louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05406804: Olfactory Stimulation for Very Low Birth Weight Infants
Official title: The Influence of Olfactory Stimulation of Breast Milk on the Stability of Physiological Indicators of Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Low Birth Weight Infant
Keywords: Olfactory stimulation
Heart rate
Oxygen saturation
Respiratory rate
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.

Detailed description: Fluctuations in vital signs of very low birth weight infants may lead to poor prognosis. Research Objectives:

To evaluate the effect of olfactory stimulation of breast milk on the stability of physiological indexes of very low birth weight infants Subjects: Very low birth weight infants whose gestational age are less than 32 weeks.

Eligibility criteria: Inclusion Criteria:

* Gestational age at birth \<32 weeks;
* Birth weight \< 1500 g;
* Admission to hospital within 24 hours after birth;
* Mother can provide breast milk

Exclusion Criteria:

* Severe congenital malformations;
* Complicated congenital heart disease;
* Congenital gastrointestinal disease;
* Intraventricular hemorrhage

Primary outcomes:
measure: Ratio of stable heart rate
timeFrame: During the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06805604: Digital Techniques
Official title: Clinical Performance and Patients Satisfaction of Innovative Digital Techniques for Fabrication of Monolithic Ceramic Crowns
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Monolithic Ceramic Crowns Fabricated by Different Digital Techniques
Keywords: digital techniques
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-02-03
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study is performed on 3 groups

- Different digital techniques used for fabrication of the monolithic ceramic crowns were chosen for the current study; milled zirconia for the group (I) and milled hybrid for the group (II) and 3D-printed hybrid for the group (III).
Primary purpose: OTHER

Brief summary: The present study is performed to evaluate clinical performance and patient satisfaction of innovative digital techniques for fabrication of monolithic ceramic crowns

Detailed description: Digital dentistry has progressed rapidly in the last few years, primarily to improve and enhance the practice of dentistry through the advancement in digital tools and techniques, providing improved accuracy and precision, enhancing patient experience, increasing efficiency and productivity, thereby resulting in better treatment outcomes, whilst also improving clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Patient with posterior molars indicated for full coverage restorations.
* Patient able to physically and psychologically tolerate conventional restorative procedures.

Exclusion Criteria:

* Patient in the growth stage with partially erupted teeth.
* Patient with poor oral hygiene and motivation.
* Patients with parafunctional habits.

Primary outcomes:
measure: the clinical performance, color stability and wear behavior of monolithic ceramic crowns fabricated using innovative digital techniques.
timeFrame: baseline, 3months and 6 months after crown cementation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dental medicine for girls Al-Azhar university
Study officials:
References:
citation: Diken Turksayar AA, Demirel M, Donmez MB, Olcay EO, Eyuboglu TF, Ozcan M. Comparison of wear and fracture resistance of additively and subtractively manufactured screw-retained, implant-supported crowns. J Prosthet Dent. 2024 Jul;132(1):154-164. doi: 10.1016/j.prosdent.2023.06.017. Epub 2023 Jul 20.
Clinical trial NCT06299904: Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
Official title: Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Second Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.


Eligibility criteria: Inclusion Criteria:

* patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;
* patients with relatively stable vital signs, with a NIHSS score of 21 points;
* patients with tracheotomy accompanied by dysphagia;
* no previous history of dysphagia;
* age ≥ 30 years and ≤80 years;
* informed consent signed by the patient and his family.

Exclusion Criteria:

* patients with medullary haemorrhage/infarction;
* patients that experienced cerebral hernia and recurrent stroke;
* patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;
* patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;
* patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;
* patients with a history of epilepsy or risk of seizures.

Primary outcomes:
measure: the score of Fiberoptic endoscopic examination of swallowing (FEES)
timeFrame: 2 weeks
measure: the score of Murray's secretion scale (MSS)
timeFrame: 2 weeks
measure: the score of penetration-aspiration scale (PAS)
timeFrame: 2 weeks
Secondary outcomes:
measure: the score of Clinical Pulmonary Infection Score (CPIS)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dalian
country: China
facility: the Second Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT02223104: Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colostomy
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.


Eligibility criteria: Inclusion Criteria:

* patient is at least 18 years old
* patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches
* patient having a colostomy for at least 1 month
* patient using currently a one-piece flat ostomy appliance with closed or drainable bags
* patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches
* patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days
* patient covered by social security

Exclusion Criteria:

* patient receiving or having received, within the last month, chemotherapy or radiotherapy
* patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin
* patient already participating in another clinical study or who have previously participated in this investigation
* pregnant or breast-feeding woman

Primary outcomes:
measure: Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
timeFrame: Up to one day for closed pouches and up to two days for drainable pouches.
Secondary outcomes:
measure: Assessment of the condition of peristomal skin
timeFrame: At V1 and V2 protocol visits (at day 0 and day 14)
measure: Acceptability of each pouch
timeFrame: At each protocol visit (day 0, day 14 and day 28)
measure: Preference between Flexima® Active and Sensura®
timeFrame: At each protocol visits (at day 0, day 14 and day 28)
measure: Assessment of the quality of life with Stoma-QoL questionnaire
timeFrame: At each protocol visits (at day 0, day 14 and day 28)
measure: Adverse(s) Event(s)
timeFrame: At each protocol visits (at day 0, day 14 and day 28)
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
References:
Clinical trial NCT03031704: French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy
Official title: French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Duodenal Adenoma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included

Brief summary: Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.

All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.

Hundred and twenty patients will be included and followed 2 years after mucosectomy.


Eligibility criteria: Inclusion Criteria:

* Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy

Exclusion Criteria:

* patients with previous endoscopic resection,
* patients prsenting lesion involving the major papilla, sub mucosal lesions
* patient with familial adenomatous polyposis
* patient undergoing use of antiplatelet agent during the five last days

Primary outcomes:
measure: Number of recurrence after surgery
timeFrame: 2 yeras
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT05965804: Vastus Medialis Activation During McMurray's Test
Official title: Muscle Activation Patterns During the McMurray's Test for Knee Examination
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electromyography
Knee Injuries
Knee Pain Chronic
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy men and women aged 18-45 recruited from the local community.

Brief summary: This study will use electromyography to evaluate activation patterns of the vastus medialis and vastus lateralis muscles during the McMurray's knee examination test in different knee positions.

Detailed description: The McMurray test is commonly used to assess knee pathology. However, it is unclear which knee position during this test best isolates activity of the vastus medialis muscle. This study will measure vastus medialis and lateralis activation using surface electromyography in 30 healthy participants performing the McMurray test. Different knee flexion and rotation angles will be evaluated to determine which position optimally activates the vastus medialis. Results may enhance utilization of the McMurray test in rehabilitation programs targeting this muscle.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-45 years
* No history of knee pathology

Exclusion Criteria:

* Contraindications to EMG
* Neurological or muscular disorders

Primary outcomes:
measure: Vastus Medialis Activation
timeFrame: Baseline
Secondary outcomes:
measure: Vastus lateralis EMG activity during McMurray test (μV)
timeFrame: baseline
measure: Force exerted during McMurray test measured by dynamometer (Newtons)
timeFrame: baseline
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT02745704: The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
Official title: The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
peginterferon alfa
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Peking University
name: Huazhong University of Science and Technology
name: Nanchang University
name: Huizhou Municipal Central Hospital
name: First People's Hospital, Shunde China
name: Shenzhen Third People's Hospital
name: First People's Hospital of Foshan
name: Tang-Du Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Yuebei People's Hospital
First posted: 2016-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

Detailed description: In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.

Eligibility criteria: Inclusion Criteria:

1. CHB patients who had received NAs for more than 12 months.
2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
3. Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL.
4. Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion Criteria:

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
2. Patients with other factors causing liver diseases.
3. Pregnant and lactating women.
4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
5. Patients with diabetes, autoimmune diseases.
6. Patients with important organ dysfunctions.
7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
9. Patients who can't come back to clinic for follow-up on schedule.

Primary outcomes:
measure: HBsAg Clearance
timeFrame: 72 weeks
measure: HBsAg Seroconversion
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The third affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05032404: Blue Note Therapeutics Product BNT 103 Usability and User Engagement
Official title: BNT 103 Usability and User Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Blue Note Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Healthcare Innovation Technology Lab
First posted: 2021-09-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This test aims to explore product development-focused usability and user engagement.

Detailed description: Sponsor is testing an innovative peer-to-peer communication tool during this trial.

Eligibility criteria: Inclusion Criteria:

* Patient can read, write, and speak in English
* Patient is between the ages of 35-55
* Diagnosed with Stage I-III breast cancer
* In active treatment or within 3 months of ending active treatment and under the care of a clinician at time of study
* Apple mobile phone or tablet user
* Willing to participate in study protocol

Exclusion Criteria:

* Any participant not meeting inclusion criteria

Primary outcomes:
measure: Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
timeFrame: Baseline up to Week 7
Secondary outcomes:
measure: Measure of Current Status - Anxiety (MOCS-A)
timeFrame: Baseline up to Week 7
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Blue Note Therapeutics
state: California
Study officials:
affiliation: Blue Note Therapeutics, Inc
name: Dianne Shumay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20.
Clinical trial NCT00018304: Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow
Official title: Insulin Action: Role of Skeletal Muscle and Insulin-Mediated Blood Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: blood pressure
insulin sensitivity
blood flow
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The overall objective of this proposal is to examine the contribution of changes in total body fat, enhancement in insulin-mediated vasodilatation and enhancement in endothelium-derived nitric oxide production to the improvements in metabolic insulin action. In addition, the study will track whether these improvements are related to changes in blood pressure.


Eligibility criteria: Age 50 - 75 years, elevated blood pressure, BMI greater than 25 but less than 40 kg/m2

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
name: Arthur Leon, M.D.
name: Alan Blank, M.D.
References:
Clinical trial NCT04955301: Consumers' Preference for Sustainable Food
Official title: Can we Prime Sustainable Food Choice? A Mix-methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Consumption
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to test and compare the effectiveness of three priming interventions on consumers' selection of sustainable foods: priming with environmental benefits, health benefits and co-benefits (environment and health benefits).


Eligibility criteria: Inclusion Criteria:

* Subjects should be aged 18 years or above
* Hong Kong residents
* Be able to read Chinese

Exclusion Criteria:

* Subjects who have vegan or vegetarian diets
* Subjects who have to follow special diets due to illnesses will be excluded.

Primary outcomes:
measure: Consumers' preference for choosing sustainable foods measured by Discrete Choice Experiment
timeFrame: Within 1 day of randomization
Secondary outcomes:
measure: Measure participants' social orientation value using Social Orientation Value Scale
timeFrame: Within 1 day of randomization
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: HKU School of Public Health
Study officials:
References: