louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00388986: A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Official title: An Open-label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, aged 18-75 years;
* type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for \>=3 months;
* untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.

Exclusion Criteria:

* type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
* diabetic neuropathy, retinopathy or nephropathy;
* patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.

Primary outcomes:
measure: AUC0-6h of plasma glucose
timeFrame: Days -1, 6 and 12
measure: AUC0-12h of GK Activator (2) and metabolite.
timeFrame: Days 6 and 12
measure: AUC0-tau of glyburide
timeFrame: Days -1 and 6
Secondary outcomes:
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
city: Honolulu
country: United States
state: Hawaii
city: Buffalo
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02644486: A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity and Glomerulopathy
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of obesity
* diagnosed ORG by renal biopsy
* LDL\>3.37mmol/L
* Proteinuria 0.5-3.5g/d
* eGFR (CKD-EPI formula) \> 30ml/min

Exclusion Criteria:

* Other concomitant renal diseases
* Endocrine or drug-induced obesity;
* Type 2 diabetes
* eyes or obvious microscopic hematuria;
* Swallowing difficulty / severe gastrointestinal dysfunction
* intestinal obstruction;
* severe arrhythmia;
* Hypophosphatemia (\<0.7mmol/L);
* allergic to Sevelamer Carbonate
* unable to well cooperate
* Females who are in the period of gestation or lactation, or refuse to use contraception;
* participated in other clinical trial of drug within three months

Primary outcomes:
measure: low-density lipoprotein
timeFrame: 12 weeks
Secondary outcomes:
measure: uric acid
timeFrame: 12 weeks
measure: blood lipids parameters (CHO, TG, HDL)
timeFrame: 12 weeks
measure: proteinuria
timeFrame: 12 weeks
measure: blood glucose
timeFrame: 12 weeks
measure: glycated hemoglobin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
References:
Clinical trial NCT02760186: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
Official title: Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2016-05-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude.

Detailed description: Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the Atacama large Millimeter Array (ALMA) base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period.

A second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. Measurements will be conducted by qualified specialists using a portable ultrasound device.

Eligibility criteria: Inclusion Criteria:

* Born, raised and currently living \<800m
* No overnight stay at altitudes \> 1500m 4 weeks before the study

Exclusion Criteria:

* Previous altitude intolerance to altitude \<3000m
* Pregnancy
* Health impairment, which requires regular treatment

Primary outcomes:
measure: ultrasound lung comets
timeFrame: change from lowland baseline at 520m, day 2 and first sojourn at 5050 m, day 2
Secondary outcomes:
measure: ultrasound lung comets
timeFrame: first sojourn at 5050 m, 7; second sojourn at 5050m, day 2, 7
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Switzerland
Study officials:
affiliation: University of Zurich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00322686: Study of Oglemilast for the Treatment of Asthma
Official title: Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: oglemilast
asthma
allergen
prevention
prophylaxis
Allergen-Induced Asthma
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.


Eligibility criteria: Inclusion Criteria:

* Mild atopic asthma
* Hyperreactivity to methacholine
* Exhibit positive response to standard allergen skin prick test

Exclusion Criteria:

* Pulmonary disease other than asthma
* Asthma exacerbation within 4 weeks
* History of substance abuse
* Active cardiac disease

Primary outcomes:
measure: To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
timeFrame: From Baseline to Day 7
Secondary outcomes:
measure: To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations
timeFrame: From Baseline to Day 14
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Forest Investigative Site
state: California
Study officials:
References:
Clinical trial NCT00681486: Ghrelin - A Possible Opportunity to Improve Appetite
Official title: Ghrelin - A Possible Opportunity to Improve Appetite, Nutritional State, Metabolic Integrity and Physical Functioning in Cancer Patients With Progressive Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Ghrelin
Nutrition
Cancer patients
Survival
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
name: Medical Research Council
First posted: 2008-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

Detailed description: Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.

Eligibility criteria: Inclusion Criteria:

* Weight loss

Exclusion Criteria:

* Diabetes

Primary outcomes:
measure: Food intake
timeFrame: June 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of surgery, Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Kent Lundholm, MD, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300986: Parameter Changes in Functional Electrical Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait Disorders, Neurologic
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for this study is adult users of standard FES for foot drop, registered with the Leeds FES service. Any upper motor neurone lesion can be the primary condition.

Brief summary: This study aims to look at how changes to a person's functional electrical stimulation might change how they walk. Functional electrical stimulation (FES) is commonly used to help people with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This group of people have muscle weakness which makes it difficult to lift the foot, which causes trips and falls.

FES reduces foot drop by using a portable device to apply short electrical pulses to the nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase, when the foot is off the floor. Typically this is achieved by using a foot-switch, which detects when the heel leaves the floor. Stimulation begins a short interval of time after the heel leaves the floor, ramps up from zero to set stimulation for the individual, and at another period of time after the heel hits the floor, stimulation ramps down from set amount to zero. There are four time intervals described here which can be varied by the clinician on the device:-

* Delay (the time between heel lift and the start of stimulation)
* Ramp up (the time for stimulation to reach full strength)
* Extension (the time between heel strike and the ramp down)
* Ramp down (the time for stimulation to reach zero from full strength) These intervals are usually set by experienced clinicians using a qualitative assessment of the patient's walking and trial-and-error. A literature review has found no published studies which compare walking with different timing. This knowledge would be useful for clinicians, who could use this information as a starting point in finding the best timing parameters for each patient.


Eligibility criteria: Inclusion Criteria:

* Upper motor neurone lesion causing foot drop
* Currently use single-channel Odstock Medical ODFS functional electrical stimulator
* Age 18 or older
* Attending Leeds FES Service follow-up clinics

Exclusion Criteria:

* • FES user for less than three months

  * Lower limb prosthesis
  * Cannot walk 5m with walking aids
  * Cannot walk twenty 5m walks within a three-hour period
  * Use FES less than once per week

Primary outcomes:
measure: Gait analysis will be measured according to routine protocol
timeFrame: Gait will be assessed over one visit of three hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00717886: Upper Extremity Lymphatic Mapping for Breast Cancer Patients
Official title: Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Axillary Lymph Node Dissection
Keywords: Breast
Lymph Nodes
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 13
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.


Eligibility criteria: Inclusion Criteria:

* Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.
* Females \> 21 years of age

Exclusion Criteria:

* Prior ipsilateral axillary surgery
* Prior ipsilateral axillary radiation
* Prior ipsilateral breast cancer
* Prior ipsilateral breast radiation
* Allergy to isosulfan blue dye
* History of ipsilateral upper extremity lymphedema
* Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast
* Prior history of neoadjuvant chemotherapy for current breast cancer
* Bulky axillary disease at presentation (N2)

Primary outcomes:
measure: Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Leslie Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01779986: Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram
Official title: Comparison of the Evaluation of CAD by CT AngioScan and Coronary Angiogram in Patient as Part of Preoperative Evaluation in Ascending Aorta Replacement Surgery Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ascending aorta aneurysm undergoing preoperative evaluation of CAD by CT-Angioscan and Coronary angiogramm before surgical reparation.

Brief summary: The use of CT Coronary Angioscan (CT-AS) is gaining popularity, but its exact value as evaluation of CAD requires confirmation. We intend to compare the results of CT-AS and convention coronary angiogram results in patients who are scheduled for an ascending aorta aneurysm reparation surgery. These examens are standard of care before this surgery, so there is no additional danger or disadvantage for the patient. We hope to confirm that CT-AS is a reliable screening test for CAD in patient undergoing heart surgery for other reason than CAD.


Eligibility criteria: Inclusion Criteria:

* Ascending aorta aneurysm waiting for surgical correction
* Willing to participate
* Needing a Coronary angiogram and a CT-AS for medical reasons

Exclusion Criteria:

* Refuse to participate
* Allergy to contrast material
* Incomplete results or having one of the test done in another hospital
* Arrythmia
* More than 6 months between the two exams

Primary outcomes:
measure: Presence of CAD
timeFrame: less than 6 monthes between two tests
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS Fleurimont
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Gerald Gahide, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192086: Goal Directed Fluid Administration for Kidney Transplantation
Official title: The Effect of Non-Invasive Goal Directed Fluid Administration on Graft Function in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: End Stage Renal Disease
Keywords: Kidney transplantation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 21
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: The goal of the proposed study is to evaluate the efficacy of a goal-directed fluid administration algorithm on early graft function in patients undergoing kidney transplantation. Fluid administration has increasingly been scrutinized within anesthesia related literature as an area for improvement, and the imbalance present between estimated blood loss and total fluid administered for kidney transplants must be amongst the highest case categories. Considering the patients are anuric for the majority of the procedure, unguided administration of multiple liters of crystalloid appears antiquated.


Eligibility criteria: Inclusion Criteria:

* end stage renal disease requiring dialysis
* age \>18y
* normal cognitive function.

Exclusion Criteria:

* severe left ventricular dysfunction (EF\<50%)
* known cardiomyopathy
* symptomatic CAD known valvular disease
* severe anemia (Hgb\<7.0)
* patients with prior transplants o
* patients who suffered surgical complications as communicated by the surgical team.

We chose these exclusion criteria to prevent enrolling patients who would not tolerate aggressive hydration possible in the treatment group. The exclusion criteria may be excessively restrictive, however, given the current practice that frequently results in rapid large volume loading without a monitor of intravascular volume status.

Primary outcomes:
measure: Effect of Plethysmography Directed Fluid Administration Tranplanted Kidney
timeFrame: 1 year
measure: Pleth Variability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: William Hand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Scott T Reeves, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06827886: GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma
Official title: GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient With Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alveolar Soft Part Sarcoma
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Patient Study (SPS)
Primary purpose: TREATMENT

Brief summary: CLIC-YYC-GPNMB-01 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-01 has progressive metastatic alveolar soft part sarcoma (ASPS). The investigators propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).


Eligibility criteria: Inclusion Criteria:

1. Completion of Informed Consent Form

Exclusion Criteria:

1. Any significant medical issue(s) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.

Primary outcomes:
measure: Assess safety of GCAR1
timeFrame: 1 year
measure: Assess for anti-tumor activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Study officials:
affiliation: Alberta Health services
name: Mona Shafey, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: