louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00486798: FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psychotic Disorders
Schizophrenia
Bipolar Disorder
Keywords: acute schizophrenia
schizoaffective disorder
psychosis Not Otherwise Specified (NOS)
bipolar mania with psychotic symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-06-15
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 study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis


Eligibility criteria: Inclusion Criteria:

* provision of written informed consent
* male or female, aged 18-65 years
* requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode
* able to swallow tablets from Day 1

Exclusion Criteria:

* In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5
* patients with known relevant clinical disease
* history of syncope, or orthostatic hypotension
* patients with known neutropenia

Primary outcomes:
measure: Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
Secondary outcomes:
measure: Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: Research Site
city: Danderyd
country: Sweden
facility: Research Site
city: Falkoping
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Ojebyn
country: Sweden
facility: Research Site
city: Pitea
country: Sweden
facility: Research Site
city: Simrishamn
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhattan
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
city: Vaxjo
country: Sweden
facility: Research Site
Study officials:
affiliation: Huddinge Hospital Stockholm Sweden
name: Jaan Ruusa, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Sweden AB
name: Birgit Ekholm, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01893398: Multistimulation Group Therapy for Alzheimer's Disease
Official title: Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Our previous findings support the notion that group activity program, based on cognitive stimulation, recreational-occupational activities and physical-psychomotor exercises, can lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD).

The purpose of this study is to clarify the efficacy of a rehabilitation program in outpatients affected by AD in mild to moderate stages.


Eligibility criteria: Inclusion Criteria:

* diagnosis of possible/probable AD
* mild to moderate stage of AD (MMSE score of 15 - 24)and CDR score of 1-2
* range years in age (65-85) and in school attendance (5-17)
* right handed

Exclusion Criteria:

* severe aphasia (Token test score \< 20)
* severe auditory and/or visual loss
* overt severe behavioral disturbances (delusions, hallucinations, agitation)
* recent (three month before the MST) introduction or dose modification of the following pharmacological treatments: cholinesterase inhibitor, memantine, antidepressant or antipsychotic drugs.

Primary outcomes:
measure: Change from baseline in behavioral level
timeFrame: Baseline, 10ws, 22ws
measure: Change from baseline in cognitive level
timeFrame: Baseline, 10ws, 22 ws
measure: Change from baseline in quality of life
timeFrame: baseline, 10ws,22 ws
Secondary outcomes:
Other outcomes:
measure: Functional MRI
timeFrame: baseline, 10 ws
Locations:
city: Milan
country: Italy
facility: IRCCS, S Maria Nascente, FOndazione don Gnocchi
Study officials:
References:
citation: Farina E, Mantovani F, Fioravanti R, Pignatti R, Chiavari L, Imbornone E, Olivotto F, Alberoni M, Mariani C, Nemni R. Evaluating two group programmes of cognitive training in mild-to-moderate AD: is there any difference between a 'global' stimulation and a 'cognitive-specific' one? Aging Ment Health. 2006 May;10(3):211-8. doi: 10.1080/13607860500409492.
citation: Farina E, Fioravanti R, Chiavari L, Imbornone E, Alberoni M, Pomati S, Pinardi G, Pignatti R, Mariani C. Comparing two programs of cognitive training in Alzheimer's disease: a pilot study. Acta Neurol Scand. 2002 May;105(5):365-71. doi: 10.1034/j.1600-0404.2002.01086.x.
Clinical trial NCT03778697: Endosleeve in Adolescents
Official title: Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity, Childhood
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: New You Medical Center
First posted: 2018-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.

Detailed description: Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures that plicate the greater curvature of the stomach. Emerging data from adult populations shows an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the safety and efficacy of ESG in adult patients who undergo the procedure under a standardized protocol and clinical care pathway, the investigators planned to study its effects on adolescents in a specialized center that offers surgical, endoscopic, and medical management of obesity under a standardized protocol and care pathway.

Eligibility criteria: Inclusion Criteria:

* BMI that is \>120% of the 95th percentile for age and gender
* Written informed assent/consent, with concomitant parental consent for patients aged ≤17 years

Exclusion Criteria:

* Age \<10 years
* Age \>21 years
* Presence of large hiatal hernia
* Previous gastric surgery
* Cognitive impairment

Primary outcomes:
measure: Weight Loss
timeFrame: One year
measure: Adverse events
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: New You Medical Center
state: Central Region
Study officials:
affiliation: King Saud University
name: Aayed R Alqahtani, MD FRCSC FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alqahtani A, Elahmedi M, Alqahtani YA, Al-Darwish A. Endoscopic Sleeve Gastroplasty in 109 Consecutive Children and Adolescents With Obesity: Two-Year Outcomes of a New Modality. Am J Gastroenterol. 2019 Dec;114(12):1857-1862. doi: 10.14309/ajg.0000000000000440.
Clinical trial NCT02030197: Impact of CRISP on Self-Efficacy, Loneliness, and Depression
Official title: Effects of an Educational Socialization Program Designed to Improve Self-Efficacy and Subsequent Effects on Decreasing Loneliness and Depression Among People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 118
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 study is to examine the effects of an innovative program, entitled CRISP (Community Integration for Socially Isolated Patients), on improving self-efficacy and assessing whether improved self-efficacy helps to reduce depression and loneliness of people with MS.

Detailed description: Whether CRISP increases self-efficacy while decreasing loneliness and depression

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years old.
* Must have a definitive diagnosis of MS by a physician.
* Must understand English at 6th grade level since the CRISP program requires participants to comprehend the educational information presented in English.
* Agree to participate in 12 group sessions over 12 weeks;
* Must have the ability to complete questionnaires in English since the outcome measures used for the study are in English.
* Must be able to commute to the site destinations

Exclusion Criteria:

* Have an actively psychotic Axis I disorder.
* Have a significant Axis II disorder of borderline personality disorder or schizoid personality disorder.
* Have a diagnosis of another neurological condition aside from MS.
* Inability to comply with study requirements/visits.

Primary outcomes:
measure: Multiple Sclerosis Self-Efficacy Scale (MSSS)
timeFrame: Change from Baseline to week 12
Secondary outcomes:
measure: UCLA Revised Loneliness Scale
timeFrame: Change from Baseline to week 12
measure: Chicago Multiscale Depression Inventory (CMDI)
timeFrame: Change from Baseline to week 12
measure: Performance Scales (PS)
timeFrame: Change from Baseline to week 12
measure: Community Integration Questionnaire (CIQ)
timeFrame: Change from Baseline to week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU MS Center
state: New York
Study officials:
References:
Clinical trial NCT02275897: Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section
Official title: Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Effects of; Anesthesia, Spinal and Epidural; in Pregnancy
Keywords: Lower Segmental Caesarean Section (LSCS)
Speed of Injection
Spinal Anaesthesia
Anesthesia
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2014-10-27
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.

Detailed description: We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* singleton term pregnancy
* American Society of Anesthesiologists (ASA) class I-II

Exclusion Criteria:

* Severe pre-eclampsia
* contraindications to spinal anaesthesia
* Height \<150cm or \>180cm
* Weight ≥100kg
* Baseline systolic BP \<90 mmHg
* Baseline systolic BP \>150mmHg
* Category 1 urgency for delivery

Primary outcomes:
measure: Incidence of Hypotension
timeFrame: First 10 minutes after injection
Secondary outcomes:
measure: Use of vasoconstrictors
timeFrame: First 10 minutes after injection
measure: Adequacy of block
timeFrame: Time of surgery
Other outcomes:
Locations:
city: Klang
country: Malaysia
facility: Hospital Tengku Ampuan Rahimah
state: Selangor
Study officials:
affiliation: Ministry of Health, Malaysia
name: Chun Fai Chiang, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiang CF, Hasan MS, Tham SW, Sundaraj S, Faris A, Ganason N. Injection speed of spinal anaesthesia for Caesarean delivery in Asian women and the incidence of hypotension: A randomised controlled trial. J Clin Anesth. 2017 Jun;39:82-86. doi: 10.1016/j.jclinane.2017.03.025. Epub 2017 Apr 1.
Clinical trial NCT00449397: Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
Official title: A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychosis
Keywords: First Episode Psychosis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determine the minimal effective dose and the impact on:

1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
2. the final maintenance doses
3. the use of other medications
4. the amount of changes to other antipsychotic medication
5. the number of hospitalization days


Eligibility criteria: Inclusion Criteria:

* Patients experiencing their first psychotic episode
* Male or Female
* Aged 15-25

Exclusion Criteria:

* Previous treatment with antipsychotic medication (longer than 1 week)
* History of a clinically significant physical illness
* Organic disorder presenting with psychotic symptoms

Primary outcomes:
measure: Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Secondary outcomes:
measure: SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Research Sites
Study officials:
affiliation: ORYGEN Research Centre/ ORYGEN Youth Health
name: Gregor Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hides L, Cotton SM, Berger G, Gleeson J, O'Donnell C, Proffitt T, McGorry PD, Lubman DI. The reliability and validity of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in first-episode psychosis. Addict Behav. 2009 Oct;34(10):821-5. doi: 10.1016/j.addbeh.2009.03.001. Epub 2009 Mar 6.
citation: Berger GE, Proffitt TM, McConchie M, Kerr M, Markulev C, Yuen HP, O'Donnell C, Lubman D, Polari A, Wood S, Amminger PG, McGorry PD. Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years. J Clin Psychiatry. 2008 Nov;69(11):1702-14. Epub 2008 Nov 18.
Clinical trial NCT04946305: A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
Official title: A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Somatostatin Receptor-positive GEP-NET
Keywords: somatostatin receptor-positive GEP-NET
Lutathera
Observational
prospective
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 89
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 with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.

Brief summary: This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.


Eligibility criteria: Inclusion Criteria:

1. Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling.

   - somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
2. Patients who are willing to provide written informed consent.

Exclusion Criteria:

1. Patients with contraindication according to prescribing information for Lutathera in Korea.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 36 weeks
measure: Incidence of Adverse Drug Reactions
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Effectiveness in terms of Overall Response Rate (ORR)
timeFrame: Up to 32 weeks (4 cycles of 8 weeks)
Other outcomes:
Locations:
city: Seongnam Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01974505: Learning Curve of Optiscope by Anesthesia Providers
Official title: Learning Curve of Optiscope by Anesthesia Providers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: Jeju National University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal intubation. This study will investigate learning curve of Optiscope by anesthesia providers.


Eligibility criteria: Inclusion Criteria:

* Patient who is scheduled general anesthesia for elective surgery

Exclusion Criteria:

* patient who is anticipated difficult airway
* patient who is needed rapid sequence induction
* Cervical injury

Primary outcomes:
measure: time to intubation
timeFrame: intubation period
Secondary outcomes:
Other outcomes:
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju Special Self-Governing Province
Study officials:
References:
Clinical trial NCT03598205: Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
Official title: Combination Therapy Based on Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema Treatment to Help the Antiedemigenous Effect of Intravitreal Dexamethasone in Subjects With Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Therapy for diabetic macular edema
Curcumin formulation (DIABEC)
Lead sponsor: Fondazione G.B. Bietti, IRCCS
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to explore the effect of a curcumin formulation in combination to intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological retinal characteristics and retreatment times.

Detailed description: Patients with diagnosis of clinically significant diabetic macular edema, confirmed by fluorangiography and OCT, undergoing to intravitreal dexamethazone injection will be enrolled in the study.

Enrollment will take place according to the inclusion/exclusion criteria set by the protocol.

The enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.

Eligibility criteria: Inclusion Criteria:

* - Patients with clinically significant diabetic macular edema in non-proliferative diabetic retinopathy, diagnosed by fluorangiography and OCT
* Naive patients
* Patients with clinically significant DME who have not been treated for more than 3 months with anti-VEGF therapy and for more than 6 months with intravitreal injection of dexamethasone
* Central retinal thickness (CRT) at OCT\> 300 microns
* Best Corrected Visual Acuity (BCVA) with ETDRS tables at 4 meters not \<20/400
* Ability to provide written informed consent and follow the procedures of the study

Exclusion Criteria:

* Retinal pathologies other than diabetic macular edema
* Proliferative diabetic retinopathy
* Opacities that limit the execution and interpretation of diagnostic tests
* Surgical interventions in the study eye in the 3 months prior to the start of treatment
* Pregnancy
* Feeding time

Primary outcomes:
measure: Mean difference in CRT from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Mean difference in BCVA from baseline to 6 months
timeFrame: 6 months
measure: Evaluation of safety: incidence of Treatment-Emergent Adverse Events
timeFrame: 6 months
measure: Retreatment times
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Università Humanitas Gavazzeni Bergamo
city: Catanzaro
country: Italy
facility: Università degli Studi Magna Graecia
city: Rome
country: Italy
facility: Fondazione G.B.Bietti-IRCCS
Study officials:
affiliation: Fondazione G.B. Bietti, IRCCS
name: Mariacristina Parravano
role: PRINCIPAL_INVESTIGATOR
References: