louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06828939: Pulmonary Vein Isolation with the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
Official title: Pulmonary Vein Isolation with the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (Paroxysmal)
Keywords: ablation
pulsed field ablation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Detailed description: This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Eligibility criteria: Inclusion Criteria:

* Recurrent symptomatic PAF with at least one documented episode
* Failure or intolerance of at least one AAD
* Age 18-75 years
* Patient is indicated for an ablation procedure according to society guidelines or study site practice
* Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study

Exclusion Criteria:

* overall good health as established by multiple criteria

Primary outcomes:
measure: Primary Effectiveness Endpoint - Acute Procedure Success
timeFrame: During procedure
measure: Primary Safety Endpoint - Rate of Primary Serious Adverse Events
timeFrame: 7 days (unless otherwise specified)
Secondary outcomes:
measure: Secondary Effectiveness Endpoint - Chronic Durability
timeFrame: 90 days
measure: Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
Study officials:
References:
Clinical trial NCT01957839: Color Doppler Analysıs Of Uterin And Intraovarian Blood Flow Before And After Treatment Wıth Cabergoline In Hyperprolactinemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Reaction to Other Drugs and Medicines
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2013-10-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the investigators examined the hypothesis that hyperprolactinemia may alter uterin, endometrial and intraovarian blood flow and may contribute to increased infertility by another way.


Eligibility criteria: Inclusion Criteria:

* Women who had blood prolactin level higher than 25ng/dl

Exclusion Criteria:

* Pregnancy
* Use of drugs effecting vasculature such as hormonal therapy, oral contraceptives, antihypertensives
* Diseases like pelvic inflammatory disease and systemic hypertension
* Women with clinically overt or treated cardiovascular disease
* Concurrent illness other than hyperprolactinemia

Primary outcomes:
measure: th effect of prolactin vascular flow and resistance
timeFrame: the effect of prolactin in vascular resistance at 2 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sisli
country: Turkey
facility: Sisli Etfal Teaching Hosital
Study officials:
affiliation: SİSLİ ETFAL TEACHİNG HOSPİTAL
name: Osman Temizkan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ono M, Miki N, Amano K, Kawamata T, Seki T, Makino R, Takano K, Izumi S, Okada Y, Hori T. Individualized high-dose cabergoline therapy for hyperprolactinemic infertility in women with micro- and macroprolactinomas. J Clin Endocrinol Metab. 2010 Jun;95(6):2672-9. doi: 10.1210/jc.2009-2605. Epub 2010 Mar 31.
citation: Temizkan O, Temizkan S, Asicioglu O, Aydin K, Kucur S. Color Doppler analysis of uterine, spiral, and intraovarian artery blood flow before and after treatment with cabergoline in hyperprolactinemic patients. Gynecol Endocrinol. 2015 Jan;31(1):75-8. doi: 10.3109/09513590.2014.958989. Epub 2014 Sep 15.
Clinical trial NCT02662439: Bioimpedance Analysis in Chronic Heart Failure
Official title: Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Bioimpedance analysis
Fluid overload
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation

Exclusion Criteria:

* High level of fatigue (the patient cannot stand on a scale)
* Amputated upper and/or lower limb(s)
* The BCM analysis is not possible technically (e.g. open wounds on the limbs)
* Severe obesity (\>130 kg)
* Patients on chronic hemodialysis or peritoneal dialysis
* Severe fluid volume in the transcellular space
* Patients with a unipolar pacemaker whose sensitivity threshold is very low
* Pregnancy, lactation

Primary outcomes:
measure: Re-hospitalization rate
timeFrame: 12 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 12 months
Other outcomes:
measure: Quality of life
timeFrame: 3 months
measure: Renal function decline
timeFrame: 3 months
Locations:
city: Budapest
country: Hungary
facility: First Department of Medicine, Semmelweis University
Study officials:
affiliation: First Department of Medicine, Semmelweis University
name: Peter Studinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02363439: Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
Official title: An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Waldenstrom's Macroglobulinemia
Lead sponsor: Idera Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 5
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: An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.

Detailed description: Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.

Eligibility criteria: Inclusion Criteria:

* Completed 24 weeks of treatment in Protocol 8400-401

Exclusion Criteria:

* Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401.
* Has evidence of disease progression under Protocol 8400-401.
* Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: During receipt of study treatment on the trial.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Idera Pharmaceuticals, Inc.
name: Mark Cornfeld, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03802539: 5-year Clinical Evaluation of Cavity Lining on the Restoration
Official title: 5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teeth; Lesion
Dental Root Caries
Keywords: Root caries
Cavity lining
Composite resin restorations
Self-etch adhesive
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.

Detailed description: Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries removal, the depth, length, and width of the cavity were measured. Lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (Glass liner II, Willmann \& Pein GmbH Dental, Barmstedt, Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. The restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U and Cochran Q tests at a significance level of 5% (P \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface

Exclusion Criteria:

* Patients who were under the age of 18 years
* Complex medical history
* Severe or chronic periodontitis
* Extreme carious activity
* Heavy bruxism
* Very deep or superficial carious lesions
* Previously restored and abutment teeth

Primary outcomes:
measure: Retention Outcome
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Koc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020 Feb;24(2):979-989. doi: 10.1007/s00784-019-03001-z. Epub 2019 Jul 4.
Clinical trial NCT00237939: A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
Official title: A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2005-10-13
Enrollment: 1200
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: The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.


Eligibility criteria: Inclusion Criteria:

* Clinical DSM-IV diagnosis of schizophrenia
* Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required

Exclusion Criteria:

* Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
* Prisoners or subjects compulsory detained

Primary outcomes:
measure: Clinical Global Impression-Improvement at endpoint
Secondary outcomes:
measure: Patients' and caregivers' medication preference
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Diest
country: Belgium
facility: Local Institution
city: Kortenberg
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Sint-Michiels
country: Belgium
facility: Local Institution
city: Sint-Niklaas
country: Belgium
facility: Local Institution
city: Sint-Truiden
country: Belgium
facility: Local Institution
city: Tournai
country: Belgium
facility: Local Institution
city: Rennes Cedex
country: France
facility: Local Institution
city: Amersfoort
country: Netherlands
facility: Local Institution
city: Raalte
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Barcelos
country: Portugal
facility: Local Institution
city: Ceira
country: Portugal
facility: Local Institution
city: Coimbra
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisbon
country: Portugal
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
Study officials:
affiliation: Faculté de Médecine de Rennes I, laboratoire de pharmacologie
name: Hervé Allain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04277039: Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain
Official title: Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: osteopathic manipulative treatment
cognitive therapy
chronic low back pain
pain
disability
Lead sponsor: Come Collaboration
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Santa Lucia
name: Niguarda Hospital
name: Orthoplus
First posted: 2020-02-20
Enrollment: 216
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire


Eligibility criteria: Inclusion Criteria:

* aged between 30 and 65 y
* diagnosis of aspecific chronic low back pain
* minimum of 3 on the NRS score

Exclusion Criteria:

* Neuropathic pain or chronic widespread pain
* Low back spinal surgery in the last three years
* Low back spinal surgery to osteoporosis and/or traumatic fractures
* Rheumatic disease
* Pregnancy or having a baby in the last 12 months
* Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.).
* The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months

Primary outcomes:
measure: Change in NRS at 3 months
timeFrame: 3 months
measure: Change in RMDQ at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Changes in CSI
timeFrame: 1 month - 3 month - 6 month
measure: Changes in Oswestry
timeFrame: 1 month - 3 month - 6 month
measure: BPQ
timeFrame: 1 month - 3 month - 6 month
measure: Changes in DASS-21
timeFrame: 1 month - 3 month - 6 month
measure: Changes in SF-36
timeFrame: 1 month - 3 month - 6 month
measure: Rate of AER
timeFrame: 1 month - 3 month - 6 month
measure: Changes in SCWT
timeFrame: 1 month - 3 month - 6 month
measure: TMT
timeFrame: 1 month - 3 month - 6 month
measure: Change in NRS at 1 month
timeFrame: 1 month
measure: Change in NRS at 6 months
timeFrame: 6 months
measure: Change in RMDQ at 1 month
timeFrame: 1 month
measure: Change in RMDQ at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Santa Lucia Foundation
state: Lazio
city: Milan
country: Italy
facility: Niguarda hospital
state: Lombardia
city: Bolzano
country: Italy
facility: Orthoplus
state: Trentino
Study officials:
affiliation: Come Collaboration
name: Francesco Cerritelli, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02782039: Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
Official title: Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anti-Phospholipids Syndrome (APS)
Systemic Lupus Erythematosus (SLE)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering of APS with or without associated SLE

Brief summary: The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE.

Detailed description: Recruitment of patients with APS and SLE treated. Retrospective and prospective register.

Eligibility criteria: Inclusion Criteria:

* Patient with APS
* Patient with SLE

Exclusion Criteria:

* Dependent person
* Hospitalized without consent and not protected by law
* Detainee

Primary outcomes:
measure: Number of patients enrolled with Anti-Phospholipids syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nathalie Costedoat-Chalumeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morel N, Bonnet C, Mehawej H, Le Guern V, Perard L, Roumier M, Brezin A, Godeau B, Haroche J, Benhamou Y, Lambert M, Yelnik CM, Maillard N, Bodaghi B, Piette JC, Costedoat-Chalumeau N. CATASTROPHIC ANTIPHOSPHOLIPID SYNDROME AND POSTERIOR OCULAR INVOLVEMENT: Case Series of 11 Patients and Literature Review. Retina. 2021 Nov 1;41(11):2332-2341. doi: 10.1097/IAE.0000000000003185.
Clinical trial NCT05196139: Visual Outcome After Vitrectomy With Subretinal tPA Injection
Official title: Visual Outcome After Vitrectomy With Subretinal tPA Injection to Treat Submacular Hemorrhage Secondary to Age-related Macular Degeneration or Macroaneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgery on the patients included in the study will have been performed using the EVA surgical system (DORC).

Brief summary: evaluate the safety of Eva surgical system

Detailed description: The purpose of this retrospective study is to evaluate the safety and clinical results using this surgical technique when performed using the EVA surgical system and associated instrumentation and disposable surgical equipment

Eligibility criteria: Inclusion Criteria:

* patients with VTX subretinal tPA ( + phaco)
* patients with submacular bleeding

Exclusion Criteria:

* none

Primary outcomes:
measure: pre-operative best corrected visual acuity
timeFrame: pre surgery
measure: Surgical adverse events
timeFrame: postoperative visit on day 1
measure: post-operative best corrected visual acuity
timeFrame: 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Peter Stalmans, PhD
role: PRINCIPAL_INVESTIGATOR
References: