cyrilzakka/clinical-trials huggingface dataset:
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

After treatment subjects will be observed for up to 1 year.

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Eligibility Criteria:
Key Inclusion Criteria:

* \> 18 to \< 80 years (at date of signing informed consent form \[ICF\]).
* Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening
* Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
* Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and \<50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
* Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
* Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest
* Vaccinated against Pneumococcus within the last 5 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days).
* Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies ≥50.0 RU/mL
* Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening

Note: France will only enroll patients in Cohort 2.

Key Exclusion Criteria:

* Hemoglobin \< 80 g/L.
* Thrombocytopenia: Platelets \< 100.0 x 109/L.
* Neutropenia: Neutrophils \< 1.5 x 109/L.
* Leukopenia: Leukocytes \< 3.0 x 109/L.
* Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.

Subjects may receive supportive therapies to meet the above criteria

* B-cells \< 5 x 106/L.
* Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
* Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).
SureScan Post-Approval Study

The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.


Eligibility Criteria:
Inclusion Criteria:

1. Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
2. Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
3. Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication

Exclusion Criteria:

1. Subject who is, or will be inaccessible for follow-up
2. Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
3. Subject with exclusion criteria required by local law
Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support

The purpose of this study is to understand the effectiveness of pharmacogenomic testing in using antidepressants and to understand how EHR - driven clinical decision support system can be used to deliver PGx test results by healhcare providers.


Eligibility Criteria:
Inclusion Criteria:

Patients who quality the criteria below:

* Patients with nonpsychotic MDD
* Patients who would like to either start a new antidepressant or change their existing antidepressant treatment
* Patients for whom antidepressant treatment is deemed appropriate by the treating clinician
* \>18 years of age
* Willingness to provide signed informed consent to participate in the study
* Will be following up or continuously visiting their physician

Providers:

* Outpatient practice providers
* Providers who are familiar with Epic

Exclusion Criteria:

Patients:

* Patients with medical contraindications that preclude antidepressant treatment
* Patients with schizophrenia, schizoaffective disorder, or who have Bipolar I disorder
* Patients currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants)
* Patients who are pregnant or have severe cognitive impairment
* Patients requiring urgent care or inpatient hospitalization at the time of consent

Providers:

• Unable or unwilling to commit time to introduce myGenes study to patients
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ostomy (ileo- or colostomy) for at least 3 months.
4. Have used a 1-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have a ostomy with a diameter of 33 mm or less.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Use irrigation during the investigation (flush the stoma with water).
8. Participating in other interventional clinical investigations or have previously participated in this investigation.
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).

OUTLINE:

Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later.

After completion of study, patients are followed up at 24 hours and 1 week.

Eligibility Criteria:
INCLUSION CRITERIA

* Provides written informed consent
* Known diagnosis of prostate cancer
* Patient has suspected recurrence based on biochemical data \[prostate-specific antigen (PSA) \> 2 ng/mL\]
* Able to remain still for duration of each imaging procedure (about one hour)

EXCLUSION CRITERIA

* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
* Metallic implants
T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)

The aim is to compare the results of using T-provisional and Mini-Crush stenting techniques in patients with bifurcation lesions in the CTO segment.


Eligibility Criteria:
Inclusion Criteria:

* Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
* Bifurcation side branch diameter \>2 mm in CTO segment, verified by coronary angiography
* Successful CTO recanalization
* Signed, documented informed consent prior to admission to the study

Exclusion Criteria:

* Age \<18 years or \>75 years
* Left main artery bifurcation lesion
* Reocclusion CTOs
* Renal insufficiency (GFR/MDRD \<30 ml/min)
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
* Known non-adherence to double anti-platelet therapy (DAPT)
* LVEF \<30%
* Continuing bleeding
* Acute coronary syndrome (ST-elevation Myocardial infarction)
* Anamnesis of previous CABG
* Pregnancy
Remote Assessment of Outpatient With Severe Acute Respiratory Syndrome (SARS-CoV-2)

Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of "at risk" patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active.

This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a PCR (polymerase chain reaction assay ) positive for Sars-COV-2 between the start of the pandemic and May 11, 2020
* Outpatient care
* Inclusion 24 months from the date of diagnosis of Sars-COV-2 (± 6 months)

Exclusion Criteria:

* Patients in EHPAD (accommodation facilities for dependent elderly people), home, retirement home, center for disabled people
* Patients under protective measure, curators or guardianship
* Patients with a pathology or condition that does not allow them to express their wishes
* Patients hospitalized when performing PCR or within 10 days with Sars-COV-2
Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero

The main objective of this study is to validate , in the neonatal period, a prognostic score for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological criteria .

The second objective of the study is to estimate the prevalence of this infection in France and to describe its epidemiology through the screening of 12,000 consecutive neonates.

Infection with cytomegalovirus (CMV) is the most frequent cause of congenital neurological handicap of infectious origin in industrialized countries. Around 10% of infected neonates have symptoms and more than 50% of those will develop long term neurological sequelae and sensorineural hearing loss. Among asymptomatic infected neonates 10 to 15% will ultimately develop hearing loss. To establish the prognosis of infected neonates remains difficult and the purpose of the study is to better define early prognosis factors The true burden of CMV congenital infection is unknown in France: the prevalence of the infection as well as the description of its epidemiology (proportion of symptomatic and asymptomatic cases, rate of long term sequelae, proportion of cases following primary or secondary maternal infections) are unknown.

Eligibility Criteria:
Inclusion Criteria:

Main objective: Neonate less than 1 month with congenital CMV infection at birth objectified by the detection of CMV in a urine sample, in saliva or blood (fresh or Guthrie card) obtained in the first 10 days life

* Whose parents accept regular monitoring by the paediatrician investigator
* For which a medical examination has been made
* Affiliated with a social security system
* And whose mother has given its written consent to the participation of their child to study

Exclusion Criteria:

- Children participating in an interventional study
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

This is a Phase II, platform, open-label, multi-drug, multicenter, global study.

This is a modular study, that includes a master protocol and substudies.

Partcipants will be randomised to one of the following intervention groups:

* Volrustomig + FOLFIRI + bevacizumab group (Arm A)
* FOLFIRI + bevacizumab group (Arm B)

The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

Eligibility Criteria:
Overall Inclusion Criteria:

* Histopathologically confirmed colorectal adenocarcinoma.
* Provision of FFPE tumor sample collected as per SoC.
* Presence of measurable disease by RECIST 1.1 criteria.
* ECOG performance status of 0 or 1.
* Life expectancy ≥ 12 weeks at the time of screening.

Substudy Inclusion Criteria:

* No radiological evidence of liver metastasis.
* No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease.
* Known pMMR/MSS status (only pMMR/MSS mCRC allowed).
* Adequate organ and bone marrow function
* Body weight \> 35 kg at screening and at randomization.
* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Overall Exclusion Criteria:

* Central nervous system metastases or spinal cord compression
* Known history of severe allergy to any monoclonal antibody or study intervention.
* Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.
* History of another primary malignancy.

Substudy Exclusion Criteria:

* Potentially resectable disease with multidisciplinary plan for radical surgery.
* Active or prior documented autoimmune or inflammatory disorders or cardiac conditions.
* Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks.
* Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident.
* History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to randomization.
* Prior exposure to immune mediated therapy.
Vesair Continued Access Trial

Single arm study of the Vesair Balloon in postmenopausal women.

All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women with SUI or stress predominant mixed incontinence
* Maximum score on IQOL of 60
* Positive cough test for leakage
* Willing to undergo procedures
* Free from infection
* Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

* SUI due to SUI
* Urge-predominant mixed incontinence
* Incontinence of neurogenic etiology
* 2 or more UTIs in past year and 1 in past 3 months
* Surgery for SUI in the past 6 months
* taking medication that can be used to treat SUI
* taking medication that affects urinary symptoms for less than 3 months
* undergoing biofeedback
* Grade 3 or worse cystocele
* last menstrual period within 12 months
* oral progesterone or estrogen in the past 12 months
* BMI \> 40
* involuntary detrusor contractions or discomfort during bladder filling
* previous stage III or worse cancer
* previous cancer of the urinary tract
* previous symptoms for early stage cancer in the past 2 years
* anticoagulation therapy other than aspirin
* history of prosthetic heart valve
* neurological or connective tissue condition or disease affecting bladder function
* known allergy to device components
Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients

It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.


Eligibility Criteria:
Inclusion Criteria:

* indication for CRT-D implantation / upgrade
* written informed consent

Exclusion Criteria:

* pregnancy
* age \< 18 years
* patients, who cannot visit the routine follow ups (within first 3.5months)
* participants to other studies with active treatment arm
Telephone Reminder to Increase Appointment Rates

Missed appointments to outpatient substance use treatment are common and costly and can have a negative effect on the health of patients.

In this quasi-experimental study, the investigators used an on-off design to examine whether a reminder "plus" intervention (telephone call from therapist before first appointment) would increase attendance and improve cancellation and rebooking practices. Secondary outcomes included satisfaction with treatment and intention to complete the treatment program.


Eligibility Criteria:
Inclusion Criteria:

* Newly referred patient
* \> 18 years
* Diagnosis: Substance related disorder

Exclusion Criteria:

* Patients who are unable to understand or score the survey due to cognitive or language barriers
Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)

The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS.


Eligibility Criteria:
Inclusion Criteria: - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis \[RRMS\] or secondary progressive multiple sclerosis \[SPMS\] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018) - Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Baseline. Participants with an EDSS score \<= 2 at Screening are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years - Participants are neurologically stable for \>= 30 days prior to both screening and baseline - Female participants must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study - Participants have given written informed consent prior to any study-related procedure - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b). Participants with secondary progressive MS without evidence of relapse.

* Disease duration more than (\>) 10 years in participants with an EDSS =\< 2.0 at screening.
* Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.
* Other protocol defined exclusion criteria could apply.
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Active moderate or severe plaque psoriasis according to the judgment of the treating physician.
* The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.

Exclusion Criteria:

* Had currently participated in another prospective study with similar objectives.
* Participant could not or would not sign informed consent.
* Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.