louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05009641: Carnitine Supplementation and Skeletal Muscle Mass
Official title: Carnitine Supplementation and Skeletal Muscle Function in Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
First posted: 2021-08-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the current research project is to investigate the effect of carnitine supplementation on muscle strength and body composition.

A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body composition.


Eligibility criteria: Inclusion Criteria:

* must be able to swallow tablets

Exclusion Criteria:

* cardiovascular disease
* liver disease
* kidney disease
* neuromuscular disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
* other severe chronic diseases

Primary outcomes:
measure: Muscle Strength using Biodex System 4 Pro dynamometer
timeFrame: 24 weeks
measure: Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720)
timeFrame: 24 weeks
Secondary outcomes:
measure: Plasma trimethylamine N-oxide concentration
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01487941: Setrox JS Master Study
Official title: Efficacy and Safety of the Setrox JS Lead (J=J-shaped, S=Screw)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pacemaker indication

Brief summary: The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".


Eligibility criteria: Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Available for follow-up visits on a regular basis at the investigational site
* Contractual capability and ability to consent
* Age ≥18 years

Exclusion Criteria:

* Meet one or more of the contraindications for pacemaker therapy
* Permanent atrial fibrillation
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker
* Pregnant and breast-feeding women

Primary outcomes:
measure: Serious Adverse Device Effect rate
timeFrame: 6 months
measure: Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: SV. Anny Clinic Brno
Study officials:
References:
Clinical trial NCT05623241: MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING
Official title: PERSPECTIVE MONOCENTRIC STUDY: USE OF LIQUID BIOPSY AND DIAGNOSTIC IMAGING IN THE SEARCH FOR CIRCULATING TUMOR DNA IN PATIENTS WITH BREAST CANCER
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Liquid Biopsy
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The liquid biopsy will be performed on all patients who undergo a mammography examination in which a malignant focal aspect has been found and who agree to participate in the study. All patients enrolled in the study will be subjected to a peripheral venous blood sample. The ctDNA will be extracted for molecular analysis and will be performed with NGS (Next Generation Sequencing) technology.

Brief summary: Evaluation of the diagnostic accuracy of Mammography in the morpho-structural analysis of mammographic images in breast cancer-diagnosed patients or patients in follow-up for breast cancer by extracting a number of features describing the texture and morphology of the lesions reported in the form of a structured report explicitly developed for the study. Correlation of the data obtained from evaluating the primary endpoint with the genetic/molecular analysis on liquid biopsy.


Eligibility criteria: Inclusion Criteria:

* full information on the study and signature of the informed consent
* biopsy-proven breast cancer or previous surgery for breast cancer
* willingness of the patient to undergo liquid biopsy

Exclusion Criteria:

* state of pregnancy or breastfeeding
* patients operated on for benign or inflammatory diseases

Primary outcomes:
measure: Radiomic of breast cancers and liquid biopsy
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University "Luigi Vanvitelli"
Study officials:
References:
Clinical trial NCT05615441: Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
Official title: Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.


Eligibility criteria: Inclusion Criteria:

Adult patients between 19 and 64 years of age, ASA class I\~III, scheduled for arthroscopic knee surgeryunder general anesthesia.

Exclusion Criteria:

Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction\<55%, pregnant or breastfeeding patients, history of substance abuse/addiction

Primary outcomes:
measure: Intraoperative remifentanil requirement
timeFrame: Within the intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Seokyung Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01673841: Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.
Official title: Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Off-pump Coronary Artery Bypass Grafting
Keywords: bypass grafting
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Belgian Foundation for Cardiac Surgery
name: CAS Medical Systems, Inc.
First posted: 2012-08-28
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective off-pump coronary artery bypass grafting.

Brief summary: In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might be related to time delay issues and to the measurement technology.

42 consenting patients undergoing elective off-pump coronary artery bypass grafting were included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed just above the eyebrows, and the sensors of the other monitor were placed just above the former sensors. The sensors placement was determined at random by a computerized randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All variables were recorded continuously. The study ended at the end of the operation.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective off-pump coronary artery bypass grafting for at least 3-vessel coronary artery disease were eligible.

Exclusion Criteria:

* Patients with arteriovenous shunts, intracardiac shunts, a previous history of cerebrovascular accident, or stenosis of the internal carotid artery of \> 60% were excluded.

Primary outcomes:
measure: Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting.
timeFrame: 4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).
Secondary outcomes:
measure: The response of cerebral oxygen saturation to major haemodynamic disturbances.
timeFrame: 2 hours after start of operation (during placement of deep pericardial stitches).
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Annelies Moerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06052241: Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics
Official title: Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics: Efficacy Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dandruff
Folliculitis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective, single-center, pre-post comparative study
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate whether they can be improved by an AI-based personalized prescription of scalp cosmetics.


Eligibility criteria: Inclusion Criteria:

1. healthy adults aged \>19 years
2. presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple)

Exclusion Criteria:

1. presence of active infectious scalp diseases
2. history of treatment with topical or systemic steroids, oral immunosuppressants, topical or systemic antibiotics, or antifungal agents that could affect the scalp conditions, within 4 weeks prior to the baseline
3. difficulty understanding or following the protocol

Primary outcomes:
measure: Total Scalp Photographic Index (SPI) score
timeFrame: week 4
Secondary outcomes:
measure: Total Scalp Photographic Index (SPI) score
timeFrame: week 8
measure: Total Scalp Photographic Index (SPI) score
timeFrame: week 12
measure: subjective improvement in scalp conditions
timeFrame: week 4
measure: participant's satisfaction
timeFrame: week 4
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-Im Na, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06498141: MucinB5 Gene Polymorphism and Leucocytes Telomere Length in Interstitial Lung Diseases
Official title: MucinB5 rs (35705950) Gene Polymorphism and Leucocytes Telomere Length in Relation to Interstitial Lung Diseases.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mucin B5 rs (35705950) Gene Polymorphism in Interstitial Lung Diseases
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with interstitial lung diseases in our center in sohag university hospital

Brief summary: This is an observertional study aimed at Study the association between Mucin B5 rs (35705950) gene polymorphism and Leucocytes telomere length in relation to interstitial lung diseases.


Eligibility criteria: Inclusion Criteria:

This study will include patients with interstitial lung diseases aged above 18 years old.

Exclusion Criteria:

* patients with emphysema or obstructive lung diseases.
* patients with active cancer
* End stage renal failure (GFR \< 30 ml/min) or on dialysis
* Liver cell failure

Primary outcomes:
measure: MucinB5 rs (35705950) gene polymorphism
timeFrame: 6 Months
measure: Leucocytes telomere length
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hosoital
Study officials:
References:
Clinical trial NCT02354534: Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Official title: A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
High-risk HPV (Any Strain)
Keywords: cervical dysplasia
HPV
Treatment
preinvasive
cervix
vaginal suppository
Cornelia Trimble
abnormal pap
CIN
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Frantz Viral Therapeutics, LLC
First posted: 2015-02-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).

The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.

Detailed description: Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Capable of informed consent
* HPV-positive by DNA test
* Histologically confirmed CIN 2, CIN 3, or CIN 2/3
* Body weight ≥ 50 kg
* Immune competent

Exclusion Criteria:

* Pregnant and nursing women
* HIV seropositive
* Active autoimmune disease
* Taking immunosuppressive medication
* Evidence of concurrent adenocarcinoma in situ
* Concurrent malignancy except for nonmelanoma skin lesions

Primary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: 41 weeks
Secondary outcomes:
measure: Viral Clearance of HPV
timeFrame: 41 weeks
measure: Histologic Regression of CIN2/3
timeFrame: 41 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Towson
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cornelia L Trimble, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148417: Clinical Study of the Solo+ Tympanostomy Tube Device
Official title: Clinical Study of the Solo+ Tympanostomy Tube Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ear Infection
Otitis Media
Lead sponsor: AventaMed DAC
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Detailed description: The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

Eligibility criteria: Inclusion Criteria:

* Listed for bilateral tympanostomy tube insertion

Exclusion Criteria:

* Anatomy that precludes sufficient visualisation of both the left and right eardrum
* Narrow ear canals
* Anatomy that precludes safe access to both the left and right eardrum
* Membrane \>25% sclerosis
* Congenital or craniofacial abnormalities
* No available baseline audiometry and tympanometry

Primary outcomes:
measure: Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
timeFrame: Intra-operative
measure: Rate of Adverse Events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Queen's Medical Center
name: Matija Daniel
role: STUDY_CHAIR
References:
Clinical trial NCT02757417: Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency
Official title: A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ureteral Injury
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Megan Billow
name: Graham Chapman
name: Sangeeta Mahajan
name: Alex Soriano
name: Sherif El-Nashar
First posted: 2016-05-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.


Eligibility criteria: Inclusion Criteria:

* - Patients must be 18 years or older as well as willing and able to provide informed consent
* Patients undergoing a scheduled gynecologic procedure with cystoscopy

Exclusion Criteria:

* - Patients are younger than 18 years
* Patients are unable or unwilling to provide informed consent
* Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
* Patients with a history of renal insufficiency
* Patients with a history of liver disease
* Patients with a history of sickle cell disease
* Patients with a history of glucose-6-phosphate dehydrogenase deficiency
* Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma

Primary outcomes:
measure: differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups
timeFrame: 12 months
Secondary outcomes:
measure: number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT04522817: CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
Official title: CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Covid-19
Keywords: Pneumonia
COVID
SARs-CoV-2
Pulmonary Inflammation
Respiratory Distress Syndrome
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Insufficiency
ARDS
pandemic
Corona Virus Infection
Coronavirus
Lead sponsor: Lisata Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 0
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: This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.

Detailed description: This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.

Eligibility criteria: Inclusion Criteria:

* Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test
* Receiving or received ventilatory support for COVID-19 pneumonia/ARDS
* Evidence for ongoing pulmonary involvement based on P/F ratio \<300
* Able to provide informed consent

Exclusion Criteria:

* Immunocompromised or current use of immunosuppressive agents other than corticosteroids
* History of autoimmune disease
* Evidence of multiorgan failure
* Subject is pregnant or lactating at the time of signing the consent
* Participation in any other clinical trial of an experimental treatment for COVID-19
* History of sickle cell disease

Primary outcomes:
measure: Adverse events
timeFrame: Through end of study (6 months)
Secondary outcomes:
measure: Change in oxygen saturation
timeFrame: Change from baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: Chief Medical Officer, Caladrius Biosciences
name: Douglas W Losordo, MD
role: STUDY_DIRECTOR
References: