louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05122520: Hydrogen and Methane Breath Test Questionnaire
Official title: A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Intestinal Bacterial Overgrowth
Lead sponsor: The Functional Gut Clinic
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 1040
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients referred for Glucose and Lactulose HMBT at the Functional Gut Clinic will be approached to see if they would like to take part in this study

Brief summary: Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production.

Recently there has been a lot of work to done by experts in the field, to ensure that performance and interpretation of these tests are standardised, to help improve the clinical utility of these investigations. Although there is a lot of information currently available demonstrating the risk factors and symptoms associated with these conditions, there is a lack of data demonstrating the factors that might lead to a positive test according to these new parameters. This study aims to collect data on symptoms and medical history, in patients referred for lactulose and glucose HMBT in order further improve the effectiveness of this test in the future.


Eligibility criteria: Inclusion Criteria:

1. Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic
2. Participant has capacity to understand written English
3. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.

Primary outcomes:
measure: Determine positive predictive symptoms for SIBO positive participants determined by HMBT
timeFrame: At same time as breath test
Secondary outcomes:
measure: Determine positive predictive symptoms for excessive methane positive participants determined by HMBT
timeFrame: At same time as the breath test
measure: Determine the frequency of recognised and potential risk factors in SIBO positive participants
timeFrame: At the same time as the breath test
measure: Determine the frequency of recognised and potential risk factors in excessive methane positive participants
timeFrame: At the same time as the breath test
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Functional Gut Clinic
state: Greater Manchester
Study officials:
affiliation: The Functional Gut Clinic
name: Anthony Hobson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05272020: Outcome, Recuperation and Hemodynamics in Aortic Stenosis
Official title: PRognosis of Outcome and Recuperation of Cardiac Hemodynamic Function After Aortic Valve REplacement in Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.


Eligibility criteria: Inclusion Criteria:

* Every patient above 18 years of age with an echocardiographic established moderate to severe AS
* A guideline indication for aortic valve replacement therapy

Exclusion Criteria:

* Unable to perform exercise testing
* Previous aortic valve intervention
* More than moderate other valvular disease
* Patients refusing participation or unwilling to sign the informed consent

Primary outcomes:
measure: Outcome defined by the occurrence of a major cardiac event
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Lieven Herbots, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00588120: Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria
Official title: Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Enteric Hyperoxaluria
Hyperoxaluria
Keywords: Hyperoxaluria
Unknown Hyperoxaluria
Enteric Hyperoxaluria
Oxaluric
High Oxalate
Oxalate
C13
Oxalate Diet
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Oxalosis and Hyperoxaluria Foundation (OHF)
First posted: 2008-01-08
Enrollment: 114
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.

Detailed description: Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period.

Eligibility criteria: Inclusion Criteria:

* Age equal to or greater than 4 years (patient must be able to void on request).
* Have good health.

Exclusion Criteria:

* Any prior history of renal disease, or hypertension
* ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study.
* Subjects with GFR \< 50 cc/min will be excluded.

Primary outcomes:
measure: Urine oxalate measured following absorption of oral oxalate dose
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dawn Milliner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02956720: UltraShape Power in Combination With U-sculpt-n Transducer
Official title: Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circumference Reduction
Lead sponsor: Syneron Candela
Sponsor class: INDUSTRY
First posted: 2016-11-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single arm
Primary purpose: TREATMENT

Brief summary: Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.


Eligibility criteria: Inclusion Criteria:

1. Subject ≥18 and ≤60 years of age at the time of enrollment
2. Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
3. For women of child-bearing potential: negative urine pregnancy test
4. General good health confirmed by medical history and skin examination of the treated area
5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
3. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
4. Previous liposuction in the treatment areas within 12 months
5. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
6. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
7. Childbirth within the last 12 months or women who are breastfeeding a child

Primary outcomes:
measure: Outer thigh circumference reduction
timeFrame: up to 24 week
measure: Treatment-related adverse events
timeFrame: up to 24 week
Secondary outcomes:
measure: Subject satisfaction questionnaire
timeFrame: up to 24 week
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Beit Noah
Study officials:
References:
Clinical trial NCT02538120: Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients
Official title: Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-09-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated.

Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).

Detailed description: The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.

Eligibility criteria: Inclusion Criteria:

* Diabetes type 1 patients
* Matched control-subjects

Exclusion Criteria:

* Patients or subjects with anti-inflammatory drugs

Primary outcomes:
measure: Neurovascular microcirculatory response
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital
name: Severine Dubois, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marche P, Dubois S, Abraham P, Parot-Schinkel E, Gascoin L, Humeau-Heurtier A, Ducluzeau PH, Mahe G. Neurovascular microcirculatory vasodilation mediated by C-fibers and Transient receptor potential vanilloid-type-1 channels (TRPV 1) is impaired in type 1 diabetes. Sci Rep. 2017 Mar 13;7:44322. doi: 10.1038/srep44322.
Clinical trial NCT01174420: Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
Official title: A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open-angle Glaucoma
Keywords: ologen
Mitomycin-C
Collagen Matrix
trabeculectomy
glaucoma
filtering surgery
Lead sponsor: Aeon Astron Europe B.V.
Sponsor class: INDUSTRY
First posted: 2010-08-03
Enrollment: 40
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: The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.

Detailed description: ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.

The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or over
* Uncontrolled open-angle glaucoma
* Subject is willing to sign informed consent
* Subject is able and willing to complete post-operative follow-up requirements

Exclusion Criteria:

* Inflammatory eye diseases
* Angle-closure glaucoma
* Secondary glaucoma with anatomical malformations of the eye
* Subjects having single functional eye
* Previous conjunctival surgery
* Known allergic reactions to ingredients of ologen Collagen Matrix
* Excessive myopia (axial length (AL)\> 27 mm or more than -10 diopters)
* Previous vitrectomy eye surgery
* Subjects do not consent to participate

Primary outcomes:
measure: Intraocular pressure (IOP) reduction
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: The University Hospital of Cologne
Study officials:
affiliation: Department of Ophthalmology, University of Cologne, Germany
name: Thomas Dietlein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03362320: Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation
Official title: A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Austrian Research Group for Regenerative and Orthopedic Medicine
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 70
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: Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.


Eligibility criteria: Inclusion Criteria:

* patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
* tear size of at least 2.5 cm and up to 4.0 cm
* signed informed consent

Exclusion Criteria:

* axillary nerve palsy

Primary outcomes:
measure: Retear rate
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Constant-Murley score
timeFrame: baseline, 24 and 60 months postoperatively
measure: Range of motion (ROM)
timeFrame: baseline, 24 and 60 months postoperatively
measure: Satisfaction with the procedure
timeFrame: 24 and 60 months postoperatively
measure: VAS
timeFrame: baseline, 24 and 60 months postoperatively
measure: SST
timeFrame: baseline and 24 months postoperatively
measure: ASES
timeFrame: baseline, 24 and 60 months postoperatively
measure: qDASH
timeFrame: baseline, 24 and 60 months postoperatively
measure: WORC
timeFrame: baseline and 24 months postoperatively
measure: SSV
timeFrame: baseline, 24 and 60 months postoperatively
measure: SF-36
timeFrame: baseline, 24 and 60 months postoperatively
measure: Tendon integrity
timeFrame: baseline and 60 months postoperatively
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: St. Vincent Shoulder & Sports Clinic
Study officials:
affiliation: Austrian Research Group for Regenerative and Orthopedic Medicine
name: Werner Anderl, MD
role: STUDY_DIRECTOR
affiliation: Austrian Research Group for Regenerative and Orthopedic Medicine
name: Philipp R Heuberer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heuberer PR, Pauzenberger L, Gruber MS, Ostermann RC, Hexel M, Laky B, Anderl W. Delaminated Rotator Cuff Tears Showed Lower Short-term Retear Rates After Arthroscopic Double-Layer Repair Versus Bursal Layer-Only Repair: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):689-696. doi: 10.1177/0363546519897033. Epub 2020 Jan 9.
Clinical trial NCT05701020: Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test
Official title: Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Epidemiology
Keywords: Abnormal pap test
Sexual Dysfunction
Epidemiology
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Human Papilloma virus is the most common sexual infection in women, which can leads to cervical lesion and cervical cancer. Pap test is recommanded in women of 25 years old until 65 years old in order to screen subclinic lesions and improve prognosis. Yet, scientific knowledge about chronic disease showed negative consequences on quality of life.

