louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06906965: Effect of the Imera Cultivar Carob in Postprandial Glycemia
Official title: Impact of the Imera Carob Cultivar in Postprandial Glycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glucose Regulation
Keywords: postprandial glucose
glucose regulation
carob
carob powder
postprandial insulin
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: An acute randomized crossover study on the effect of a carob beverage on postprandial glycemic response

Detailed description: This is an acute randomized crossover study on the effect of an Imera cultivar carob beverage on postprandial glycemic response in healthy individuals as opposed to sucrose-based beverage containing sugar in alike concentration

Eligibility criteria: Inclusion Criteria:

* healthy male adults of normal body fat mass

Exclusion Criteria:

* obesity (according to body fat mass), type 1 Diabetes, hypertension and other cardiovascular diseases, thyroid disorder, liver, kidney, gastrointestinal disease, mental illness, use of nutraceutical supplements or natural products for weight loss and the background of dietitian/nutritionist.

Primary outcomes:
measure: Postprandial glucose
timeFrame: 3 hours
Secondary outcomes:
measure: Postprandial insulin
timeFrame: 3 hours
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Department of Nutrition and Dietetics, HarokopioUniversity of Athens
state: Attica
Study officials:
References:
Clinical trial NCT01357265: Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
Official title: A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Seasonal Influenza
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.


Eligibility criteria: Inclusion Criteria:

Healthy, adult and elderly volunteers over 18 years

Exclusion Criteria:

Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.

Primary outcomes:
measure: To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
timeFrame: 22 days including follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Via Dei Vestini
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
state: Cheiti
city: Via Pastore
country: Italy
facility: Dipartimento di Scienze della Salute Università di Genova
state: Genova
city: Via Polidoro-Vasto
country: Italy
facility: Distretto Sanitario di Base di Fossacesia
state: Lanciano
city: Via S. Spaventa
country: Italy
facility: ASL Lanciano - Vasto,
state: Lanciano
city: Via Stamira d'Ancona
country: Italy
facility: Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute
state: Milano
city: Via Pergolesi 33
country: Italy
facility: Dipartimento di malattie infettive Ospedale San Gerardo
state: Monza
Study officials:
References:
Clinical trial NCT01395966: Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Official title: Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Keywords: with tubes
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 331
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.


Eligibility criteria: Inclusion Criteria:

* 6 months to 12 years
* ear tube in the ear which will be treated
* otorrhea for 3 weeks or less
* moderate or severe otorrhea

Exclusion Criteria:

* other ear diseases

Primary outcomes:
measure: Time to Cessation of Otorrhea
timeFrame: From baseline until the end of the study ( up to 22 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Laboratorios Salvat, S.A.
state: Barcelona
Study officials:
References:
citation: Spektor Z, Pumarola F, Ismail K, Lanier B, Hussain I, Ansley J, Butehorn HF 3rd, Esterhuizen K, Byers J, Douglis F, Lansford B, Hernandez FJ. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Apr 1;143(4):341-349. doi: 10.1001/jamaoto.2016.3537.
Clinical trial NCT01787266: Symptoms and Function During and After Pregnancy
Official title: Symptoms and Function During and After Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Girdle Pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women in week 32 - 36

Brief summary: The purpose of this study is to:

1. describe degree of symptoms and disability during and after pregnancy
2. to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing
3. to examine the responsiveness of The Pelvic Girdle Questionnaire


Eligibility criteria: Inclusion Criteria:

* Pregnancy week 32-36
* Understand and read/write a questionnaire in Norwegian or English

Exclusion Criteria:

* Not able to understand and fill in a questionnaire

Primary outcomes:
measure: the pelvic girdle questionnaire
timeFrame: 10 weeks postpartum
Secondary outcomes:
measure: Pain intensity, Numeric rating scale
timeFrame: 10 weeks postpartum
Other outcomes:
measure: Short Form -8 (SF-8)
timeFrame: 10 weeks postpartum
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT01451866: Comparison Between Classic Leg-press Training and Complex Leg-press Training on a Dynamic Leg-press
Official title: Comparison of a Classic Leg-press Training Compared to a Complex Training on a Dynamic Leg-press With Visual Feed-back. Pilot-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy
Keywords: resistance training
Healthy People Programs
Lead sponsor: University of Applied Sciences of Western Switzerland
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 34
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: PREVENTION

Brief summary: A complex training on a dynamic leg-press with visual feed-back will improve coordinative capacity, power, sensorimotor and cognitive aspects more than a classic training on the same leg-press but without visual feed-back.

Detailed description: The project evaluates two different resistance training programs on a leg press. One group will perform a standard resistance training with the aim of muscle hypertrophia, the other group will perform a complex resistance training combining rate of force development training, power training, speed endurance as well as sensorimotor aspects (i.e. following visual feedback to reproduce given forces or joint angles).

Hypotheses: Participants in the complex training group will change the relation between counter movement jump and squat jump, i.e. they will more improve in the counter movement jump because of improved sensorimotor capacity.

Eligibility criteria: Inclusion Criteria:

* Healthy adult (\>18yrs) participants
* Able to do resistance training

Exclusion Criteria:

* Recent injuries preventing resistance training

Primary outcomes:
measure: coordination
timeFrame: 5 weeks
Secondary outcomes:
measure: Power
timeFrame: 5 weeks
measure: Balance
timeFrame: 5 weeks
measure: Power - Endurance
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Leukerbad
country: Switzerland
facility: Swiss Olympic Medical Center Leukerbad
state: VS
Study officials:
affiliation: HES-SO Valais
name: Roger Hilfiker, MPTSc.
role: STUDY_CHAIR
References:
Clinical trial NCT05728866: Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke
Official title: Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke.

Detailed description: The study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. Results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment.
* Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury.
* At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior.
* Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study.
* Absence of significant cognitive impairment as determined by a Mini-Mental Status Examination score of greater than or equal to 24.
* The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke.

Exclusion Criteria:

* Unable to provide informed consent.
* Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale.
* Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale.
* History of greater than two strokes.
* Suffered a stroke less than 6-months prior to participating in the study.
* A history of, or being susceptible to, cyber-sickness (i.e., motion sickness).
* Unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and
* A history of seizures.

Primary outcomes:
measure: Change in hemiplegic arm movements
timeFrame: Baseline to approximately 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Virginia Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04042766: Laser Vaginal Treatment for GSM
Official title: Laser Vaginal Treatment for GSM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopausal Urethral Atrophy
Vulvar Atrophy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario
First posted: 2019-08-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.


Eligibility criteria: Inclusion Criteria:

1. Females aged 45-70 years;
2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
3. at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness \| itching \| irritation \| soreness/pain \| dyspareunia;
4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.

Exclusion Criteria:

1. Patient is pregnant/lactating
2. unexplained abnormal genital bleeding
3. current acute vaginal/ bladder infection
4. antibiotic use the past 30 days;
5. women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
6. concurrent use of any other new GSM treatment
7. pelvic surgery \<3 months
8. current treatment for chronic pelvic pain

Primary outcomes:
measure: subjective measure of change in: the patient's most bothersome symptom
timeFrame: Baseline and 3 months after treatment start
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, University of Toronto
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Patricia Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02181166: Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Myofascial Trigger Point
Keywords: Breast Neoplasms
Mastectomy
Myofascial pain syndromes
Physical Therapy Modalities
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points. This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer. This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation cinesioterapia +). The stance, the plantar pressure distribution and the balance will be assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points will be assessed with the use of infrared thermography, algometry and numerical rating scale of pain (END). Moreover, the quality of life of the volunteers will be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and after thirty days. Normality test is used to verify data distribution and consistent statistical test for proper intra and comparisons between groups, being thus considered two factors in the comparisons, time and group. A significance level of 5% is assumed.


Eligibility criteria: Inclusion Criteria:

* mastectomy
* aged between 35 and 70 years
* myofascial trigger point in the upper trapezius muscle

Exclusion Criteria:

* metastasis or recurrence of breast cancer
* bilateral mastectomy
* in physiotherapy treatment
* degenerative diseases of the spine
* use of muscle relaxants or anti-inflammatory analgesics in the last week
* report of fibromyalgia

Primary outcomes:
measure: Pain
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: Skin Temperature
timeFrame: 2 years
measure: Posture
timeFrame: 2 years
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Vânia Ferreira, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02581566: Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.

Exclusion Criteria:

* Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.

Primary outcomes:
measure: postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: c-reactive protein
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT06000566: Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
Official title: Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Juvenile Rheumatoid
Medication Adherence
Quality of Life
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 174
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric group of age (0 to 18 years), all patients diagnosed with JIA, all patients are using drugs for their diagnose

Brief summary: The goal of this observational study is to learn about the drug compliance of patients with juvenile idiopathic arthritis and, to figure our factors that affect the compliance.

The main questions it aims to answer are:

* Medication use and compliance in children with chronic diseases is an important problem, but do patients with JIA really use their medications in harmony?
* Does the level of adherence to medications affect the quality of life of patients with JIA?

Participants will be asked to fill the demographic form which includes personal information and nutritional habbits, Morisky Drug Compliance Scale - 8 and the pediatric quality of life inventory forms, with attending researcher Yesfa Sebnem Ozbay, M.D.

This study is not an interventional study.


Eligibility criteria: Inclusion Criteria:

* Being followed up with the diagnosis of Juvenile Idiopathic Artritis (JIA) from the pediatric rheumatology outpatient clinic of Istanbul University, Istanbul Faculty of Medicine

Exclusion Criteria:

* Refusal of patients or their parents to participate in the study
* Although the patient is followed up with the diagnosis of JIA, not using medication

Primary outcomes:
measure: Drug Compliance by Morisky Medication Adherence Scale 8 (MMAS-8)
timeFrame: November 2022 - August 2023
measure: Disease activation score
timeFrame: November 2022 - August 2023
measure: PedsQL (Pediatric Quality of Life Inventory)
timeFrame: November 2022 - August 2023
Secondary outcomes:
measure: Descriptice characteristics outcome measure
timeFrame: November 2022 - May 2023
measure: Details of medication
timeFrame: November 2022 - May 2023
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih
Study officials:
affiliation: IstabulU
name: Nuray Aktay Ayaz, M.D, M.Sci, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04723966: Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital
Official title: Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TPN in Preterm
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include all male and female preterm infants receiving total parenteral nutrition in NICU of Cairo university Children hospital

Brief summary: The aim of this work is evaluation of electrolytes and minerals homeostasis and occurrence of complications among preterm babies receiving total parenteral nutrition, and admitted to the neonatal intensive care units of Cairo University Children hospitals.


Eligibility criteria: Inclusion Criteria:

- All preterm infants with gestational age \< 34 weeks, Receiving total parenteral nutrition. Normal serum magnesium.

Exclusion Criteria:

* Any full-term neonates Any patient with TORCH infection, chromosomal, metabolic disorders or surgical abnormality of the hepatobiliary system

Primary outcomes:
measure: electrolyte and mineral disturbance associated with TPN in preterm receiving it
timeFrame: 14 days
Secondary outcomes:
measure: prevalence of cholestasis and sepsis in preterm receiving TPN
timeFrame: 14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: Almanyal
Study officials:
References: