louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03024879: The Effect of Motilin on the Frequency and Amount of Food Intake
Official title: Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Healthy
Obesity
Keywords: Motilin
Erythromycin
Food intake
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators aimed at evaluating the role of motilin in the regulation of food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers and is significantly increased in obese patients. Its role in food intake regulation might contribute to the pathogenesis of obesity.


Eligibility criteria: Inclusion Criteria:

* BMI \< 30 kg/m² for lean volunteers
* BMI \> 30 kg/m² for obese volunteers
* Subject is capable and willing to give informed consent
* Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

Exclusion Criteria:

* Female volunteer is pregnant or breastfeeding
* GI diseases, major abdominal surgery
* Major psychiatric illnesses
* Volunteers that use drugs affecting the GI tract or the central nervous system
* Volunteers suffering from endocrine diseases such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
* Volunteers that have undergone surgical procedure for weight loss

Primary outcomes:
measure: Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
timeFrame: Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake
Secondary outcomes:
measure: Frequency of food intake correlated with motilin plasma levels
timeFrame: Assessment will be done over a period of 5 hours
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deloose E, Biesiekierski JR, Vanheel H, Depoortere I, Tack J. Effect of motilin receptor activation on food intake and food timing. Am J Clin Nutr. 2018 Apr 1;107(4):537-543. doi: 10.1093/ajcn/nqx044.
Clinical trial NCT06194279: Analysis of Different Postoperative Analgesia Strategies Following Scoliosis Surgery
Official title: Analysis of Different Postoperative Analgesia Strategies Following Scoliosis Surgery: Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic Scoliosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged \> 15 years who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023

Brief summary: Idiopathic scoliosis surgery is a major surgery, causing significant post-operative pain which can have a significant impact, both for the patient and for society. Different analgesic strategies have emerged in recent years, within the framework of multimodal analgesia including systemic analgesics, but also axial or peripheral loco-regional anesthesia (LRA). These techniques are integrated into the recommendations of learned societies, aimed at optimizing the post-operative rehabilitation of patients.

If intrathecal morphine injection (ITM) and spinal erector block (ESPB) have already shown their effectiveness in reducing postoperative pain, the combination of these techniques can have a real benefit in major spinal surgery. , and has not yet been studied.


Eligibility criteria: Inclusion Criteria:

* Patient aged \> 15 years
* Patient who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023
* Patient or holder of parental authority not opposing the reuse of their data for scientific research purposes

Exclusion Criteria:

* Oral or written refusal of the patient (or the holder of parental authority) to reuse their data for scientific research purposes
* History of spinal surgery
* Level 3 analgesics at home
* Protection of justice, titular or curatorship

Primary outcomes:
measure: Morphine dose administered 24 hours post-operative
timeFrame: 24 hours post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie Réanimation Médecine Péri Opératoire - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02253979: Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube
Official title: Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endotracheal Intubation
Airway Management
One Lung Ventilation
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. This study was designed to compare the VivaSightTM DL to the standard DLT.

Detailed description: Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The efficiency of the DLT depends on its exact position in the airways, as verified by fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side port. The view from the camera appears continuously on a monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The primary end point is the time required for intubation with visual confirmation of DLT position.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing video assisted thoracoscopic lung lobectomy

Exclusion Criteria:

* anticipated difficult intubation, patients who required rapid sequence induction
* patients with known tracheal pathology

Primary outcomes:
measure: Time required for endotracheal intubation with visual confirmation of double lumen tube position position.
timeFrame: During induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Senior Surgeon, Department of Cardio-Thoracic Surgery
name: Dan Levy-Faber, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20.
citation: Inoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. doi: 10.1093/bja/aeh055.
citation: Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
Clinical trial NCT01043679: Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania
Official title: A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar, Mania
Utapine
Seroquel
Keywords: Bipolar, Mania
Utapine
Seroquel
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 40
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 goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.

Detailed description: Utapine and Serquel belong to anti-bipolar medication family, both are approved by DOH (Department of Health, Taiwan), both has same ingredient but different manufacture. From clinical trial reports, both has excellent effectiveness and safety. The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients for different ingredient and different manufacture.

Eligibility criteria: Inclusion Criteria:

1. Male or female age 18-65 years with diagnosis of bipolar I disorder who will be included by DSM-IV criteria made at least one manic or mixepisode record before study entry.
2. Having a minimum score of 20 on the Young Mania Rating Scale (YMRS), plus a score of at least 4 on two of the core YMRS items of Irritability,Speech, Content, and Disruptive/Aggressive Behavior.
3. At least 4 will be on the Severity of Illness item of the Clinical Global ImpressionsNBipolar(CGINBP)assessment tool.
4. Patient with good compliance to study medicine and adherence to study protocol.

Exclusion Criteria:

1. Had received treatment with clozapine within 28 days of the start of the trial.
2. Had been hospitalised for 3 weeks or longer for the index manic episode.
3. DSM-IV criteria for rapid cycling or a current mixed episode.
4. Intolerance or lack of response to quetiapine or clozapine before this trial be diagnosed by investigator.
5. Neurodegenerative disease eg:Parkinson desease、Huntington disease、Pick's disease.
6. Medicine or drugs which can change mental condition be judged by investigator.
7. EKG abnormality
8. Drug or alcohol abuser

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Chin-Hong Chan, MD.,MS.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03158584: Effect of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries,
Official title: Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Abdominal Surgeries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10 μg/kg).

Detailed description: After obtaining approval of the local ethics committee of faculty of medicine, Assiut University , Assiut , Egypt , and parent's written informed consent, This randomized double -blinded prospective study conducted on ( 45 ) pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries

Eligibility criteria: Inclusion Criteria

* weight between 10-30 kg ,
* American Society of Anesthesiologists (ASA) I - II
* major abdominal surgeries

Exclusion Criteria

* Children with sacral bone abnormalities
* spina bifida
* coagulopathy
* mental delay or retardation

Primary outcomes:
measure: visual analog scale
timeFrame: 24 hours postoperative .
Secondary outcomes:
measure: rams y sedation score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: south egypt cancer instutite
name: Sahar A Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03555084: Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 16
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: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).


Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* willingness to wear custom made Hearing aids
* Informed Consent as documented by signature
* Benefit with TFG tool at least on one ear

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Limited dexterity (not able to change a 10size Hearing aid battery)
* no Benefit of the TFG tool on both ears
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Visibility and Wearing Comfort
timeFrame: 3 weeks
Secondary outcomes:
measure: Measurement of acoustic Feedback Thresholds
timeFrame: 3 weeks
Other outcomes:
measure: TFG Fitrate
timeFrame: 3 weeks
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT00561184: Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
Official title: A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Avian Influenza
Keywords: H5N1 Pandemic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test


Eligibility criteria: Inclusion Criteria:

* Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202

Exclusion Criteria:

* Pregnant or breastfeeding
* Receipt of another vaccine or any investigational agent within the past 4 weeks
* Surgery planned during the study period

Primary outcomes:
measure: Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
timeFrame: 7 days
measure: Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.
timeFrame: 7 days
Secondary outcomes:
measure: Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines.
timeFrame: 8 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
city: Genova
country: Italy
facility: 01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova
city: Lanciano
country: Italy
facility: 03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol. 2010 Nov;17(11):1817-9. doi: 10.1128/CVI.00461-09. Epub 2010 Sep 1.
Clinical trial NCT01958684: Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion
Official title: A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Bleeding pattern
LNG-IUS
Cu-IUD
postabortion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 512
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects should go through the surgical abortion should meet both inclusion and exclusion criteria. And they are willing to sign an informed consent. And all recruitment should be conducted after the decision of treatment.

Brief summary: To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.


Eligibility criteria: Inclusion Criteria:

* Reproductive women in good general health and requesting long-term contraception
* Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
* History of regular cyclic menstrual periods
* Written ICF was obtained

Exclusion Criteria:

* Suspected septic abortion and incomplete abortion, as well as missed abortion
* The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed

Primary outcomes:
measure: The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion
timeFrame: Months 4 to 6
Secondary outcomes:
measure: Menstrual bleeding intensity
timeFrame: up to 6 months
measure: Abortion related bleeding days
timeFrame: up to 1 month
measure: Time to the first menstrual bleeding following abortion
timeFrame: up to 2 months
measure: Participants continuation rates of Mirena and Cu-IUD
timeFrame: up to 6 months
measure: Reasons for discontinuation of Mirena and Cu-IUD
timeFrame: Up to 6 months
measure: Participants satisfaction rates of Mirena and Cu-IUD
timeFrame: Up to 6 months
measure: Percentage of participants with adverse events
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Many Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Chen X, Li Q, Wang X, Chen J, Lv W, Shi B, Wang H, Luo J, Li J. Bleeding pattern difference between levonorgestrel intrauterine system and copper intrauterine devices inserted immediately post-abortion: a multicenter, prospective, observational cohort study in Chinese women. Curr Med Res Opin. 2018 May;34(5):873-880. doi: 10.1080/03007995.2017.1421919. Epub 2018 Feb 7.