However, no study until now has striven to evaluate the consequences of an abnormal pap test on sexuality in adult women. The aim of this study is to evaluate if an abnormal pap test have an impact on the sexual functions in women because of the anxiety and psychological consequences of the diagnosis


Eligibility criteria: Inclusion Criteria:

* Adult women with an abnormal pap test.
* Diagnosis known 4 to 12 weeks before the appointment for colposcopy

Exclusion Criteria:

* Cervical cancer
* Pregnancy

Primary outcomes:
measure: % ofpositive response rate at the first question of the questionnaire
timeFrame: 18 months
Secondary outcomes:
measure: Number of causes of woman alteration sexual function alteration
timeFrame: 18 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05610020: Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity
Official title: Heparin Binding Protein as a Reliable Prognostic Biomarker for Severity of Sepsis in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
HBP
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult confirmed septic patients

Brief summary: the aim of the study is to correlate between the severity of sepsis and serum heparin binding protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic biomarker in sepsis


Eligibility criteria: Inclusion Criteria:

* adult whose age between 20 to70 years old
* patients suffered from sepsis or septic shock (under the third international consensus definition of sepsis and septic shock)

Exclusion Criteria:

* Any pregnancy female
* Any patient who is Neutropenic secondary to malignancy
* Patients who is taking immunosuppressive therapy
* Patients who is suffering fromHematological malignancy

Primary outcomes:
measure: Evaluate the level of Heparin binding protein in relation to patient clinical improvement measured by SOFA Score
timeFrame: 72 hours after meeting sepsis ceriteria
Secondary outcomes:
measure: Heparin binding protein and mortality
timeFrame: 28 days after meeting sepsis ceriteria
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Omar Hamdy
Study officials:
References:
Clinical trial NCT05708820: Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control
Official title: Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type I
Keywords: Diabetes Mellitus, Type I
education programme
online
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.

Detailed description: Study area: adults with type 1 diabetes, HbA1c \>7.5%, \>3 years diagnosed. Methods: randomized clinical trial. It will include 60 participants . The improvement of Glycated Haemoglobin in both groups before and after intervention will be compared; adherence to the treatment, quality of life, time in the glycaemic range, perception of hypoglycaemia and knowledge about diabetes.

Eligibility criteria: Inclusion Criteria:

* HbA1c ≥7,5%
* More than 3 years of diagnosis
* Ability to follow online sessions
* Having a device to follow up the education programme

Exclusion Criteria:

* Pregnants
* People on corticosteroid treatment
* People with severe disease
* People with continuous subcutaneous insulin infusion (CSII)

Primary outcomes:
measure: HbA1c
timeFrame: Change from Baseline at 12 months
Secondary outcomes:
measure: Time in Range (TIR)
timeFrame: Change from Baseline at 12 months
measure: Knowledge related to diabetes management
timeFrame: Change from Baseline at 12 months
measure: Awareness of hypoglycemia
timeFrame: Change from Baseline at 12 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona
Study officials:
affiliation: Hospital Universitari Mútua Terrassa
name: Núria Alonso, RN
role: PRINCIPAL_INVESTIGATOR
References: