louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01544712: Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
Official title: Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Traumatic Osteonecrosis of the Femoral Head (Hip)
Keywords: osteonecrosis
cell-based therapy
bone marrow
mesenchymal stem cell
hip
core decompression
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 50
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: In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.


Eligibility criteria: Inclusion Criteria:

1. patients who have a non traumatic ON of the femoral head
2. Stage 3 ON (subchondral fracture).
3. Age \> 18 years
4. Be able and willing to participate in the study

Exclusion Criteria:

1. evidence of malignant disorder in the past five years
2. Patient unable to undergo a MRI.
3. Patient who is positive for an HIV, hepatitis B or C infection.

Primary outcomes:
measure: reduction of total prosthesis
timeFrame: 24, 60 months
Secondary outcomes:
measure: Pain reduction
timeFrame: 24, 60 months
measure: functional status
timeFrame: 24, 60 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liège
Study officials:
References:
citation: Hauzeur JP, De Maertelaer V, Baudoux E, Malaise M, Beguin Y, Gangji V. Inefficacy of autologous bone marrow concentrate in stage three osteonecrosis: a randomized controlled double-blind trial. Int Orthop. 2018 Jul;42(7):1429-1435. doi: 10.1007/s00264-017-3650-8. Epub 2017 Oct 7.
Clinical trial NCT02729012: Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study
Official title: Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With Allergic Rhinitis. RinASol- Pilot Study (Allergic Rhinitis Solution)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: Children
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology.

The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)


Eligibility criteria: Inclusion Criteria:

* Clinical history of Allergic Rhinitis (for at least 1 year)
* 6 years old ≤ children age ≤ 14 years old
* Total Symptom Score 5: \>5 in the last 4 days before screening. Exclusion Criteria
* Signs of acute infections of upper and lower respiratory tract.
* Metabolic, immunological, systemic diseases
* Respiratory tract deformity
* Systemic/Topical therapies with antibiotics or corticosteroids in the previous 30 days.
* Active smoker.

Primary outcomes:
measure: Symptom score assessment
timeFrame: 28 days
Secondary outcomes:
measure: Nasal cytology pattern
timeFrame: 28 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
affiliation: IBIM,CNR, PALERMO, ITALY
name: Stefania La Grutta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05241912: Supernormal Oxygen Delivery for Patients With Severe Burns
Official title: Supernormal Oxygen Delivery for Patients With Severe Burns：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Burn Surgery
Dobutamine
Lead sponsor: Guangzhou Red Cross Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.

Detailed description: This is a randomized double-blinded study to investigate the effect of control group and the goal-directed fluid therapy group on complications during surgery of the burn patients. The groups are designated as the control group and the oal-directed fluid therapy group to further evaluate significant differences in complications during the surgery.

Eligibility criteria: Inclusion Criteria:

* Severe burn patients

Exclusion Criteria:

* Patients or families refuse to sign consent

Primary outcomes:
measure: Complication
timeFrame: One week after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Red cross hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06831812: Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Alzheimer Disease
Alzheimer Disease (AD)
Alzheimers Disease Prevention
Keywords: vaccine
AD
prevention
precinical AD
asymptomatic AD
Alzheimer disease
Lead sponsor: Nuravax, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Arvax
First posted: 2025-02-18
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60. Participants will receive three intramuscular injections of either adjuvanted AV-1959R (100 µg or 300 µg) or adjuvanted placebo at Weeks 0, 4, and 14, followed by an 8-week follow-up. Researchers will monitor for side effects and measure anti-Aβ antibody levels to assess immune response. This study will help determine if AV-1959R is safe and effective in generating a targeted immune response.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female adults, 40-60 years old.
* BMI 18.0-32.0 kg/m².
* No significant medical conditions or abnormal MRI, ECG, or lab tests.
* Signed informed consent and ability to follow study procedures.
* Females must be postmenopausal or surgically sterile.
* Males must use contraception or be vasectomized.

Exclusion Criteria:

* History of Alzheimer's, stroke, or neurodegenerative disease.
* MRI abnormalities, such as infarcts or microbleeds.
* Serious illness, surgery, or hospitalization in the last 4 weeks.
* Significant heart, lung, liver, kidney, or immune disorders.
* Recent drug/alcohol abuse or severe allergies.
* Abnormal lab tests (e.g., high liver enzymes, kidney dysfunction, HIV, Hepatitis B/C positive).
* Use of investigational drugs or amyloid/tau therapies in the last year.
* Chronic use of immunosuppressants, anticoagulants, or blood products.
* Pregnant, breastfeeding, or women of childbearing potential.
* Recent blood donation (\>400 mL) in the last 30 days.

Primary outcomes:
measure: Safety and tolerability of AV-1959R compared to placebo
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Immunogenicity of AV-1959R: Anti-Aβ antibody response
timeFrame: Up to 26 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Arvax
Study officials:
affiliation: Arvax
name: Hovhannes Madoyan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02407912: Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer
Official title: Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion, Malignant
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.

Detailed description: The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Eligibility criteria: Inclusion Criteria:

* Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;
* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;
* A leucocyte count of≥4000µl;
* A platelet count of≥100000µl;
* A normal creatinine level;
* Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal;
* Survival time ≥12 weeks.

Exclusion Criteria:

* Previously treated malignant pleural effusion;
* Pericardial effusion；
* Pregnant；
* Uncontrolled hypertension or diabetes；
* Liver cihrosis.

Primary outcomes:
measure: overall response rate
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Department of medical oncology
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital of Shantou University Medical College
name: Hongbiao Wang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213512: Effect of Anti CD20 in Pemphigus Desease
Official title: Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pemphigus
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.


Eligibility criteria: Inclusion Criteria:

* age\>18
* pemphigus corticoresistant
* pemphigus cortico dependant
* contre-indications : systémic steroids

Exclusion Criteria:

* age \< 18
* cardiopathie
* pregnant woman
* absence contraception
* no consentment

Primary outcomes:
measure: primary end-point was the rate of CR three months after the last infusion of Rituximab
Secondary outcomes:
measure: secondary end-points were :
measure: rate of CR during the study period
measure: time from the start of Rituximab to CR
measure: number and length of time to relapses
measure: treatment tolerance
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH-Rouen
state: Seine maritime
Study officials:
affiliation: UH-Rouen
name: pascal Joly, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joly P, Mouquet H, Roujeau JC, D'Incan M, Gilbert D, Jacquot S, Gougeon ML, Bedane C, Muller R, Dreno B, Doutre MS, Delaporte E, Pauwels C, Franck N, Caux F, Picard C, Tancrede-Bohin E, Bernard P, Tron F, Hertl M, Musette P. A single cycle of rituximab for the treatment of severe pemphigus. N Engl J Med. 2007 Aug 9;357(6):545-52. doi: 10.1056/NEJMoa067752.
Clinical trial NCT02168712: Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease
Official title: Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Interval exercise training
Continuous exercise training
Quality of life
Safety
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 80
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: Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. However, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality.

The purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application.

We included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.


Eligibility criteria: Inclusion Criteria:

* Coronary heart Disease, with functional class II-III according to New York Heart Association classification system.
* At least 4 weeks from acute cardiac event, percutaneous or surgery revascularization.
* Optimized medical treatment in adequate doses ( betablockers, ACE inhibitors, ARA II, statins and antiplatelet drugs)
* Age \> 18 years old.
* Willing to participate and sign an informed consent form

Exclusion Criteria:

* Residual ischemia waiting for revascularization.
* Any cardiac event for the last 4 weeks
* Abnormal Ergometry with hemodynamic or clinically significant arrhythmias during the procedure.
* History of severe ventricular arrhythmia
* Uncontrolled glycaemia or blood pressure
* Moderate to severe Chronic Pulmonary Obstructive Disease
* Osteomuscular and/or mental disorder that hampers an adequate adherence to the intervention program
* Other vascular diseases: rheumatologic/ autoimmune disorders, thrombopathies, hemophilia.
* Active oncologic disease.
* Treatment with corticosteroids.

Primary outcomes:
measure: Impact on functional capacity
timeFrame: 2 months
Secondary outcomes:
measure: quality of life
timeFrame: 2 months
Other outcomes:
measure: Incidence of Adverse Events
timeFrame: 2 months
Locations:
city: Valdemoro
country: Spain
facility: Hospital Infanta Elena
state: Madrid
Study officials:
References:
Clinical trial NCT05344612: Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
Official title: Clinical Outcomes and Cost-effectiveness of a Diagnostic and Treatment Strategy of Upfront CTCA Plus Selective Non-invasive Functional Imaging Compared With Standard Care in Patients With Chest Pain and Suspected Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
CAD
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 6444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rationale:

Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (CAD). In addition to high healthcare costs, some of the examinations do not assess the presence of CAD, which means that patients may be undertreated and are at risk for myocardial infarction. A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (CTCA) as initial examination may reduce major adverse cardiac events (MACE) and may reduce healthcare costs. In addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (CAG's).

Objectives:

* To show that the intervention is non-inferior to the control with regards to clinical outcomes
* To show superiority of the intervention with regards to clinical outcomes

Study design: National multicenter prospective randomized controlled trial.

Study population: Patients with suspected stable CAD.

Intervention: upfront CTCA to diagnose CAD and guide optimal medical therapy (OMT). Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization.

Control: Standard of care. Diagnosis and treatment are at the discretion of the attending cardiologist.

Main study end point: Composite of all-cause mortality and non-fatal myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* \>18 years

Exclusion Criteria:

* Presentation with acute coronary syndrome
* Acute coronary syndrome within last 3 months
* History of obstructive coronary artery disease on imaging
* History of PCI and/or CABG
* Severe renal failure
* Severe allergy to ionidated contrast medium
* Known pregnancy
* Patients with an estimated life expectancy of less than 1 year

Primary outcomes:
measure: Composite of all-cause mortality and non-fatal myocardial infarction
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
References:
Clinical trial NCT04243512: Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
Official title: Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivorship
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.

Detailed description: In this study, the feasibility of delivering a time-restricted eating (TRE) intervention among fatigued cancer survivors will be assessed. The participants will be asked to eat ad libitum only within a self-selected 10-h window each day for 14 days. The primary aim is to assess the adherence of the participants to the 10-h TRE intervention.

Eligibility criteria: Inclusion Criteria (Participants must...)

* Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 4 months and not more than 5 years prior to enrolling,
* Have a baseline level of fatigue, as determined by reporting a score of 3 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
* Be able to speak English,
* Be at least 18 years old,
* Be willing and able to adhere to study procedures, and
* Be able to provide written informed consent.

Exclusion Criteria (Participants must not...):

* Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
* Be underweight, as defined as a body mass index ≤20.0 kg/m2.
* Not have surgery planned in the next month,
* Not have any contraindications to the proposed nutrition intervention as identified by
* their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
* Not be taking insulin, or
* Be on enteral or parenteral nutrition.

Primary outcomes:
measure: Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Wilmot Cancer Institute
state: New York
Study officials:
References:
citation: Kleckner AS, Altman BJ, Reschke JE, Kleckner IR, Culakova E, Dunne RF, Mustian KM, Peppone LJ. Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. J Integr Oncol. 2022;11(5):379. Epub 2022 May 30.
Clinical trial NCT03444012: ADHERE-S (NIS Brilique)
Official title: Non-interventional Prospective Data Collection on Persistence and Adherence on Ticagrelor in ACS Adult Patients in Serbia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACS (Acute Coronary Syndrome)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ACS patients

Brief summary: noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* diagnosed with ACS - STEMI or NSTEMI or unstable angina, invasively or non-invasively treated
* Patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. Enrolment in this study must not be trigger for ticagrelor initiation.
* read and signed the Informed Consent Form

Exclusion Criteria:

Any contraindications as per approved SmPC of Brilique

• Patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.

Primary outcomes:
measure: duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome
timeFrame: 1 year (12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: CHC Bezanijska Kosa
city: Belgrade
country: Serbia
facility: CHC Zemun
city: Belgrade
country: Serbia
facility: CHC Zvezdara
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute for cardiovascular diseases, Dedinje
city: Belgrade
country: Serbia
facility: Medical Military Academy
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Sremska Kamenica
country: Serbia
facility: Institute for cardiovascular diseases of Vojvodina
Study officials:
References: