louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00836927: Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)
Official title: An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Cancers
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Ariad Pharmaceuticals
First posted: 2009-02-04
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* Must have participated on a deforolimus (ridaforolimus) parent trial
* Must have derived a clinical benefit from the parent trial
* Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only
* Participant of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug
* Signed informed consent

Exclusion Criteria:

* Has not participated on a parent trial
* Women who are to receive study drug who are pregnant or lactating
* Any condition in the Investigator's judgment that renders the participant unable to fully understand and provide informed consent and/or comply with the protocol

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
measure: Overall Survival (OS)
timeFrame: Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00969527: Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
Official title: Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Oncoxin
Viusid
dietary supplements
rheumatoid arthritis
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 86
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 the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Treatment-naive subjects with recent onset rheumatoid arthritis
* Signed informed consent

Exclusion Criteria:

* Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset
* Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis

Primary outcomes:
measure: Disease Activity Score (DAS 28 score) at week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of patients with Adverse Events at week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: Fructuoso Rodriguez Orthopedic Hospital
Study officials:
affiliation: "Fructuoso Rodríguez" Orthopedic Hospital
name: Juan Carlos Delgado Morales, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04128527: AuraOnce Performance Observation
Official title: Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 16
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 planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask.

Brief summary: This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.

The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.

Detailed description: This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.

The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

Eligibility criteria: Inclusion Criteria:

* Subjects \> 18 years
* Subjects planned for diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.

Exclusion Criteria:

- Subjects where use of AuraOnce cannot be clinically justified

Primary outcomes:
measure: Number of Participants With Leakage Observed During Procedure
timeFrame: During procedure, less than 1 hour
Secondary outcomes:
measure: Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))
timeFrame: During procedure, less than 1 hour
measure: Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))
timeFrame: During procedure, less than 1 hour
measure: Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5))
timeFrame: During procedure, less than 1 hour
measure: Number of Participants With Correct Placement of Mask
timeFrame: During procedure, less than 1 hour
measure: Number of Participants Where Tip of the Mask is Folded
timeFrame: During procedure, less than one hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT00592527: Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes
Official title: Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-14
Enrollment: 132
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: This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 12 months since diagnosis
* Insulin naive subjects
* OAD treatment for at least 4 months with max. two OAD treatments
* Body mass index below 30.0 kg/m2
* HbA1c between 7.0-11.0%

Exclusion Criteria:

* OAD treatment with three or more OADs
* Secondary diabetes
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
* Uncontrolled hypertension
* Known or suspected allergy to trial product or related products

Primary outcomes:
measure: HbA1c
timeFrame: after 20 weeks of treatment
Secondary outcomes:
measure: Fasting plasma glucose (FPG)
measure: Within-subject variation
measure: Change in body weight
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Kochi
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: Nagpur
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ramachandran A, Harish K, Sundaram A, Mayur P, Sunil GS, Srishyla MV. Improved Efficacy when Insulin Detemir is added to OADs in Indian Subjects with Type 2 Diabetes. Diabetes 2006; 55 (Suppl. 1): A469 (2028-PO)
Clinical trial NCT00738127: Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations
Official title: Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operative Time
Grip Strength
Pain
Functional Status
Keywords: Acute trans-scaphoid perilunate dislocations
Open reduction and internal fixation
Kirschner-wire
Range of motion
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 801
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.

Detailed description: Open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations. We study a new surgical technique that allows for early wrist excises postoperatively. We compare this technique to Inoue et al. 's techniques affect the objective and subjective outcomes. We also compared the long-term outcomes of these two procedures performed in similar patient groups.Although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.

Eligibility criteria: Inclusion Criteria:

* Clinical treatment of acute trans-scaphoid perilunate dislocations
* Must have open reduction and internal fixation

Exclusion Criteria:

* Patients whose age under 18 years
* Associated with severe crush, avulsion, or opened injury

Primary outcomes:
measure: In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.
timeFrame: 1992-2004
Secondary outcomes:
measure: Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.
timeFrame: 1992-2004
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The Second Hospital of Qinhuangdao
state: Hebei
Study officials:
affiliation: The Second Hospital of Qinhuangdao
name: Xu Zhang, MD
role: STUDY_CHAIR
References:
citation: Moneim MS, Hofammann KE 3rd, Omer GE. Transscaphoid perilunate fracture-dislocation. Result of open reduction and pin fixation. Clin Orthop Relat Res. 1984 Nov;(190):227-35.
Clinical trial NCT06399627: Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
Official title: Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Bypass, Off-Pump
Iron Deficiencies
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 433
Sex: ALL
Minimum age (years): 29
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-anemic patients who underwent off pump coronary artery bypass surgery

Brief summary: This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11\~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. These two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes.

The primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. Occurrence of any one of these outcomes counted as primary end point met. Secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who received off pump coronary artery bypass surgery (OPCAB) between 2016.11.01-2023.05.31

Exclusion Criteria:

* preoperative anemia (male Hb \<13g/dL, female Hb\<12g/dL)
* emergency surgery
* redo-off pump coronary artery bypass surgery
* minimally invasive coronary artery bypass surgery
* OPCAB in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta)
* intraoperative on pump conversion
* lack of sufficient preoperative data (ferritin, transferrin saturation, C-reactive protein) to determine iron status
* administration of intravenous iron within 4 weeks or parenteral iron of more than 2 weeks prior to surgery
* enrollemnt in other clinical studies

Primary outcomes:
measure: Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
timeFrame: from the end of surgery until patient discharge (assessed up to day 60)
measure: Number of participants with acute kidney injury
timeFrame: until 7 days after surgery
measure: Number of participants with post operative myocardial infarction
timeFrame: until 48 hours post-surgery
Secondary outcomes:
measure: Post discharge hemoglobin
timeFrame: Until 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health system, Severance Hospital
Study officials:
References:
Clinical trial NCT02962427: Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.
Official title: Treatment of Post-dural Puncture Headache in Postpartum Parturients: Comparing Sphenopalatine Ganglion Block to Epidural Blood Patch.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Headache
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.

Detailed description: The purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. A known dural puncture is defined as free flow of cerebral spinal fluid (CSF) during neuraxial placement. An unknown dural puncture is defined as neuraxial placement where free flow of CSF is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the International Classification of Headache Disorders.

Eligibility criteria: Inclusion Criteria

1. Age 18 years or age or greater
2. Postpartum obstetric parturient who was previously admitted to UCH.
3. Diagnosis of post-dural puncture headache based on the International Classification of Headache Disorders:

   1. Dural puncture has been performed
   2. Headache has developed within 5 days of the dural puncture
   3. Not better accounted for by another ICHD-3 diagnosis.
   4. Occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally.

Exclusion Criteria

1. Refusal to participate in the study
2. Placement of an EBP within the past 5 days
3. Allergy and/or intolerance to any the study materials
4. Contraindications to an EBP
5. Plan for therapeutic anticoagulation post-partum

Primary outcomes:
measure: Change in The Numerical Rating Scale Pain Score
timeFrame: Baseline and 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz Medical Campus - School of Medicine, Dept. of Anesthheisology
name: Cristina Wood, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218127: Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens
Official title: Opioid Maintenance: Optimum Stabilization and Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: Heroin dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-22
Enrollment: 142
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.

Detailed description: Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.

This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.

Eligibility criteria: Inclusion Criteria:

* Current opiate dependence
* Provides acceptable proof of identity
* History of 5 or more years of regular heroin use or dependence
* Reads and writes English

Exclusion Criteria:

* Significant suicidal or homicidal ideation, intent, or plan
* Current AXIS I psychotic, depressive, or anxiety disorder
* Meets DSM-IV criteria for dependence on any drug other than nicotine
* Impending legal complications or incarceration
* On parole or probation that requires reports of drug use or research data
* Currently receiving treatment for opiate dependence
* Currently participating in a 12-step substance detoxification program
* Medical condition that contraindicates administration of ORLAAM
* Plans to leave Houston, Texas within the year following study entry
* Pregnant or breastfeeding
* History of heart problems, including heart arrhythmias
* Requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)

Primary outcomes:
measure: drug use
timeFrame: herion use over 20 week period
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Department of Psychatiry, Mental Services
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Grabowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966927: Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid
Official title: Assessment of Functional Independence and Quality of Life in Italian Population of Adolescents With Spina Bifid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Dysraphism
Keywords: quality of life
functional independence
spina bifid
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2009-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with spina bifid referred to primary care clinic

Brief summary: The purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an Italian population.

Detailed description: We submitted the Quality of Life in spina bifid Questionnaire to subjects who participated in the study and the Spinal Cord Independence Measure to the parents of subjects.

Eligibility criteria: Inclusion Criteria:

* recurrence of clinic control in Unit for Spina Bifid in Parma
* 14-21 years old

Exclusion Criteria:

* subjects unable to understand the items of the questionnaire (mental retardation and need for help at school )
* subjects without any caregiver

Primary outcomes:
measure: correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence
timeFrame: 5 months
Secondary outcomes:
measure: correlation between functional level of independence and motor level of neurological lesion
timeFrame: 5 months
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Unit for Care of Spina Bifida
Study officials:
affiliation: UDGEE- Unit Care of Spina Bifida Parma
name: Manuela Lodesani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buran CF, Sawin KJ, Brei TJ, Fastenau PS. Adolescents with myelomeningocele: activities, beliefs, expectations, and perceptions. Dev Med Child Neurol. 2004 Apr;46(4):244-52. doi: 10.1017/s0012162204000404.