louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00557752: Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
Official title: Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post-Traumatic Respiratory Failure
Lead sponsor: Hospital Virgen de la Salud
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2007-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
* Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
* The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
* As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Informed consent obtained.
* pO2/FiO2 \<200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.

Exclusion Criteria:

* Orotracheal intubation indicated for any other reason.
* Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
* Severe traumatic brain injury.
* Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
* Cervical injury with specific treatment contraindicating a facial mask.
* Bronco-pleural fistula.
* Gastro-intestinal trauma.

Primary outcomes:
measure: Intubation rate
timeFrame: 1 month
Secondary outcomes:
measure: Pneumothorax rate
timeFrame: 1 month
measure: Pneumonia rate
timeFrame: 1 month
measure: Intensive Care Unit stay
timeFrame: 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
affiliation: Hospital Virgen de la Salud
name: Gonzalo Hernandez, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.
citation: Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, Hiradier P. Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial. Chest. 2010 Jan;137(1):74-80. doi: 10.1378/chest.09-1114. Epub 2009 Sep 11.
Clinical trial NCT02059252: Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
Official title: Proof of Concept Study Assessing Safety, Tolerability and Performance of SmartMatrix Dermal Replacement Scaffold
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Lead sponsor: Smart Matrix Limited
Sponsor class: OTHER
Collaborators: name: Welsh Centre for Burns and Plastic Surgery, Swansea, UK
name: Queen Victoria Hospital NHS Foundation Trust
First posted: 2014-02-11
Enrollment: 5
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: SmartMatrix™ is a single layer dermal replacement scaffold for full thickness skin replacement. The scaffold consists of a porous matrix of cross-linked human fibrin plus alginate that has been designed and optimised to facilitate wound closure and healing through cellular ingress and rapid growth of new blood vessels.

This proof of concept study will involve patients with surgical wounds resulting from the excision of basal cell carcinoma (BCC) and squamous cell carcinoma SCC).


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age
* Suspected or histologically proven BCC or SCC
* Suspected or histologically proven BCC or SCC ≥1cm ≤3cm in diameter on either leg
* Expected defect following surgery ≥3cm, ≤6cm in diameter
* Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study

Exclusion Criteria:

* Aged \<18 years of age
* Pregnant or lactating females
* Skin lesion \>4cm in diameter or size that will result in post-surgical defect \>6cm in diameter
* Lesion located over joint, i.e. ankle or knee
* Patient who are smokers
* Diabetic patients
* Patients diagnosed with peripheral vascular disease or venous stasis
* Patients receiving regular systemic steroids
* Patients who are immuno-compromised (either acquired or congenital)
* Patients with a known coagulopathy (either acquired or congenital) but not including patients on aspirin or other anti-platelet therapy
* Patients who have received radiotherapy treatment to the area about to be treated with Smart Matrix
* Concurrent participation in another experimental intervention or drug study
* Unwilling or unable to provide informed consent

Primary outcomes:
measure: Safety
timeFrame: 6 months
Secondary outcomes:
measure: wound healing
timeFrame: 6 months, 12 months
measure: cosmesis
timeFrame: 6 months, 12 months
measure: pain at dressing change
timeFrame: 3 months
measure: dressing change
timeFrame: 3 months
Other outcomes:
Locations:
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: The Welsh Centre for Burns and Plastic Surgery
Study officials:
affiliation: The Welsh Centre for Burns and Plastic Surgery, Morriston Hospital, Swansea, UK
name: Iain Whitaker, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04342052: Glaucoma After Congenital Cataract Surgery
Official title: Glaucoma After Congenital Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Congenital Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 351
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital cataracts was performed.

Brief summary: To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.

Detailed description: A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
* cataract surgery performed in ZOC;
* age at cataract removal younger than 16 years;

Exclusion Criteria:

* the preoperative IOP was above 21 mm Hg;
* family history of glaucoma;
* signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
* ocular trauma history;
* previous surgery intervention and
* they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.

Primary outcomes:
measure: the incidence of glaucoma after congenital cataract surgery
timeFrame: baseline
Secondary outcomes:
measure: Risk factors of glaucoma after congenital cataract surgery
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
References:
Clinical trial NCT00835952: ATX-101 Abdominoplasty
Official title: Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in Subjects Undergoing Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Characteristics of Subcutaneous Fat
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty


Eligibility criteria: Inclusion Criteria:

* Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

* History of interventions in the abdominal area

Primary outcomes:
measure: Adverse events, laboratory test results, physical examinations
timeFrame: 1 - 28 days
Secondary outcomes:
measure: Histopathology
timeFrame: 1 - 28 Days
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
Study officials:
affiliation: Kythera Biopharmaceuticals, Inc.
name: Patricia Walker, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03907059: Plant-based Dietary Protein and Resistance-training Adaptations
Official title: Does Exclusive Consumption of Plant-based Dietary Protein Impair Resistance Training-induced Muscle Adaptations?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: protein source
hypertrophy
resistance training
plant-based protein
omnivorous
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. Leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence RT-induced gains in muscle mass and strength. In general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. In this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.


Eligibility criteria: Inclusion Criteria:

* Healthy young men
* Vegans ≥ 1 y or omnivorous subjects
* Physically active but no resistance-trained subjects
* Without any chronic injury that impairs resistance training performance
* Protein intake \> 0.8 g/protein/kg body weight

Exclusion Criteria:

* Use of creatine or beta-alanine supplements for the last 3 months
* Use of proteins and/or amino acids supplements for the last 1 month
* Engagement in specific dietary restrictions
* Previous use of anabolic steroids
* Engagement in any training program

Primary outcomes:
measure: Muscle cross-sectional area
timeFrame: 12 weeks
measure: Muscle strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Leg lean mass
timeFrame: 12 weeks
measure: fiber cross-sectional area
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Hamilton Roschel, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18.
Clinical trial NCT00689559: Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects
Official title: A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
AZD3480
Aripiprazole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent
* Clinically normal physical findings and laboratory values

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within three weeks before the first dose
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Lennart Jeppsson
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions UK
name: Ctril Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04679259: Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction
Official title: Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 149
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Postoperative cognitive dysfunction is defined as a cognitive decline arising after surgery. In the present study, the authors evaluate the level of D-Amino Acid Oxidase, D-serine and Serine in blood as an indicator of postoperative cognitive dysfunction after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective cardiac surgery

Exclusion Criteria:

* MMSE \<24
* History of psychological or neurological diseases
* Illiteracy

Primary outcomes:
measure: Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery
timeFrame: At 1, 2, and 7 day after surgery
Secondary outcomes:
measure: Concentration of D-serine in blood
timeFrame: At 1, 2, and 7 day after surgery
measure: Concentration of Serine in blood
timeFrame: At 1, 2, and 7 day after surgery
measure: The incidence of postoperative cognitive dysfunction
timeFrame: At 7 day after surgery
measure: The incidence of postoperative delirium
timeFrame: Daily for 7 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07008859: Correlation Between Voice Pitch Changes and Tension of Suboccipital Muscles In Normal Subjects
Official title: Correlation Between Voice Pitch Changes and Tension of Suboccipital Muscles In Normal Subjects
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Voice Change
Suboccipital Muscles Tension
Keywords: voice pitch changes
tension of suboccipital muscles
correlational study
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: participatnts are normal people ,both gender , aged 20-60 years . number of participants are 119

Brief summary: this study for investigation of correlation between voice pitch and tension of suboccipital muscles

Detailed description: participants will be assigned randomly , normal people i will use 2 instruments first : compturized speech lab (CSL) to analyze voice pitch second: electromyography EMG to measure suboccipital muscle tension during speech this task will be repated twice first one during normal speech , second one during change in voice pitch

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 20-60 years.
* No history of musculoskeletal disorders, voice disorders, or neurological conditions.
* Normal voice function (Voice Handicap Index \[VHI\]-10 ≤ 11) .

Exclusion Criteria:

* Individuals with neck pain or injury in the past six months.
* History of vocal pathologies, recent surgeries, or auditory impairments

Primary outcomes:
measure: tension of suboccipital muscles
timeFrame: immediately during voice pitch changes
Secondary outcomes:
measure: suboccipital muscles tension
timeFrame: 5 minutes :tension will be measured twice during speech
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy , Cairo University
Study officials:
affiliation: Cairo University
name: basant sabry elbana, bachelor of physical therapy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05831059: A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia
Official title: A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.


Eligibility criteria: Inclusion Criteria:

* Subjects voluntarily participate in the study and sign the informed consent form;
* The age is between 18 (inclusive) and 85 (inclusive), regardless of gender;
* Body mass index (BMI) ≤ 45;
* Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later;
* Glycated hemoglobin\<8%;
* Not participating in the drug/medical device test within 3 months before the test;

Exclusion Criteria:

* Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score
* Ulcer is red and swollen, or active inflammatory infection;
* The affected limb has lesions such as blackening and gangrene of the toe skin;
* Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors;
* Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects);
* The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets);
* People with allergic diseases and allergic constitution;
* Have a history of drug abuse or drug addiction;
* There are contraindications to pulsed radio frequency therapy;

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai XINHUA Hospital
Study officials:
References: