louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03409497: Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
Official title: Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Welch's Food Corporation
First posted: 2018-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Detailed description: Investigators earlier studies and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on blood sugar levels. Investigators aim to better understand the consumption of 100% grape juice with a meal modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

Eligibility criteria: Inclusion Criteria:

* BMI between 25.0-34.9 kg/m2
* Willingness to eat all test foods
* Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day
* Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)

Exclusion Criteria:

* Taking medications known to affect glycemia, lipid metabolism or appetite
* Body weight fluctuation of \>5kg in the past 3 months
* Taking vitamin or other supplements
* Smokers
* Acute or Chronic disease

Primary outcomes:
measure: change in blood glucose over 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Appetite
timeFrame: 24 hours
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coelho OGL, Alfenas RCG, Debelo H, Wightman JD, Ferruzzi MG, Mattes RD. Effects of Concord grape juice flavor intensity and phenolic compound content on glycemia, appetite and cognitive function in adults with excess body weight: a randomized double-blind crossover trial. Food Funct. 2021 Nov 15;12(22):11469-11481. doi: 10.1039/d1fo02049h.
Clinical trial NCT00177697: A Mentor-Based Approach to Long-Term Weight Loss
Official title: A Mentor-Based Approach to Long-Term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Weight Loss
Obesity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-15
Enrollment: 174
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.


Eligibility criteria: Inclusion Criteria:

1. Female
2. 21-55 years of age
3. BMI = 25-35 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Primary outcomes:
measure: weight loss
Secondary outcomes:
measure: fitness
measure: dietary intake
measure: mediators
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810497: Analysis of Postoperative Bandage Use Protocols in Otoplasty
Official title: Analysis of the Influence of Different Protocols of Postoperative Elastic Bandage Use in the Results of Otoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prominent Ears
Keywords: External ear
Ear abnormalities
External ear cartilages
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. We hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.


Eligibility criteria: Inclusion Criteria:

* Congenital bilateral ear prominence
* 10 years-old or older
* No previous attempt of surgical treatment

Exclusion Criteria:

* Pregnant women
* Breastfeeding women
* Blod clotting disorders or current anticoagulant use
* Uncontrolled systemic diseases

Primary outcomes:
measure: Incidence of re-operation
timeFrame: until 12 months
Secondary outcomes:
measure: Change from immediate postoperative period of helix-mastoid distance
timeFrame: 6 months
measure: Change from immediate postoperative period of helix-mastoid distance
timeFrame: 12 months
Other outcomes:
measure: Incidence of hemorrhagic complications
timeFrame: 1 month
Locations:
city: Campinas
country: Brazil
facility: Unicamp Hospital
state: São Paulo
Study officials:
affiliation: Division of Plastic Surgery, Faculty of Medical Sciences, University of Campinas - Unicamp
name: Davi R Calderoni, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04237597: Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
Official title: Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
* Subject meets all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria:

* Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
* Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
* Subject does not meet any other exclusion criteria outlined in the clinical study protocol.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0 to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development. LP
state: Texas
Study officials:
References:
Clinical trial NCT06048497: The Role of Carotid Flow Time-Based Fluid Administration in Caesarean Section
Official title: The Role of Carotid Flow Time-Based Fluid Administration in the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Caesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia
Cesarean Section
Keywords: Cesarean section
Carotid flow time
Preload fluid
Hypotension
Spinal anesthesia
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 72
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA II pregnant women between the ages of 20 and 40 who were undergoing elective cesarean section, and had uncomplicated singleton term pregnancies, and agreed to participate in the study were included.

Brief summary: It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery. Pregnant women who underwent cesarean section under spinal anesthesia were included in this prospective study. In the preoperative care unit, patients were assigned to two groups according to their baseline FTc values. Patients with baseline FTc \< 327 ms were assigned to the first group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc \> 327 ms. On the other hand, patients with baseline FTc \> 327 ms were assigned to the second group, and preload fluid was not administered to these patients. Intraoperative hemodynamic data were recorded for each patient.


