louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06319586: The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries
Official title: The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: for Upper Limb Soft Tissue Coverage
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The radial forearm flap is a very useful and versatile flap with a long vascular pedicle and a thin, pliable skin. It's used in reconstruction of the mutilated hand as a reverse pedicled flap. The dominant pedicle is the radial artery, with venous outflow through the dual system of the venae comitantes and cephalic vein. Sensory innervation may be derived from the medial and lateral antebrachial cutaneous nerves. The radial forearm flap offers the advantage of a large area of donor tissue from the involved extremity with the potential for inclusion of bone, nerve, and tendon grafts. Sacrifice of the radial artery has not been associated with significant patient symptoms However, the donor defect can be troublesome, frequently requiring skin grafting directly over the paratenon of the flexor tendons, producing an undesirable donor site appearance


Eligibility criteria: Inclusion Criteria:

* patients aging 5 to 80 years.
* Soft Tissue defects following MCA injuries.
* Defect size less than 30 cm

Exclusion Criteria:

* Peripheral vascular disease
* Underling bone osteomyelitis
* Unhealthy skin of volatile aspect of donor forearm
* Defect more than 30 cm
* Ulnar artery previous ligated

Primary outcomes:
measure: Viability of the flap
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Noaman HH. Management of upper limb bone defects using free vascularized osteoseptocutaneous fibular bone graft. Ann Plast Surg. 2013 Nov;71(5):503-9. doi: 10.1097/SAP.0b013e3182a1aff0.
citation: Noaman HH, Shiha AE. Repeated upper limb salvage in a case of severe traumatic soft-tissue and brachial artery defect. Microsurgery. 2002;22(6):249-53. doi: 10.1002/micr.10045.
citation: Noaman HH. Salvage of complete degloved digits with reversed vascularized pedicled forearm flap: a new technique. J Hand Surg Am. 2012 Apr;37(4):832-6. doi: 10.1016/j.jhsa.2012.01.032. Epub 2012 Mar 6.
citation: Kaufman MR, Jones NF. The reverse radial forearm flap for soft tissue reconstruction of the wrist and hand. Tech Hand Up Extrem Surg. 2005 Mar;9(1):47-51. doi: 10.1097/01.bth.0000154479.20226.22.
Clinical trial NCT05999786: ERAS Swallowing Rehabilitation in Elder Patients
Official title: Effectivity of Early Recovery Accelerated Swallowing Program on Promoting Swallowing Recovery in Older Patients With High Risk of Oral Frailty Requiring Endotracheal Intubation During General Anesthesia: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: The Upper Esophageal Sphincter Contraction Strength
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients receive early recovery of swallowing rehabiliation before surgery and continued to after surgery
Primary purpose: PREVENTION

Brief summary: The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery.

Detailed description: The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery requiring tracheal intubation will be recruited. Patients will be randomized into an intervention and a control group. Patients in the intervention groups will received the ERAS-W program, while those in the control group will receive the swallowing education video.

Eligibility criteria: Inclusion Criteria:

* elective surgery
* general anesthesia with endotracheal intubation

Exclusion Criteria:

* major organ dysfunction, ex: chronic kidney disease, hear failure
* bleeding tendency

Primary outcomes:
measure: UES pressure, mmHg
timeFrame: about six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00951886: The Validity of Forced Expiratory Maneuvers in Ataxia Telangiectasia Studied Longitudinally
Official title: The Validity of Forced Expiratory Maneuvers in Ataxia Teleangiectasia Studied Longitudinally
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ataxia Telangiectasia
Keywords: Ataxia Teleangiectasia
Spirometry
Respiratory rare diseases
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-08-04
Enrollment: 28
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Ataxia Telangiectasia who are followed and treated in the National A-T center at Safra Children's Hospital, Sheba Medical Center, Ramat-Gan, Israel

Brief summary: Rationale: Forced spirometry maneuvers are not routinely performed in patients with Ataxia Telangiectasia (A-T), even though they suffer from respiratory illnesses.

Objectives: To study the feasibility and validity of forced spirometry in A-T patients.

Methods: Patients will perform spirometry during clinical visits. Parameters studied will be technical quality, relation to predicted values, age, pulmonary illness, body mass index, mutational status and mutation.


Eligibility criteria: Inclusion Criteria:

* Patients with proven Ataxia Telangiectasia

Exclusion Criteria:

* inability to perform spirometry

Primary outcomes:
measure: spirometry measurements
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Pediatric Pulmonary Unit, The Edmond and Lily Safra Children's Hospital Chaim Sheba Medical Center, Tel HaShomer
Study officials:
References:
Clinical trial NCT03129386: Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction
Official title: Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult subjects with no antecedent history of neuromuscular or cardiorespiratory disease.

Brief summary: This study is investigating the normal range of maximal diaphragm thickness during a sniff inspiratory manoeuvre using ultrasound in healthy subjects stratified by age and gender.

Detailed description: Diaphragm dysfunction is associated with poor clinical outcomes in critically ill patients but is difficult to diagnose. Traditionally, diaphragm function is measured by evaluating inspiratory muscle strength via maximal inspiratory pressure (MIP). However, this technique relies on a volitional maximal effort and can be challenging for patients to perform.

An alternative to measuring inspiratory muscle strength is the sniff inspiratory pressure approach. During short, sharp sniffs, the diaphragm is maximally activated.

Currently, there are no reported values of the normal range of maximal diaphragm thickness during a sniff maneuver. This study will define the normal range of values for sniff maximal diaphragm thickening fraction, maximal thickening against an occluded airway, and diaphragm thickening during resting tidal breathing in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Antecedent history of neuromuscular or cardiorespiratory disease

Primary outcomes:
measure: Sniff diaphragm thickening fraction
timeFrame: Day 1
measure: Maximal diaphragm thickening fraction
timeFrame: Day 1
measure: Resting tidal thickening fraction
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Ewan C Goligher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805686: " En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maculopathy
Keywords: Toxicity, Drug
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-06-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be detected at the infra-clinical state, when it can still be reversible. Identifying early retinal anatomical changes has always represented (a challenge for medical interns, dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a long and tedious exam, offered by only few medical centers. It is recommended to find a simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid (junction line between, the external and internal photoreceptor segments) using optical coherence tomography (OCT-SD) "en face" enables us, to obtain a panoramic viewing of the state of the photoreceptor layer, and to detect any modification, even subtle, within this layer. The OCT-SD "en face" can be easily done by any ophthalmologist who owns one.

The proportion of "en face" OCT-SD showing suggestive retinal damage and patients who present retinal damage in relation with synthetic antimalarial treatments and diagnosed by mfERG is considered in this study.


Eligibility criteria: Inclusion Criteria:

* Patients treated with synthetic antimalarials with retinal damage (in relation with the antimalarial treatment) recently diagnosed by mfERG
* Patients treated with synthetic antimalarials in the past, who stopped treatment because of a supposed retinal damage not confirmed by mfERG

Exclusion Criteria:

- State of ocular structures preventing the realization of exams

Primary outcomes:
measure: concordance between mfERG and "En-face" OCT
timeFrame: after 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02084186: Moxibustion for Mild and Moderate Ulcerative Colitis
Official title: The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnosis of UC
* Mayo ≤10
* Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
* Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
* A written informed consent

Exclusion Criteria:

* Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
* Pregnancy or lactation

Primary outcomes:
measure: disease activity index (DAI)
timeFrame: 3 months
Secondary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 3 months
measure: symptom score
timeFrame: 3 months
measure: histomorphology observation of intestinal mucosa
timeFrame: 3 months
measure: metabolic profile of intestinal mucosa, urine, plasma and serum
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture-Moxibustion and Meridian
Study officials:
affiliation: Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine
name: Huangan Wu, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02401763: Investigating the Role of Mucin and Mucin Glycosylating Enzymes in Nasopharyngeal Carcinoma and Salivary Gland Cancer and Their Correlation With Clinical Prognosis
Official title: Investigating the Role of Mucin and Mucin Glycosylating Enzymes in Nasopharyngeal Carcinoma and Salivary Gland Cancer and Their Correlation With Clinical Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salivary Gland Cancer
Nasopharyngeal Carcinoma
Keywords: biomarker
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NPC and salivary gland tumor diagnosed and treated in HTUH

Brief summary: Nasopharyngeal carcinoma (NPC) is the tenth leading cancers in Taiwan and investigating its biomarker is important for understanding the mechanism of its pathogenesis.

Detailed description: NPC is the tenth leading cancers in Taiwan and investigating its biomarker is important for understanding the mechanism of its pathogenesis.

Eligibility criteria: Inclusion Criteria:

* NPC and salivary gland tumor diagnosed and treated in HTUH

Exclusion Criteria:

* previous treatment or surgery

Primary outcomes:
measure: The difference of expression level of mucin glycosylating enzymes (by immunohistochemistry) in nasopharyngeal carcinoma and salivary gland tissues
timeFrame: 1~5 years after patients received definite therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NTUH
name: Pei-Jen Lou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530863: Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
Official title: Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Pregnancy Related
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women

Detailed description: This is a randomized, 60-day research study that is evaluating the effect of a simplified behavioral relaxation intervention in pregnant and postpartum patients aimed to improve their insomnia symptoms. The investigators will be enrolling a total of 20 patients who indicate self-reported insomnia symptoms.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 55
* In second or third trimester of pregnancy (Gestation weeks 18-32)
* Able to speak, read and write fluent English
* Has regular access to a smartphone and/or smart tablet
* sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for ≥3 nights/week, must persist for at least 1 month

Exclusion Criteria:

* Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period.
* Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)

Primary outcomes:
measure: PSQI, Sleep Quality
timeFrame: 30 days
measure: Total Wake Time, Sleep Diary
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nalaka Gooneratne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00317863: Zink and Bone Strength
Official title: Zink and Bone Strength
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coxarthrosis
Fracture of Femoral Neck
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.

Brief summary: Zink and bone strength

Detailed description: blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all had a hip-replacement. All patients were evaluated by DEXA-scanning.

Eligibility criteria: Inclusion Criteria:

Postmenopausal women with osteoarthrosis or femoral neck-fracture i one hip

Exclusion Criteria:

pathology or prosthesis in contralateral hip

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Klinik Farsoe
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Janne Ovesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092963: Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)
Official title: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-29
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.


Eligibility criteria: Inclusion Criteria:

* 6-month history of migraine
* Migraine attacks typically mild when they begin with 1-4 migraine attacks per month

Exclusion Criteria:

* Heart disease
* High blood pressure

Primary outcomes:
measure: Percentage of patients who are pain free at 2 hours postdose.
measure: Tolerability as measured by subjective adverse experience reporting.
Secondary outcomes:
measure: Percentage of patients with 24 hour sustained pain freedom
measure: Percentage of patients free at 30/45/60/90 minutes postdose
measure: Percentage of patients with associated symptoms at 2 hours
measure: Percentage of patients requiring rescue med between 2 & 24 hours
measure: Percentage of patients with functional disability at 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24. doi: 10.1111/j.1526-4610.2006.00466.x.
citation: Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13.
citation: Cady R, Martin V, Mauskop A, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. doi: 10.1111/j.1468-2982.2007.01391.x. Epub 2007 Aug 6.
citation: Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.