louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00456482: Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
Official title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Non-infectious Uveitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 239
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,
* Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,
* Had clinically 'quiet' eyes at surgery.

Exclusion Criteria:

* Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

Primary outcomes:
measure: Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.
timeFrame: 1 year pre-implantation; 3 years post-implantation
Secondary outcomes:
measure: Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.
timeFrame: 1 year pre-implantation; 3 years post-implantation
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Timothy L Comstock, OD
role: STUDY_DIRECTOR
References:
citation: Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
Clinical trial NCT03397082: Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration
Official title: Topic Use of Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Control During Endouterine Manual Aspiration: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Endouterine manual aspiration
Paracervical blockade
Lidocaine gel
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade alone in the management of pain during endouterine manual aspiration.


Eligibility criteria: Inclusion Criteria:

* Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).

Exclusion Criteria:

* Allergy to lidocaine.

Primary outcomes:
measure: Global evaluation of pain
timeFrame: 5 minutes post procedure
Secondary outcomes:
measure: Adverse reaction
timeFrame: 5 minutes post procedure
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Maternity Hospital
name: Osvaldo Reyes, Md
role: STUDY_DIRECTOR
affiliation: Saint Thomas Maternity Hospital
name: Ariel Veces
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520982: Early Neurovascular Adaptations in Aging Women
Official title: Early Neurovascular Adaptations in Aging Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Women
Sympathetic Nervous System
Aging
Blood Flow
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Our goal is to enhance our understanding of early vascular adaptations in aging women with an emphasis on the sympathetic nervous system.


Eligibility criteria: Inclusion Criteria:

* Assigned female at birth (AFAB)
* 18-55 years of age

Exclusion Criteria:

* Assigned male at birth (AMAB)
* Pregnancy, breastfeeding
* Body mass index ≥30 kg/m2
* Taking medications known to affect metabolic, autonomic, and/or respiratory function
* Oral hormonal contraception in last 6 month
* History of hormone replacement therapy
* History of hyster- or oophor-ectomy
* Current smoking/Nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Chronic disease
* Blood pressure ≥140/90 mmHg
* Communication barriers

Primary outcomes:
measure: Magnitude of forearm blood flow
timeFrame: Change from baseline during infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References:
Clinical trial NCT04413682: Telerehabilitation vs Supervised Exercises in MS
Official title: Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Telerehabilitation
Supervised exercises
Structured exercise
Quality of Life
Activities of Daily Living
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Medipol University
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.

Detailed description: Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.

Eligibility criteria: Inclusion Criteria:

patients with:

1. Stable period at the time of application to the clinic
2. Expanded Disability Status Scale Levels between 2 - 6.5
3. Appropriate cognitive level to understand the exercises
4. No diseases to affect their participation in exercise programs

Exclusion Criteria:

patients with:

1. Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
2. A new history of previous attacks
3. No reliable informed consent

Primary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: Changes after 12 weeks
measure: Nottingham Health Profile, First section (NHP-I)
timeFrame: Changes after 12 weeks
measure: Quality of life scale (QoLS)
timeFrame: Changes after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: etarakci@istanbul.edu.tr
name: Ela Tarakci, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03922282: BABA Robotic Thyroidectomy Without Gas is Safe Enough as That Use a Gas
Official title: A Prospective, Randomized, and Controlled Study of the Safety and Efficacy in Gasless BABA(Bilateral Axillo-breast Approach) Robotic Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Thyroid Diseases
Keywords: Gasless
Bilateral axillo-breast approach
Da Vinci
Robot-assisted thyroid surgery
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, a randomized controlled study was conducted between two groups of 14 classic recipients of Carbon dioxide insufflation during BABA robotic-thyroidectomy and 14 recipients of Gasless method during BABA robotic-thyroidectomy. This is a study to see if there is any difference in hemodynamic and metabolic changes and pain .


Eligibility criteria: Inclusion Criteria:

* Subject who will have thyroid surgery

Exclusion Criteria:

* Subject who underwent thyroid surgery
* Subject who underwent any radiotherapy on neck
* Subject who need to neck dissection
* Subject under 18 years or over 70 years
* Bad general condition
* High American Society of Anesthesiologists(ASA) score (over 3)
* Breast feeder or pregnancy
* Subject who disagree to do this trial

Primary outcomes:
measure: heart rate
timeFrame: Change from baseline heart rate at the end of surgery
measure: mean arterial pressure
timeFrame: Change from baseline mean arterial pressure at the end of surgery
measure: cardiac index
timeFrame: Change from baseline cardiac index at the end of surgery
measure: cardiac output
timeFrame: Change from baseline cardiac output at the end of surgery
measure: pH
timeFrame: Change from baseline pH at the end of surgery
measure: PaCO2
timeFrame: Change from baseline PaCO2 at the end of surgery
measure: VAS(visual analog score)
timeFrame: change from baseline VAS up to 3days after surgery
measure: BHC(bottom hit count)
timeFrame: change from baseline BHC up to 3days after surgery
measure: number of analgesics
timeFrame: change from baseline number of analgesics up to 3days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong sik Bae
Study officials:
References:
Clinical trial NCT01343082: DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Official title: A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma or Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-27
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Change From Baseline in IOP (Intraocular Pressure) at End of Study
timeFrame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
Clinical trial NCT05993182: Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block.
Official title: Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Cesarean Section Complications
Subarachnoid Block
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg

Detailed description: In cesarean section, under subarachnoid block the most common complication is hypotension with a reported incidence greater than 80%. Hypotension may occur even after left uterine displacement and preloading with crystalloid. The severity of hypotension depends on the degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of local anesthetic drugs administered. The most effective treatment of hypotension associated with cesarean section under subarachnoid block is the administration of vasopressor drugs.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists 1 and 2 patients
* Gestational amenorrhea of \> 32 weeks
* Elective cesarean section
* Patient willing for spinal anesthesia.
* Singleton pregnancy with cephalic presentation.
* Baseline systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 70-89 mmHg.

Exclusion Criteria:

* Any contraindication to spinal anesthesia, i.e., local infection at the site of injection
* valvular heat diseases
* bleeding tendency
* any co-morbidity like diabetes mellitus
* liver cirrhosis
* renal failure
* any obstetric complications like placenta previa
* pregnancy-induced hypertension or HELLP syndrome
* multiple gestations
* fetal malformation
* coagulopathies
* morbid obesity and spine deformity
* profound hypotension (total spinal) bradycardia and need atropine and severe bleeding

Primary outcomes:
measure: Survival analysis or time until an event occurs
timeFrame: Intraoperatively
Secondary outcomes:
measure: Starting point or Base line time
timeFrame: Intraoperatively
measure: Survival time
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
References:
Clinical trial NCT05781282: Pulmonary Vein (PV) Imaging by Intracardiac Echography (ICE) After Ablation
Official title: Pulmonary Vein Imaging by ICE After Atrial Fibrillation Ablation to Predict Recurrences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation Recurrent
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences

Detailed description: Patient undergoing first RF ablation for sympomatic paroxysmal atrial fibrillation will be enrolled. ICE visualization of PV antra before and after PV deconnection (electrophysiological endpoint). Changes in echogenicity as documented by ICE will be evaluated by a dedicated software and correlated to long term recurrences

Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation ablation candidates

Exclusion Criteria:

* Previous catheter ablation
* Persistent atrial fibrillation

Primary outcomes:
measure: Atrial fibrillation recurrences
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli Roma IRCCS
Study officials:
affiliation: Fondazione Policlinico Agostino Gemelli Roma IRCCS
name: Gianluigi Bencardino, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leo M, De Maria GL, Briosa E Gala A, Pope M, Banerjee A, Kelion A, Pedersen M, Rajappan K, Ginks M, Bashir Y, Hunter RJ, Betts T. INtra-procedural ultraSound Imaging for DEtermination of atrial wall thickness and acute tissue changes after isolation of the pulmonary veins with radiofrequency, cryoballoon or laser balloon energy: the INSIDE PVs study. Int J Cardiovasc Imaging. 2021 Dec;37(12):3525-3535. doi: 10.1007/s10554-021-02417-7. Epub 2021 Sep 23.
Clinical trial NCT03030482: Evaluation of Touch Massage on Anxiety in Critically Ill Patients
Official title: Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
intensive care
mechanical ventilation
touch massage
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.


Eligibility criteria: Inclusion Criteria:

* All adult patients (age≥18 years) hospitalized in Intensive Care Unit \> 24 h
* Requiring mechanical ventilation or not
* Securité Sociale affiliated
* Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back)
* No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment

Exclusion Criteria:

* Pregnant
* Legal guardianship
* Neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism,
* Patient with upper limbs neuromuscular disorders
* Cutaneous lesion (zone of touch massage)
* Temperature ≥ 38,5°C
* A positive score of CAM ICU scale
* Patient refuse to participate

Primary outcomes:
measure: Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
timeFrame: 60 minutes
Secondary outcomes:
measure: Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).
timeFrame: 60 minutes
measure: Measure the analgesic effect of touch massage to critically ill patient awake, communicating
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Versailles Hospital
state: Yvelines
Study officials:
References:
Clinical trial NCT06388382: Investigation of the Audible ICD Alert Tone
Official title: Investigation of the Audible Alert Tone in ICD Patients with Subcutaneous Cardioverter Defibrillators
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Implantable Defibrillator User
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: S-ICD all comers

Brief summary: Ability of ICD patients to hear the audible ICD alert is being assessed.


Eligibility criteria: Inclusion Criteria:

* patient equipped with a subcutaneous ICD
* willing to participate

Exclusion Criteria:

* S-ICD implantation within the past 3 weeks
* patient is deaf

Primary outcomes:
measure: Alert tone audible
timeFrame: 1 minute after demonstration
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
Study officials:
References: