louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00812045: Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Induced sputum
cystic fibrosis
biomarker
CYBER
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 44
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: The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Have a clinical diagnosis of cystic fibrosis with an FEV1 \>40% of predicted normal
* Be able to comply with induced sputum procedure
* post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy)

Exclusion Criteria:

* Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
* Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
* Known to be infected with Burkholderia cepacia

Primary outcomes:
measure: Effect on biomarker levels in induced sputum
timeFrame: 2 times at baseline and after 4 weeks treatment
measure: Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)
timeFrame: At inclusion, at randomisation and after 4 weeks treatment
Secondary outcomes:
measure: Safety and tolerability (adverse events, vital signs and laboratory safety variables)
timeFrame: throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up)
measure: Effect on biomarkers in blood
timeFrame: 2 times, at baseline and after 4 weeks treatment
measure: Effect on biomarkers in urine
timeFrame: 2 times, at baseline and after 4 weeks treatment
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
Study officials:
affiliation: AstraZeneca R&D Charnwood
name: Andrew J Lockton, MD
role: STUDY_DIRECTOR
affiliation: The Ottawa Hospital
name: Shawn Aaron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04602845: Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients
Official title: The Effects of Remimazolam Tosilate Sedation Compared With Midazolam Sedation in Dental Patients: A Double Blind, Prospective , Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation Complication
Midazolam
Remimazolam
Keywords: Remimazolam
Midazolam
Sedation
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.


Eligibility criteria: Inclusion Criteria:

1. Age 18-60
2. BMI in 18-30Kg / m2
3. ASA classification I-II level
4. Sign informed consent
5. Patients whose outpatient treatment time less than 1 hour
6. The methods of local anesthesia including: periosteum infiltration method, periodontal ligament injection method, regional nerve block method

Exclusion Criteria:

1. Patients who are allergic to benzodiazepines, opioids, flumazenil or have contraindications
2. Long-term use of benzodiazepines
3. Long-term use of opioids
4. Participate in other clinical trials within 4 weeks
5. Women during pregnancy or breastfeeding
6. Patients who have a history of drug abuse or long-term alcohol abuse
7. Patients who suffer from mental illness or unable to cooperate with the experiment

Primary outcomes:
measure: Success rates of sedation
timeFrame: Day 0
Secondary outcomes:
measure: Time to reach ideal sedation
timeFrame: Day 0
measure: Differences in blood pressure between the two groups
timeFrame: Day 0
measure: Differences in heart rate between the two groups
timeFrame: Day 0
measure: Differences in basic vital signs between the two groups
timeFrame: Day 0
measure: Deepest sedation of MOAA/S
timeFrame: Day 0
measure: Deepest sedation of Bispect ral index(BIS) value
timeFrame: Day 0
measure: Recovery of orientation
timeFrame: Day 0
measure: Benzodiazepine dosage
timeFrame: Day 0
measure: Respiratory complication occurrence rate
timeFrame: Day 0
measure: Discharge time
timeFrame: Day 0
measure: The Hopkins Language Learning Test score
timeFrame: Day 0
measure: Usage rate of flumazenil
timeFrame: Day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Beijing
city: Haidian
country: China
facility: Zijian Guo
state: Beijing
Study officials:
affiliation: Department of anesthesiology of peking university school of stomatology
name: Xudong Yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02162745: Nasal Irrigation in Infants With Bronchiolitis.
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Normal saline solution
Hypertonic solution
Nasal irrigation
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 133
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.

Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.

The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.


Eligibility criteria: Inclusion Criteria:

* infants \<1 year
* diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
* oxygen saturation between 88 and 94%

Exclusion Criteria:

* previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
* chronic illness

Primary outcomes:
measure: Oxygen saturation (%)
timeFrame: up to 50 minutes after allocation
Secondary outcomes:
measure: Respiratory effort (WARME score)
timeFrame: 5, 15, 20, 50 minutes after allocation
Other outcomes:
Locations:
city: Pordenone
country: Italy
facility: Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
state: Friuli Venezia Giulia
city: Trieste
country: Italy
facility: Emergency Department, IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Dino Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Silvana Schreiber, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT04942145: Effect of Virtual Reality on Dental Patients
Official title: Behaviour, Anxiety Management, Personality Traits and Coping of Dental Patients Through Virtual Reality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Behavior Problem
Anxiety, Dental
Keywords: virtual reality
dental anxiety
behaviour
psychological factors
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Clinicians should appreciate the effectiveness of virtual reality (VR) headsets for managing both the anxiety and the behaviour of dental patients. The aim of this study was to assess the effectiveness of using a VR headset as a distraction for managing the anxiety and behaviour of patients during their dental treatment related to underlying psychological factors.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with dental needs.
* Children with parental consent

Exclusion Criteria:

* patients with cognitive impairments

Primary outcomes:
measure: Dental anxiety
timeFrame: 3 years
measure: Behaviour
timeFrame: 3 years
measure: Personality traits
timeFrame: 3 years
measure: coping strategies
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Clinica Odontológica de la Universidad de Salamanca
city: Salamanca
country: Spain
facility: Javier Montero
Study officials:
References:
Clinical trial NCT04361045: StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students
Official title: Randomized Control Trial of Online Mental Health Promotion Program for University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depressive Symptoms
Stress, Psychological
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 1631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was a randomized controlled trial of an original online mental health promotion program. This study aimed to: 1) establish program effectiveness by examining symptom change between conditions and 2) examine predictors of symptom change. The program was previously tested in open trial feasibility study by the same Principal Investigator and has since been rebuilt as informed by feasibility findings and participant qualitative feedback.

Participants were randomly assigned to either a waitlist condition or eight weeks of the intervention condition. Baseline, posttest, and follow-up electronic surveys collected self-reported symptoms of stress, anxiety, and depression. Motivational variables were also assessed at baseline and then tested as moderators of intervention effects.


Eligibility criteria: Inclusion Criteria:

* enrolled as a student at UCLA (Fall 2017 - Winter 2018)

Exclusion Criteria:

* concurrent enrollment in a similar online anxiety and depression treatment study on campus
* invalid data reporting (e.g., straight-lined responses to surveys) -- post hoc exclusion

Primary outcomes:
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: [Time Frame: Baseline to Posttest (~8 weeks)]
Secondary outcomes:
measure: Program Adherence
timeFrame: [Time Frame: Baseline to Posttest (~8 weeks)]
measure: Program Satisfaction
timeFrame: Posttest (~8 weeks)
Other outcomes:
measure: Subjective Happiness Scale
timeFrame: [Time Frame: Baseline to Posttest (~8 weeks)]
measure: Patient Health Questionnaire-9
timeFrame: [Time Frame: Baseline to Posttest (~8 weeks)]
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Denise Chavira, PhD
role: STUDY_CHAIR
affiliation: Harvard University
name: Leslie Leslie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanano M, Rith-Najarian L, Boyd M, Chavira D. Measuring Adherence Within a Self-Guided Online Intervention for Depression and Anxiety: Secondary Analyses of a Randomized Controlled Trial. JMIR Ment Health. 2022 Mar 28;9(3):e30754. doi: 10.2196/30754.
Clinical trial NCT04433845: The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Official title: The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Treatment Resistant Depression
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
Collaborators: name: COMPASS Pathways
First posted: 2020-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

Exclusion Criteria:

* Comorbidities

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: From Baseline (Day -1) to three weeks post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sheppard Pratt
state: Maryland
Study officials:
affiliation: Sheppard Pratt Health System
name: Scott Aaronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06512545: Modified Second Haplo-transplantation for Graft Failure
Official title: Second Haploidentical Transplantation with Modified Regimen for Graft Failure After the First Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft Failure
Stem Cell Transplant Complications
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.


Eligibility criteria: Inclusion Criteria:

* 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic stem cell transplantation; 3.Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.

Exclusion Criteria:

* 1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\>2; 5. Expected life time\<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,

Primary outcomes:
measure: Engraftment of neutrophils
timeFrame: 28 days after second transplantation
Secondary outcomes:
measure: Engraftment of Platelet
timeFrame: 100 days after second transplantation
measure: TRM at 28 day
timeFrame: 28 days after second transplantation
measure: TRM at 100 day
timeFrame: 100 days after second transplantation
measure: GVHD
timeFrame: Participants will be followed for an expected average of 1 year
measure: OS
timeFrame: Participants will be followed for an expected average of 1 year
measure: LFS
timeFrame: Participants will be followed for an expected average of 1 year
measure: CIR
timeFrame: Participants will be followed for an expected average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Institute of Hematology, Peking University People's Hospital
name: Xiao-Jun Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02287545: Biomechanical Changes After Trabeculectomy
Official title: Corneal Biomechanical Changes Following Trabeculectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Primary
Keywords: open angle glaucoma
corneal biomechanics
trabeculectomy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary open-angle glaucoma patients assigened for a trabeculectomy.

Brief summary: Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy.

Detailed description: Prior to trabeculectomy corneal biomechanics are measured with the Ocular Response Analyzer (ORA, Reichert) and the Corvis st (Oculus). Both instruments work with an air-puff which deforms the cornea. Intraocular pressure is measured like in non-contact air-puff tonometry. The ORA also measures corneal hysteresis (CH) and the corneal resistance factor (CRF) which are qualitative measures of corneal biomechanics. The Corvis is a high-speed Scheimpflug-camera (4330 frames/sec) that records the quantitative movements of the cornea. At least 6 month after uncomplicated trabeculectomy the measurements are repeated.

Eligibility criteria: Inclusion Criteria:

* Glaucoma patients in need of further IOP-reduction despite maximally tolerated therapy and assigned for trabeculectomy. Minimum of 18 years.

Exclusion Criteria:

* Corneal pathologies.

Primary outcomes:
measure: Corneal biomechanical changes following trabeculectomy
timeFrame: 2-3 years
Secondary outcomes:
measure: Intraocular pressure after trabeculectomy
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technical University Dresden
state: Saxony
Study officials:
affiliation: Technische Universität Dresden
name: Karin R Pillunat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059045: Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
Official title: Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemangioma of Preterm Infants
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 14
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective controlled study evaluating cryocontact therapy of infantile hemangiomas of preterm infants

Principal investigator: Rangmar Goelz, MD Coworkers: M Möhrle, M Moll, HM Häfner, W Schippert, C Meisner, M Röcken, CF Poets

Background Despite their frequent occurrence, there is no established therapeutic procedure for localized infantile hemangioma in preterm infants. A PubMed search with the key words hemangioma, controlled study, infant or childhood revealed five studies (1-5), none of them included preterm infants, even though low birth weight and prematurity have been described as the most significant risk factors

Aim:

To evaluate cryocontact therapy of infantile hemangioma (IH) of 1 - 10 mm diameter in preterm infants \<=34 weeks of gestational age (GA) using a liquid nitrogen cooled metal at the Department of Neonatology at the Tuebingen University Hospital.

Method:

In a prospective controlled study, preterm infants \<= 34 weeks GA with at least 2 IH should be randomized to have one treated with cryocontact therapy using a liquid nitrogen cooled metal (-196°C), while the other one is left untreated. Primary endpoint is an intact skin at the site of the hemangioma at 1 year corrected age . The study starts at August 1st, 2004. Cryocontact is done by 3 trained dermatologist (MM, HMH, WS), outcome documentation, including photodocumentation, by 2 neonatologist (RG, MoMo).

Statistical Analysis: A sample size of 25 intrapersonal pairs of treated and untreated IH is needed to show a significant difference with alpha=0.05 and beta=0.9 between treated IH and controls, assuming that 5% of the treated IH and 40% of the controls have an unsuccessful primary outcome. Documentation will be made on standardized forms and the data will be transferred to Excel. Biometric calculations will be handled with SAS 9.1.3. for Windows using Fisher´s Exact Test for difference in proportions.

Ethics:

The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents must give written informed consent.


Eligibility criteria: Inclusion Criteria:

* preterm infants \<=34 weeks GA with hemangioma

Exclusion Criteria:

* no hemangioma

Primary outcomes:
measure: Hemangioma outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital
name: Rangmar Goelz, MD
role: PRINCIPAL_INVESTIGATOR
References: