louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03117036: Prospective Cohort Study for Lymphoma: Samsung Lymphoma Cohort Study III
Official title: A Prospective Study for Patients With Lymphoid Malignancy at the Samsung Medical Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, Non-Hodgkin
Lymphoma, Hodgkin
Keywords: lymphoma
cohort
serum
cell-free DNA
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Genomic Institute
First posted: 2017-04-17
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphoma. All patients should receive systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled

Brief summary: This prospective study enrolls patients who are diagnosed with aggressive lymphoma including Hodgkin and non-Hodgkin lymphomas. Enrolled patients will be treated according to our institution' treatment policy in clinical practice. The disease status including response to therapy and survival status will be regularly updated during the study period. Patients' serum and cell-free DNA will be collected and analyzed.

Detailed description: The study population is aggressive lymphomas requiring systemic chemotherapy. Newly diagnosed or relapsed/refractory patients can be enrolled into the study. Patients can be treated according to the principle of routine care of our institute. The study process is as follows.

1. Registration after informed consent.
2. Laboratory and radiological evaluation after registration including collection of serum and cell-free DNA from patients' peripheral blood
3. Interim and final response evaluation including collection of serum and cell-free DNA from patients' peripheral blood
4. Regular monitoring disease status and update of survival status
5. Laboratory and radiological evaluation after relapse or progression including collection of serum and cell-free DNA from patients' peripheral blood

Eligibility criteria: Inclusion Criteria:

1. Pathologically diagnosed Hodgkin and non-Hodgkin lymphomas
2. 20 years
3. Patients requiring systemic chemotherapy with curative intent
4. Written informed consent

Exclusion Criteria:

1. Myeloid malignancy
2. Multiple myeloma
3. Patients do not require systemic chemotherapy with curative intent

Primary outcomes:
measure: Response rate
timeFrame: 3 months after chemotherapy
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 year
measure: Overall survival
timeFrame: 3 year
measure: Biomarker
timeFrame: 3 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Seok Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704936: Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination
Official title: Analysis of Lipid Profiles in Samples Sperm and Seminal Plasma Under Artificial Insemination
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Primary Infertility
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
Collaborators: name: University of the Basque Country (UPV/EHU)
First posted: 2016-03-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo cycles of artificial insemination with own semen. Donor semen samples are intended for cycles of artificial insemination of donor Once the technical and knowing the value of the ßhCG (indicating pregnancy hormone)determined up to a maximum of 4 treatments, the population for this study were divided into three groups

Brief summary: Identify, by Lipidomics approaches, biochemical markers of fertility / infertility in sperm and seminal plasma linking the success or failure of the artificial insemination (IUI)

Detailed description: Analyze lipid profiles in samples of sperm and seminal plasma of three populations:

1. male sperm donors
2. men assigned to a program of assisted reproduction with normal sperm / slightly abnormal successfully in the IUI;
3. attached to a program of assisted reproduction with male semen Normal / slightly abnormal unsuccessfully in IUI

Establish partnerships between the composition of fatty acids, especially fatty acids polyunsaturated (PUFA) of the omega-3 (w3) series of samples analyzed parameterssemen and results of the IA to identify biochemical markers of fertility.

Assess markers found by checking the increase in the rate of success in the IA.

Eligibility criteria: Inclusion Criteria Group A women donor group

* Fallopian unobstructed Men donor group
* Appear as sperm donor
* Age between 18-35 years
* Sexual abstinence 3-5 days

Exclusion Criteria Group A:

* Uterine malformations (fibroids, adenomyosis, uterine malformations or acquired congenital) and fallopian tubes (tubal occlusion)
* Obesity BMI (Body Mass Index)\> 30 kg / m2
* Presence of altered tubal toxic habits (smoking\> 15 cigarettes per day, alcohol or drug abuse).

Inclusión / Exclusion Criteria Group B and C:

* ≤ 38 years
* Natural cycles and stimulated
* The criteria inclusion / exclusion group A
* Time sterility not exceeding three years.

Primary outcomes:
measure: Identify, by Lipidomics approaches, biochemical markers of fertility / infertility sperm and seminal plasma linking the success or failure of the artificial insemination
timeFrame: 18 months
Secondary outcomes:
measure: Descriptive analysis of semen parameters versus DHA and EPA levels
timeFrame: 18 months
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
Study officials:
affiliation: IVI Bilbao
name: Marcos Ferrando, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189436: Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Official title: A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-19
Enrollment: 61
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Detailed description: Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Eligibility criteria: Inclusion Criteria:

* Children ages 1-8 years old
* Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care
* Subjects must be able to show efficient use with a jet nebulizer

Exclusion Criteria:

* Subjects requiring hospitalization
* Subjects receiving oral steroids 1 week prior to presentation to emergency department.
* Subjects with FEV1 \< 50% of predicted
* Subjects with co-morbid medical conditions (renal or cardiovascular disease)
* Subjects with reported history of HIV
* Subjects unable to follow up for study visits
* Subjects who are frequently enuretic

Primary outcomes:
measure: Wheezing/Asthma/Bronchospasm Relapse Rate
timeFrame: 3 weeks
Secondary outcomes:
measure: Urinary Cortisol Levels
timeFrame: 3 weeks
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Bellevue Pediatric Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: David Skoner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861236: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina
Official title: Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Hormone Dependent Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients with Advanced Prostate Cancer that receive Firmagon therapy in the context of usual clinical practice

Brief summary: Prospective, observational study to collect and analyze data on patients with advanced hormone dependent prostate cancer treated with Firmagon® according to routine medical practice in Argentina


Eligibility criteria: Inclusion Criteria:

* Advanced Prostate Cancer patients to be treated with Firmagon in the context of usual clinical practice
* Written informed consent

Exclusion Criteria:

* Contraindications to Firmagon
* Patients already on Firmagon therapy

Primary outcomes:
measure: Progression-free survival (PFS) failure rate (with failure defined as either prostate-specific antigen (PSA) failure, introduction of additional therapy related to prostate cancer, or death)
timeFrame: During 3 years treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ingeniero Pablo Nogués
country: Argentina
facility: Hospital de Trauma y Emergencia Dr Federico Abete
state: Buenos Aires
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT05083936: Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
Official title: Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Suspected or Diagnosed Central Nervous System Lymphoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall goal of this imaging trial is to prospectively compare the usefulness of 18F-FDG PET and 18F-FET PET in evaluating treatment response and predicting prognosis in patients with central nervous system lymphoma.


Eligibility criteria: Inclusion Criteria:

In order to be eligible for participation in this trial, the subject must:

* Be ≥ 19 years of age.
* Patients diagnosed with central nervous system lymphoma by surgery/biopsy or suspected of central nervous system lymphoma by anatomical imaging examination such as MRI.
* Patients who have results or are planning to examine 18F-FDG PET in the above patients.

Exclusion Criteria:

The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:

* Pediatric and adolescent patients under 19 years of age.
* The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) to children.
* Patients with diagnosed or suspected lymphoma lesions in organs other than the cetral nervous system.
* Based on the investigator's judgement, if the patient makes it impossible to collect complete data for a clinical trial due to personal or other reasons.
* Patients who cannot stably have PET/CT due to claustrophobia, dyskinesia, anxiety disorder, seizure, etc.
* Based on the investigator's judgement, if the patient has a serious and/or uncontrolled and/or unstable medical disease (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic renal disease or chronic liver disease, etc.)

Primary outcomes:
measure: Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma
timeFrame: 20-40 minutes post injection
Secondary outcomes:
measure: 1.5 year progression free survival
timeFrame: 18months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
Study officials:
References:
Clinical trial NCT06866236: Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression
Official title: Use of NAD Oxidase Modulation Agent QRX-3 for Prevention and Treatment of Progressive Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Diseases
Acute Kidney Injury
Kidney Failure
Lead sponsor: Neukidney Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo double control
Primary purpose: TREATMENT

Brief summary: Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study we are using a novel drug to target improved function of the kidneys.

Detailed description: Chronic kidney disease has been linked to impaired activity of mitochondrial dysfunction along with oxidative intracellular mechanisms that result in the cascade of progressive damage within renal tubular cells. Several treatment options for mitochondrial dysfunction have been suggested to target the loss of nephrons via renal fibrosis and tubular senescence of the kidney cells by enhancing the mitochondrial activity of these cells via the NAD/NAD+ redox pathway as well as reduce the presence of fibrogenic intracellular inflammatory markers .

QRX-3 is a formulated novel drug designed to supply and optimize NAD+ mitochondrial availability and prevent this nephron loss .

In this study we evaluate the effect of intervention with this novel drug therapy on chronic kidney disease CKD population with slowly declining renal function.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria

  * Patient with Chronic kidney disease
  * Estimated Glomerular function by MDRD of less than 60mls/min
  * Patients with declining renal function ( as measured by eGFR by MDRD )
  * Rate of decline of eGFR over the last one year of less than 20%
  * Negative Serology markers for CKD etiology
  * Provider perceived adherence to study follow up

Exclusion Criteria:

Rapid rate of decline in kidney function of \> 20 % over last one year

* Symptomatic renal failure
* Presence of any suspected Acute renal failure superimposed
* Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI
* No known reversible cause of renal decline

Primary outcomes:
measure: change in Glomerular filtration rate
timeFrame: 1 year
Secondary outcomes:
measure: change in Proteinuria
timeFrame: 1 year
measure: change in rate of Glomerular filtration rate decline
timeFrame: 1 year
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Neukidney Inc
state: Texas
Study officials:
References:
Clinical trial NCT06959836: Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
Official title: Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AORTIC VALVE DISEASES
Aortic Valve Stenosis and Insufficiency
Aortic Valve Surgery
Mitral Valve Regurgitation
Mitral Valve Surgery
Lead sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent aortic or mitral valve replacement (native valve or bioprosthesis) with the VIVERE® Bovine Pericardial Bioprosthetic Valve.

Brief summary: This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).

Detailed description: A multicenter, observational, retrospective, single-arm study. This study will include patients who underwent valve replacement (native or bioprosthetic) of the aortic or mitral valves using the VIVERE Bovine Pericardial Bioprosthetic Valve, between 2017 and 2022. Data will be collected up to 3 years post-procedure.

Eligibility criteria: Inclusion Criteria:

* All patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the native valve or bioprosthesis in the aortic or mitral position, in accordance with the Instructions for Use (IFU).
* Patients aged \> 18 years.

Exclusion Criteria:

* Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
* Contraindications specified in the IFUs.

Primary outcomes:
measure: Safety performance
timeFrame: Hospital discharge or within 30 days of the procedure, whichever occurs first.
measure: Efficacy outcome
timeFrame: 3 years post-implant
Secondary outcomes:
measure: Clinical success
timeFrame: Hospital discharge
measure: Composite serious valve-related adverse events (non-linearized)
timeFrame: From immediately after the intervention until study completion, with an average follow-up of 3 years
measure: Hemodynamic Performance
timeFrame: From immediately after the intervention until study completion, with an average follow-up of 3 years
measure: Structural Valve Deterioration
timeFrame: 30 days, 1 year, 2 years, and 3 years
measure: Serious Adverse Events (linearized rates)
timeFrame: 30 days, 1 year, 2 years, and 3 years
measure: All-Cause Mortality
timeFrame: 3 years post-valve implantation
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Hospital Nossa Senhora (Fundação Pio Xii)
state: SP
city: Jundiaí
country: Brazil
facility: Hospital de Caridade São Vicente de Paulo
state: SP
city: São José do Rio Preto
country: Brazil
facility: Hospital Beneficência Portuguesa
state: SP
Study officials:
References:
Clinical trial NCT00039936: Treatment of Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia
Obesity
Keywords: Binge Eating
Obesity
Cognitive
Behavior
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2002-06-19
Enrollment: 180
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 multicenter (2 sites) randomized trial evaluating three group treatment models for subjects with binge eating disorder. One model is a cognitive behavior treatment (CBT) group, one is partial self help, and one is self help only.


Eligibility criteria: * Meet binge eating disorder (BED) Criteria
* Not psychotic
* Not in other treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: NRI
state: North Dakota
Study officials:
References:
Clinical trial NCT00262236: Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension
Official title: A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, Aliskiren, Atenolol, Blood Pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 693
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 study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.


Eligibility criteria: Inclusion Criteria:

1. Outpatients 18 years of age and older.
2. Patients with essential hypertension.

Exclusion Criteria:

Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 12 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 12 weeks
measure: Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
measure: Blood pressure of < 140/90 mmHg after 12 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceutical
role: STUDY_DIRECTOR
References:
citation: Dietz R, Dechend R, Yu CM, Bheda M, Ford J, Prescott MF, Keefe DL. Effects of the direct renin inhibitor aliskiren and atenolol alone or in combination in patients with hypertension. J Renin Angiotensin Aldosterone Syst. 2008 Sep;9(3):163-75. doi: 10.1177/1470320308096411.