louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01856348: Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers
Official title: Effects of Vitamin D3 (1,25 Dihydroxyvitamin D3) on Pharmacokinetics and Absorption of Folic Acid and Fexofenadine in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Physiological Effects of Vitamin D
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is conducted to assess the effect of a vitamin D3 supplementation on the activities of two intestinal transporters and on the pharmacokinetics of the transporter substrates folic acid and fexofenadine.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

1. male or female
2. age 18 to 65 years at study entry
3. signed informed consent form
4. Body Mass Index \> 18 - \< 30 kg/m2
5. Participants must not have any other diseases (as assessed by the screening examination)
6. Participants must not take any concomitant medications except oral contraceptives in females
7. Normal blood count

Exclusion criteria:

1. Subjects with confirmed or suspected hypersensitivity towards the study medications
2. Contemporaneous participation in any other study
3. Females only: pregnancy
4. Females only: breast-feeding
5. Clinically significant abnormal laboratory findings
6. Known or suspected present or past malignancies of any kind
7. Known or suspected active infections, serious infections in the preceding 3 months
8. Positive hepatitis B, hepatitis C and / or HIV 1/2 serology
9. Subjects known or suspected not to comply with the study regulations
10. Subjects employed at the participating departments of the University Hospital Zürich.
11. Known or suspected present or past diseases which may interfere with the study
12. smokers
13. alcohol or drug abuse

Primary outcomes:
measure: Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D
timeFrame: 10 days
measure: Ratio of Area under the concentration vs. time curve (AUC) of folic acid after vitamin D over AUC of folic acid before vitamin D
timeFrame: 10 days
Secondary outcomes:
measure: Number and characteristics of participants with adverse events
timeFrame: 10 days
measure: transporter mRNA quantity
timeFrame: 10 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Pharmacology and Toxicology
name: Gerd A Kullak-Ublick, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02099448: Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP
Official title: Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: CorAlert Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing elective cardiac catheterization, during which LVED and aortic pressures are recorded

Brief summary: The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.


Eligibility criteria: Inclusion Criteria:

1. Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age
2. Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded
3. Willing and able to sign informed consent prior to study initiation

Exclusion Criteria:

1. Subject has a baseline heart rate of \< 60 or \>100 beats/min
2. Subject has moderate to severe valvular disease
3. Subject suffers from atrial fibrillation or other tachyarrhythmias
4. Subject suffers from hemodynamic instability
5. Subject is candidate for primary PCI

Primary outcomes:
measure: Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization
timeFrame: During elective cardiac catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References:
Clinical trial NCT01024348: Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy
Official title: Open-label Study of the Safety and Effectiveness of Short-term Therapy With Extended-release Tramadol (TRAMADEX-OD) in the Management of Pain After Knee Arthroscopy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: Surgery, knee arthroscopy
Pain, postoperative
tramadol, extended release
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extended-release tramadol is indicated for the management of moderate to severe pain in adults who require around-the-clock treatment. It provides an extended duration of action, more constant plasma concentrations, a reduced dosing frequency, and the potential for improved compliance and therapeutic outcomes.

The present study was designed to evaluate the safety and effectiveness of this medication in the treatment of early postoperative pain after knee arthroscopy.


Eligibility criteria: Inclusion Criteria:

* Men and nonpregnant women
* Age: 18-65 years
* ASA classification I or II
* ambulatory knee arthroscopy under spinal anesthesia

Exclusion Criteria:

* Pregnancy
* Intolerance to any opioid, tramadol or paracetamol
* spine surgery in the past
* renal or hepatic impairment
* cardiac or respiratory conditions that put the patient at risk for respiratory depression
* patients receiving: monoamine oxidase inhibitors, carbamazepine, quinidine, selective serotonin reuptake inhibitors or tricyclic antidepressants

Primary outcomes:
measure: Safety and effectiveness of TRAMADEX-OD will be evaluated by recording adverse events and using a visual analogue score for pain evaluation
timeFrame: up to 48 hours
Secondary outcomes:
measure: Patient satisfaction will be evaluated by a telephone interview
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical center, Jerusalem, Israel
name: Yaacov Gozal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04504448: A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Guangzhou Henovcom Bioscience Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer, age 18-65 years
* BMI between 18-32 kg/m2,and body weight not less than 50.0kg.

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: Number of subjects with adverse events and concomitant medications
timeFrame: Between screening and 7-9 days after the last dose
measure: Number of subjects with vital sign measurements
timeFrame: Between screening and 7-9 days after the last dose
measure: Number of subjects with clinical laboratory test results
timeFrame: Between screening and 7-9 days after the last dose
measure: Number of subjects with 12-lead ECGs
timeFrame: Between screening and 7-9 days after the last dose
measure: Number of subjects with physical examinations
timeFrame: Between screening and 7-9 days after the last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron
state: Maryland
Study officials:
References:
Clinical trial NCT00499148: Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
Official title: Effect of Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* Between 18 and 75 years of age
* Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
* If of childbearing potential, is practicing birth control
* BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
* If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit

Exclusion Criteria:

* Uses insulin for glucose control or has type 1 diabetes
* History of diabetic ketoacidosis.
* Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
* Active malignancy
* Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
* End state organ failure or status post organ transplant
* History of renal disease
* Current hepatic disease
* History of severe gastroparesis
* Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
* Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
* Clotting or bleeding disorders
* Allergic or intolerant to any ingredient found in the study products

Primary outcomes:
measure: positive AUC for plasma glucose
timeFrame: 4 hours
Secondary outcomes:
measure: positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Jennifer A. Williams, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05493748: Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
Official title: Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: Overactive Bladder Syndrome
Bladder Training
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental, before-after trial.
Primary purpose: TREATMENT

Brief summary: According to International Urogynecological Association and International Continence Society joint report on the terminology for female pelvic floor dysfunction, overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. Bladder training lasting for a minimum of 4 to 6 weeks is indicated as a first-line treatment. The investigators' goal is to compare changes in satisfaction, measured in terms of quality of life, in 2 groups of women with different main accompanying symptoms in OAB (frequency vs. nocturia), before and after bladder training utilizing telemedicine (virtual bladder training), for 4 to 6 weeks.


Eligibility criteria: Inclusion Criteria:

* women over 18 years of age
* Live in Buenos Aires City
* Overactive Bladder Syndrome
* Access to virtual appointment

Exclusion Criteria:

* Previous overactive bladder syndrome treatment.
* Prior stress urinary incontinence or pelvic organ prolapse surgery.
* History of Neurogenic Bladder, pelvic organs prolapse or pelvic radiation.
* Pregnancy.

Primary outcomes:
measure: Change in King's Health Questionnaire (KHQ) score
timeFrame: Change from Baseline King's Health Questionnaire at 6 weeks
measure: Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score
timeFrame: Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References:
Clinical trial NCT01420848: Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student
Official title: The Effectiveness of the Auriculotherapy on Reducing Stress and Anxiety in Nursing Student: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Anxiety
Keywords: stress disorders
anxiety disorders
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 71
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of true and placebo auriculotherapy.

Detailed description: Although researches on stress have a strong focus on stress at work,it is very important the evaluation of the stress and its consequences in Nursing students. This allows to understand which stress factors experienced in a negative way could interfere on the adaptive success in school activities. Students can experience symptoms of the alarm phase of stress such as tachycardia, muscle tension, skin and cold extremities, and also the second phase of stress such as headache, sleepiness, irritability and difficulty concentrating. High levels of stress have a substantial effect on attention and can lead to errors, lack of concentration and fluctuations in the level of attention. The auriculotherapy may have an important role as a coping strategy for stress and anxiety. It is a fast, relatively simple, easily performed, safe and without major side effects.

Eligibility criteria: Inclusion Criteria:

* Average and high score by the List of Stress Symptoms
* Voluntary participation in the study
* Availability of time for submission to the sessions

Exclusion Criteria:

* Pregnancy
* Medical license or vacation during the period
* Low score of stress

Primary outcomes:
measure: Students Stress Levels
timeFrame: 90 days
Secondary outcomes:
measure: Students Anxiety Levels
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência
Study officials:
affiliation: University of Sao Paulo
name: Juliana M Prado
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Leonice FS Kurebayashi
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Maria Julia P Silva
role: STUDY_CHAIR
References:
citation: Giaponesi ANL, Leão ER. Auriculotherapy as an intervention to reduce stress reduction among the nursing team in intensive care. Nursing (São Paulo);12(139):575-579, dez. 2009. ilus.
citation: do Prado JM, Kurebayashi LF, da Silva MJ. Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):727-35. doi: 10.1590/s0104-11692012000400013. English, Portuguese, Spanish.
Clinical trial NCT06860048: Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
Official title: Randomized Controlled Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ergonomics
Lead sponsor: Prince of Wales Hospital, Sydney
Sponsor class: OTHER_GOV
First posted: 2025-03-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer.


Eligibility criteria: Inclusion Criteria:

* Robotic surgeon

Exclusion Criteria:

-

Primary outcomes:
measure: Muscle fatigue
timeFrame: 2 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Department of Surgery, Prince of Wales Hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT02120248: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Official title: The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: WIC
Oregon
Breastfeeding
Peer Counseling
Exclusive Breastfeeding
Lead sponsor: Oregon WIC Program
Sponsor class: OTHER_GOV
Collaborators: name: USDA Food and Nutrition Service
First posted: 2014-04-22
Enrollment: 1948
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Eligibility criteria: Inclusion Criteria:

* Pregnant Oregon WIC participants in Jackson, Washington and Hood River counties or Umatilla Morrow Head Start.

Exclusion Criteria:

* WIC participant outside of the 4 study agencies.

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Exclusive breastfeeding
timeFrame: 3 months postpartum
Other outcomes:
measure: Partial Breastfeeding
timeFrame: 3 months
measure: Partial breastfeeding
timeFrame: 6 months postpartum
Locations:
Study officials:
References:
citation: Reeder JA, Joyce T, Sibley K, Arnold D, Altindag O. Telephone peer counseling of breastfeeding among WIC participants: a randomized controlled trial. Pediatrics. 2014 Sep;134(3):e700-9. doi: 10.1542/peds.2013-4146. Epub 2014 Aug 4.
Clinical trial NCT03855748: Hip Peak Torque in Running and Jumping Activities in Healthy Active Subjects
Official title: Hip Peak Torque in Running and Jumping Activities in Healthy Active Subjects - a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Injuries
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: Hip-related groin pain is common in sports that involves change of direction, kicks and sprint accelerations such as football, ishockey, tennis and basketball. Groin pain symptoms either pre- or post-treatment may be load-related, there is limited information on how different sporting activities affect hip joint loading. Thus, the purpose of this explorative cross-sectional study is to investigate hip peak torque in running and jumping activities in healthy active subjects.

Such information may guide furture rehabilitation strategies and return to sport sport criteria.

Twenty healthy subjects from the Capital Region of Denmark with an age of 18-40 will be included.

Hip joint kinetics and kinamatics will be obtained during the following activities for each subjects:

1. Walking
2. Jogging (8-11 km/h)
3. Maximal 6 meters sprint acceleration
4. Single leg drop jump from 35 cm height
5. Horizontal jump with single leg landing with a distance of 100% and 150% of leg length
6. Maximal change of direction at 45, 135, 180 degrees
7. Single-leg cross-country skiing exercise


Eligibility criteria: Inclusion Criteria:

* Subjects who are healthy and physically active.

Exclusion Criteria:

* Any history of lower limb surgery or fracture
* Lower limb injuries, joint or muscle pain with a duration of more than 6 weeks within the past year.
* Body Mass Index more than 30 kg/m2

Primary outcomes:
measure: Hip peak torque, Nm/kg
timeFrame: Baseline (week 0)
Secondary outcomes:
measure: Angle at peak torque, degrees
timeFrame: Baseline (week 0)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Sports Orthopedic Research Center - Copenhagen (SORC-C)
name: Lasse Ishøi, PhD student
role: PRINCIPAL_INVESTIGATOR
References: