louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06138093: Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
Official title: Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy
Keywords: tracheostomy
respiratory insufficiency
respiratory function tests
mechanical ventilators
rehabilitation
critical care
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.

Detailed description: See protocol document.

Eligibility criteria: Inclusion Criteria:

* Tracheostomy for minimum 7 days
* Age \> 18 years
* Capped uncuffed tube size 7 or 8 for at least 24 hours

Exclusion Criteria:

* Cognitive dysfunction (patients who are not able to cooperate with investigation)

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
measure: Voice quality
timeFrame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
measure: Peak expiratory flow (PEF)
timeFrame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
measure: Forced vital capacity (FVC)
timeFrame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
name: Rasmus E Kraghede, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
name: J. Michael Hasenkam, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT00925093: Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Official title: Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Neurosurgery
Keywords: vancomycin
teicoplanin
linezolid
intravenous
cerebrospinal fluid
CSF
pharmacokinetics
penetration
blood-brain barrier
Pharmacokinetics of three antibiotics in relation to cerebrospinal fluid
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Already having an external CSF drain
* Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")

Exclusion Criteria:

* Infection or colonization requiring other than standard prophylactic antibiotics

Primary outcomes:
measure: Concentration of antibiotics in cerebrospinal fluid
timeFrame: 1, 2, 4, 6, 12 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02210793: Dry Eye Evaluation After Transepithelial PRK
Official title: Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Transepithelial PRK
Dry eye
Schirmer test
Tear break up time
Dry eye after advanced surface ablation technique
Lead sponsor: AL-Nour Eye Hospital
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik

Detailed description: Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months

Eligibility criteria: Inclusion Criteria

* Myopia -1 to -6 diopters
* Astigmatism -0.5 to - 4 diopters

Exclusion Criteria:

* Pregnancy and lactation
* Keratoconus
* Previous refractive surgery
* Previous herpetic keratitis

Primary outcomes:
measure: qualitative assessment of dry eye syndrome
timeFrame: 6 months
measure: quantitative of dry eye after surgery
timeFrame: 6 months
Secondary outcomes:
measure: haze
timeFrame: 6 months
Other outcomes:
measure: healing time of epithelial defect epithelial defect
timeFrame: 2-5 days
Locations:
city: Giza
country: Egypt
facility: Al Nour Eye Hospital
Study officials:
affiliation: Cairo University
name: Ahmed M Shalaby, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mahmoud H Abu Steit, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed Salah, MBBCH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01292993: A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
Official title: A Phase 1, Randomized, Open-Label, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.


Eligibility criteria: Inclusion Criteria:

* Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
* Body mass index (BMI)≥18 to ≤35 kg/sq m
* Able to provide written consent
* Vital signs within sponsor-defined ranges

Exclusion Criteria:

* Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
* No investigational agent or study treatment within 30 days prior to Day 1.
* No protein or antibody-based therapeutic agents within 3 months prior to screening
* Use of any tobacco product
* History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months prior to screening
* History of any serious adverse reaction or hypersensitivity to metformin or LX4211.
* History of renal disease or significantly abnormal kidney function test
* History of hepatic disease or significantly abnormal liver function test
* History of any active infection within 30 days prior to Day 1
* History of any surgical or medical condition or clinically significant laboratory or physical finding
* Positive urine glucose at Screening
* Use of drugs or alcohol

Primary outcomes:
measure: Plasma concentration of LX4211 and metformin after concurrent single-dose administration
timeFrame: Up to 43 days, including screening
Secondary outcomes:
measure: Urinary glucose excretion
timeFrame: Up to 43 days, including screening
measure: Fasting plasma glucose
timeFrame: Up to 43 days, including screening
measure: Postprandial glucose
timeFrame: Up to 43 days, including screening
measure: Insulin
timeFrame: Up to 43 days, including screening
measure: Peptide YY
timeFrame: Up to 43 days, including screening
measure: Glucagon-like peptide (GLP-1)
timeFrame: Up to 43 days, including screening
measure: Glucose-dependent insulinotropic peptide
timeFrame: Up to 43 days, including screening
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Ikenna Ogbaa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06738693: External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes
Official title: External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 42
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: The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:

Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.

Participants will:

Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.

Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.

Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older.
* Diagnosed with recent (\<1 week) intra-articular distal end radius fractures.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Open fractures classified as Gustilo grade II or higher.
* Fracture avulsion or dislocation.
* Vascular injury associated with the fracture.
* Extra-articular fractures of the distal radius.
* Preexisting joint or carpal bone disease affecting rehabilitation.
* Patients unwilling to provide consent.

Primary outcomes:
measure: Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney
timeFrame: 24 weeks post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dharan
country: Nepal
facility: BPKIHS
state: Koshi
Study officials:
References:
Clinical trial NCT01200511: Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Official title: A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: intraocular lens
multifocal
toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Detailed description: Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Eligibility criteria: Inclusion Criteria:

* Sign informed consent;
* Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
* Able to undergo second eye surgery within one month (30 days) of first eye surgery;
* Able to attend postoperative examinations per protocol schedule;
* Qualify for a AcrySof IQ Toric IOL in both eyes;
* Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
* Residual refractive cylinder of ≤0.5 D in both eyes;
* Good ocular health;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
* Amblyopia;
* Previous corneal surgery;
* Clinically significant corneal endothelial dystrophy;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
* History of retinal detachment;
* Pregnant or planning to become pregnant during course of study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Uncorrected Visual Acuity Across a Range of Distances at Month 6
timeFrame: Month 6 from second eye implantation
measure: Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
timeFrame: Month 6 from second eye implantation
measure: Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
timeFrame: Month 6 from second eye implantation
Secondary outcomes:
measure: Patient Reported Outcomes at Month 6
timeFrame: Month 6 from second eye implantation
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Brand Lead, Surgical, Global Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT01500811: Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
Official title: Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hip Osteoarthritis
Keywords: chondrocyte hip osteoarthritis intra articular injection
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2011-12-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There are treatments available to help manage these symptoms like weight loss, and analgesics. Surgery is the appropriate treatment in patients who have failed these conservative treatments. The aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.

Detailed description: In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis diagnosed by MRI

Exclusion Criteria:

* Pregnancy or lactating
* Positive tests for HIV, HCV, HBV
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder.

Primary outcomes:
measure: joint swelling
timeFrame: 2 months
measure: deterioration of joint function
timeFrame: 2 months
measure: dispenea
timeFrame: 1 week
measure: skin rash
timeFrame: 1 week
Secondary outcomes:
measure: Quantitative changes in pain intensity
timeFrame: 2 months
measure: physical function improvement
timeFrame: 2 months
measure: subchondral bone edema
timeFrame: 2 months
measure: cartilage thickness
timeFrame: 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan Cell therapy Center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: scientist
name: Mohsen Emadeddin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05724511: The Effect of Probiotics on Depression Syndrome and Risk Factors of Cardiovascular Disease in Hemodialysis Patients
Official title: Department of Nutrition, China Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression Mild
Cardiovascular Diseases
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: As the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients. Besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population. Both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients. Therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients. This is a randomized controlled trial. All patients will be assigned at random to intervention group or control group. This study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period. The investigators provide probiotics (C. butyricum MIYAIRI 588) to intervention group and provide nothing to the control group.

All patients need to maintain the lifestyle during study period. Genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.


Eligibility criteria: Inclusion Criteria:

* Adults aged 20 years or older undergoing hemodialysis (at least 3 months), 3 times per week, and URR ≥65%

Exclusion Criteria:

1. allergic to the components of the intervention drug, low tolerance of milk or dairy products
2. Has the diagnosis of dementia, delirium, bipolar disorder, schizophrenia, or liver failure
3. Beck Depression Inventory Chinese version 2.0 score higher than 14, or has significant suicide risk during study
4. Following significantly clinical syndrome: obsessive compulsive disorder, schizoid personality disorder, schizotypal personality, paranoid、antisocial Personality Disorder, histrionic personality disorder
5. With addiction to alcohol or drugs, terminal cancer, severe infection, heart failure, central venous catheter in the past 6 months
6. Taking antibiotics, anti-oxidant vitamin supplement, probiotics, prebiotics, antidepressants, anti-anxiety medicine, yogurt and the products in the past 3 months
7. Pregnant or lactating

Primary outcomes:
measure: The change of depression score
timeFrame: Change from Baseline depression score at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT03582111: Ultrasound Diagnosis of Cleft Lip and Palate
Official title: Ultrasound Diagnosis of Cleft Lip and Palate - FENCHU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Keywords: Ultrasound
Pregnancy
Diagnosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fœtus with cleft lip diagnosed at mid-trimester ultrasound screening in Montpellier hospital (Arnaud de Villeneuve) between February 2009 and December 2016.

Brief summary: Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present.

The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.


Eligibility criteria: Inclusion criteria:

* Age over 18
* Prenatal ultrasound diagnosis of cleft palate/lip.
* Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy

Exclusion criteria:

- Diagnosis not confirmed at birth and ultrasound picture not interpretable

Primary outcomes:
measure: Compare the prenatal and postnatal diagnosis of cleft lip and palate
timeFrame: At birth
Secondary outcomes:
measure: Study the cleft palate diagnosis when cleft lip is present
timeFrame: At birth
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Cyrielle LEFEBVRE, Midwife
role: PRINCIPAL_INVESTIGATOR
References: