cyrilzakka/clinical-trials huggingface dataset:
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a combination stage, and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. imvotamab will be administered intravenously (IV).

Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.

Imvotamab is an engineered bispecific IgM antibody for the treatment of patients with CD20-positive cancers. It contains ten high affinity binding domains for CD20, and one binding domain for CD3. Imvotamab is able to eliminate CD20-positive lymphoma cells by engaging T-cells and lymphoma cells, leading to T-cell dependent cellular cytotoxicity. Additionally, imvotamab is also able to eliminate lymphoma cells by recruiting complement to the surface of lymphoma cells, leading to complement dependent cytotoxicity.

In our preclinical studies, we observed activity against rituximab resistant cells carrying low levels of CD20. We have also observed much lower cytokine release with imvotamab relative to comparable IgG format bispecific T-cell engaging antibodies, which is expected to result in reduced risk of the serious adverse effects from cytokine release syndrome (CRS).

For the combination stage, imvotamab will be combined with loncastuximab tesirine, a CD19-targeting antibody drug conjugate.

Eligibility Criteria:
Key Inclusion Criteria:

* \> 18 years of age: ECOG PS 0 or 1
* Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma (DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation
* Relapsed or refractory to at least two prior systemic treatment regimens (must include anti-CD20 chemo-immunotherapy regimen). FL/MZL may be enrolled with a least 2 prior systemic regimens which must include an anti-CD20, without the need for a prior chemotherapy regimen)
* At least one bi-dimensionally measurable lesion (\>1.5cm in it's longest dimension by computerized tomography (CT scan)
* Good organ function
* Not eligible for autologous stem cell transplant (DLBCL subjects), due to chemoresistant disease, medically unfit (organ function), or unwilling.

Key Exclusion Criteria:

* Prior allogeneic transplant
* ASCT within 100 days prior to the first imvotamab administration.
* Lack of response to prior treatment with CAR-T therapy, subjects with less than 3 months from prior CAR-T therapy to first dose of imvotamab, and prior CAR-T therapy only allowed with Medical Monitor approval.
* Concurrent serious co-morbidities that could limit patients full participation and compliance.
* Prior CD-targeting bispecific antibodies.
* Prior loncastuximab tesirine.
A Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation

The purpose of this study is to determine the efficacy and safety of Betahistine Mesilate in the treatment of patients with vertigo caused by Cerebral Infarction in posterior circulation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.
Transseptal Italian Registry (TITLE)

The goal of this observational study is to learn about the changing over the time of transseptal (TSP) catheterization for catheter ablation of arrhythmias in the left heart. This study aims to investigate if auxiliary tools for TSP catheterization improved the safety and efficacy.

Data regarding transseptal catheterization in the Centers involved will be retrospectively collected over the past 10 years.

Will be collected:

1) patients characteristics

1. type of procedure requiring transseptal catheterization
2. success rate
3. adverse events
4. use of tools for transseptal catheterization:

   * intracardiac echocardiography (ICE) guidance
   * simplified transseptal puncture
   * "pig tail" catheter
   * "safe sept" guidewire
   * powered radiofrequency transseptal needle

Eligibility Criteria:
Inclusion Criteria:

* patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)

Exclusion Criteria:

* patients with learning disabilities
The Effect of MK0633 in Patients With Chronic Asthma (0633-007)

A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production
* Males and females 18-70 years of age

Exclusion Criteria:

* History of kidney or chronic liver disease
* Recent history of heart problems within the past 3 months
* Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects with Chronic Hepatitis B Virus Infection

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥ 18.0 and \< 35.0 kg/m(2), where BMI = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg
2. Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented
3. Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening
4. Lack of bridging fibrosis or cirrhosis

Exclusion Criteria:

1. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
3. Clinically significant diseases or conditions
4. History of hepatocellular carcinoma
Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery

There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. The goal of this exploratory study was to determine the factors that influence PtCO2 variations during CPB.

DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every 10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively included.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.

Exclusion Criteria:

* The exclusion criteria were: age \<18, pregnancy, septic or emergency surgery.
Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Children 5-11 Years Old

Myopericarditis is a rare complication to messenger ribonucleic acid (mRNA) COVID-19 vaccines, especially in male adolescents and young adults. The risk in children 5-11 years old is unknown. In Denmark, the Pfizer-BioNTech mRNA COVID-19 vaccination was recommended from December 1, 2021 in individuals aged 5-11 years old. We aim to estimate the incidence of myopericarditis in children 5-11 years old after mRNA COVID-19 vaccination among vaccinated individuals based on a nationwide prospective population-based cohort study with detailed clinical phenotyping.

AIM The project seeks to estimate the incidence of myopericarditis in children 5-11 years old after mRNA COVID-19 vaccination.

HYPOTHESIS The incidence of myopericarditis after mRNA COVID-19 vaccination in children 5-11 years old is significantly lower than the incidence in adolescents.

METHOD Prospective nationwide population-based cohort study of all individuals aged 5-11 years hospitalized due to myocarditis and pericarditis after COVID-19 mRNA vaccination in the period December 1, 2021 to February 1, 2022. The setting is a multicenter study including all 18 Danish Pediatric Departments, providing 24 hours emergency service, and in- and out-patient treatment for all Danish inhabitants aged ≤ 17 years. As part of a pediatric nationwide COVID-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of vaccine-associated disease.

To calculate the incidence of myopericarditis among Danish individuals 5-11 years old, the number of individuals who have been mRNA COVID-19 vaccinated will be attained from the National COVID-19-vaccine Database at the Statens Serum Institut.

Eligibility Criteria:
Inclusion Criteria: Children 5-11 years old hospitalized due to myocarditis and pericarditis following mRNA vaccination

Exclusion Criteria: Viral or bacterial cause of myopericarditis, or other known cause of myopericarditis
EVENDOL Scale Validation for at Term New-born

Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn, especially after a birth injury, but it is sometimes difficult ti define.

There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data available are those of the perinatal survey 2010, with the number of operative vaginal deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the seat (4.7%). These delivery modes can be purveyors of pain.

At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013, and 15 in the delivery room. But this consumption is a poor reflection of the pain because treatment could be given pain-authenticated (measured with the EDIN scale), and because a bottle is discarded one month after opening.

The scales measuring pain used in the new-born at term based on the assessment of change in behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related to health care.

The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant proportion of newborns. This scale appears suitable for evaluation of the newborn to term maternity

Objectives:

Principal: validation of the instrument "EVENDOL" in the new-born at term.

Secondary:

* EVENDOL is equivalent to EDIN to diagnose the pain of the newborn at term.
* While being faster and easier to dimension.
* EVENDOL preferred by caregivers

Methodology and conduct of the study:

DESIGN: Study of practical evaluation of observational, prospective, multicenter.

Places of study: maternity of Saint Joseph Hospital, and Kremlin Bicetre. A feasibility study is underway, it was started in neonatology Antoine Béclère. Time study: 12 to 18 months Required subjects: 100 patients (1/3 painless children, 2/3 of painful children).

Eligibility Criteria:
Inclusion Criteria:

* New born at term (≥ 37 weeks)
* Suspects or without pain
* From 0 to 28 days of life,
* Able to be studied and monitored by the researcher.

Exclusion Criteria:

* Prematurity: newborn \<37 SA
* Children in intensive care or intensive care unit
* Children in vital distress
* Major malformation syndrome
* Non-Francophone Parents
Bevacizumab Treatment For Type 1 ROP

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.

Eligibility Criteria:
Inclusion Criteria:

The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:

1. Birth weight \< 1251 grams
2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will be excluded from study participation.

1. Previous treatment for ROP
2. Stage 4 or 5 ROP in either eye
3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
6. Active ocular infection or purulent nasolacrimal duct obstruction in either eye

One eye will be excluded, and other eye may be eligible, if either of the following are present:

* Visually significant ocular anomaly (e.g., cataract, coloboma)
* Opacity that precludes an adequate view of the retina
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.

To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID + standardized dose of methadone, on plasma total and unbound methadone enantiomer pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of methadone on plasma amprenavir PK will also be assessed by comparison to historical control data.


Eligibility Criteria:
Inclusion Criteria:

* Subject is enrolled in a certified methadone maintenance program for at least 12 weeks prior to Period 1, Day 1.

Subject is receiving methadone = 200mg QD that has remained unchanged for 30 days The subject is male, female and is between the age of 18 and 64 years of age.

A female is eligible to enter and participate if she is of non-childbearing potential or of childbearing potential. If of childbearing potential, females must have a negative serum pregnancy test at Screening, and agree to one of the following:

Complete abstinence from sexual intercourse from 2 weeks prior to administration of the study drug. Sexual intercourse with only vasectomized partner.

Body mass index of 19.00 to 32.00 kg/m2. Willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.

Able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.

Able to give written informed consent prior to screening.

Exclusion Criteria:

* Subject has a clinically significant abnormality identified on the screening medical or laboratory evaluation, including 12-lead ECG.

Subject has any preexisting condition which could interfere with the absorption, metabolism, and/or excretion of the study drugs.

Subject currently has or has a history of decompensated liver disease (i.e., ascites, esophageal or rectal varices, hepatic encephalopathy) or current evidence of active hepatitis (AST or ALT \> 2.5x ULN).

Subject has evidence of liver impairment at screening (i.e., INR \> 1.7, total bilirubin \>2.0 mg/dL, albumin \<3.5 g/dL).

Subject has inadequate venous access. Subject has a history of any hypersensitivity reaction to any component of FPV, APV, RTV, or to any drug chemically related to FPV, APV, or RTV.
Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction

Necrotizing enterocolitis is the most common gastroenterological emergency in neonatology. Its mortality is high, ranging from 15 to 30%. Prematurity is the main risk factor for necrotizing enterocolitis, as well as the very low birth weight (\<1500 g) associated with prematurity. Among the early neonatal complications of intrauterine growth restriction neonates, necrotizing enterocolitis is frequently reported in the literature. The situation of chronic hypoxia of these fetuses is at the origin of a vascular redistribution favoring the cerebral circulation to the detriment of the mesenteric vascularization, which could lead to the development of an necrotizing enterocolitis. However, data from the literature concerning this over-risk of necrotizing enterocolitis in the case of intrauterine growth restriction are discordant. The heterogeneity of the definitions used for the intrauterine growth restriction and diagnostic criteria for necrotizing enterocolitis from one study to another could explain these discrepancies. The investigator's hypothesis is that the risk of necrotizing enterocolitis is higher among newborns in intrauterine growth restriction compared to control children.


Eligibility Criteria:
Inclusion Criteria:

* All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
* with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2011 to 31 december 2016.

Inclusion Criteria for control group:

* All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
* without isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2011 to 31 december 2016.

Exclusion Criteria:

* Infants born out of the hospital and secondarily hospitalized in our department
* unaccompanied pregnancies
* multiple pregnancies
* children with malformations or genetic abnormalities,
* medical termination of pregnancy
* fetal deaths in utero
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used dated NMES techniques.

The objective of this study is to compare the two methods in terms of blood flow.

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent Pneumatic Compression (IPC) involves the use of an inflatable cuff placed around the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Both IPC and NMES have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used dated NMES techniques.

The objective of this study is to compare the two methods in terms of lower limb haemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* Free from any known illness.
* Between 18 and 40 years of age.

Exclusion Criteria:

* History of heart/respiratory problems
* Pregnancy
* Presence of implants, including cardiac pacemakers or orthopaedic implants
* History of a neurological disorder
* History of severe arterial disease or known dermatological problems.
The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease

To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Men or postmenopausal women with stable coronary heart disease
* Coronary heart disease should be verified by coronary angiography with at least 50% stenosis in at least one coronary vessel.

Exclusion Criteria:

* Patients with myocardial infarction within the last tree months
* Persons with a present or earlier alcohol abuse
* Persons with a present or earlier drug abuse
* Person with malign disease
* Persons, that we consider unsuitable to carry through the examines.