louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03538080: ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking
Official title: Evaluation du pré-marquage Par AccuVein® au Cours Des échographies Doppler de repérage saphène.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Diseases of Veins and Lymphatics
Keywords: venous disease
peripheral vascular disease
vascular surgery
ultrasound imaging
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ultrasound marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting is a long, tedious, low-grading examination, generating overconsumption of many consumables including marking markers that may damage the probes, of the modern and expensive ultrasound doppler. Augmented reality devices can visualize the superficial veins and hope to simplify the investigation, improve the comfort of the patient during the examination by significantly reducing the time of the examination. There is few data in the literature on the value of using augmented reality devices of this type. The AccuVein® system is a patient-friendly, non-contact, non-invasive technique that minimizes discomfort due to standing time and thus improves patient comfort.

Detailed description: At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept. In included patients, in parallel to the standard ultrasound investigation for marking of saphenous veins for which the patient is referred, AccuVein® system will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility criteria: Inclusion Criteria:

* Patients referred for venous marking
* Affiliation to the French National healthcare system
* French speaking patients

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* patients protected by decision of law

Primary outcomes:
measure: Time to perform the saphenous vein marking with AccuVein® system
timeFrame: inclusion
Secondary outcomes:
measure: Degree of satisfaction of the vascular physician and the surgeon
timeFrame: inclusion
measure: Rate of consumables
timeFrame: inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: UH Angers
name: HENNI MD SAMIR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410980: Assessing the Effects of Tretinoin Cream on Human Skin With Optical Imaging Technologies
Official title: In-vivo Non-invasive Skin Imaging Pilot Study to Assess the Effects of Tretinoin Cream Using Multi-photon Microscopy and Multi-spectral Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Collagen Fibril Alteration
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Unilever R&D
name: Beckman Laser Institute University of California Irvine
First posted: 2015-04-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.

Detailed description: The researchers will evaluate changes in the dermis and skin properties as the effect of treatment with Tretinoin cream (0.1%) by using the following optical imaging techniques.

1. Multiphoton microscopy using a clinical tomograph (MPTflex, Jenlab, Germany)
2. Multispectral Imaging using a device developed at Beckman Laser Institute, UC Irvine

Eligibility criteria: Inclusion Criteria:

* Female 45 years of age or older - Skin type scale I to III

Exclusion Criteria:

* Large amount of dark, coarse hair on the arms
* History of allergies to alpha hydroxy acids (AHAs), retinoids, soaps, fragrances, sunscreens or Latex
* Currently using over-the-counter AHA or retinol within one month or prescription retinoid within three months of the start of the study.
* History of skin cancer, including squamous or basal cell carcinoma at the treatment site or history of malignant melanoma.
* History of diabetes
* Currently pregnant or nursing

Primary outcomes:
measure: Skin Collagen/Elastin ratio over time - Change from baseline in sun exposed, and non sun exposed skin areas.
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Mihaela Balu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02906280: RCT Comparing 19Ga vs 22Ga EBUS-TBNA Needles in Carcinoma.
Official title: Randomized Controlled Trial Comparing the Performance of 19 Gauge Versus 22 Gauge EBUS-TBNA Needles in Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Neoplasm
Keywords: EBUS-TBNA
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

Detailed description: All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.

Eligibility criteria: Inclusion Criteria:

* (suspected) stage IV lung carcinoma identified on spiral computed tomography scan
* requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis

Exclusion Criteria:

* uncontrolled coagulopathy
* tracheal stenosis

Primary outcomes:
measure: Tissue core
timeFrame: 14 months
Secondary outcomes:
measure: Tumor cellularity per area of diagnostic tissue
timeFrame: 14 months
measure: Quantity of DNA extracted
timeFrame: 14 months
measure: Success rate of Next Generation Sequencing
timeFrame: 14 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals KU Leuven
Study officials:
References:
Clinical trial NCT03790280: High Frequency Oscillation in Pediatric Epilepsy Surgery
Official title: High Frequency Oscillation in Pediatric Epilepsy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Epilepsy
Epilepsy Surgery
High Frequency Oscillation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 17
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into standard arm and the treatment arm in a 1:1 ratio.
Primary purpose: TREATMENT

Brief summary: High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new biomarker for epileptogenic tissue. The purpose of this study is to see if epilepsy surgery guided by the combination of HFO on ECoG and standard clinical practice can result in a greater likelihood of seizure freedom, versus standard clinical practice alone, without HFOs.

Detailed description: Intra-operative electrocorticography (ECoG), based on interictal spike and spike patterns, is performed to optimize delineation of the epileptogenic tissue in the operating room during epilepsy surgery. Similarly, extra-operative electrocorticography is often recorded over days to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not clearly localized with non-invasive studies and/or with intra-operative ECoG. Surgical resection following extra-operative ECoG is then "tailored' by the seizure onset zone as the gold standard.

High frequency oscillations have been identified as a more precise biomarker for epileptogenic tissue. The aim of this double-blind randomized surgical trial is to determine if HFO- tailored surgery combining HFOs and current standard of care, compared to current standard of care alone, will lead to a better seizure outcome.

Eligibility criteria: Inclusion Criteria:

* Age 0-21 years
* Refractory focal epilepsy
* Planned resective epilepsy neurosurgery
* Includes intraoperative or extraoperative electrocorticography with grids
* Planned resective epilepsy surgery approved by institutional surgery board

Exclusion Criteria:

* Subjects undergoing non-resective neurosurgery
* Does not include intraoperative or extraoperative electrocorticography with grids
* Planned resective surgery is a hemispherectomy/hemispherotomy

Primary outcomes:
measure: Post-operative Seizure-free Rate
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Post-operative Complication
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
Clinical trial NCT04373980: Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
Official title: Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Phototherapy Complication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the influence of the use of different types of phototherapy on different lymphocytes subsets CD4 and CD8 in the treatment of hyperbilirubinemia in neonates.


Eligibility criteria: Inclusion Criteria:

Term neonates with a gestational week higher than 37weeks, according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns are determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.

* Clinically significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
* No pathologic etiological factors for hyperbilirubinemia

Exclusion Criteria:

* Total bilirubin level of \>20 mg/dl.
* Prematurity.
* Sepsis.
* Congenital anomaly.
* Elevation in direct bilirubin level.
* History of immune deficiency the family.
* History of preeclampsia or any other diseases or drug use of the mother

Primary outcomes:
measure: Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT01429480: Comparison of TAP (Transversus Abdominis Plane) and Ilioinguinal/Iliohypogastric Nerve Block for Analgesia of Open Inguinal Herniorrhaphy
Official title: Comparison Between Two Ultrasound-guided Blocks (Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks) for Pain Relief After Open Inguinal Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Analgesia, postoperative
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-09-07
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TAP was recommended by PROSPECT for further investigation as an appropriate analgesic method after open herniorrhaphy. Ilioinguinal/iliohypogastric nerve block is one of the oldest methods of analgesia. The researchers wish to investigate whether the TAP block is as effective as the ilioinguinal/iliohypogastric nerve block?


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective primary unilateral open tension-free mesh inguinal hernia repair

Exclusion Criteria:

* Inability to consent to the study
* BMI more than 40
* Skin infection near injection site
* Chronic hepatic or renal failure
* Peripheral neuropathy
* Proven opioid dependency
* Coagulopathy
* Thrombocytopenia
* Dementia
* Lack of orientation
* Impossibility to understand VAS
* Patients suffering from chronic pain

Primary outcomes:
measure: postoperative pain
timeFrame: 2 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
citation: Stav A, Reytman L, Stav MY, Troitsa A, Kirshon M, Alfici R, Dudkiewicz M, Sternberg A. Transversus Abdominis Plane Versus Ilioinguinal and Iliohypogastric Nerve Blocks for Analgesia Following Open Inguinal Herniorrhaphy. Rambam Maimonides Med J. 2016 Jul 28;7(3):e0021. doi: 10.5041/RMMJ.10248.
Clinical trial NCT05989880: Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
Official title: Pilot Feasibility Trial of the SafeLM Supraglottic Airway
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie


Eligibility criteria: Inclusion Criteria:

* elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

Exclusion Criteria:

* pregnancy
* known or suspected difficult airway management
* history of oropharyngeal or upper airway surgery
* known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
* BMI greater than 40 kg/m2
* unable to undergo intubation via the oral route
* known or suspected full stomach or other risk factors for aspiration
* contraindication for the use of neuromuscular blocking agents
* history of significant gastroesophageal reflux disease (GERD)
* Vulnerable populations (cognitively impaired persons, prisoners)

Primary outcomes:
measure: Intubation success rate
timeFrame: at the time of intubation
Secondary outcomes:
measure: Number of insertion attempts required to achieve effective oxygenation and ventilation
timeFrame: at the time of intubation
measure: Time to insertion
timeFrame: at the time of intubation
measure: Subjective ease of insertion of the airway device
timeFrame: at the time of intubation
measure: Safety of the SafeLM as an SGA
timeFrame: at the time of intubation
measure: Safety of the SafeLM as a conduit for intubation
timeFrame: at the time of intubation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lauren M Nakazawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05863780: Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome.
Official title: Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome on Pain, ROM and Functional Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: median neuropathy
thenar muscle atrophy
compression neuropathy
flexor retinaculum
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of flexor retinaculum stretch and carpal mobilizations in carpal tunnel syndrome patients.

Detailed description: * Carpal Bones Mobilization tends to improve the symptoms of carpal tunnel syndrome.
* Manual stretching of the flexor retinaculum effective in CTS patients.
* As there are no studies available to compare the effectiveness of flexor retinaculum stretch and carpal bone mobilization for the treatment of CTS, hence the purpose of this study is to find the effectiveness of carpal bone mobilization and flexor retinaculum stretch in improving Pain, ROM and Functional Status in patient with CTS.

Eligibility criteria: Inclusion Criteria:

* Females
* Age between 18-40 years
* Unilateral CTS
* Already diagnosed patients of CTS.

Exclusion Criteria:

* Fracture of wrist
* Dislocation
* Congenital abnormalities
* Rheumatoid arthritis
* Osteoarthritis
* Liver failure
* Pregnancy
* Bilateral CTS
* Systemic neurological condition e.g.: GB syndrome, multiple sclerosis.

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4th week
measure: Boston Carpal Tunnel Questionnaire (BCTQ) scale (SSS, FSS)
timeFrame: 4th week
measure: 6-item CTS symptoms scale (CTS-6)
timeFrame: 4th week
measure: ROM wrist flexion
timeFrame: 4th week
measure: ROM wrist extenion
timeFrame: 4th week
measure: ROM radial deviation
timeFrame: 4th week
measure: ROM ulnar deviation
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawal Institute of Health Sciences
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Islamabad physiotherapy rehabilitation centre
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Affan Iqbal, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352780: Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters
Official title: Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Psoriasis
Keywords: motivational interviewing
psoriasis
self management
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2011-05-12
Enrollment: 169
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate clinical and health economic parameters in relation to individual motivational counseling by phone.

Detailed description: A chronic condition such as psoriasis requires a high level of self- management and requires for many patients behaviour change to improve health outcome. Changing behaviour is a challenge that requires a commitment by the patient to implement successfully. Motivational interviewing is a patient centered directive counseling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. It is a well-known method of counseling, and is considered to be a useful intervention strategy in the treatment of lifestyle problems.

This study is a randomized controlled trial using telephone motivational interviewing. The counseling intervention comprises 6 telephone calls during a 12 week period, after attending 3 weeks of supervised climate therapy on the Canary Islands

Eligibility criteria: Inclusion Criteria:

* Conducted 3 weeks of supervised climate therapy in The Canary Islands
* Able to write and communicate in Norwegian
* PASI more than 7 on application

Exclusion Criteria:

* more than 5 climate therapy treatments during the last 10 years

Primary outcomes:
measure: SAPASI (+ PASI at T1 and T2)
timeFrame: Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks
measure: HeiQ
timeFrame: change from baseline to 3 months, 6 months
Secondary outcomes:
measure: 15D
timeFrame: Change in 15D from baseline to 6 weeks and 12 weeks
measure: Questionnaire about lifestyle
timeFrame: Change in lifestyle parametres from baseline to 6 weeks and 12 weeks
measure: BIPQ-2
timeFrame: Change from baseline to 3 and 6 months
measure: Psoriasis Knowledge questionnaire
timeFrame: change in knowledge from baseline to 3 weeks, 3 months and 6 monthts
measure: Willingness to change to manage psoriasis
timeFrame: change from baseline to 3 months and 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital, Department for clima therapy
city: Oslo
country: Norway
facility: University of Oslo, Departement of health and society
Study officials:
affiliation: University of Oslo, Departement of Health and Society,Department of Health Sciences
name: Astrid K. Wahl, PhD
role: STUDY_CHAIR
References: