louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00535808: Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study
Official title: Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Oxygenation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In a prospective and randomized study protocol, three different blood pressure regulating agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect on the cerebral oxygen balance between both hemispheres during aortic coarctation repair. Cerebral and somatic saturation will be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and the somatic regions. Arterial blood pressure, central venous pressure, heart rate and systemic saturation will be recorded continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6 definite time intervals. The study ends at the end of the operation.


Eligibility criteria: Inclusion Criteria:

* All neonates and infants
* Aged 0-18 year
* With aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass will be included.

Exclusion Criteria:

* All patients with an associated cardiac effect are excluded.

Primary outcomes:
measure: Cerebral saturation
timeFrame: During operation
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Annelies Moerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448208: Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors
Official title: Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Tumors
Keywords: PET scan
CT scan
24-100
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: NeuroEndocrine Tumor Research Foundation (NETRF)
First posted: 2024-06-07
Enrollment: 50
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: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).

Brief summary: People with neuroendocrine cancer typically have imaging scans before and after treatment, including positron emission tomography (PET) scans. The scans are analyzed using a set of criteria that describes how the disease has responded to treatment. The purpose of this study is to establish new criteria for doctors to use when evaluating these PET scans. Researchers are testing whether these new criteria are useful for predicting whether a person's cancer gets better, gets worse, or stays the same. Researchers will also compare these new criteria to the current standard criteria for evaluating imaging scans.


Eligibility criteria: Subjects affected by histologically proven, somatostatin-receptor positive, metastatic or inoperable well-differentiated G1, G2 or G3 neuroendocrine tumors (NETs) candidate to receive PRRT with 177Lu-DOTATATE per standard of care.

Inclusion Criteria:

1. Histologically proven or cytologically confirmed, metastatic or inoperable NETs
2. Measurable disease as defined by RECIST 1.1.
3. Overexpression of somatostatin receptors of the target lesions at somatostatin receptor imaging (68Ga-DOTATATE or 64Cu-DOTATATE PET/CT) with SUV of lesions greater than normal liver at least in 1 metastasis.

Exclusion Criteria:

1. Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
2. Presence of somatostatin receptor negative lesions.

Primary outcomes:
measure: validate the PRESCIENT criteria
timeFrame: 1 year
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: Lisa Bodei, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02011308: KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)
Official title: The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH (Benign Prostatic Hyperplasia)
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University of Turku
name: Tampere University
name: South Ostrobothnia Health Care District
name: Oulu University Hospital
First posted: 2013-12-13
Enrollment: 217
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.


Eligibility criteria: Inclusion Criteria:

* Men undergoing surgery for BPH

Exclusion Criteria:

* Previous prostate surgery
* Carcinoma of the prostate
* Neurogenic bladder
* Bladder carcinoma

Primary outcomes:
measure: IPSS (International Prostate Symptom Score)
timeFrame: 12 months
Secondary outcomes:
measure: DAN-PSS (Danish Prostate Symptom Score)
timeFrame: 3, 6 and 12 months
measure: Maximum flow rate (Qmax)
timeFrame: 3, 6 and 12 months
measure: Residual urine
timeFrame: 3, 6 and 12 months
measure: Length of catheterization
timeFrame: Postoperative recovery
measure: Length of hospital stay
timeFrame: Postoperative recovery
measure: Perioperative bleeding
timeFrame: Time of operation
measure: IIEF (International Index of Erectile Function questionnaire)
timeFrame: 12 months
measure: TRUS (transrectal ultrasound)
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Hannu T Koistinen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348608: Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart
Official title: Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary
Angiography
X-ray
CAD
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years old.
* Subject must have been referred for an elective coronary angiography for one of several specified conditions.

Exclusion Criteria:

* The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 μmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 μmol/L), the investigator should follow the practising guideline(s) of their institution.
* Subject has a known allergy to iodinated contrast agent
* Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images.
* The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.
* Use of nitroglycerin is contraindicated.
* Subject has had a prior CABG procedure.
* Subject has a metal cardiac stent in place or artificial heart valve(s).
* Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.

Primary outcomes:
measure: To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Veronica Reichl
role: STUDY_DIRECTOR
References:
Clinical trial NCT03196908: Impact of Energy Drink Brands on Heart Rhythm
Official title: Impact of Energy Drink Brands on Heart Rhythm in Healthy Volunteers: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrical Alternation of Heart
Blood Pressure
Keywords: ECG
Blood Pressure
Energy Drinks
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To assess the cardiac effects of energy drink brands in healthy volunteers

Detailed description: Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female adults 18 - 40 years old
* Participants must be willing to refrain from caffeine and alcohol use ≥48 hours prior to sessions on Day 1, 8, and 15

Exclusion Criteria:

* Presence of any known medical condition confirmed through participant interview
* QTc interval greater than 450 milliseconds (ms).
* Blood pressure greater than 140/90 mmHg.
* Current smokers
* Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
* Pregnant or currently breast-feeding

Primary outcomes:
measure: Corrected QT (QTc) Interval
timeFrame: 4 hours
Secondary outcomes:
measure: QT
timeFrame: 4 hours
measure: PR
timeFrame: 4 hours
measure: QRS
timeFrame: 4 hours
measure: Heart Rate (HR)
timeFrame: 4 hours
measure: Central blood pressure
timeFrame: 4 hours
measure: Peripheral blood pressure
timeFrame: 4 hours
Other outcomes:
Locations:
city: Stockton
country: United States
facility: University of the Pacific
state: California
Study officials:
affiliation: University of the Pacific
name: Sachin Shah, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah SA, Szeto AH, Farewell R, Shek A, Fan D, Quach KN, Bhattacharyya M, Elmiari J, Chan W, O'Dell K, Nguyen N, McGaughey TJ, Nasir JM, Kaul S. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019 Jun 4;8(11):e011318. doi: 10.1161/JAHA.118.011318. Epub 2019 May 29.
Clinical trial NCT03628508: Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
Official title: External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: muscle tension
alignment
knee osteoarthritis
loading
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2018-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.


Eligibility criteria: Inclusion Criteria:

1. Age between 50-80
2. having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
3. having medial knee pain on most days of the month
4. having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking

Exclusion Criteria:

1. having lateral tibiofemoral compartment osteophytes greater than the medial side.
2. having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
3. having a systemic arthritic condition (e.g., rheumatoid arthritis)
4. having a knee joint replacement or high tibial osteotomy in the past
5. having any other muscular, joint or neurological condition influencing lower limb function
6. unable to walk unaided
7. having low back, hip, ankle or foot pain \> 3 on numerical rating scale
8. having a body mass index (BMI) \>36 kg/ m2

Primary outcomes:
measure: Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
timeFrame: At baseline and one week after intervention
Secondary outcomes:
measure: Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
timeFrame: At baseline and one week after intervention
measure: Tibial Torsion as Assessed by X-ray Imaging
timeFrame: At baseline
measure: Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
timeFrame: At baseline and one week after intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Siu Ngor Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639808: Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
Official title: Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroparesis
Diabetes Mellitus
Keywords: delayed gastric emptying
symptomatic gastroparesis
diabetes mellitus
Lead sponsor: Tranzyme, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Subject has type 1 or type 2 diabetes mellitus
* Subject has documented diagnosis of gastroparesis by:
* Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
* A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
* Subject has normal upper endoscopy
* If female, must be permanently sterilized or postmenopausa.

Exclusion Criteria:

* Patient has received any investigational drug within the preceding 30 days
* Patient is taking unstable doses of medication that affects gastric motility
* Patient has co-morbid condition
* Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
* Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
* Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
* Patient has known history of alcoholism

Primary outcomes:
measure: 12-lead ECG data
timeFrame: 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.
Secondary outcomes:
measure: Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal
timeFrame: Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Hospital
city: Copenhagen
country: Denmark
facility: Hvidore Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT05858008: Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
Official title: Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-05-15
Enrollment: 15
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.

Detailed description: This study will investigate the feasibility of implementing a time-restricted eating (TRE) intervention in females with mild cognitive impairment. Data will be collected for 10 weeks. Baseline food timing, activity/sleep, metabolic health (fasting labs and anthropometric measures), and cognitive testing will be collected in the first two weeks. Subjects will then be invited to enroll in a TRE intervention for 8 weeks. Subjects will be educated about the potential health benefits of TRE, and then each subject will self-select a 10-hr window and consume all daily calories during this time frame. Subjects will text the time of their first and last daily calories for the duration of the study. At the end of the 8-week TRE intervention, metabolic, anthropometric, activity/sleep, and cognitive measurements will be collected.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal Women
* Age 45-95
* Diagnosis of mild cognitive impairment

Exclusion Criteria:

* Individuals prone to hypoglycemia
* Liver disease
* Taking medications that affect eating behaviors
* Alcohol consumption of \>2 drinks per day
* Significant circadian disruption
* Having care-taking responsibilities that significantly affect sleep
* Shift work or irregular lifestyle
* Diagnosed clinical eating disorder
* Participating in a formal weight loss program

Primary outcomes:
measure: Number of participants adhering to TRE protocol
timeFrame: From enrollment to study completion up to approximately 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Julie Pendergast, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990808: The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
Official title: A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 46
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: This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.


Eligibility criteria: Inclusion Criteria:

* Patient's weight has been stable for at least 6 weeks
* Patient is in good health based on medical history, physical exam, and laboratory tests
* Patient has dyslipidemia

Exclusion Criteria :

* Patient has a history of stroke, seizures, or major neurological disorders
* Patient has a history of cancer
* Patient is currently taking any lipid-lowering medications or substances except for statins
* Patient consumes excessive amounts of alcohol or caffeine
* Patient has multiple and/or severe allergies to food or drugs

Primary outcomes:
measure: Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Millar JS, Reyes-Soffer G, Jumes P, Dunbar RL, deGoma EM, Baer AL, Karmally W, Donovan DS, Rafeek H, Pollan L, Tohyama J, Johnson-Levonas AO, Wagner JA, Holleran S, Obunike J, Liu Y, Ramakrishnan R, Lassman ME, Gutstein DE, Ginsberg HN, Rader DJ. Anacetrapib lowers LDL by increasing ApoB clearance in mildly hypercholesterolemic subjects. J Clin Invest. 2015 Jun;125(6):2510-22. doi: 10.1172/JCI80025. Epub 2015 May 11.
citation: Thomas T, Zhou H, Karmally W, Ramakrishnan R, Holleran S, Liu Y, Jumes P, Wagner JA, Hubbard B, Previs SF, Roddy T, Johnson-Levonas AO, Gutstein DE, Marcovina SM, Rader DJ, Ginsberg HN, Millar JS, Reyes-Soffer G. CETP (Cholesteryl Ester Transfer Protein) Inhibition With Anacetrapib Decreases Production of Lipoprotein(a) in Mildly Hypercholesterolemic Subjects. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1770-1775. doi: 10.1161/ATVBAHA.117.309549. Epub 2017 Jul 20.