Kornimate/medical-research-clean huggingface dataset:
[68ga]-neobomb1 imaging in patients with malignancies known to overexpress gastrin releasing peptide receptor (grpr)

Conditions: Breast Cancer; Prostate Cancer; Colorectal Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer

Summary: this was a phase ii, multi-center, open label, single dose study in patients with tumor types known to overexpress gastrin-releasing peptide receptor (grpr), including breast, prostate, colorectal, non-small cell lung cancer (nsclc) and small-cell lung cancer (sclc).

a total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). in total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).

Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age * subjects must have signed and dated an informed consent prior to any study-specific procedures * subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed. * dosimetry group: luminal breast cancer, adenocarcinoma of the prostate * non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma * at least one malignant lesion detected via functional or morphological imaging (pet combined to appropriate tracer according to tumor type, ct, mri) within 3 months prior to \[68ga\]-neobomb1 administration * the eastern cooperative oncology (ecog) performance status 0-2. * subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial. exclusion criteria: * renal insufficiency or an egfr \<50 ml/min/1.73m2 * hematological toxicity grade \> 2 (toxicity grading scale in vaccine clinical trials) * participation in any other investigational trial within 30 days of study entry * subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding * concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results * concurrent bladder outflow obstruction or unmanageable urinary incontinence * known or expected hypersensitivity to \[68ga\]-neobomb1 or any excipient present in \[68ga\]-neobomb1 * any condition that precludes raised arms position * prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide * history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Keywords: [68ga]-neobomb1
clinical trial of l. reuteri in infantile colic 2017

Conditions: Infantile Colic

Summary: rct to evaluate the safety and efficacy of lactobacillus reuteri dsm 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)

rct to evaluate the safety and efficacy of lactobacillus reuteri dsm 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. as primary outcome we will measure the difference between children receiving l. reuteri dsm 17938, 108 cfu vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by barr diary. secondary/exploratory outcomes will be average of crying time on day 7 and 14 (barr diary) of l. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (barr diary) of l. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; qol (pedsql-2.0-family impact module au2.0 spa-mx) changes from baseline to days 7, 14 and 21 and edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21

Eligibility criteria:
inclusion criteria: * younger than 10 weeks of age * full term infant (37-42 weeks gestational age) * birth weight ≥ 2,500g * apgar score ≥ 7 at 5 minutes * infantile colic diagnosed according to modified wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment) * parental motivation to postpone changes in the infant feeding mode, unless necessary * stated availability throughout the study period * parent(s) willingness and ability to fill out charts and questionnaires * signed informed consent exclusion criteria: * failure to thrive * chronic illness or major medical problem * gastrointestinal disease * use of any antibiotic 2 weeks before day 1 in the study. this applies also to lactating mothers whose infants participate in the trial * use of supplements/eaten foods that contain lactobacillus reuteri, 2 weeks before day 1 * use of proton pump inhibitors in the week (7 days) prior to enrolment * if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period * use of infant formula with hydrolysed protein * infant receiving solid foods (such as cereals, mashed fruits or vegetable purée) * change of feeding mode planned by parents during the study period
outcomes using mars for patients with alf

Conditions: Alcoholic Hepatitis; Acute Liver Failure

Summary: retrospective chart review will be conducted on patients at methodist dallas medical center, meeting the inclusion criteria from january 1, 2019 to december 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures.

retrospective chart review will be conducted on patients at methodist dallas medical center, meeting the inclusion criteria from january 1, 2019 to december 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures. patient's charts will be accessed on epic by the pi or delegated study personnel. the investigator's anticipate completion of this study by january 31, 2022.

Eligibility criteria:
inclusion criteria: • the patient was diagnosed with: alcoholic hepatitis; aoclf; or acute fulminant liver failure • the patient underwent at least one round of dialysis using plasma exchange or marstm exclusion criteria: * patient not meeting the inclusion criteria will be excluded. all patients who underwent mars at mdmc will be included in the study population.
diagnostic value of hand ultrasound versus mri in rheumatoid arthritis

Conditions: Patient's With Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. it is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations. if left untreated, ra leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality. early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.


Eligibility criteria:
inclusion criteria: 1. adult-onset disease. 2. patients who fulfill the 2010 american college of rheumatology/european league against rheumatism classification criteria for rheumatoid arthritis. exclusion criteria: 1. any patient with any collagen disease rather than rheumatoid arthritis. 2. patients with joints deformities. 3. patient's with implanted metal clips or wires or artificial pacemaker.
reactogenicity study of cervarix and gardasil in uk adolescent girls

Conditions: HPV Infections

Summary: this is a phase iv study to evaluate the body's immune response of participants to the cervarix and gardasil vaccines against the human papilloma virus (hpv) types associated with increased risk of cervical cancer.

this study looks at possible cross reactivity between different hpv serotypes and both peripheral antibodies and mucosally-secreted antibodies.

Eligibility criteria:
inclusion criteria: * aged between 13 and 15 years at the time of the first immunisation * female * no contraindications to vaccination as specified in the "green book" - immunisation against infectious disease, hmso. * written informed consent obtained from parent or guardian of subject exclusion criteria: * pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill). * breast-feeding mothers * allergic to vaccine components

Keywords: hpv human papilloma virus cervical cancer vaccine
proximity alarms to reduce patient falls

Conditions: Aging

Summary: the purpose of this study is to test an intervention to introduce and implement proximity alarms on the risk of falls in hospitalized patients.

proximity alarm systems are promoted as an approach to reduce falls and decrease use of physical restraints in hospitals, but they have not been tested rigorously. this study will implement proximity alarms at methodist-university hospital (m-uh), a 652-bed urban community hospital in memphis, tennessee. the hospital provides primary to tertiary care to a diverse adult patient population. the group randomized trial will be conducted on 16 25-bed general medical-surgical nursing units at m-uh. nursing units will be randomized within blocks of 2 based on rates of falls that occur during an initial 3-month observation period. over a 15-month intervention, 8 nursing units will be randomized to receive the alarm-based intervention, and 8 will utilize existing nursing care methods to minimize falls. intervention units will receive an adequate supply of proximity alarm monitoring systems to apply to all patients considered by nursing staff to be at high risk for falls. an implementation team, consisting of a nurse-champion, geriatrician and biomedical instrumentation specialist, will train and conduct regular follow-up on intervention units to address technical issues related to use of the alarms. the primary outcome measure, patient falls, will be ascertained prospectively by a nurse-manager using a method developed to collect patient (e.g., orientation and postural blood pressure) and environmental data collected in a standardized manner. the primary aim of the study is to determine whether proximity alarm monitoring reduces falls. the study has been designed to test the hypothesis that patient falls will be 25% lower on intervention units compared to control units. the secondary aims are to determine whether proximity alarm monitoring reduces the use of physical restraints, or decreases patient care costs. this will be the first methodologically sound study to evaluate this promising approach to reducing falls in hospitals. whether or not alarms successfully reduce falls, findings from this study have the potential to widely impact purchasing decisions and clinical practice related to fall prevention in acute-care settings.

Eligibility criteria:
inclusion criteria: * patient admitted to one of 16 study units at methodist university hospital

Keywords: hospitalization fall risk frailty
the efficacy of ticagrelor on abdominal aortic aneurysm (aaa) expansion

Conditions: Abdominal Aortic Aneurysm

Summary: abdominal aortic aneurysm (aaa) is a major health problem and ruptured aaa is a common cause of death in europe and north america. a key limitation of contemporary treatment strategies of aaa is the lack of therapy directed at reducing expansion. although surgical repair is an effective treatment for large aaa, it is associated with significant mortality and morbidity as well as substantial cost. the rationale for this randomized controlled study is to investigate whether treatment with ticagrelor inhibits growth of small abdominal aortic aneurysms.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * male and female patients * age 50-85 years * documented infrarenal aortic aneurysm between 35-49 mm * acetylsalicylic acid (asa)-naïve exclusion criteria: * short expected survival. * on anti-platelet therapy. * on long-term oral or parenteral anticoagulant treatment. * on strong inhibitors of cyp3a enzyme (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir). * on cyp3a (cytochrome p450, family 3, subfamily a) substrates or inducers \>40mg daily doses (simvastatin, lovastatin, rifampin/rifampicin, phenytoin, carbamazepine, phenobarbital). * known or suspected connective tissue disorder (marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta. * increased risk for bradycardia or ongoing treatment with any bradycardia inducing drug. * contraindication for ticagrelor; hypersensitivity to ticagrelor or any of the excipients, active pathological bleeding, history of intracranial hemorrhage, moderate or severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy), on haemodialysis. * known haemostatic or coagulation disorder, gastrointestinal bleeding within the past 6 months, or increased bleeding risk due to surgery or trauma within 30 days. * mri exclusion criteria, such as: severe claustrophobia, pacemaker, metallic implants in brain, cochlear implants. * metallic implants in aortic region. * enrolled in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to visit 1 of the current study. * any condition or laboratory finding which in the opinion of the investigator makes the patient unsuitable for inclusion (eg, active malignancy other than squamous cell or basal cell skin cancer, long-term concomitant treatment with non-steroidal anti-inflammatory drugs (nsaids).

Keywords: aorta aneurysm antiplatelet
urinary aquaporine 2 in patients with syndrome of inappropriate adh-secretion caused by treatment with antiepileptic medicine

Conditions: Syndrome of Inappropriate ADH-secretion

Summary: patients treated with the antiepileptic drug oxcarbazepine often develop syndrome of inappropriate secretion of antidiuretic hormone(siadh)we want to test the hypothesis, that these patients have a higher reabsorption of water during the aquaporine2 water channels,a higher concentration of vasopressine (avp), and a lower clearance of water.this situation will tend to normalize, when the patients are treated with fluid restriction

the purpose of the study is to determine the amount of aquaporine2(aqp2)in the urine in patients treated with the antiepileptic drug oxcarbazepine before and after the administration of fluid restriction

Eligibility criteria:
inclusion criteria: age more than 18 years, both men and women, patients with epilepsia treated with oxcarbazepine, and a sodium content in plasma lower than 130 mmol/liter exclusion criteria: severe diseases in the heart, lungs or liver;diabetes mellitus, other not-well treated diseases in endocrine organs, cancer; unwillingness to participate
study to evaluate the presence of a hangover effect in healthy adults after administration of songha® night tablets

Conditions: Healthy

Summary: study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of songha® night


Eligibility criteria:
inclusion criteria: * healthy male or female caucasian subjects aged 20-60 years * normal outcome in pittsburgh sleep quality index (psqi), below mean +2 standard deviation (sds) * no manifest sleep disorder diagnosed by polysomnography * normal pupillary function * willing and able to give written informed consent in accordance with good clinical practice (gcp) and local legislation prior to participation in the study and able to perform the study during the full time period of 36 days exclusion criteria: * subjective sleep duration of less than 3 hours in the night before the test * caffeine, nicotine or alcohol on the day (from midnight) of the test * alcohol consumption on the evening before visits 3, 5 or 7 * eye-drops or other drugs, taken orally or intravenously, influencing pupil size or motility * shift work * drug and alcohol abuse * use of psycho-active drugs during the past 30 days * any treatment that might interfere with the evaluation of the test drug * any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome p450 * any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.) * known hypersensitivity to any of the ingredients of the study drugs * pregnant or nursing women or inadequate birth control methods (this applies to female of childbearing potential only) * participation in another trial within the past 30 days
the norwegian adult achondroplasia study

Conditions: Achondroplasia

Summary: the study aims to investigate the norwegian adult achondroplasia population regarding degree and extent of symptoms and clinical manifestations and how this population manages in daily life, including demographics, physical function, and work participation.

the present study aims to investigate the degree and extent of spinal stenosis, chronic pain, sleep apnoea, impaired hearing, cardiovascular risk factors and body composition in norwegian adults with achondroplasia. the study will also explore these factors' impact on physical function, ability to perform daily activities, work participation and needs for assistive devices and social benefits. the study is conducted in collaboration with the norwegian restricted growth association, and trs national resource centre for rare disorders, sunnaas rehabilitation hospital, lovisenberg hospital and oslo university hospital.

Eligibility criteria:
inclusion criteria: * residents of norway * aged 16 years or older * clinical and genetic diagnosis of achondroplasia * speak and understand the norwegian language. exclusion criteria: * severe cognitive deficits, mental illness or substance abuse * having a medical condition making them unable to participate in the study.
doctor-parent interactions with medical scribes

Conditions: Burnout, Professional

Summary: the purpose of the study is to collect outcomes related to a quality improvement project assessing the feasibility and effectiveness of a medical scribe program in which medical scribes accompany clinicians during their visits with patients. the medical scribes involved in the project are professional scribes and medical students who will accompany clinicians during patient visits and takes notes, enabling the clinician to engage more directly with the patient.

the study has several specific objectives. this study aims to examine the impact of using medical scribes on (1) patient experience (e.g. patient satisfaction) (2) clinician experience (e.g. stress load, burnout, evaluation of the visit, amount of time spent after hours inputting notes), and (3) clinician-patient interaction (e.g. patient and clinician engagement during the visit).

Eligibility criteria:
provider participants inclusion criteria: 1. attending clinicians with privileges at penn state hershey children's hospital and/or the penn state hershey internal medicine. this may include attending mds or dos and nurse practitioners (nps). 2. voluntary participation in the medical scribe qi project. 3. consents to participate in the study. exclusion criteria: 1. clinician is not participating in the scribe project. 2. clinician does not consent to participate in the research portion of this project. patient participants inclusion criteria: 1. patient (if 18 years or older) or parent/guardian (p/g) of patient being seen by a participating clinician. 2. patient was not seen by a resident or medical student prior to meeting with clinician. 3. english speaking/reading. 4. patient or p/g has capacity to consent. exclusion criteria: 1. patient is seeing a clinician who has not consented to participate in the research portion of the study. 2. non-english speaking/reading. 3. patient or p/g lacks capacity to consent.

Keywords: medical scribe outpatient ehr
oct-a and amblyopia

Conditions: Amblyopia

Summary: detect changes in retinal vessel density in the superficial and deep capillary plexuses using octa in children with anisometropic amblyopia


Eligibility criteria:
inclusion criteria: 1. unilateral anisometropia. 2. refractive error less than -6.00 d and +4.00 d. 3. age less than 12 years. 4. no previous amblyopia treatments exclusion criteria: 1. high refractive error. 2. bilateral amblyopia. 3. age more than 12 years. -
targeted pcr and acute endophthalmitis

Conditions: Acute Endophthalmitis Post-operative

Summary: endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). this is a diagnostic and therapeutic emergency. each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover. the etiological treatment will be adapted according to the infectious agent.

the main goal of this prospective multi-centre trial is to improve the sensitivity and rapidity of the infectious agent's identification involved in endophthalmitis cases, particularly virulent species (like staphylococcus aureus, streptococcus pneumoniae...) from ocular samples with the help of real-time pcr. this will help the ophthalmologist to be more efficient in accordance with the kind of the bacteria. data will also enable to compare both pcr techniques used in this study. the secondary goal of the prospective study is to characterize the resistance of bacterial's species found during acute endophthalmitis with the antibiogram and by the study of resistance genes, to enable to correlate the resistance in vitro with the therapeutic response in vivo and get precious epidemiological data to adapt prophylactic antibiotic.

Eligibility criteria:
inclusion criteria: * subjects affiliated to the social security system * signed informed consent documentation * patients over 18 years * male or female person * patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis, or within the context of a scheduled surgery with sampling of aqueous humour. * has given his or her consent, having been provided with detailed informations regarding to intraocular sampling. exclusion criteria: * antibiotherapy via intravenous (\< 8 days) for patients non suffering from endophthalmitis (control group) * patient's participation to the study refused * patients under 18 years * patients adults under guardianship or curatorship, or unable to express his/her consent. * pregnant women * breastfeeding women * person deprived of liberty

Keywords: acute endophthalmitis. pcr ocular sampling