cyrilzakka/clinical-trials huggingface dataset:
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers

Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal circulation through placenta. Even in the absence of a direct (vertical) transmission of pathogens to fetuses, certain infections make the neonates more prone to allergies and some adverse events of early vaccinations. We postulate that the basal immune status of neonates born to HIV and LTBI infected mothers is primed by gestational exposure to immunological active molecules, which could results in an altered response to early BCG vaccination. Transcripts expression identified by RNA sequencing are compared between sets of mother-child and their respective umbilical cord blood, and between groups of infected and non-infected pairs.

The study is comparing the transcriptomic profiles of maternal peripheral blood with those of the corresponding umbilical cord blood and neonatal peripheral blood pre- and post-BCG vaccination.

For RNA sequencing, the samples are collected in Tempus RNA Blood tubes at 5 time-points (TP): maternal peripheral blood at the time of initial diagnosis with HIV (first OBGYN consultation @ 12-16 weeks of pregnancy - TP1); repeated HIV test in 3rd trimester of pregnancy (34-36 weeks- TP2); umbilical cord blood (after delivery and ligation- TP3); neonates (24 hours after birth and after HBV vaccination, prior to BCG vaccination- TP4); and neonates (7 days after BCG vaccination- TP5).

As an indicator of the inflammatory status, the peripheral blood samples collected at the same TP are stained for serological markers of inflammation, exhaustion, maturation and activation.

An advanced bioinformatics analysis examines the immune-associated transcripts in RNAseq samples to assess the V(D)J recombination of T-cell and B-cell receptors along with immune-associated SNPs.

The main goal of the study is to identify in umbilical cord blood the genomic biomarkers of the neonatal basal immune status for guiding an optimal BCG immunization protocol for such neonates and to avoid potential adverse events after vaccination.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women, 18-45 years old, capable of reading and understanding the informed consent and the purpose of the study The newborns of the enrolled pregnant women. Women of reproductive age with or without HIV and LTBI infections

Exclusion Criteria:

Pregnant women younger than 18 years or older than 45 years of age Pregnant women and infants with known genetic abnormalities, including primary immunodeficiencies; or receiving immunosuppressive therapy; Infants infected in utero, perinatally, or neonatally with hepatitis B virus, Treponema pallidum (syphilis), Toxoplasma gondii, rubella virus, cytomegalovirus, or herpes simplex virus.

Pregnant women with known history of alcohol or drug abuse, cancer diagnosis and treatment with chemotherapeutic agents, radiation.

Pregnant women with history of organ transplantation.
"MenPhys: Intervention Protocol for Physical Wellness in Mental Health"

The primary aim of this project is to establish the acceptability of the PAI (physical activity intervention) to service users by evaluating if participants can be recruited into the study and if they complete the intervention.

Secondary aims are to estimate if, compared with treatment as usual (TAU), the PAI intervention (1) positively impacts on subjects' psychiatric symptoms (2) succeeds in improving cardiovascular fitness performance. In addition, will be considered the impact of the PAI versus TAU on sleep behavior, quality of life, drug consumption, reduces sedentary behaviour and unscheduled readmissions to the department within 30 days and within 7 days after their dismission.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any SMI
* Meeting any one of the following criteria as determined by a care co-ordinator:

  1. Overweight
  2. At risk for or have type 2 diabetes mellitus
  3. In the clinician's view, have a sedentary lifestyle
  4. Smoke tobacco
* Ability to provide informed consent
* Ability to understand Italian

Exclusion Criteria:

* under the age of 18
* not having a diagnosis of SMI
* be unable to do exercises
* be unable to give informed consent
Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure

The purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (SAHS) syndrome and treatment with continuous air pressure (CPAP) on the circadian intraocular pressure (IOP) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between SAHS and glaucoma.

OBJECTIVES: 1. To study the PIO and its fluctuations in patients with SAHS before starting treatment with CPAP. Objective 2. To assess the effect of CPAP on circadian IOP patterns. 3. Evaluate the effect of changes in IOP in patients with OSA treated with CPAP in the nerve fiber layer of the retina.

METHODS: A prospective study to be monitored continuously for 24 hours IOP by contact lens device Sensimed Triggerfish (Sensimed AG, Switzerland). Objective 1. To monitore and compare the IOP for 24 hours at 74 patients diagnosed with SAHS before starting treatment with CPAP and 37 patients without OSA. Objective 2. To study the impact of CPAP treatment by a study design in two stages CPAP / sham CPAP. A first monitoring of IOP will be compared before starting treatment with CPAP, with monitoring a month (CPAP-sham CPAP) and 12 months after initiation of treatment with CPAP. Objective 3. To correlate the values obtained from the monitoring of IOP in the thickness of the nerve fiber layer of the retina, as measured by optical coherence tomography, at baseline and at 12 months after starting treatment with CPAP.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Seeking a sleep study using a cardio-respiratory polygraph study
* Having spherical refraction between -5D and 3D, cylinder correction \<2D, as well as a slit lamp examination with anterior chamber normal and an open irido-corneal angle

Exclusion Criteria:

* Presence of severe drowsiness or risk profession that requires urgent treatment with CPAP
* Any known intolerance to silicone, any alteration in the anterior pole of the eye that contraindicates the use of a contact lens, severe dry eye, keratoconus or any other corneal alteration, a history of conventional intraocular or laser surgery, whether for cataracts, glaucoma, refractive or retina surgery.
* Glaucoma patients will be excluded at the start of the study.
* When both eyes of each patient meet the inclusion criteria, the investigator will randomly select the eye to be studied.
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.

Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.

Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.

Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed abdominal aortic aneurysm \> 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or
* Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.

Exclusion Criteria:

* Less than 21 years of age,
* Life expectancy less than 2 years,
* Pregnant,
* Religious cultural or other objection to the receipt of blood or blood products,
* Unwilling to comply with follow-up schedule,
* Unwillingness or inability to provide informed consent to both trial and procedure.
* Patients not expected to live more than 2 years from enrollment
* Patient has a ruptured aneurysm
* Aneurysm extends above renal arteries
* Proximal neck of aneurysm has significant loose thrombus associated with it
* Patient with an acute or chronic aortic dissection or mycotic aneurysm
* Patient has current non-localized infection (may be recruited following remission of the infection)
* Patient is allergic to device materials
* Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl
* Patient is clinically and morbidly obese such that imaging would be severely adversely affected
* Patient has renal failure (serum creatinine \> 2.5 mg/dL)
* Patient has an uncorrectable bleeding abnormality
* Patient has unstable angina
* Patient is receiving dialysis:
* Inflammatory aneurysm
* MI in last 6 months
* End stage COPD
* Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)
* Significant (\>80%) renal artery stenosis which cannot be readily treated
Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)

To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture in patients with osteoporosis who were randomly assigned to either treatment arm receiving daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy group) for 36 months, followed by a 12-month follow-up observation to examine the preventive effect on the fracture risk.


Eligibility Criteria:
Inclusion Criteria:

Inpatient or outpatient is not asked. If using any anti-osteoporotic agent other than calcium preparations (i.e., contraindicated for concomitant use stipulated in the protocol of this post-marketing study), such agent must be discontinued. Even after the discontinuation, calcium dosing is permitted with a condition that the subsequent use is started after a 8-week elapse from the discontinuation.

* Patients with primary osteoporosis (diagnosed according to "Diagnostic Criteria for Primary Osteoporosis issued by the Japanese Society for Bone and Mineral Research (1995)."
* Post-menopausal patients aged 50 years or older.
* Patients who agree to participate in a 4-year follow-up observation.
* Patients who provide written informed consent.

Exclusion Criteira:

* Patients on warfarin potassium (Warfarin®) therapy.
* Patients with hypercalcemia.
* Patietns with renal calculus.
* Patients with a known history of hypersensitivity to calcium or menatetrenone preparations.
* Patients with severe complication in the hepatic, renal, gastrointestinal, cardio- and cerebrovascular system.
* Patients who underwent bilateral ovariectomy.
* Patients with radiotherapy in the pelvis or para-aortic area.
* Patients with the following X-ray findings;

  1. Patients showing osteophytes connecting with adjacent vertebral osteophytes
  2. Patients showing hyperostosis of ligament around the vertebral body
  3. Patients showing inter-body fusion
  4. Patients who experienced surgical intervention(s) in the spine
  5. Patients with scoliosis which disturbs a diagnosing of vertebral fracture
* Patients who have been treated with anti-osteoporotic agents, other than calcium preparation, within 8 months prior to the study treatment (but not applied to the following; if discontinued, non-treated, or shifted to calcium monotherapy for 8 weeks or longer before starting the study treatment).
* Patients who experienced bisphosphonates in the past.
* Patients who are likely to show insufficient absorption of liposoluble agents such as biliary atresia, impaired bile secretion, etc.
* Other patients who are judged to be ineligible for study entry by the investigator or investigator.
S9715, Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with advanced cancer of the nasopharynx.

OBJECTIVES: I. Gather additional information and experience regarding the preferred treatment from clinical trial SWOG-8892, chemoradiation for patients with advanced nasopharyngeal cancers (NPC). II. Evaluate survival and progression-free survival and patterns of tumor failure in this new group of patients. III. Assess severe or lethal toxicities that may be encountered after this regimen is employed more widely. IV. Collect NPC tumor specimens for ongoing and future clinical correlative research.

OUTLINE: Patients receive cisplatin by intravenous infusion on day 1 over a 15-20 minute period. This is repeated every 21 days for the first three initial treatments. Patients also receive radiation therapy once daily five times a week during this cycle of treatment. Approximately three weeks after completion of the above treatment, patients are given cisplatin by intravenous infusion over 15-20 minutes as above but at a lower dose. On the same day as cisplatin infusion, patients receive fluorouracil by continuous intravenous infusion over 24 hours for 4 days in a row. This is repeated every 28 days for a total of 3 treatments. Patients are followed until death.

PROJECTED ACCRUAL: 100 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven nasopharyngeal carcinoma (excluding adenocarcinoma), stage III or IV with no evidence of distant metastatic disease (M0) No lung, bone, or liver metastases as proven within 42 days of registration by: -CT scan or nucleotide study of the chest or chest x-ray -liver and bone scan if alkaline phosphatase is greater than the institutional upper limit of normal (ULN), or if clinically indicated -liver scan if SGOT is greater than the institutional ULN

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.6 mg/dL AND/OR Creatinine clearance at least 50 mL/minute Other: Not pregnant or nursing Women/men of reproductive potential must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No previous chemotherapy to the primary site or nodes Endocrine therapy: Not specified Radiotherapy: No previous radiotherapy (except for nonmelanomatous skin cancer outside of the radiation therapy treatment volume) Surgery: No previous surgery to the primary site or nodes
Gene Expression That Predicts Radiation Exposure in Humans

To verify and validate a biodosimetry test for determining absorbed ionizing radiation dose by analyzing gene expression signatures of blood samples collected from patients treated with Total Body Irradiation (TBI).

In order validate the performance of DxTerity's Radiation Biodosimetry Test (RBT) system, several clinical centers will provide controlled, de-identified blood samples and associated clinical information to DxTerity Diagnostics (DxTerity). Variations in dose and frequency of delivery in TBI protocols are expected between the clinical centers and this has been accounted for in the study design. Samples from up to 200 participants will be collected via this protocol. Blood samples for this study will be collected from radiation therapy patients receiving TBI as part of a therapeutic regimen from the site.

Blood samples (up to 4 mL per time point) may be obtained at the time of routine blood collection; participation in this biomarker study will not affect any aspect of patient treatment. Study samples will be obtained prior to, during, and post-radiation treatment regimen. Associated clinical information will be collected from the subject's medical record, as well.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients age 2 or older.
2. Weigh at least 13kg (30lbs), and in the opinion of the investigator, are healthy enough to participate in study activities.
3. Evidence of a personally signed and dated informed consent/assent document indicating that the subject or a legally acceptable representative (parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
4. Diseases treated with HSCT, including malignant and nonmalignant diseases.
5. Planned fractionated total body irradiation (TBI) as part of clinical care with a cumulative dose ≥6 Gy or a single dose between 1.5 and 3.0 Gy.

Exclusion Criteria:

1. Subjects who have received chemotherapy within 21 days prior to TBI.
2. Concurrent chemotherapy with Fludarabine or an investigational product
3. Cytokine inhibitor or cytokine-inducer therapy within 30 days prior to and during the irradiation regimen
4. Subjects who have received GCSF within 30 days prior to TBI
5. Participants, who in the opinion of the investigator, may not be able to comply with the requirements of the study.
Practices Made by Patients to Avoid Insulin Injection Pain

Abstract Objective: This study was conducted to determine the knowledge levels of DM patients about the disease and insulin use, and their practices to avoid insulin injection pain.

Methods: Data were collected from 399 patients who administered insulin injections in the study. Patient identification form, disease and treatment compliance form, Morisky-8 Treatment Adherence Scale (MMAS-8), and Visual Analog Scale were used for data collection. The data were collected by the same researcher by face-to-face interview technique.

The face-to-face interview technique was applied to all patients who met the inclusion criteria and accepted to participate in the study, in the waiting area of the internal medicine outpatient clinic. Data were collected by the same researcher. Questionnaire forms were filled in the form of questions and answers in 10-15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65, diagnosed with diabetes mellitus at least 1 year ago, injecting themselves with insulin.

Exclusion Criteria:

* Having no communication problems, and having no mental illness were included in the study.
Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.

To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.

A review state that "Interstitial lung disease presents clinical features of exertional desaturation and a nonproductive cough. Patients with ILD have significantly reduced exercise capacity as manifested by a reduced maximum work load achieved during exercise, as well as a reduced maximal oxygen uptake VO2max." in previous studies Pulmonary rehabilitation is the use of exercise, education and behavioral interventions for diseases such as non-ILD restrictive lung disease, asthma, lung cancer, bronchiectasis , and pulmonary hypertension, pre and post op thoracic surgery patients.

Quality of life (QOL) as an individual's perception of contentment or satisfaction with life in areas he or she considers important, and we define health-related quality of life (HRQL) as an individual's perception of the impact of health (in all its many facets) on his or her quality of life. a study on pulmonary rehabilitation outcomes between individuals with chronic obstructive lung disease (COPD) and non-COPD disease and its impact on gender.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of non-COPD disease interstitial lung disease (pulmonary fibrosis), restrictive lung disease (TB, pneumonia), Bronchiectasis, and Asthma with FEV1 below 50%, FVC\<80%, and FEV1/FVC\>70%

Exclusion Criteria:

* Clinically/vitally unstable or having Uncontrolled DM/HTN, Current smokers or ex-smokers of less than 1 year.
Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae

The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.


Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 year old
* Patient benefits from social security
* Signed informed consent
* A urinary tract infection due to a confirmed ESBL producing strain (detected by the use of a rapid diagnostic test applied on the urine) requiring parenteral antimicrobial therapy
* Hospitalized patient
* For women able to procreate: Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide and condom. (All forms of hormonal contraception are acceptable

Exclusion Criteria:

* Patient infected with a bacteria which is not an ESBL-producing or AmpC hyperproducing Enterobacteriaceae
* Patients infected with a strain sensible to both fluoroquinolones and trimethoprim/sulfamethoxazole
* Patients infected with a strain resistant to temocillin
* Hospital-acquired urinary tract infection (defined as a urinary infection that occurred at least 48h post admission in the hospital)
* Patients has received any dose of active antimicrobial therapy (an antibiotic to which the infecting bacterium is susceptible) in the last 48h (prior to enrolment) except ≤ 2 dose of gentamicin.
* Patients presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin) due to Gram negative bacteria.
* Patients needing concomitant antimicrobial therapy.
* Septic shock
* Children (up to 18 years old)
* Women who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause)
* Patients with any kind of urinary/bladder catheter (JJ ureteral probe, ...)
* Hypersensitivity to the active substance, to penicillins or to any other type of beta-lactam agent
* Chronically dialyzed patients
* Patients having a creatinine clearance \< 30 mL/min
* Complete obstruction of the urinary tract
* Perinephretic or intrarenal abscesses
* Tutorship or curatorship patient
* Patient unable to give his consent