louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00998075: Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately
Official title: A Phase I, Open-Label, Randomized, Single-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg With Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peptic Ulcer Disease
Keywords: Bioequivalence
ASA
Esomeprazole
peptic ulcer disease
primary cardiovascular protection
healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. Two different forms of esomeprazole (tablets and capsules) will be investigated.


Eligibility criteria: Inclusion Criteria:

* Non-smoking male or female within the age range of 20 to 50 years
* Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2

Exclusion Criteria:

* Documented upper gastrointestinal surgery
* Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit

Primary outcomes:
measure: Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations
timeFrame: PK samples to be taken for bioanalysis over a 24-hour period following dosing on Day 1 of Period I and Day 1 of Period II and III.
Secondary outcomes:
measure: Pharmacokinetics (PK): Total area under the plasma concentration-time curve (AUC0-inf), AUC0-t, Cmax, time to Cmax (Tmax), and half-life (t½) of esomeprazole
timeFrame: PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: AstraZeneca R&D
name: TJørgen Næsdal, MD, PhD
role: STUDY_DIRECTOR
affiliation: Biovail Contract Research (BCR)a Division of Biovail Corporation
name: Pierre Geoffroy, M.D. C.M., M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02307175: A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication
Official title: A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) in Patients With Thyroid Scan Indication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Thyroid Disease
Congenital Hypothyroidism
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 18 and 80 years of age with thyroid scan indication

Brief summary: Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m pertechnetate produced by high energy cyclotron at CHUS.

Detailed description: The proposed clinical trial will be a prospective, case-controlled Phase I, open label, single site study. The first 10 consecutively enrolled patients will receive CYCLOTEC standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent case-matched controls, will receive GPERT and will also have additionnal whole body scan.

Eligibility criteria: Inclusion Criteria:

* Prescribed thyroid scan
* Provided written informed consent prior to participation
* Biochemical parameters within 5 times of the normal limits for age
* WBC count \> 3.0/μL
* ANC count 1.5/μL
* Platelets \> 75,000/μL
* Haemoglobin \> 10 g/dL
* Karnofsky Performance Scale score \> 50

Exclusion Criteria:

* Nursing or pregnant females
* Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the scan
* WBC \< 3.0/μL
* ANC \< 1.5/μL
* Platelets \< 75,000/μL
* Haemoglobin \< 10 g/dL
* Unable and unwilling to follow instructions and comply with the protocol
* Unable or unwilling to provide written informed consent prior to participation in the study
* Karnofsky Performance Scale score \< 50

Primary outcomes:
measure: Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Eric Turcotte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621075: Correlation OF Hemodynamics in Pulmonary Hypertension With Perfusion Lung Scans
Official title: Correlation of Hemodynamics in Pulmonary Hypertension With Perfusion Lung Scans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH; V/Q SCAN;RHC;Echo;CT Scans; Angiography;PFTs
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary Arterial Hypertension

Brief summary: The goal of our study is to correlate data from non-invasive tests such as perfusion lung scans with hemodynamic measurements from right heart catherizations.

Detailed description: Data collected from PAH patients who have had non-invasive Ventilation/Perfusion testing, Echocardiography, Chest CT Scan, Pulmonary Function Testing and the correlation of those results to the hemodynamic parameters Right Heart Catherization results and the various biomarkers.

Eligibility criteria: Inclusion Criteria:

* Pulmonary Arterial Hypertension

Exclusion Criteria:

* Non-Pulmonary Arterial Hypertension

Primary outcomes:
measure: The correlation of patients' hemodynamic parameters with their perfusion index/pulmonary index as measured by ventilation perfusion scans in patients diagnosed with Pulmonary Hypertension.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: North Shore-Lij Health System
state: New York
Study officials:
affiliation: Northwell Health
name: ARUNABH TALWAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02051075: Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
Official title: A Randomized Controlled Trial to Compare Fertilizations With Immotile Sperm After Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Keywords: IVF
ICSI
Asthenospermia
pentoxyphylline
Spermatozoa
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However, fertilization rate with this method is still lower compared with ICSI using motile sperm. One of the reasons for that is the immotile sperm inability to activate the oocyte Our research hypothesis is that better fertilization rate can be accomplished in these cases by combining PXN sperm activation with Ca ionophore oocyte activation.


Eligibility criteria: Inclusion Criteria:

* Women up to 35 years of age
* immotile sperm
* At least 6 mature eggs

Exclusion Criteria:

* globozoospermia
* "Freeze all" cycles because of OHSS risk.

Primary outcomes:
measure: Clinical pregnancy
timeFrame: One month post oocyte retrieval
Secondary outcomes:
measure: Fertilization rate
timeFrame: One day post oocyte retrieval
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical Center
Study officials:
References:
Clinical trial NCT05679375: IV and Intrathecal Ketamine in Cesarean Section
Official title: Comparison Between the Analgesic Effects of Intrathecal Versus Intravenous Ketamine After Spinal Anaesthesia for Elective Caesarean Delivery :a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.


Eligibility criteria: Inclusion criteria:

• Pregnant undergoing elective cesarean section

Exclusion Criteria

* Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
* body mass index ≥40kg/m2, height \<150cm
* Current use of pain medication including opioids
* history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
* chronic pain was excluded.
* contraindications to spinal anaesthesia,
* severely compromised fetus requiring general anesthesia and those patients who received labor analgesia

Primary outcomes:
measure: Time to the first analgesic request
timeFrame: First Postoperative day
Secondary outcomes:
measure: Postoperative pain scores NRS at rest and on movement; (2, 4, 6, 12, and 24 hours) postoperative
timeFrame: first postoperative day
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Abd El-Rahman AM, Mohamed AA, Mohamed SA, Mostafa MAM. Effect of Intrathecally Administered Ketamine, Morphine, and Their Combination Added to Bupivacaine in Patients Undergoing Major Abdominal Cancer Surgery a Randomized, Double-Blind Study. Pain Med. 2018 Mar 1;19(3):561-568. doi: 10.1093/pm/pnx105.
Clinical trial NCT02612675: Glycemic Response to Oral Nutrition Supplements
Official title: Plasma Glucose and Insulin Response to Two Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized, cross-over study of two oral nutrition supplements in individuals with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alpha-glucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria:

* Allergy to milk protein or any other component of the formula

Primary outcomes:
measure: Area under the blood glucose curve (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, PA
state: Texas
Study officials:
affiliation: Diabetes & Glandular Disease Clinic, PA
name: Sherwyn Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huhmann MB, Smith KN, Schwartz SL, Haller SK, Irvin S, Cohen SS. Plasma glucose and insulin response to two oral nutrition supplements in adults with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2016 Aug 31;4(1):e000240. doi: 10.1136/bmjdrc-2016-000240. eCollection 2016.
Clinical trial NCT03321175: Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
Official title: Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Complications, Wound, Hematoma
Keywords: Wound
infection
cesarean section
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be performed by an online software. Randomized cards will be in sealed envelopes and will be open by surgeon at the time of surgery.
Primary purpose: PREVENTION

Brief summary: to evaluate the effect of subcutaneous irrigation on wound complications

Detailed description: Cesarean section is the most common abdominal operation performed worldwide. As with every other surgical procedure, it is sometimes accompanied by surgical complications. Wound complications are encountered in approximately 5% of women that undergo CS and include haematomas, seromas and infection. To evaluate the effects and benefits of subcutaneous irrigation during cesarean section we decide to conduct this randomized study.

Eligibility criteria: Inclusion Criteria:

* Age 18-40, undergoing cesarean section

Exclusion Criteria:

* patients with systemical disease, body mass index\>30

Primary outcomes:
measure: wound complications
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
References:
Clinical trial NCT00643175: Effectiveness of Automated Inpatient Endocrinology Consultation for Osteoporotic Hip Fracture
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoporosis
Keywords: The main objective is to have an endocrinologist treat osteoporosis in patients with fragility hip fractures.
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Using the existing WebCAIS order system, an automated endocrinology consult and appropriate laboratory studies will be drawn on all non-traumatic hip fractures. Data from these patients will be collected in a prospective study, and the patients will be followed up over time to check adherence to osteoporotic medical therapy and future incidence of re-fracture.

Brief summary: Osteoporosis has been called a "silent epidemic" whose prevalence is increasing. It often presents as a fragility fracture, with hospitalizations resulting from minimally traumatic hip fractures. While the fractures are treated appropriately, the underlying pathology is often ignored. Numerous studies have shown that prior fracture increases the risk for further fracture. In 2004 the Surgeon General released a report on osteoporosis, the details of which include multi-disciplinary treatment of osteoporotic fractures. Treatment of osteoporosis after hip fracture is also being targeted as a future hospital quality assessment measure. Hospitals which have no plan in place to address osteoporosis treatment after hip fracture may be cited, and may have medicare money withheld. The goal of the study is to create an automated in-patient endocrinology consultation for osteoporotic hip fractures. We plan to gather patient data in a prospective manner including the endocrinologist recommendations, adherence to medical therapy after discharge, and future fracture rates. Possible planned interventions include only appropriate medical therapy for osteoporosis, DEXA bone scanning, and regularly scheduled telephone follow-up.


Eligibility criteria: Inclusion:

1. over 55
2. non-traumatic hip fracture

Exclusion criteria:

1. currently on anti-osteoporosis pharmacotherapy including bisphosphonates, PTH, and calcitonin
2. high energy nature of fracture, including MVA, fall from height greater than 3 feet
3. severe dementia, lack of capacity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
References:
Clinical trial NCT06330675: Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT
Official title: Safety and Benefits of Mobilization at 4 Hours Compared to 24 Hours After Implantation of an Intracardiac Electronic Device: a Randomized Clinical Trial of Non-inferiority, Open and Controlled in Parallel Groups
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pacemaker
Defibrillators, Implantable
Keywords: Pacemaker
Implantable cardioverter-defibrillator
Early mobilization
Bed-rest
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Cardiocentro Ticino
First posted: 2024-03-26
Enrollment: 558
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: Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Signed informed consent form
* New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)

Exclusion Criteria:

* CIED implants after recent cardiac surgery
* Upgrade or revision of implanted device
* CRT implantation
* Intraoperative complications

Primary outcomes:
measure: Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion
timeFrame: Within 48 hours post operative
Secondary outcomes:
measure: Post-operative pain
timeFrame: 24 hours
measure: Sleep disturbance
timeFrame: The first night after surgery
measure: Postoperative urinary retention
timeFrame: Within 24 hours post operative
measure: Delirium
timeFrame: Within 24 hours post operative
measure: Orthostatic intolerance
timeFrame: First out-of-bed mobilization
measure: Quality of recovery
timeFrame: Day 1
measure: Pressure ulcer
timeFrame: Within 48 hours post operative
Other outcomes:
measure: Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection
timeFrame: 3 month
Locations:
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino Institute - EOC
Study officials:
affiliation: Cardiocentro Ticino Institute - EOC
name: Elena Caporali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04206475: Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
Official title: Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: an intensive program specific to the training and re-adaptation of memory function in children versus standard rehabilitation
Primary purpose: TREATMENT

Brief summary: Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods for non-focused cognitive remediation are available to the pediatric field. The aims of this feasibility trial are the description, implementation, and test of an intensive program specific to the training and re-adaptation of memory function in children (IM-FTP). Method: Eleven children and adolescents with ABI (mean age at injury=12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient received a psychometric evaluation and a brain functional MRI at enrollment and at discharge. Ten pediatric controls with ABI (mean age at injury=13.8 years) were clinically assessed, and rehabilitated through a standard program.


Eligibility criteria: Inclusion Criteria:

* i) age at first assessment between 6 and 18 years;
* ii) time between injury and first assessment \<3 months;
* iii) documented evidence of a severe ABI of traumatic or non-traumatic (i.e. anoxic, vascular or infectious) etiology, as indicated by a Glasgow Coma Scale (GCS, \[26\]), score ≤8 at insult;
* iv) presence of severe memory impairment, as assessed at first evaluation;
* v) sufficient attentive skills for attending a simple task and understanding simple commands/directions, and sufficient verbal comprehension for executing simple procedures/exercises;
* vi) absence of congenital pathology or disability previous to the injury;
* vii) medical records sufficiently detailed to determine the injury severity and neurological findings;
* viii) absence of severe motor or sensitive deficits.

Exclusion Criteria:

* none

Primary outcomes:
measure: Psychometric evaluation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
References: