louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06340087: Impact Hesperetin in Combination with Sucrose on Blood Glucose Regulation
Official title: Einfluss Des Süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung Teil 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Glucose Fluctuations
Hunger
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this cross-over intervention study is to investigate the influence of hesperetin applied in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution and an isocaloric sucrose-only solution on markers of energy metabolism

Detailed description: The study is designed as a randomised cross-over intervention study with three arms. The aim is to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in combination with 50 mg/L of the polyphenol hesperetin, and a less sweet 7% sucrose solution w/o hesperetin on time-dependent blood glucose fluctuations and ad libitum energy intake in metabolically healthy male volunteers.

To investigate the underlying mechanisms, the individual appetite score, metabolic and hormonal responses to the interventions and will be measured. In addition, the participants' individual thresholds for sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners, and their body composition will be recorded as potential influencing factors.

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* normal taste responses towards sweet taste

Exclusion Criteria:

* pregnancy or breast-feeding
* regular smokers
* disturbed glucose and/or lipid metabolism
* regular intake of medication
* known allergies against one of the test compounds
* ageusia alcohol or drug addiction intake of antibiotics within the past 2 months

Primary outcomes:
measure: Change in blood glucose concentration
timeFrame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
measure: Change in appetite score
timeFrame: Difference between before and 120 minutes after drinking of the test solution
measure: Change in food intake
timeFrame: 120 minutes after drinking of the test solution
Secondary outcomes:
measure: Change in regulating hormones
timeFrame: 15, 30, 60, 90, and 120 minutes after drinking the test solution
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Christian Doppler Laboratory for Taste Research
Study officials:
affiliation: University of Vienna
name: Barbara Lieder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04299087: Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
Official title: Changes in Cortical Oscillations Induced by Repetitive Transcranial Magnetic Stimulation (rTMS) Therapy in Patient Populations With Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia
Tremor
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will include subjects diagnosed with Dystonic Tremor (DT), Essential Tremor (ET), and healthy controls in the age range of 21-80 years. Electroencephalography (EEG) will be used as the primary outcome measure. Transcranial Magnetic Stimulation (TMS) will be used over the motor cortices or cerebellar cortices as an intervention that is expected to have short-term (less than an hour) electrophysiological effects.

Detailed description: The primary goal of this study is to compare differences in cortical activity of patients with tremor before and after applying a session of rTMS. Specifically, the investigators will apply rTMS to the primary motor cortex (M1) as our group and others have shown abnormal function of the region. Moreover, a study shows that targeting of M1 and the dorsal premotor cortex (dPMC) with rTMS results in a trend towards improved clinical outcome in patients with focal hand dystonia and cervical dystonia. The central hypothesis of this study is that rTMS can modify cortical oscillations in patient populations with tremor and that the investigators will be able to detect these changes with the use of Electroencephalography (EEG). By applying inhibitory rTMS to the motor cortices, the investigators may expect a shift in cortical oscillations towards normal activity.

Eligibility criteria: Inclusion Criteria for Dystonia and/or tremor:

- Diagnosis of Dystonia and/or tremor according to the Consensus Statement of the Movement Disorders Society

Exclusion Criteria Dystonia and/or tremor:

* Pregnancy
* Active seizure disorder
* Presence of a metallic object such as a pacemaker, implants, metal rods, and hearing aid
* History of stroke

Inclusion Criteria for Healthy controls

- There is no history of any neurological disorders.

Exclusion Criteria for Healthy controls

* Pregnancy
* Any neurological disorders
* Presence of a metallic body in their brain
* History of stroke

Primary outcomes:
measure: Cognitive Assessment Using MoCA Version 7.1 Scores
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: David Vaillancourt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01234987: Diagnosis of Cancer Using Breath Samples
Official title: Diagnosis of Cancer Using Breath Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Breast Cancer
Colon cancer
Lung Cancer
Lead sponsor: Technion, Israel Institute of Technology
Sponsor class: OTHER
Collaborators: name: Rambam Hospital
First posted: 2010-11-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People that undergo screening for breast, colon or lung cancers people diagnosed with breast, colon or lung cancers

Brief summary: The purpose of this study is to collect breath samples from healthy and cancer sick patients. The breath, collected to special bags, will be transferred to laboratories in the Technion and analyzed using an electronic nose system developed in Hossam Haick's labs (Chemical Engineering, Technion). The hypothesis is that based on the analysis of the chemical bio-markers present in the exhaled breath, cancer states can be distinguished from healthy subjects or before and after treatment, allowing a technique for diagnosis of cancer and/or cancer treatment.


Eligibility criteria: Inclusion Criteria:

* The cancer is local or homeostatic
* The subject did not undergo surgery for tumor removal, chemotherapy or radiation treatment prior to first sampling
* The subject signed an informed consent form

Exclusion Criteria:

* The subject is addicted to drugs or alcohol
* The subject smoked in the last hour
* There are communication problems with the subject

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT02260687: Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
Official title: Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Neovascularization
Keywords: Aflibercept
Anti-VEGF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-10-09
Enrollment: 353
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with mCNV(myopic choroidal neovascularization) diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.

Brief summary: The objectives of this study are to investigate the safety and effectiveness of EYLEA.

Detailed description: This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.

The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice) .

Eligibility criteria: Inclusion Criteria:

* Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization).

Exclusion Criteria:

* Patients who have already received EYLEA treatment.

Primary outcomes:
measure: Number of episodes of Adverse drug reaction (ADR's)
timeFrame: Up to 12 months
measure: Number of episodes of Infections
timeFrame: Up to 12 months
measure: Number of episodes of Serious Adverse Events(SAE's)
timeFrame: Up to 12 months
measure: Number of episodes of Ocular Adverse events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean changes in visual acuity
timeFrame: Baseline up to 12 months
measure: Mean changes in retina thickness
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01959087: Single Port Colic Laparoscopic Surgery
Official title: Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Crohn's Disease
Diverticulitis
Keywords: Single port surgery
Colonic surgery
Postoperative morbidity
Postoperative outcomes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2013-10-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.

Detailed description: The aim of this study is to compare surgical results of colonic resection performed by single port and multiport laparoscopic approaches. Primary endpoint is the length of postoperative hospital stay. Secondary endpoints include postoperative mortality, postoperative morbidity, conversion rates, postoperative recovery, aesthetic results, postoperative pain, and costs

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
* Informed consent signed
* Social Insurance

Exclusion Criteria:

* Digestive stoma in place or planned during the intervention
* Body mass index \> 30 kg/m2
* History of previous laparotomy, except Mc Burney, Pfannenstiel ou subcostal
* Subtotal colectomy
* Transverse colectomy
* Proctectomy or total coloproctectomy
* Synchronous metastasis
* Preoperative suspicion of T4 colorectal cancer
* Emergency procedure
* Associated resection (except appendectomy or liver biopsy)
* Pregnancy or current breast feeding.

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: Operative mortality
timeFrame: 30 days
measure: Post-operative morbidity
timeFrame: Day 30
measure: Conversion rates
timeFrame: Day 1
measure: Pathologic results
timeFrame: Day 180
measure: Postoperative recovery
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 6 days
measure: Aesthetic results
timeFrame: 180 days
measure: Costs
timeFrame: Day 180
measure: Lenght of true hospitalization stay
timeFrame: 30 days
measure: Technical feasability
timeFrame: Day 1
measure: Post-operative quality of life
timeFrame: Day 180
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service de Chirurgie Colorectale
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yves PANIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836.
Clinical trial NCT06446687: Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge
Official title: Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Implant Site Reaction
Maxillary Deficiency
Keywords: Closed Sinus lifting
Bone Gain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting


Eligibility criteria: Inclusion Criteria:

1. Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
2. Residual bone height 4-8mm in the estimated implant positions.
3. The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
4. The edentulous ridges are covered with optimal thickness of mucoperiosteum.

Exclusion Criteria:

1. Patients with a systemically diseases or inflammation whether local or generalized.
2. Patients with bleeding disorders.
3. Subjected to irradiation in the head and neck area less than 1 year before implantation.
4. Poor oral hygiene and motivation.
5. Pregnant or nursing.
6. Severe bruxism or clenching.
7. Active infection or severe inflammation in the area intended for implant placement.
8. Unable to open mouth sufficiently to accommodate the surgical tooling.

Primary outcomes:
measure: Cone beam computed tomography (CBCT) bone height formation around dental implants
timeFrame: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
Secondary outcomes:
measure: Cone beam computed tomography (CBCT) density formation around dental implants
timeFrame: Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06709287: Side Effects of Different Treatment Methods
Official title: Comparison of Orthodontics Adverse Effects: Braces Versus Clear Aligners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Root Resorption
Pain
Chewing Function
Keywords: root resorption
pain
chewing function
fixed orthodontic treatment
clear aligner therapy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 49
Sex: ALL
Minimum age (years): 12
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 22 patients (14 females, 8 males; mean age: 17.05 ± 4.51 years) who underwent fixed orthodontic therapy were included in the fixed treatment group and 27 patients (20 females, 7 males; mean age: 22.57 ± 7.37 years) who underwent clear aligner therapy were included in the clear aligner group.

Brief summary: this study aimed to compare the effects of fixed orthodontic treatment and clear aligner therapy on root resorption, periodontal status, pain experience and chewing performance.

Detailed description: The aim of the study is to compare the potential side effects of fixed orthodontic treatment and clear aligner therapy. 27 individuals who were treated with clear aligners (20 Female, 7 Male; mean age: 22.57 ± 7.37) and 22 patients treated with braces (14 Female, 8 Male; mean age: 17.05 ± 4.51) formed the study group. The periodontal statuses of the patients(Probing depth, bleeding on probing, plaque index) were evaluated before treatment (T0), 3 months (T1) after, and at 6th month (T2) following the beginning of the treatment. The amount of root resorption in maxillary \& mandibular incisors was evaluated on periapical radiographies taken with the paralleling technique. Pain experience and chewing function were also recorded during treatment.

Eligibility criteria: Inclusion Criteria:

* patients treated with fixed braces or clear aligners
* patients with mild to moderate crowding
* patients without root canal treatment or resorption in anterior teeth
* patients with completed root development
* patients with good periodontal health at the beginning of the treatment
* patients with no congenitally missing or impacted tooth.

Exclusion Criteria:

* history of orthodontic therapy
* poor patient compliance
* presence of any craniofacial syndrome or systemic disease
* presence of cleft lip and palate
* trauma history
* mental retardation
* use of oral antiseptic solutions during orthodontic treatment
* need for scaling and root planning during treatment
* clear aligner patients with delayed movement of the anterior teeth.

Primary outcomes:
measure: The primary outcomes of the study were pain scores and chewing performance scores.
timeFrame: 0-1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Bezmialem Vakif University
state: Istanbul
Study officials:
References:
Clinical trial NCT03168087: Plasmalyte-148 Solution and Blood Coagulation
Official title: The Effect of a Plasmalyte-148 Solution on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2017-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Fluids administered intravenously may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution in plasmalyte-148 solution. Investigators have therefore performed the present study to measure the effect of a plasmalyte-148 solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication

Primary outcomes:
measure: FIBTEM
timeFrame: During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary outcomes:
measure: INTEM
timeFrame: During the rotational thromboelastometry analysis/ an average of 1 hour
measure: EMTEM
timeFrame: During the rotational thromboelastometry analysis/ an average of 1 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyun-Jung Shin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056987: Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
Official title: Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lenses
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 36
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 overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.

Detailed description: Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).

Eligibility criteria: Key Inclusion Criteria:

* Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
* Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
* Willing to NOT use rewetting/lubricating drops at any time during the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
* Habitual AOHP contact lens wearers (in the past 3 months).
* Monovision wear during the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Distance VA (logMAR) With Study Lenses
timeFrame: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: