louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02556307: A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Slovenian patients with chronic hepatitis C (CHC) treated with Peginterferon alfa-2a and ribavirin.

Brief summary: In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* Male and female patients \>/= 18 years
* Positive test for HCV
* Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Exclusion Criteria:

* Concomitant infection with HIV or hepatitis B
* Participation in a clinical trial within 30 days prior to study start
* Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment
timeFrame: 6 months after the last study drug administration (up to 123.6 weeks)
Secondary outcomes:
measure: Percentage of Participants With Undetectable HCV RNA
timeFrame: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)
measure: HCV RNA Values
timeFrame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
measure: Thrombocyte Values
timeFrame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
measure: Leukocyte Values
timeFrame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
measure: Hemoglobin Values
timeFrame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)
measure: Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin
timeFrame: Up to 99.6 Weeks
Other outcomes:
Locations:
city: Celje
country: Slovenia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Novo Mesto
country: Slovenia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290207: The Different Response of Endocrine Hormones to Hypoglycemia in Patients With Type 1 or Type 2 Diabetes
Official title: A Study of Endocrine Hormone Changes in Newly Diagnosed Patients With Type 2 and Type 1 Diabetes Using Hyperinsulinaemic Hypoglycaemic Clamp Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Normal subjects and newly diagnosed male patients with type 1 or type 2 diabetes

Brief summary: Endocrine hormones, not only blood glucose responsive hormones, but also sexual hormones, thyroid hormones, growth hormones and so on, may have response and activites in hypoglycemia. However, the different responses of endocrine hormones to hypoglycemia in patients With diabetes remain unclear.

Detailed description: This study will observe the changes of insulin, C-peptide, glucagon, growth hormone, IGF-1, ACTH, cortisol, thyroid function, sexual hormone in newly diagnosed men with type 2 and type 1 diabetes mellitus using hyperinsulinaemic hypoglycaemic clamp technique

Eligibility criteria: Inclusion Criteria:

- Patients

* newly diagnosed male patients with type 1 or type 2 diabetes (diagnostic criteria of World Health Organization)
* aged 18-50 years
* has not been treated with any hypoglycemic drugs
* HbA1c\>9% Normal subjects: healthy and had no known illness

Exclusion Criteria:

* patients with insulin allergy.
* any history of hypoglycemic agent intake or were presently taking hypoglycemic agents
* any abnormality in liver or kidney function on blood and urine investigations
* any history of systemic corticosteroid use in 3 months
* any recent infections or acute medical events
* any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Primary outcomes:
measure: endocrine hormone changes
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical Univesity
Study officials:
References:
Clinical trial NCT00987207: Pharmacological Postconditioning During the Aortic Valvular Surgery
Official title: Pharmacological Postconditioning During the Aortic Valvular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Valvular Surgery
Keywords: Postconditioning
cyclosporine A
myocardial ischemia
cardiac surgery
aortic valvulopathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.


Eligibility criteria: Inclusion Criteria:

* Male or females, scheduled for an aortic valvular surgery;
* 18 years of age or older.

Exclusion Criteria:

* Combined valvular and coronary surgery;
* Significant coronary artery stenosis (upper than 70%);
* Left ventricular dysfunction (ejection fraction \< 40%);
* Emergency surgery and/or infectious endocarditis;
* Known cyclosporin hypersensitivity;
* History of known recent immunosuppression (\< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis;
* Renal insufficiency (creatininaemia \> 150 µmol/l);
* Hepatic insufficiency (prothrombin time \< 50%);
* Uncontrolled arterial hypertension defined by a systolic arterial pressure \> 180 mm Hg;
* Women of child bearing potential, who are pregnant or not under efficient contraception;
* Patients treated with nicorandil, sulfonylurea or rosuvastatine;
* Patients under judicial control.

Primary outcomes:
measure: The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.
timeFrame: 72 hours
Secondary outcomes:
measure: Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE
timeFrame: 72 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon, France
name: Pascal CHIARI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiari P, Angoulvant D, Mewton N, Desebbe O, Obadia JF, Robin J, Farhat F, Jegaden O, Bastien O, Lehot JJ, Ovize M. Cyclosporine protects the heart during aortic valve surgery. Anesthesiology. 2014 Aug;121(2):232-8. doi: 10.1097/ALN.0000000000000331.
Clinical trial NCT06829407: Effect of Different Subcutaneous Injection Methods on Pain and Satisfaction
Official title: Evaluation of the Effects of Different Methods Used in Subcutaneous Heparin Injections on Pain and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Injection Site
Keywords: pain
low molecular weight heparin
palm stimulator
extended injection time
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this study is an experimental, parallel-group (intervention-control), randomized controlled design
Primary purpose: PREVENTION

Brief summary: This study; In patients treated with subcutaneous heparin A randomized controlled trial was planned to determine the effect of the injection time and the device called "Palm Stimulator" to reduce the pain felt during injection.


Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* The one who is literate,
* No physical, mental disabilities or communication difficulties,
* Low Molecular Weight Heparin in the treatment plan,
* No history of allergy,
* Agreeing to participate in the research,
* There is no scar tissue, incision or infection in the area to be injected,
* Patients who will receive a 1-day injection and whose pain score is between 1-10 according to VAS will be admitted.

Exclusion Criteria:

* Who gave up participating in the research while continuing the research,
* Using subcutaneous insulin therapy,
* There is an amputation in the right/left arm area where the study will be performed,
* There is scar tissue, incision or signs of infection in the area to be injected,
* Patients who received injections for 1 day and whose pain score is 0 (zero) according to VAS will not be admitted.

Primary outcomes:
measure: Scale Patient Identification Form
timeFrame: during injection procedure
measure: Visual Scale for pain
timeFrame: during injection procedure
measure: Visual Comparison Scale for Satisfaction
timeFrame: during injection procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya Üniversitesi
Study officials:
References:
Clinical trial NCT04944407: Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease
Official title: Minimal Invasive Laser Hemorrhoidoplasty vs Conventional Excisional Hemorrhoidectomy in II-III Grade Hemorrhoidal Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 220
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study aims to evaluate the effectiveness and long term outcomes of laser hemorroidoplasty versus conventional milligan morgan hemorrhoidectomy in II-III degree hemorroidal disease.

Detailed description: Background Hemorrhoidal disease (HD) is a widespread condition and several surgical techniques have been proposed to date without achieving a definitive consensus. Laser Hemorrhoidoplasty (LHP) is a minimal invasive procedure for HD treatment determining the shrinkage of the hemorrhoidal piles by diode laser limiting the postoperative discomfort and pain. The aim of the current prospective randomized trial is to evaluate the postoperative outcomes of HD patients undergoing LHP vs conventional Milligan-Morgan hemorrhoidectomy (MM).

Methods. Operative time, postoperative pain and complications, resolution of symptoms, patients 'quality of life, patients' evaluation of treatment and length of return to daily activity of II-III grade symptomatic HD patients undergoing LHP vs MM were prospectively evaluated. The patients were followed-up for 24 months looking for recurrence of prolapsed hemorrhoid or symptoms.

Eligibility criteria: Inclusion Criteria:

* II-III hemorrhoidal disease
* failure of conservative treatment
* ASA I-II

Exclusion Criteria:

* acutely thrombosed hemorrhoids
* patients affected by IBD involving rectum or anus
* patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol

Primary outcomes:
measure: Pain evaluation
timeFrame: 30 postoperative days.
measure: Analgesic use
timeFrame: 30 postoperative days.
Secondary outcomes:
measure: Presence of recurrence
timeFrame: 24 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT05678907: Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization
Official title: Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Episode
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 150
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: Patients hospitalized for a characterized depressive episode and considered in remission at discharge.

Brief summary: This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.

Detailed description: Patients in the study were hospitalized following a characterized depressive episode. The study is based on a review of these patients' medical records and data from the three-month assessment. No additional assessments are planned.

Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older, having been informed of the research
* Patient hospitalized at the Auzon Clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder)
* Discharged from hospitalization
* Considered in remission (total or partial) and with a MADRS score \< 20

Exclusion Criteria:

* Patient hospitalized for \< 15 days
* Patient with bipolar depression
* Patient with a psychotic disorder
* Patient using narcotics with a "moderate to severe" severity
* Patient previously included in this study
* Patient under court protection, guardianship or curatorship
* Patient unablé to respond correctly to a depression self-assessment questionnaire

Primary outcomes:
measure: Depressive episode relapse
timeFrame: Month 3
Secondary outcomes:
measure: Psychic symptoms of depression
timeFrame: Month 3
measure: Depressive symptomology
timeFrame: Month 3
Other outcomes:
Locations:
city: La Roche-Blanche
country: France
facility: Clinique de l'Auzon
Study officials:
References:
Clinical trial NCT05935007: Aveir DR Real-World Evidence Post-Approval Study
Official title: Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Pacemaker
Arrythmia
Bradycardia
Keywords: bradycardia
sick sinus rhythm
pacemaker
av block
vasovagal syncope
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 1805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who had an implant of the Aveir DR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis

Brief summary: The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

Detailed description: This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.

Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Eligibility criteria: Eligibility Criteria:

* Implanted with an Aveir DR leadless pacemaker
* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period
* Ability to link with Medicare fee-for-service data

Primary outcomes:
measure: Number of Subjects Free from Acute Aveir DR System-Related Complications
timeFrame: 30 Days
measure: Number of Subjects Free from Chronic Aveir DR System-Related Complications
timeFrame: 5 Years
Secondary outcomes:
measure: Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related
timeFrame: 5 Years
measure: Number of Subjects with End of Device Service Events
timeFrame: 5 Years
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Abbott
state: California
Study officials:
affiliation: Abbott
name: Nicole Harbert
role: STUDY_DIRECTOR
References:
Clinical trial NCT01466309: Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA
Official title: The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OSA
Complication
Keywords: AHI
ESS
VAS
FOSQ
SF-36
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.

Detailed description: Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years with OSA
* AHI \> 5
* Refused CPAP therapy

Exclusion Criteria:

* Poor oral hygiene
* Untreated TMD
* Inadequate healthy teeth (\< 6)
* Severe or unstable medical problems.

Primary outcomes:
measure: Apnea-Hypopnea index
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants with Adverse Events"
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Yes
name: wish banhiran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02397109: mDixon TSE MRI Sequence And Conventional MRI Sequences In Dysimmune Orbitopathies (DDX)
Official title: Study Of The Agreement Between The mDixon TSE Sequence And Conventional MRI Sequences In The Evaluation Of Dysimmune Orbitopathies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysthyroid Ophthalmopathies
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-03-24
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a dysthyroid orbitopathy undergoing a MRI

Brief summary: The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor muscles and the orbital fat.

If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional contribution to the clinic, guiding the therapeutic management by detecting inflammatory lesions not found on clinical examination in 1/3 of cases.

The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal analysis oculomotor abnormalities as well as the orbital fat.

Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous fat removal.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 to 90 years, suffering from thyroid dysfunction proved by clinical and laboratory tests, with a bilateral clinical dysthyroid orbitopathy and undergoing an eye MRI

Exclusion Criteria:

* Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
* Patient under guardianship
* Patient not willing to participate.
* Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
* Motion artifact on the sequences, not corrected by the repeat sequences
* Metal artifact prohibiting the analysis of the region of interest

Primary outcomes:
measure: Assessment, by the determination of the Cohen's kappa coefficient, of the concordance between the conventional sequences (T1, T2, T2-fat-sat) and the mDIXON sequence for the diagnosis of inflammatory or non-inflammatory dysthyroid orbitopathy.
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile De France
Study officials:
References:
Clinical trial NCT01023009: Postoperative Evolution After Small Gauge Vitrectomy Without Eye Occlusion
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vitrectomy
Keywords: Occlusion
vitrectomy
small gauge vitrectomy
Postoperative occlusion
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients in inmediate postoperative vitreorretinal surgery without any complications

Brief summary: After an uneventfully small gauge vitrectomy we don´t think is necessary to occlude the eye for 24 hours


Eligibility criteria: Inclusion Criteria:

* All patients with uneventful vitrectomy

Exclusion Criteria:

* Complicated vitrectomy or corneal lesion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Maria A Martinez-Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References: