louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01084187: Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction
Official title: Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Arterial Hypertension
Endothelial Dysfunction
Keywords: erectile dysfunction
arterial hypertension
flow mediated vasodilation
endothelial dysfunction
carotid intima media thickness
vardenafil
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.

Detailed description: To achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. All patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. They will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.

Eligibility criteria: Inclusion Criteria:

* arterial hypertension and erectile dysfunction of vascular origin for at least 6 month

Exclusion Criteria:

* other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event

Primary outcomes:
measure: clinical response to vardenafil
timeFrame: four weeks
Secondary outcomes:
measure: endothelial dysfunction
timeFrame: four weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
Study officials:
affiliation: Hospital Universitario Pedro Ernesto
name: Mario F Neves, MD, PhD.
role: STUDY_CHAIR
affiliation: State University of Rio de Janeiro
name: Valter Javaroni, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Wille Oigman, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05329987: Analysis of Postural Transitions in Subjects Affected by Parkinson Disease
Official title: Analysis of Postural Transitions in Subjects Affected by Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Rehabilitation
Postural Transfers
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 23
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: Population of subjects affected by Parkinson Disease

Brief summary: This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.


Eligibility criteria: Inclusion Criteria:

* Subjects with Idiopathic Parkinson's Disease;
* Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
* Subjects must be able to walk at least 10 meters independently with or without any walking aid

Exclusion Criteria:

* Non-clinically stable subjects;
* Subjects in OFF phase during the evaluations;
* Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
* Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)

Primary outcomes:
measure: Change in execution time of Postural Transfers
timeFrame: Change from Baseline at 10 weeks
measure: Change of execution velocity of Postural Transfers
timeFrame: Change from Baseline at 10 weeks
measure: Change of antero-posterior acceleration during Postural Transfers execution
timeFrame: Change from Baseline at 10 weeks
measure: Change of superior-inferior acceleration during Postural Transfers execution
timeFrame: Change from Baseline at 10 weeks
Secondary outcomes:
measure: Change in Time Up and Go Test
timeFrame: Change from baseline at 10 weeks
measure: Change in 10 meter walking test
timeFrame: Change from baseline at 10 weeks
measure: Change in Berg Balance Scale Score
timeFrame: Change from baseline at 10 weeks
measure: Change in Short-Form 12 score
timeFrame: Change from baseline at 10 weeks
Other outcomes:
Locations:
city: Rovato
country: Italy
facility: Fondazione Don Carlo Gnocchi
state: BS
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Riccardo Buraschi, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06713187: Interleukin23 in Systemic Lupus
Official title: Role of Interleukin 23 in Systemic Lupus Erythematosus Related Interstial Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus Related Interstial Lung Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: assement of interleukin 23 in serum of patients with systemic lupus erythematosus related interstial lung disease .

Detailed description: for all patients detailed history taken clinical and rhumatological examination will be assessed and SLEDAI score will be collected from the case record of the patients\&laboratory investigation included 1_erythrocytic sedimentation rate.2_complete blood count.3_interleukin23 .4_complement 3\&4.5_Antinuclear Antibodies.6_Anti double stranded antibodies.7_full basic biochemical test(24 urine protien)8_high resolution computed tomography.

Eligibility criteria: Inclusion Criteria:

* patients with systemic lupus erythematous and patients with systemic lupus erythematosus with interstial lung disease.

Exclusion Criteria:

* patients with chest conditions rather than interstial lung disease \&who receiving biological blocking antibodies\& those treated with immunosuppressive drugs.

Primary outcomes:
measure: interleukin 23
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
citation: Yap DY, Lai KN. Cytokines and their roles in the pathogenesis of systemic lupus erythematosus: from basics to recent advances. J Biomed Biotechnol. 2010;2010:365083. doi: 10.1155/2010/365083. Epub 2010 May 6.
citation: Haroon MM, Hegazy GA, Hassanien MA, Shaker O, Hussein WH. Significance of Interleukin 23 in Systemic Lupus Patients: Relation to Disease Activity and Damage Indices. Biologics. 2023 Jan 18;17:1-9. doi: 10.2147/BTT.S389021. eCollection 2023.
citation: Sisto M, Lisi S. Interleukin-23 Involved in Fibrotic Autoimmune Diseases: New Discoveries. J Clin Med. 2023 Sep 1;12(17):5699. doi: 10.3390/jcm12175699.
citation: Senoo S, Taniguchi A, Itano J, Oda N, Morichika D, Fujii U, Guo L, Sunami R, Kanehiro A, Tokioka F, Yoshimura A, Kiura K, Maeda Y, Miyahara N. Essential role of IL-23 in the development of acute exacerbation of pulmonary fibrosis. Am J Physiol Lung Cell Mol Physiol. 2021 Nov 1;321(5):L925-L940. doi: 10.1152/ajplung.00582.2020. Epub 2021 Sep 15.
Clinical trial NCT01733433: Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability
Official title: Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability (CAI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ankle Instability
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. Subjects with CAI will perform these exercises with and without tape. Hypothesis is that subjects with CAI that tape will enhance postural control.


Eligibility criteria: Inclusion Criteria:

* a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks
* repeated ankle sprains
* presence of giving way
* feeling of weakness around the ankle
* a decreased functional participation (recreational, competitive or professionally)

Exclusion Criteria:

Primary outcomes:
measure: Immediate postural control with tape on ankle.
timeFrame: for 75 minutes, the duration of the exercises.
Secondary outcomes:
measure: Subjective evaluation of the effect of taping on pain
timeFrame: 1 minute after the exercises (which last approximately 75 minutes).
measure: Subjective evaluation of the effect of taping on difficulty level.
timeFrame: 1 minute after the exercises (which last approximately 75 minutes).
measure: Subject evaluation of the effect of taping on instability feelings.
timeFrame: 1 minute after the exercises (which last approximately 75 minutes).
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Philip Roosen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04934033: Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice
Official title: Nice Healthy Brain - Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to constitute a cohort of healthy subjects in brain MRI, including functional and diffusion sequences, together with a language and cognitive assessment. This will make it possible to compare the data with those obtained in the same center and under the same examination conditions in brain tumor patients. The investigators seek to evidence general patterns of cerebral morphological and functional changes, correlated with behavioural scores, in brain-damaged patients.


Eligibility criteria: Inclusion Criteria:

* cerebral and psychiatric healthy volunteer
* agreeing to participate in this research
* 30 and 50 years old or between 60 and 75 years old

Exclusion Criteria:

* contra-indication to MRI
* refusal of patient participation
* pregnant, lactating or parturient women
* vulnerable people

Primary outcomes:
measure: Number of cerebral MRI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
state: Provence Alpes Cote d'Azur
Study officials:
References:
Clinical trial NCT01895933: Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
Official title: The Aim of This Study is to Evaluate the Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel Made by D Med
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Keywords: Investigational device (chitosan gel)
Wound healing
Endoscopic sinus surgery
SurgiShield
Lead sponsor: D.med
Sponsor class: INDUSTRY
Collaborators: name: Dankook University
name: Chungbuk National University
First posted: 2013-07-11
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* older than 21 years of age
* both side sinusitis
* will undergo endoscopic sinus surgery
* volunteers with informed consent and signature

Exclusion Criteria:

* suppressed immunity patient
* systemic grave condition
* pregnant
* cancer
* severe disease patients
* asthma patients
* AIDS
* cystic fibrosis
* ciliary immobility syndrome
* neutropenia neutrophil
* immunoglobulin deficiency
* wound healing immune disease
* severe liver disease
* severe kidney disease
* lymph or blood clotting disorder or patients treated with coagulants
* patients taking oral or parenteral glucose for diabetes thrombocytopenia
* infectious disease
* currently lactating
* severe septal deviation
* case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the Lund-Mackey CT scan scoring system PNS(ParaNasalSinus)
* shellfish allergy
* food allergy
* had endoscopic sinus surgery in the past
* patient with large sinus polyps
* patients who have received treatment for extrasinus complication

Primary outcomes:
measure: Adhesion Rate
timeFrame: at 2 weeks
Secondary outcomes:
measure: Adhesion Rate
timeFrame: at 1 and 4 weeks
Other outcomes:
Locations:
city: ChungJu
country: Korea, Republic of
facility: Chungbook National University Hospital
state: ChoongChungBukDo
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
Study officials:
References:
Clinical trial NCT06731933: Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
Official title: Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinoma
Keywords: gene therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Epidermolysis Bullosa Research Partnership
First posted: 2024-12-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence.

Prevention of SCC's in the RDEB subjects will increase their life span.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
2. Presence of biopsy proven squamous cell carcinoma (SCC)
3. Ability to understand and the willingness to provide written informed consent.
4. US based participants are willing to use beremagene geperpavec (BVEC)
5. Subject is 18 years or older
6. participant willingness to use an effective method of contraception

Exclusion Criteria:

1. Inability to travel to site for study visit
2. Subject is pregnant
3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

Primary outcomes:
measure: Recurrence rate of Squamous Cell Carcinoma
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Bari
country: Italy
facility: Azienda Ospedliero-Universitaia
Study officials:
affiliation: Stanford University
name: Peter Marinkovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813733: Determinants of Thyroid Surgery Outcomes
Official title: Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Disease
Keywords: thyroid surgery
surgical outcomes
patient safety
healthcare quality
surgeons performance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a thyroid procedure during study period in 5 high volume referral centers in France were eligible for inclusion.

Brief summary: In a large prospective cross-sectional study, the investigators aimed to identify the determinants of thyroid surgery outcomes and quantify the relative influence of preoperative and intraoperative factors. For this purpose, the investigators considered the interplay of several characteristics specific to surgeons, patients, and surgical procedures.


Eligibility criteria: Inclusion Criteria:

- All patients who underwent a thyroid procedure between April 2008 and July 2008.

Exclusion Criteria:

- Participation refusal

Primary outcomes:
measure: Recurrent laryngeal nerve palsy
timeFrame: During inpatient stay and at 6 months following surgery
Secondary outcomes:
measure: Secondary hypoparathyroidism
timeFrame: During inpatient stay and at 6 months following surgery
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-Christophe Lifante
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01877733: Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty
Official title: Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Resistance training
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Nord-Trøndelag HF
First posted: 2013-06-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.

Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.

The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.


Eligibility criteria: Inclusion Criteria:

* unilateral osteoarthritis,
* \< 75 years

Exclusion Criteria:

* disease(s) that compromise testing/training,
* unable to understand written and verbal instructions and information,
* osteoarthritis in the contralateral leg that needs treatment.

Primary outcomes:
measure: Muscle strength in leg extension and leg press
timeFrame: Measured preoperatively, after 7 days, 10 wks and 1 year
Secondary outcomes:
measure: 6 minute walk test
timeFrame: preopertively, 7 days postoperatively and after 1 year
measure: KOOS; Knee injury and osteosarthritis outcome score
timeFrame: Preoperatively (within 1 month prior to surgery), 7 days postoperatively and 10 wks and 1 year postoperatively
measure: EQ-5D (measure of health outcome)
timeFrame: Preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
measure: VAS scale recording pain
timeFrame: preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Vigdis S Husby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Husby VS, Foss OA, Husby OS, Winther SB. Randomized controlled trial of maximal strength training vs. standard rehabilitation following total knee arthroplasty. Eur J Phys Rehabil Med. 2018 Jun;54(3):371-379. doi: 10.23736/S1973-9087.17.04712-8. Epub 2017 Sep 13.
citation: Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
Clinical trial NCT06709833: Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation
Official title: Meningioma and Embolism Thrombosis Risk & Investigation of Coagulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningeoma
Thrombembolism
Surgical Resection
Keywords: meningeoma
thrombembolism
tissue-factor
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial tumors

1. meningeoma
2. glioma (control)

Brief summary: Despite being generally benign tumors, meningiomas are associated with an increased risk for thrombembolic complications after surgical resection. The molecular mechanisms underlying this circumstance are still unknown.

In this prospective observational trial, the investigators aim to evaluate the changes in coagulation and platelet function caused by tumor resection.

Blood samples are obtained by patients undergoing meningioma resection before and immediately after resection to detect said changes.

As a control cohort, blood samples are obtained from patients undergoing resection for glioma.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing resection for meningioma or
* Patients undergoing resection for glioma or
* Healthy controls
* written consent for study participation

Exclusion Criteria:

-

Primary outcomes:
measure: Tissue factor
timeFrame: duration of surfical tumor resection (a few hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital for Anaesthesiology and Intensive Care Medicine, Tuebingen
state: Baden-Wuerttemberg
Study officials:
References: