Kornimate/medical-research-clean huggingface dataset:
surveillance of healthcare-associated infections & antimicrobial resistance

Conditions: Antimicrobial Resistance

Summary: the aims of this project, called "surveillance of healthcare-associated infections \& antimicrobial resistance", or "share", are to 1) enhance laboratory capacity to detect emerging amr patterns; 2) strengthen hospital epidemiology programs to use data to prevent, detect, and contain emerging amr threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of infection prevention and control (ipc) resources to prevent, detect, and contain emerging infectious disease threats

the world health organization (who) has declared antimicrobial resistance (amr) one of the top 10 global public health threats facing humanity. amr burden is higher in low-and-middle-income countries (lmics) where, in recent decades, incidence and mortality from healthcare-associated infections (hai) due to multidrug resistant organisms (mdro) have dramatically increased. for example, neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south asia and sub-saharan africa, including botswana.1,2 one in three newborns with an mdro bloodstream infection will die.3 in 2021, to respond to the global threat of amr, u.s. centers for disease control \& prevention (cdc) announced the launch of a global "network of networks" to tackle the problem of amr and healthcare-associated infections (hais). the network, called "global antimicrobial resistance laboratory and response network", solicited funding applications; in december of 2021, botswana was announced as recipient of a 5-year cooperative agreement following the successful application for funding for a comprehensive amr surveillance project. the project was developed by investigators from botswana-upenn partnership (bup) in collaboration with botswana's ministry of health \& wellness (mohw) and the university of botswana (ub).

Eligibility criteria:
inclusion criteria: * hospital inpatient admission to participating wards. exclusion criteria: * diagnosis of a bleeding disorder * platelet counts of \<50,000 * diagnosis of coagulopathy * presence of active bleeding * inability to have a nares swab collected due to some other condition where nasal swabbing would be contraindicated * inability to have a rectal swab collected due to some other condition where rectal swabbing would be contraindicated
long term safety and efficacy study of tolebrutinib (sar442168) in participants with relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: primary objective: to determine the long-term safety and tolerability of sar442168 in rms participants secondary objective: to evaluate efficacy of sar442168 on disease activity, assessed by clinical and imaging methods

approximately 62 months including the 8 weeks post-treatment visit

Eligibility criteria:
inclusion criteria: * participants must have completed treatment in the dri15928 study * female participants must continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. menopause is defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (fsh) level \>30 ui/l. * the participant must have given written informed consent prior to undertaking any study related procedure. exclusion criteria: * the participant has a confirmed concomitant laboratory or ecg abnormality or medical condition deemed by the investigator incompatible with continuation of sar442168 treatment. * the participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last dri15928 visit and the first treatment visit in the lts16004 study. * the participant has received a non-study ms disease modifying treatment between the last imp treatment in study dri15928 and inclusion in study lts16004, which by judgement of the investigator may add unjustified risk to switching back and continuing treatment with sar442168. washout periods after treatment with non-study dmts should be respected except for interferons or glatiramer acetate treatment. * the participant is receiving strong inducers or inhibitors of cyp3a or cyp2c8 hepatic enzymes. * the participant is receiving anticoagulant/antiplatelet therapies, including: * acetylsalicylic acid (aspirin) * antiplatelet drugs (eg, clopidogrel) * warfarin (vitamin k antagonist) * heparin, including low molecular weight heparin (antithrombin agents) * dabigatran (direct thrombin inhibitor) * apixaban, edoxaban, rivaroxaban (direct factor xa inhibitors) note: all above drugs need to be stopped at least 5 half-lives before study drug administration except for aspirin, which needs to be stopped at least 8 days beforehand. * prior/concurrent clinical study experience. the participant is taking part in another interventional clinical trial of another drug substance. * uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures * the participant is pregnant or is a breastfeeding woman. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
renewing health - regions of europe working together for health

Conditions: Type 2 Diabetes; Coronary Artery Disease; Heart Failure; Atrial Fibrillation; Other Arrhythmias

Summary: the purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the sf-36 questionnaire and reduce a value of hba1c under 6,5 % among those type 2 diabetes patients who had elevated value of hba1c when recruited.

renewing health is a project covering 9 different european states. it aims at evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. in 9 european regions in the implementation of health-related information and communication technologies service solutions are already operational at local level for the remote monitoring and the treatment of chronic patients suffering from diabetes,chronic obstructive pulmonary disease or cardiovascular diseases. the services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping health care professionals to detect early signs of worsening in the monitored pathologies. every area will designed its own real-life trial with certain common elements.

Eligibility criteria:
inclusion criteria: * age \> 18 years * capability of filling in questionnaires in finnish language. * be able to use remote patient monitoring system * be able to use the devices provided * has adequate cognitive capacities to participate * in their medical records, one or both of the following diagnoses: a) type 2 diabetes, for enrolment * diagnosed over 3 months prior to the enrolment and * hba1c \> 6,5 % b) heart disease, for enrolment * ischemic heart disease or * heart failure or * atrial fibrillation or * other arrhythmia * be able to walk exclusion criteria: * not willing to participate (e.g., not willing to sign the consent)
allergens in inner-city schools and childhood asthma

Conditions: Asthma

Summary: asthma is a disease that affects more than 12% of americans under the age of 18 for over 14 million missed school days per year, and is the number one cause of school absences in america. elementary school children spend 6 to 10 hours a day in school, and most of that time is spent in one classroom. the goals of this project are to provide an understanding of exposure risk factors specific to the classroom. this is critical, because the classroom environment could potentially be considered as an effective target for prevention of inner-city asthma morbidity by reducing exposures to many symptomatic children through an intervention in the school classrooms.


Eligibility criteria:
inclusion criteria: * grades k-8 the school year following spring recruitment (ages 4-15) * attend one of the schools in the fall where permission obtained for classroom sampling. * able to provide assent and parent/guardian able to provide informed consent physician-diagnosed asthma and wheezing in the previous 12 months exclusion criteria: * significant pulmonary diseases other than asthma that might influence test results or pose risks (e.g., cystic fibrosis, sarcoidosis, bronchiectasis) * cardiovascular disease that requires daily medication * taking a beta blocker * active smoker * unable to follow through with study visit or complete study procedures

Keywords: pediatric childhood allergy
effect of misoprostol in reducing post partum hemorrhage after labor induction by oxytocin

Conditions: Prevention of Post Partum Hemorrhage After Labor Induction

Summary: the use of oxytocin for labor induction may cause receptor exhaustion and thus making its use in the third stage of labor ineffective in reducing post partum blood loss as compared to other uterotonics.so, we studied the effect of other uterotonic which is misoprostol in reducing post partum hemorrhage.

our study will be carried out at makassed general hospital, a tertiary-level maternity unit performing about 1000 deliveries annually. after approval by the hospital ethics and research committee, women with single viable pregnancy, in cephalic presentation, at full term and whom labor was induced by oxytocin will be eligible for inclusion. after informed consents is obtained, the parturients will be assigned randomly according to a computer generated sequence in block lists of 25each time to receive either 1000mcg of misoprostol rectally or 20 units of oxytocin intravenously to run at a rate of 150ml/hr. the medications will be given just after cord clamping and before delivery of the placenta. active management of the third stage of labor will be carried out simultaneously with early cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine massage in addition to the uterotonic according to assignment of the patient. assessment of the uterine condition will be done by the obstetrician or his assistant, together with visually estimating the amount of blood loss. once uterine atony or estimated blood loss (ebl) of more than 500 ml is noticed, another uterotonics will be administered according to the condition and at the discretion of the obstetrician. failure to achieve adequate uterine contraction and to control post partum hemorrhage (pph) by the routine uterine massage will urge the use of either different uterotonics or surgical intervention if necessary. blood transfusion will be ordered for the cases whose visual estimation of blood loss is more than 1000ml or when the patient was hemodynamically unstable. in order to compare the effect of each medication alone on the amount of blood loss, we will then exclude those patients who received blood transfusion or additional uterotonics. a base line hemoglobin and hematocrit levels will be withdrawn on admission and another reading 12 hours postpartum.

Eligibility criteria:
inclusion criteria: * women with single viable pregnancy, * cephalic presentation, * at full term * whom labor was induced by oxytocin were eligible exclusion criteria: * delivery by cesarean section * received other prophylactic uterotonics
chidamide in patients with recurrent and refractory diffuse large b

Conditions: Diffuse Large B-cell Lymphoma

Summary: a multicenter, prospective, observational clinical protocol for chidamide in combination with rituximab and lenalidomide (cr2) in real-world practice in patients with relapsed/refractory diffuse large b-cell lymphoma

this is a prospective, multicenter, observational investigator-initiated clinical study. the subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large b-cell lymphoma who will begin cr2 therapy at the time of enrollment. patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. the first visit was considered an enrollment visit. the specific dosage of cr2 will be determined according to the standard clinical practice of the treating physician. participation in the study did not affect treatment decisions. patients who could not continue with the cr2 regimen would terminate the visit early and then withdraw from the study. according to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.

Eligibility criteria:
inclusion criteria: 1. the decision of treating physicians to make cr2 regimen was not related to whether they participated in the study or not; 2. age 18 and above, no gender limitation; 3. patients with pathologically confirmed diffuse large b-cell lymphoma (dlbcl) who have relapsed or failed to respond to at least one systemic therapy; 4. have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion \> 1cm; 5. the serum pregnancy test of female subjects of childbearing age was negative; 6. understand the test procedure and content, and sign the informed consent voluntarily. exclusion criteria: 1. the decision of treating physicians to make cr2 regimen was not related to whether they participated in the study or not; 2. age 18 and above, no gender limitation; 3. patients with pathologically confirmed diffuse large b-cell lymphoma (dlbcl) who have relapsed or failed to respond to at least one systemic therapy; 4. have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion \> 1cm; 5. the serum pregnancy test of female subjects of childbearing age was negative; 6. understand the test procedure and content, and sign the informed consent voluntarily.
covid-19 in liver transplant recipients

Conditions: Liver Transplant; Complications; COVID19; Respiratory Failure

Summary: prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of covid-19 in lt in spain.

coronavirus disease 2019 (covid-19) is a novel viral disease caused by the sars-cov-2 infection with a particular predominance of upper and lower respiratory tract symptoms. first diagnosed in china in late 2019, the virus has progressed to a state of pandemia, involving spain with a important outbreak. while the outcomes of viral infections in solid organ transplant (sot) recipients tend to be worse than those from the general population due to chronic immunosuppression, there is little information on the incidence and outcomes of covid-19 in liver transplant (lt) recipients. lt recipients are usually under less immunosuppression than other sot and the clinical expression and outcomes of covid-19 may be different to the reported outcomes in other sot. the spanish society of liver transplantation, which includes 25 lt programs, has promoted a nationwide registry for lt with covid-19 to help ascertain the incidence and outcomes and help evidence-based management .

Eligibility criteria:
inclusion criteria: * liver transplant recipient * confirmed (pcr positive) sars-cov-2 infection * informed consent
a treatment ind for 566c80 therapy of pneumocystis carinii pneumonia

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to facilitate provision of atovaquone (566c80) to patients who have mild to moderate pneumocystis carinii pneumonia (pcp) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (tmp / smx ); to monitor serious adverse events attributable to 566c80.


Eligibility criteria:
inclusion criteria patients must have the following: * clinical diagnosis of acute mild to moderate pneumocystis carinii pneumonia. * dose-limiting intolerance to tmp / smx or inadequate response to tmp / smx. * willingness and ability to give informed consent. the clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566c80. patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate \> 30 breaths/minute), rapid deterioration in (a-a)do2 and chest radiograph may not be appropriate candidates for oral therapy, including 566c80. therapy with parenteral pentamidine should be undertaken in these cases. treatment with iv trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. patients with severe pcp who are intolerant and/or unresponsive to therapy with tmp / smx and parenteral pentamidine may enroll in the 566c80 open-label compassionate plea protocol. exclusion criteria patients with the following prior conditions are excluded: history of serious or dose-limiting adverse experience during previous 566c80 therapy, thought to be attributable to the drug.

