louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03990298: Prospective Use of Awake Endoscopy for Inspire Activation
Official title: Prospective Use of Awake Endoscopy to Direct Inspire Therapy for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to examine a new method of device configuration for the Inspire upper airway stimulator. First, the investigators will attempt to determine optimal configuration by quantifying changes in upper airway size with different implant configurations using awake nasal endoscopy. The configuration/voltage that results in the greatest increase in upper airway size and is tolerated by the patient will be selected. Participants will then undergo a sleep study so that increased airway size may be correlated with changes in sleep study parameters including AHI and oxygen desaturation index (ODI). Airway size and sleep study parameters using the standard device configuration (+-+)/voltage will be compared to airway size and sleep study parameters using the test, or "optimal," configuration/voltage to determine the usefulness of awake endoscopy in activation of the Inspire device.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe OSA who have undergone Inspire UAS implantation by the principal investigator
* Must have symptoms of OSA prior to Inspire implantation
* AHI between 15 and 65, where central and mixed apnea is 25% or more, and the level of collapse is in the soft palate area BMI less than 32
* Age 18 or above

Exclusion Criteria:

* Significant central sleep apnea
* Presence of other sleep disorders
* History of neurologic or neuromuscular disease
* Historical or present substance abuse
* Bleeding disorders
* Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
* Pregnancy

Primary outcomes:
measure: Distribution of Electrode Configurations Resulting in Greatest Retropalatal Expansion Among Cohort Subjects
timeFrame: One month after surgical implantation of UAS
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Erica Thaler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053698: Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.
Official title: Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Keywords: Aqueous Flare
Retinal Detachment
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 48
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: All patients addressed at the Ophthalmology Department for Rhegmatogenous Retinal Detachment and who matched the inclusion criteria.

Brief summary: To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :

* Group 1 : 48 eyes primarily treated with gas tamponade
* Group 2 : 11 eyes primarily treated with silicone oil tamponade
* Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
* Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse


Eligibility criteria: Inclusion Criteria:

* adult patients
* patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade)
* aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months

Exclusion Criteria:

* diabetic retinopathy
* glaucoma
* non rhegmatogenous retinal detachment
* active uveitis
* pseudoexfoliation syndrome.

Primary outcomes:
measure: Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)
timeFrame: preoperatively and postoperatively at 2 weeks and 3 months after surgery
Secondary outcomes:
measure: Change in aqueous flare measurement (measured with a laser flare-cell meter)
timeFrame: postoperatively at 2 weeks and 3 months after surgery
measure: Comparison of aqueous flare values (measured with a laser flare-cell meter) between patients who relapsed and patients who didn't relapse
timeFrame: preoperative
measure: Evolution of measures of visual acuity
timeFrame: preoperatively and postoperatively at 3 months
measure: Evolution of macular status
timeFrame: preoperatively and postoperatively at 3 months
measure: Relapsing status (yes or not)
timeFrame: at 3 months postoperative
Other outcomes:
Locations:
city: Nancy
country: France
facility: BERROD Jean-Paul MD
state: Grand EST
Study officials:
affiliation: Central Hospital, Nancy, France
name: Jean-Paul BERROD, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03097198: Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia
Official title: Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Keywords: Juvenile
Traditional Chinese Medicine
Plum-blossom needle
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 98
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.

Detailed description: Plum-blossom needle is a historical treatment technology of Traditional Chinese Medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.

Eligibility criteria: Inclusion Criteria:

* The result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal
* Distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses
* Myopia diopter spherical lenses must be ≤-3.00 D which measured under cycloplegia
* Subjects must be between 8 and 20 years of age

Exclusion Criteria:

* Diopter spherical lenses be \>-3.00 D , or uncorrected distance visual acuity \<0.1, or pathologic myopia with eye complications
* Diopter spherical lense ≥1.50 D or cylindrical lenses ≥1.00 D, as measured under cycloplegia
* The affected eyes have other diseases which affect the determination of acupuncture efficacy
* Subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases
* Longterm use of other related drugs or treatments, which have not been terminated
* Parents or subjects refuse to participate this trial
* Participating other ongoing clinical trials

Primary outcomes:
measure: Changes of vision acuity
timeFrame: Every 30 days for 150 days
measure: Changes of cycloplegic refractive errors
timeFrame: Every 30 days for 150 days
Secondary outcomes:
measure: Changes of accommodation responses
timeFrame: Every 30 days for 150 days
measure: Changes of accommodation facility
timeFrame: Every 30 days for 150 days
measure: Changes of ciliary body thickness
timeFrame: Every 30 days for 150 days
measure: Changes of axial length
timeFrame: Every 30 days for 150 days
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Clinical&Epidemiological Eye Research Center
name: Yuanbo Liang, Doctor
role: STUDY_DIRECTOR
References:
citation: Chen L, Liang Y, Xu M, Zheng J, Yu H, Tang L. Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial. J Tradit Chin Med. 2020 Apr;40(2):333-339.
Clinical trial NCT06288698: Understanding Patient Engagement Trends in TBI Clinical Research
Official title: Analyzing Enrolment and Engagement Trends in Individuals Confronting TBI: Insights From TBI Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: TBI
Keywords: TBI
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with TBI who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Participant must be 18 years of age or older
* Confirmed diagnosis of TBI

Exclusion Criteria:

* Enrolled in another research study
* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Inability to provide written informed consent

Primary outcomes:
measure: Number of TBI patients who decide to enroll in a clinical research
timeFrame: 3 months
measure: Rate of TBI patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Perry DC, Sturm VE, Peterson MJ, Pieper CF, Bullock T, Boeve BF, Miller BL, Guskiewicz KM, Berger MS, Kramer JH, Welsh-Bohmer KA. Association of traumatic brain injury with subsequent neurological and psychiatric disease: a meta-analysis. J Neurosurg. 2016 Feb;124(2):511-26. doi: 10.3171/2015.2.JNS14503. Epub 2015 Aug 28.
citation: Kaur P, Sharma S. Recent Advances in Pathophysiology of Traumatic Brain Injury. Curr Neuropharmacol. 2018;16(8):1224-1238. doi: 10.2174/1570159X15666170613083606.
citation: VanderVeen JD. TBI as a Risk Factor for Substance Use Behaviors: A Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1198-1209. doi: 10.1016/j.apmr.2020.10.112. Epub 2020 Nov 2.
Clinical trial NCT05513898: Treatment of Pilonidal Cyst With Holmium Laser
Official title: Treatment of Pilonidal Cyst With Holmium Laser
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Cyst
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 231
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: The patients participating in the study were operated on at the centre between AUGUST and NOVEMBER 2020. The study is based solely on a review of the medical records of these patients. No further evaluation is planned.

Brief summary: Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

Detailed description: From the medical records of a series of patients treated for pilonidal cysts with Holmium laser:

1. Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing)
2. Secondary objectives: to assess the following:

   * Healing rate at last follow-up (1 month after surgery)
   * Recurrence rate at last follow-up (1 month after surgery)
   * Consumption of \>1 level analgesics in the week and month following the procedure
   * Duration of nursing care

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older, who has been informed of the research;
* Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure.

Exclusion Criteria:

* Patient under legal protection, guardianship or curatorship;
* Patient who has indicated his opposition to the use of his data.
* Patient undergoing emergency surgery for an abscess

Primary outcomes:
measure: Healing rate
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT03700398: Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma
Official title: Early Detection of Oropharyngeal and Hypopharyngeal Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma by White Light Imaging and Optical Enhancement(OE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Optical Enhancement Endoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 214
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: the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.


Eligibility criteria: Inclusion Criteria:

* order than 18 years old
* Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma

Exclusion Criteria:

* Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
* Advanced pharynx/hypopharyngeal squamous cell carcinoma
* Pregnant women and lactating women
* pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
* Previous chemotherapy or radiation therapy affected observation
* Not completed gastroscopy or refused to take biopsy for various reasons
* Mental illnesses such as anxiety and depression affect the endoscopic observation
* Severe systemic disease, can not tolerate gastroscopy
* Refusal to sign informed consent books

Primary outcomes:
measure: detect rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00126698: Prophylactic Antibiotics on Urethral Catheter Withdrawal
Official title: Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Bacteriuria
Keywords: Bacteriuria
Urinary Catheter
Urinary tract infection
Prophylaxis
Urinary catheter removal
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2005-08-04
Enrollment: 100
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: Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.

Detailed description: Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The researchers undertake a double-blind, placebo-controlled trial to assess the efficacy of single-dose therapy of trimethoprim-sulfamethoxazole or ciprofloxacin, versus placebo therapy in selected groups of surgical patients who had bladder drainage scheduled to last longer than 3 days.

Eligibility criteria: Inclusion Criteria:

* Urethral catheter in situ for at least 3 days (72h)

Exclusion Criteria:

* Pregnancy
* Impaired renal or hepatic function (serum creatinine \> 150 mmol/l, serum transaminases \> 75 IU/l)
* Fever
* Symptomatic urinary tract infection
* Antibiotic use ≤ 48 hours before urinary catheter removal
* Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin
* Urologic pathology

Primary outcomes:
measure: Symptomatic bacteriuria
measure: Asymptomatic bacteriuria
Secondary outcomes:
measure: Antibiotic resistance patterns
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Hospital
state: Utrecht
Study officials:
affiliation: Sint Antonius Hospital, Nieuwegein
name: M. Tersmette, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03418298: Prehabilitation in Patients With Esophageal or Gastric Cancers
Official title: Prehabilitation in Patients With Esophageal or Gastric Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 30
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: Objectives: The primary objective of this study is to assess the feasibility of a internet-based preoperative exercise program in patients with esophageal or gastric cancers. Secondary objectives are to evaluate the effects of this preoperative program on functional capacity, anxiety and depression, quality of life and fatigue Methods: This feasibility study will be conduct at University Hospital Saint-Luc in Brussels. Twenty patients with esophageal or gastric cancers will participate in internet-based program 3 sessions per week. Each session will combine aerobic and resistance training. Moreover, inspiratory muscle strengthening (IMT) will be performed daily. The researcher will conduct weekly telephone calls to educate and motivate subjects. Assessments will be performed at baseline, one day before surgery, 1 month and 3 months after surgery. The following parameters will be measured: functional capacity, quality of life, fatigue, anxiety and depression.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of esophageal cancer or gastric cancer requiring surgery
* More than 18 years
* Able to read, write and understand French or English
* Time before surgery \> 2 weeks

Exclusion Criteria:

* Surgical emergency
* Cognitive or neuropsychiatric diseases
* Neuromuscular or orthopedic disorders limiting exercises
* Cardiopulmonary disease contraindicating exercises

Primary outcomes:
measure: Retention rate
timeFrame: At study completion (3 months after surgery)
measure: Attendance
timeFrame: At study completion (3 months after surgery)
measure: Program satisfaction
timeFrame: At study completion (3 months after surgery)
measure: Percentage of patients who experienced one or more adverse events
timeFrame: At study completion (3 months after surgery)
measure: Recruitment rate
timeFrame: At study completion (3 months after surgery)
Secondary outcomes:
measure: Change in functional capacity
timeFrame: Baseline, one day before surgery, 1 and 3 months after surgery
measure: Change in quality of life
timeFrame: Baseline, one day before surgery, 1 and 3 months after surgery
measure: Change in fatigue
timeFrame: Baseline, one day before surgery, 1 and 3 months after surgery
measure: Change in anxiety and depression
timeFrame: Baseline, one day before surgery, 1 and 3 months after surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Woluwé-Saint-Lambert
Study officials:
References:
Clinical trial NCT04092998: Circumcision With Use of Thermocautery and Histopathological Changes
Official title: Histopathological Changes and Surgical Complications in Thermocautery Circumcision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circumcision
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: male infant presented for Circumcision
Primary purpose: TREATMENT

Brief summary: Histo pathological changes that occurs in thermo cautery circumcision and the range of damage prepuce from thermal effect in comparison with scalpel circumcision

Detailed description: Circumcision is one of the most commonly performed surgical procedures worldwide. It is known that more than one million children are circumcised annually in the USA alone . Moreover, the WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS . Because of this, thousands of people have been circumcised by many migratory circumcision teams, especially in Africa.

Considering that 1 200 000 children are born annually in Turkey and 51% of them are male, on the basis of data from the Turkish Institute of Statistics, it may be speculated that about 60 000 circumcisions are performed annually in Turkey.

However, the circumcision procedure cannot be performed in health institutions as a routine procedure because of health regulations. When the Social Security Institute incorporated circumcision into the social insurance coverage in 2007, it led to circumcision being performed in the health institutions. Health institutions that were already burdened cannot meet the demands for circumcision. Thus, the search has begun for faster and reliable circumcision techniques with fewer complications. The present study aimed to compare bipolar thermal cautery-assisted circumcision technique, considered to be capable of meeting such demands, with the classical circumcision technique.

Aim of Work This study is aiming to assess the outcome of using thermo cautery in circumcision

Surgical Steps:

small skin incision over prepuce by thermo cautery

stitching if there is bleeding

Insertion of a urinary catheter if suspect uretheral injury

Eligibility criteria: Inclusion Criteria:

* all male gender

Exclusion Criteria:

* females
* micro penis
* hypospedias
* epispedias
* ambigilious genitalia

Primary outcomes:
measure: early wound complications
timeFrame: 1 week
measure: late wound complications
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: gamal makhlouf
role: STUDY_DIRECTOR
References: