louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06833398: Comparison Between Arthroscopic Simple Biceps Tenotomy & Anchor Technique Tenotomy with Clinical and Ultrasound Assessment
Official title: Arthroscopic Simple Biceps Tenotomy Versus Anchor Tenotomy Technique, Clinical Outcome and Ultrasound Assessment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Simple Biceps Tenotomy
Anchor Tenotomy
Keywords: Arthroscopic biceps tenotomy
Long head of biceps tendon (LHB) Popeye deformity Ultrasound assessment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between arthroscopic simple biceps tenotomy \& anchor tenotomy technique regarding clinical outcomes \& ultrasound assessment

Detailed description: This research compares two surgical techniques for addressing pathologies of the long head of the biceps (LHB) tendon: arthroscopic simple biceps tenotomy and anchor tenotomy. The LHB tendon, originating from the supraglenoid tubercle, plays a critical role in forearm supination, elbow flexion, and shoulder abduction. Pathologies affecting this tendon often cause significant shoulder pain, with surgical options including tenotomy and tenodesis. While simple tenotomy is quick and avoids implant complications, it may result in cosmetic deformities like the "Popeye" sign and muscle cramps. Anchor tenotomy, a novel technique, aims to minimize these issues by preventing the Popeye deformity. This study employs a prospective randomized double-blinded controlled trial design at Assiut University Hospitals, involving 72 patients with LHB pathologies such as tendinitis, rotator cuff tears, and subacromial impingement. Exclusion criteria include prior tenodesis or neuromuscular diseases. Clinical outcomes will be assessed using functional scores (e.g., Oxford Shoulder Score), ultrasound evaluation of tendon positioning, and follow-up examinations at intervals up to one year post-surgery. The primary outcome focuses on the presence of the Popeye deformity, while secondary outcomes include postoperative shoulder function and tendon distalization measured via ultrasound. This research aims to provide evidence-based insights into the comparative effectiveness of these two techniques in improving clinical outcomes and minimizing complications.

Eligibility criteria: Inclusion Criteria:

* Patients with LHB pathologies such as :

Biceps tendinitis Rotator cuff tears Subacromial impengiment Instability \& traumatic causes

Exclusion Criteria:

* LHB Tenodesis Patients with neuromuscular disease

Primary outcomes:
measure: evaluate for popeye sign after arthroscopic simple biceps tenotomy vs anchor technique tenotomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT04299698: Interaction of Genetic and Environmental Factors for Body Fat Mass Control
Official title: Interaction of Genetic and Environmental Factors for Body Fat Mass Control: Observational Study for Lifestyle Modification and Genotyping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unrecognized Condition
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Semiconductor R&D center
First posted: 2020-03-09
Enrollment: 259
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are all lived in South Korea in Seoul and Kyeonggi-do.

Brief summary: Although the effect of interaction between genetic and environmental factors on body fat mass (BFM) has been proposed, how lifestyle changes affect body weight with regard to the genetic composition needs to be verified. The investigators designed an observational study, consisting of healthy adults with single nucleotide polymorphism (SNP) genotyping and longitudinal monitoring of lifestyle including food consumption and physical activities. The investigators recruited the participants who desired to control their body fat mass. Participants freely choose one of the options among carbohydrate intake reduction, fat intake reduction or exercise amount increment to control their body fat mass. Their lifelog on exercise and diet were collected, using a wearable device, for three months. Further, the investigators assessed anthropometric and serologic markers to measure the effect of participant's lifestyle modification. The investigators evaluate the influence of genetic compositions on body fat reduction induced by lifestyle change. Four different genome-wide polygenic scores (GPS) of volunteers are calculated to test the genetic effects of each modification. In this lifestyle observational study, the investigators expect to validate the interaction of genetic and environmental factors in determining BFM, and implicate the healthcare utility of lifestyle modifications using personalized and genomic perspective.


Eligibility criteria: Inclusion Criteria:

* Age from 19 to 65

Exclusion Criteria:

* Among those reveal to participate one who is under diabetes condition were excluded on the study.
* Pregnant women
* Participants taking weight control pills

Primary outcomes:
measure: Change of body fat mass
timeFrame: baseline and 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Genomic Institute
name: Woong-Yang Park, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01108198: Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study
Official title: Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Phimosis
Keywords: phimosis,
non-retractable foreskin
topical steroids
children
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 100
Sex: MALE
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: During last years topical steroid creams have been suggested to be effective treatment for non-retractable foreskin instead of circumcision.

Aim of this study is to investigate the efficacy, safety and persistence of treatment results of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.


Eligibility criteria: Inclusion Criteria:

* non-retractable foreskin requiring treatment

Exclusion Criteria:

* age under six years old, previous operation or steroid treatment for phimosis

Primary outcomes:
measure: Retractability of foreskin
timeFrame: 4-16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital, Department of Children and Adolescents
Study officials:
References:
Clinical trial NCT06808698: A Study of the Intestinal Microbiome in Patients with Cirrhosis
Official title: A Study of the Intestinal Microbiome in Patients with Cirrhosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting our hospital with liver cirrhosis

Brief summary: This study aims to establish a cohort for analyzing the gut microbiome of patients with liver cirrhosis and to identify factors that influence the prognosis of these patients.


Eligibility criteria: Inclusion Criteria:

1. Aged 19 years or older:
2. Patients visiting the hospital with liver cirrhosis.
3. Patients diagnosed with liver cirrhosis who can understand the information provided to them or their representatives and have voluntarily given written consent to participate in this study

Exclusion Criteria:

1. Cases not meeting the inclusion criteria
2. Patients who refuse participation
3. Patients who have taken or been administered antibiotics within the past 2 weeks or are scheduled to take or receive antibiotics during the study period
4. Cases where the diagnosis is unclear
5. Cases with incomplete data or missing investigation items
6. Individuals deemed unsuitable by the principal investigator for other reasons

Primary outcomes:
measure: Incidence rate of non-targeted complications according to changes in the gut microbiome
timeFrame: baseline, Month 12
Secondary outcomes:
measure: Liver cancer incidence rate according to gut microbiome composition
timeFrame: Baseline, 12 Month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02350998: Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Official title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bilateral Middle Ear Effusion
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
* Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
* Subject has a history of sensorineural hearing loss
* Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy

Primary outcomes:
measure: Otoscopic Examination: Auricle and Meatus
timeFrame: Up to 1 month
measure: Otoscopic Examination: Tympanic Membrane
timeFrame: up to 1 month
measure: Otoscopic Examination: Tube Patency
timeFrame: Up to 1 month
Secondary outcomes:
measure: Feasibility of Administration
timeFrame: Day 1
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Ear, Nose and Throat
state: California
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates
state: North Carolina
city: Matthews
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose and Throat
state: North Carolina
city: Orangeburg
country: United States
facility: Carolina Ear, Nose and Throat
state: South Carolina
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05265598: Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis (Sonic)
Official title: Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prosthetic-joint Infection
Keywords: debridement, antibiotics and implant retention (DAIR)
sonication fluid analysis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the required criteria will be extracted from an existing clinical consultation database of the clinic of infectious disease. All patients in this database were treated and recorded on a consultative base between 2011 and 2021 by the Department of Orthopaedics and Traumatology and the Department of Infectious Diseases at the University Hospital Basel for a suspected PJI.

Brief summary: This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Detailed description: Implant associated infections in orthopaedics and trauma surgery are a well-known and feared complication. Prosthetic-joint infection (PJI) is caused by a biofilm which is located atop the surface of the implant which as growing with the duration of the PJI. This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Eligibility criteria: Inclusion Criteria:

* patients who underwent a revision surgery of hip, knee and shoulder arthroplasties operated at the university hospital of Basel between 2011 and 2021,
* patients who had a PJI as a suspected diagnosis and
* have microbiological cultures from sonication fluid from removed prosthesis.

Exclusion Criteria:

* patients in the database who

  1. have non-bacterial microbiological positive cultures (e.g. fungal infection) and
  2. have not received a sonication of the removed prosthesis during the diagnostic process

Primary outcomes:
measure: number of bacteria
timeFrame: one time assessment at baseline
measure: duration of the infection
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Martin Clauss, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05990998: A Head-to-head Comparison of [68Ga]Ga-FAPI and [68Ga]Ga-TATE PET/CT in Patients With Nasopharyngeal Carcinoma: a Single-center, Prospective Study
Official title: First Affiliated Hospital of Fujian Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tumor Positron-Emission Tomography
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.

Detailed description: Patients with newly diagnosed or previously treated NPC will be recruited in this study.

Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and 68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.

Eligibility criteria: Inclusion Criteria:

* Patients of either gender, aged ≥ 18 years.

  * Patients with newly diagnosed or previously treated NPC
  * A diagnostic magnetic resonance imaging (MRI) of the tumor region within the previous 1 weeks prior to dosing day is available.
  * signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: SUVmax
timeFrame: through study completion, an average of 2 years
measure: Lesion numbers
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659398: Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Official title: Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mild Cognitive Impairment
Keywords: Alzheimer's Disease
cerebral blood flow
ophthalmic blood flow
blood viscosity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).


Eligibility criteria: Inclusion Criteria:

* An adult between 18 and 85 years of age.
* Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
* Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
* Able to speak and read English.
* Willing to comply with study specific instructions, and complete all study procedures according to protocol.
* Able to understand study rationale and sign informed consent.

Exclusion Criteria:

* Diagnosed with glaucoma
* History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
* Currently taking warfarin and dabigatran (Pradaxa).
* History of having arrhythmias - can interfere with EECP triggering.
* Subject has bleeding diathesis.
* Subject has active thrombophlebitis.
* Subject has severe lower extremity vaso-occlusive disease.
* Subject has a documented aortic aneurysm requiring surgical repair.
* Subject is pregnant.
* Subject with blood pressure higher than 180/110 mmHg.
* Subject with a heart rate more than 120 bpm.
* Subject with high risk of complications from increased venous return.
* Subject with clinically significant valvular disease.
* Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
* Subjects with pacemakers and other metallic implantable devices.

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: Baseline, Week 7, 6 Month
Secondary outcomes:
measure: Change in Ophthalmic blood flow (OBF)
timeFrame: Baseline to Week 7
measure: Change in Blood Viscosity
timeFrame: Baseline to Week 7
measure: Cholesterol composition of the blood
timeFrame: Baseline to week 7
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patrick Moriarty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376398: Survey: COVID-19 Patients Managed in the Operating Theatre of Belgian Hospitals
Official title: Survey on Patients With Suspected or Confirmed COVID-19 Requiring Anesthesia Care for Their Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Society for Anesthesia and Resuscitation of Belgium
First posted: 2020-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric and adult patients who are tested positive for COVID-19 or who are suspected to be infected and who require anesthesia care for their intervention

Brief summary: COVID-19 pandemic has an important impact on the health care provided by the anesthesiologists. Different societies of anesthesiology have provided guidelines and recommendations on how to manage patients who have been tested positive for COVID-19 or suspected to be infected. It is therefore important to know whether these guidelines have been implemented or were possible to be implemented. Otherwise patients who are presenting COVID-19 often show pulmonary complications. The airway management and the ventilation management of these patients can be therefore challenging and can possibly influence their outcome. It is thus important to obtain a large database with information about the characteristics of these patients, how these patients have been managed and their in-hospital outcome. Information regarding the correct implementation of guidelines is as well necessary for future guidance of health care providers.


Eligibility criteria: Inclusion Criteria:

* All patients (pediatric/adults/parturients) who are tested positive for COVID-19 or who are suspected to be infected

Exclusion Criteria: No oral consent

-

Primary outcomes:
measure: Global evaluation of the implication of the Belgian anesthesiologists during COVID-19 pandemic
timeFrame: 30 days
Secondary outcomes:
measure: If any compare our results with other countries
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
References: