tegaderm as the dressing for 45-60 minutes before the cream was wiped off. spinal injection using 27g needle were performed after the intervention to each groups. needle bevels were aligned parallel to dura fibres. patients' visual analog score (vas) and movements were recorded. evaluation was only done in the first injection attempt, and was followed until the depth of the needle was around 5 mm. after the injection was successfully performed, patients' position were changed into supine position. evaluation and recording were performed by person who was blinded from the intervention. vital signs were recorded for every 3 minutes in the first 15 minutes, and then every 5 minutes until the end of the procedure.

Eligibility criteria:
inclusion criteria: * woman aged \>18 years old * american society of anesthesiologists (asa) physical status i-iii who were planned to undergo one-day care elective surgery at operating room in spinal anesthesia * patients who were planned to undergo brachytherapy exclusion criteria: * subjects with history of allergy to anesthetic agents * unstable hemodynamic * history of active psychotropic drug consumption * spinal anesthesia contraindications such as local infection, severe coagulopathy, severe hypovolemia, or increased intracranial pressure
determination of genetic relatedness of linezolid-resistant vancomycin-resistant enterococci (vre) surveillance cultures

Conditions: Isolate; Linezolid

Summary: the study will help in identifying the best empiric antibiotic option for linezolid resistant vancomycin-resistant enterococci (vre) infections. this research is important because it allows the determination of resistance rates to antibiotics that may not be frequently tested to by the clinical microbiology laboratory at upmc-presbyterian. it also will provide antibiotic minimum inhibitory concentrations (mics) for these pathogens which may help in identifying the best empiric antibiotic option for linezolid-resistant vre infections.

after 20 linezolid-resistant vre isolates are identified, genetic relatedness will be determined using a method known as pulse-field gel electrophoresis (pfge). no patient related data will accompany these isolates, nor will any related identifiers. these isolates will be tested using standardized susceptibility methods. we will then grow each isolate and test via approved laboratory standards (e-test, ab biodisk, stockholm, sweden) to the drug linezolid. those determined to be resistant using this approved methodology will be saved until 20 isolates are identified. for resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Eligibility criteria:
inclusion criteria: * dr. harrison's laboratory collected the rectal surveillance isolates for infection control purposes. the isolates will be from january 1, 2006 to december 31, 2006.

Keywords: isolate infection linezolid
a 16 week study evaluating the introduction of a gmp based protein substitute in participants with pku

Conditions: Phenylketonurias

Summary: this study aims to measure changes in participants' blood phenylalanine (phe) levels in participants with pku when switching from a conventional amino acid based protein substitute to a gmp based protein substitute (pku sphere) over a 16 week period.

this is a stepped wedge, open-label study of pku sphere for the dietary management of participants with phenylketonuria. it will be carried out with 33 participants who will be randomised into one of three clusters. the total study length per patient is 16 weeks. each cluster transitions from taking their standard amino acid product alone to incorporating pku sphere (at least 50% of their protein substitue requirement) at different timepoints: week 5, 9 or 13. participants will have a face-to-face clinical review at the time of recruitment (week 0) and at 16 weeks (completion of the study). they will also have an additional telephone review when they switch onto pku sphere. blood samples will be taken at baseline, and then every two weeks for the duration of the study. in addition to these study visits and procedures, routine clinical care will continue in line with local guidelines.

Eligibility criteria:
inclusion criteria: * diagnosis of pku made in neonatal period * treated by a low-phenylalanine diet and necessity of intake of at least one protein substitute per day * aged 10 years and above * three blood phe measurements taken within the preceding six months * willing to replace current amino acid based protein substitute with pku sphere * ability to take at least 50% of protein requirements as pku sphere * ability to comply with the study protocol, in the opinion of the investigator * willingly given, written, informed consent from patient or parent/guardian * willingly given, written assent (if appropriate) exclusion criteria: * women who are pregnant or planning to become pregnant during the study period * participants with atypical pku (e.g. bh4 deficient) * intake of sapropterin dihydrochloride (kuvan) in the six weeks prior to recruitment in the study * patients with soya, milk or fish allergies * any other severe disease

Keywords: phenylketonuria pku child children adult adults gmp glycomacropeptide amino acid mixture amino acid protein supplement protein substitute
acute physiological effects of electronic sigarette vs cigarette smoking

Conditions: Individuality

Summary: because e-cigarettes do not contain or burn tobacco, they do not appear to deliver the known toxins found in conventional cigarette smoke.however e-cigarettes with low dose of tobacco were found to have immediate adverse physiologic effects after short-term use that are similar to some of the effects seen with tobacco smoking. in this study we wanted to assess the short-time effect of one e-cigarette with no tobacco vs a "traditional" cigarette. 10 n-smoking subject and 10 actual smokers will be enrolled in the randomized trial.

on day 1 the subjects will be asked to smoke either the e-cigarette or a "traditional" one for 5 minutes. on day 2 the subject will be ask to smoke for 5 minutes the other kind of cigarette. exhaled nitric oxide will be measured in a sitting position with a nose clip using an analyzer equipped with a software program. the patient will be instructed to inhale as deeply as possible to total lung capacity through a filter mouthpiece and consecutively exhale at a mouth fl ow rate of 50 ml/s for 10 s. three consecutive trials will be performed with a 30-s interval. dynamic lung volumes: flows and lung volumes will be measured in the sitting position, a spirometry system (heated pneumotach, with the highest fev 1 recorded in line with pulmonary guidelines. spirometry will be measured according to the recommendations of the american thoracic society/european respiratory society task force guidelines. fev 1, fvc, fev 1 %, peak expiratory fl ow (pef), and maximal expiratory fl ow (mef) at 25%, 50%, and 75% of vital capacity will be measured. each maneuver will be repeated for at least three technically acceptable forced expiratory fl ow curves.

Eligibility criteria:
inclusion criteria: * 10 no smoking healthy individuals * 10 smoking (\>20 pack/yr) healthy individuals exclusion criteria: * pre-existing diseases * fev1/fvc ratio\<70%
analysis of palliative surgery in view of quality of life and prognosis

Conditions: Cancer; Quality of Life

Summary: the purpose of this study is to define if palliative surgery in patients with cancer improves quality of life and prognosis.

the purpose of this study is to find out if palliative surgery in patients with cancer improves quality of life and prognosis. there will be a scheduled assessment of quality of life and assessment of postoperative complications. prognostic scoring will be performed before surgical intervention.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of inoperable cancer * planned surgery * able to give interview * written informed consent exclusion criteria: * unconsciousness * psychiatric disorder * not able to communicate in german

Keywords: surgery prognostic palliation
comparison of skin prick testing and intradermal skin test result of local and imported insect allergen extracts

Conditions: Allergy to Arthropod Sting

Summary: comparison the results of skin prick testing and intradermal skin test result of local and imported insect allergen extracts in patients with serious insect sting allergy reactions

the patients with serious insect sting allergy reactions were evaluated and skin prick test and intradermal test with local and imported insect allergen extracts were performed. specific ige for insects was also performed. the results of skin prick testing and intradermal skin test of local and imported insect allergen extracts were compared. the results also compared with specific ige to insects

Eligibility criteria:
inclusion criteria: * patients with severe insect allergy reaction * allow being done skin test and blood foe specific ige exclusion criteria: * serious systemic diseases * severe asthma * pregnant or nursing * severe and extended skin lesion

Keywords: insect sting allergy hymenoptera allergy local insect allergen extracts
a carotid stenting boston scientific surveillance program

Conditions: Carotid Artery Disease

Summary: cabana is a multicenter u.s. surveillance registry that will be conducted to compile early clinical outcomes data for the carotid wallstent endoprosthesis and filterwire ez system in routine clinical practice and to assess the adequacy of the boston scientific corporation (bsc) carotid stenting training program.


Eligibility criteria:
inclusion criteria: * subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease. * subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram or * subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram. * subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the filterwire ez system. * subject is willing and able to comply with all follow-up requirements. * subject has provided a signed informed consent prior to participation in the registry. exclusion criteria: * patients in whom anticoagulant and/or antiplatelet therapy is contraindicated * patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system * patients with uncorrected bleeding disorders * lesions in the ostium of the common carotid artery.

Keywords: cerebrovascular disease carotid stent stent carotid endarterectomy (cea)
osteoporosis school

Conditions: Osteoporosis

Summary: the purpose of this study is to investigate the efficacy of systematic education (osteoporosis school) on fall frequency, compliance and quality of life of a group of patients more than fifty years of age. hypothetically, systematic information can increase compliance to the medical treatment, decrease the frequency of falls and increase the quality of life.

in most randomized trials compliance to medical treatment in osteoporosis is very high, but compliance tends to be considerably inferior in routine treatment compared to scientific trials. this fact is caused by a narrow selection of motivated patients in the randomized trials. perhaps, the information given to the patients in scientific trials is more thorough than information given in a routine setting. there are no trials available that document that compliance to medical treatment of patients with osteoporosis can be increased by intensive systematic information. change of lifestyle is an important part in the treatment of these patients. the patients are encouraged to eat more healthy food combined with an intake of calcium and vitamins, reduction of alcohol and tobacco consumption if needed and prevention of fall incidence through changes in the house. the quality of life is often reduced, partly due to chronic pain, altered social status, physical handicap and partly due to the heavy knowledge of having a chronic decease. adaption to the last-mentioned factors can possibly lead to a considerably better quality of life in spite of the unchanged physical handicap. randomized trials on efficacy of systematic patient education has in general been positive in other contexts. young patients with diabetes offered coping skills training have therefore a better metabolic control and quality of life. no similar randomized trials are available on the efficacy of a systematic education program in osteoporosis.

Eligibility criteria:
inclusion criteria: * fracture caused by osteoporosis * fifty years or more of age * informed consent exclusion criteria: - physically or mental state that does not participation

Keywords: osteoporosis fall frequency medical treatment compliance quality of life systematic education
intralipid for repeated implantation failure

Conditions: Infertility

Summary: intralipid infusion can improve outcome in women with recurrent intracytoplasmic sperm injection ( icsi) failure due to elevated th1 cytokine response.

infertile patients undergoing intracytoplasmic sperm injection (icsi) cycle with history of repeated implantation failure, intralipid will be given to the intervention group. the primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.

Eligibility criteria:
inclusion criteria: * infertile patients undergoing icsi cycle with history of repeated implantation failure exclusion criteria: 1. disturbances of normal fat metabolism such as pathologic hyperlipemia 2. allergic to it; or to eggs, soybean oil, or safflower oil. 3. severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder. 4. uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.

Keywords: repeated implantation failure intralipid