louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06222567: Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery
Official title: Assessing the Effect of Additional 5 Minutes Pumping on Expression Volume in Breastfeeding Human Initiating Breastfeeding.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Pumping
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: Medela AG
First posted: 2024-01-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study hypothesizes that human who are both breastfeeding and pumping in the first days postpartum have more expression volume with an additional 5 minutes of pumping with Maintain program after pumping with the INITIATE program.

Detailed description: This study aims to assess if expression milk volume could be improved for patients pumping milk for a clinical indication by implementing five minutes more pumping with the MAINTAIN program, a different sucking pattern, to initiate and benefit milk production. The results of this study will provide important information that validates the proposed changes as well as build clear recommendation for using the Symphony program cards in this population.

Eligibility criteria: Inclusion Criteria:

* Subject ≥ 18 years old
* Infant was born maximum 4 (96 hours) days ago
* Subject has an clinical indication to pump for reasons
* The subject signs the informed consent documentation

Primary outcomes:
measure: Total expression volume in milliliter
timeFrame: T1= 15 minutes, T2=20 minutes
Secondary outcomes:
measure: Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4) and patient characteristic. Milk yielded in milliliters per minute after 15 and 20 minutes pumping.
timeFrame: T1= 15 minutes, T2=20 minutes
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG Hospital
Study officials:
affiliation: OLVG Hospital
name: Fedde Scheele, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02925767: Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
Official title: Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled non-inferiority trial based on split-body was planned to compare the efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.

Detailed description: The 308-nm excimer laser (EL) has been widely used for localized vitiligo. Recently, the 311-nm Ti:Sapphire laser (TSL) was developed to treat patients with vitiligo. To compare the efficacy of TSL vs. EL in the treatment of vitiligo.

A randomized controlled non-inferiority trial based on split-body was planned. The paired symmetric vitiliginous lesions will be randomized to either TSL or EL treatment groups. All lesions will be treated twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks, and the non-inferiority margin was set at 10%. Overall 16 patients will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Age: older than 19
* A patient with stable non-segmental vitiligo
* A patient with symmetrical vitiligo lesions
* A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
* A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages

Exclusion Criteria:

* Age: lower than 20
* A pregnant or lactating patient
* A patient with active or spreading vitiligo
* A patient who cannot understand the study or who does not sign the informed consent

Primary outcomes:
measure: The repigmentation rate (change from baseline) of the vitiliginous patch
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: The adverse effects of both two laser treatments
timeFrame: At 4 weeks, 8 weeks, and 12 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Bae JM, Eun SH, Lee HN, Kim GM, Grimes PE, Lee JH. Comparison of 311-nm Titanium:Sapphire laser and 308-nm excimer laser treatment for vitiligo: A randomized controlled non-inferiority trial. Lasers Surg Med. 2019 Mar;51(3):239-244. doi: 10.1002/lsm.23048. Epub 2019 Jan 25.
Clinical trial NCT06442267: Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support
Official title: A Three-arm Randomized Controlled Non-inferiority Pilot Study Comparing Anticoagulation Strategies Using Unfractionated Heparin, Argatroban and Low-molecular-weight Heparin for Extracorporeal Membrane Oxygenation Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Respiratory Insufficiency
Circulatory Failure
Thromboembolism
Bleeding
Keywords: ECMO
Anticoagulation
Thromboembolic Event
Bleeding
extracorporeal life support
anticoagulant
heparin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A three-arm randomized controlled non-inferiority pilot study comparing anticoagulation strategies using unfractionated heparin, argatroban and enoxaparin for extracorporeal membrane oxygenation support conducted as an investigator-initiated, prospective, parallel group, open-label, active comparator controlled, single center, phase IV study to evaluate the non-inferiority of enoxaparin or argatroban for anticoagulation during ECMO therapy in comparison to the current standard, unfractionated heparin, as measured by the incidence of thromboembolic events during the duration of ECMO therapy


Eligibility criteria: Inclusion Criteria:

* either

  * require ECMO support or
  * have been started on ECMO therapy within the last 12 hours

Exclusion Criteria:

* Patients exhibiting contraindications to anticoagulation in general or any of the three investigated substances
* Patients who are pregnant
* Patients suffering from a clinically relevant pre-existing coagulopathy
* Patients, for whom screening, randomization and implementation of study protocol cannot be initiated within 12 hours after cannulation
* Patients receiving ongoing therapeutic systemic anticoagulation prior to ECMO implantation, or exhibiting an indication for therapeutic anticoagulation (e.g., pulmonary embolism)
* Patients whose total duration of ECMO support lasts less than 24 hours
* Patients with start of ECMO support during CPR (eCPR)
* Patients with passive decarboxylation, without an active pumping system
* Patients, who have been weaned off ECMO support within the last 30 days
* Patients with central ECMO cannulation and/or after cardiopulmonary bypass

Primary outcomes:
measure: Incidence of thromboembolic events during ECMO therapy
timeFrame: through duration of the ECMO run; an average of 14 days
Secondary outcomes:
measure: Bleeding events
timeFrame: through duration of the ECMO run; an average of 14 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical Univeristy of Vienna
name: Johannes Gratz, PD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766167: Clinical Pharmacology Study of MP-424
Official title: Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Genotype 2
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets:

* Pharmacokinetics of MP-424 after a single and multiple doses.
* Safety and tolerability of single and multiple doses of MP-424.


Eligibility criteria: Inclusion Criteria:

* Korean healthy male volunteers aged 20 to 55 years

Exclusion Criteria:

* Subjects with a BMI of \<18.5 or \>25.0, or body weight of \<50kg at prior examination
* Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery)
* Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease
* Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination
* Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion
* Subjects who test positive on urinalysis for drug use (amphetamine, benzodiazepine, barbiturates, cannabinoid, cocaine, opiates, and methadone) at prior examination
* Subjects who do not agree to use a physical contraceptive method during the study period
* Subjects who do not agree to use contraceptive methods for 90 days after final administration of the study drug
* Subjects who have consumed grapefruit, Seville orange, star fruit, cranberry, or any processed food containing these fruits within 7 days before the commencement of study drug administration
* Subjects who have consumed health foods containing St John's Wort within 2 weeks before study drug administration

Primary outcomes:
measure: MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
timeFrame: up to 1 week
measure: Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers
timeFrame: up to 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02904967: Identification of New Genetic Markers of Risk of Venous Thromboembolism Recurrence by Analyzing Whole Genome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a chronic disease with a recurrence rate of 30% at 10 years.

Reduce the risk of recurrence is a serious public health issue. For this it is necessary to identify patients at high risk of recurrence. However, until now, only 50% of recurrences are in the presence of known risk factors, suggesting that there are still yet unidentified risk factors.

The assumption behind this project is that there are specifically associated genetic polymorphisms to the risk of VTE recurrence.

The aim of our project is to identify these polymorphisms from genome-wide data MARTHA cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for approximately 500,000 polymorphisms.

The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be compared between cases and controls. The identification of these new genetic variants associated with VTE recurrence should allow us to improve the pathophysiological knowledge of the disease, reduce the frequency of episodes and focus research on new therapeutic approaches.


Eligibility criteria: Inclusion Criteria:

* Caucasian topic
* Personal history of VTE confirmed by the reference diagnostic tests

Exclusion Criteria:

* Pregnant or breastfeeding women

Primary outcomes:
measure: allelic frequency of 500,000 already genotyped polymorphisms
timeFrame: 36 months
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 NCT03582267: The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
Official title: The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Trauma
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Nutrition interventions may present a safe and relatively risk free intervention for protection against subconcussive impacts. Docosahexaenoic acid (DHA, 22:6n-3) is the principal Omega 3 polyunsaturated fatty acid in the brain, playing an integral role in the brain's development and structural integrity. The goal of this study is to determine if supplementation with DHA attenuates blood biomarkers of repetitive head trauma linked to sub-concussive impacts sustained in rugby participation.


Eligibility criteria: Inclusion Criteria:

* Canadian national rugby athletes on 7s and 15s teams

Exclusion Criteria:

* None

Primary outcomes:
measure: Blood concentration of neurofilament light protein
timeFrame: 12 times throughout course of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian Universti
state: Texas
Study officials:
References:
Clinical trial NCT03479567: Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
Official title: Fine and Gross Motor Function and Relationship With Muscle Tone in Older Adults With and Without Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Gait
Balance
Muscle Tone
Fine Motor Function
Paratonia
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cross-sectional
Primary purpose: OTHER

Brief summary: The purpose of this study was (1) to investigate changes in gait, balance, fine motor function, and muscle tone, and (2) to find out if there is a correlation between muscle tone/presence of paratonia and motor function (gross and fine) in mild and moderate dementia.Three groups of participants were included in the study: healthy elderly (n=60), participants with mild dementia (n=31) and participants with moderate dementia (n=31). Measurements of fine motor function, balance, gait, presence of paratonia and muscle tone measurements were performed.


Eligibility criteria: Inclusion Criteria:

* age \>= 65 years
* walk independently for at least 11 meters
* HC: no cognitive deterioration, MiD: dementia, Global Deterioration Scale\<5, MoD: dementia, Global Deterioration Scale 5 or 6

Exclusion Criteria:

* recent (≤ 6 months) orthopedic surgery

Primary outcomes:
measure: walking speed
timeFrame: through study completion, an average of 3 years
measure: step regularity
timeFrame: through study completion, an average of 3 years
measure: mediolateral jerk
timeFrame: through study completion, an average of 3 years
measure: anteroposterior jerk
timeFrame: through study completion, an average of 3 years
measure: Fine motor function
timeFrame: through study completion, an average of 3 years
measure: presence of paratonia
timeFrame: through study completion, an average of 3 years
measure: MyotonPRO measurement of muscle tone
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: MyotonPRO measurement of elasticity
timeFrame: through study completion, an average of 3 years
measure: MyotonPRO measurement of mechanical stiffness
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Vakgroep Revaki - Ghent University
Study officials:
References:
Clinical trial NCT07027267: Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
Official title: A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sinus Endoscopic Surgery
Turbinate
Keywords: Sinus surgery
FESS
middle turbinate
Lead sponsor: Spirair, Inc
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery

Detailed description: To evaluate the safety and effectiveness of the Spirair implant as a primary treatment to achieve medialization of the middle turbinate after functional endoscopic sinus surgery.

Eligibility criteria: Inclusion Criteria:

* ≥18 to ≤ 70 years of age at time of consent
* Subject scheduled to undergo bilateral endoscopic sinus surgery
* Able to speak, read and understand English
* Willing and able to provide informed consent and comply with the study protocol

Exclusion Criteria:

* History of removal of one or both middle turbinates
* Presence of significant concha bullosa, which requires surgical excision
* Presence of non-viable tissue at the implantation site
* Active infection at the implantation site
* Chronic nasal decongestant use (i.e. Afrin, etc)
* Recreational intra-nasal drug use within 12 months of enrollment
* Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
* Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials

Primary outcomes:
measure: Miller Synechia Score
timeFrame: 8 Weeks
Secondary outcomes:
measure: Middle Turbinate Position Grade
timeFrame: 4 and 8 weeks
measure: Miller Synechia Score
timeFrame: 4 weeks
measure: Inflammation assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Science Center
state: Louisiana
city: Houston
country: United States
facility: Houston Methodist ENT Specialists
state: Texas
Study officials:
References:
Clinical trial NCT04597567: Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures
Official title: Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Spine Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracolumbar
Keywords: Metal removal
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Comparing clinical outcome between patients who underwent metal removal and those who retained the metal


Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* Posterior fixation
* Six to nine months after fixation
* Neurologically free patient
* Fracture consolidation detected by ct
* Types A3\&A4 fractures

Exclusion Criteria:

* unstable fractures B\&C
* pathological fractures
* multilevel fractures
* poly trauma patients

Primary outcomes:
measure: EQ-5D-5L questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Oswestry disability index
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
Clinical trial NCT00047567: Open-label Adjunctive Zonisamide for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Disorders
Keywords: ZONISAMIDE
BIPOLAR
Lead sponsor: Elan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.


Eligibility criteria: * Bipolar I/II
* Average intelligence
* Taking at least one, but no more than two mood stabilizers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: