cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Antibodies Against SARS-CoV-2 Virus That Causes COVID-19 in Tübingen Children

This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.

The world is confronting Coronavirus Disease-2019 (COVID-19) pandemic caused by SARS-CoV-2 virus, which is causing many deaths and burden on intensive care facilities. Data regarding epidemiologic characteristics in children and young adults is limited, especially in the context of educational settings. Due to mild symptoms or even asymptomatic cases in children, the rate of SARS-CoV-2 infected children is underestimated. Therefore, the present study aims to determine the incidence of SARS-CoV-2 infection in children at 3 timepoints during 12 months expressed as seroconversion measured in non-invasive saliva sampling in Tübingen, a defined study area. Children and adolescents (N = 1850) in the age of 1 to 17 years will be recruited via child-care, kindergarten and primary and secondary schools and followed-up for 12 months: shortly after release of lock-down measures in summer 2020, before winter and after the winter. An adult cohort (adult comparator group) is sampled at the same time points for incidence comparisons. To validate the ELISA for SARS-CoV-2 antibody measurements in saliva compared to blood, and to understand the half-life of SARS-CoV-2 antibodies in respective body fluids, peripheral blood and in saliva will be sampled every 2 months in an additional adult group (adult validation group).

Eligibility Criteria:
Inclusion Criteria:

* Children from 1 months to 18 years
* Written informed consent of the parent/legal guardian (study population is minor)
* Written assent when children are ≥ 12 years
* Enrolled in a kita, kindergarden, primary, or secondary school located in Tübingen

Adult population:

* Individuals \>18 years who recovered from a confirmed SARS-CoV-2 infection.
* Or individuals \> 18 years with an unknown status of previous SARS-CoV-2 infection

Exclusion Criteria:

* Unwilling to give consent
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621

To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.

This is a 2-stage, randomized, double-blind, dose-ranging, multi-center phase 2 study designed to evaluate the efficacy, safety, and PK of UB-621 given at 2.5 or 5 mg/kg in adult subjects with recurrent genital HSV-2 infection. The study consists of 2 stages of enrollments, in which 40 subjects will be enrolled in the first stage and randomly assigned to receive placebo or UB-621 at 2.5 mg/kg in a 1:3 ratio into Cohort 1 at Bv6 (Day B57), and another 40 subjects will be enrolled in the second stage and randomly assigned to receive placebo or UB-621 at 5 mg/kg in a 1:3 ratio into Cohort 2 at Bv6 (Day B57) after review by the Data Safety Monitoring Committee (DSMC). The DSMC will review safety data after all subjects of Cohort 1 complete the visit Fv6 (Day F28) and make the recommendation whether to proceed with enrollment for Cohort 2.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age inclusive.
* Subject must be HSV-2 seropositive
* Subjects have a history of recurrent genital herpes in the past year
* Subjects have a negative result on the HIV Ab/Ag assay
* Subjects must agree to use contraception during study participation
* Subjects must be willing NOT to use any topical genital therapy and systemic anti-HSV therapy from the beginning of the study till the end of week 16.
* Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks prior to and upon the administration of study drug.
* Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.

Exclusion Criteria:

* Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-621.
* Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
* History or current evidence of malignancy except for a localized non-melanoma skin cancer
* Known immunosuppression
* Exposure to HSV vaccine
* Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
* Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study
* Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.
* Renal impairment and/or hepatic impairment
* ECG abnormalities of clinical relevance or cardiovascular conditions
Effectiveness of a Workplace "Sit Less and Move More" Web-based Program in Spanish Office Employees (Walk@WorkSpain)

This study assesses the short and mid-term impacts of a workplace web-based intervention (Walk@WorkSpain, W@WS) on self-reported occupational sitting time, step counts, activity-related energy expenditure, physical risk factors for chronic disease and efficiency-related outcomes in Spanish office employees. Half of participants had access to the W@WS website program while the other half was asked to maintain habitual behaviour.

Rising numbers of people have to sit for long hours every day especially for work and transport (3401184). This sedentary pattern that has been detrimentally associated with obesity and cardiovascular disease markers (4604082). However, replacing as little as 10 minutes of sedentary time with the same amount of light or moderate physical activity is associated with substantial health benefits (i.e. reduction of the metabolic syndrome) (26635358).

Because eighty percent of adults in developed countries spend one third of their working day doing sedentary, desk-based tasks (24603203) -representing a high exposure to this established health risk- displacing occupational sitting with physical activity may be a feasible option for improving office employees´ health and therefore public health (26984326).

In this context, there is a need to develop and evaluate translational research, based on theoretically-derived strategies, that can be successfully embedded into workplaces (26984326).

Eligibility Criteria:
Inclusion Criteria:

* Office employees (university administrative and academic staff) with low and moderate physical activity levels (0 to 3,000 MET·min·wk-1 according to the International Physical Activity Questionnaire)

Exclusion Criteria:

* Highly active office employees (\>3,000 MET·min·wk-1 according to the International Physical Activity Questionnaire)
Transitional Care Program in Stroke Patients With Hemiplegia.

This study examines the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission.

The research conceptual framework is based on the Transitional Care Model by Naylor. Sixty participants with stroke patients at Charoenkrung Pracharak Hospital will be recruited. These participants are stratified by block randomization using NIHSS score and divided into 2 groups; a control group (n=30) and an intervention group (n=30).

The program consisted of 2 phases: 1) Phase I during hospital admission and 2) Phase II following hospital discharge

This study is to examine the effects of a transitional care program in stroke patients on self-care behavior, quality of life, and hospital readmission.

The research conceptual framework base on Transitional Care Model by Naylor. Sixty participants with stroke patients at Charoenkrung Pracharak Hospital will be recruited. These participants are stratified block randomization using NIHSS score and divide into 2 groups; control group (n=30) and intervention groups (n=30).

The program consisted of 2 phases: 1) Phases I during hospital admission and 2) Phases II following hospital discharge for 4 weeks. The instruments used in this study for collecting the data are 1) The Personal Data Form, 2) The Self-care Behavior Questionare and 3) The Stroke Impact Scale (SIS) 3.0. Data will be analyzed using descriptive statistics and two-way repeated measures ANOVA.

The result of this study will be used to develop guideline for nursing care in stroke patients during the transition from hospital to home. This program will help the patients improve their self-care, quality of life, and reduce hospital readmission

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 years old.
* The first diagnosis is acute ischemic stroke.
* Hemiplegia
* NIHSS 5-14 point (moderate impairment)
* Telephone and Line Application used.
* Can read and communicate in Thai language
* Accept participants to research and inform consent.

Exclusion Criteria:

* Aphasia
* The Six Item Cognitive Impairment Test: 6CIT from 8 points in age from 60 years old.
* Participants with illness severity or dead during the study.
* Reject the study
Oral vs Intravesical Analgesia for Office Bladder Botox Injections

OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.

The primary aim of this randomized clinical trial is to compare the analgesic effect of oral phenazopyridine to that of intravesical lidocaine during intradetrusor injections of onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will achieve this by measuring the mean visual-analog pain scores (VAS) in women who are randomized to receive either oral phenazopyridine or intravesical lidocaine.

Secondary aims include assessment of:

1. Overall Patient Satisfaction: To compare overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
2. Ease of Procedure: To compare the physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.
3. Office Efficiency/Total Appointment Duration: To compare total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, adult females 18 years of age or older
* Diagnosis of idiopathic overactive bladder
* Planning office-based bladder injection of onabotulinumtoxinA
* Willing and able to complete all study related items and interviews
* Grossly neurologically normal on exam

Exclusion Criteria:

* Known neurologic diseases (multiple sclerosis, Parkinson Disease, CVA within 6 months, myasthenia gravis, Charcot-Marie-Tooth disease, peripheral neuropathy, and complete spinal cord injury) believed to affect urinary function
* Planned injection of \>100 units of onabotulinumtoxinA
* OnabotulinumtoxinA given for another indication within the previous 3 months (if cumulative dose would total \>400 units)
* Any intradetrusor onabotulinumtoxinA injections in the previous 12 months
* Serum creatinine level greater than twice the upper limit of normal within the year prior to enrollment
* Allergy to lidocaine
* Allergy to onabotulinumtoxinA
* Allergy to phenazopyridine
* Untreated urinary tract infection (UTI)
* Currently pregnant or lactating.
* Known urinary retention (post-void residual \>200mL) and inability to perform intermittent self-catheterization
* Uninvestigated hematuria (gross or microscopic)
* Current or prior bladder malignancy
* Previous bladder augmentation or surgically altered detrusor muscle
* Prior pelvic radiation
* Primary language other than English or Spanish
Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose

Intranasal insulin is reported to improves memory performance in patients suffering from cognitive impairment. The investigators have previously shown that intraoperative insulin administration preserves both short and long-term memory function after cardiac surgery. Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin concentrations in the cerebrospinal fluid without major effects on peripheral insulin level. Patients undergoing major surgery are exposed to carbohydrate and insulin metabolism alteration. The goal of the study is to study the effect of intranasal insulin on blood glucose, plasma and cerebrospinal insulin concentration in patients undergoing cardiac surgery or endovascular thoracic aneurysm repair.

Clinical trials have demonstrated that intranasal insulin improves both memory performance and metabolic integrity of the brain in patients suffering from Alzheimer's disease or cognitive impairment. A single dose of intranasal insulin acutely improved memory in memory-impaired older adults. Cognitive impairment in post-operative period is an increasing problem as more elderly patients undergo major surgery. The investigators have previously shown that intraoperative insulin administration while maintaining normoglycaemia preserves both short and long-term memory function after open heart surgery.

Applying insulin as a nasal spray bypasses blood-brain barrier and cause significant and sustained elevation of insulin concentrations in the cerebrospinal fluid (CSF) without major effects on peripheral insulin levels. The administration of 40 IU of intranasal insulin(INI) rapidly increases CSF insulin concentration within seven minutes, peaking after 30 minutes and remaining elevated for more than 80 minutes.

Presently it is not clear if CNS insulin plays a relevant role in controlling blood glucose in humans.

Patients undergoing major surgery are exposed to metabolic and endocrine alterations in carbohydrate, protein, and insulin metabolism, often summarized as the catabolic stress response. While the effect of intravenous insulin on glucose metabolism during surgery has been extensively studied the influence of intranasal insulin administration on intraoperative plasma insulin and blood glucose concentrations is unknown.

Goal and Objectives The goal of the present study is to study the effect of intranasal insulin on

* blood glucose and plasma insulin concentrations in patients undergoing elective cardiac surgery
* blood glucose, plasma insulin and cerebrospinal insulin concentration in patients undergoing elective endovascular thoracic aneurysm repair.

Eligibility Criteria:
Inclusion Criteria:

All patients (\>18 years) undergoing elective open heart surgery requiring CPB or elective endovascular thoracic aortic aneurysm repair at the RVH.

Exclusion Criteria:

1. Planned use of drugs that effect plasma glucose concentration during the first four hours of surgery.
2. Patients with allergy to insulin
3. Patients with a base line blood glucose less than 3.9 mmol/L
Effects of Platelet-Rich Plasma and Ozone Therapy in Knee Osteoarthritis

Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.

Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.

Eligibility Criteria:
Inclusion Criteria:

* 30-70 years old, Stage 2-3 gonarthrosis according to KL
* Voluntariness to participate in the study

Exclusion Criteria:

* Cognitive dysfunction
* General medical condition is not suitable for injections and evaluations
* History of knee injections in the last 3 months
* History of previous knee surgery
* Bleeding disorders or those taking medications that may cause bleeding disorders after injections
High Dose Vitamin C in the Critically Ill Patient

The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

It has been shown that the stress that occurs during trauma, infection and/or shock depletes many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to further complications. The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Activation of the Mass Transfusion Protocol following surgery or trauma.
* Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension (i.e. systolic blood pressure \<90mmHg or drop of systolic blood pressure \>40mmHg in the presence of infection) that does not respond to a 2 liter fluid bolus.

Exclusion Criteria:

* Age less than 18 years.
* Pregnant women.
* Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney or end stage renal disease, rise in creatinine \> 1 g/dl within 24 hours prior to enrollment.
* Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive care unit
* Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate dehydrogenase deficiency, Sickle Cell Disease and Thalassemia.
* Patients in isolated cardiogenic shock.
* History of liver cirrhosis
* Transplant patients (liver, kidney, heart)
Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes

The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals without known cardiovascular diseases

Exclusion Criteria:

* drugs that interfere with cholesterol metabolism
* other use of dietary supplements
* vegetarianism
Effect of Dexamethasone on Postoperative Inflammatory Factors

This topic foe randomized prospective study.Detection of elderly patients with lunmbar spinal postoperative inflammatory substances in the blood and drainage of liquid level ,clear whether low-dose dexamethasone can inhibit the inflammation, the observation of elderly patients with lumbar spinal postoperative drainage star, to explor whether low-dose dexamthasone can reduce postoperative incision drainage, thus impove the postoprative drainage tube pull rate within three days, which in turn reduce because of the place a retrograde infection caused by drainage tube.

A total of 100 patients undergoing posterior lumbar disc fusion were randomly divided into control group (group C,n=50) and dexamethasone group (group D,n=50). Group D was given 0.15mg/kg dexamethasone (2ml) intravenously after anesthesia induction. Group C was also intravenously injected with 2ml normal saline after anesthesia induction.On this basis, monitor the main results and secondary results

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥65years of age
* American Society of Anesthesiologists (ASA) physical status 2-4
* Elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia
* Requiring a hospital stay of at least one postoperative night
* A surgical skin incision \>5 cm in length or multiple incisions with a total incision length of \>5 cm

Exclusion Criteria:·

* Poorly controlled diabetes (HbA1c\>9.0%)
* Endovascular procedure with a small (\<5 cm length) skin incision Ophthalmic surgery
* Planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)
* Recent (\<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics
* Chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)
Guaraná for Radiation Related Fatigue in Breast Cancer Patients

We hypothesize that Guaraná, a native plant from the Amazon, might improve radiation-induced fatigue in breast cancer patients undergoing treatment. In order to assess this, we randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the radiation.

The aim of this study is evaluate the favourable effects of Guaraná in memory and cognition in humans After approval by our Institutional Review Board, we included consenting patients with a histological diagnosis of early stage Breast Cancer for whom adjuvant radiation therapy was indicated. We excluded patients with a previous history of Radiation Therapy, anemia or clinical depression. We also excluded patients who were unable to grant informed consent or those who had medical contraindindications for the use of Guaraná (because of its psycho stimulant effect) such as uncontrolled hypertension, previous history of cardiac arrhythmia and insomnia.

The radiation therapy for patients who underwent mastectomy consisted of 28 fractions of 180cGy.

This study had a double-blind randomized design with crossover between experimental arms. After getting informed consent, we randomized patients at the beginning of radiation treatments (Phase I) to either 75 mg of Guaraná extract daily (Group A) or to Placebo (Group B). Randomization was centralized by the pharmacist. Halfway through the radiation treatments (Phase II), we switched patients from placebo to guaraná and vice versa. The protocol ended at the last session of radiation treatments (Phase III). In each of these three phases a new assessment of fatigue and depressive symptoms was undertaken, ie: immediately before the first radiation treatment (phase I); at switching (phase II) and right before the start of the last radiation treatment (phase III). At these three assessment points, patients had to complete the Chalder Fatigue Scale,4 the MD Anderson Brief Fatigue Inventory (available at http://www.mdanderson.org/topics/fatigue/) available in Portuguese, and the Beck Inventory Depression Scale II also validated in Portuguese.

We conducted the statistical analysis of the data with the Numerical Control Software Solution (www.ncss.com). We employed the repeated measures analysis of variance (ANOVA) test to compare tests scores within the same patient group and the ANOVA test to compare test's scores between the two groups (at similar phases of the study).

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of early stage Breast Cancer
* 18 years old or older

Exclusion Criteria:

* prior breast radiation
* anemia
* clinical depression
* unable to sign informed consent