Keywords: trimethoprim-sulfamethoxazole combination pneumonia, pneumocystis carinii antifungal agents acquired immunodeficiency syndrome atovaquone
ecopipam tablets to study tourette's syndrome in children and adolescents

Conditions: Tourette Syndrome

Summary: this study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of tourette's syndrome (ts). half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets

multicenter, placebo-controlled, double-blind, randomized, parallel-group, phase 2b study in pediatric subjects (aged greater than equal to 6 to less than 18 years of age) with ts. following a 28-day screening period and baseline visit, eligible subjects will be randomized 1:1 to receive either ecopipam hydrochloride (hcl) or matching placebo for a 12 week treatment period. doses will be titrated up and down from target dose of 2 mg/kg/day. follow up visit will be conducted after the last dose of study medication.

Eligibility criteria:
inclusion criteria: * ≥ 6 and \< 18 years of age * ≥ 18 kg (\~ 40 lbs.) * ts diagnosis and both motor and vocal tics that cause impairment with normal routines * minimum score of 20 on the ygtss-total tic score * may not be taking any medications used to treat motor or vocal tics for at least 14 days prior to baseline. * effective contraception during the study and 30 days after last study dose for sexually active subjects exclusion criteria: * certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) * unstable medical illness or clinically significant lab abnormalities * risk of suicide * pregnant or lactating women * moderate to severe renal insufficiency * hepatic insufficiency * positive urine drug screen * unstable doses for drugs to treat anxiety, depression, attention deficit hyperactivity disorder * certain medications that would lead to drug interactions * recent behavioral therapy
comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor epidural analgesia

Conditions: Labor Analgesia

Summary: sixteen million babies were born in 2010, approximately half were by cesarean. labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. however this labor analgesia rate is quite low in china (\<5%) while in western country, this rate is up to 60%. programmed intermittent epidural bolus (pieb) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with continuous epidural infusion(cei) with patient controlled epidural analgesia (pcea) which is used most commonly. in that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the pieb technique. in china, multiple factors contribute to the reasons of low labor analgesia rate. from the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in chineseparturients. this clinical trial is designed to prove pieb used ropivacaine is safer and more effective than cei for labor analgesia in chinese parturients.


Eligibility criteria:
inclusion criteria: * subjects who agree to join this study * age: 22y-40y * american society of anesthesiologists (asa) physical status 1 or 2 * gestation : 37-41 weeks * primipara * singleton fetus and head presentation * in early labor: cervical dilation for 1-3cm * requesting labor epidural analgesia exclusion criteria: * contraindication for epidural analgesia * height less than 150 cm or more than 170 cm * morbid obesity (bmi more than 35) * high-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia) * received parenteral opioids * unable to perform motor block evaluation tests
safety and tolerability study of rn6g in subjects with advanced dry, age-related macular degeneration including geographic atrophy

Conditions: Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration

Summary: the purpose of this study is to determine the safety and tolerability of multiple doses of rn6g in subjects with advanced dry, age-related macular degeneration including geographic atrophy.


Eligibility criteria:
inclusion criteria: * be of non-child bearing potential * diagnosis of dry amd including uni- or multi-focal geographic atrophy without foveal involvement * bcva of 20/50 or better in the study eye exclusion criteria: * evidence of ocular disease other than advanced amd or ga in the study eye * history or diagnosis of exudative (wet) amd, with subretinal or choroidal neovascular lesions in the study eye * presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or gastrointestinal system * requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve

Keywords: phase 1b advanced dry age-related macular degeneration rn6g
sofosbuvir/velpatasvir fixed-dose combination and ribavirin for 12 or 24 weeks in participants with chronic genotype 1 or 2 hepatitis c virus infection who have previously failed a direct-acting antiviral-containing regimen

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) and ribavirin (rbv) in participants with chronic genotype 1 or 2 hepatitis c virus (hcv) infection who have previously failed a direct-acting antiviral (daa)-containing regimen.


Eligibility criteria:
key inclusion criteria: * genotype 1 or 2 hcv infection * chronic hcv infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy * previously treated with a daa-containing regimen of at least 4 week duration note: other protocol defined inclusion/exclusion criteria may apply.