louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06116253: Advanced Diffusion Imaging in Renal Cancer Patients
Official title: Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.


Eligibility criteria: Inclusion Criteria:

* Renal mass patients scheduled for laparoscopic partial nephrectomy.
* eGFR above 30 ml/min/m2.
* Ages 21 to 85
* Must be willing and able to provide consent.

Exclusion Criteria:

* All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.
* Pregnant women are not eligible for participating in this study.
* Acute claustrophobia

Primary outcomes:
measure: Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery
timeFrame: Baseline (1 Week Prior to Operation)
Secondary outcomes:
measure: Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery
timeFrame: Up to Year 1 Post-Operation
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Eric Sigmund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05676853: A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency
Official title: A Phase 3 Open-Label Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Arginase I Deficiency
Hyperargininemia
Keywords: ARG1-D
Lead sponsor: Aeglea Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.

Detailed description: Open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.

Eligibility criteria: Inclusion Criteria:

1. Prior enrollment in pegzilarginase clinical studies, with completion of treatment or continued dosing as of the study termination date
2. Written informed consent by subject/parent/legal guardian, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
3. Negative pregnancy test within 7 days prior to dosing in childbearing subjects if they are sexually active
4. If the subject (male or female) is engaging in sexual activity that could lead to pregnancy, must be surgically sterile, post-menopausal (female), or must agree to use a highly effective method of birth control during the study and for a minimum of 30 days after the last study drug administration. Highly effective methods of contraception include combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation, progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device, or intrauterine hormone-releasing system

Exclusion Criteria:

1. Subjects with acute or ongoing hyperammonemia within 6 weeks of the first dose
2. Subjects with medical conditions or underlying issues that, in the opinion of the Investigator, would preclude participation in the study

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: Baseline through week 54
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Aeglea BioTherapeutics, Inc.
name: Cortney Caudill
role: STUDY_DIRECTOR
References:
Clinical trial NCT03383653: Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
Official title: Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Pregnant
Keywords: Td Vaccine
Safety
Pregnant
Pregnant Women
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Indonesian Vaccine Safety Advisory Committee
First posted: 2017-12-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 pregnant woman, 18-39 years old From provincial health primary center

Brief summary: To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

Detailed description: Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)

Eligibility criteria: Inclusion Criteria:

* Healthy Pregnant Woman aged 18-39 years old
* 27-36 weeks of pregnancy
* Subject have been informed properly regarding the study and signed the informed consent form
* Subject will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

* Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination

Primary outcomes:
measure: Any serious adverse event occurring from inclusion until 30 minutes after the injection
timeFrame: 30 minutes
Secondary outcomes:
measure: Percentage of local and systemic events occurring within 72 hours after each injection
timeFrame: 72 hours
measure: Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.
timeFrame: 72 hours - 28 days
measure: Percentage of serious adverse events within 28 days after injection
timeFrame: 28 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jakarta Provincial Ministry of Health
state: Jakarta Province
Study officials:
affiliation: Indonesian Vaccine Safety Advisory Commitee
name: Julitasari Sundoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00353353: The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12
Official title: The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: no specific conditions
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2006-07-18
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.

Detailed description: During a 12 week period subjects will consume

* bread fortified with folic acid and vitamin B12 or
* placebo bread (not fortified)

Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices.

We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.

Eligibility criteria: Inclusion Criteria:

* age 50-75y

Exclusion Criteria:

* consumption of \< 3 slices of bread/day
* use of B-vitamins in the period three months prior to the study
* treatment with B12-injections in the last 5y
* illness or use of medication interfering with folate or vitamin B12 metabolism

Primary outcomes:
measure: serum B12 status
measure: serum folate status
Secondary outcomes:
measure: erythrocyte folate;
measure: homocysteine;
measure: MMA;
measure: holoTC
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Petra Verhoef, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Ingeborg Brouwer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Martijn Katan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winkels RM, Brouwer IA, Clarke R, Katan MB, Verhoef P. Bread cofortified with folic acid and vitamin B-12 improves the folate and vitamin B-12 status of healthy older people: a randomized controlled trial. Am J Clin Nutr. 2008 Aug;88(2):348-55. doi: 10.1093/ajcn/88.2.348.
Clinical trial NCT03088553: Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment
Official title: Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Organ Transplantation
Keywords: Ganciclovir
trough concentrations
CMV viral load
safety
Solid organ transplantation (heart, kidney or liver)
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid organ transplanted patients with CMV reactivation or CMV disease.

Brief summary: This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.

Detailed description: The primary objective of the study is to determine whether higher concentrations of ganciclovir can reduce the time of negation of the CMV-DNA load.

Secondary objectives are to determine the concentration-toxicity relationship of ganciclovir and the relationship between concentrations of ganciclovir and apparition of CMV gene mutations responsible of drug resistance.

Each week, trough concentrations of ganciclovir are measured, associated with control of CMV-DNA load and all biological analysis currently necessary for the monitoring of the infection.

Eligibility criteria: Inclusion Criteria:

* more than 18 years-old
* Solid organ transplanted patients needing a treatment by oral or intravenous (val)ganciclovir
* Non-opposition to participate in the study.

Exclusion Criteria:

* pregnancy
* opposition to participate in the study
* incapable person

Primary outcomes:
measure: Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
References:
Clinical trial NCT00848653: ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)
Official title: The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients indicated for CRT therapy

Brief summary: The ELECtrode configuraTION CRT Study (ELECTION)

Detailed description: Cardiac resynchronization therapy (CRT) is an accepted treatment for selected heart failure patients. This therapy is delivered using a device (pacemaker (PM) +/- defibrillator (ICD) ) and leads placed in the right atrium (RA), right ventricle (RV) and left ventricle (LV). Rates of LV lead implantation failure and post operative lead related have decreased dramatically over the years, however, the incidence of lead dislodgement and phrenic nerve stimulation is still high. This study is a prospective evaluation of the benefits of having various pace/sense electrode configurations available in a CRT system.

Eligibility criteria: Inclusion Criteria:

* Patients selected for a Guidant system, symptomatic heart failure, LV dysfunction, QRS width \> 120 ms, \> or = 18 yrs, able to understand the procedure, available for follow-up.

Exclusion Criteria:

* \< 18 years, life expectancy \< 6 months, expectation of heart transplantation during the study period, patients who have or are likely to receive a mechanical tricuspid valve, documented aortic stenosis, hypertrophic obstructive cardiomyopathy, inability or refusal to complete the follow-up at an approved centre, enrollment in another cardiovascular clinical investigation unless approved by the Manager of Clinical Studies, Guidant Canada, inability or refusal to sign consent.

Primary outcomes:
measure: to test and compare all available LV pacing and sensing configurations
timeFrame: 6 months
Secondary outcomes:
measure: to track all programming changes made to the LV pacing/sensing configurations
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Laval
name: Jean Champagne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Champagne J, Healey JS, Krahn AD, Philippon F, Gurevitz O, Swearingen A, Glikson M; ELECTION Investigators. The effect of electronic repositioning on left ventricular pacing and phrenic nerve stimulation. Europace. 2011 Mar;13(3):409-15. doi: 10.1093/europace/euq499. Epub 2011 Jan 26.
Clinical trial NCT03351153: Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty
Official title: Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty: Study Protocol for a Single-center, Open-label, Diagnostic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 86
Sex: ALL
Minimum age (years): 32
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To verify that CT scan and X-ray can predict the collapse of the necrotic femoral head before hip arthroplasty and effectively guide the surgical management.

Detailed description: Osteonecrosis of the femoral head (ONFH) is a common and frequently occurring disease. The main clinical manifestations are hip pain and dysfunction. The etiology and pathogenesis of ONFH caused by various reasons are the problems that have not been solved yet in the field of orthopedics. If want to achieve satisfactory therapeutic effect, surgical choice is essential. It is very important for prognosis to master the indications of operation and take appropriate treatment measures, especially the great difference between palliative surgery and hip arthroplasty.

To determine whether the femoral head collapses and the degree of collapse of the articular cartilage of the femoral head can help physicians to select an optimal surgical plan. Chinese scholars commonly believe that if the femoral head collapse is less than 2 mm, investigators can choose autologous bone graft, allogeneic bone graft and other palliative surgery. If the femoral head collapse is more than 2 mm, investigators can choose total hip arthroplasty. However, above standard has not been extensively accepted worldwide.

Eligibility criteria: Inclusion Criteria:

* Unilateral ONFH confirmed preoperatively (FICAT stages III and IV; Appendix 1)14
* Unilateral total hip arthroplasty
* Age range: 32-68 years
* Irrespective of sex
* Sign the informed consent

Exclusion Criteria:

* Infection
* Tuberculosis
* Tumor
* Severe osteoporosis

Primary outcomes:
measure: Sensitivity
timeFrame: At preoperative 1 week
Secondary outcomes:
measure: Specificity
timeFrame: At preoperative 1 week
measure: positive predictive value
timeFrame: At preoperative 1 week
measure: Negative predictive value
timeFrame: At preoperative 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Third Hospital of Hebei Medical University
name: Di Qin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198053: the Effect Between Platelet Reactivation and Antiplatelet Drugs
Official title: Effect of 180 mgTicagrelor Compared With 90 mg Ticagrelor on Platelet Reactivity in Patients Undergoing Elective PCI.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Effect Disorder
Platelet Procoagulant Activity Deficiency
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and dyspnea risk, both loading double dose and following second dose time had potential risk and inconvenient in routine clinical work, especially in elective PCI of comparable stable patients in Chinese. The benefit and risk should be balanced in such patients. The investigators supposed loading single dose and followed by second routine time dose was superior to clopidogrel and safer than ticagrelor previously prescribed.

Detailed description: All admission patients were divided into two groups, the first group were prescribed loading dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and post-operation. All bleeding or dyspnea events were recorded in hospital period.

Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events were recorded in hospital period.

Eligibility criteria: Inclusion Criteria:

coronary artery disease, percutaneous coronary intervention

Exclusion Criteria:

high risk bleeding patient, allergic to the drugs

Primary outcomes:
measure: Platelet reactivity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: LI QUAN, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03070353: Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
Official title: Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cirrhosis, Liver
AKI
Keywords: Cirrhosis
AKI
Albumin
Dextran
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Focus on clinical response after receiving treatment
Primary purpose: TREATMENT

Brief summary: A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI

Detailed description: A pilot study of Dextran-40 infusion in decompensated cirrhotic patients complicating with AKI. Dextran-40® was administered at 1 g/kg/day for two days. AKI reversal was defined when serum creatinine was \< 1.5 mg/dL. Albumin infusion was given if AKI reversal did not occur.

Eligibility criteria: Inclusion Criteria:

* Decompensated cirrhosis with acute kidney injury
* Ager over 18 years old

Exclusion Criteria:

* Having chronic kidney disease, severe heart or lung disease, severe sepsis
* Pregnant
* Receiving nephrotoxic agents
* Having history of allergic to Dextran

Primary outcomes:
measure: AKI reversal
timeFrame: 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Ramathibodi Hospital
name: Abhasnee Sobhonslidsuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niemi TT, Miyashita R, Yamakage M. Colloid solutions: a clinical update. J Anesth. 2010 Dec;24(6):913-25. doi: 10.1007/s00540-010-1034-y. Epub 2010 Oct 17.
Clinical trial NCT00229853: Thoracoscopic Vascular Rings Chart Review
Official title: Thoracoscopic Vascular Rings Chart Review
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiovascular Abnormalities
Keywords: Children's Healthcare of Atlanta
pediatric
Thoracoscopic Vascular ring
diverticulopexy
Vascular Ring Division
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retro chart review

Brief summary: The purpose of this study is to review the use of diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome.

Detailed description: In addition to dividing the vascular ring, some surgeons stress the importance of performing a diverticulopexy (an additional stitch which holds the ring open and prevents recurrence). This is a difficult step to perform through the thoracoscope.

We plan to review the use of this step, the diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome. Once we have accomplished this, we hope to present our initial results of this new procedure.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing vascular ring division at Children's Healthcare of Atlanta at Egleston Hospital between 2001 and 2004

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References: