cyrilzakka/clinical-trials huggingface dataset:
RUT vs. Molecular Testing for H. Pylori

The rapid urease test (RUT) is frequently performed for diagnosis of Helicobacter pylori infection in clinical practice. The RUT is a simple and inexpensive method that utilizes a commercial kit containing urea and a pH indicator such as phenol red. In the presence of H. pylori urease, urea is hydrolyzed to ammonia, which raises the pH of the medium, and changes the color of the kit from yellow to magenta or pink. The sensitivity and specificity of RUT were reported to range between 80-100% and 97-99%, respectively. When endoscopy is performed, RUT is known as the first-line method used for H. pylori diagnosis. However, RUT is an indirect test method, and has the disadvantage of causing false positivity due to other urease-producing bacteria.

To date, gold standards for H. pylori diagnosis are culture and histological examination Because H. pylori is a rather fastidious and slow-growing bacterium, antimicrobial susceptibility testing using culture methods is time-consuming (10-14 days) and requires specific expertise. Recently, dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection. Moreover, molecular testing can identify point mutations related to clarithromycin resistance. It can be performed in a standard thermocycler and takes only 4 h to complete. The concordance rate between conventional clarithromycin susceptibility testing and DPO-PCR was excellent up to 95%. However, there was no comparison study between RUT and molecular testing for H. pylori diagnosis.

The investigators aim to compare the diagnostic accuracy of the RUT and molecular testing, and identify clinical factors associated with the discordant results between the two methods.

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness

This study evaluates the consumption of Açaí Juçara pulp in endothelial function and arterial stiffness in overwheight and obese individuals. Half of participants will receive a hipocaloric diet and two Açaí Juçara pulps for daily consumption, while the other half will receive just a hipocaloric diet.

Obesity is the most prevalent nutritional disease and a growing public health problem worldwide. This clinical condition is an established risk factor for cardiovascular diseases.

Açaí Juçara is a brazilian fruit, rich in antioxidants, like anthocyanin. This compound have antioxidative and vasodilatory properties. Prospective studies have shown that the antioxidant present in berries can improve vascular health, like endothelial function, measured by Flow Mediated Dilatation (FMD) and arterial stiffness, measured by Pulse Wave Velocity (PWV).

Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle
* Overwheight or obesity "1" diagnostic (BMI \>25kg/m² and \<35kg/m²)

Exclusion Criteria:

* Alcoolism
* Smoking
* Diagnostic of Diabetes Mellitus or Coronary Artery Disease
* Use of Statin Therapy
* Cardiovascular diseases
* Infectious Disease
NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.

It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will demonstrate improved sensitivity over that of standard urine cytology for patients with superficial transitional cell carcinoma at high risk of recurrence.

Patients who have been previously treated for bladder cancer and are at a high risk for recurrence are being monitored for recurrence every 3 months with urine cytology and cystoscopy as part of standard care.The NMP22 Bladder Cancer ® Test Kit has been designed to provide an alternative to regular urine cytology. A urine sample will be provided and divided with a portion being used to assess the NMP22 test kit and the remaining sample to be sent to the lab for regular urine cytology. Patient charts will be reviewed by a medical student to record age, clinical stage, pathologic stage, time to disease progression/recurrence, site of recurrence and survival data.

Eligibility Criteria:
Inclusion Criteria:

* · History of pTis, pT1, large (\>2cm) pTa or multiple pTa bladder cancer tumours.

Written Informed Consent prior to any study-related procedures.

Exclusion Criteria:

* History of bladder cancer tumours other than those listed in inclusion
In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma

Glioblastoma (GBM) is the most frequent brain tumor. Currently survival is poor and few treatments are available. Recent data show that there is no immune privilege of the central nervous system (CNS) and that GBM are invaded by effector CD8 T cells, letting us hypothesis that GBM growth is dependent of immunosurveillance.

The aim of this study is to better understand the antitumor immune response against GBM to unravel new effectors and immunosuppressive pathways important for the regulation of anticancer immunity and to discover new immune activating strategies with the objectives to isolate subgroups of GBMs that could benefit from an immunotherapy approach. To achieve this goal, GBM tumor samples and a blood sample will be collected during the initial tumor resection.

The sites involved in the recruitment of the patients will be the neurosurgical teams in Brussel, Dijon, Nantes and Padova.

Primary objective :

The primary objective is to determine for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters

Secondary objectives :

To identify the best combination of in vivo immune parameters that is predictive of 1-year overall survival To determine the impact of immune parameters on overall survival Create a collection of biological samples

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed, brain tumor
2. Gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron.
3. Subjects ≥18 and ≤75 years of age at surgery
4. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
5. Confirmation of the diagnosis of grade IV GBM by the local pathologist with an independent neuropathologist who will review this diagnosis
6. Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent temozolomide chemotherapy.
7. Tumor biopsy for biological analysis has to be performed before using ultrasonic surgery

Exclusion Criteria:

1. Patient with other type of primary brain tumor or metastases
2. Patients with only biopsy performed for the diagnosis
3. Subjects under guardianship, curatorship or judicial protection
4. Female subjects who are pregnant or breast-feeding
Progressive Muscle Relaxation and Cigarette Craving

Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.

The study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* Daily cigarette smokers

Exclusion Criteria:

* Hospitalization
* Participating in cigarette dependency treatment or trying to quit smoking with other methods
* Uncontrolled blood pressure
* Current other substance users (except alcohol)
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.

The radiation involved in this study is:

-Proton Radiation

This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.

The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.

In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 3 years and ≤ 18 years at the time of registration
* Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
* Life expectancy ≥ 12 months.
* Signed informed consent document and assent when appropriate.
* HGB of \> 10 g/L and PLT count \> 80 K/uL

Exclusion Criteria:

* Any prior therapeutic radiation therapy \> 500 cGy has been delivered.
* Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
* Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements.
* Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
* Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.
Food Effect Study of CTP-543 in Healthy Volunteers

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18 and 55 years of age, inclusive
* Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening

Exclusion Criteria:

* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions
* PR interval \> 220 msec or QRS duration \> 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
* Urinalysis positive for greater than trace blood, protein or glucose
* History of drug or alcohol abuse within 6 months of screening
* History of tobacco product use within 3 months prior to the study
* Inability to comply with dietary restrictions during study participation
* Blood donation or collection within 8 week prior to dosing
* Positive pregnancy test
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)

To determine whether tariquidar + combined first-line chemotherapy of paclitaxel/carboplatin in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly improve overall survival compared with placebo + paclitaxel/carboplatin. To compare the effects of tariquidar/paclitaxel/carboplatin with placebo/paclitaxel/carboplatin on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with Stage IIIb/IV NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage IV, requiring first-line chemotherapy.
2. Patients who have a WHO performance status of 1 or 0 and life expectancy of greater than 3 months.
3. Patients who are 18 years of age or older and age of consent.
4. Patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control.
5. Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine less or equal to 141 µmol/L (1.6 mg/dL) or calculated creatinine clearance greater or equal to 60 mL/min prior to study treatment.
6. Patients who are able to give written informed consent and comply with the protocol.

Exclusion Criteria:

1. Patients who are eligible for radiotherapy or surgery for curative intent.
2. Patients who have had previous chemotherapy for NSCLC.
3. Patients who have a WHO performance status greater than 1.
4. Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from WHO histological typing of lung tumors \[1\]).
5. Patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma.
6. Patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections.
7. Patients who have symptomatic brain metastases.
8. Patients who have peripheral neuropathy of CTC grade 2, 3, or 4.
9. Patients who have other medical or surgical conditions that would contraindicate chemotherapy.
10. Patients who have received experimental therapies within the last 4 weeks.
11. Patients who have known hypervitaminosis or known sensitivity to ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin E.
Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins and Lower Limb Function

The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.

The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old (the latter to reduce likelihood of heart disease)
* Medically stable with medical clearance from physician to participate
* Motor-incomplete spinal cord injuries at or below C2 and at or above L5
* AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.)
* More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery
* Ability to advance one step overground with or without assistive devices;

Exclusion Criteria:

* Severe concurrent illness or pain
* Recurrent autonomic dysreflexia
* History of cardiovascular/pulmonary complications
* Concurrent physical therapy
* Pregnant at time of enrollment or planning to become pregnant
* Untreated painful musculoskeletal dysfunction, fracture or pressure sore
* History of seizures or epilepsy
* Recurring headaches
* Concussion within the last six months
* Depression or manic disorder
* Metal implants in the head, or pacemaker
* Aversion to needles
A Study to Confirm the Long-term Safety and Effectiveness of Kalydeco in Patients With Cystic Fibrosis Who Have an R117H-CFTR Mutation, Including Pediatric Patients

The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco® (ivacaftor) in US CF patients with the R117H-CFTR mutation \<18 years of age and to describe the long-term safety and effectiveness of Kalydeco in CF patients with the R117H-CFTR mutation overall and in patients ≥18 years. The long-term safety and effectiveness of Kalydeco will be examined in totality through the evaluation of the primary outcome measures.

Patient follow-up (i.e., collection of outcomes data after treatment initiation) in the Non-Interventional Cohort will be at least 36 months. The study also includes retrieval of retrospective data entered into the registry for 36 months before the initiation of Kalydeco treatment, from patients matched for Non-Interventional Cohorts. This will permit a within-group comparison of outcomes before and after Kalydeco treatment for effectiveness and safety. The interventional cohort will not be utilized.

Eligibility Criteria:
Inclusion Criteria:

Non Interventional Cohort

* Male or female with confirmed diagnosis of CF
* Must have at least 1 allele of the R117H-CFTR mutation
* Enrolled in the US CFF Patient Registry
* With a record of Kalydeco treatment initiation from 01 January 2015 through 31 December 2016

Historical Cohort

* Patients with CF in the CFF Patient Registry as of 01 January 2009
* Must have at least 1 allele of the R117H-CFTR mutation
* Patients with no evidence of any prior Kalydeco exposure
Therapeutic Adherence in Patients With Chronic Diseases

Objectives of the study are:

* The validation of the GMAS questionnaire in patients with chronic disease.
* Measurement of the level of therapeutic adherence in patients with chronic illness.
* Measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.

The research is multicentre and will be conducted at the Fondazione Policlinico Gemelli IRCCS in Rome as reference centre together with the other participating centres. Patients will be enrolled at the centres involved, either during visits or during their hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Chronically ill;
* Age 18 years or older;
* Willingness to participate in the study;
* Chronic illness diagnosed at least 3 months before the start of the study;
* Reading and signing the informed consent.

Exclusion Criteria:

* Reduced command of the Italian language;
* Subjects suffering from severe psychiatric disorders;
* Serious clinical conditions that do not permit completion of the questionnaire;
* Refusal to sign the informed consent to participate in the study.
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit

This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.

Exclusion Criteria:

* Insertion of the central catheter in emergency situations;
* Anatomical abnormalities of upper extremity affecting PICC placement;
* Current or recent (within 1 month) diagnosis of bacteremia
* Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;
* Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant

This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.


Eligibility Criteria:
Inclusion Criteria:

1. Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
2. Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
3. Be in neutral alignment +/- 5 degrees of the mechanical axis.
4. Be between age 35 and 75 at the time of the planned surgery.
5. Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
6. Have a normal mental status.
7. Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
8. Be able and willing to understand and sign the informed consent form.

Exclusion Criteria:

1. Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
2. Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
3. Have a varus or valgus knee deformity \> 5 degrees.
4. Have a laxity level of more than II (ICRS), secondary to previous injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL).
5. Have patella instability or non-anatomically positioned patella
6. Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
7. Need a tibial osteotomy at the time of surgery.
8. Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
9. Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
10. Have a knee flexion contracture \> 10 degrees
11. Be unable to flex the knee to 90 degrees
12. Have a leg length discrepancy causing a noticeable limp.
13. Have had a previous major knee condyle surgery
14. Present with insufficiency fractures or avascular necrosis of the medial compartment.
15. Have an active infection or tumor.
16. Have any type of knee joint inflammatory disease including Sjogren's syndrome.
17. Have neuropathic knee osteoarthropathy, also known as Charcot joint.
18. Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
19. Be pregnant or is a female intending to become pregnant during the study period.
20. Be mentally incapacitated.
21. Be a prisoner.
22. Be a patient who has economic incentive not to improve (e.g., workman's compensation patient)
23. Be morbidly Obese (BMI \> 35).
24. Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee