cyrilzakka/clinical-trials huggingface dataset:
Impact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features

HPV is known to be the causal agent in the majority of cervical cancers. However, the role of the cervical bacterial microbiome in cervical cancer is not clear


Eligibility Criteria:
Inclusion Criteria:

* Women in fertile age

Exclusion Criteria:

* severe comorbidities
Safety Evaluation of a Q-fever Vaccine, NDBR 105

The purpose of this study is to evaluate the safety of Q Fever vaccine, NDBR 105, and collect data on incidence of occupational Q Fever infection in at risk personnel.

Study Objectives:

1. Continue to collect and assess safety data on Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105, and 2) Provide vaccine that potentially protects personnel at risk for occupational exposure to Q Fever and collect data on incidence of occupational Q Fever infection (subclinical and clinical) in immunized personnel.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old, or if on active military duty, 17 years old.
* Females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test antigen AND vaccine. (Exception: documented hysterectomy or \> three years of menopause.) The results must be negative.
* Volunteer must be actively enrolled in the SIP
* Volunteer must be considered at risk for exposure to C. burnetii.
* Volunteer must sign and date the approved ICD and HIPAA Authorization.
* Volunteer must have an up-to-date (within one year) medical history, physical examination, and laboratory tests on their charts and be medically cleared for participation by an Investigator. Examinations or tests may be repeated within one year at the discretion of the enrolling physician.
* Volunteer must be willing to return for all follow-up visits.
* Volunteer must agree to report any AEs which may or may not be associated with administration of the test article for at least 28 days after vaccination. All SAEs and UAEs will be reported for the duration of the volunteer's participation in the study (one year).

Exclusion Criteria:

* Prior history of Q fever disease or vaccination.
* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests (two times the normal range or at the discretion of the PI).
* Personal history of an immunodeficiency or current treatment with an immunosuppressive medication or autoimmune disease.
* Confirmed HIV infection.
* Heart valve disease: murmur with abnormal echocardiogram (if murmur is detected on examination, volunteer will be referred to cardiologist to rule out pathology.)
* Positive pregnancy test or lactating female (females must agree to not become pregnant for three months after vaccination.)
* Any known allergies to components of the vaccine.
* Administration of another inactivated vaccine within 7 days or a live or IND vaccine within 28 days of Q fever vaccination.
* Any unresolved AE resulting from a previous immunization.
Sofia RSV FIA Field Study

The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).
3. Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.
4. Subjects must present with one or more of the following to be eligible for enrollment:

   * Fever, ≥ 37.8º C (100º F) at present or within past 24 hours
   * Moderate to severe runny nose\*
   * Moderate to severe congestion\*
   * Decreased appetite
   * Coughing
   * Sneezing\*
   * Wheezing
   * Irritability
   * Decreased activity
   * Labored breathing

Exclusion Criteria:

1. Subjects nineteen years of age or older.
2. The parent or legal guardian is unable to understand and consent to participation.
3. Current or prior treatment during this infection with anti-RSV Synagis®.
Effect of Surfaces on Fall in Elderly

To investigate the effects of Thai dance exercises over 6 weeks on functional outcomes and incidence of fall in community-dwelling older individuals.

To compare effects of exercise training on hard, soft and sand surfaces in community-dwelling older individuals


Eligibility Criteria:
Inclusion Criteria:

* age at least 60 yr old
* fall

Exclusion Criteria:

* having pain (VAS \>5)
End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide Poisoning

The purpose of this study is to determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.


Eligibility Criteria:
Inclusion Criteria:

* Carbon monoxide exposure

Exclusion Criteria:

* Less than 18 years old
* Suicide attempt
* Unable to provide informed consent
* Pregnant
Ultrasound-guided Transversus Abdominis Plane Block After Hysterectomy

In this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management in patients undergoing abdominal hysterectomy.

Patients undergoing abdominal hysterectomy (n=75) at Parkland Hospital will be randomized into one of three groups to receive either ultrasound-guided bilateral TAP block with or without NSAIDs and acetaminophen (Groups 1 and 2) or the conventional analgesic regimen (Group 3) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique, will be standardized and similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively. The pre-anesthesia care unit personnel will identify patients during their preoperative clinic visit. There will be no incentive or payment to the patients.

Patients in Group 1 and 2 will receive ultrasound-guided bilateral TAP block after surgery. In the first 24-h postoperative period, patients in Groups 1 and 3 will receive acetaminophen 650 mg every 6 h orally, ketorolac 30 mg every 6 h, and morphine via an intravenous patient controlled analgesia (IV-PCA) system to maintain adequate pain control. Patients in Group 2 will receive IV-PCA morphine for the first 24 hours in addition to the ultrasound-guided bilateral block. In the 24-48 h study period, all patients will receive oral ibuprofen 800 mg three times a day and a combination of hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets every 6h, prn. The postoperative analgesia will be documented using the visual analog score (0=no pain,10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.

Primary endpoint will be in about 24 hours after surgery morphine consumption. The secondary endpoints will include the VAS pain score at 6, 12, 24 and 48 hours after surgery and side effects associated with morphine use.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Female ASA physical status 1-3 scheduled for abdominal hysterectomy
* Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

* History of relevant drug allergy
* Age less than 18 or greater than 80
* Chronic opioid users who may have a tolerance to opioids
* Psychiatric disturbance
* Inability to understand the study protocol procedures
* Patient refusal
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis

In this prospective cohort study, the patients who were diagnosed with either uterine fibroid (control group) or adenomyosis (study group), were examined with transvaginal ultrasound and shear wave elastography. Definitive diagnosis was established by pelvic MRI. Shear wave elastography data of both groups were compared. Features of adenomyosis on transvaginal ultrasound were also recorded for study group.

In this prospective cohort study, the patients who applied to the Gynecology and Infertility Outpatient Clinic in Istanbul University Faculty of Medicine between October 2018 and October 2021 due to abnormal uterine bleeding, pelvic pain, infertility were evaluated. The patients who were diagnosed with adenomyosis and uterine myoma according to clinical evaluation were included and grouped. Clinical diagnosis were confirmed with contrast enhanced pelvic magnetic resonance imaging. No histopathological confirmation were included in this study. 34 patients were included in adenomyosis group and 31 patients were included in myoma group. All patients were evaluated with shear wave elastography; 3 regions of interest were selected for each elastographic evaluation. Average shear values were determined automatically; then, minimum and maximum mean shear values were recorded accordingly. Elastography values of both groups were compared in order to detect any statistically significant difference between 2 groups. In addition to elastography evaluation, the compatibility of transvaginal ultrasound and magnetic resonance were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who applied to outpatient clinic due to abnormal uterine bleeding, pelvic pain, infertility.

Exclusion Criteria:

* Patients who are currently pregnant or has current malignancy, use combined oral contraceptives, gonadotropin releasing hormone agonist, intrauterine device or currently taking hormonal replacement therapy.
Bariatric Electrical Impedance Tomography

This study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in obese patients scheduled for laparoscopic bariatric surgery in the perioperative phase.

Eligible patients with written informed consent, scheduled for laparoscopic bariatric surgery. As for standard of care no premedication will be given for bariatric patients. Patients will be monitored according the local standard.

Thoracic electrical impedance tomography measurements (each measurement will last 1 min) will be performed at the following time points: before induction of the anaesthesia; before the surgical procedure when the induction is terminated and recruitment manoeuvers have been performed; after the termination of the surgical procedure; before transport to the Post anaesthesia Care Unit (PACU); before the discharge from the PACU after 2 hours of monitoring. An additional thoracic electrical impedance tomography measurement (duration 1 min) will be performed before discharge at home. For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm. Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40
* ASA physical status 1 to 4
* Over 18 years of age providing written informed consent

Exclusion Criteria:

* BMI \<40
* Known severe pulmonary hypertension,
* Need of home oxygen therapy
* Known heart failure
* Suspected, or known recent pulmonal infections
Valvular Microbiota and Valvulopathy

Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011.

Having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. This study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (AVR) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. This would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.


Eligibility Criteria:
Inclusion Criteria:

* Indication for surgical AVR:

  * Tight RA:

    * symptomatic (dyspnea, syncope/lipothymia, angina);
    * and/or echocardiographic criterion:
* valve surface \< 1cm2 (and/or 0.6cm2/m2);
* average transvalvular gradient \> 40mmHg;
* aortic jet velocity (Vmax) \> 4.0m/s;

  * or low transvalvular gradient (mean gradient \< 40mmHg) + left ventricular ejection fraction (LVEF) \< 50% but contractile reserve;
  * and/or high calcium score on CT angiography;

    * Asymptomatic tight RA and:
  * LVEF \< 50% without other cause;
  * and/or symptoms during exercise;
  * and/or low surgical risk + severity criteria: Vmax \> 5.5m/s (or progression \> 0.3m/s/year), NT-proBNP level \> 3Xnormal, severe pulmonary arterial hypertension (pulmonary systolic pressure \> 60mmHg);

    * Moderate AR + concomitant surgical indication for another heart disease;
    * Severe AI: regurgitant orifice \> 30mm2, regurgitated volume \> 60ml/beat,
  * symptomatic (dyspnea, syncope/lipothymia, angina);
  * and/or left ventricular dysfunction: LVEF \< 50%, end-diastolic diameter \> 70mm, end-systolic diameter \> 50mm (or \> 25mm/m2);
  * and/or concomitant surgical indication for another heart disease.
Does Assessment of Ambulance Medical Service Leads to Reduced Number of Transports to the Emergency Room?

There is a need to reduce the number of ambulance transports to the Emergency Room to the patients who are not in need of urgent medical care. There are currently no studies and the aim of the study is to investigate if the ambulance transports to the Emergency Room can be reduced by a dialogue between a Registered Nurse in ambulance and a Medical Doctor in the Primary Care (called "Ambulant assessment"). In this connection there is also a need to follow up patients that not have been transported to the Emergency Room, secondary ambulance transport, relapse within 48 hours, type of examination and treatment and mortality.


Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years
* ambulance missions in the Community of Borlänge/Falun (case) and Community of Leksand (control)
* weekday and weekend, 08:00 to 22:00
* initially evaluated not to need urgent Medical care according RETTS

Exclusion Criteria:

* initially evaluated need urgent Medical care according RETTS
* the patient unable to give consent to the study
* patient with existing care plan
* ambulance mission without patient
A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies

This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
* CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study

Exclusion Criteria:

* Pregnant or lactating women
* Refusal to use adequate contraceptive measures among men and women of childbearing potential
Effectiveness of Exercises Given Along With Ergonomics Training in Textile Workers

The aim of this study is to investigate the effectiveness of ergonomic training and exercise training given to workers in a textile factory.

The study will include workers between the ages of 18-60 who have neck pain and work at Ölmezler Textile Industry Trade limited company in Van province. Participants will be divided into two groups as experimental and control groups. All participants will receive ergonomic training. In addition, exercise training will be given to individuals in the experimental group. Exercises will be explained individually and will be supported with an exercise brochure. Craniosacral therapy will also be applied to the experimental group and a brochure will be given to teach joint protection principles. Participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. The given exercises will be followed with an exercise follow-up chart. An evaluation will be made before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-60 years old
* Working full time
* Experiencing neck pain

Exclusion Criteria:

* Being under 18 or over 60 years old
* Presence of diseases accompanying neck pain
* Exercise intolerance
* Working part time
The QUALITY Vets Project: Muscle Quality and Kidney Disease

Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.

The accelerated muscle wasting associated with chronic kidney disease (CKD) is a source of morbidity and an increased incidence of bone fracture secondary to falls. However, sarcopenia secondary to CKD is not routinely screened or assessed in this patient population. This protocol, "Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans Project" (i.e., QUALITY VETS) is a VA Center for Innovation (VACI) funded pilot study with the purpose of using a clinically viable sarcopenia screening approach for Veterans with CKD who are currently receiving care at the Renal Service.

The investigative team will screen and assess diminished muscle mass, quality, and performance in Veterans with CKD (Stage 3 and 4), and also examine the relationship between the muscle characteristics and estimated fall risk within the sample. Key outcome measures will be obtained within the domains of muscle performance (peak grip strength), functional status (Short Physical Performance Battery), estimates of tissue/body composition (diagnostic ultrasound and DXA), and fall risk (Timed Up-and-Go test). Secondary measures will include questionnaires regarding of fall avoidance, physical activity, depression, and quality of life (QoL).

The general analysis approach will be to characterize the proportion of participants with: sarcopenia based on the European Working Group on Sarcopenia in Older People (EWGSOP) algorithm, low muscle quality based on preliminary echogenicity cut off values and criterion strength values, and an elevated risk of falling based on the Timed Up-and-Go age-dependent cut off values. Investigators will determine the magnitude of association between the skeletal muscle outcomes and fall risk within the participant sample. Hazard ratios will be used to estimate the impact of the sarcopenia classification and echogenicity values on the positive classification of fall risk.

The optimal treatment of Veterans with CKD who have an elevated risk of falls may be enhanced by the timely identification of accelerated muscle changes. The QUALITY-VETS Project will help to determine appropriate screening and assessment strategies that could be implemented in subsequent longitudinal studies involving exercise interventions and fall prevention training.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients (with or without a gait aid)
* 18-84.9 years of age with CKD stage 3 or 4
* Receiving care at the DC or SF VA Medical Center Renal Service
* Able to speak and read English
* Orientation to person, place, and time

Exclusion Criteria:

* Acute renal failure
* Pregnancy
* Any uncontrolled cardiovascular or musculoskeletal disease that, in the opinion of the principal investigator, could make participation unsafe
* Body size exceeds the dimensional limits of the DXA scanner
Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload

Safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (DR) tablets in patients with systemic iron overload.

This study is looking at the safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (DR) tablets in patients with systemic iron overload who are currently taking deferiprone immediate-release tablets (Ferriprox) three times a day. Ferriprox doses range from 75 milligrams per kilogram of body weight (mg/kg) per day to 100 mg/kg per day. Half the patients in the study will be on a dosage that is closer to the low end of the range, and half will be on a dosage that is closer to the high end. Both groups will be switched for one month to deferiprone DR tablets at approximately the same total daily dosage that they have been taking for Ferriprox.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 18 years.
2. Diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a regular regimen of red blood cell transfusions.
3. On a stable regimen (≥3 months) of Ferriprox tablets for the treatment of systemic iron overload.
4. Absolute neutrophil count ≥1.5 x 10\^9/L at screening.
5. A record of at least 12 measured alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.

Exclusion Criteria:

1. Receipt of any iron chelator other than Ferriprox (i.e., combination therapy) in the last 3 months, or planning to receive it at any time during the period of the study.
2. ALT and/or AST value \> 5 times the upper limit of normal (ULN) at screening
3. Active case of hepatitis B or C at screening.