louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00629551: An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
Official title: An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder
Depression
Major Depressive Episode
Antidepressant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 825
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 main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).


Eligibility criteria: Inclusion Criteria:

* Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

* Symptoms of current depressive episode for less than 30 days or more than 2 years
* Mild depression, as measured by standard clinical research scales
* Significant suicide risk
* Lack of sexual activity (including masturbation)
* Other psychiatric conditions that would obscure the results of the study
* History of failure to respond to antidepressant treatment
* Pregnancy or breast-feeding

Primary outcomes:
measure: Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score
timeFrame: 8 weeks
measure: Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score
timeFrame: weeks
Secondary outcomes:
measure: Change from baseline in the Clinical Global Impression severity of illness score
timeFrame: 8 weeks
measure: Change from baseline in the HAM-D depressed mood item scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01347151: A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: C-spine Movement During Intubation
Keywords: Glide scope
Pentax
C spine movement
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 200
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: PREVENTION

Brief summary: Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view with minimal cervical spine movement. This study wants to compare cervical spine movement during intubation when using these two devices. The C-spine motion will be recorded by using fluoroscopic video to measure the angular displacement of the vertebrae.

Detailed description: The primary outcome is the angular displacement of the vertebrae and secondary outcome is the hemodynamic changes after intubation.

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Age 18-75 years old
* Elective noncardiac surgery requiring general anesthesia with tracheal intubation

Exclusion Criteria:

* Gastroesophageal reflux disease
* Body mass index greater than 35 kg/m2
* Possibility of pregnancy
* Previous neck surgery
* Unstable C-spine/ C-spine abnormality
* Known difficult airway
* Suspected difficult airway

Primary outcomes:
measure: the angular displacement of the vertebrae
timeFrame: 30 seconds
Secondary outcomes:
measure: the hemodynamic changes after intubation.
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
Study officials:
affiliation: Depatment of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand
name: Nalinee Kovitwanawong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370851: Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
Official title: Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinal Disease
Keywords: intravitreal Avastin
BRVO
Macular edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE

Detailed description: After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

* patients with acute BRVO with less than three month duration

Exclusion Criteria:

* vision less than 20/320 and vison more than 20/50
* duration more than 3 months
* history of glaucoma and diabetic retinopathy
* any media opacity that prevent funduscopy

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: At 12 week
measure: Macular thickness by OCT
timeFrame: At 12 week
Secondary outcomes:
measure: Need for macular photocuagulation
timeFrame: At 12th week
measure: Incidence of new vessel formation
timeFrame: At 12th week
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Siamak Moradian, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Siamak Moradian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moradian S, Faghihi H, Sadeghi B, Piri N, Ahmadieh H, Soheilian M, Dehghan MH, Azarmina M, Esfahani MR. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1). Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.
Clinical trial NCT00174551: Feasibility Study: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD
Official title: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Rainier Associates
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigating the effect of prazosin for nighttime symptoms of civilian Posttraumatic Stress Disorder.

Detailed description: Each subject will receive prazosin and placebo trials, the order randomized. Day and nighttime symptoms will be monitored.

Eligibility criteria: Inclusion Criteria:

* must meet DSM-IV criterion for PTSD

Exclusion Criteria:

* Must not have untreated sleep apnea

Primary outcomes:
measure: Sleep time
measure: REM sleep time
measure: Nightmare frequency
measure: CGI
Secondary outcomes:
measure: Distressed Awakenings frequency
measure: PCL-C
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Fletcher B. Taylor
state: Washington
Study officials:
affiliation: Rainier Associates
name: Fletcher B Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507751: Pharmacokinetics of Meropenem During High-dose CRRT
Official title: Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Renal Failure
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: University of Warmia and Mazury in Olsztyn
First posted: 2018-04-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severely ill patients treated in ICU

Brief summary: Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.

Detailed description: This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.

Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.

Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum meropenem concentration will be measured by high-performance liquid chromatography.

Each patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required.

Eligibility criteria: Inclusion Criteria:

* Patients who require ICU treatment due to severe infection
* age 18-80 years
* an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria:

* allergy to meropenem
* lack of consent to participate in the study
* age of patients below 18 or above 80 years

Primary outcomes:
measure: Plasma concentration of meropenem
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie
Study officials:
References:
Clinical trial NCT02791451: Predicting Exacerbation of COPD With Wireless Telemonitoring
Official title: Open-Label Prospective Study of Predicting Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) With Wireless Telemonitoring of Respiratory Rate, Heart Rate and Sleep
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Keywords: COPD
telemonitoring
exacerbation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2016-06-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label single-center 6-month prospective clinical trial predicting exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the Turku University Hospital due to acute exacerbation of COPD.

Detailed description: A bed sensor based on ballistocardiogram (BCG) will be used to wireless telemonitoring of respiratory rate, heart rate and sleep for six months after an acute exacerbation of COPD.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients treated due to acute exacerbation of COPD at the pulmonary wards of the Turku University Hospital

Exclusion Criteria:

* Those sleeping with a bed partner and not having separate mattresses
* Patients with pacemaker

Primary outcomes:
measure: Time window to detect acute exacerbation of COPD
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01369251: Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord
Official title: Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infection
Skin Diseases, Bacterial
Granuloma
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 400
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.


Eligibility criteria: Inclusion Criteria:

* Appropriate for gestational age newborn

Exclusion Criteria:

* Not appropriate for gestational age newborn

Primary outcomes:
measure: omphalitis incidence
Secondary outcomes:
measure: umbilical granuloma incidence
measure: time to cord separation
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
Study officials:
affiliation: ASST Fatebenefratelli Sacco
name: Cristina Meroni
role: STUDY_DIRECTOR
affiliation: ASST Fatebenefratelli Sacco
name: Maria Teresa Garavaglia
role: STUDY_CHAIR
affiliation: Università di Milano
name: Ludovica Tagliabue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06691451: Inherited Thromophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission
Official title: Inherited Thrombophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut universty
First posted: 2024-11-15
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study will be conducted at internal medicine department Assiut universty

Brief summary: Inherited thombopllia and thrombotic risks in inflammatory bowel Disease during activity and remission

Detailed description: Inflammatory bowel diseases (IBD) are systemic conditions characterized by multiple intestinal and extra-intestinal manifestations related to the associated chronic inflammatory state. Among their diverse extra-intestinal complications, venous thromboembolism (VTE) remains one of the most under recognized causes of morbidity and mortality in these patients, highlighting the need for a better understanding of the underlying mechanism of hypercoagulability, in addition to the role of acquired and inherited risk factors that further increase the risk of thrombosis with its impact on patients' outcomes.\[1, 2\]

Eligibility criteria: Inclusion Criteria:

* Age (18yrs - 65yrs) both sex

Exclusion Criteria:

* Presence of acquired cause (pregnancy, recent surgery, history of drug, History of malignant Disease, History of blood or blood product transfusion in last 4 weeks)

Primary outcomes:
measure: Comparison between the number of IBD patients with tendency to thrombosis in cases of activity-
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yazici A, Senturk O, Aygun C, Celebi A, Caglayan C, Hulagu S. Thrombophilic Risk Factors in Patients With Inflammatory Bowel Disease. Gastroenterology Res. 2010 Jun;3(3):112-119. doi: 10.4021/gr2010.06.209w. Epub 2010 May 20.
Clinical trial NCT03247751: Evaluation of the Rotational Stability
Official title: Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-08-14
Enrollment: 95
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: To evaluate rotational stability of the investigational device implanted after cataract surgery.

Detailed description: The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Eligibility criteria: Inclusion Criteria:

* Adults, 18 years or older
* Subject who diagnosed unilateral or bilateral age-related cataract.
* Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
* Calculated IOL power in within the range of investigational IOL.
* Subject is able to understand, agree and sign the informed consent statement.
* Subject is able and willing to comply with the postoperative follow-up examination schedule.

Exclusion Criteria:

* Uncontrolled systemic or ocular disease.
* Extremely shallow anterior chamber.
* Previous intraocular and corneal surgery.
* Traumatic cataract.
* Pregnancy or lactation.
* Concurrent participation in another drug and device clinical investigation.

Primary outcomes:
measure: The intraocular lens rotation
timeFrame: postoperative 6 months
Secondary outcomes:
measure: visual acuity
timeFrame: postoperative 6 months
measure: Adverse event
timeFrame: postoperative 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06830551: The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment
Official title: Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.

Detailed description: Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.

The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs
* signing of informed consent

Exclusion Criteria:

* Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.

Primary outcomes:
measure: Corneal damage measured with National Eye Institute (NEI) score
timeFrame: one week before the start of treatment and thirty days after the end of treatment.
Secondary outcomes:
measure: Change in discomfort
timeFrame: one week before the start of treatment and thirty days after the end of treatment.
measure: Change in quality of life
timeFrame: one week before the start of treatment and thirty days after the end of treatment.
measure: Change in quality of life
timeFrame: one week before the start of treatment and thirty days after the end of treatment.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luigi Fontana, MD
role: PRINCIPAL_INVESTIGATOR
References: