louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03798041: Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision
Official title: Early Debridement Within 24 Hours After Surgery Compared Routine Debridement (24 Hours Later) for Wound Healing of Abdominal Incision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Keywords: Surgical Wound
Suture, Complication
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Wound healing after surgery is a complex procedure. Liquefaction of the fat and necrosis of inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours after surgery. As such, early debridement within 24 hours after surgery might improve the healing of the wounds. This study is designed to compare the impact of early debridement of the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be included in this study, and divided into 2 groups randomly. Then, the healing of the wound, stitch removal time, incidence of incision complications will be compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* the patient with major abdominal incision.

Exclusion Criteria:

* Pregnant woman
* Patient with diabetes
* Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
* Severe lung diseases such as COPD and asthma
* Patients undergoing emergent surgery or infectious surgery
* Patients with surgical site infection or abdominal abscess
* No autonomy, inability or unwillingness to participate in follow-up

Primary outcomes:
measure: healing time, d (day)
timeFrame: From date of surgery to the date of stitches off (up to 1 month)
Secondary outcomes:
measure: incidence of incision complications
timeFrame: From the date of surgery to stitches off (up to 1 month)
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Xu-Feng Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03679234: Impact of Infant Formula on Caregiver-perceived Intolerance
Official title: Impact of Infant Formula on Caregiver-perceived Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-09-20
Enrollment: 51
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms


Eligibility criteria: Inclusion Criteria:

* Healthy infant
* Full-term (\> 37 weeks gestation)
* Birth weight \> 2500 and \< 4500 g
* 14-60 days of age on enrollment
* Singleton birth
* Infant's mother has elected not to breastfeed prior to enrollment
* Infant exclusively formula-fed for at least 5 days prior to enrollment
* Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
* Caregiver wishes to switch infant's formula
* Has not received solid foods
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)
* Has switched formula more than two times since hospital discharge
* Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
* Congenital illness or malformation that may affect infant feeding and/or growth
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving probiotic supplements
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
* Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.

Primary outcomes:
measure: Infant GI Symptom Burden
timeFrame: 3 weeks
Secondary outcomes:
measure: Formula Intake
timeFrame: 24 hours
measure: Fussiness
timeFrame: 24 hours
measure: Formula Satisfaction Questionnaire
timeFrame: 3 weeks
measure: Adverse Events
timeFrame: 24 hours and 3 weeks
Other outcomes:
Locations:
city: Norwich
country: United States
facility: Norwich Pediatrics Group
state: Connecticut
city: Owensboro
country: United States
facility: Qualmedica Research
state: Kentucky
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research, LLC
state: Tennessee
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Nestle Nutrition
name: Ryan Carvalho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05681234: Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma
Official title: Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Carcinoma
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single arm study to evaluate the safety and biodistribution of 18F-labeled RD2 PET/CT Imaging in patients with small liver carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Patients with highly suspected tumor；
2. Patients underwent PET/CT examination within 1 week;
3. Patients voluntarily signed informed consent;
4. Over 18 years old, male or female.

Exclusion Criteria:

1. Pregnant women;
2. Lactating women;
3. Patients with impaired renal function.

Primary outcomes:
measure: Evaluation of tissue distribution of 18F-RD2
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00073034: Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 3 Fixed Doses of EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus
Diabetic Neuropathy, Painful
Keywords: Neuropathic Pain
Diabetic Neuropathy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-11-18
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: EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. It is a selective antagonist that binds competitively to the glutamate site of the N-methyl-D-aspartate (NMDA) receptor.

This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with placebo in subjects with neuropathic pain associated with diabetic neuropathy.


Eligibility criteria: Inclusion Criteria:

* Women of childbearing potential must have a negative serum pregnancy test result at screening
* Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet
* Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy

Exclusion Criteria:

* Pregnancy, lactation, or plans to become pregnant during the study
* Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control
* History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02458534: The Comparison of Mcgrath Mac, C-MAC, and Macintosh Laryngoscope in Novice Users: a Manikin Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Simulated manikin
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for novice users in manikin.


Eligibility criteria: Inclusion Criteria:

* Medical students

Exclusion Criteria:

* wrist disease excluded.

Primary outcomes:
measure: time to intubation
timeFrame: within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin
Secondary outcomes:
measure: success rate of the first intubation attempt
timeFrame: Within 3 minutes after the insertion of the laryngoscope into the mouth of the manikin
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01252134: Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
Official title: The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Soft Contact lens
Multi-purpose solution
Wettability
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Soft contact lens wear on a daily wear basis
* Able to wear lenses at least 8 hours
* Generally healthy with normal ocular health
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Use of additional lens cleaners
* Known sensitivities to any ingredient in any of the study products
* History of ocular surgery/trauma within the last 6 months
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Ex Vivo Contact Angle
timeFrame: 8 hours
Secondary outcomes:
measure: Subjective Comfort
timeFrame: 8 hours
measure: Corneal Staining Type
timeFrame: 8 hours
measure: Corneal Staining Extent
timeFrame: 8 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03105934: Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
Official title: Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.


Eligibility criteria: Inclusion Criteria:

* With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
* With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines

Exclusion Criteria:

* That according to investigator criteria cannot participate in the trial

Primary outcomes:
measure: Image measurements
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Enric Domingo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576134: The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement
Official title: Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Swallowing Disorders
Dysphagia
Laryngeal Neoplasms
Keywords: Larynx, tracheotomy, titanium beads
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx


Eligibility criteria: Inclusion criteria:

* Age more than 18
* Swallowing troubles

Exclusion criteria:

* Pregnant women
* Contraindications to general anesthesia

Primary outcomes:
measure: Respiratory evaluation
timeFrame: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36
Secondary outcomes:
measure: Nasofibroscopy
timeFrame: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Christian DEBRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07013734: Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients
Official title: Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Monitoring of Depth of Anesthesia
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from Maisonneuve-Rosemont Hospital undergoing elective surgery.

Brief summary: The goal of this observational study is to find out how changes in body position during surgery might affect brain monitoring results in patients who are under general anesthesia.The main question it aims to answer is:

- Does patient positioning have an impact on Bispectral Index (BIS) and Nociception Level (NOL) index monitoring (which are values of awareness in anesthesized patients).

Participants will undergo their surgery as planned, except for these extra features:

* Extra monitors placed to check brain activity, pain response, and brain oxygen levels.
* Before the surgery, while the patient is asleep, the patient's table will be moved into two different positions for 2 minutes each to see if the values on the monitor change.

Participants will then have to answer a short questionnaire after surgery about their memories before and after the anesthesia.


Eligibility criteria: Inclusion Criteria:

* Fully consented, adult patients above 18 years old;
* Supine positioning during the surgery;
* Surgery requiring patient positioning with Vacuform mats.

Exclusion Criteria:

* Patient with Body Mass Index (BMI) ≥ 35;
* Patients over 80 years old.

Primary outcomes:
measure: Variation in Bispectral Index (BIS)
timeFrame: Perioperative period
Secondary outcomes:
measure: Variation of Nociception Level (NOL) Index
timeFrame: Perioperative period
measure: Variation of the patient's cerebral saturation measured with cerebral oximetry
timeFrame: Perioperative period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06361134: Efficacy of Supporting SAFE Early Intervention
Official title: Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Physiotherapy
Early Intervention
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.


Eligibility criteria: Inclusion Criteria:

Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),

Having a NICU history of 15 days or more,

Exclusion Criteria:

congenital malformations, metabolic and genetic disease musculoskeletal system anomaly

Primary outcomes:
measure: Test of Infant Motor Profile
timeFrame: 10 weeks
Secondary outcomes:
measure: Bayley Scales of Infant and Toddler Development, Third Edition,
timeFrame: 10 weeks
measure: Infant/Toddler Sensory Profile 2
timeFrame: 10 weeks
measure: Infant/Toddler HOME Inventory
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
References:
Clinical trial NCT02834234: Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays
Official title: Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Mesothelioma
Keywords: mesothelioma
peritoneum
genomic
CGH arrays
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of peritoneal mesothelioma

Brief summary: Peritoneal mesothelioma is a rare disease representing one third of all mesothelioma and nothing is known about molecular characteristics of this disease. As main cancers, genetic heterogeneity is probable. This genomic profiling associates Comparative Genomic Hybridization (CGH) array, BAP1 sequencing and gene expression in order to discover a biomarker that could be used in the treatment of this rare disease. Corresponding histopathological and immunohistochemical report as all clinical data are available. All data with be merged to underline a few genes of interest on which we will focus our next investigations. Depending of our preliminary results, BAP1 mutations are expected, as it was also described in pleural mesothelioma. Mutations in oncogenic drivers that could be targeted by specific therapy will be on particular interest in management of this rare disease with bad prognosis.


Eligibility criteria: Inclusion Criteria:

* surgical biopsy od the peritoneal tumor with frozen samples
* age \> 18 years old

Exclusion Criteria:

* absence of peritoneal mesothelioma
* absence of frozen samples

Primary outcomes:
measure: BAP1 mutations
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01841034: Impact of an Antioxidant Alimentary Complement on Sperm Data
Official title: Evaluation of a 6 Months Treatment of Conceptio (EA) on Sperm Data in Infertile Men With Oligoasthenozoospermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Male
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient receipt within the framework of the care of an infertility in the pole ORG, whatever is the étiologie and the type of treatment proposing and presenting during at least two spermogrammes an oligospermie and\\or an asthénospermie.

Brief summary: Male infertility is a multifactorial disease process with a number of potential contributive causes. Considering the majority of male infertility cases are due to deficient sperm production of unknown origin, environmental and nutritional factors must be evaluated. The purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile men with oligoasthenozoospermia.


Eligibility criteria: Inclusion Criteria:

* Number of sperm cells \< 15M / mL and\\or mobility \< 40 %.
* Signature of a form of not opposition to the research.
* Membership in a social security system.

Exclusion Criteria:

* Number of sperm cells = 100M / mL.

Primary outcomes:
measure: Spermatic parameters (numeration and mobility spermatic)
timeFrame: At the inclusion and 6 months after the inclusion
Secondary outcomes:
measure: Rate of fragmentation of the DNA
timeFrame: At the inclusion and 6 months after the inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - CECOS- Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: ISNARD Véronique, PH
role: PRINCIPAL_INVESTIGATOR
References: