cyrilzakka/clinical-trials huggingface dataset:
Screening for Breast Cancer With Digital Breast Tomosynthesis

Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.

The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).

Women will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.

All examinations will be read by two independent radiologists, in case of discordance a third reading is asked.

Eligibility Criteria:
Inclusion Criteria:

45-70 years old women invited to breast cancer screening program who accepted to participate

Exclusion Criteria:

* previous breast cancer diagnosis
* pregnancy or suspicion of pregnancy
* presence of BRCA1/2 gene mutation
* Previous Digital Breast Tomosynthesis performed
* unable to understand informed consent
* chemotherapy in progress
* presence of breast implant
GNAO1 Natural History Study

The purpose of the GNAO1 Natural History Study is to establish the clinical phenotype of GNAO1 associated neurologic disease, its association with genotype, and areas of clinical importance within the disease.

GNAO1 associated neurologic disease is a rare autosomal dominant neurodevelopmental disorder characterized genetically by heterozygous de novo mutations in GNAO1 gene which encodes Gαo, the α subunit of Go, a G protein signal transducer. Phenotypically, it is characterized by developmental delay, epilepsy and/or movement disorder. Medical therapy is symptomatic and often ineffective for many patients. While there are basic and translational studies underway to develop more mechanistic treatments aimed at developing disease modifying treatments, our general knowledge of the natural history of GNAO1 associated neurologicis is extremely limited, making it difficult to select the best measures for identifying changes over time. Without this information,it will be difficult to detect any potential therapeutic efficacy in future trials of novel therapies. To address this critical void in our understanding, we propose to retrospectively and prospectively examine symptom progression(short-and long-term)and developmental outcomes in patients with GNAO1 associated neurologic disease. Retrospective data will be collected on a cohort of 50 patients. Standardized historical clinical information will be received from the physicians and care-givers of these patients, in collaboration with the Bow Foundation Registry. These data will provide an overview of the onset and severity of symptoms over development. In addition, prospective data will be acquired during in-person clinical evaluations of a cohort of 15-20 patients who are not receiving any experimental interventions. In combination, these two approaches will provide critical information about the natural history of GNAO1 associated neurologic disease in children, identify metrics that track change most reliably over time, and collect pilot data for larger future studies.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the Bow Foundation GNAO1 registry.
* Evidence of a known pathogenic mutation in GNAO1 or a variant of unknown significance and clinical symptoms likely to be consistent with GNAO1 as determined by study physicians.

Exclusion Criteria:

* Inability to obtain informed consent from parents or adult subjects.
* Inability to obtain medical records.
Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients

Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.

Obesity is a chronic disease associated with chronic inflammation, insulin resistance, dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA which could be detected with alkine comet assay and its version with use of formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume samples. Dietary caloric restriction has beneficial effects on insulin sensitivity, inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce, especially on the changing levels of DNA damage.This study will assess the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body composition and biochemical parameters.

Eligibility Criteria:
Inclusion Criteria:

* body mass index ≥ 35 kg/m2

Exclusion Criteria:

* pregnancy
* actual tumor diseases
* recent diagnostic or treatment exposures to ionizing radiation in the period of one year
* individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data

This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.


Eligibility Criteria:
Inclusion criteria:

DLBCL population:

* Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
* Diagnosed with DLBCL (International Classification of Diseases \[ICD-10 C833\]) when receiving CAR-T AND
* Being 18 years of age or older.

ALL population:

* Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
* Diagnosed with ALL (ICD-10 C910) when receiving CAR-T AND
* Being 25 years of age or younger.

Exclusion criteria:

DLBCL population:

• Patients hospitalised with a diagnosis other than DLBCL during the historical period or during the index stay.

ALL population:

• Patients hospitalised with a diagnosis other than ALL during the historical period or during the index stay.
A Study of CLR325 in Chronic Stable Heart Failure Patients.

The purpose of this study was to determine the safety and tolerability of CLR325 intravenous (i.v.) infusion in patients with stable heart failure to determine if further clinical development of the drug in this indication was warranted.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients \>18 years of age
* Body weight between 50 kg and 140 kg
* Cardiac ejection fraction of ≤ 45% assessed within the last 6 months
* For PA catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization
* In the opinion of the investigator, heart failure patients who do not require a change in their dose of acetylcholinesterase (ACE), angiotensin receptor blocker (ARB), β-blocker, mineralocorticoid receptor antagonist, or diuretic for 24 h after randomization.
* At Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) assessment in the supine position after the subject has rested for at least five minutes.

Key Exclusion Criteria:

* Impaired renal function as indicated by clinically significant abnormal creatinine values (Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 calculated using the Modification of Diet in Renal Disease Study (MDRD) equation)
* History of chronic hepatitis of any non-cardiac etiology
* History of any active or clinically significant cardiac tachyarrhythmia (such as recurrent atrial fibrillation with rapid ventricular response within the last year) and patients with chronic atrial fibrillation with a pulse rate ≤ 100 bpm
* Patients who received an i.v. infusion of a cardiac inotrope (e.g., dobutamine or milrinone) in the last 24 h prior to randomization
* Patients with any significant change in their dose of their ACE, ARB, mineralocorticoid receptor antagonist, diuretic, or β-blocker within the last 12 h
* Patients with known significant valvular heart diseases indicated by the following:

  * severe aortic stenosis (aortic valve area \< 1.0 cm2 or peak gradient \> 50 mm Hg as determined by echocardiography)
  * severe mitral stenosis
* History of acute coronary syndrome within the last 60 days as determined by both clinical and enzymatic criteria
* For echocardiography-based cohorts only, patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days
* For PA catheter cohorts, patients with a pulmonary capillary wedge pressure of \<10 mm Hg at Baseline. For echocardiographic cohorts, patients with a lateral E/E' ratio of \< 7 on their baseline echocardiogram. For patients in whom a lateral E/E' ratio cannot be determined (e.g., patients in atrial fibrillation), a central venous pressure of \< 5 mm Hg on baseline echocardiogram as determined by inferior vena cava criteria.
A Study of PTS for Patients With Solid Tumors

The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment.

The study will be an open, uncontrolled, single-center, phase I study to assess the safety and tolerability of local intra-tumoral injection 2.0ml (660mg), 4.0ml (1220mg), 6.0ml (1880mg) and 8.0ml (2440mg) PTS in female breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are diagnosed as unsuitable for surgical operations or refuse to do so.
* Subject's performance status is classified as Grade 0 to Grade 3. Estimated survival time should be longer than 6 months of time.
* Physical examinations show no serious functional disorders of the heart, liver, kidneys, or blood.
* Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3 months recovery time is required before treating with this investigational drug.
* Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not suitable for surgery, or refuses to be operated.
* Subject should show lobular atelectasis with either complete or incomplete obstruction of the bronchi.
* Physical examinations should show no functional disorders of the heart, liver, kidneys, central nervous system, and blood.
* Subject performance status to be classified from Grade 0 to Grade 3, who can tolerate the fiberoptic bronchoscopy treatments.
* In-patient is preferred. When subject is in satisfactory conditions, the out Cpatient can also be enrolled in this trial.
* Two to three months recovery time is required for the subject has just received radio or chemotherapy.
* Emergency request, subjects with serious lobular atelectasis and almost complete obstruction of the bronchi.
* With the aid of a tracheal intubation and the help of the respirator, PTS may be intraumorally injected into the obstructed lesion via fiberoptic bronchoscopy outside of the tube, alongside of the intubation.

Exclusion Criteria:

* Pregnant women and children will not be used as test subjects.
* Subjects with serious functional disorders of the heart, liver, kidneys, or blood will be excluded.
* Subjects who do not want to participate in the trial will not be used as test subjects.
* Subject does not agree to participate.
* Subject performance status is Grade 4, and the one who does not want to tolerate the discomfort of the PTS treatments via fiberoptic bronchscopy.
Phone Nurse Consultation Benefit on Compliance With PreOperative Instructions for Patients Undergoing Scheduled Surgery

A preoperative reception unit (PORU) has been created at Foch Hospital to receive patients needing surgery and entering the same day of the operation (D0) as part of the reduction in average lengths of stay. This new mode of care requires a specific organization which requires the patient to become the main actor in his preparation.To optimize and make this new care fluid, a phone nurse consultation has been set up to support patients. The objective of this consultation is to discuss with the patient the different stages of his journey. The nurse checks the patient's level of information and reformulates if necessary so that he can receive clear and appropriate information, verifies that the patient has correctly integrated all that is expected for his preoperative preparation. It thus makes it possible to anticipate the issues that could impact the patient care process.The relevance of this consultation has never been assessed. However, the nurses have always good feedback from patients who are often surprised, satisfied with this interview and attentive. On the other hand, nurses who receive patients on the day of their intervention in PORU observe better fluidity in the care of patients who have had a phone nurse consultation. The patient is better prepared, which allows simpler and faster care.

This randomized controlled study will allow investigators to validate the perception of nurse and to assess the relevance of this phone nurse consultation in the best preoperative preparation of patients, the management of preoperative anxiety and the fluidity of patient care.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or over,
* Willing to undergo a scheduled surgery at Foch Hospital and entering the hospital the same morning of his intervention in the Preoperative Reception Unit (PORU),
* Having a scheduled pre-anesthetic consultation visit,
* Having signed a consent form,
* Affiliated with a health insurance plan.

Exclusion Criteria:

* Patient who does not speak or understand French,
* Patient requiring an invasive radiology procedure,
* Patient deprived of liberty or under guardianship.
Registry Study of the NDO Surgical Plicator for the Treatment of GERD

The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.

This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject is suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
* Subject agrees to study participation and signs/dates an informed consent form.

Exclusion Criteria:

* Significant esophageal dysmotility as determined by manometry
* Esophagitis grade III or IV (Savary-Miller)
* Barrett's epithelium
* Hiatus hernia \> 2cm
* Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
* Esophageal or gastric varices
* Previous endoscopic or surgical anti-reflux procedure
* Other esophageal or gastric surgery
* Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
* Pregnancy.
A Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent;
2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane BCMA expression
4. All genders, ages: 18 to 75 years#
5. The expect time of survive is above 3 months;
6. KPS\>60
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;

13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous women
2. \> 18 years and \< 45 years

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years or older than 45 years
3. Those who were not willing to or could not finish the whole study at any time
4. Alcohol addictive or narcotic dependent patients
5. Subjects with a nonvertex presentation
6. Diagnosed diabetes mellitus and pregnancy-induced hypertension
7. Twin gestation and breech presentation
8. Pregnant fever
Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).

This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years.

The major aim of the study is to test whether intermittent hypoxaemia is a major driver of the progression of chronic obstructive lung disease (COPD). The second aim is to analyse whether dysregulation of the L-arginine / dimethylarginine pathway is a mechanistic link between intermittent hypoxemia and lung function decline, and whether plasma biomarkers are suitable to identify COPD patients at high risk of rapid lung function decline and mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes with a diagnosis of chronic obstructive lung disease (COPD) stages 2-3, groups B and E according to GOLD 38 as assessed by their primary family doctor or pneumology specialist who are treated with long-acting bronchodilators on a stable dose for at least four months prior to inclusion into the study;
2. Age at inclusion 18 - 80 years;
3. Physical ability and willingness to perform 6-minute walk testing and bicycle ergometry testing;
4. Signed written informed consent form

Exclusion Criteria:

1. Participation in another clinical study within the last 3 months before inclusion into the present study;
2. Any somatic or psychic disease that may hamper participation in the study or compliance with the study protocol (at the investigator's discretion);
3. Any somatic disease that puts the patient at increased risk when performing the exercise tests or impairs the patient's ability to properly perform the exercise tests, like advanced coronary artery disease, advanced chronic heart failure, uncontrolled hypertension, orthopaedic, or neurological diseases (non-exclusive list of examples);
4. Any disease or health condition that reduces the patient's life expectancy to less than the expected time frame of this study, other than chronic obstructive lung disease (at the investigator's discretion);
5. Pregnancy or nursing.