louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04061629: Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
Official title: Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 147
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring an endotracheal tube for surgery.

Brief summary: Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.


Eligibility criteria: Inclusion Criteria:

* Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria:

* Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.

Primary outcomes:
measure: Number of participants that needed their ETT exchanged
timeFrame: Immediately following intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06253429: Alpha-lipoic Acid in Diabetic Nephropathy
Official title: Oxidative Stress in Children and Adolescents With Diabetic Nephropathy and the Role of Adjuvant Alpha-lipoic Acid as an Antioxidant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Endothelial dysfunction in diabetes is a central event in the pathogenesis of different microangioapthic changes. Nephropathy in patients with type 1 diabetes is a severe microvascular complication.

Detailed description: Better understanding of the pathogenesis of microvascular complications in type 1 diabetes have paved the way for novel therapeutic targets and possible adjuvant therapeutic modalities. Oxidative stress is considered a common and important factor that links hyperglycemia with the vascular complications in diabetes, including of diabetic nephropathy (DN).

Alpha lipoic acid (ALA), or thioctacid, is an antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes. ALA can scavenge free radicals, activate antioxidant systems, and also affect inflammatory markers. It also has unique characteristic. ALA can play as a reduction for oxidized forms of components with antioxidant properties and neutralize reactive oxygen species. Thus, it called as antioxidant of antioxidants

Eligibility criteria: Inclusion Criteria:

* Children and adolescents with type 1 diabetes
* The presence of diabetic nephropathy

Exclusion Criteria:

* Renal impairment due to causes other than diabetes
* Other diabetic complications than nephropathy
* Elevated liver enzymes
* Hypersensitivity to lipoic acid
* Participation in a previous investigational drug study within the 30 days preceding screening

Primary outcomes:
measure: Changes in Total antioxidant capacity and Malondialdehyde
timeFrame: 3 months
measure: Changes in urinary albumin excretion rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Yasmine I Elhenawy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02580929: Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients
Official title: Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Radiotherapy
General Surgery
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: Beijing Hope Run
First posted: 2015-10-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of HCC
2. In high risk of recurrence of HCC but still can endure palliative resection
3. KPS scores are \>90
4. With Child-Pugh Class A liver funcion, serum bilirubin\< 1.5\*normal maxism; ALT and AST\< 1.5\*normal maxism; normal creatinine and urea nitrogen; WBC\>4×109/L, Hb\>110g/L, PLT\>90X109/L.
5. Have signed informed consent

Exclusion Criteria:

1. HCC cannot be operated
2. With Child-Pugh Class B/C
3. Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
4. Have other severe disease
5. With active hepatitis
6. Have accepted local radiation therapy in other hospitals
7. KPS scores≤70
8. Tumor edges cannot be defined
9. Have severe cirrhosis complication
10. Intensity modulated radiation therapy cannot reach required dose
11. Cannot cooperate
12. Lactant or pregnant
13. Cannnot be informed

Primary outcomes:
measure: mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: WU FAN
Study officials:
References:
citation: Wu F, Chen B, Dong D, Rong W, Wang H, Wang L, Wang S, Jin J, Song Y, Liu Y, Fang H, Tang Y, Li N, Zhu X, Li Y, Wang W, Wu J. Phase 2 Evaluation of Neoadjuvant Intensity-Modulated Radiotherapy in Centrally Located Hepatocellular Carcinoma: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Dec 1;157(12):1089-1096. doi: 10.1001/jamasurg.2022.4702.
Clinical trial NCT02391129: Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement
Official title: Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periprosthetic Fractures
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 102
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: We retrospectively reviewed a consecutive series of 102 patients with Vancouver type-B2, B3 and C periprosthetic fractures and unstable femoral stem, which had been prospectively entered, in our hip-trauma database.

Brief summary: The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.


Eligibility criteria: Inclusion Criteria:

* Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.

Exclusion Criteria:

* Patients with pathological fractures,
* Vancouver type-A, Bl, and
* stable femoral prosthesis stem,
* Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.

Primary outcomes:
measure: Clinical Outcome (Range of Motion of the hip)
timeFrame: follow up of at least 1 year
measure: Radiographic Outcome (boney consolidation of the fracture)
timeFrame: follow up of at least 1 year
Secondary outcomes:
measure: Patient's Mobility (assessed by the Parker's Mobility Score)
timeFrame: follow up of at least 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06656429: Outcome of Transforminal Epidural Injections in Patients with Lumbar Radicular Pain
Official title: Outcome of Transforminal Epidural Injections in Patients with Lumbar Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Redicular Pain
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental study
Primary purpose: TREATMENT

Brief summary: Back pain is the most common chronic pain disorder of adult population. Lumbar radicular pain occurs due to irritation or compression of the nerve roots in the lower back. Various non-surgical methods can also be exercised that have been used to treat lumbar radicular pain since the ancient times. Despite the availability of various treatment options, achieving optimal pain relief and functional recovery remains challenging. Lumbar Transforaminal Epidural Steroid Injections (TFESI) are commonly used to manage this condition, but there is variability in patient response and limited data on the effectiveness of TFESI in different demographic and clinical subgroups.


Eligibility criteria: Inclusion Criteria:

* Both genders
* Aged between 45 and 80 years
* Experiencing lumbar radicular pain

Exclusion Criteria:

* History of spinal fracture or previous spinal surgery
* Recurrent pain within 3 months of prior treatment
* Ongoing steroid therapy
* IKnown allergy to dexamethasone or lidocaine

Primary outcomes:
measure: Pain score
timeFrame: 4-week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
Study officials:
affiliation: Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan
name: Muhammad Zarak Awais, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269029: Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD
Official title: Effect of Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Moderate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease

Detailed description: The purpose of this study is designed to compare the therapeutic effect of chest mobility exercises and proprioceptive neuromuscular facilitation stretching on improving chest expansion and functional capacity in patients with chronicobstructivepulmonarydisease?

Eligibility criteria: Inclusion Criteria:

All patients will have the following criteria:

1. Age: 50-60 years old
2. All patients will be in mild to moderate of COPD. In accordance with criteria of Global Initiative for Chronic Obstructive Lung Disease (GOLD) (GOLD I-II).
3. BMI: obese class 1 (30-34.9).
4. Sex: male
5. They suffered from mild dyspnea, chronic cough and expectorations, with forced expiratory volume in one second (FEV1sec) from 50% to 80% of predicted value.

Exclusion criteria:

Patients with the following criteria will excluded from the study:

1. Severe psychiatric or cognitive impairments.
2. Progressive neuromuscular disorders.
3. Decreased level of consciousness.
4. Unstable fracture.
5. pacemaker inserted for fewer than 2 days
6. Deep-venous thrombosis (to minimize risk for pulmonary embolism from being in a prone position.
7. Mean arterial blood pressure of less than 65 mm Hg with or without vasopressors.
8. Tracheal surgery or sternotomy in the last 15 days.
9. Massive haemoptysis.
10. Intracranial pressure of more than 30 mm Hg or cerebral perfusion pressure of less than 60 mm Hg.

Primary outcomes:
measure: Pulmonary function test
timeFrame: One week for each comparator
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university- faculty of physical therapy
state: Dokki
Study officials:
affiliation: Faculty of physical therapy- internal medicine department
name: Zahra Serry
role: STUDY_DIRECTOR
References:
Clinical trial NCT03021629: Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma
Official title: Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Primary Open-angle Glaucoma
High Myopia
Vitamin D Receptor Polymorphisms
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 500
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary open-angle glaucoma patients, high myopia patients and age-matched people in the Han population

Brief summary: Vitamin D deficiency is known to be significantly associated with high myopia. This study investigated the vitamin D status in patients with high myopia and primary open-angle glaucoma, in order to understand the relationship between high myopia and the development of primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.


Eligibility criteria: Inclusion Criteria:

-primary open-angle glaucoma (1) intraocular pressure above 21 mmHg or more in each eye without therapy; (2) wide anterior chamber angle; (3)glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect in at least one eye;(4) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry in at least one eye.

c(with refractive error \>6D) were recruited.

Exclusion Criteria:

* the presence of any secondary glaucoma with an exfoliation syndrome or a history of ocular trauma, high myopia, macular degeneration, other ocular diseases, and also a known history of systemic diseases and administration of vitamin D3 or other analog.

High myopia patients with ocular disease such as glaucoma, a history of administration of vitamin D3 or other analog or a history of retinopathy or connective tissue disorders associated with myopia, such as Stickler or Marfan syndromes, were not included.

Primary outcomes:
measure: Serum levels of 1a, 25-Dihydroxyvitamin D3
timeFrame: 1 day visit
Secondary outcomes:
measure: gene polymorphisms of vitamin D receptor
timeFrame: 1 day visit
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT02626429: Protein Requirements In Active Female Populations
Official title: Evaluation of Protein Requirements in Active, Young Adult Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2015-12-10
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in active, young adult females using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility criteria: Inclusion Criteria:

* Healthy, active, young adult females who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
* A minimum score of 10 on the Beep Test (a measure of aerobic fitness)

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use

Primary outcomes:
measure: 13CO2 (carbon dioxide) excretion (μmol/kg/h)
timeFrame: 4 hours / study day
Secondary outcomes:
measure: 13C-Phenylalanine Oxidation (μmol/kg/h)
timeFrame: 4 hours / study day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01316029: Safety/Effectiveness Study of a Single Session of Laying-on-of-hands in Various Settings in Japan
Official title: A Large Cross-sectional Study of Laying-on-of-hands in Japan: Who Responds to it and What Facilitates the Response?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Signs and Symptoms
Physical Disorders
Personal Satisfaction
Keywords: Laying-on-of-hands
Therapeutic touch
cross-sectional study
healing environment
safety and effectiveness
optimal condition for the intervention
Lead sponsor: MOA Health Science Foundation
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 44587
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any Japanese people who were interested in receiving laying-on-of-hands

Brief summary: The purpose of this study is to determine the symptomatic changes after a single session of laying-on-of-hands in various settings, and to evaluate optimal conditions for the outcomes.

Detailed description: Laying-on-of-hands is applied in many different situations; however, most reports published previously described its efficacy in a clinical setting, with its administration conducted by a few expert practitioners. This study aimed to determine the symptomatic changes after a single session of the Okada Purifying Therapy, a form of laying-on-of-hands, in various settings, and to analyze factors influencing the outcomes.

Eligibility criteria: Inclusion Criteria:

* able to receive laying-on-of-hands for 30 minutes or longer from the investigators
* able to self-evaluate the change of their symptoms
* competent to answer the Japanese questionnaires
* aged 16 years or older

Exclusion Criteria:

* those who did not match the inclusion criteria

Primary outcomes:
measure: Severity of various symptoms
timeFrame: Baseline and immediately after a single intervention
Secondary outcomes:
measure: Adjusted odds ratios of the factors influencing the outcomes
timeFrame: in 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: MOA Health Science Foundation
Study officials:
affiliation: MOA Health Science Foundation
name: Kiyoshi Suzuki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351429: Study of PGA Suture in Ophthalmology
Official title: Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Trabeculectomy
Sutures
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2006-07-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures

Detailed description: The sutures are classified into non-absorbable and absorbable sutures. Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology, cardiology, neurology and plastic \& reconstructive surgeries. In ophthalmology, PGA sutures are used in Trabeculectomy (Glaucoma), Orbit and Oculoplasty, Lid and Socket Reconstruction, Squint, ptosis and retinal detachment surgeries.

Glaucoma patients who met the inclusion criteria were recruited for this study. Uniform surgery and suturing technique was performed in all patients (Trabeculectomy with IOL implantation). Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery.

Patients were followed up during 1 day, 1 month and 3 months post operatively. Visual acuity, Intraocular Pressure (IOP), suture characteristics, wound integrity, inflammation and conjunctival status were examined during each follow up visit.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing Trabeculectomy with IOL implantation
* Current residence within 60 kms of madurai

Exclusion Criteria:

* Life threatening illness
* Immunosuppressive disorders
* Chronic infection

Primary outcomes:
measure: Suture characteristics
timeFrame: 1 month, 3 months
Secondary outcomes:
measure: Bleb characteristics
timeFrame: 1 month, 3 months
measure: Conjunctival status
timeFrame: 1 month, 3 months
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Ramaswamy Krishnadas, DO, Dip NB
role: PRINCIPAL_INVESTIGATOR
References: