louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02583100: Improving Outcomes in Cleft Palate Surgery
Official title: Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.

Detailed description: This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair.

The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons.

The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.

Eligibility criteria: Inclusion Criteria:

Active surgeon performing cleft palate repair in the US or Canada.

Exclusion Criteria:

none

Primary outcomes:
measure: Oro-nasal Fistula
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Durham
country: United States
facility: Duke Children's Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Craniofacial Clinic
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Daniel Grossoehme
role: PRINCIPAL_INVESTIGATOR
affiliation: Phoenix Children's Hospital
name: Thomas Sitzman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06106100: Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease
Official title: Efficacy and Safety of Endoscopic Anti-reflux Mucosal Ablation Therapy for Gastroesophageal Reflux Disease: a Single Blind Randomized Sham Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate :

* Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score
* Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment.

The primary endpoint will be symptoms relief (GERD-HRQL decreases \> 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.


Eligibility criteria: Inclusion Criteria:

* Adults aged over 18 years old
* History of GERD for over 6 months, who had received PPIs for over 6 months but still had symptoms of typical GERD symptoms (GERD-HRQL score of \>8, acid reflux sensation or heartburn), and/or other symptoms as lump throat, night cough, acid related chest tightness (without other possible explanation of these symptoms)
* Acid exposure time \> 6%
* DeMeester score ≥ 14.72

Exclusion Criteria:

* Pregnancy
* BMI\>=35
* Hiatal hernia \> 2cm or Flap Valve Hill grade III/IV
* GERD LA grade C/D or esophageal ulcer
* Abnormal anatomy of esophagus (esophagectomy, stricture, diverticulum)
* Barrett's esophagus with dysplasia
* Esophageal motility disorders
* History of gastroparesis
* Cirrhosis
* Esophageal and gastric varices
* Previous gastric surgery and anti-reflux procedures
* History of scleroderma or dermatomyositis
* Coagulation disorders (Bleeding tendency and coagulopathy)
* History of oncological disease (not active within 2 years)

Primary outcomes:
measure: Improvement of gastroesophageal reflux disease symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Complication rate
timeFrame: 12 months
measure: PPI dependency
timeFrame: 12 months
measure: Changes in acid exposure time
timeFrame: 12 months
measure: Changes in DeMeester score
timeFrame: 12 months
measure: Changes in lower esophageal sphincter pressure
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01297400: Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Official title: Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Burns
Keywords: Burns, Partial Thickness Burns
Lead sponsor: Skingenix, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-16
Enrollment: 60
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: To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.

Detailed description: This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.

Eligibility criteria: Inclusion Criteria:

1. Adults, 18 years of age or older on the day of signing the informed consent.
2. Thermal Burns not exceeding a total body surface area (TBSA) OF 25%, with at least one partial thickness burn of 0.5% TBSA or greater. If full thickness burn(s) are present at screening, the total full thickness burn area shall not exceed 10% TBSA. Note: TBSA excludes areas of superficial (first degree) burns.
3. Able and willing to give informed consent and comply with study procedures.

Exclusion Criteria:

1. Any burn that at screening is:

   1. infected.
   2. circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
   3. partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
2. Severe inhalation injury or other significant non-burn trauma.

Primary outcomes:
measure: Time to healing (≥95% re-epithelialization) of the partial thickness target burn.
timeFrame: 28 days Treatment Period
Secondary outcomes:
measure: Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment.
timeFrame: 28 days Treatment Period
measure: Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28.
timeFrame: 28 days Treatment Period
measure: Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28.
timeFrame: 28 days Treatment Period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valleywise Health Medical Center
state: Arizona
city: Sacramento
country: United States
facility: University of CA Davis Medical Center
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Augusta
country: United States
facility: Joseph M. Still Burn Center, Doctor's Hospital
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
affiliation: Valleywise Health Medical Center
name: Kevin Foster
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04790500: Effects Of Muscle Energy Technique Versus Mobilization
Official title: Effects Of Muscle Energy Technique Versus Mobilization On Pain And Disability In Post-Partum Females With Sacroiliac Joint Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Keywords: Mobilization
Muscle energy technique
Postpartum
Sacroiliac joint pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain

Detailed description: The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain in postpartum females and to check whether the amount of gaining range of movement is similar among postpartum female undergoing with mobilization therapy and with muscle energy technique.

Eligibility criteria: Inclusion Criteria:

* 20-40 year having unilateral back pain around or on sacral sulcus,
* Positive posterior pain provocation test for Sacroiliac joint dysfunction,
* Low back pain within six weeks of delivery
* Pain while sitting down, lying on the ipsilateral side of pain, or climbing stairs.
* Local tenderness of the posterior aspect of the sacroiliac joint
* Pain is usually localized over the buttock.
* Sharp, stabbing, and/or shooting pain which extends down the posterior thigh usually not past the knee.
* C-section

Exclusion Criteria:

* Neurological deficit
* Spinal tumors
* Scoliosis,
* Underwent spinal surgery and prolapsed
* Intervertebral disc with or without radiculopathy

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: 4th week
measure: Modified Oswestry disability index
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan railway hospital
state: Punjab
Study officials:
affiliation: Riphah college of rehabilitation and allied health sciences - Rawalpindi
name: Anam Aftab, Phd*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693000: Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis
Official title: Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Keratotic Nodular Size
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Arsenic is one of the largest mass poisonings in Bangladesh. Arsenic keratosis of the palm and sole is a common feature of arsenicosis. Brinjal or eggplant ubiquitous vegetable found in different parts of the world, including Bangladesh, scientifically known as Solanum melongena. A study showed ointment containing crude extract of Solanum melongena peel origin is effective in arsenic keratosis. Solasodine is one of the active compounds of Solanum melongena peel. In the current study, an ointment containing a single compound solasodine isolated from Solanum melongena peel . The ointment made from solasodine extract was distributed among arsenic keratosis patients to see the effect.

Detailed description: About millions of Bangladeshi people are chronically exposed to high arsenic concentrations (above 50 micrograms/liter) through contaminated drinking water and thus suffer from arsenic-related health hazards called arsenicosis. Arsenic keratosis is one of the commonest skin manifestations of arsenicosis that occur in the palm and sole that is troublesome for the working people and females suffered a negative socio-economic impact.

Two studies were conducted in the same department where topical ointment prepared from the crude extract of S. melongena peel was found effective in arsenical keratosis.

The present study was conducted to confirm the previous study and identify that solasodine isolated from S. melongena peel is responsible for the cure of the lesions of arsenical keratosis. Thus, it may be possible for the chemical synthesis of solasodine, and an effective, inexpensive topical ointment can be prepared for the cure of arsenical keratosis.

Eligibility criteria: Inclusion Criteria:

* Presence of moderate to severe palmar arsenical keratosis
* Drinking arsenic-contaminated water for at least six months
* Patient voluntarily agreed to participate

Exclusion Criteria:

* Age less than 18 years or more than 60 years
* Pregnant and nursing mother
* Skin diseases like atopic dermatitis eczema and psoriasis
* Patient allergic to brinjal (eggplant)
* Patient taken any treatment of arsenicosis for the last six months

Primary outcomes:
measure: Arsenical Keratotic nodular size of the palm
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Comilla
country: Bangladesh
facility: Muradnagar Upazilla
Study officials:
References:
Clinical trial NCT04579900: Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
Official title: Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It is now well documented that changes in gut microbiota composition accompany obesity and type 2 diabetes (T2D) and contribute to low-grade inflammation, insulin resistance,and glucose intolerance. It is not yet clear if T2D predisposes the intestine to allow more microbial products or possibly live bacteria to subvert the gut mucosal barrier. However, it is known that hyperglycemia during T2D induces a more permissive gut barrier allowing increased penetration of microbes and their products into the blood. An important next step is to determine which strains of bacteria promote dysbiosis, allowing bacteria or bacterial components to subvert the gut barrier and alter glucose control. It is hypothesized that gut microbes in the colon and other lower gut segments are key modulators of energy balance, glucose homeostasis and insulin sensitivity.

Detailed description: The gut acts as a barrier to bacteria and nutrients and participates in glucose homeostasis via endocrine actors and the gut-brain-peripheral axis. It is unclear how T2D alters microbes in upper and lower intestine of humans. Studies in animals show that T2D promotes translocation of microbes to the blood and tissues to promote metabolic dysfunction. It is crucial to determine whether bacteria or their components subvert the gut barrier in human T2D, and then to identity the relevant bacterial strains in tissues that control blood glucose. The overall objective of our research program is to demonstrate that specific microbes in the gut, circulation, and key metabolic tissues are involved in the progression of T2D. We will define the microbial signatures of T2D in duodenal biopsies and stool samples by comparing T2D and non-T2D subjects.

Eligibility criteria: Inclusion Criteria:

* T2DB de novo or non T2DB patients

Exclusion Criteria:

* oral hypoglycemic agents or lipidlowering or antihypertensive drugs

Primary outcomes:
measure: Microbial signature
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: INAF, Université Laval
state: Quebec
Study officials:
affiliation: Laval University
name: André Marette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05521100: Application of Vascular Closure Device in Transvenous Cardiac Intervention
Official title: Comparison of Safety and Efficacy Between the Application of Vascular Closure Device and Conventional Figure-of-eight Suture in Transvenous Cardiac Interventional Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Complications
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery

Detailed description: Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery.From the operation success rate, postoperative bleeding, immobilization time, the rate of revisiting the doctor due to wound problems within 1 month, etc.

Eligibility criteria: Inclusion Criteria:

* Patients receiving lower extremity venous intervention with a diameter of 12F or more

Exclusion Criteria:

* None

Primary outcomes:
measure: Vascular bleeding event rate
timeFrame: 1month
Secondary outcomes:
measure: bed braking time
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jun Zhang
state: Shanghai
Study officials:
affiliation: Tongji University
name: Yawei Xu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00969800: Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections
Official title: Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Infection
Keywords: Common cold
Influenza
Pneumonia
Lead sponsor: Taiko Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 1469
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is to test whether a chlorine dioxide gas-generating device, which releases a low concentration gas of chlorine dioxide in a sustained manner, can protect against respiratory infections in elderly individuals living in nursing homes. Such a device is used as a deodorant for normal domestic purposes. The investigators reasoned that the antiviral and antibacterial properties of chlorine dioxide might lead to a lowering in the incidence of respiratory infectious diseases. The study is designed as a randomized placebo-controlled double-blind crossover multicentre trial involving approximately 1500 subjects.

Detailed description: Chlorine dioxide (ClO2), which is used as household deodorant, is a volatile gas that displays very strong oxidative activity. Indeed, the powerful oxidative activity of chlorine dioxide (Ogata, N., Biochemistry 46, 4898-4911, 2007) is responsible for its antimicrobial activity against bacteria (Benarde, M. A., et al. Appl. Mircrobiol. 15, 257-265, 1967), fungi (Morino, H., et al. Yakugaku Zasshi 127, 773-777, 2007) and viruses (Ogata, N. and Shibata, T. J. Gen. Virol. 89, 60-67, 2008). Recently, we found that the rate of absenteeism due to illness in a school was lower in classrooms where a chlorine dioxide gas-generating device was placed than in classrooms with no such device. Based upon this unexpected observation we hypothesize that chlorine dioxide gas, at a concentration low enough not to harm humans, may lower the incidence of respiratory infections by inactivating airborne microorganism within an enclosed space.

Eligibility criteria: Inclusion Criteria:

* Those who who agrees with the aim of the study

Exclusion Criteria:

* Those who do not agree with the aim of the study

Primary outcomes:
measure: The number of incidence of respiratory infections
timeFrame: Four months
Secondary outcomes:
measure: The incidence of adverse effects
timeFrame: Four months
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Reifuen Nursing Home
Study officials:
affiliation: Taiko Pharmaceutical Co., Ltd.
name: Norio Ogata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757600: Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Macular Hole
Official title: Long-term Anatomical and Functional Outcomes of Idiopathic Macular Hole Surgery. The Yield of Spectral-domain OCT Combined With Microperimetry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 23
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent successful surgery for MH defined as closure of the hole, at least 1 year before.

Brief summary: To evaluate the correlations between anatomical and functional changes studied with microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of idiopathic macular hole (MH).


Eligibility criteria: Inclusion Criteria:

* Closure of the hole seen on the OCT at 1 year postoperative

Exclusion Criteria:

* Patients with an axial length over 26 mm, diabetes, macular diseases, glaucoma, or postoperative retinal detachment were excluded

Primary outcomes:
measure: Macular sensitivity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Department CHU Dijon
state: Burgundy
Study officials:
References:
citation: Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26.