louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00702494: Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours
Official title: An Open, Phase I, Dose Escalation Study of the Monoclonal Antibody TB-403 Directed Against PlGF, Given as Multiple IV-doses to Patients With Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: placental growth factor
monoclonal antibody
Phase I
solid tumors
Patients with solid tumors
Lead sponsor: BioInvent International AB
Sponsor class: INDUSTRY
Collaborators: name: Oxurion
First posted: 2008-06-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.

In this study we are investigating the tolerability and safety of TB-403 in patients with solid tumors who receives multiple intravenous doses of TB-403.


Eligibility criteria: Inclusion Criteria:

* Confirmed malignity
* Measurable disease
* Performance status 1 or less (ECOG)

Exclusion Criteria:

* Acute illness or infection
* Concurrent second malignancy

Primary outcomes:
measure: Safety and tolerability of an anti-PlGF antibody
timeFrame: 85 days
Secondary outcomes:
measure: Determine multiple dose IV pharmacokinetics
timeFrame: 85 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Onkologisk Klinik 5072 Finsencentret Rigshospitalet
city: Herlev
country: Denmark
facility: Onkologisk Afdeling 54B1 Herlev Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulrik Lassen, MD, PhD
role: STUDY_CHAIR
affiliation: BioInvent International AB
name: Lena Winstedt, PhD
role: STUDY_DIRECTOR
affiliation: Herlev Hospital, Herlev, Denmark
name: Dorthe Nielsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00666094: A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes
Official title: A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hyperglycemia
Keywords: Type 2-diabetes
exercise therapy
RCT
Norway
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2008-04-24
Enrollment: 26
Sex: MALE
Minimum age (years): 35
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.

Detailed description: Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited.

Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2-diabetes
* Male, 35-71 years
* Managing their diabetes through a lifestyle and/or the drug metformin only
* Able to participate in either of the exercise groups

Exclusion Criteria:

* Symptomatic cardiovascular disease
* Uncontrolled hypertension
* Physical or cognitive disabilities that will interfere with participating in the exercise regimes.
* Trained consistently during the last six months.

Primary outcomes:
measure: HbA1C
timeFrame: 12.01.08
Secondary outcomes:
measure: body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides
timeFrame: 12.01.08
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU
Study officials:
affiliation: National Taiwan Normal University
name: Liv B Augestad, PhD
role: STUDY_DIRECTOR
References:
citation: Moe B, Augestad LB, Åsvold BO, Flanders WD. Effects of aerobic versus resistance training on glycaemic control in men with type 2 diabetes. European Journal of Sports Science 11(5): 365-374, 2011
Clinical trial NCT06250894: Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
Official title: A Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy (S-1/Oxaliplatin, SOX) and Radiotherapy for the Neoadjuvant Treatment of Locally Advanced Esophagogastric Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: PD-1
Neoadjuvant Chemoradiotherapy
Gastroesophageal Junction Cancer
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Age 18-70, male and female.
* Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.
* No previous anti-tumor treatment.
* ECOG score was 0-1.
* Expected survival of ≥ 6 months
* Adequate organ reserve function.

Exclusion Criteria:

* Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.
* Known Her-2 positive( IHC 3+ or FISH positve).
* Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody
* Severe allergic reaction to monoclonal antibody.
* Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study
* Known endoscopic signs of active bleeding from the lesion

Primary outcomes:
measure: Pathologic Complete Response
timeFrame: 10 days after operation
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 6 months after the recruitment of the last subject.
measure: Disease-Free-Survival (DFS)
timeFrame: Through study completion, an average of 1 year
measure: Number of participants with AEs (Adverse Events)
timeFrame: Through study completion, an average of 1 year
measure: Major pathologic response (MPR)
timeFrame: 10 days after operation
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Min Jin
state: Hubei
Study officials:
References:
Clinical trial NCT06887894: Biomarkers and Unstable Carotid Plaque
Official title: EVALUATION OF NEW BIOMARKERS IN THE IDENTIFICATION OF UNSTABLE CAROTID PLAQUE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 200
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: All the patients with significant internal carotid artery stenosis referred to the Unit of Vascular Surgery of Fondazione Policlinico Gemelli IRCCS Rome for carotid artery endoarterectomy.

Brief summary: This prospective study investigated associations between circulating miRNAs and symptomatic and asymptomatic ICAS, carotid plaque morphology and future cardiovascular events.


Eligibility criteria: Inclusion Criteria:

* Presence of significant internal carotid artery stenosis referred to carotid artery endarterectomy.
* Age\>18 years

Exclusion Criteria:

* Presence of significant internal carotid artery stenosis referred to carotid artery stenting

Primary outcomes:
measure: miRNA levels
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT00624494: Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery
Official title: Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Hemodynamic Monitoring
Goal Directed Therapy
Keywords: venous oxygen saturation
transpulmonary thermodilution
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2008-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Detailed description: At the present time, there is an increasing tendency to perform off-pump coronary artery bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view of the anesthesiologist and the intensivist. The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease, ranked ASA II-III and scheduled for elective OPCAB

Exclusion Criteria:

* Age \< 18 years
* Severe valve dysfunction or peripheral vascular disease
* Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
* Transfer to CPB during surgery

Primary outcomes:
measure: length of hospital stay
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Dep. of Anesthesiology, Northern SMU
Study officials:
affiliation: Northern SMU
name: Mikhail Y Kirov
role: STUDY_DIRECTOR
References:
citation: Smetkin AA, Kirov MY, Kuzkov VV, Lenkin AI, Eremeev AV, Slastilin VY, Borodin VV, Bjertnaes LJ. Single transpulmonary thermodilution and continuous monitoring of central venous oxygen saturation during off-pump coronary surgery. Acta Anaesthesiol Scand. 2009 Apr;53(4):505-14. doi: 10.1111/j.1399-6576.2008.01855.x. Epub 2009 Jan 15.
Clinical trial NCT05860894: Post Intensive Care Unit Atrial Fibrillation
Official title: Post Intensive Care Unit Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Critical Illness
Keywords: intensive care unit
atrial fibrillation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2023-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Atrial fibrillation (AF) is a common heart rhythm disorder in the intensive care unit (ICU). It can be precipitated by multiple factors but it is unclear whether AF persists after discharge from the ICU, and long term. This study will investigate whether AF recurs up to one year after ICU discharge.

Detailed description: Atrial fibrillation (AF) is the most common heart rhythm disorder encountered in the intensive care unit (ICU). It can be precipitated by multiple factors present in critically ill patients, such as tissue hypoxia, metabolic disorders etc. There is a paucity of data regarding the persistence of AF in these patients after discharge from the ICU, and in the longer term. Therefore, this study will investigate whether AF recurs up to one year after ICU discharge using an implantable ECG Holter device in adult patients discharged alive from the ICU, with documented new onset AF.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* New onset atrial fibrillation diagnosed in the ICU (12 lead ECG or documented episode of atrial fibrillation lasting at least 30 seconds)
* Patient hospitalized in the ICU with at least one of the following two criteria:

  * orotracheal intubation for mechanical ventilation
  * AND/OR treatment with amines (vasopressors or inotropic agents)
* Written informed consent
* Patient affiliated to a social security regime (or beneficiary thereof)

Exclusion Criteria:

* Documented history of atrial fibrillation
* patients admitted to the ICU after cardiothoracic surgery
* Patients with life expectancy \<12 months
* Patients under legal or judicial protection
* Patients with no social security coverage
* Patients within the exclusion period of another clinical trial

Primary outcomes:
measure: Rate of recurrence of atrial fibrillation
timeFrame: up to 1 year after ICU discharge
Secondary outcomes:
measure: Burden of atrial fibrillation in absolute value
timeFrame: up to 2 years after ICU discharge
measure: Burden of atrial fibrillation (percentage of time spent in atrial fibrillation)
timeFrame: up to 2 years after ICU discharge
measure: Rate of Stroke
timeFrame: up to 2 years after ICU discharge
measure: Number of participants with Change in treatment
timeFrame: up to 2 years after ICU discharge
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire de Besancon
Study officials:
References:
Clinical trial NCT03771794: Heart Rate Variability Augmentation With RR2 Neuromodulation Device
Official title: Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: HRV
Peripheral neuromodulation
Autonomic balance
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system

Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode
Primary purpose: TREATMENT

Brief summary: Brief Summary: A randomized double-blinded, sham-controlled, crossover study

Condition or Disease: impaired autonomic balance measured by heart rate variability

Detailed description: A randomized double-blinded, sham-controlled, crossover study

Condition or Disease: impaired autonomic balance measured by heart rate variability

Intervention/treatment:

Device: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation system

Study Design:

Study Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation: Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in healthy adults

Eligibility criteria: Inclusion Criteria:

-

Inclusion criteria :

1. Healthy male and female volunteers ages 25-60
2. 2 minute HRV measurement with SDNN\<35 ms (below 35 ms)
3. Participants able and willing to comply with the study protocol
4. Participants able and willing to sign a written informed consent

Exclusion Criteria:

-

Exclusion criteria :

1. Participant with a known cardiovascular disease
2. Participants with COPD
3. Participants with any known history of epilepsy
4. Participants with detected arrhythmia on test day
5. Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.)
6. Heavy smokers (more than 1 package of cigarets a day)
7. Participants with a plan to change medications
8. History of vasovagal syncope
9. Pregnancy or bleeding
10. Participants enrolled in another clinical trial

Primary outcomes:
measure: Percentage of patients with 15% or HRV change immediately after neurostimulation session
timeFrame: 1 week
Secondary outcomes:
measure: Decrease in heart rate
timeFrame: 1 week
Other outcomes:
measure: Percentage of patients with 5% or more decrease in blood pressure
timeFrame: 1 week
measure: Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)
timeFrame: 1 week
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
References:
Clinical trial NCT03206294: Impact of Pharmacist in Cardiology Service
Official title: Presence of a Clinical Pharmacist in a Cardiology Department: What Impact on the Management of Diabetic Patients Within Care Pathways? Example of Inpatient Cardiac Patients at GHPSJ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathy, Diabetic
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. That's why the pharmacist's presence during the hospitalization seems to be a good alternative to make the link between hospital and the outside pharmacist where patient take his treatment.

Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.

By this conciliation the aim of the study is to show and quantify the impact of pharmacist presence on therapeutic target .


Eligibility criteria: Inclusion Criteria:

* Diabetes type 2 patient hospitalized in cardiology service
* Hospitalization more than 24 hours
* with insuline or/and oral anti diabetic

Exclusion Criteria:

* diabètes type 1
* iatrogenic hyperglycaemia
* hospitalization for cardia angiography

Primary outcomes:
measure: Measurement of biological test glycosylated haemoglobin evolution between the entrance and discharge
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: Romain CADOR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602394: Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to lithium, or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services, 11248 Wilcrest Green, , Houston77042
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So R Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00625794: Nicotine Replacement and Counseling In Adolescents
Official title: A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.


Eligibility criteria: Inclusion Criteria:

* Be between 15 and 18 years-old
* Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.

Exclusion Criteria:

* Adolescents who were using or had used nicotine replacement in the prior week were excluded.
* Those who used bupropion (Zyban®) within the past 30 days were also excluded.

Primary outcomes:
measure: Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability of the Nicotine Nasal Spray by Adolescents.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mark Rubinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: