cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases

The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. One of the ways to prevent such complications is vaccination. In 2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major concerns for public health. Patients under immunosuppressive therapy have indication for immunization against influenza virus H1N1. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome, 100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by the Local Ethical Committee. All subjects were vaccinated against influenza virus A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination., Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity as well as treatment. Continuous variables will be compared by t-test to evaluate differences between patients with rheumatic diseases versus healthy controls. Differences between categorical variables will be evaluated using the chi-square or Fisher exact test. Statistical significance was set at p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatic diseases according to international criteria of each disorder

Exclusion Criteria:

* Previous and confirmed infection by virus A(H1N1)/2009
* History of anaphylatic reaction to egg components
* Acute fever
* Guillain-Barré syndrome, heart failure (classes III or IV), demyelinating disease
Evaluation of Spa Medicine on the Example of Comprehensive Therapy in the Spa Resort Przerzeczyn Zdroj

Observation conducted during the 21 days of treatment in the health resort of Przerzeczyn Zdroj. In a treatment of applied therapy: redon-sulfide baths, partial mud baths, kinesitherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field, ultrasonotherapy, cryotherapy, electrotherapy, light therapy. Study group with joint or back pain due to osteoarthritis or degenerative disc disease. The control group was selected by the spa workers, healthy individuals, nonsmokers, who did not drink alcohol. It was recommended to retain the previous lifestyle and use of resort's facilities was prohibited. In both of these groups, appropriate pre- and post-treatment studies were performed.

The observation was conducted during 21 days of medicinal stays in the health resort of Przerzeczyn Zdroj. The treatment included a comprehensive therapy: redon-sulfide baths, partial mud baths, kinesitherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field, ultrasonotherapy, cryotherapy, electrotherapy, light therapy.

The study group consisted of patients with joint or back pain due to osteoarthritis or degenerative disc disease.participating in therapy. On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, the concentration of endorphins and serotonin, bilirubin, uric acid, albumin) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity VAS scale and anxiety and depression levels - HADS scale.

The control group was selected by the spa workers. On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, the concentration of endorphins and serotonin) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity: VAS scale and anxiety and depression levels - HADS scale.

Eligibility Criteria:
Inclusion Criteria:

* the presence of degenerative disc disease and/or osteoarthritis ;
* age range 30-69 years;
* the written consent to participate in research;
* no impediment to comprehensive treatment at the spa.

Exclusion Criteria:

* the lack of consent to participate in research;
* the age under 30 and over 70 years;
* the presence of diseases constituting a contraindication to therapy (compatible with the standard list of indications and contraindications to spa therapy);
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects between the ages of 18-40 years.
* The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
* Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
* Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.

Exclusion Criteria:

* Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
* Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
* Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) \>10.
Evaluation of a Project to Distribute Water Filters and Cookstoves in Western Rwanda

DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 700,000 households in Rwanda. Prior to the full roll out of the campaign, the implementers are conducting a pilot project among 2000 households in western Rwanda. The objectives of this pilot evaluation are to document the delivery of the intervention to the intervention population, assess coverage and uptake of the intervention target households and conduct a 5-month randomised controlled trial among 500 households to assess the impact of the intervention on drinking water quality and indoor air quality.


Eligibility Criteria:
Inclusion Criteria:

* All households in three selected villages

Exclusion Criteria:

* None
Concurrent Training for Optimal Physiological and Physical Benefits

It is widely accepted that aerobic exercise and strengthen training are the core components of most workout programs. However, there is no clear consensus on whether the order in which the exercises are performed impacts their effectiveness. Therefore, the overarching aim of the study is to understand the optimal order of two types of concurrent training program for 13 weeks by comparing the effectiveness of the training on body composition, predicated maximal oxygen uptake (MaxVO2), dynamic respiratory parameters, and muscle strength in healthy middle-aged people. Methods:Thirty-three moderately-active middle-aged and healthy participants were randomly assigned to the strength+aerobic group (SAG, n = 16) and aerobic+strength group (ASG, n = 17). Body composition, aerobic endurance, respiratory parameters and upper and lower strength were assessed before (pre-test) and after (post-test) a 13-week intervention. The chi-square test and the independent t-test will be used to compare sociodemographic variables between the groups. A 2 x 2 analysis of variance (ANOVA) with repeated measures (group x measurement) will be conducted.

This study will enhance our understanding of the concurrent training effect on muscle composition and strength. These training programs allow for reducing the duration of the training, which can be an important factor in making adults more willing to participate in physical activity.


Eligibility Criteria:
Inclusion Criteria:

* middle-aged adults ( over the age of 40)
* No history of cardiovascular or neuromuscular disorders
* not having orthopedic disorder or neurologic disorders.

Exclusion Criteria:

* adults using artificial prosthesis
* participation in any structured training program
* any disease that precludes exercise or necessitates special care (for example, coronary artery disease, thrombosis, moderate or severe bone disease, and lung or renal disease)
Incidence and Outcomes of Acute Kidney Injury in Trauma Patients Admitted to Critical Care

Acute kidney injury (AKI) is a common complication that increases lenght of stay and mortality in trauma patients admitted to the intensive care unit (ICU). The aim of this study is to identify the incidence and outcomes of trauma patients, defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria, at single center level 3 ICU.

Trauma can cause high mortality and morbidity by affecting different organ systems. Acute kidney injury (AKI) is a common complication in trauma patients admitted to the intensive care unit (ICU). Direct kidney injury, hypotension, hypoperfusion, rhabdomyolysis, abdominal compartment syndrome, sepsis and critical care medications are possible causes of AKI in trauma patients. The incidence of AKI can be up to 10%, and mortality rate up to 60-80% in trauma patients. Since AKI is not only a rare complication but also a risk factor for mortality in critically ill trauma patients, it is essential to establish a strategy to prevent AKI and related complications, to determine the incidence and risk factors of AKI, and to improve patients outcomes. Survivors of AKI may have variable recovery of kidney function and might prone to late morbidity and mortality. In this study incidence of AKI was defined using the KDIGO criteria according to the change of serum creatine levels.

171 all type of trauma patients admitted to level 3 ICU, from January 2014 to December 2018 included the retrospectve observational study. Demographic data, type of injury, rates of complications, risk factors for AKI, mortality, lenght of stay (LOS) in ICU were evaluated. Acute Physiology and Chronic Health Evaluation (APACHE II and IV) score, Simplified Acute Physiology Score (SAPS II and III), Glasgow Coma Scale (GCS), Injury Severity Score (ISS) and, Trauma Injury Severity Score (TRISS) were calculated on the day of admission. AKI was defined using the KDIGO criteria according to the serum creatinine. The SPSS 11.5 program was used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* all type of trauma patients admitted to level 3 ICU, from January 2014 to December 2018

Exclusion Criteria:

-
Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus

10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Results were compared between these groups.


Eligibility Criteria:
Inclusion Criteria:

* the criteria of type 1 and type 2 diabetes

Exclusion Criteria:

* no diabetes
Novel Robotic Prostatectomy Technique for Early Urinary Continence

The goal of this a single arm prospective study is to evaluating the 3-month return of urinary continence outcomes of patients undergoing the transvesical retzius sparing robotic radical prostatectomy (TRS-RALP) for standard of care surgical prostate removal for treatment of prostate cancer.

The main question it aims: To have patients respond to questionnaires to collect exploratory data on patient's quality of life (QoL; EuroQol-5 Dimension 5-Level \[EQ-5D-5L\] and prostate cancer related urinary, bowel, and sexual function questionnaires (Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP), at their standard of care perioperative visits at baseline and at 4 weeks, 3- and 6-months post operatively.

Patients undergoing robotic prostatectomy will have their surgery performed utilizing TRS-RALP technique, which is a novel combination of two previously described techniques. This technique is a recent alteration to our standard of care method of prostate removal, and comprises two halves of two previously validated techniques performed in succession. No new safety signals are anticipated, and the technique has been in use since May 2023. The purpose of this technique change is to improve the rate of return urinary continence, which early institutional experience supports. This trial protocol has been generated to formally evaluate this continence return improvement inside a statistical framework for prospective verification in our entire patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing standard of care robotic radical prostatectomy for localized prostate cancer

Exclusion Criteria:

* Patients with previous pelvic surgery
* Patients with previous pelvic radiotherapy
* Patient with previous focal therapy for prostate cancer
* Patients aged \< 18 years at diagnosis
* Legally incapable patients
* Patients who are unable to receive information about the study in a language they understand
* Patients who are unable to complete questionnaires and have no companion to help complete them
* Patients undergoing a concomitant cancer surgery
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Minimal age of 18 years

Exclusion Criteria:

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* SROM at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Previous cone biopsy or cerclage
* Major uterine structural anomalies
* Placenta previa
Increasing Smoking Cessation Counselling in Primary Care Using a Chronic Disease Management System

This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.


Eligibility Criteria:
Inclusion Criteria:

* Physician subscribers to P-PROMPT CDMS

Exclusion Criteria:

* Paper users
* Physicians expected to retire during the course of the study
* Physicians whose billing files are not set-up with DataSynch
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Primary Objective:

To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).

Secondary Objectives:

* To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
* To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

Total duration of the study per subject (excluding screening) is about 22 weeks.

Eligibility Criteria:
Inclusion criteria :

* Healthy male /or female subjects,
* aged 18 to 65 years old,
* with LDL-C \> 130 mg/dL
* not receiving lipid lowering therapy.

Exclusion criteria:

* Healthy subjects with history or presence of clinically relevant illness.
* Subjects currently taking statins, ezetimibe or fenofibrate.
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cold Atmospheric Plasma Device Extension Study

Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.


Eligibility Criteria:
Inclusion Criteria:

* All patients from 4-21 years old with at least 1 lesion of vercurra or molluscum.
* Willingness of the participant and their guardian to provide consent when applicable.

Exclusion Criteria:

* Unwillingness to participate in the study
* Received any treatment on the lesion in the past month determined by review of their medical record
* Immunodeficiency determined by review of their medical record.
* Adverse response to prior treatments determined by review of medical record.
* Signs of self-resolution determined by study team members.
* Conditions that lead to excessive scarring determined by study team members.
* Face and genital lesions determined by study team members.
Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation

The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols

This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20).

Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred.

Secondary aims are:

* Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".
* Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed.
* Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred.
* Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers

Eligibility Criteria:
Inclusion Criteria:

* Normal uterine cavity
* One or more years of infertility
* Normal male partner semen analysis

Exclusion Criteria:

* Age \<18 years old or \>37 years old
* Antral Follicle Count (AFC) \<8
* Abnormal male partner semen analysis or use of donor sperm
* Vaginal inflammation or genital (vaginal, uterine, tubal) infection
* Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension)
* Uterine anatomic abnormalities
* Allergy to plastics or inability to use diaphragm retention device
* Untreated hydrosalpinx
* Current alcohol abuse (defined by \>14 drinks/week)
* Prior history of IVF cycle where fertilization did not occur
* History of recurrent pregnancy loss
Aorfix Intelliflex First in Human Study

The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

Exclusion Criteria:

1. Do not comply with the indications for Aorfix™ in the IFU.
2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
3. Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.