louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00243724: HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease
Official title: An Open-Label, Parallel-Group, Multi-Centre Study to Determine the Effect of Treatment With Esomeprazole for Six Months on Histological Markers of Esophageal Epithelial Acid-Related Disease in Patients With Upper GI Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Heartburn
Dyspepsia
Keywords: immunohistochemical
erosive esophagitis
Acid reflux disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-25
Enrollment: 350
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: Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* 18 years or older
* history of upper GI symptoms

Exclusion Criteria:

* Peptic ulcer disease
* upper gastrointestinal surgery
* malignancy

Primary outcomes:
measure: Change from baseline after 6 months in the level of ki-67 expression and histological markers of esophageal epithelial acid-related disease after acid-suppressive therapy with esomeprazole
Secondary outcomes:
measure: Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Canada Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06017024: New Microprocessor-Controlled Prosthetic Knee Evaluation
Official title: Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Above Knee (Injury)
Keywords: Micro-processor controlled knee
Lower Limb prosthesis
Patient-specific Functional Scale
Lead sponsor: Proteor Group
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.


Eligibility criteria: Inclusion Criteria:

* Able to understand and give informed consent
* Man or woman, more than 18 y.o
* Lower limb amputee KD or AKA, unilateral or bilateral
* K3/K4 activity level
* Already fitted with FR-reimbursed MPK
* Being comfortable in their socket (SCS\>=5)

Exclusion Criteria:

* Protected person
* Pregnant or breast feeding lady
* Person having pathologies affecting their sensitivity
* Using walking aids
* Weighting more than 136kg
* Insufficient hip joint or pelvic voluntary muscle control
* Insufficient cognitive ability to charge the knee and care for the device

Primary outcomes:
measure: Personal goal achievement
timeFrame: test sessions 1 and 2 (20 minutes)
Secondary outcomes:
measure: Functional walking test - mobility capacity
timeFrame: test sessions 1 and 2 (8 minutes)
measure: Functional walking test - fast walking speed
timeFrame: test sessions 1 and 2 (1 minute)
measure: Functional test - ability to walk downhill
timeFrame: test sessions 1 and 2 (3 minutes)
measure: Functional test - ability to walk downstairs
timeFrame: test sessions 1 and 2 (3 minutes)
measure: Questionnaire to assess comfort in the socket
timeFrame: test sessions 1 and 2 (1 minute)
measure: Questionnaire to assess satisfaction
timeFrame: test sessions 1 and 2 (5 minutes)
measure: Questionnaires to assess quality of life
timeFrame: test sessions 1 and 2 (5 minutes)
measure: Prosthesis Evaluation Questionnaire
timeFrame: test sessions 1 and 2 (29 minutes)
Other outcomes:
Locations:
city: Hyères
country: France
facility: Hôpital Léon Bérard
city: Lamalou-les-Bains
country: France
facility: Clinique du Dr Ster
city: Nancy
country: France
facility: UGECAM Nord-Est IRR
city: Ploemeur
country: France
facility: Centre Mutualiste de Kerpape
city: Saint-Herblain
country: France
facility: UGECAM La Tourmaline
Study officials:
References:
Clinical trial NCT00001624: Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
Official title: Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperinsulinemia
Keywords: BQ-123
Endothelin
Insulin
Plethysmography
Vasoconstriction
Healthy Volunteer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.

Detailed description: Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.

Eligibility criteria: Between 40-65 years old.

No medications.

No medical problems.

No serum cholesterol levels below 200 mg/dl.

No contraceptives.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Haynes WG, Webb DJ. Contribution of endogenous generation of endothelin-1 to basal vascular tone. Lancet. 1994 Sep 24;344(8926):852-4. doi: 10.1016/s0140-6736(94)92827-4.
citation: Donckier J, Stoleru L, Hayashida W, Van Mechelen H, Selvais P, Galanti L, Clozel JP, Ketelslegers JM, Pouleur H. Role of endogenous endothelin-1 in experimental renal hypertension in dogs. Circulation. 1995 Jul 1;92(1):106-13. doi: 10.1161/01.cir.92.1.106.
Clinical trial NCT01504724: Effect of the Adjunctive IVB Before PRP
Official title: Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Retinopathy
Keywords: central macular thickness
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.

Detailed description: This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured

Eligibility criteria: Inclusion Criteria:

* patients with severe NPDR or early PDR without macular edema
* best-corrected visual acuity (BCVA) of 20/25 or better
* patients who were followed up for at least 6 months after the first PRP.

Exclusion Criteria:

* patients with retinal or choroidal diseases except diabetic retinopathy
* contraindications to fluorescein angiography (FA) or bevacizumab
* patients who had previous treatments including anti-angiogenic medications and laser photocoagulation
* patients with previous vitrectomy
* patients with uncontrolled hypertension, a recent myocardial infarction or cerebral vascular accidents.

Primary outcomes:
measure: Central macular thickness
timeFrame: 6 months after first PRP session
Secondary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: 6 months after first PRP session
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Dong Ho Park
Study officials:
affiliation: Kyungpook National University Hospital
name: Dong Ho Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jo YJ, Heo DW, Shin YI, Kim JY. Diurnal variation of retina thickness measured with time domain and spectral domain optical coherence tomography in healthy subjects. Invest Ophthalmol Vis Sci. 2011 Aug 17;52(9):6497-500. doi: 10.1167/iovs.11-7403.
Clinical trial NCT06751524: Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval
Official title: Botensilimab and Balstilimab Expanded Access Program
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Colorectal Cancer (CRC)
Pancreatic Cancer
Non-Small Cell Lung Cancer (NSCLC)
Hepatocellular Carcinoma (HCC)
Melanoma
Sarcoma
Ovarian Cancer
Prostate Cancer
Keywords: Compassionate Use
Early Access
Expanded Access
Managed Access
Pre-approval Access
Special Access
Named Patient Program (NPP)
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Detailed description: This EAP is available for indications where there is reasonable scientific basis for use. Availability will depend on territory eligibility.

Eligibility criteria: Key Inclusion Criteria:

* The patient's disease is serious or life-threatening.
* The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.
* Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment.
* Sufficient clinical data are available to identify an appropriate dose and treatment duration.
* The patient's treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.
* The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.
* Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
* The request must be made by the patient's treating physician.

Note: Other defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Agenus Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01348724: Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118
Official title: A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After [14C]-Labelled Oral Administration of NKTR-118 to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Radioactive carbon
Absorption
Distribution
Metabolism
Excretion
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study to Assess the Absorption, Metabolism and Excretion of \[14C\] NKTR-118 after a Single-Dose Oral Administration.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and a minimum weight of 50 kg
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within 12 months of screening visit 1
* Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day

Primary outcomes:
measure: Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces
timeFrame: Range of Day 1 until day 10
measure: Concentration of total radioactivity in blood and plasma samples
timeFrame: Range of Day 1 until day 10
measure: Concentration of NKTR-118 in blood and plasma sample
timeFrame: Range of Day 1 until day 10
Secondary outcomes:
measure: Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples
timeFrame: Range of Day -1 until follow up visit (Visit 3)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles, Inc.
name: Marianne Kasti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mark Sostek, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Emeline Ramos
role: STUDY_CHAIR
References:
Clinical trial NCT01385124: Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation
Official title: Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Graft Versus Host Disease
Keywords: Cannabidiol
GVHD
Allogeneic transplantation
Prophylaxis
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.

The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.

As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing allogeneic stem cell transplantation.
2. No previous history of psychosis. -

Exclusion Criteria:

1. Previous history of psychosis.
2. Consumption of cannabis during the last 2 moths before transplantation. -

Primary outcomes:
measure: Overall percentage of patients with acute GVHD at day 100 post-transplant
timeFrame: day 100
Secondary outcomes:
measure: Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant
timeFrame: day 100
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Davidoff Cancer Center, Beilin hospital, Rabin medical center
Study officials:
affiliation: Davidoff cancer center, Beilinson hospital, Rabin Medical Center
name: Moshe Yeshurun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeshurun M, Shpilberg O, Herscovici C, Shargian L, Dreyer J, Peck A, Israeli M, Levy-Assaraf M, Gruenewald T, Mechoulam R, Raanani P, Ram R. Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study. Biol Blood Marrow Transplant. 2015 Oct;21(10):1770-5. doi: 10.1016/j.bbmt.2015.05.018. Epub 2015 May 30.
Clinical trial NCT00135434: Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Official title: Effect of HIV Protease Inhibitor Drugs on Glucose and Insulin Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examined the effects of two commonly prescribed HIV drugs on the way the body metabolizes glucose, insulin and fat.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Primary outcomes:
measure: Insulin sensitivity by euglycemic hyperinsulinemic clamp method
Secondary outcomes:
measure: Insulin sensitivity by oral glucose tolerance
measure: Lipids and lipoproteins
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Clinical Pharmacology Unit, Bristol-Myers Squibb Company
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01451034: Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
Official title: Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: WHYX Lesion
Extremely Well Differentiated Intestinal-type Adenocarcinoma
Keywords: WHYX lesion
endoscopic resection
complete resection
complete resection rate
endoscopic feature
Average size discrepancy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 872
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.


Eligibility criteria: Inclusion Criteria:

* From January 2009 to December 2010 enrolled 872 patients with EGC

Exclusion Criteria:

* EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion

Primary outcomes:
measure: complete resection rate
timeFrame: 6 months after endoscopical resection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: