louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06910696: Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block
Official title: Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block for Rapid Recovery and Rehabilitation After Lumber Discectomy: A Randomized Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Achievement of High-quality Analgesia, Rapid Recovery With Rehabilitation in Lumber Spine Discectomy
Keywords: erector spinae plane block modified thoracolumbar interfascial plane block perioperative analgesia lumber spine discectomy?
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-04-04
Enrollment: 144
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to compare of better postoperative analgesia following lumber spine discectomy


Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient.
* Physical status: ASA 1\& II.
* BMI = (25-30 kg/m2).
* Type of operation: elective Lumbar discectomy .

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Patients receiving anticoagulants.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Primary outcomes:
measure: Length of hospital stay
timeFrame: up to 1 weak postoperative.
Secondary outcomes:
measure: The recovery time
timeFrame: up to 30 minutes postoperative.
measure: The time of discharge
timeFrame: up to 2 hours postoperative.
measure: 6 minutes walk test
timeFrame: 24 hours postoperative
measure: Functional reach test
timeFrame: 24 hours postoperative
measure: Time up and go test
timeFrame: 24 hours postoperative
measure: Pain intensity
timeFrame: 30 minutes after the end of the surgery, as well as 3, 6, 12, and 24 hours postoperatively
measure: Time to first call analgesia
timeFrame: 24 hours postoperative
measure: Total naluphine consumption
timeFrame: 24 hours post-operative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: faculty of medicine,zagazig university Egypt Ext. 002 K.Howida@yahoo.com
Study officials:
References:
Clinical trial NCT02090296: Risk-based Therapy for Sickle Cell Anemia: A Feasibility Study
Official title: Reticulocyte as Risk Marker: Targeted Therapy for Infants With Sickle Cell Anemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sickle Cell Anemia
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sickle cell anemia (SCA) patients experience organ damage that begins at an early age and results in significant morbidity and early mortality. Although all SCA patients share the same genetic mutation, the clinical complications are highly variable with some patients experiencing frequent and severe complications, while others have few serious complications. If SCA severity could be predicted early in life, those patients at greatest risk for complications could receive treatment prior to the onset of organ damage. No general SCA severity predictor or one that can be informative early in life exists. The investigators preliminary research has identified the absolute reticulocyte count (ARC) as a potential early predictive risk marker for SCA complications in pediatric patients. A higher ARC between ages 2 and 6 months of age is associated with an increased risk of hospitalization in the first 3 years of life; the mean ARC for the 36 patients who were hospitalized for SCA complications was significantly higher than that of the remaining 23 in those who were not hospitalized. Moreover, total hospitalizations were nearly three times higher by age 2 years in those infants who had an ARC of \> 200 than for those infants whose ARC was \<200. The proposed study will determine if ARC can be used as a risk-stratifier in asymptomatic infants with SCA and ascertain its value in targeting hydroxyurea therapy to those infants at highest risk of SCA sequelae.


Eligibility criteria: Inclusion Criteria:

* ages 6-12 months
* Sickle cell anemia (HbSS)
* steady state absolute reticulocyte count between 2-6 months is available in the medical record

Exclusion Criteria:

* receiving hydroxyurea or chronic monthly blood transfusions
* patient enrolled in preliminary study

Primary outcomes:
measure: Sickle Cell Clinical Change from Baseline to Study Completion ( 18 months)
timeFrame: Every 4 weeks for the 18 months study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT00824096: Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Extubation Stridor
Keywords: endotracheal intubation
cuff-leak test
post-extubation stridor
bronchoscopy
corticosteroids
Cuff-leak volume less than 24%
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2009-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.


Eligibility criteria: Inclusion Criteria:

* Age equal or greater than 18 years old
* Intubation over 24 hrs
* Match weaning profile
* Cuff leak volume less than 24%
* VS and subject/family agree

Exclusion Criteria:

* Re-Intubation
* History of upper air way obstruction
* Severe CV disease (ex. AMI)
* Active UGI Bleeding
* Blood sugar persistent more than 250 mg/dl under medication control
* Risk of IICP
* Open T.B.
* Bleeding tendency/ Platelet less than 40 thousands
* Subject or family refuse

Primary outcomes:
measure: The accuracy of bronchoscopy to predict post-extubation stridor.
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Intensive Care Medicine; Chi Mei Medical Center
Study officials:
References:
Clinical trial NCT00382096: Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
metformin
hemoglobin A1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 1179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
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 efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
* Diagnosis of T2DM for at least 4 weeks prior to study entry
* Age 18 - 78 years inclusive
* Body mass index (BMI) of 22 - 40 kg/m2
* HbA1c: 7.5 - 11% inclusive
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria

* Pregnant or lactating female
* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: At week 24
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: At week 24
measure: Percent of patients with endpoint HbA1c <7%
timeFrame: At week 24
measure: Percent of patients with reduction in HbA1c >/=0.7%
timeFrame: At week 24
measure: Adverse event profile after treatment
timeFrame: At week 24
measure: Change from baseline in body weight
timeFrame: At week 24
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Multiple Locations
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06741696: Saline At Different Temperatures After 3rd Molar Surgery
Official title: Does Saline Irrigation At Different Temperatures Affect Pain, Edema, and Trismus After Impacted Third Molar Surgery: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain, Acute
Keywords: 3rd molar surgery, saline irrigation at different temperatures
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 48
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blind, single-center, split-mouth, randomized prospective clinical trial was conducted among 48 systemically and periodontally healthy patients who had bilaterally asymptomatic mandibular third molars.

Detailed description: Patients were randomly allocated into 2 groups (n = 24) according to the temperature of the saline used. In each patient, one impacted third molar was determined as the test group Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded. Data were analyzed using the Shapiro-Wilk test, the chi-square test, one-way analysis of variance, Duncan test, the Kruskal-Wallis test, the Dunn test, and the Friedman test (P \< .05).

Eligibility criteria: Inclusion Criteria:1. Patients who met the requirements of the study, such as attending follow-up sessions and signing the informed consent. 2. Patients with bilateral mandibular asymptomatic vertical third molar teeth with impaction of Class I, level C.22 3. Patients who did not have any significant medical diseases or drug use, were not pregnant, had no allergy, and did not smoke.

-

Exclusion Criteria:

1 Patients with complicating systemic disease ( American Society of Anesthesiologists : 3- 6). 2. Patients who have second molars with severe periodontal defect or deep periodontal pocket (probing depth \>4 mm). 3. Patients with poor oral hygiene. 4. Patients with a history of using analgesics 12 hours ago or antibiotics 1 month before. 5. The presence of cysts or tumors around the impacted third molar.

-

Primary outcomes:
measure: post operative pain after 3rd molar surgery
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Dentistry
state: Punjab
Study officials:
affiliation: Armed Forces Institute of Dentistry , Rawalpindi
name: hafsa razzaq razzaq, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03379896: Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms
Official title: Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Antigen-presenting Function
γδ T Cells
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis from department of Critical Care Medicine of West China Hospital are included if they meet the study criteria on ICU admission. Healthy control subjects are adult volunteers from our hospital staff and their family members with no significant acute or chronic illnesses.

Brief summary: Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms

Detailed description: The latest definition of sepsis highlights the role of dysregulated host response to infection in organ dysfunction aggravation. Maintenance of immune homeostasis of septic patients through immunotherapy is the key breakthrough to improve success rate. Antigen-presenting cell (APC) is the bridge that connects the innate and adaptive immunity. Decrease of count and function of APC has been shown to be associated with worsened clinical outcomes in patients with sepsis. Gamma-delta T cells (γδ T cells) are the newly identified population of T lymphocytes. Recent studies have found that γδ T cells possess unique and powerful antigen-presenting function, making them the hot topic in infection and cancer research. Based on the results, the investigator plan to evaluate the antigen-presenting function changes of γδ T cells in septic status by analyzing the antigen-presenting related molecules on γδ T cells, antigen protein uptake ability, and their function on the proliferation and activation of CD8+ T lymphocytes. Furthermore, the investigator will explore the mechanism and signal pathways for the APC function changes of γδ T cells. Findings from this research could help explain the mechanism of sepsis induced immune dysfunction, enrich our understanding of the important role of γδ T cells, and build a good foundation for immunotherapy in sepsis.

Eligibility criteria: Inclusion Criteria:

1. ≥18 year old;
2. a known or suspected infection based on clinical data at the time of admission and sepsis-induced dysfunction of at least one organ.

Exclusion Criteria:

1. autoimmune disease,
2. history of transplantation,
3. acute tuberculosis,
4. chronic hepatitis B or C infection,
5. HIV infection,
6. active malignancy, and
7. long-term use of cortical steroids.

Primary outcomes:
measure: 28-day clinical outcome
timeFrame: 28-day after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04809896: Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm
Official title: Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Arch Aneurysm
Keywords: Proximal descending aorta aneurism
Proximal and distal neck (length >20mm et diameter >20mm and <40mm
thoracic endovascular aortic repair
Intra-abdominal septic complications
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population requiring this procedure is elderly, with major comorbidities and some of these indications are given in an emergency context.

Brief summary: The aim was to evaluate early and medium-term outcomes of single and double fenestrated physician-modified endovascular grafts (PMEGs) for endovascular aortic arch degenerative aneursym repair.

The evolution of stent-graft technology recently has meant the development of custom-made branched stent-grafts to achieve total endovascular aortic arch repair for high-risks patients. The disadvantages of custom-made include manufacture and deliver times for urgent cases and the associated high costs. Unfortunately there is also a high rate of embolization associated with this approach probably related to the complexity of deploying a multi-branched unibody stent-graft. A further alternative is physician modified endografts (PMEGs) for zone 0 TEVAR involving the deployment of a conventional stent-graft device ex-vivo, fashioning of customized fenestrations (for supra aortic trunk) and re-constrainment into the delivery system. The authors have previously shown the feasability in vitro and they have reported their experience for arch aortic lesion. The aim of this study is to evaluate the outcomes for aortic arch degenerative aneursym repair which is the most risky procedure


Eligibility criteria: Inclusion criteria:

- patients operated on in our department between 2000 and January 2020 for a thoracic endoprosthesis

Exclusion Criteria:

- Patient who reject the study protocol

Primary outcomes:
measure: Rate of retrograde aortic dissection
timeFrame: day 1
Secondary outcomes:
measure: Rate of endoleak
timeFrame: day 1
measure: Rate of stroke
timeFrame: day 1
measure: Rate of Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: ludovic CANAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01535196: Vitamine D Treatment in Chronic Heart Failure
Official title: Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Heart Failure
Vitamin D Adverse Reaction
Keywords: vitamin D
heart failure
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure.

Type of study: Controlled, randomized, double blind, placebo control

Number of patient: 300; 150 treated and 150 placebo controlled

Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month

Duration of study:1+1 year

Primary end points:

Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,

Secondary end points:

Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes

Visits:

Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,


Eligibility criteria: Inclusion Criteria:

* NYHA II-IV
* vitamin D level between 10-30 ng/ml
* ejection fraction by ultrasound \< 40 %

Exclusion Criteria:

* blood calcium \> 2,6 mmol/l
* urinary calcium \> 0,1 mmol/body weight kg/die
* blood phosphorus \> 1,45 mmol/l
* nephrolithiasis in the history
* GFR \< 30 ml/min
* vitamin D injection in the last 6 month
* actual 1,25-OH2-D3 vitamin treatment
* Myocardial infarction or serious coronaria stenosis in the anamnesis uncontrolled atrial fibrillation
* serious valve disease

Primary outcomes:
measure: Survival rate
timeFrame: 2 years
Secondary outcomes:
measure: D-vitamin supplementation safety
timeFrame: 1 year
measure: ejection fraction by ultrasound
timeFrame: 2 years
measure: serum brain natriuretic peptid level
timeFrame: 2 years
measure: walking test in 6 minutes
timeFrame: 2 years
measure: well-being score
timeFrame: 2 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Ist Department of Medicine
city: Budapest
country: Hungary
facility: Semmelweis University Cardiovascular Center
Study officials:
affiliation: Semmelweis University
name: Istvan Takacs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699096: Perfluorooctyl Bromide Which Empowers the Liquid to Flat the Detached Retina and Displace the Underneath Fluids Anteriorly
Official title: Perfluorooctyl Bromideessential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Disease
Lead sponsor: EL Romany Ophthalmics Factory
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Perfluorohexyloctaneis Essential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset


Eligibility criteria: Inclusion Criteria:

* - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;

Exclusion Criteria:

* Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;

Primary outcomes:
measure: flat the detached retina and displace the underneath fluids anteriorly
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Girgis Boules
state: Kubri EL Kubba
Study officials:
References:
Clinical trial NCT02326896: MACOCHA Score Predicts Intubation Failure
Official title: The New MACOCHA Score Predicts Intubation Failure of Non-anesthesiologist ICU Trainees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult
Intubation; Complication
Keywords: intubation
intensive care unit
MACOCHA Score
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients intubated in the ICU

Brief summary: Risk factors for difficult intubation are well described in anesthesiology. But intubation in the intensive care unit (ICU) is a challenging issue, associated with severe life-threatening complications. Non-anesthesiologist trainees performing ICU intubation may not fully appreciate the potential difficulty and complications.

Therefore in this retrospective analysis the MACOCHA score will be used to determine difficult intubation in the ICU and predict intubation failure.


Eligibility criteria: Inclusion Criteria:

* patients intubated in the ICU
* \>18 years of age

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Intubation complication
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Tienush Rassaf, MD
role: PRINCIPAL_INVESTIGATOR
References: