cyrilzakka/clinical-trials huggingface dataset:
Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells

Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Since 2018, patients with relapsed or refractory lymphoma can benefit from immunotherapy based on CAR-T cells (Chimeric Antigenic Receptor - T cells), drugs derived from gene therapy and products from the patient's own T cells. The efficacy of these drugs, their development in more and more indications and in continuous earlier lines of treatment, their unprecedented adverse effects and their very high cost justify the search for predictive factors of efficacy and tolerance in order to optimize their use and benefit the greatest number of eligible patients. A better understanding of quality of life and its determinants in patients who received CAR-T cells could play a major role in predicting efficacy and tolerance. Quality of life data have indeed been deemed insufficient in phase 1-2 trials which have demonstrated the benefit of CAR-T cells in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in 3rd line of treatment or more and led to obtaining their marketing authorization. It is therefore necessary to assess the quality of life of patients treated in routine care with CAR-T cells. The European Qualitop project aims, from self-questionnaires, to explore the quality of life during the 2 years following the initiation of immunotherapy with a multidimensional approach integrating genetic factors, lifestyle habits and psychosocial determinants of patients. In this context, the Qualitop CAR-T study is a prospective non-comparative real-life study aimed at describing the multidimensional quality of life, its psychosocial determinants and drug consumption in patients with relapsed or refractory DLBCL treated with CAR -T cells.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* eligible for treatment with CAR-Tcells (outside a clinical trial) in an indication of diffuse large B-cell lymphoma for which treatment with CAR-Tcells is scheduled
* follow-up in the Hematology department of the Hospices Civils de Lyon (Pr. Hervé Ghesquières)
* having given their non-objection to participate in the study.

Exclusion Criteria:

* Adults subject to a measure of legal protection (curatorship, guardianship)
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care and persons admitted to a health or social establishment
* People with a major psychiatric disorder likely to hinder the conduct of the study, in the opinion of the investigator
* Not fluent in French-
* simultaneous participation in another research involving the human person, except if it is a study falling within category 3 of the Jardé Law which does not call into question the follow-up of patients in the present study.
Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts

The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this group, and whether this effect differs between Black and White women.

Women with dense breasts have 3-5-fold increased risk for breast cancer as women without dense breasts. Dense breast tissue can "mask" small tumors, leading to reduced mammography sensitivity. Recent randomized controlled trials demonstrate that supplemental breast MRI screening improves detection of small, invasive cancers that are not detected by mammography. In January 2022, a Pennsylvania law went into effect mandating insurance coverage of supplemental screening for women with extremely dense breasts. Currently only a small fraction of eligible women with extremely dense breasts are receiving supplemental breast MRI screening. Clinical pathways to identify patients who are eligible for insurance coverage of supplemental breast MRI screening and communicate this option to patients and providers are needed to ensure equitable access to supplemental screening. This study therefore proposes a stepped wedge cluster randomized clinical trial to determine whether electronic health record (EHR) and secure text message nudges increase utilization of supplemental breast MRI screening among eligible women with extremely dense breasts.

Eligibility Criteria:
Patient participants:

Inclusion Criteria:

* Women aged 40-74
* Recent non-actionable mammogram of less than 6 months
* Mammogram performed at Penn Center for Advanced Medicine, Penn Presbyterian Hospital, Pennsylvania Hospital, or Radnor
* Valid mobile phone number

Exclusion Criteria:

* Prior history of breast cancer
* No breast MRI within the past 2 years
* No prior actionable mammogram within 6 months
* No recent or concurrent ultrasound

Provider participants:

Inclusion Criteria:

* Provider needs to have ordered the initial screening mammogram
* Employed by Penn Health System and access to Penn Chart
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma

This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.

The aim of this study is to determine if paclitaxel given together with ramucirumab (IMC-1211B) as second line therapy will prolong overall survival (OS) compared to paclitaxel alone.

Approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.

Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.

Ramucirumab (IMC-1211B) DP/placebo will be administered IV on Days 1 and 15, paclitaxel will be administered IV on Days 1, 8 and 15 of a 4 weekly cycle.

Participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
* Metastatic disease or locally advanced, unresectable disease
* Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
* Organs are functioning well (liver, kidney, blood)
* Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

* First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
* Previous systemic therapy with other anti-angiogenic drugs
* Uncontrolled high blood pressure
* Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
* Evidence of central nervous system (CNS) metastasis at baseline
Propranolol for Diabetic Retinopathy

This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.

Oral propranolol 120mg daily will be given to 10 patients with proliferative diabetic retinopathy over a 12 week period to evaluate the effect on retinal neovascularization.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* Eyes with proliferative diabetic retinopathy and neovascularization
* Eyes with a history of panretinal photocoagulation treatment and persistent neovascularization deemed by the investigator to be a potential threat to visual acuity either by causing a vitreous hemorrhage or tractional retinal detachment. (Group 1 - maximum 5 eyes enrolled with these characteristics)
* Eyes without a history of panretinal photocoagulation treatment, but that do not have high-risk proliferative diabetic retinopathy characteristics (i.e. these are eyes that have early proliferative diabetic retinopathy that are not yet at a high-risk for vitreous hemorrhage and tractional retinal detachment such that panretinal photocoagulation laser may be deferred). (Group 2 - maximum 5 eyes enrolled with these characteristics)

Exclusion Criteria:

* Either panretinal photocoagulation laser or focal/grid laser into study eye within 3 months of study enrollment
* Anti-Vascular endothelial growth factor injection into study eye within 3 months of study enrollment
* Contraindications to beta-blockers such as: allergy, previous intolerance, abnormally slow heart rates, asthma or chronic obstructive pulmonary disease, use of medications that have an effect on certain drug metabolic pathways that may cause interactions.
* Known coronary arterial disease or left ventricular dysfunction, or known peripheral vascular disease
* Resting heart rate \<60 or systolic blood pressure \<90 and/or diastolic blood pressure \<50
* Pregnancy
* All patients will either be post-menopausal, have adequate birth control and, if of childbearing age, will have a urinary pregnancy test performed
* Allergy to fluorescein dye
* Media opacity obscuring adequate determination of neovascularization including dense cataract or dense vitreous hemorrhage
* Patient is already taking an oral beta-blocker
* Vulnerable populations such as prisoners and minors will also be excluded
Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19

Hospitalized patients with COVID-19 will be included in the study in centers around Poland. After the hospitalization, a short questionnaire will be completed, including pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission, the course, complication and the duration of hospitalization. The questionnaire will be available in paper form and on-line.

SARS-Cov-2 infection is characterized by a varied clinical course, from asymptomatic to severe respiratory failure in the course of pneumonia, which can be fatal. There are reports in the literature regarding the relationship between the course of an acute respiratory disease syndrome caused by SARS-CoV-2 virus infection (Coronavirus 2019, COVID-19) and the history of cardiovascular diseases (CVD), including hypertension. It is postulated that the shared element of the pathogenesis of CVD, hypertension and COVID-19 is the renin-angiotensin system and one of its elements, the angiotensin converting enzyme 2 (ACE2). It has been postulated by some authors that in the course of hypertension and antihypertensive treatment with renin-angiotensin system inhibitors, there may be an upregulation of ACE2, which in turn may be related to a higher risk of more severe course of COVID-19. On the other hand there is also data the renin-angiotensin system inhibitors by increasing ACE2 concentration may be protective in the course of severe pneumonia.

The study undertaken by the National Institute of Cardiology aims to assess the safety of the cardiovascular drugs in relation to the occurrence of complications during hospitalization in patients with CVD and COVID-19 infection. The study is being conducted by Polish-German collaboration and was initiated by prof Reinhold Kreutz from Institute of Clinical Pharmacology and Toxicology, Charite, Berlin, Germany and team from National Institute of Cardiology lead by prof. Andrzej Januszewicz and prof. Tomasz Hryniewiecki, Director of the National Institute of Cardiology.

Hospitalized patients with COVID-19 will be included in the study in centers around Poland. After the hospitalization, a short questionnaire will be completed, including pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission, the course, complication and the duration of hospitalization. The questionnaire will be available in paper form and on-line.

It will also be planned to include control groups from the official databases: 1) patients with SARS-CoV-2 infection not requiring hospitalization, and 2) structure-matched and co-existing disease matched control group from the general population.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with COVID-19

Exclusion Criteria:

* None
Assessment of Serum Leptin in Vitiligo Patients

Evaluation of serum leptin in vitiligo patients and control Assessing its correlation to the body mass index and disease dermographic data .

, leptin is supposed to contribute to vitiligo pathogenesis through promoting the release of pro-inflammatory mediators such as tumor necrosis factor α "TNF," IL-2 and IL-6, as well as enhancing cytotoxic T cells "CD8" recruitment and inhibiting the functions of regulatory T cells "Tregs". Leptin can also aid in induction of oxidative stress by activating nicotinamide adenine dinucleotide phosphate (NADPH) oxidase• Venous blood samples will be taken from patients and controls to evaluate serum leptin: Morning samples will be taken after 12-h overnight fast in plain vacutainer tubes and directly centrifuged (1098 g for 15 min).

* Sera will be then collected in plain, capped, 5 ml centrifuge tubes "Eppendorf" and freezed at -20ᵒC in a well-monitored freezer until the analysis is performed• Serum leptin will be quantitatively assessed in vitro using DRG leptin Sandwich Enzyme Linked Immuno-Sorbent Assay "ELISA".
* ELISA will be performed according to manufacturer's guidelines where each run included a standard curve.
* Using the mean absorbance value for each sample, the corresponding concentration from the standard curve will be determined.

Eligibility Criteria:
Inclusion Criteria:

* All patients with vitiligo who are above the age of 18 years

Exclusion Criteria:

* Patients with other autoimmune diseases
Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical setting in Hungary.

This was a prospective, open label, multicenter, observational cohort study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. AbbVie offered an array of services as part of a patient support program, called AbbVie Care 2.0, to study participants. The purpose of the AbbVie Care 2.0 program was to provide educational resources that aimed to help participants understand their health condition and disease management (e.g., lifestyle - exercise or diet), but also help to them understand how to administer the product safely and be empowered to stay on track with their prescribed treatment plan, all with the goal of maximizing patient outcomes. There were five target visits: a baseline visit at enrollment and follow-up visits at 3, 6, 9 and 12 months.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) by the treating physician
* Age ≥ 18 years at the time of enrollment
* RA, AS, PsA, Ps, UC or CD patients for whom adalimumab treatment was indicated as per local Summary of Product Characteristics (SmPC) and professional/reimbursement guidelines
* Participants assigned to adalimumab treatment not more than 1 month prior to inclusion
* Participants to whom participation in AbbVie Care 2.0 Patient Support Program (PSP) program was offered and participant decided to join and had started the PSP
* Participants willing to be involved in the study and to sign patient informed consent form (ICF) and subject information form (SIF) in order to allow use and disclosure of his/her personal health information

Exclusion Criteria:

* Participants who could not be treated with adalimumab according to the local adalimumab SmPC and local professional and reimbursement guidelines
* Participants treated with \> 1 prior biologic disease modifying anti rheumatic drug (DMARD) for RA, AS, PsA, Ps, UC or CD
* Prior treatment with adalimumab for more than 1 month
* Participants currently participating in other clinical research studies
* Participants who were unwilling or unable to complete the quality of life and other patient-reported questionnaires
Dexamethasone on Fetal and Uteroplacental Doppler

The current study aims to investigate the effects of dexamethasone exerted on fetal and uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for preterm birth after 24 hours of its administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia

Exclusion Criteria:

* Patients who were actively in labor, presented with premature rupture of membranes, intrauterine growth restriction (IUGR), those who had received corticosteroids in their pregnancies and/or fetuses with suspected structural abnormalities
A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).


Eligibility Criteria:
Inclusion Criteria:

* females of infertile couples for whom COS and IVF or ICSI is indicated
* body mass index between 18 and 29 kg/m2
* willing and able to give written informed consent.

Exclusion Criteria:

* More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)
* History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment
* Less than 2 ovaries or any other ovarian abnormality including endometrioma
* Presence of unilateral or bilateral hydrosalpinx
* Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
* History of or current polycystic ovary syndrome (PCOS)
* History of/or current endocrine abnormality
* Any clinically relevant hormone value outside the reference range during the early follicular phase
* Any clinically significant abnormal laboratory value
* Hypertension or currently treated hypertension
* Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease
* Alcohol or drug abuse, or history thereof
* Current serious allergic symptoms
* Abnormal cervical smear
* Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;
* Contra-indications for the use of gonadotropins
* Use of hormonal preparations within 1 month prior to the date of signing consent;
* Administration of any investigational product within 3 months prior to screening.
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.

The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.

The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient is currently in NYHA Class II or III.
* For patients with LVEF \>40% measured on most recent available echocardiography within the previous 12 months:

  * ONE (1) of the following echocardiography findings: LA width (diameter) \>3.8 cm, LA length \>5.0 cm, LA area \>20 cm2, LA volume \>55 ml, LA volume index \>29 ml/m2, LVH defined by septal thickness or posterior wall thickness of \>1.1 cm AND
  * ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP \>100 pg/ml or NT-proBNP \>300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP \>300 pg/ml or NT-proBNP \>900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
* For patients with LVEF \<40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:

  * ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP \>150 pg/ml or NT-proBNP \>600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP \>450 pg/ml or NT-proBNP \>1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
* Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
* Patient is of legal age to give informed consent and is willing to participate in the trial.

Key Exclusion Criteria:

* Patient is currently implanted with any other active electronic medical device.
* Patient has undergone a heart transplant.
* Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.
* Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.
* Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy

The aim of this study is to compare the geriatric patients with the non-geriatrics undergoing outpatient unilateral herniorrhapy in terms of local anesthesia, sedation, recovery and early morbidity.

A retrospective data analysis will be conducted and the patient records will be evaluated for patient characteristics local anesthesia, sedation, recovery and early morbidity.

Eligibility Criteria:
Inclusion Criteria:

patients with a unilateral inguinal hernia undergoing herniorrhaphy

Exclusion Criteria:

none