louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05003739: Hip Arthroplasty with Logica Mirror Femoral Stem
Official title: A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty with Logica Mirror Stem.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Replacement
Keywords: Cemented femoral stem
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 62
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 from Nemocnice Kyjov Hospital (CZ)

Brief summary: Logica Mirror femoral stem is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect additional evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within three years after the surgery, and thus to assess the short-term performance and safety of this implant.


Eligibility criteria: All patients that underwent partial or total hip arthroplasty and implanted with LOGICA MIRROR femoral stem between Jan 2010 and Dec 2021 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice.

Additional Inclusion criteria:

* Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment;
* Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF.

Exclusion criteria

* Age \< 18 years;
* Female patients who are pregnant, nursing, or planning a pregnancy

Primary outcomes:
measure: Harris Hip Score - Functional change
timeFrame: From preoperative (baseline) to 3 years after surgery
Secondary outcomes:
measure: Oxford Hip Score - Functional change
timeFrame: From preoperative (baseline) to 3 years after surgery
measure: VAS satisfaction
timeFrame: From 6 weeks to 3 years after surgery
measure: Radiographic implant evaluation and stability assessment of Logica Mirror stem
timeFrame: From discharge to 3 years after surgery
measure: Survival rate of the implant
timeFrame: 3 years
measure: Safety profile of Logica Mirror by recording adverse events (AE), serious adverse events (SAE), device deficiency (DD), adverse device effect (ADE), serious adverse device effect (SADE)
timeFrame: From intraoperative to 3 years after surgery
Other outcomes:
Locations:
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov Hospital
state: CZ Republic
Study officials:
References:
Clinical trial NCT04126239: Validation of a Food Addiction Screening Test
Official title: Validation Study of a Rapid Screening Test of Food Addiction in Patients Suffering From Obesity and Healthy Volunteer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Addiction
Obesity
Keywords: food Addiction
Obesity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 1610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * BMI ≥ 30
* Able to consent

Brief summary: Food addiction (FA) is a behavioral addiction characterized by a high consumption of palatable foods, which markedly activate the reward system, despite adverse consequences. FA was first described in 1956 but remains controversial. The Yale Food Addiction Scale (YFAS), developed by Gearhardt et al. in 2009, is currently regarded as the "Gold Standard" for FA screening. In a previous study, we established a Food Addiction Screening Test using artificial intelligence. The main objective of the present study is to validate the sensitivity, specificity and precision for FA diagnosis in a sample of patient suffering from obesity and healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30
* Able to consent

Exclusion Criteria:

* Non-french speaker
* Patient unable to use internet tools

Primary outcomes:
measure: FAST score
timeFrame: Baseline
measure: YFAS 2.0
timeFrame: Baseline
measure: BES score
timeFrame: Baseline
measure: DEBQ score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Sylvain ICETA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Emmanuel Disse, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486639: Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
Official title: Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder Syndrome
Bladder Outlet Obstruction
Benign Prostate Enlargement
Stress Incontinence (Female) (Male)
Bladder Disease
Keywords: Urodynamics
Bladder sensation
confounding factors
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-04-03
Enrollment: 330
Sex: ALL
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: All patients reffered to Asaf HaRofeh Medical Center for Urodynamic examination

Brief summary: Urodynamic examination evaluates storage and empting phases of the urinary bladder. It enables the clinician to correlate physiologic findings to patients' complains. The data gathered during the examination divided to storage and empting.

During the storage phase, bladder sensation is measured while the bladder is filled with sterile water. During years of practice, we noticed that early sensation (bladder over-sensitivity) is occasionally associated with bladder outlet obstruction (as demonstrated in the emptying phase of the examination.

Detailed description: The study includes patients who were referred to Urodynamics examination due to lower urinary tract symptoms. There is no actual intervention during the examination. Though, patients are asked to fill an International prostate symptom score (IPSS-questionnaires).

Eligibility criteria: Inclusion Criteria:

* All patients refered to Asaf HaRofeh Medical Center for Urodynamic examination

Exclusion Criteria:

* Inability to sign an informed concent
* Administration of analgesics 8 hours prior to the examination
* Known urethral stricture
* Chronic bladder or urethral pain
* Active cystitis
* Permanent urinary catheter

Primary outcomes:
measure: Early sensation during the filling phase
timeFrame: During the urodynamic examination
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell Walsh Urology chapter 73
citation: Lee WC, Wu HP, Tai TY, Yu HJ, Chiang PH. Investigation of urodynamic characteristics and bladder sensory function in the early stages of diabetic bladder dysfunction in women with type 2 diabetes. J Urol. 2009 Jan;181(1):198-203. doi: 10.1016/j.juro.2008.09.021. Epub 2008 Nov 14.
citation: Schurch B, Schmid DM, Kaegi K. Value of sensory examination in predicting bladder function in patients with T12-L1 fractures and spinal cord injury. Arch Phys Med Rehabil. 2003 Jan;84(1):83-9. doi: 10.1053/apmr.2003.50007.
citation: El-Zawahry A, Alanee S, Malan-Elzawahry A. The Use of Urodynamics Assessment Before the Surgical Treatment of BPH. Curr Urol Rep. 2016 Oct;17(10):73. doi: 10.1007/s11934-016-0626-y.
Clinical trial NCT04607239: The Impact of Telemonitoring in the Management of Hypertension
Official title: HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Services Administration
Telemedicine
Hypertension
Keywords: Telecommunication
Telecare
Teleconsult
Telemanagement
Telemonitoring
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 460
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from:

* a weekly telephone call for collection of home Blood Pressure measurements , therapeutic education \& treatment compliance check
* a monthly call for treatment titration and side effects check
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.


Eligibility criteria: Inclusion Criteria:

Included are patients with:

* age ≥ 35 years old
* newly diagnosed hypertention
* uncontrolled hypertention

Exclusion Criteria:

Excluded are patients with:

* orthostatic hypotension
* chronic renal failure (serum creatinine \> 200 micromol / L)
* acute coronary syndrome
* coronary revascularization or stroke within the past 3 months
* known secondary causes of hypertension
* pregnancy
* New York Heart Association Class III or IV heart failure or left ventricular ejection fraction \< 30%
* dementia or another cause that prevents the application of remote monitoring

Primary outcomes:
measure: Mean of 24h systolic blood pressure (SBP)
timeFrame: 0 - 180 days
Secondary outcomes:
measure: Mean of 24h diastolic blood pressure (DBP)
timeFrame: 0-180 days
measure: percentage of blood pressure load
timeFrame: 0-180 days
measure: percentage of Dipping
timeFrame: 0-180 days
measure: Mean of the Short Form survey (SF-12) scores
timeFrame: 0-180 days
measure: frequency of cardiovascular complications
timeFrame: 180 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba Hospital
Study officials:
References:
citation: Ben Hafaiedh S, Ben Daya Y, Radoui AH, Bouchoucha M, Razgallah R, Nouira S. Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study). JMIR Res Protoc. 2022 Mar 1;11(3):e26184. doi: 10.2196/26184.
Clinical trial NCT03595839: Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula
Official title: Fistuolotomy With or Without Marsupialization for Treatment of Simple Anal Fistula: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.


Eligibility criteria: Inclusion Criteria:

* Both genders
* Age: 18-65 years
* All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

Exclusion Criteria:

* High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
* Recurrent anal fistulas.
* Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
* High risk patients according to ASA (American society of anesthesiologists )
* Any degree of incontinence.
* Patients with previous anal surgery.

Primary outcomes:
measure: Time to complete healing
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279939: Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Official title: Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Vascular
Normal Eyes
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 95
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

Detailed description: The objectives of this study are:

1. To compare the OCTA image quality between the SPECTRALIS and the predicate.
2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.

Eligibility criteria: Inclusion Criteria:

All subjects:

* Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
* Age ≥ 22

Subjects with Normal Eyes:

* Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
* Corrected visual acuity ≥ 20/40 in each eye
* No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye

Subjects with Pathology:

* Subjects with retinal conditions in at least one eye.
* Subjects included can have a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

Exclusion Criteria:

* Subjects unable to read or write
* Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
* Subjects who cannot tolerate the imaging procedures
* Subjects with known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
* Subjects with contraindication to pupillary dilation in study eye

Primary outcomes:
measure: OCTA image quality
timeFrame: day 1
measure: Clinically relevant findings on OCTA
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
affiliation: Retina Consultants Houston
name: David Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03387839: Antero-Posterior Knee Stability
Official title: Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Total Knee Arthroplasty
Stability
Knee Osteoarthritis
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Internal database of prior total knee replacement patients.

Brief summary: A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Patients willing to sign the informed consent.
* Patients able to comply with study requirements including stress x-rays and self-evaluations.
* Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
* Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.
* Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* Patients that have had a high tibial osteotomy or femoral osteotomy.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers.
* Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
* Patients with knee fusion to the affected joint.
* Patients with an active or suspected latent infection in or about the knee joint.
* Patients that are prisoners.

Primary outcomes:
measure: Measurement of antero-posterior stability of the knee with stress x-rays.
timeFrame: 1 year post-operative
Secondary outcomes:
measure: Knee Society Score (KSS)
timeFrame: 1 year post-operative
measure: Lower Extremity Activity Scale (LEAS)
timeFrame: 1 year post-operative
measure: Forgotten Joint Score (FJS)
timeFrame: 1 year post-operative
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center
name: David F Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05863039: Resistance Training With Blood Flow Restriction
Official title: Resistance Training With Blood Flow Restriction for the Lower Extremity Muscles
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: resistance training
strength training
blood flow restriction
motor units
body composition
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Blood flow restriction associated with resistance training is suggested to potentiate increases in muscular strength and hypertrophy. This study will compare the effects of resistance training associated with blood flow restriction with a regular resistance training program. Findings of this project will provide important information regarding a promising intervention to potentiate muscle performance.

Detailed description: The purpose of this study is to determine alterations in motor unit behavior of the tibialis anterior muscles after a resistance exercise program associated with blood flow restriction. Our working hypothesis is that blood flow restriction to working muscles will induce greater changes in muscle activation, lean mass and muscle size compared with a training at same intensity without blood flow restriction.

Eligibility criteria: Exclusion Criteria:

* presence of neurological diseases,
* presence of metal implants or joint replacement
* any restriction to perform physical activity
* pregnancy

Primary outcomes:
measure: Force
timeFrame: 10 sessions (up to 6 weeks)
Secondary outcomes:
measure: Body composition
timeFrame: Start and end of the protocol
Other outcomes:
Locations:
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Hugo Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619239: Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
Official title: A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Newly Diagnosed Glioblastoma
Keywords: Phase 1b
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Patients will be enrolled in two stages:

* Dose-escalation stage: Approximately 12-24 patients will be enrolled.

Detailed description: Detailed Description:

• Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7

* pre-determined dose(Level I)\~ pre-determined dose(Level IV)

Eligibility criteria: \[Inclusion Criteria\]

1. Ability to understand and willingness to sign a written informed consent document (ICF).
2. Age ≥ 19 years
3. Able to comply with the study protocol, in the investigator's judgment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

\[Exclusion Criteria\] General Exclusion Criteria

1. Unable to comply with study and follow-up procedures
2. Is pregnant or breastfeeding
3. Have clinically significant cardiac disease (New York Heart Association, Class II or greater) including myocardial infarction, unstable arrhythmias, and/or unstable angina in the past 3 months
4. Have clinically significant liver disease, including alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

Primary outcomes:
measure: DLT(Dose-Limiting Toxicity) Assessment
timeFrame: Through study completion, an average of 2 years
measure: Incidence, nature and severity of Adverse events
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: PD(pharmacodynamic) profile [ALC result]
timeFrame: Through study completion, an average of 2 years
measure: Anti-tumor Activity [OS]
timeFrame: Through study completion, an average of 2 years
measure: Anti-tumor Activity [PFS]
timeFrame: Through study completion, an average of 2 years
measure: Immunogenicity[ ADA and neutralizing antibody]
timeFrame: Through study completion, an average of 2 years
measure: Exploratory Biomarker [serum Interleukin-7]
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
state: Seocho
Study officials:
References: