TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Therapy.
Brief Summary: In this clinical trial, the investigators want to know if cabazitaxel is more effective than methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head and neck in palliative treatment.


Options:
A: Efficacy (18 weeks)
B: Compliance (weekly during treatment)
C: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.
Brief Summary: This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis \> 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.


Options:
A: Survival at one year (one year)
B: Mortality (18 months)
C: To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. (When 97 patients are included (% of the whole population))
D: Paracentesis free survival (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Sham Controlled Randomised Trial of Intraperitoneal Bupivacaine During Acute Laparoscopic Cholecystectomy
Brief Summary: Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common procedure. This can be performed as an emergency operation when a patient has a complication of gall stones such as acute inflammation or pancreatitis. There are several trials which demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder surgery during a planned elective operation decreases post operative pain. This is the first trial to investigate the efficacy of this local anaesthetic during emergency cholecystectomy.


Options:
A: VAS pain score (1, 4, 8 hours after operation and at discharge)
B: VAS pain score
C: Time to discharge patient after surgery (6 hours postoperative)
D: Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain], (6 and 24 hours after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Millions of children in North America receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. Children frequently use technologically advanced devices such as computers and cell phones. Based on this familiarity, the investigators introduced another sophisticated device - a humanoid robot to- interact with children during their vaccination. The investigators hypothesized that these children would experience less distress than children who did not have this interaction.


Options:
A: technical quality of the LP, classified as success or failure. (immediate)
B: Pain score (NCCPC-PV scale) (intraoperative)
C: Observation Scale of Behavioral Distress-Revised (OSBD-R)
D: Faces Pain Scale-Revised (5 mins before and immediate after vaccination)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
Brief Summary: The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.


Options:
A: Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
B: Time to Relapse During the Double-Blind Phase (Approximately Week 60)
C: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. (Baseline to Week 6)
D: The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period (After 68 relapse events)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
Brief Summary: Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration

The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.

In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.


Options:
A: Change in inhaler, turbuhaler, and diskus technique (Baseline and 1-month follow-up)
B: Adherence rate (at three months)
C: medication adherence (on year)
D: Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
Brief Summary: Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration

The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.

In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.


Options:
A: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)
B: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)
C: Adherence rate (at three months)
D: Score of Asthma Control Questionnaire (baseline and over a year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study of the Feedback From an Adherence Monitor on Asthma Control
Brief Summary: Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration

The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.

In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.


Options:
A: medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
B: Patient Adherence to Inhaled Corticosteroids (ICS) (1 year)
C: Adherence rate (at three months)
D: Modified Medication Possession Ratio (Measured over 19 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RAPID: Reducing Pain; Preventing Depression
Brief Summary: The primary question addressed by this prevention study is to explore if improving pain and disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA) and mild depressive symptoms.


Options:
A: The Visual Analog Scale (VAS) (Change from Baseline in Visual Analog Scale at Immediate post-intervention); The Visual Analog Scale (VAS) (Change from Baseline in Visual Analog Scale at 2 days); Western Ontario and McMaster Universities (WOMAC) Index (Change from Baseline in WOMAC at 2 days); Self-Leeds Assessment of Neuropathic Symptoms and signs (S-LANSS) Scale (At Baseline); Pressure Pain Threshold (PPT) (Change from Baseline in PPT at Immediate post-intervention); Pressure Pain Threshold (PPT) (Change from Baseline in PPT at 2 days); Thermal Perception and Pain Thresholds (Change from Baseline in Thermal Perception and Pain Thresholds at Immediate post-intervention); Thermal Perception and Pain Thresholds (Change from Baseline in Thermal Perception and Pain Thresholds at 2 days); Hand-Held Dynamometer (Change from Baseline in Hand-Held Dynamometer at Immediate post-intervention); Hand-Held Dynamometer (Change from Baseline in Hand-Held Dynamometer at 2 days); Standard Goniometer (Change from Baseline in Standard Goniometer at Immediate post-intervention); Standard Goniometer (Change from Baseline in Standard Goniometer at 2 days); Three-meter Timed "Up and Go" (Change from Baseline in Three-meter Timed "Up and Go" at Immediate post-intervention); Three-meter Timed "Up and Go" (Change from Baseline in Three-meter Timed "Up and Go" at 2 days)
B: Change in Pain on the VIsual Analog Scale (VAS) (6 weeks); Change in WOMAC Pain Scale (6 weeks)
C: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Change from baseline at 9 weeks, 1 year and 2 years)
D: Patient Global Impression of Change for Knee Pain (Assessed after the 8-16 week intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Pharmacological Intervention to Prevent Delirium: Haloperidol Prophylaxis in Older Emergency Department Patients
Brief Summary: The investigators propose a multicenter, randomized, double-blinded, placebo-controlled trial to study the effect of additive low-dose haloperidol prophylaxis on top of exciting care in a general population of older patients (age 70 years and over) acutely admitted to the hospital through the emergency department (ED) for general medicine and surgical specialties, and who are at-risk for developing in-hospital delirium on admission according to the VMS delirium risk questions (one or more positive answers out of three questions).

The investigators hypothesize that this intervention will reduce the incidence of in-hospital delirium as well as duration and severity of delirium.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
B: Incidence of postoperative delirium (During the first 7 days after surgery.)
C: Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (7 days postoperatively)
D: The initial day and number of days there is a significant change from baseline in the mean Delirium Observation Screening (DOS) score, and/or delirium is diagnosed according to the DSM-IV criteria. (Assessed within 1 to 7 days after initiation of the study intervention.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose-Response of Manipulation for Cervicogenic Headache
Brief Summary: This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.


Options:
A: Headache days change from baseline for cervicogenic headache (0, 6, 12, 24, 39, 52 weeks)
B: Pain intensity (Ninety days)
C: Numeric pain rating scale (NPRS) (Baseline); Numeric pain rating scale (NPRS) (post 3 weeks); Pain pressure threshold (baseline); Pain pressure threshold (post 3 weeks); Thoracic ROM (Baseline); Thoracic ROM (post 3 weeks)
D: Neck Disability Index (NDI) (baseline and post intervention 2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safeguarding the Brains of Our Smallest Children - a Pilot Study
Brief Summary: Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.


Options:
A: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)
B: The burden of hypo- and hyperoxia (0-72 hours of life)
C: change of medical management elicited by cerebral oxygenation out of range (0-72 hours of life)
D: Cerebral tissue oxygen saturation (crSO2) (15 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch
Brief Summary: The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.


Options:
A: risk of ovarian hyperstimulation syndrome (12 days)
B: Rate and degree of OHSS (composite outcome) (14 days)
C: Moderate or severe ovarian hyperstimulation syndrome (Within 4 weeks of HCG adminstration)
D: Percentage and severity of OHSS in two groups (6 days after embryos transfer (ET))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch
Brief Summary: The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.


Options:
A: Moderate or severe ovarian hyperstimulation syndrome (Within 4 weeks of HCG adminstration)
B: risk of ovarian hyperstimulation syndrome (12 days)
C: Percentage and severity of OHSS in two groups (6 days after embryos transfer (ET))
D: OHSS (41 days after hCG injection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial of a Standardised and User-friendly Real-time PCR Assay for the Diagnosis of TB Using Tracheal Aspirates Obtained From Patients in the ICU
Brief Summary: Aim:

To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically ventilated in ICU, using tracheal aspirates.

Hypothesis:

Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will impact on rates of treatment initiation and hospital stay.


Options:
A: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (2 months after enrollment)
B: Treatment time (Up to 8 weeks)
C: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
D: Rates of TB treatment initiation (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial of a Standardised and User-friendly Real-time PCR Assay for the Diagnosis of TB Using Tracheal Aspirates Obtained From Patients in the ICU
Brief Summary: Aim:

To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically ventilated in ICU, using tracheal aspirates.

Hypothesis:

Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will impact on rates of treatment initiation and hospital stay.


Options:
A: Correlation between baseline clinical characteristics and presence of microbiologically confirmed active tuberculosis. (Two years); Comparison of ART outcome in patients taking concomitant anti-tuberculosis therapy and those only taking ART. (Three years)
B: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
C: Sensitivity and specificity (10 months)
D: Rates of TB treatment initiation (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial of a Standardised and User-friendly Real-time PCR Assay for the Diagnosis of TB Using Tracheal Aspirates Obtained From Patients in the ICU
Brief Summary: Aim:

To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically ventilated in ICU, using tracheal aspirates.

Hypothesis:

Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will impact on rates of treatment initiation and hospital stay.


Options:
A: All-cause mortality (8 weeks)
B: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
C: All-cause mortality 12 weeks after inclusion (12 weeks)
D: Rates of TB treatment initiation (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Weight-loss Diet Strategies and Exercise on Dynamics of Body Fat Depots and Metabolic Rate
Brief Summary: The investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases.


Options:
A: body fat composition (0, 6,18 months); obesity (0, 6, 18 months); abdominal obesity (0, 6, 18 months)
B: Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group (12 months); Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group (12 Months); Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group (12 months); Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group (12 Months)
C: Percent Change in Body Weight From Baseline to 48 Weeks (Baseline, 48 weeks)
D: Weight loss (2 years)

Answer: A