louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03553134: Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward
Official title: Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 41
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns over 35 weeks of amenorrhoea

Brief summary: There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.

Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.

The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.


Eligibility criteria: Inclusion Criteria:

* Written consent of parent
* Newborns over 35 weeks of amenorrhoea hospitalized in the maternity ward

Exclusion Criteria:

* person not affiliated to a health insurance scheme
* Sepsis
* Ductal dependent heart disease
* Neurological impairment (anoxoischemic encephalopathy Sarnat\>1, pH\<7 and/or lactates\>11, meningitis)
* Obstetrical trauma (instrumental delivery by forceps, vacuum cup or spatulas)
* Potentially lethal malformation
* Anemia (hemoglobin\<14g/dl)
* Polyglobulia (hemoglobin\>22g/dl)
* Small for gestational age (weight\<10th percentile)
* Large for gestational age (weight\>97th percentile)
* Proven gestational diabetes (non-insulin-dependent and insulin-dependent)
* Maternal medical treatment (cardiac or anti-epileptic)
* Inadequate parent understanding

Primary outcomes:
measure: Right and left average velocity of the cerebral artery
timeFrame: Change from birth to 48 hours of life
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00180934: Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
Official title: Interest of a Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area: a Multicentric Phase III Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Recurrence of Head and Cancer in Irraiated Area
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial


Eligibility criteria: Inclusion Criteria:

* head and neck squamous cancer
* both sexes
* \>=18 years
* recurrence treated by surgery and initially treated by radiotherapy
* with written informed consent at entry time

Exclusion Criteria:

-

Primary outcomes:
measure: Overall survival at 3 years
Secondary outcomes:
measure: Local event-free survival
measure: Toxicity
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: François JANOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02263534: Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
Official title: Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
tension free vaginal tape
single incision minisling
midurethral sling
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.


Eligibility criteria: Inclusion Criteria:

* Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

Exclusion Criteria:

* Patients with overactive bladder on urodynamic study.
* Patients with voiding dysfunction.
* Patients with intrinsic sphincteric deficiency.
* Patients with previous anti-incontinence surgery.
* Patients on anti-coagulant therapy.
* Immune-compromised patients (DM, patients on corticosteroids treatment).
* Refusal of surgery.

Primary outcomes:
measure: objective cure rate of urinary incontinence at 12 months after surgery
timeFrame: 12 months
measure: subjective cure rate of urinary incontinence at 12 months after surgery
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with short- term complications
timeFrame: 12 months
measure: Number of participants with long-term complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: ahmed reda, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898934: Vitamin D Supplementation in PCOS Patients
Official title: Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Keywords: PCOS
Vitamin D
Supplementation
Ovulation
Pregnancy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 170
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 2 groups will be treated at the same time
Primary purpose: TREATMENT

Brief summary: To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

Detailed description: This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.

Eligibility criteria: Inclusion Criteria:

* PCOS
* Infertile
* Vitamin D deficient

Exclusion Criteria:

* Age less than 20 and more than 35
* Non PCOS patients
* Obese patients
* Previous ovarian surgery
* Previous oophrectomy of one ovary

Primary outcomes:
measure: Ovulation rate
timeFrame: 3 months
measure: Pregnancy rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Algharbia
Study officials:
References:
Clinical trial NCT05018234: Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Official title: Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: oral appliance
sleep apnea
hypoxia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.


Eligibility criteria: Inclusion Criteria:

* No history of obstructive sleep apnea
* No active jaw joint pain
* No active moderate to severe periodontal disease
* Presence of 12 teeth per arch

Exclusion Criteria:

* presence of severe bruxism

Primary outcomes:
measure: safety of device as measured by the number of patients with adverse events
timeFrame: During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2)"
Secondary outcomes:
measure: Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey
timeFrame: 1 month after enrollment(appointment 2)
measure: Comfort of the novel OA device as measured by the post care patient feedback survey
timeFrame: 1 week after appointment 2(appointment 3)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Aaron Glick, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01660334: Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Special Investigation of Vfend on Scedosporisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scedosporium Infection
Keywords: Systemic Mycosis
Scedosporium infection
Scedosporisis
Japanese
voriconazole
VFEND
Regulatory Post Marketing Commitment Plan.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A1501077 prescribes the voriconazole (VFEND).

Brief summary: To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.


Eligibility criteria: Inclusion Criteria:

Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.

Exclusion Criteria:

Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.

Primary outcomes:
measure: Number of Participants With Serious Treatment Related Adverse Events.
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04051034: Heat Therapy and Omega 3 on Cardio-Metabolic Health
Official title: Heat Therapy and Omega 3 on Metabolic and Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 60
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: Currently, controlled studies are lacking which test the benefits of: 1) ω3 PUFA; and 2) heat therapy on improving vascular-metabolic-microbiota health in Hispanic American populations. The investigator's objective is to determine if this modality (heat therapy i.e., warm water immersion, hot tubs) combined with dietary interventions (increased fish and/or fish oil intake) may be feasible treatments to improve cardiovascular risk factors and reduced comorbidities in Hispanic populations.

Detailed description: In a double-blind, placebo-controlled design, participants will be randomized to the following experimental treatments:

1. 4 g omega 3 daily for 12 weeks combined with 6 weeks of heat therapy
2. Placebo pill daily for 12 weeks with 6 weeks of heat therapy (HT)

non-obese healthy will only serve as controls and enroll in placebo and neutral control therapy conditions.

HT will entail 14 consecutive days of 1.5 hours passive heating (increase internal temperature 1.2°C above baseline), followed by 4 weeks of HT, 3 days per week.

Eligibility criteria: Inclusion Criteria:

* BMI\>30-40,
* fasting glucose 100-125,
* blood pressure 130-139/80-89,
* Hispanic American,
* age 18-65 years

Exclusion Criteria:

* non-Hispanic,
* BMI\<30, \>40,
* fasting glucose \<100, \>125,
* blood pressure \<130,\>139 systolic, \>90 diastolic,
* age \<18, \>65 years

Primary outcomes:
measure: Metabolic flexibility
timeFrame: Change from baseline to 12 week metabolic flexibility
measure: Microbiome
timeFrame: Change from baseline to 12 week in the phyla, genus and species of gut bacteria
measure: Short chain fatty acids
timeFrame: Change from baseline to 12 week short chain fatty acids, acetate, propionate, and butyrate (C4).
measure: Vascular Health
timeFrame: Change from baseline to 12 week vessel function
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Eric Rivas
state: Texas
Study officials:
References:
Clinical trial NCT01003834: Computerized Screening, Brief Intervention, and Referral to Treatment in Primary Care
Official title: Computer vs Therapist-Delivered Brief Interventions for Substance Use in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Keywords: substance use
drug use
drug abuse
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-10-29
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled clinical trial to evaluate the effect of a computerized screening, assessment, and brief intervention on substance use in patients recruited from a primary care clinic. Study participants will be assigned to one of the following 4 study groups: computerized health screening alone (standard care) (SC); computerized assessment-only intervention (CA); computerized assessment followed by a computer-directed motivational intervention (CACI); or computerized assessment followed by a therapist-delivered motivational intervention (CATI). Data regarding substance use, medical and psychosocial functioning, and economic outcomes will be collected.

The investigators hypothesize that patients randomized to CACI and CATI will be more likely to report drug abstinence at the 3-month follow-up visit and will show greater reductions in drug use at 1, 3 and 6 months follow-up than patients assigned to CA or SC. Similarly, patients in the CACI and CATI groups will report greater reductions in HIV risk behaviors, lower rates of medical and psychosocial problems, and increased economic gains at the 6-month follow-up. In addition, patients in the assessment only intervention (CA) will have outcomes superior to those found for SC patients. A cost-effectiveness analysis will also be done comparing economic costs associated with CA, CACI and CATI and their relationship to substance use reductions and related improvements in medical and psychosocial outcomes at the 6 month follow-up.


Eligibility criteria: Inclusion Criteria:

* 18 - 65 years
* Primary care clinic patient

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Substance use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dace Svikis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263834: Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome
Official title: The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glaucoma
Keywords: Trabeculectomy
bevacizumab
intraocular pressure
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).

Detailed description: Prospective interventional clinical trial

Single center, outcome assessor-masked, active control, randomized controlled trial

Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma with primary mmc-trabeculectomy indication

Exclusion Criteria:

* combined phacoemulsification with trabeculectomy
* no more than 6 month of cataract surgery before trabeculectomy
* revised trabeculectomy
* active uveitic glaucoma
* neovascular glaucoma
* par planar vitrectomy
* conjunctival surgery
* allergy to bevacizumab or mitomycin C
* ischemic heart disease
* cerebrovascular disease
* renal failure
* liver failure

Primary outcomes:
measure: Intraocular pressure
timeFrame: 6 month
Secondary outcomes:
measure: Bleb characteristic grading
timeFrame: 6 month
measure: systemic Blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Hat-yai
country: Thailand
facility: Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Weerawat Kiddee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04621734: Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Official title: Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Tube Complication
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 35
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.

Detailed description: The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.

Eligibility criteria: Inclusion Criteria:

* Need for nasoenteric feeding
* Admitted to University Hospital
* Age 0-18 years

Exclusion Criteria:

* Facial trauma
* Nasal airway obstructions
* Thrombocytopenia (\<100 K/μL)
* s/p septoplasty
* Patients with vomer bone graft
* Nasoenteric feeding tube placed and secured prior to being screened for study
* Contraindication for the use of the BridlePro
* Does not meet inclusion criteria

Primary outcomes:
measure: Number of Tube Dislodgements Per 10 Tube Days.
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health System
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Veronica Armijo, MD
role: PRINCIPAL_INVESTIGATOR
References: