louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05464823: Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
Official title: Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To learn more about the usefulness of molecular testing with the Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.

Detailed description: Primary Objective:

• To determine the feasibility and turnaround of clinical WES and transcriptome sequencing

Secondary Objectives:

* To determine the frequency of actionable DNA and RNA alterations
* To determine the concordance of DNA and RNA alterations
* To determine the frequency of molecularly matched therapy
* To determine the feasibility of identifying mechanism(s) of acquired resistance with genomic profiling
* To determine the feasibility of molecularly matched therapy to acquired resistance alterations

Exploratory Objectives:

* To determine the feasibility of prioritizing targets with precision analytics
* To determine clinical outcomes in patients receiving molecularly matched therapy
* To determine the role of additional emerging diagnostic technologies

Eligibility criteria: Patient Eligibility:

Inclusion Criteria:

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.
2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
3. Provision of written informed consent for the study.

Exclusion Criteria:

1. None

Primary outcomes:
measure: Percentage of participants who have genomic test results available in <=7 days
timeFrame: through study completion an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason Westin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554423: Four-Arm Randomized Control Trial of Brief MI Versus Couples-Based HIV/STI Prevention in South Africa
Official title: Four-Arm RCT of Brief MI vs. Couples-Based HIV/STI Prevention in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: HIV Prevention Intervention
Lead sponsor: The City College of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-15
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral Therapy for HIV Prevention in Pretoria, South Africa. The RCT will evaluate the efficacy of a brief motivational interview (BMI) and a cognitive-behavioral couples' (IFCBT) intervention alone and in combination against a comparison condition to reduce new cases of HIV and sexually transmitted infections and increase condom use and decrease sexual risk behavior, drug use, and intimate partner violence among young female drug users in Pretoria, South Africa and their primary intimate partners. In the RCT, 384 couples comprised of young female drug users who do (N = 192) and do not (N = 192) trade sex and their primary intimate heterosexual partners will be randomly assigned to one-of-four conditions: (1) testing and counseling; (2) brief motivational interview (BMI); (3) cognitive-behavioral couples' intervention (IFCBT); or (4) BMI and IFCBT combined. Eligibility criteria for couples include an HIV-negative drug using female aged 18 to 40 and their primary intimate partner or spouse who is also HIV negative. Each partner of each couple will be administered assessments with a rapid test for HIV and urine tests for Chlamydia, gonorrhea, trichomoniasis, and drug use at baseline and 3-month, 6-month, and 12-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Live in the Pretoria, South Africa region
* 18-40 Years of Age
* In a steady, intimate relationship for 6 months or longer
* Used illicit drugs in the past 6 months

Exclusion Criteria:

* Acute suicidality/homicidality

Primary outcomes:
measure: Biologically confirmed infectious disease status
timeFrame: Outcome measure will be assessed up to 18 months after enrollment.
measure: Condom use and sexual risk behavior
timeFrame: Outcome measure will be assessed up to 18 months after enrollment.
measure: Drug taking risk behavior
timeFrame: Outcome measure will be assessed up to 18 months after enrollment.
measure: Intimate partner violence
timeFrame: Outcome measure will be assessed up to 18 months after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Louis Pasteur Medical Centre
state: Gauteng
Study officials:
affiliation: University of Florida
name: William W Latimer, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06741423: Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases Via Radiomics
Official title: Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases on CT Scans Via an Extended-Radiomics Approach: a Multi-Centric, International Retrospective Analysis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retroperitoneal Sarcoma
Retroperitoneal Fibrosis
Keywords: radiomics
auto-segmentation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with retroperitoneal fibrosis, sarcoma or other retroperitoneal diseases who have pre-op abdominal ct scans of good quality.

Brief summary: A retrospective study utilizing archived CT scans of patients diagnosed with retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) in order to implement a radiomics algorithm which is able to differentiate between these malignancies.

Detailed description: The aim of this project is to develop a radiomics algorithm that can reliably identify retroperitoneal fibrosis (Ormond's disease) and retroperitoneal sarcomas, automatically segment them and differentiate them from other retroperitoneal diseases. Radiomics is a technique that uses artificial intelligence to extract characteristics from radiological image data that are not visible to humans and to identify image morphological patterns of diseases. As it is difficult to differentiate between diseases using image data alone, clinical data such as symptoms and laboratory values are to be correlated with the image data and utilized by the algorithm. Among other things, this should increase the sensitivity, accuracy and specificity of image-based diagnostics in order to enable faster, non-invasive diagnosis.

Eligibility criteria: Inclusion Criteria:

* Patients of any age or gender.
* CT scans confirming the presence of a retroperitoneal mass.
* Confirmed diagnosis of retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) through pathology reports or clinical follow-up.

Exclusion Criteria:

* Poor quality CT scans where the region of interest is not clearly visible.
* Previous treatments or surgeries that might alter the radiomic features of the tumors.

Primary outcomes:
measure: Radiomic accuracy for retroperitoneal fibrosis
timeFrame: 6 months
Secondary outcomes:
measure: Radiomic accuracy for retroperitoneal sarcomas
timeFrame: 10 Months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University International Hospital
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
state: Baden Württemberg
Study officials:
References:
Clinical trial NCT04356638: a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
Official title: A Partially Double-Blinded, Randomized, Controlled, Placebo-Controlled Study, a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anxiety State
Perioperative/Postoperative Complications
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH\&RC standard of care. Compare the safety and the frequency of adverse effects of treatment arms.


Eligibility criteria: Inclusion Criteria:

* All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital \& Research Center (KFSH\&RC) age 1-12 years

Exclusion Criteria:

* Weight ≥ 40 kilograms
* Allergies to the study drug
* Refused to take the study drug
* Severe learning disability
* Patient on Digoxin medication
* Patient on beta-blocker medication
* Cardiac disease with abnormal conduction system
* Nasal anatomical abnormality

Primary outcomes:
measure: Anxiety Level
timeFrame: 30 Minutes
measure: Safety - Hemodynamic stability
timeFrame: 30 Minutes
measure: Safety - Respiratory function
timeFrame: 30 Minutes
measure: Oxygen saturation
timeFrame: 30 Minutes
Secondary outcomes:
measure: Visual Analog Scale for child anxiety
timeFrame: 10 Minutes
measure: IV cannulation procedure completion and number of attempts - yes or no
timeFrame: 10 Minutes
measure: Likert scale assessment of how cooperative/easy to handle the child
timeFrame: 10 Minutes
measure: Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects
timeFrame: 60 Minutes
measure: Post Hospitalization Behavior Questionnaire for Ambulatory Surgery
timeFrame: Day 2 post procedure
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Ganesh Sivasankara, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621738: Effect of Mental Stress on Platelet Function in Healthy Subject
Official title: Effect of Mental Stress on Platelet Function in Healthy Subject
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: mental stress
cardiovascular risk factor
platelet adhesion
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects, aging 18-80 years

Brief summary: Psychological stress is an independent cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could one of the mechanisms linking psychological stress and cardiovascular diseases


Eligibility criteria: Inclusion criteria:

* Healthy subjects
* No smokers
* Written informed consent

Exclusion criteria:

* Smoking
* Alcohol- or Drug Abuse
* Pregnancy
* Use of benzodiazepins, Aspirin or NSAIDs in the last week before inclusion
* Participation to another study within the last month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Cardiovascular Center Cardiology Univeristy Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: Cardiovascular Center Cardiology University Hospital Zurich
name: Georg Noll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00236938: Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Official title: Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: iron
peritoneal dialysis
anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Detailed description: This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Hemoglobin \>= 9.5 and \<= 11.5 g/dL.
* Ferritin \<= 500 ng/ml.
* Serum Transferrin Saturation (TSAT) \<= 25%.
* Stable erythropoietin (EPO) Regimen for 8 weeks.
* No iron for last 4 weeks before randomization.

Exclusion Criteria:

* Known Sensitivity to Iron Sucrose.
* Suffering concomitant severe diseases of the liver \& cardiovascular system.
* Pregnancy / Lactation.
* Inadequate dialysis.
* Current treatment for asthma.
* Significant blood loss.
* Probability of need for transfusion or transfusion within 1 week of enrollment.
* Anticipated major surgery.
* Hemochromatosis / hemosiderosis.

Primary outcomes:
measure: Mean Change From Baseline to the Highest Hemoglobin up to Day 71
timeFrame: Change from Baseline up to Day 71
Secondary outcomes:
measure: The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
timeFrame: Change from Baseline up to Day 71
measure: The Mean Change From Baseline to the Highest Ferritin up to Day 71
timeFrame: Change from Baseline up to Day 71
measure: The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
timeFrame: Change from Baseline up to Day 71
Other outcomes:
Locations:
Study officials:
affiliation: American Regent, Inc.
name: Mark A Falone, MD
role: STUDY_DIRECTOR
References:
citation: Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29.
Clinical trial NCT02578238: Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
Official title: Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Crohn's Disease
Keywords: Korea
Humira
Pediatric Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 143
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric CD patients who have been prescribed Humira® by the treating physician

Brief summary: This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
* Patients who have given written authorization to use their personal health data for the purposes of this study.

Exclusion Criteria:

* Any contraindications to Humira as listed on the approved product market authorization (labeling)
* Patients who is participating on other clinical trials.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
timeFrame: From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie korea
name: Eunjung Gu, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00698438: Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study
Official title: Prospective, Randomized Clinical Trial,to Compare Standard Trabeculectomy to the Ex-PRESS Mini Glaucoma Shunt Implantation Under a Scleral Flap in Eyes With Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: At least 18 years of age
Open-angle glaucoma
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2008-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the purpose of this study was to compare standard trabeculectomy to the Ex-PRESS mini glaucoma shunt implantation under a scleral flap in eyes with open-angle glaucoma.In this report, we describe the results of a prospective, randomized trial in which subjects with bilateral primary open-angle glaucoma underwent the two procedures in fellow eyes.Design: Prospective, randomized clinical trial.

Participants: 15 subjects with bilateral primary open-angle glaucoma Methods: Subjects underwent the two procedures in fellow eyes. Safety and efficacy were evaluated for up to two years.

Main Outcome Measures: Mean IOP and surgical success rates. Results: Mean IOP was similar in Ex-PRESS and trabeculectomy eyes at all time points except month 9, when Ex-PRESS eyes had lower mean IOP (13.2 mmHg vs 16.5 mmHg, respectively; p=0.025). Percent IOP reduction was also similar at all time points except postoperative day 1, when trabeculectomy eyes were lower (75.5% vs 65.8%, respectively; p=0.003), likely due to a higher rate of early hypotony in trabeculectomy eyes versus Ex-PRESS eyes (47% vs 7%, respectively). Complete (without medications) and qualified (with or without medications) successes were more common at all IOP cut-off values in Ex-PRESS eyes than trabeculectomy eyes at last visit (p=0.015, p=0.015 respectively). Postoperative complications were uncommon in both groups, but trabeculectomy eyes required more postoperative interventions than Ex-PRESS eyes.


Eligibility criteria: Inclusion Criteria:

* Subjects were at least 18 years of age and
* Had medically uncontrolled primary open-angle glaucoma requiring incisional surgery for reduction of intraocular pressure in both eyes.
* Subjects with prior cataract or failed filtration surgery in either eye were eligible to participate if surgery occurred at least 3 months prior to enrollment.

Exclusion Criteria:

* Any form of glaucoma other than primary open-angle glaucoma;
* History of or active uveitis; or
* Any ocular abnormality that would prevent accurate assessment of intraocular pressure

Primary outcomes:
measure: Mean IOP and surgical success rates. na
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg,
country: South Africa
facility: Department of Ophthalmology, University of the Witwatersrand,
Study officials:
References:
Clinical trial NCT04385238: Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
Official title: Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pregnancy Complications
Mental Health Wellness 1
Anxiety
Depression
Ptsd
Coronavirus
Lead sponsor: Pregistry
Sponsor class: INDUSTRY
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2020-05-12
Enrollment: 6894
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women or women who have been pregnant in the last 6 months.

Brief summary: The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.

Detailed description: Millions of women will give birth during the pandemic of Coronavirus Disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The consequences of COVID-19 for pregnant women and their offspring are unknown. This lack of information leads to anxiety among pregnant women, women who are considering getting pregnant, and their families. It is therefore important to assess the wellbeing and mental health of women during the COVID-19 pandemic.

The international nature of the online survey will allow the evaluation of how living during the COVID-19 pandemic affects pregnant and recently pregnant women at a global level, including the evaluation of potential cultural and geographic differences.

Eligibility criteria: Inclusion Criteria:

* Pregnant women or women who have been pregnant within the last 6 months
* Able to give electronic informed consent

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Number of Participants With Symptoms of Post-traumatic Stress Disorder
timeFrame: Anytime during pregnancy or within 6 months after given birth.
measure: Number of Participants With Symptoms of Anxiety and Depression
timeFrame: Anytime during pregnancy or within 6 months after given birth.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pregistry
state: California
Study officials:
affiliation: Department of Epidemiology, Harvard T.H. Chan School of Public Health
name: Karestan Koenen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Epidemiology, Harvard T.H. Chan School of Public Health
name: Sonia Hernandez-Diaz, MD, DrPh
role: STUDY_DIRECTOR
affiliation: Pregistry
name: Diego Wyszynski, MD, MHS, PhD
role: STUDY_DIRECTOR
References: