Kornimate/medical-research-clean huggingface dataset:
covid-19 vaccine effectiveness in albanian health workers

Conditions: Covid19

Summary: the purpose of this study is to evaluate the effectiveness of the covid-19 vaccine in hospital based hws in albania. this will answer critical questions about the real-world performance of covid-19 vaccines in one of the key target groups for vaccination.

this protocol describes a prospective one-year cohort study of hospital-based health workers in albania to evaluate the effectiveness of covid-19 vaccine in preventing laboratory-confirmed sars-cov-2 infection and covid -19 disease. the investigators will measure the effectiveness of covid-19 vaccines against laboratory-confirmed sars-cov-2 infection in both symptomatic and asymptomatic hospital health workers. sars-cov-2 infection will be diagnosed using symptom questionnaires and pcr testing. additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.

Eligibility criteria:
inclusion criteria: * all health workers eligible to receive the covid-19 vaccination according to the national guidelines of institute of public health. * health workers working at tirana university hospital "mother theresa", university hospital "shefqet ndroqi", durres regional hospital and fier regional hospital. * health workers who have already been vaccinated against covid-19 as part of the early covid-19 vaccine rollout can be included, as long as information can be collected about the date and type of the vaccine that was administered. however, priority will be given to enrolling health workers who have received their covid vaccine no more than 4 days prior to the day of enrolment in the study. exclusion criteria: * health workers who are not eligible for covid-19 vaccination or have a contraindication to vaccination should not participate in the study. * health workers who do not work at tirana university hospital "mother theresa", university hospital "shefqet ndroqi", durres regional hospital and fier regional hospital.

Keywords: vaccine effectiveness health care worker albania
efficacy and safety of synchronized cardiac support in cardiogenic shock patients

Conditions: Cardiogenic Shock; Extracorporeal Membrane Oxygenation; ECLS; VA ECMO

Summary: the study aims to investigate the safety and efficacy of the synchronized cardiac support treatment wit the icor kit and the xenios console with modified sensor box ecg and software version 3.2.4

the current study hypothesizes that the scs treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on scs treatment versus before treatment start. patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (va ecmo) for cardiocirculatory stabilization will be treated with synchronized cardiac support. synchronized cardiac support describes an electrocardiogram (ecg)- triggered pulsatile va-ecmo based on r-wave detection. during diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. this provides a mechanical circulatory support pulse with oxygenated blood during diastole. the synchronized cardiac support treatment is used in a standard va ecmo configuration by two femoral single vessel cannulas. patients following cardiac resuscitation will undergo targeted temperature management 32- 36°c according to guideline. the duration of treatment can be up to 14 days.

Eligibility criteria:
inclusion criteria: 1. informed consent signed and dated by study patient/legal representative and investigator/authorised physician 2. minimum age of 18 years 3. patients in cardiogenic shock 4. cardiogenic shock is defined as: 1. systolic blood pressure \< 90 mmhg for at least 30 min 2. inotropes and/or vasopressors are needed to maintain systolic blood pressure \> 90 mmhg 3. clinical signs of heart insufficiency with pulmonary congestion 5. signs of end organ hypoperfusion with at least one of the following criteria: 1. cold, damp skin or extremities 2. oliguria (≤ 30 ml/h) 6. serum lactate \> 3.0 mmol/l exclusion criteria: 1. in case of female patients: pregnancy or lactation period 2. participation in an interventional clinical study during the preceding 30 days 3. previous participation in the same study 4. age \> 85 years 5. cardiac arrest out of hospital with return of spontaneous circulation (rosc) \> 30 min 6. no flow time \> 5 min 7. mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture) 8. non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.) 9. fever (body temperature \> 38.0 °c) or other evidence of sepsis 10. onset of cardiogenic shock \> 6 h before enrolment 11. lactate \> 16 mmol/l 12. severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters 13. contra-indications for anticoagulation 14. contra-indication for va ecmo, e.g. unrecoverable heart and not a candidate for transplant or vad

Keywords: cardiogenic shock extracorporeal membrane oxygenation synchronized cardiac support ecls va ecmo
single-dose study to assess pharmacokinetics of solifenacin succinate suspension in children and adolescents

Conditions: Urinary Bladder, Overactive

Summary: this single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.

this is a multicenter, open-label, sequential, single ascending dose study. the study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. the study will be conducted in pediatric oab patients to establish the single-dose pk and the acute safety profile of solifenacin aqueous suspension. each of the six groups will consist of at least six patients. the study will start with the lowest dose group in adolescent patients (12 to 17 years). when this group has completed the study, their safety and concentration data will be reviewed by a safety review committee. if no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. when these groups have completed the study, their safety data and drug concentration data will also be reviewed. if no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.

Eligibility criteria:
inclusion criteria: * symptoms of urgency, diagnosed as oab according to international children's continence society (iccs) criteria * daytime urgency incontinence at least once/day exclusion criteria: * daytime voiding frequency less than 5 * uroflow indicative of pathology other than oab * maximum voided volume \> age expected capacity (\[age +1\] x 30) in ml * post voiding residual (pvr) \> 10% of the functional bladder capacity * monosymptomatic enuresis * congenital anomalies of the genito-urinary tract or nervous system * current constipation (when treated the patient can enter the study) * current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative) * serum creatinine more than or equal to 2 times the upper limit of normal (uln) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) more than or equal to 2 times uln, or bilirubin more than or equal to 1.5 times uln

Keywords: overactive bladder solifenacin suspension pharmacokinetics single-dose pediatric
dasatinib in combination with revlimid (and dexamethasone)

Conditions: Multiple Myeloma

Summary: the purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * men and women age ≥ 18 years * confirmed diagnosis of multiple myeloma (mm) with measurable disease assessed within 1 month prior to treatment initiation * evidence of relapsed or refractory disease and at least one prior therapy for mm * eastern cooperative oncology group scale (ecog) performance status of 0 - 2 * last mm treatment at least 21 days prior to treatment initiation• bone marrow transplant (bmt) at least 3 months prior to treatment initiation * required baseline hematology and chemistry parameters * resolution of acute toxicity due to prior therapy to grade \<2 per national cancer institute (nci) common terminology criteria for adverse events (ctcae) version 3.0 exclusion criteria: * women who are pregnant or breastfeeding * men whose sexual partners are women of child bearing potential (wocbp) or wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least one month (4 weeks) after the last dose of study medication. * clinically significant cardiac disease (new york heart association \[nyha\] class iii or iv) * abnormal corrected qt interval using fridericia's formula (qtcf) interval prolonged (\> 450 msec) * medications that are generally considered to have a risk of causing "torsades de pointes" * malabsorption syndrome or uncontrolled gastrointestinal toxicities * clinically significant pleural effusion in the previous 12 months or current ascites * clinically-significant coagulation or platelet function disorder * dementia, chronic medical or psychiatric condition, or laboratory abnormality * other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, serious uncontrolled medical disorder or active infection * intolerance to dasatinib and/or lenalidomide * subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis related to prior thalidomide treatment
effect of esophageal contractile reserve on changes in esophageal motility and symptoms after ars in patients with gerd

Conditions: Esophageal Motility Disorders

Summary: rapid swallow (mrs) can assess the contractile reserve capacity of the oesophageal body and identify and diagnose oesophageal motility disorders, but the impact of preoperative oesophageal reserve capacity on postoperative symptoms and motility in patients with gerd remains unclear. the aim of this study was to assess the effect of pre-operative oesophageal reserve capacity on post-reflux symptoms and motility in patients with gerd by using a high-resolution oesophageal manometry-based provocation test, mrs, to track pre-operative ineffective oesophageal motility (iem).

lower oesophageal sphincter relaxation is an important cause of gerd and ineffective oesophageal motility may be associated with gerd, but the mechanism of oesophageal corporal motility disorders is unclear. high-resolution manometry (hrm) has shown to be more accurate than conventional manometry in assessing oesophageal motility, and can provide guidance for gerd surgery. the aim was to conduct a cohort study to investigate the yu'h of patients with preoperative esophageal motility disorders with or without esophageal reserve, based on the assessment of esophageal motility by high-resolution esophageal manometry to follow up changes in esophageal motility and symptoms in patients after anti-reflux surgery.

Eligibility criteria:
inclusion criteria: * age over 18 years old * patients to be treated surgically for gastroesophageal reflux disease * ineffective esophageal motility diagnosed by high resolution esophageal manometry according to chicago classification version 4.0 * obtaining informed consent exclusion criteria: * previous other upper gastrointestinal surgery * pregnant women and other people with contraindications to surgery and tests * other specifically defined esophageal motility disorders, such as nutcracker esophagus

Keywords: contraction reserve
sleep disordered breathing, endothelial function, and adverse events in pregnancy

Conditions: Pregnancy Related; Sleep-Disordered Breathing

Summary: this is a prospective longitudinal cohort study whereby pregnant individuals are asked to complete an 8-day testing protocol to measure their sleep and cardiovascular health at two timepoints during pregnancy.

the goal of this observational study is to examine the effect of sleep disordered breathing on the health of the heart and blood vessels of the mother during pregnancy. the main questions it aims to answer are: * is sleep disordered breathing associated with impaired the function of the heart and blood vessels in pregnancy? * is higher levels of physical activity associated with a reduced risk of sleep disordered breathing in pregnancy? participants will complete an 8 day long study protocol at two time points during pregnancy (20-24 weeks gestation and 28-36 weeks gestation). during each testing period they will be asked to: * complete one night of at-home sleep testing and and one night of overnight vital signs monitoring (ambulatory blood pressure and heart rate monitoring devices) * wear two accelerometers and complete a 7-day sleep log * complete a set of questionnaires * visit the laboratory for a fasted blood draw and ultrasound assessment of their cardiovascular health (resting heart rate and blood pressure, flow mediated dilation and pulse wave velocity tests) participants will also be asked to complete a short follow-up survey in the postpartum period.

Eligibility criteria:
inclusion criteria: * over 18 years of age * pregnant (20-24 weeks gestation at enrollment) exclusion criteria: * worked shift work past 11pm in the previous month * previously diagnosed with a sleep disorder by a physician

Keywords: cardiovascular health
liposomal amphotericin in disseminated leishmaniasis

Conditions: Disseminated Leishmaniasis

Summary: disseminated leishmaniasis (dl) is an emerging and severe form of leishmaniasis, with increasing prevalence in bahia, brasil. it is characterized by multiple acneiform, papular and ulcerated lesions localized on the face, chest, abdomen and extremities. the number of lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40% of the cases. dl is a hard to cure disease and therapeutic failure with pentavalent antimony has been documented in up to 70% of the cases caused by l. braziliensis in the endemic area of corte de pedra, bahia. the majority of dl patients need several courses of antimony or the use of high dose of amphotericin b desoxicolate to cure. therefore dl patients are exposed to relevant drug toxicity, high morbidity due to a long lasting disease, with an important socio-economic impact. our hypothesis is that liposomal amphotericin b has a higher cure rate than historic cure rates of pentavalent antimony in the treatment of disseminated leishmaniasis.


Eligibility criteria:
inclusion criteria: * a) clinical diagnosis of disseminated leishmaniasis according to case definition; b) illness duration of less than three months, c) parasite identification by culture or polymerase chain reaction methods, d) no previous treatment for leishmaniasis. exclusion criteria: * a) immunodeficiency or antibodies to hiv, b) pregnancy or patients not willing or unable to use contraceptives during and 3 months after the end of therapy c) alt, ast ≥3x normal reference values, creatinine and bun ≥1.5x normal reference values, d) any evidence of serious underlying disease (cardiac, renal, hepatic, or pulmonary) including serious infection other than dl.

Keywords: disseminated leishmaniasis liposomal amphotericin b leishmania braziliensis
the exploratory study of electroacupuncture in the treatment of peripheral neuropathy induced by platinum based chemotherapy drugs

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.


Eligibility criteria:
inclusion criteria: 1. the histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before. 2. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill world health organization (who) grade 2 or more. 3. zubrod - eastern cooperative oncology group-who (zps) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months. 4. gender unrestricted, aged between 18 to 80 years old. 5. voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up. exclusion criteria: 1. patients who suffer from peripheral neuropathy due to infection, radiotherapy, hiv, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases. 2. patients who are being treated with other drugs that may lead to neurotoxicity . 3. patients with blood coagulation disorder. 4. pregnancy and lactating women. 5. patients with infection, scarring or defects near the acupoint sites. 6. received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional chinese medicine (acupuncture, moxibustion, cupping, chinese medicine therapy one month before.
the efficacy and safety of total myeloid irradiation (tmi) in the treatment of adult acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: observation of event-free survival, engraftment rate, overall survival (os), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (all) receiving a conditioning regimen including total marrow irradiation (tmi) followed by allogeneic hematopoietic stem cell transplantation. aim to further enhance transplant outcomes in all patients based on the existing basis.

observation of event-free survival, engraftment rate, overall survival (os), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (all) receiving a conditioning regimen including total marrow irradiation (tmi) followed by allogeneic hematopoietic stem cell transplantation. aim to further enhance transplant outcomes in all patients based on the existing basis.exploratory endpoint: event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (efs).secondary exploratory endpoints: (1) rate of granulocyte and platelet hematopoietic recovery. (2) incidence of toxicity related to the conditioning regimen.

Eligibility criteria:
inclusion criteria: * subjects eligible for inclusion in this study must meet all of the following criteria: (1) definitive diagnosis of acute lymphoblastic leukemia requiring allogeneic hematopoietic stem cell transplantation. (2) age greater than or equal to 16 years. exclusion criteria: * subjects meeting any of the following criteria are not eligible for inclusion in this study: (1) patients with extramedullary infiltration (excluding central nervous system leukemia). (2) patients undergoing second transplantation. (3) patients with concurrent malignancies. (4) patients with malignancies secondary to a second tumor. (5) patients assessed by the investigator to have accompanying diseases that are deemed to pose a serious risk to the patient\&#39;s life or interfere with the patient\&#39;s completion of this study.
pharmaceutically-enhanced reinforcement for reduced alcohol and smoking

Conditions: Alcohol Use Disorder (AUD); Nicotine Use Disorder

Summary: using a randomized controlled trial (rct), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: cm) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (aud) who have initiated pharmacotherapy (varenicline; vc) for smoking cessation.

this randomized, placebo-controlled trial to determine the effectiveness of contingency management for reducing alcohol use and cigarette smoking among adults who want to quit or reduce their co-addiction. contingency management is a powerful and cost-effective technique that has been used successfully for decades to promote abstinence from benzodiazepines, cocaine, tobacco, etc. contingency management, and a non-contingent control condition will be used combined with varenicline (vc) and manualized counseling in the form of module videos.

Eligibility criteria:
inclusion criteria: 1. 4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days 2. seeking aud treatment 3. seeking smoking cessation treatment 4. aged 18+ years 5. dsm-5 diagnosis of aud 6. currently smoking daily according to phenx smoking status (100 or more lifetime cigarettes plus current daily smoking) 7. ability to read and speak english 8. ability to provide written informed consent 9. breath alcohol of 0.00 during informed consent 10. provision of at least 1 etg-positive urine test at any time during the induction period and at least one cot-positive urine test at any time during the induction period; and 11. attended at least 4 of 6 possible visits during the induction period. exclusion criteria: 1. significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal 2. currently receiving any pharmacotherapy for alcohol 3. currently receiving any pharmacotherapy for smoking 4. no suicide attempt in the last 20 years and 5. any other medical (discernable by initial blood tests) or psychiatric condition that drs. layton or rodin determine would compromise safe participation.

Keywords: alcohol use disorder contingency management incentives for sobriety varenicline nicotine use disorder
puerarin versus atorvastatin in treating metabolism syndrome in patients with chronic rheumatic diseases

Conditions: Rheumatoid Arthritis

Summary: to evaluate the effect of puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases


Eligibility criteria:
inclusion criteria: * patients with a definite diagnose with rheumatic disease * patients with metabolic syndrome * without conflict to the written, informed consent signed prior to the enrollment * no severe hepatic or renal disorders * no known carotid artery stenosis * no coagulation disorders * no hypertension exclusion criteria: * being in pregnancy, lactation period or under a pregnancy plan * being allergic to the test drug * not compatible for the trial medication * without full legal capacity

Keywords: puerarin tablet rheumatoid arthritis metabolism syndrome
a study of ly3375880 in adults with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the reason for this study is to see if the study drug ly3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * participants must have diagnosis of ad \>= 12 months according to the american academy of dermatology criteria. * participants must have moderate to severe ad at screening and randomization. * participants must have inadequate response to topical medications within 6 months of screening (or history of intolerance). exclusion criteria: * participants must not have concurrent treatment with topical or systemic treatments for ad.

Keywords: eczema atopic eczema