louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02129179: The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure
Official title: The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2014-05-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to assess the effect of glucagon-like peptide-1 on cardiac output and transpulmonary gradient in patients undergoing right heart catheterisation for clinical reasons.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Able to give informed consent
* On the waiting list for heart transplant
* Left Ventricular Dysfunction awaiting catheterisation

Exclusion Criteria:

* Nicorandil, glibenclamide, Dipeptidyl Peptidase-4 inhibitor, Glucagon-Like Peptide-1 receptor agonist or insulin
* Women of child bearing age and breast feeding women
* Cardiac pacemaker or other implanted metallic device
* Unable to give informed consent

Primary outcomes:
measure: Change in Pulmonary Vascular Resistance with Glucagon-Like Peptide-1
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
Study officials:
References:
citation: Clarke SJ, Pettit S, Giblett JP, Zhao T, Kydd AC, Albrechtsen NJW, Deacon CF, Parameshwar J, Hoole SP. Effects of Acute GLP-1 Infusion on Pulmonary and Systemic Hemodynamics in Patients With Heart Failure: A Pilot Study. Clin Ther. 2019 Jan;41(1):118-127.e0. doi: 10.1016/j.clinthera.2018.11.013. Epub 2018 Dec 28.
Clinical trial NCT01007279: Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)
Official title: ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periprocedural Myocardial Necrosis
Keywords: Percutaneous angioplasty
Myocardial Infarction
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ).Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is copidogrel loading dose administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg) loading dose of Rosuvastatin administered within 24h before the procedure may be effective in reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single center,prospective randomized study to assess whether a single,high (40mg) loading (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation.


Eligibility criteria: Inclusion Criteria:

* Patients with stable angina

Exclusion Criteria:

* Baseline myocardial enzyme rise

Primary outcomes:
measure: Myocardial enzymes arise
timeFrame: 6-12-24 hours
Secondary outcomes:
measure: MACE
timeFrame: 1-6-9 MONTHS
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Umberto I
Study officials:
References:
Clinical trial NCT05106179: The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma
Official title: The Efficacy and Safety of Beta-blockers Drugs in Adults With Spinal Hemangioma: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Tumor
Spinal Hemangioma
Beta Blocker Toxicity
Keywords: β-blockers
Vertebral Hemangioma
Efficacy
Lead sponsor: Center for Vascular Pathology, Moscow
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal.

This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.


Eligibility criteria: Inclusion Criteria:

* vertebral hemangioma

Exclusion Criteria:

* symptomatic bradycardia
* AV block
* decompensated heart failure
* asthma

Primary outcomes:
measure: Reducing tumor growth
timeFrame: 3 months
measure: Reducing tumor
timeFrame: 6 months
measure: Life-quality
timeFrame: 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The Vascular Anomalies Center (VAC) "Hemangioma"
Study officials:
affiliation: The Vascular Anomalies Center (VAC) "Hemangioma",
name: Ekaterina Listovskaia, MD
role: STUDY_CHAIR
affiliation: The Vascular Anomalies Center (VAC) "Hemangioma"
name: Dmitry Romanov, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06446479: Effects of THC on Alcohol Consumption and Neural Correlates of Reward
Official title: Effects of THC on Alcohol Consumption and Neural Correlates of Reward
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cannabis Use Disorder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Colorado State University
First posted: 2024-06-06
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.

Detailed description: Participants will undergo a screening assessment, baseline session and two laboratory visits. The laboratory visits will involve an MRI scan and the opportunity to consume alcohol in our BAR lab. Prior to the MRI, participants will consume, a placebo (0mg) or high (20mg) dose of oral THC (dronabinol). Visits will be separated by 7 to 14 days. Dronabinol is an FDA-approved product that will be dispensed by our on-campus pharmacy

Eligibility criteria: Inclusion Criteria:

* Drink alcohol
* Use cannabis
* Contact site for additional details

Exclusion Criteria:

* MRI contraindications (implanted metal, weight \> 315 lb, etc.).
* Contact site for additional details

Primary outcomes:
measure: Change in alcohol cue-elicited brain activation (fMRI) between medication periods
timeFrame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
measure: Change in cannabis cue-elicited brain activation (fMRI) between medication periods
timeFrame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
measure: Alcohol self-administration
timeFrame: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
measure: Self-reported alcoholic drinks consumed
timeFrame: one report per day for the 14 days after the final laboratory visit on day 14.
measure: Self-reported cannabis use
timeFrame: One report per day for the 14 days after the final laboratory visit on day 14
measure: Self-reported cannabis and alcohol co-use
timeFrame: One report per day for the 14 days after the final laboratory visit on day 14.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References:
Clinical trial NCT05221879: Anti-factor Xa Based Venous Thromboembolism Prophylaxis
Official title: Anti-factor Xa Based Venous Thromboembolism Prophylaxis: Dose Adjustment in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dose Adjustment of Enoxaparin in ICU Patients
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above


Eligibility criteria: Inclusion Criteria: Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h.

-

Exclusion Criteria: Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance \< 30 mL/min.

-

Primary outcomes:
measure: Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin
timeFrame: Up to 72 hours from ICU admission.
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT03110679: Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
Official title: Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
autologous bone marrow concentrate
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: autologous bone marrow concentrate vs. hyaluronic acid.
Primary purpose: TREATMENT

Brief summary: OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.

Detailed description: a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients, aged between 18 and 75 years;
2. Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
3. Failure after two months of conservative treatment;
4. Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
5. Signature of informed consent.

Exclusion Criteria:

1. Patients incapable of discernment;
2. Patients with malignancy
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with metabolic disorders of the thyroid;
6. Patients belonging abuse of alcohol, drugs or medications;
7. Patients with misalignment of the lower limbs than 10 °;
8. Body Mass Index\> 40;
9. Patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.

Primary outcomes:
measure: International Knee Documentation Committee (IKDC)-Subjective score
timeFrame: Time Frame: 6 months
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC)-Subjective score
timeFrame: Time Frame: 1,3,6, 12, 24 months evaluation
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS).
timeFrame: Time Frame: 1,3,6, 12, 24 months evaluation
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
References:
Clinical trial NCT00497679: AZD1152 in Patients With Advanced Solid Malignancies-Study 3
Official title: A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 7-Day Intravenous Infusion in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumours
Keywords: advanced solid tumours
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of a solid, malignant tumour

Exclusion Criteria:

* Participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug
* Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
* Recent major surgery within 4 weeks prior to entry to the study

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Assessed at each visit
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Assessed at predetermined timepoints after dose administration
measure: Effect on biomarkers
timeFrame: Assessed after treatment
measure: Anti-tumor activity
timeFrame: Assessed at the end of treatment
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: University of Oxford
name: David Kerr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03240484: Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement
Official title: Examining Effects of Spinal Arthrodesis on Outcomes Following Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Fusion
Total Hip Replacement
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 160
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: Approximately 70 patients who underwent total hip arthroplasty (THA) and spine fusion (SF) surgery will be called by the surgeon or research team and asked if they wish to participate in the study. A second group of approximately 45 patients who have only had a THA (and no SF) will serve as a comparison group. A third group of approximately 45 patients who have only had an SF surgery (and no THA) will also be recruited.

Brief summary: The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement.

Detailed description: The purpose of the study is to explore the long term functional status of people who have had both a spinal fusion procedure and a total hip replacement. Studies have found that those who have received spinal fusion may have worse outcomes following a total hip replacement than those who have not received a spinal fusion. The information obtained from this study will allow surgeons and researchers to better understand why some who've had a spine fusion have more complications post total hip replacement compared to those who did not have spinal fusion surgery.

Eligibility criteria: Inclusion Criteria:

* Willing to come to the Civic Campus for a surgical follow-up visit
* Speaks English and/or French
* Group 1 patients must have had a spine fusion (SF) and total hip arthroplasty (THA)
* Group 2 patients must have had a total hip replacement (THA) and no history of spine fusion (SF)
* Group 3 patients must have had a spine fusion (SF) and no history of total hip arthroplasty (THA)

Exclusion Criteria:

* Patient does not meet all 'inclusion' criteria
* Patient is unable to answer questionnaires
* Unable to get x-rays for other medical reasons
* Severe dementia

Primary outcomes:
measure: Implant positioning
timeFrame: 6months or greater post-operative
Secondary outcomes:
measure: Hip dysfunction and osteoarthritis outcome score (HOOS)
timeFrame: 6months or greater post-operative
measure: Oxford Hip Score
timeFrame: 6months or greater post-operative
measure: SF-12 Questionnaire
timeFrame: 6months or greater post-operative
measure: Oswestry low back disability questionnaire
timeFrame: 6months or greater post-operative
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Research Institute
name: Wade Gofton, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00324584: Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study
Official title: Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes mellitus
telecare
telemedicine
insulin pump therapy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

Detailed description: We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus
* Age ≥ 18
* HbA1c between 7.5 and 10%
* Treated with continuous subcutaneous insulin infusion for a minimum of 3 months

Exclusion Criteria:

* Unstabilized diabetic microangiopathy
* Ongoing pregnancy or planned pregnancy
* Unwilling to perform a minimum of 4 capillary blood tests per day
* Unable to use the GlucoNet device

Primary outcomes:
measure: Glycated hemoglobin HbA1c
measure: monthly mean capillary blood glucose value
measure: blood glucose variability index (MAGE Index and LBGI index)
measure: quality of life score (DQOL score)
measure: frequency of hypoglycemic episodes (<70 mg/dl)
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Department of Endocrinology
city: Toulouse
country: France
facility: University Hospital, Department of Endocrinology
Study officials:
affiliation: Universty Hospital, Grenoble, France
name: Pierre Y Benhamou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Toulouse, France
name: Helene Hanaire, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble, France
name: Serge Halimi, MD
role: STUDY_DIRECTOR
affiliation: CIC-INSERM
name: Jean L Bosson, MD, PhD
role: STUDY_DIRECTOR
References: