TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAP-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient - and Observer-blinded Multicenter Trial
Brief Summary: Brief summary

Background:

A large proportion of dental practice involves the treatment of caries in the permanent dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost through sickness. We do not know whether a stepwise excavation is better or worse compared with one final completed excavation in adults with deep caries with or without pain. A deep carious lesion is in the risk zone of being pulpal exposed during excavation.

Aim:

The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation during two visits versus óne completed excavation of deep caries in permanent teeth with or without pain.

Patients:

Consecutive patients contacting the units involved in the CAP trial for the treatment of deep caries. The trial will comprise 300 patients.

Design:

CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients that fulfill the inclusions criteria and none of the exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. Allocation ratio is 1:1.

Interventions and products:

Patients are allocated for stepwise excavation in two visits or final excavation in one visit. The patients will not be informed about the result of the randomisation, i.e. the type of intervention. Therefore, all patients will be contacted for two visits. The second visit in the stepwise excavation group wil be used for the second and final excavation, and for the performance of a permanent restoration. The second visit in the one step excavation group will solely be used for the performance of a permanent restoration. The interventions in both groups are completed following 8-10 weeks after the randomisation.

A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a resin material is used for the final restoration(Herculite®).


Options:
A: The restoration survival (changes from baseline up to 36 months) (The treatments will be evaluated after 1 week up to 36 months)
B: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (1year control data for all treatments primo 2008)
C: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. (6 months)
D: Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions. (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy on CAP-1 Patients: A Randomised, Patient - and Observer-Blinded Multicenter Trial
Brief Summary: CAP-2 Trial

Background: This trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1 trial). The investigators lack systematic knowledge concerning the treatment of the exposed pulp and whether the capping of a pulp represents the same outcome as the partial removal of an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).

Aim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have received either a final excavation or a stepwise excavation and where this intervention has led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain after excavation and placement of a temporary restoration.

Patients: Patients include consecutive patients with deep caries who have been participating in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief has not been obtained.

Design: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients who fulfill the inclusion criteria will be centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. The allocation ratio is 1:1.

The Interventions and Products: Patients are allocated for direct pulp capping or partial pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the type of intervention. In both groups the patient receives a calcium hydroxide seal covering the exposure and a glass ionomer restoration. The final resin restoration is placed following 4 weeks.


Options:
A: Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device. (6 months)
B: The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer. (1 year after inclusion in the CAP-2)
C: restauration evaluation (18 months)
D: Success (re-intervention required no/yes) (36 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
Brief Summary: The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.


Options:
A: Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization (8-10 days post-randomization); Survival to days 28 and 60 post-randomization and to Hospital Discharge (28 days to more than 60 days post-randomization)
B: 28-day mortality from all causes (28 days)
C: Mortality at 28 days (day 28)
D: Mortality (at 28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
Brief Summary: The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.


Options:
A: Mortality at 28 days (day 28)
B: Survival in 28 days (28 days)
C: 28-day mortality from all causes (28 days)
D: Arterial Oxygenation (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
Brief Summary: The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.


Options:
A: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)
B: Hospital Mortality
C: Oxygenation as measured by the PO2/FiO2 (P/F) ratio (72 hours from enrollment)
D: Mortality at 28 days (day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
Brief Summary: To examine the impact of cognitive-behavioural therapy on both the episodic and functional outcome of bipolar disorder, in combination with pharmacotherapy.

Primary Hypothesis is twofold:

1. Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by percentage of time spent ill (both syndromic and subsyndromal) and number of episodes, as compared to psychoeducation
2. Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.


Options:
A: Score on the MADRS depression rating scale at week 8 compared to baseline
B: Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).; Modified Social Adjustment Scale (SAS II-B; Bauer, 2001); ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
C: Time to Withdrawal From Study (Randomization to Study Withdrawal (up to Week 26))
D: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (8 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of 2 Versus 3 Pneumococcal Conjugate Vaccinations Prevnar on Nasopharyngeal Carriage, Transmission and Herd-immunity;a Randomized, Controlled Study
Brief Summary: Two( 2) or three (3) instead of four vaccinations before the age of 6 months with pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal disease like meningitis, at least on the short term till 18-24 months of age. The current hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal transmission and induce no herd-immunity. Furthermore, antibody development and memory may benefit from carriage of vaccine type S. pneumoniae


Options:
A: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).)
B: Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria (Any time from 2 weeks after the administration of dose 3 up to Month 22)
C: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (Any time from 2 weeks after Dose 3 up to 31 August 2010)
D: Nasopharyngeal bacterial (pneumococcal) colonization at 6 weeks, 6, 12, 18 and 24 months in infants and at 12 and 24 months of family members (duration of study, 23 months per subject); transmission to family members( sib, caregiver) (at infants age of 12 and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of 2 Versus 3 Pneumococcal Conjugate Vaccinations Prevnar on Nasopharyngeal Carriage, Transmission and Herd-immunity;a Randomized, Controlled Study
Brief Summary: Two( 2) or three (3) instead of four vaccinations before the age of 6 months with pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal disease like meningitis, at least on the short term till 18-24 months of age. The current hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal transmission and induce no herd-immunity. Furthermore, antibody development and memory may benefit from carriage of vaccine type S. pneumoniae


Options:
A: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).)
B: Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine); Antibody Concentration Against Protein D (PD) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine)
C: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (Any time from 2 weeks after Dose 3 up to 31 August 2010)
D: Nasopharyngeal bacterial (pneumococcal) colonization at 6 weeks, 6, 12, 18 and 24 months in infants and at 12 and 24 months of family members (duration of study, 23 months per subject); transmission to family members( sib, caregiver) (at infants age of 12 and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients
Brief Summary: Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer, fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM antibody is a promising innovative therapeutic approach.


Options:
A: Overview of Treatment-emergent Adverse Events (TEAEs) (Continuously for up to 16 weeks)
B: Occurrence of adverse events (side effects) (12 weeks (1 cycle of study treatment))
C: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) (Every 12 weeks up to recurrence or up to 3 months after last administered dose)
D: Selection of better dose level based on the confirmed tumor response.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ResQ Trial: Comparison of Standard CPR Alone Versus Active Compression Decompression CPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest
Brief Summary: The purpose of this study is to determine whether performing active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to conventional standard cardiopulmonary resuscitation (S-CPR) will impact the neurologic recovery and survival to hospital discharge following out-of-hospital cardiac arrest.


Options:
A: Hospital Discharge (From time of first contact until hospital discharge, up to 90 days.)
B: Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 (When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge)
C: Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
D: Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3). (Hospital discharge or death prior to discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Brief Summary: Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.


Options:
A: Percentage of patients with complete abortion (success rate). (1 week)
B: mean duration from the initial misoprostol dose until complete fetal expulsion (24 hours)
C: Number of surgical evacuation in each group (during de study)
D: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Brief Summary: Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.


Options:
A: Number of surgical evacuation in each group (during de study)
B: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)
C: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) (Day 8 from first misoprostol dose)
D: Success rate of abortion (24 hours); Interval to abortion (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Brief Summary: Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.


Options:
A: doxycycline side effects (24 hours)
B: Number of surgical evacuation in each group (during de study)
C: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)
D: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Brief Summary: Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.


Options:
A: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (one week after initial treatment)
B: doxycycline side effects (24 hours)
C: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
D: Number of surgical evacuation in each group (during de study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Brief Summary: Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.


Options:
A: feasibility (3 weeks)
B: Complete evacuation (six weeks after initial treatment)
C: Number of surgical evacuation in each group (during de study)
D: Complete abortion (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
Brief Summary: The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to:

1. the risk of stroke and death within 30 days of the procedure;
2. the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.


Options:
A: Any stroke or death within 30 days of the procedure (during de study)
B: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
C: Participants With a New Brain Infarction Detected Using Magnetic Resonance (24 hours after intervention)
D: Stroke and death (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Brief Summary: The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.


Options:
A: Incidence of hip fxs; Incidence of new vertebral fxs
B: N/A
C: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
D: Incidence of invasive breast cancer; superiority of one of the therapies. (Time from randomization to the occurance of invasive breast cancer.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Brief Summary: The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.


Options:
A: 1.Changes of calcification score of coronary arteries and aorta; 2.Changes of bone density
B: Change in degree of arterial stiffness measured by pulse wave velocity (18 months); Changes in vascular calcification on CT scans of superficial femoral artery and aorta (18 months)
C: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
D: Percentage of Participants With New Vertebral Fractures Through Month 24 (24 months); Percentage of Participants With a Clinical Fracture at the Primary Analysis (The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).)

Answer: C