louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01257516: An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
Official title: An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of 660 Mg (2 X 330 Mg Tablets) Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 300 Mg Of The Immediate Release Formulation Administered Twice Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg)
timeFrame: 5 days
Secondary outcomes:
measure: Safety endpoints include evaluation of adverse events
timeFrame: 5 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.
Clinical trial NCT05750316: Impact of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Black Adults, a Pilot Study
Official title: Effect of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Healthy Black Adults: A Randomised Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Black Ethnicity
Keywords: Black ethnicity
Blood Glucose
Leaves
Cowpea
Vegetable
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Intake of foods high in carbohydrates causes a spike in glucose in the blood. Repeated high blood glucose spikes are associated with an increased risk of diabetes. People of black ethnicity have higher risk of diabetes. Vegetables may help in the regulation of blood glucose. Cowpea, also referred to as black-eyed peas (Vigna unguiculata) leaves, contain polyphenols and fibre that can help regulate blood glucose.

The study will be an acute, single-blind, randomised control trial with a cross-over design involving healthy black participants aged ≥18 years. This clinical trial aims to investigate if consuming cowpea leaves can reduce blood glucose spikes after consuming a meal high in carbohydrates. Participants will be randomised to consume either bread with jam containing freeze-dried cowpea leaves (active intervention) or jam without any freeze-dried powder (control group). Blood glucose will be monitored before the intervention and every 15 minutes after the intervention using a continuous glucose monitor.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 18 years
* Participants from Black, Black British, Caribbean or African ethnic backgrounds,which includes: Caribbean, African, Any other Black, Black British, or Caribbean background
* Should be able to give informed consent
* Should be willing to provide GP's contact details

Exclusion Criteria:

* Pregnant or lactating mothers
* Special dietary requirements such as vegetarians and vegans
* Participants who are on a specialised diet such as a weight reduction diet
* Having any chronic illness or taking medication for chronic illness
* Participants whose blood results indicate illness
* Participants on mediation for hypertension or hyperlipidaemia
* Sportsmen or women or vigorous exercise for more than 5 times per week
* Alcohol (more than 14 units per week) or drug abusers.

Primary outcomes:
measure: Change in postprandial blood glucose measured by incremental area under the curve and area under the curve
timeFrame: At baseline (t=0 hours) and 15 minutes interval until (t=3 hours)
Secondary outcomes:
measure: Change in blood pressure
timeFrame: At baseline (t=0 hours) and every 30 minute until (t=3 hours)
measure: Microvascular blood flow
timeFrame: At baseline (t=0 hours) and (t=2.5 hours)
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
References:
Clinical trial NCT04298216: Transhepatic Versus Subcostal Views to Assess Inferior Vena Cava Variation in Pediatric Patients
Official title: Evaluation of Transhepatic Versus Subcostal Inferior Vena Cava Views to Assess Inferior Vena Cava Variation in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inferior Vena Cava Abnormality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Currently, in order to visualize the inferior vena cava (IVC) of the heart using ultrasound, physicians traditionally place the ultrasound probe onto the "Subcostal" area which is located below the chest in the upper abdomen area. In this location, the pressure from the ultrasound probe is often uncomfortable for adults, and even more so for pediatric patients. Previous research and physician experience have demonstrated that it is possible to visualize the heart in the "transhepatic" area which is located under the arm on the side of the chest. By placing the ultrasound probe in this location, it is more comfortable for the patient when applying pressure, and this study aims to prove the effectiveness of visualizing the heart through this new location.


Eligibility criteria: Inclusion Criteria:

1. Be between ages of 2-18 years of age
2. Have parental consent
3. located at an inpatient/outpatient facility at LPCH
4. Be hemodynamically stable

Exclusion Criteria:

1. Emergent Surgical Procedures
2. BMI greater than 24

Primary outcomes:
measure: Time
timeFrame: For the entirety of the ultrasound procedure.
measure: Accuracy of the IVC Analysis
timeFrame: For the entirety of the ultrasound procedure.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00861016: Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet in Patients With Mild to Moderate Hypertension
Official title: An Open-Label, Non-Comparative, Multi-Centre Study to Evaluate the Efficacy and Safety of Metoprolol Succinate Prolonged-Release Tablet (Betaloc Zok) in Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Post marketing study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-comparative, multi-centre clinical study to evaluate the Efficacy and safety of Metoprolol Succinate prolonged-release tablet (Betaloc Zok) in patients with mild to moderate essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Newly diagnosed essential hypertension who have not received anti- hypertensive treatment, or patients without antihypertensive medication in two weeks before screening, 90mmHg\<SiDBP \<110mmHg and SiSBP \<180mmHg.

Exclusion Criteria:

* Known or suspected secondary hypertension
* Resting HR is \< 55bpm.
* Sick sinus syndrome
* Atrioventricular block of first degree (with P-R\>0.24seconds), or second or third degree

Primary outcomes:
measure: Percent of subjects reaching blood pressure target at wk 8 after metoprolol succinate prolonged release tablet treatment, and magnitude of systolic and diastolic blood pressure reduction from baseline among subjects who reached target (below 140/90mmHg).
timeFrame: Day -7- -1, Day1, Day 28, Day 56,Day 84
Secondary outcomes:
measure: The magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects at week 8 after metoprolol succinate prolonged release tablet treatment.
timeFrame: Day -7- -1, Day1, Day 28, Day 56,Day 84
measure: The percentage of subjects reaching blood pressure target at week 4, and the magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects and those subjects who reached target
timeFrame: Day -7- -1, Day1, Day 28, Day 56,Day 84
measure: The percentage of subjects reaching blood pressure target at week 12, and the magnitude of systolic and diastolic blood pressure reduction from baseline among all the subjects and those subjects who reached target
timeFrame: Day -7- -1, Day1, Day 28, Day 56,Day 84
Other outcomes:
Locations:
Study officials:
affiliation: BeiJing Hypertension League
name: Lisheng Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884116: Comparison of NSAID Patch Given in Monotherapy and NSAID Patch in Combination With Transcutaneous Electric Nerve Stimulation, Heating Pad, or Topical Capsaicin in the Treatment of Patients With Myofascial Pain Syndrome of the Upper Trapezius: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome of the Upper Trapezius
Keywords: Capsaicin
myofascial pain syndrome
non-steroidal anti-inflammatory agents
transcutaneous electric nerve stimulation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and various treatment modalities have been introduced. If self-applicable physical modalities and medications that are used for treatment of MPS patients are combined, they may open up new possibilities for effective and practical self-care. The aim of this study is to compared the therapeutic effect of non-steroidal anti-inflammatory drug (NSAID) patch given in monotherapy and NSAID patch in combination with transcutaneous electric nerve stimulation, heating pad, or topical capsaicin in the treatment of patients with MPS of the upper trapezius.


Eligibility criteria: Inclusion Criteria:

1. Patients over 20 years of age with diagnosis of myofascial pain syndrome of the upper trapezius.
2. Visual analogue scale (VAS, 0 = no pain, 10 = worst pain) greater than

Exclusion Criteria:

1. Pregnant or breast feeding women, patients who have taken opioids within seven days, patients with severe disease (heart disease, liver disease, etc) that might affect the results of the study, patients who have participated in another clinical study within 30 days.

Primary outcomes:
measure: The differences of the VAS pain scores
timeFrame: 2weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
Clinical trial NCT05772416: Neonatal Neurological Examination to Detect Infants at Risk
Official title: Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Encephalopathy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions

Brief summary: The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

Detailed description: The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

Infants at risk of neurological abnormlaiyies, such as very pèretrm infants and infants with asphyxia or with overt neyurologocal abnormla signs suh as convilsions will be assessed with a structured neurological examination and followed over time.

Eligibility criteria: Inclusion Criteria:

all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions

Exclusion Criteria:

families unwilling to sign consent

Primary outcomes:
measure: Hammersmith Neonatal and infant Neurological examination
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico gemelli
Study officials:
affiliation: F Policlinico Gemelli IRCCS
name: Eugenio Mercuri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188916: A Clinical Comparison of Three Bronchial Blockers for One-Lung Ventilation in Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Surgery
Keywords: Bronchial blockers
Lung isolation
Thoracic Anesthesia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: This is a clinical trial comparing surgical conditions during one-lung ventilation with three different bronchial blockers or with double-lumen endobronchial tubes.


Eligibility criteria: Inclusion Criteria:

* Left thoracotomy

Exclusion Criteria:

* Contraindication to lung isolation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Peter Slinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06361316: Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer
Official title: Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Adjuvant Therapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2024-04-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. ECOG performance status 0 or 1.
2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
3. ECOG performance status 0 or 1.
4. Life expectancy of greater than or equal to 6 months.
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Patients who cannot eat orally and have gastric emptying disorder after surgery;
2. Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
3. Patients who cannot eat orally and have gastric emptying disorder after surgery;
4. Patients who cannot eat orally and have gastric emptying disorder after surgery;

Primary outcomes:
measure: Disease Free Survival, DFS
timeFrame: baseline up to approximately 21.6 months.
Secondary outcomes:
measure: Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE
timeFrame: baseline up to approximately 7 months.
measure: Overall Survival, OS
timeFrame: baseline up to approximately55 months.
measure: Quality of life, QOL
timeFrame: baseline up to approximately 55 months.
measure: The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
timeFrame: baseline up to approximately 7 months.
measure: he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance
timeFrame: baseline up to approximately 7 months.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: FirstNanjingMU
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: KuiRong Jiang, archiater
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625816: Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery
Official title: Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery: A STROBE-compliant Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Disorder
Postoperative Pain
Shoulder Injuries
Immobilization
Asymmetric Limb Muscle Stiffness
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 55
Sex: ALL
Minimum age (years): 26
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an observational cross-sectional study. Post-operative patients need an immobilization period for a certain period of time after surgery. Kinetic chain changes due to immobilization can affect the symmetry of the core muscle. Therefore, in this study, core muscle asymmetry (CMA) is measured using a whole body tilt device for inpatients who have undergone arthroscopic shoulder surgery. We would like to make a clinical suggestion for post-operative rehabilitation by identifying the characteristics of CMA according to the left or right site.


Eligibility criteria: Inclusion Criteria:

* arthroscopic shoulder surgery
* limit of motion due to shoulder pain

Exclusion Criteria:

* orthopedic surgery or other medical history in the lower extremities
* neurological history or are taking related medications
* chronic headache or disease related to the inner ear
* cardiovascular disease that may affect balance ability or take related medications
* acute dizziness
* when performing other balance training

Primary outcomes:
measure: direction core muscle ratio (DCMR)
timeFrame: 1 Day
measure: core muscle state ratio (CMSR)
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sahmyook University
Study officials:
References: