cyrilzakka/clinical-trials huggingface dataset:
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.


Eligibility Criteria:
Inclusion Criteria

* Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer
* Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease)
* Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2
* Patients must be age ≥ 18 years
* Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the imaging
* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria

* Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments)
* Patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan
* Patients may not be receiving any other treatments or investigational agents
* Patients with a GFR \<30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria
* Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral)
* Patients who have received androgen deprivation therapy or prior surgery for prostate cancer
* Patients who report taking multivitamins and/or folate supplements on the day of the scan
Reliability and Validity of Urdu Version of Global Physical Activity Questionnaire (GPAQ-U)

The GPAQ questionnaire is used to measure the physical activity. In this study, Investigators will observe the reliability and validity of global physical activity questionnaire in Urdu language in Pakistan among students to assess physical activity.

The aim of study is to translate and culturally adapt Global physical Activity Questionnaire (GPAQ) into Urdu language and secondly to investigate the reliability and validity of GPAQ in Pakistan among university students. This study will be cross sectional survey study in which convenience sampling technique will be used.

The results of study will help to know the validity and reliability of GPAQ in Urdu version among students in Pakistan. The reliability of the questionnaire will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient with 100 patients

Eligibility Criteria:
Inclusion Criteria:

- Male and female aged over 18 years Pakistani national and native Urdu speakers Able to read and understand Urdu Studying in University level

Exclusion Criteria:

Male or female having any disability Any recent illness or any injury
Maternal Plasmatic Regulatory T Cells and Th17 as Possible Diagnosis Markers of Acute Chorioamnionitis

The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.

Acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. The PPROM is a high risk condition for developing chorioamnionitis. Available biological markers have a low prognostic value. Indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery.

Moreover, pregnancy is an immunologic particular condition. Indeed an immune tolerance is required with respect to the fetus and is mediated by Treg lymphocytes, which suppressed Th17 activity.

Recent studies have shown among women with frequent miscarriages, a balance between Treg and Th17, with a decrease in Treg number and an increase in Th17 number in decidua and blood.

In case of infection, the immune pro-inflammatory response (Th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. This restoration of this pro-inflammatory response could be due to a modification of Treg number ou tolerogenic activity.

In this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of Th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Patient affiliated with a social security scheme
* term pregnancy betwwen 24 and 34 weeks
* PPROM diagnosis
* singleton pregnancy

Exclusion Criteria:

* delivery occured in 1 hour after admission
* hemorragic praevia placenta or retro-placental hematoma
* confirmed autoimmune or inflammatory disease
* confirmed infectious disease by VIH, VHC, and VHB
NC Thermometer (Gen 3) ISO 80601-2-56 Validation

The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.

The purpose of this clinical study is to validate the clinical accuracy of the NC° Thermometer (Gen 3) according to the requirements of ISO 80601-2-56:2017. The NC° Thermometer (Gen 3) (the device under study (DUT)) is a predictive thermometer that operates in adjusted mode. The Welch Allyn oral thermometer (Welch Allyn Spot Vital Signs 420 SureTemp temperature module, Welch Allyn, San Diego, CA) with a measurement accuracy of ± 0.1 °C in monitor mode will be used the reference clinical thermometer (RCT). During the clinical study, subjects will be asked to perform three consecutive oral measurements with the DUT, and one oral measurement with the RCT.

Eligibility Criteria:
Inclusion Criteria:

* They are more than 5 years old
* They have not taken any antipyretic in the preceding 120 minutes
* They have no medical conditions which might impact the clinical accuracy validation results, such as inflammation at the measuring site (the mouth)
* They are not taking medications such as barbiturates, thyroid preparations, antipsychotics, and recent immunizations
Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)

This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered by the Aerolizer device in terms of efficacy, in patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* History of asthma attacks
* Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value

Exclusion Criteria:

* Asthma is not stable: patients were admitted to hospital or received emergency room treatment
* Patients whose asthma drugs need changing within the month prior to the start of the study
Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes

Functional fitness training (FFT) is a prominent exercise regimen, that has emerged as the dominant fitness trend of the 21st century , advocating high-intensity exercises with repetitive, impactful movements that often result in increased intra-abdominal pressure (IAP) and neuromuscular fatigue. This demanding training pattern, characterized by minimal rest pauses, has been associated with potential health concerns, particularly urinary incontinence (UI). In athletes, UI is intricately connected to the frequency of exposure to increased IAP during high-impact activities. These activities assume even greater significance in sports, particularly in FFT, where there is an increased frequency of impactful foot contact on the ground and intensive abdominal exercises, potentially correlating with the overload of the pelvic floor muscles and the emergence of dysfunctions. Therefore, this study aims to examine the effects of a 12-week training program focused on Kegel exercises performed with diaphragmatic breathing in nulliparous female FFT athletes. The central hypothesis postulates that after the 12-week intervention, these women will exhibit enhancements in both the muscular activation and contractile capacity of their pelvic floor, leading to a reduction in instances of urine leakage.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous FFT female athletes
* had been practicing FFT or weightlifting for at least 2 years
* train a minimum of 3 days/week
* had not previously performed pelvic floor exercises
* had no medical contraindications or previous pelvic floor surgeries

Exclusion Criteria:

* Any criterion that does not meet the inclusion criteria
Extension to the Study of Efficacy of CDZ173 in Patients with APDS/PASLI

This study is designed to provide long-term CDZ173 treatment, a selective PI3Kδ inhibitor, to the patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI who participated in the CCDZ173X2201 study or who were treated previously with PI3Kδ inhibitors other than CDZ173. The study is open-label designed to establish the long-term safety, tolerability, efficay and pharmacokinetics of CDZ173 in the target population.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Paients must have participated in the study CCDZ173X2201 or were treated previously with PI3Kδ inhibitors other than CDZ173.
* Patients who are deemed by the Investigator to benefit from PI3Kδ inhibitor therapy.
* Patients or their legal representatives (for patients under the age of 18 years) must be able to communicate well with the Investigator, to understand and comply with the requirements of the study.
* Documented APDS/PASLI-associated genetic PI3K delta mutation.

Exclusion Criteria:

- Any medically significant disease or condition that is unrelated to APDS/PASLI

Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient

This study will evaluate the perceptions of the effects of two anxiolytic medications commonly used during dental treatment in patients weighing 40 kilograms or more.

Midazolam and nitrous oxide are commonly used in pediatric patients requiring anxiolysis during dental treatment. Triazolam and nitrous oxide are commonly used in adult patients requiring anxiolysis during dental treatment. The participants in this study are patients already scheduled for 2 sedation appointments to complete their dental treatment. The medications are both benzodiazepines that have similar risks, neither medication has greater adverse effects than the other. This study will evaluate the perceptions of the effects of the medications via a parent survey and chart review. The goal of the study is to determine which anxiolytic medication is perceived to provide a better sedation experience for older pediatric patients based on parent perception of the medication's effects and the patient's behavior during dental treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Weigh 40 kilograms or more.
2. 2/4 or 3/4 Frankl Behavioral Rating at their evaluation appointment.
3. Dental treatment that requires two sedation appointments. Dental treatment that requires sedation includes: fillings, crowns, pulpotomies and/or extractions.
4. Between the ages of 7-17 years old.

Exclusion Criteria:

1. Patients taking any of the following medications will be excluded from the study: Atripia, cimetidine, diltiazem, erythromycin, fluconazole, grapefruit juice, isoniazid, itraconazole, ketoconazole, nefazodone, rifampicin, ritonavir, fusidic acid, idelalisisb, methadone, olanzapine, thalidomide and/or troleandomycin.
2. Pregnant patients will be excluded.
3. Patients that have HIV-1 that is being treated with a protease inhibitor will be excluded.
4. Patients with a MTHFR mutation will be excluded.
5. Patients with acute narrow angle glaucoma will be excluded.
6. Patients that have had a previous adverse, paradoxical or allergic reaction to any benzodiazepines will be excluded from the study.
7. Patients unable to swallow medication in tablet form.
8. Patients that do not speak English as their primary language.
Lung Cancer Biomarkers and Screening

RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer.

PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.

OBJECTIVES:

* Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers.
* Identify preneoplastic cellular changes and lesions in these patients.

OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk).

Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy.

Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy.

PROJECTED ACCRUAL: A total of participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Screening Cohort

  * At high- or low-risk for lung cancer
  * Smoking history ≥ 20 pack years\*

    * With or without workplace exposure to asbestos
* NOTE: \* Participants with \< 20 pack years of smoking are eligible if 50 years of age or older
* Rule-Out Lung cancer group

  * Referred for evaluation of suspicious nodules with 1 of the following diagnoses:

    * Lung cancer
    * Nonmalignant nodules (control group)

PATIENT CHARACTERISTICS:

* Not pregnant
* No prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

* Not specified
Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men

It seems plausible that increased aromatase activity in obese men, as a result of a larger fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition increases testosterone levels, which may affect hepatic and cardiac function.

In this intervention study two groups of hypogonadal obese men are compared. Group A is treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a group with normal testosterone and low oestrogen concentrations. Group B is treated with placebo once every two days during four months; this group will retain low testosterone - and high oestrogenic concentrations.

The primary objective of the study is to evaluate effects of changed sex steroids in obese men on hepatic and cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* Obese male subjects
* Planned for gastric bypass (BMI \> 30 kg/m²)
* low testosterone levels
* age between 20 and 65

Exclusion Criteria:

* Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumours, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
* Treatment with corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
* Impaired renal function defined as serum-creatine \> 1.5 mg/dL
* Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
* Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
* Palpable prostate nodule or induration, Prostate-specific antigen (PSA) \> 3 ng/mL, prostatism, untreated sleep apnea syndrome, erythrocytosis (hematocrit \> 50%) or hyperviscosity. (cfr. Endocrine Society Clinical Practice Guideline by Bhasin S et al.)
* Known or suspected abuse of alcohol or narcotics
Use of Ketamine Associate With an Opioid for Sedation in ICU

The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.

All consecutive mechanically ventilated patients admitted in the intensive care unit (ICU)will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.

Eligibility Criteria:
Inclusion Criteria:

* all patients under mechanical ventilation

Exclusion Criteria:

* pregnant
* psychotic
* chronic use of opiates
* age \< 18 years
The Cardiopulmonary Effects and Diaphragm Function of Complete Inspiratory Muscle Training in Patients With Upper Abdominal Surgery

Upper abdominal surgical treatment may have reduced respiratory muscle function and mucociliary clearance, which might be a consequence of postoperative pulmonary complications (PPCs). The threshold inspiratory muscle training (IMT) may serve as an effective modality to improve respiratory muscle strength and endurance in patients. However, whether this training could help patients with upper abdominal surgery remain to be determined.


Eligibility Criteria:
Inclusion Criteria:

1. ≧20 years old with upper abdominal surgery,
2. American Society of Anesthesiologists; ASA) I-IV
3. body Mass Index; BMI≥ 18
4. able to follow exercise protocol. T

Exclusion Criteria:

1. history of prior abdominal surgery
2. high risk of exercise contraindications (e.g. severe cardiac or cardiovascular disease), 3) American Society of Anesthesiologists; ASA) V-IV

4) unable to follow exercise protocol 5) severe organ failure
A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer

The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.


Eligibility Criteria:
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

* Age 18 years or older
* Diagnosis of colorectal cancer or adenocarcinoma of the appendix
* A tumor mass that can be measured
* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1
* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures

Exclusion Criteria:

* Women that are pregnant or lactating
* Prior treatment with Irinotecan
* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication
* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization
* Current enrollment in another clinical trial
* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer
Post-COVID 19 Patients Undergoing Surgery

More and more patients are undergoing elective surgery after SARS-CoV-2 infection, and little is known about the residual pulmonary changes in these patients after infection and postoperative pulmonary complications. So, we propose an observational study comparing postCOVID-19 patients with normal population (control group) undergoing surgery.

The most common lung complications of severe COVID-19 are pneumonia and hypoxemic respiratory failure/ARDS. Manifestations of lung inflammation or fibrosis were also observed in late stages of COVID-19 causing respiratory sequelae. Fibrous lesions may form during the healing of pulmonary chronic inflammation or proliferative diseases, with gradual replacement of cellular components by scar tissues indicating a poor outcome of COVID-19. Ultrasound allows to stratify the severity of lung damage and combined with the clinic, can help estimate the patient's prognosis and support therapeutic decision-making. On the other hand, pulmonary inflammatory processes and fibrosis are responsible for a decrease in respiratory distensibility or pulmonary compliance. Pulmonary parenchyma distensibility is known as static distensibility or compliance and it´s calculated by mechanical ventilators during general anesthesia.

There are no studies that determine the results of lung ultrasound and pulmonary compliance in preoperative and intraoperative period respectively in postCOVID patients, and the postoperative complications of postCOVID patients are poorly understood.

Eligibility Criteria:
Control group

Inclusion criteria.:

-Patients over the age of 18 who did not have COVID-19 and who are going to undergo scheduled surgery

Exclusion criteria:

* Patients under the age of 18.
* Unstable patients in shock
* Patients in current state of pulmonary hypertension or heart failure
* Patients with moderate-severe pulmonary pathology prior to surgery.
* Patients previously surgery for chest surgery
* Patients in current state of respiratory infection

Post-COVID group Inclusion criteria

-Post-COVID-19 patients (confirmed by PCR) \>18 years undergoing scheduled surgery without pulmonary disease prior to SARS-CoV-2 infection, that at the time of surgery present negative PCR and absence of clinic due to SARS-CoV-2 infection.

Exclusion criteria:

* Patients under the age of 18
* Unstable patients in shock
* Patients in current state of pulmonary hypertension or heart failure
* Patients with moderate-severe pulmonary pathology prior to SARS-CoV-2.
* Patients previously surgery for chest surgery
* Patients in current state of respiratory infection