cyrilzakka/clinical-trials huggingface dataset:
Impact of HIV on Measles and Measles Immunisation

We conducted a longitudinal study to assess the immunogenicity of standard-titer measles vaccine in HIV-infected and uninfected Zambian children. The study hypothesis was that HIV-infected children would have higher rates of primary and secondary measles vaccine failure compared to uninfected children, contributing to decreased levels of population immunity to measles and facilitating measles virus transmission in regions of high HIV prevalence.

Despite great progress in measles control in sub-Saharan Africa, measles remains a significant cause of morbidity and mortality in young children. In regions of high HIV prevalence, measles virus transmission may be sustained despite high immunization coverage rates if HIV-infected children are important transmitters of measles virus. Factors potentially contributing to enhanced measles virus transmission by HIV-infected children include an early decline in protective maternal antibody titers resulting in susceptibility to measles at a younger age, and high rates of primary and secondary measles vaccine failure. To evaluate the potential impact of the HIV-1 epidemic on immunity following measles vaccination, we conducted a longitudinal study to compare the primary vaccine failure rate and rate of antibody decline following administration of standard-titer measles vaccine at nine months of age to HIV-infected and HIV-uninfected Zambian children. Our results show that children born to HIV-infected women have lower levels of passively-acquired maternal antibodies to measles virus prior to the age of routine vaccination at 9 months, and HIV-infected children are particularly susceptible to measles in infancy. This finding supports the WHO recommendation to provide the first dose of measles vaccine to HIV-infected children at 6 months. Furthermore, HIV-infected children develop adequate primary antibody responses to measles vaccine in the months following vaccination but lose protective antibody titers by two to three years of age. Mitigating the potential impact of this decreased immunogenicity on the level of population immunity to measles virus was the high mortality rate observed among HIV-infected children. Improved access to antiretroviral therapy will likely improve the survival of HIV-infected children without enhancing protective immunity to measles virus, although this has yet to be investigated. We are working to incorporate our findings into a mathematical model to better understand the impact of the HIV-1 epidemic on measles control strategies and to investigate the immunologic mechanisms for impaired memory B cell responses in HIV-infected children.

Eligibility Criteria:
Inclusion Criteria:

* children aged 2 to 8 months presenting for well-child care
* reside within 10 miles of the study clinic
* parents or caretakers provide signed informed consent

Exclusion Criteria:

-children with severe illness
Effect Of Position On Laryngeal Visualisation With The C-Mac Videolaryngoscope

The aim of this study is to demonstrate the effect of C-Mac videolaryngoscopy with Miller Blade size 0 and 1 on the intubation conditions in children less than 2 years age with a roll inserted under the shoulders.

The laryngoscopic view of the glottis is improved when the angle of the line of vision between the pharyngeal - laryngeal axis and the oral cavity axis is narrow. A roll inserted under the shoulders of the infant will help line up the oral, laryngeal, and pharyngeal axes making direct laryngoscopy easier.

The investigators hypothesized that laryngoscopic view and intubation conditions using C-Mac videolaryngoscope with Miller Blade size 0 and 1 would be better with a roll under shoulder in children under 2 years.

Eligibility Criteria:
Inclusion Criteria:

* less than 2 years age undergoing general anaesthesia with tracheal intubation for elective surgery
* American Society of Anesthesiologists' physical status either 1 or 2 are included

Exclusion Criteria:

* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention.

Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period. A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility Criteria:
Inclusion Criteria:

* born, raised and currently living \<1300m
* No overnight stays at altitudes \>1500m 4 weeks before the study

Exclusion Criteria:

* previous altitude intolerance \<3000m
* pregnancy
* health impairment, which requires regular treatment
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).


Eligibility Criteria:
Inclusion Criteria:

* CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
* Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
* Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

Exclusion Criteria:

* Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
* Patients must not have received bilateral pelvic irradiation.
* Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or without collar design. Randomized study design focusing on radiolucent lines on standard x-ray.


Eligibility Criteria:
Inclusion Criteria:

* primary THA

Exclusion Criteria:

* fractured hips
Significance of Cortactin Expression in Colorectal Adenocarcinomas

Colorectal carcinoma is one of the most aggressive malignant epithelial neoplasms affecting the gastrointestinal tract. The incidence of colorectal carcinoma is obviously increasing in developing countries, where the physical inactivity and the consumption of animal fat-rich food became more evident. Colorectal tumorigenesis is a multistep process which is initiated by adenoma and is terminated by carcinoma, the latter shows variable degrees of tumor differentiation and invasiveness. During the adenoma-carcinoma process; a series of genetic mutations occur. Detection of these genetic mutations will help in the development of novel therapeutic agents, which in turn will improve patients' outcomes. Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11. CTTN binds to and activates Arp 2/3 and stabilizes the dynamic actin assembly after its formation. So, it become clear that CTTN is involved in the formation of the leading-edges cellular protrusions.

Colorectal carcinoma is a highly lethal malignant epithelial tumor involving humans. The incidence of colorectal carcinoma is steadily increasing in developing countries, this could be assigned to low physical activity together with high consumption of animal fat-rich food. malignancy of the colon is a multistep process which is initiated by adenoma that proceeds to carcinoma, the latter includes a wide variety of tumor phenotypes. During the adenoma-carcinoma process; a series of genetic and epigenetic alterations occur. Detection of these genetic alterations is of great benefit in the future management of colorectal carcinomas. Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11. CTTN anchors the dynamic actin assembly . CTTN is implicated in the formation of the leading-edges cellular protrusions.the aim of this study is to evaluate expression of CTTN in 50 cases of colorectal adenocarcinomas and their adjacent normal colonic mucosae.

Eligibility Criteria:
Inclusion Criteria:

* patients with colorectal carcinomas who underwent colectomy operations.

Exclusion Criteria:

* specimens obtained by lower endoscopy only, patients who received pre-operative chemotherapy.
Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD

Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients An investigator-initiated, prospective, controlled, multicenter study

TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely comfortable and uncomplicated alternative to numerous other approaches in non-invasive ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated complications as patients could not tolerate high airflow delivered by a thin nasal cannula without humidification and warming, thus causing concomitant negative effects. The new therapy TNI shows a high rate of acceptance by children, too.

At present, there are two different types of devices available for nasal insufflation in clinics:

TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier for clinical compressed air, which can be combined with oxygen.

TNI 20 oxy The system, which is unique throughout the world, is optimized for the application of flows of up to 20L/min and fulfils the minimum requirements of the "American Society of Testing and Materials" for a high flow air humidifier in the non-invasive application of 10 mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient temperature. Condensation is prevented in the nasal applicator by heating the tube as far as the nostrils. The device automatically controls humidity and temperature depending on the prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by means of a standard pressure regulator.

Eligibility Criteria:
Inclusion Criteria:

- COPD patients with an indication for long-term oxygen therapy Age 30 - 80 years COPD GOLD °III

Exclusion Criteria:

- Clinical instability of the patient No lung function testing possible Exacerbation within the last 14 days prior to inclusion into the study Serious concomitant diseases that may jeopardize the inclusion of the patient into the study from the investigator's point of view Anaemia, defined by a haemoglobin \<10 G/L Patients with hypercapnia, defined by a paCO \<46mmHg Participation of the patient in any other ongoing study
Cone Beam CT for Daily Image Guidance - Prostate Cancer

Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate
* Patient undergoing dose escalated conformal external beam radiation therapy
* Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score \<8, Clinical T category \<T3, Clinical N category 0 or X, M category 0 or X
* Age 18 years or older
* ECOG performance status 0 or 1
* Informed consent

Exclusion Criteria:

* Inflammatory bowel disease or collagen vascular disease
SATisfaction and Adherence to COPD Treatment

The present study will explore the patients satisfaction to COPD medical treatment (i.e. pharmacological and not pharmacological treatment) in a clinical real-world setting and how the satisfaction for medical treatment is related to clinical parameters, quality of life, illness perception and treatment adherence evolution.

Moreover health care resource consumption will be observed during the observation period.


Eligibility Criteria:
Inclusion criteria:

1. Patients aged equal or more than 40 years
2. Patients must have a documented diagnosis of chronic obstructive pulmonary disease (COPD)
3. Patients with no exacerbations in the last 3 months
4. Patients requiring regular treatment according to GOLD guidelines, i.e.: undergoing stable pharmacological treatment for COPD since at least 3 months
5. Written informed consent to both participation in the study and privacy form
6. Patients capable of discernment and able to read or write in Italian language.

Exclusion criteria:

1. Patients who are currently participating in a clinical trial on experimental drugs.
2. Patients naïve to pharmacological treatment for COPD
3. Diagnosis of Asthma COPD Overlap Syndrome (ACOS)
A New Mode of Action of Anti-TNF, Reverse Signaling, in Rheumatoid Arthritis

Blood test in Rheumatoid Arthritis (RA) patients with good response to anti-Tumor Necrosis Factor (anti-TNF) and in patients with moderate or non-response will be done in the month following the evaluation of clinical response to therapy. Isolation of mononuclear cells and purification of monocyte by negative selection. Cell culture of monocyte in presence or not of anti-TNF for 24 hours and analyze of CD36 (cluster of differentiation antigen 36) expression (principal outcome). For secondary outcomes analyze monocyte phenotype, NRF2 nuclear translocation, and clinical data of patients.


Eligibility Criteria:
Inclusion Criteria:

* RA defined according to the American College of Rheumatology (ACR) 2010 criteria,
* treated by anti-TNF + methotrexate, good responders in in one arm, and moderate or non-responders in the other arm according to EULAR (European Ligue Against Rheumatism) response criteria after three months of treatment

Exclusion Criteria:

* contra-indication to anti-TNF
* corticosteroid more than 10mg by a day equivalent prednisone,
* modification of DMARD (disease-modifying antirheumatic drugs) in the last three months
* comprehension trouble
* Factors modifying CD36 -cluster of differentiation antigen 36- expression as diabetes mellitus, kidney disease, HIV
Assessment of the Clinical Utility of Non Invasive Peripheral Signal Averaged Pulse Volume

The purpose of this study is to determine the clinical usefulness of measuring the heart's pumping ability by measuring the Peripheral Pulse Volume (PPV).

Peripheral Pulse Volume (PPV) is the change in the volume of a limb that occurs when blood passes through the limb. The limb also acts as an electrical conductor whose electrical impedence changes with limb geometry and volume. Each time the heart beats, the volume of the limb segment changes, and therefore its electrical impedence changes. A plethysmograph can be used to measure volume changes of a part of the body by producing a plethysmographic waveform. Selectively capturing a number of these plethysmographic wave forms with acceptable noise levels and averaging them using the EKG as a reference-timing signal generate a highly reproducible pulse volume signal. Signal averaged pulse volume measurement will be obtained non-invasively from the lower extremities of patient volunteers. A disposal non-occluding electrical monitoring strap will be applied to the calf of each patient. Changes in the calf's size/volume caused by changes in the patient's cardiac output and calf blood flow will result in electrical impedance changes. These changes will be recorded by an analog admittance plethysmograph attached to the lower extremity strap. The analog plethysmograph is coupled to a digital computer for signal enhancement and measurement.

Eligibility Criteria:
Inclusion Criteria

* Coronary care unit patients with indwelling right heart (Swan Ganz) catheters with or without intraaortic balloon assist pumping devices.
* Congestive Heart Failure patients on and off various therapeutic inotropic agents with or without indwelling heart catheters
* Cardiac catheterization laboratory patients undergoing prophylactic IABP in the presence of left main or diffuse unstable CAD
* Chronic renal failure patients undergoing hemodialysis.
* Peripheral Vascular Disease patients
* Patients undergoing Tilt Table Testing
* Any patients undergoing right heart catheterization Exclusion criteria -- Non specified
Development of a Computer-aided Polypectomy Decision Support

Quality components of colonoscopy include the detection and complete removal of colorectal polyps, which are precursors to CRC. However, endoscopic ablation may be incomplete, posing a risk for the development of "interval cancers". The investigators propose to develop a solution based on artificial intelligence (AI) (CADp computer-aided decision support polypectomy) to solve this problem.This research project aims to develop CADp, a computer decision support solution (CDS) for the ablation of colorectal polyps from 1 to 20 mm.

This research project aims to develop CADp, a computer-based decision support (CDS) solution for the removal of colorectal polyps ranging from 1-20 mm. The investigators will use a video and image dataset of polypectomy procedures to train the CADp model; thus, it can provide real-time overlaid video feedback for polypectomy procedures based on five specific metrics: 1) estimation of polyp size; 2) prediction of morphology and histology; 3) suggestion of an appropriate resection accessory and technical approach based on the characteristics, size, and histology of the polyp according to current guidelines; 4) image overlay, based on semantic image segmentation technology, showing the extent of the lesion and suggestion of an appropriate resection margin contour around the polyp to ensure its complete removal; 5) post-resection analysis to identify any remnant polyp tissue or insufficient resection margin that may increase this risk.

The investigators will collect a set of images and video data from live polypectomy procedures to leverage recent advances in AI technology to train deep learning models. This dataset will be obtained prospectively from a cohort of adults (ages 45-80) undergoing screening, diagnostic, or surveillance colonoscopies. To train the CADp solution, the investigators will obtain the corresponding completeness of resection status using the yield of post-resection margin biopsies. The dataset will be divided into two groups, the training, and the CADp test, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 45-80 years
* Indication to undergo a lower GI endoscopy.

Exclusion Criteria:

* Known inflammatory bowel disease
* Active colitis
* Coagulopathy
* Familial polyposis syndrome;
* Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class \>3
* Emergency colonoscopies
Sarcopenia and Physical Performance in Hemodialysis Patients

Many systems such as the cardiovascular, pulmonary, musculoskeletal, hematological, immunological, gastrointestinal, central nervous system are affected due to decreased kidney function. The aim of this study was to investigate the relationship between physical performance and sarcopenia, peripheral muscle strength, activities of daily living, cognitive functions, physical activity level, fragility, pain in hemodialysis patients.

A high prevalence of sarcopenia has been reported in end stage kidney disease. The incidence of sarcopenia increases with age. Muscle atrophy is caused by an imbalance between the anabolic and catabolic processes in chronic kidney disease. Sarcopenia and physical inactivity progress synergistically. Decreased physical performance is associated with sarcopenia. In hemodialysis patients, daily physical activity level and physical performance decrease. Cognitive impairment is common in chronic kidney disease. Uremic toxins can cause a decrease in cognitive function. One of the most important problems associated with hemodialysis is pain and pain negatively affects functional capacity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with end stage kidney disease
* Receiving hemodialysis for more than 3 months
* Being clinically stable
* Volunteering to participate in the research

Exclusion Criteria:

* Having an orthopedic disease that may affect functional capacity
* Having cardiac event in the past 3 months
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers

A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids

A study will be performed to evaluate changes in prescribing behavior of prescribers.

1. For products that are indicated for use in opioid-tolerant patients only (i.e., fentanyl transdermal patches, extended-release hydromorphone pills and extended-release morphine pills \>90mg), describe trends in the proportion of prescriptions for these products to opioid-non-tolerant patients in the year preceding the availability of REMS-compliant CE courses and compare the proportion of prescriptions to opioid non-tolerant patients pre- versus post-REMS CE course availability
2. For products whose labels indicate that higher dosage strengths should only be used in opioid-tolerant patients, describe trends in the proportion of prescriptions prescribed to opioid non-tolerant patients with a high starting dosage strength; compare the proportion of prescriptions for such products that are prescribed to opioid non-tolerant patients with a high starting dosage strength pre- versus post-REMS CE course availability
3. Describe trends in the proportion of prescriptions for ER/LA opioids prescribed to patients that have early refills of prescriptions and compare this proportion pre- versus post-REMS CE course availability.
4. Compare the concomitant use of benzodiazepines with ER/LA opioids before and after REMS implementation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects filling a prescription for a product of interest during the specified time period will be included.

Exclusion Criteria:

* None