Kornimate/medical-research-clean huggingface dataset:
understanding and modeling reservoirs, vehicles and transmission of esbl-producing enterobacteriaceae in the community and long term care facilities

Conditions: Resistance Bacterial; Enterobacteriaceae Infections

Summary: the continuing spread of extended-spectrum beta-lactamase-producing enterobacteriaceae (esbl-pe) is among the most important problems in antimicrobial resistance. it is also a good model to investigate the epidemiological complexity of resistance in enterobacteriaceae. available data on the transmission determinants of esbl-pe in community settings are scarce, methodologically limited and mostly based on single centre studies. a comprehensive investigation using present typing and modelling techniques is warranted to develop a sound quantitative understanding of the interactions involved. a consortium of investigators with diverse expertise from countries with high and low endemicity of esbl-ep has been created. transmission and persistence of esbl-pe within households and long-term care facilities will be studied. individual and group-level determinants for transmission and persistence will be quantified, together with other ecological variables including environmental, food and wastewater contamination. advanced molecular typing techniques and state of the art analytical methods will be used. data generated in this project will directly inform a suite of mathematical models which, in addition to encapsulating current understanding of the processes, will be used to explore the potential effectiveness of different interventions to control esbl-pe spread. the expected outputs are a comprehensive characterisation of esbl-pe transmission considering bacterial clones and mobile genetic elements, as well as individual and ecologic-level factors in different settings, to inform public health authorities about interventions that should be prioritised to control transmission of these organisms.


Eligibility criteria:
inclusion criteria: * residents of the bellevaux ltcf (besançon - france) * patients discharged from the university hospital of besançon and carrying esbl-e. coli or k. pneumoniae and their household members exclusion criteria: * participation rejection
neuromodulation treatment of vestibular migraines

Conditions: Headache

Summary: this is a non-randomized pilot study to test the efficacy of neuromodulation via caloric stimulation on vestibular migraines. all subject who meet the study criteria will be in an active treatment group. all subjects will report the frequency of the migraines and undergo periodic testing of symptoms.

this is a non-blinded, non-randomized pilot study of individuals with vestibular migraines. the goal is to test the efficacy of neuromodulation on both migraine and dizziness symptoms in patients with documented vestibular migraines. treatment will consist of 9 months of active treatment followed by 3 months of observation. the active treatment requires two daily 20 minute sessions wearing a device over the ears that delivers a very small amount of warm air to the ears. all subjects will undergo a series of tests at baseline and at discrete intervals during the 1 year of observation. primary and secondary endpoints are listed below:• primary efficacy endpoints 1. reduction in the frequency and severity of migraine headaches (self reported in pain diary) 2. reduction in the frequency and intensity of perceived vestibular symptoms (dizziness handicap inventory (dhi), activity balance confidence scale (abc), oscillopsia test, symptoms questionnaire), ovrt goggle profile. secondary efficacy endpoints for the pilot study 1. improvement in sleep quality and/or quantity as assessed by the epworth sleep scale. 2. improvement in quality of life as assessed by the hit-6 survey. 3. improvement in mood/anxiety as assessed with the t2 mood tracker app (national center for telehealth \& technology).

Eligibility criteria:
inclusion criteria: 1. adults, between the ages of 18 and 75 who have been diagnosed with vm least 3 months prior to entering into the study. 2. the investigator must have confidence in the patient's ability to reliably use the cvs device and complete the requirements of the study. exclusion criteria: 1. are pregnant 2. have a history of cardiovascular disease 3. work night shifts 4. have a history of unstable mood disorder or unstable anxiety disorder 5. use a hearing aid 6. have a cochlear implant 7. abuse alcohol or other drugs 8. are experiencing medication overuse headaches (individuals with respect to whom the investigator is concerned that analgesic abuse is involved based on the ichd-ii guidelines). 9. have had eye surgery within the previous three months or ear surgery within the previous six months 10. have active ear infections or a perforated tympanic membrane 11. have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial

Keywords: vestibular migraines dizziness migraine headache
an effectiveness and safety study of pf-04383119 for the treatment of pain in interstitial cystitis

Conditions: Cystitis, Interstitial

Summary: the purpose of this study is to determine whether pf-04383119 is effective in the treatment of pain associated with interstitial cystitis.


Eligibility criteria:
inclusion criteria: * male and female adults at least 18 years of age; * moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level. exclusion criteria: * less than 6 months since onset of interstitial cystitis symptoms; * history of recurrent urinary tract infections, or genitourinary cancer; * history of hepatitis b, c or human immunodeficiency virus (hiv); * use of certain drugs given into the bladder up to 1 month prior to study entry.

Keywords: painful bladder syndrome monoclonal antibody
dosing of ketorolac impacts post-cesarean pain managemenet (king)

Conditions: Post Cesarean Pain

Summary: this is a randomized controlled single blinded trial to compare the morphine milligram equivalents (mme) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.

administration of a dose of ketorolac for postoperative pain management at end of cesarean is routine practice at our institution. this is a randomized controlled single blinded trial at the ohio state university comparing a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room immediately after cesarean section. potential study participants will be identified at the time of admission to labor and delivery unit. inclusion criteria must be met, namely patient's age, mode of delivery via cesarean section. the decision for mode of delivery will be at the discretion of the primary obstetrics (ob) provider. indications for cesarean delivery would be: scheduled cesarean due to history of previous uterine surgery including prior cesarean section, failed induction of labor, arrest of second stage of labor, non-reassuring fetal status. patients will be approached for consent and enrollment when decision is made to proceed for cesarean section by their primary provider. patients with allergy to non-steroidal anti-inflammatory drugs (nsaids), history of opioid use disorder, chronic pain disorders, or undergoing an emergent cesarean section, will be excluded from the study. once the decision has been made by the primary obstetrics (ob) provider to proceed with cesarean delivery, participants will be randomized in to one of two groups: * single dose of iv ketorolac 30mg vs. * single dose of iv ketorolac 60mg the intervention and primary outcome will take place over the span of 24 hour post-cesarean. once enrolled and randomized, patients will be given either 60 mg or 30 mg of iv ketorolac at the end of the procedure. all other obstetric care will be at the discretion of the primary provider, including but not limited to pain management postoperatively. analysis will be by intent to treat. the secondary outcomes will be collected during the hospital stay until discharge.

Eligibility criteria:
1. inclusion criteria: * pregnant individuals aged 18-45 with a viable single or twin intrauterine pregnancy * cesarean section as the delivery mode * regional anesthesia (spinal, epidural, combined spinal epidural) 2. exclusion criteria: * known allergy or adverse reaction to non-steroidal anti-inflammatory drugs (nsaids), aspirin, or ketorolac * patients with peptic ulcer disease, preexisting kidney or liver disease * hemodynamically unstable due to hemorrhage * acute or chronic pain disorder * physician/provider or patient refusal * estimated blood loss \> 2000 ml * general anesthesia * opioid use disorder * emergent cesarean delivery * coagulation disorders * active asthma * patients weighing \<50 kg

Keywords: postoperative pain cesarean ketorolac
omics sequencing of specimen derived from patients with endometriosis

Conditions: Endometriosis

Summary: endometriosis is a type of chronic inflammatory gynecological disease, mainly took place in peritoneal cavity. in order to investigate the possible correlation between microbes and endometriosis, the investigators planed to perform 16s rdna amplicon sequencing, metagenomic sequencing and metabolomic sequencing of paired samples derived from feces, cervical mucus, blood and peritoneal fluid.


Eligibility criteria:
inclusion criteria: 1. the subject who is female. 2. the subject who is infertility or sub-fertile. 3. the subject whose age was between 18-52 years old. 4. the subject who is suspected to have endometrioma. 5. the subject whose menstrual cycle length is between 28-35 days. 6. the subject without the history of abdominal or pelvic surgery. 7. the subject who has dysmenorrhea. 8. the subject who has dispareunia. 9. the subject who was informed the risks and benefits of the experiment and provided written informed consent, and gave their approval. 10. the subject who has chronic pelvic pain and the pain get worse during periods. 11. the subject who has no sexual activity within a week. 12. the subject who has no history of acute or chronic pelvic inflammatory disease. 13. the subject who has confirmed em with biopsy. 14. the subject without hormonotherapy within 6 months. 15. the subject without medical history of antibiotics within 6 months. exclusion criteria: 1. the subject who has hernia. 2. the subject who is pregnant. 3. the subject who has malignant tumor. 4. the subject who has gene therapy history. 5. the subject who has abdominal or pelvic surgery history. 6. the subject who has peritonitis. 7. the subject who is below 18 years old or over 52 years old. 8. the subject who can not endure laparoscopy. 9. the subject who has cardiovascular disease. 10. the subject who has systemic or regional acute inflammation. 11. the subject who has chronic liver or kidney disease. 12. the subject whoes body mass index ≤ 18.5 or ≥ 28 (kg m-2). 13. the subject who has coagulation defects or hematologic diseases. 14. the subject who has tuberculosis or chronic obstructive pulmonary disease. 15. the subject whoes alcohol consumption ≥ 60 g d-1, or smokers (≥20 cigarettes d-1). 16. the subject who has hypertension, diabetes, hyperthyroidism and ect. 17. the subject whoes medical history of transfusion, stem cell or bone marrow transplantation. 18. the subject who has contraindication of tracheal intubation anesthesia. 19. the subject who received hormonotherapy within 6 months. 20. the subject who has immunodeficient, allergic or autoimmune diseases. 21. the subject who used antibiotics within 6 months. 22. the subject who is drug abuse.

Keywords: endometriosis microbiota metabolomic
acitretin plasma levels under hemodialysis

Conditions: Carcinoma, Squamous Cell

Summary: acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.

acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined. * trial with medicinal product

Eligibility criteria:
inclusion criteria: * hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin exclusion criteria: * hepatopathy * pregnancy

Keywords: squamous cell carcinoma of the skin under hemodialysis
observational study to evalute the efficacy and safety of avastin (bevacizumab) in addition to platinum-based chemotherapy for first-line treatment of participants with non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to examine the efficacy of bevacizumab in addition to platinum-based chemotherapy for first-line treatment of participants with advanced stage (iiib/iv) non-small cell lung cancer (nsclc) other than predominantly squamous cell histology.


Eligibility criteria:
inclusion criteria: in accordance with the spc. most important criteria: * histology or cytology proven inoperable, locally advanced,metastatic or recurrent (stage iiib/iv) nsclc other than predominantly squamous cell histology * first-line treatment is indicated * no previous treatment with bevacizumab exclusion criteria: in accordance with the spc. most important criteria: * hypersensitivity to the active ingredient or to any of the excipients * hypersensitivity to products derived from chinese hamster ovary (cho) cells or to other recombinant human or humanized antibodies * pregnancy * bevacizumab is contraindicated in the presence of untreated central nervous system metastases
evaluation of efficacy and safety of folfiri association treatment in patients 70 years of age and older with gastric cancer

Conditions: Gastric Cancer

Summary: the number of patients over 70 years old with cancer is increasing in france. this population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in france. folfiri (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. it increases the level of response and survival without major toxicity. it becomes necessary to evaluate patients, to propose adapted treatments for their conditions. the principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. the researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. they will receive folfiri and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. these evaluations include tests of cognitive functions (mms), nutritional status (mna), co-morbidity (cirs-g), mobility (get up and go), activities (adl; iadl), quality of life (qlq-c30), depression (gds-15) and lachs-balducci screening.


Eligibility criteria:
inclusion criteria: * 70 years of age or older * gastric cancer, locally advanced or metastatic * no previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months * one measurable lesion * ecog \< 3 * biology and biochemistry within normal limits * life expectancy \> 12 weeks exclusion criteria: * other palliative chemotherapy for this cancer * other cancer in the last 5 years * previous treatment with irinotecan * atropine treatment not possible * concomitant cancer therapy except bone radiotherapy * metastases to brain or meninges with symptoms * other severe pathology uncontrolled * problem of compliance

Keywords: chemotherapy gastric cancer geriatric evaluation efficacy safety
a study of belimumab in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (sle) disease.


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of sle by acr criteria. * active sle disease. * autoantibody-positive. * on stable sle treatment regimen. key exclusion criteria: * pregnant or nursing * have received treatment with any b cell targeted therapy. * have received treatment with a biological investigational agent in the past year. * have received iv cyclophosphamide within 180 days of day 0. * have severe lupus kidney disease. * have active central nervous system (cns) lupus. * have required management of acute or chronic infections within the past 60 days. * have current drug or alcohol abuse or dependence. * have a historically positive test or test positive at screening for hiv, hepatitis b, or hepatitis c.

Keywords: antibodies autoimmune diseases systemic lupus erythematosus sle belimumab lupus
foundation for sarcoidosis research advanced cures registry (fsr-sarc registry)

Conditions: Sarcoidosis

Summary: the goal of the study is to create a longitudinal study of patient reported outcomes for people living with sarcoidosis that maintains privacy. patients report on the following: demographics, disease symptoms, diagnostic journey, provider experience, disease treatment, and burden of disease. the goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.

participants review a document, understanding your participation, and check boxes on the participant informed consent document that confirms they understand the risks/benefits of participation (or assent if the patient is a minor age 7-18), they create an online account, and then are asked to complete the baseline survey questionnaire. participants confirm they understand that their participation is completely voluntary, that their identifying information will be secured and encrypted, their private health information will be stored separately in a secure database. their private information will never be shared with other people, unless its required by law. the registry may share de-identified information with researchers and other databases. their personal information will be protected and not shared. they may choose to stop their participation at any time by contacting fsr. they are not required to fill out all the questions and can leave any unanswered. they will be contacted by the registry once a year to update or correct their health information. they can choose to be contacted by fsr if a study becomes available that they may wish to know more about.

Eligibility criteria:
inclusion criteria: 1. english speaking 2. consent 3. sarcoidosi diagnosis - exclusion criteria: none
a phase i/ii study to assess the safety, pharmacokinetics, and anti-tumor activity of oral hp518 in mcrpc patients

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the overall objective of this phase 1 study is to evaluate the safety, pk,and anti-tumor activity of daily oral dosing with hp518,selecting the rp2d of hp518 based on assessments of patients with progressive mcrpc in dose-escalation phase

this first in human dose escalation and expansion study of hp518 in patients with progressive mcrpc after nha and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered hp518, but also to provide preliminary efficacy for the reference of future studies.

Eligibility criteria:
inclusion criteria: 1. male, age ≥18 2. patients with androgen receptor (ar) ligand binding domain (lbd) activation mutations (the dose expansion part of stage ii) 3. has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics. 4. has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by ct/mri at the beginning of study. 5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy. 6. must have recovered from toxicities related to any prior treatments 7. ongoing adt with lhrh agonist/antagonist therapy or history of bilateral orchiectomy. 8. ecog performance status score of 0 to 1. exclusion criteria: 1. combination of research or commercially available drugs targeting ar 2. has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177lupsma-617, radium 223, parp inhibitor) within 4 weeks prior to the first dose of hp518. 3. has gastrointestinal disorder affecting absorption (e.g., gastrectomy). 4. has significant cardiovascular disease.
modified dosage for severe acute malnutrition

Conditions: Severe Acute Malnutrition

Summary: protocols for the community-based management of acute malnutrition (cmam) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. the overarching goal of this research project is to simultaneously test two novel simplified approaches in cmam with potential to improve program coverage. the simplified approach includes two parallel clinical trials for sam and mam treatment. two fixed-dose regimes of rutf will be tested against the current weight-based dosing of rutf for children with sam.


Eligibility criteria:
inclusion criteria: 1. age 6-59 months 2. reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year 3. uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. pass appetite test conducted at the time of enrollment 5. consent for randomization into the study given by mother, father, and/or other primary caregiver 6. mid-upper arm circumference less than 115 mm and/or nutritional edema 7. weight-for-height z-score (whz) less than -3 exclusion criteria: 1. complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. this includes, but is not limited to: a. hypothermia b. high fever c. signs of hypoglycemia d. lethargy or altered mental status e. moderate to severe dehydration f. shock g. other medical complications requiring hospitalization or higher-level medical evaluation 2. treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months 3. known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food