Eligibility criteria: Inclusion Criteria:

* 20-40 years of age pregnant women
* American Society of Anesthesiologists (ASA) physical status-II patients
* Uncomplicated, singleton, term pregnancy
* Elective C/S surgery

Exclusion Criteria:

* Placental disorders
* Gestational hypertensive disorders
* Morbid obesity (BMI\>39 kg/m2)
* Carotid stenosis more than 50%
* Baseline SAP more than 160 mmHg
* Arrhythmia
* History of cardiovascular or cerebrovascular disease, and chronic kidney disease (estimated glomerular filtration rate \<60 mL/min/1.73 m2)
* Emergency surgery

Primary outcomes:
measure: The incidence of intra-operative hypotension
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Saricam
city: Adana
country: Turkey
facility: Çukurova University; Faculty of Medicine
state: Sarıçam
Study officials:
affiliation: Çukurova University, Balcalı Hospital
name: Demet Laflı Tunay, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179997: Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacio Clinic Barcelona
First posted: 2010-08-11
Enrollment: 156
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the response to cardiac resynchronization therapy when the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to response when it was optimized following QRS width criteria.


Eligibility criteria: Inclusion Criteria:

* Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.

Exclusion Criteria:

-

Primary outcomes:
measure: 6-month echocardiographic response
Secondary outcomes:
measure: 6-month clinical response
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari
state: Catalonia
Study officials:
References:
Clinical trial NCT06597097: Evaluation of Interprofessional Relations Between Primary Care and Hospital Centers in the Experimentation of Medical Cannabis in France Carried Out by the ANSM (ECIPCanna)
Official title: Evaluation of Interprofessional Relations Between Primary Care and Hospital Centers in the Experimentation of Medical Cannabis in France Carried Out by the ANSM
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Medical Cannabis
Keywords: Cannabis for medical use
Outpatient medicine
Prescription
Pharmacy
Primary care
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare professionals participating in the experiment conducted by the French National Agency for Safety and Health:

* Hospital doctors
* General practitioners
* Community pharmacists
* Hospital pharmacists

Brief summary: An observational study to explore inter-professional relations and perceptions around the experimentation of medical cannabis, conducted by the French National Agency for Safety and Health. The study aims to identify the barriers and facilitators to prescribing and dispensing medical cannabis and to analyse healthcare professionals' perceptions of medical cannabis in France. Using a qualitative method based on semi-directed interviews and focus groups, the study will involve hospital physicians, general practitioners, and community and hospital pharmacists participating in the the French National Agency for Safety and Health experiment. The primary objective is to understand the dynamics between health professionals involved in the medical cannabis programme, while secondary objectives include proposing strategies to overcome barriers to the provision of medical cannabis.


Eligibility criteria: Inclusion Criteria:

* Healthcare professional participating in the experiment conducted by the the French National Agency for Safety and Health: Hospital doctor, general practitioner, community pharmacist, or hospital pharmacist
* Non-opposition

Exclusion Criteria:

* Refusal of participation by hospital doctor, general practitioner, community pharmacist, or hospital pharmacist

Primary outcomes:
measure: Exploring the inter-professional relationships of those involved in the medical cannabis experiment being conducted by the French National Agency for Safety and Health
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT00007397: Age, Risk Factors for CVD and Cognitive Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Neurologic Manifestations
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-12-19
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To relate cardiovascular disease (CHD) risk factors to cognitive performance among middle-aged and elderly men and women over a 10 year longitudinal study period.

Detailed description: BACKGROUND:

The Framingham Heart Study is a major epidemiological investigation of prospective relationships between risk factors for the development of cardiovascular disease (CVD risk factors) and CVD risk factor outcomes. The Framingham Study and other large, prospective studies have resulted in an extensive literature on the impact of CVD risk factors (including age) and CVD outcomes. Comparatively, there have been many fewer studies of the impact of CVD risk factors on cognitive functioning, and possibly no studies of the effect of objectively measured, competing risk factors on cognitive functioning.

DESIGN NARRATIVE:

Dr. Elias and colleagues used cardiovascular risk factor data from the Framingham Heart Study (N= 2,123) in a prospective design allowing them to relate CVD risk factors (including age and gender) to two outcome measures: (1) level of cognitive performance and (2) change in cognitive performance over a 10 year longitudinal study period. The overall goals were to determine the best multivariate combination of biological and psychosocial risk factors for the prediction of lowered cognitive ability in middle-aged and elderly men and women, and to evaluate the relative impact of age, gender, and other biological and psychosocial risk factors on cognitive functioning.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Merrill Elias
References:
citation: Elias MF, Elias PK, Sullivan LM, Wolf PA, D'Agostino RB. Lower cognitive function in the presence of obesity and hypertension: the Framingham heart study. Int J Obes Relat Metab Disord. 2003 Feb;27(2):260-8. doi: 10.1038/sj.ijo.802225.
citation: Elias MF, Sullivan LM, D'Agostino RB, Elias PK, Beiser A, Au R, Seshadri S, DeCarli C, Wolf PA. Framingham stroke risk profile and lowered cognitive performance. Stroke. 2004 Feb;35(2):404-9. doi: 10.1161/01.STR.0000103141.82869.77. Epub 2004 Jan 15.
citation: Elias PK, Elias MF, D'Agostino RB, Sullivan LM, Wolf PA. Serum cholesterol and cognitive performance in the Framingham Heart Study. Psychosom Med. 2005 Jan-Feb;67(1):24-30. doi: 10.1097/01.psy.0000151745.67285.c2.
Clinical trial NCT04303897: Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma
Official title: A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are being implanted with the approved XEN product via the specific urgent medical needs for named patient use regulatory pathway in Hainan. The XEN Glaucoma Treatment System (XEN) is comprised of the XEN45 Gel Stent and XEN® Injector.

Brief summary: Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.


Eligibility criteria: Inclusion Criteria:

* Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy

Exclusion Criteria:

* Angle closure glaucoma where angle has not been surgically opened
* Previous glaucoma shunt/valve in the target quadrant
* Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
* Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
* Active iris neovascularization or neovascularization of the iris within six months of the surgical date
* Anterior chamber intraocular lens
* Presence of intraocular silicone oil
* Vitreous present in the anterior chamber

Primary outcomes:
measure: Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Mean decrease in IOP
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Boao Super Hospital /ID# 233669
state: Hainan
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06594497: Motor Imagery Training Football Players With Anterior Cruciate Ligament Repair
Official title: The Effect of Motor Imagery Training on Knee Functions and Kinesiophobia in Football Players With Anterior Cruciate Ligament Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Volunteer participants who have undergone anterior cruciate ligament surgery at Bursa Çekirge State Hospital and meet the inclusion criteria will be included in the study. The study will select a sample group from the universe using the probability sampling method (simple random sampling). Participants will be divided into 2 groups: Conventional Physiotherapy + Kinesthetic motor imagery training group and Conventional physiotherapy group with randomization software (https://www.randomizer.org/). Conventional physiotherapy practices created by the physician will be applied by physiotherapists working in the hospital. Knee functions will be evaluated with the IKDC scale, reaction time will be assessed with video recording supported by the Kinovea program, kinesiophobia will be assessed with the Tampa kinesiophobia scale, and finally, autonomic functions will be evaluated with the polar device. Measurements will be repeated after 6 weeks of interventions.


Eligibility criteria: Inclusion Criteria:

* Individuals with anterior cruciate ligament repair,
* Individuals who have no experience in this type of training,
* Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
* Individuals who agree to the purposes of this study and to participate voluntarily.

Exclusion Criteria:

* Have previous experience in Motor Imagery techniques or training,
* Having any orthopedic problem that prevents walking,
* Having a history of neurological disease,
* People being treated with any medication that affects the central nervous system

Primary outcomes:
measure: Kinesiophobia
timeFrame: Through study completion, an average of 1 year
measure: Activity Level
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Knee Fuctions
timeFrame: Through study completion, an average of 1 year
measure: Self-confidence Level
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Meltem Işıntaş
role: STUDY_DIRECTOR
References: