TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
Brief Summary: The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing social anxiety in adults with autism.

The main questions it aims to answer are:

* Do two sessions of MDMA-assisted therapy reduce social anxiety?
* What dose of MDMA is most effective at reducing social anxiety?

Researchers will compare two blinded sessions of MDMA-assisted therapy to two blinded sessions of placebo with therapy.

Participants will undergo three non-drug preparatory therapy sessions before the first blinded medication session. After each medication session, participants will undergo three non-drug integrative therapy sessions.

In Stage 2, participants who received placebo with therapy in the first two blinded sessions will be able to undergo two sessions with MDMA-assisted therapy.


Options:
A: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
B: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)
C: Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2 (1-Month Post Experimental Session 2); Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2 (Baseline to 1-Month Post Experimental Session 2)
D: Total Number of Subjects With Reported Side Effects as Assessed by Dosage Record and Treatment Emergent Symptom Scale (DOTES) (4, 8, and 12 weeks); The Clinical Global Rating Scale (CGRS) Improvement Subscale Score (12 weeks); Glutathione (GSH) Levels in Peripheral Blood, Measured by State-of-the-art High-performance Liquid Chromatography (HPLC) (12 weeks); Irritability Subscale of the Aberrant Behavior Checklist (ABC) (baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Microfinance Intervention to Improve Health of Trauma Survivors in DRC
Brief Summary: The objective is to test the effectiveness of a village-led microfinance program, Pigs for Peace, on health, household economic stability, and reintegration of trauma survivors to family and community.

The five-year experimental trial will use mixed-methods to address the following aims:

1. Determine the effectiveness of a village-led microfinance program on participants health and reintegration in intervention households compared to participants in delayed control households. Health and reintegration will be measured at baseline and six, twelve, and 18-months post-baseline using self-report in both intervention and delayed control groups. We hypothesize that at six, twelve and 18 months post-baseline participants in intervention households will have improved health and increased reintegration to families in comparison to participants in control households.
2. Determine the effectiveness of a village-led microfinance program on household economic stability in intervention households compared to delayed control villages. Household economic stability will be measured at baseline and six, twelve and 18 months post- baseline using self-report in both intervention and control households. We hypothesize that at six, twelve and 18-months post-baseline the intervention households will have improved household economic stability in comparison to control households.
3. Examine the role of a village-led microfinance program on village-level health, economics, stigma and reintegration of survivors and their families in intervention and delayed control villages. Village members (n=5 in each village, n=50 total) will complete a baseline and 18 month post-baseline qualitative interview to examine the role of microfinance on village-level health, economics, stigma and reintegration in both intervention and control households.


Options:
A: Change from baseline Mental health distress at 18 months (Baseline and 18 months post baseline)
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
C: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
D: Eyberg Child Behavior Inventory (Baseline, post- intervention and 12-month post-intervention follow-up); Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) (Baseline, post- intervention and 12-month post-intervention follow-up); Sinovuyo Observational Coding System (Baseline, post- intervention and 12-month post-intervention follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients
Brief Summary: Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.


Options:
A: Reduction of UP by more than 50% after Pregabalin administration (2012)
B: Severity of Pruritis as measured by a visual analogue scale (VAS) (3 months)
C: Subjective measurement of reduction in pruritus (3 months)
D: Severity of Pruritis, as measured by a visual analogue scale (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Brief Summary: We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.

Why?

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:

* What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
* What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
* What is the incidence of ARDS based on the Berlin definition within this patient cohort?
* What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
* What is the natural history of ARDS?
* What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?

When?

The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.

What data is required?

A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.


Options:
A: Development of ARDS (28 days)
B: Survival (Approximately 25 days)
C: Ventilator free days within 28 days after enrollment (28 days)
D: Achievement of VT reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at VT of 6 mL/kg. (maximum 28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Brief Summary: We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.

Why?

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:

* What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
* What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
* What is the incidence of ARDS based on the Berlin definition within this patient cohort?
* What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
* What is the natural history of ARDS?
* What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?

When?

The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.

What data is required?

A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.


Options:
A: Time to Recovery (Day 1 through Day 29); Time to Recovery by Race (Day 1 through Day 29); Time to Recovery by Ethnicity (Day 1 through Day 29); Time to Recovery by Sex (Day 1 through Day 29)
B: Development of ARDS (28 days)
C: In-hospital mortality (3 weeks)
D: Time to Clinical recoveryTime to Clinical Recovery (TTCR) (up to 28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Brief Summary: We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.

Why?

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:

* What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
* What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
* What is the incidence of ARDS based on the Berlin definition within this patient cohort?
* What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
* What is the natural history of ARDS?
* What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?

When?

The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.

What data is required?

A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.


Options:
A: change in extravascular lung water within 7 days of treatment (change from baseline - day 7)
B: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
C: Development of ARDS (28 days)
D: All cause mortality (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Brief Summary: We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.

Why?

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:

* What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
* What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
* What is the incidence of ARDS based on the Berlin definition within this patient cohort?
* What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
* What is the natural history of ARDS?
* What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?

When?

The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.

What data is required?

A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.


Options:
A: Mortality rate (at day 90)
B: Survival in 28 days (28 days)
C: Development of ARDS (28 days)
D: A composite outcome of mortality and time off the ventilator at 28-days. (Day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Brief Summary: We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.

Why?

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:

* What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
* What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
* What is the incidence of ARDS based on the Berlin definition within this patient cohort?
* What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
* What is the natural history of ARDS?
* What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?

When?

The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.

What data is required?

A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.


Options:
A: adherence to our explicit mechanical ventilation protocols; (duration of mechanical ventilation); to measure and understand the reasons for crossovers between groups (duration of mechanical ventilation); to estimate the rate of patient recruitment, and understand barriers to recruitment; to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment
B: All-cause hospital mortality (Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.)
C: Reduction of the mortality rate of ARDS patients at d90 (36 months)
D: Development of ARDS (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Brief Summary: We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.

Why?

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions:

* What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter?
* What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support?
* What is the incidence of ARDS based on the Berlin definition within this patient cohort?
* What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity?
* What is the natural history of ARDS?
* What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients?

When?

The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere.

What data is required?

A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.


Options:
A: Development of ARDS (28 days)
B: Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation (5 min after the onset of mechanical ventilation)
C: Hospital Mortality
D: 60 day mortality (60 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
Brief Summary: The primary objective of the study was to compare the growth parameters of children approximately 2\* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.

(\* The mean age of subjects was 33.0 months due to a delay in the study start-up.)


Options:
A: Weight-for-Length Z-Scores (2 years of age)
B: Body weight measured at each study visit (12 months)
C: Mean weight gain (6 months)
D: Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing (up to 8 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass - a Randomized Control Clinical Trial
Brief Summary: The great saphenous vein is the most commonly used material in coronary vascular bridging operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the incision open groin to ankle. This operation may damage the lymphatic, cause lymph circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around hematoma and other a series of symptoms.Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following Stripping saphenous vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC application on postoperative complications and wound healing after Stripping saphenous vein in Coronary bypass in comparison to conventional suction drain.


Options:
A: Early Complications of Vascular Zone (2 weeks)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass - a Randomized Control Clinical Trial
Brief Summary: The great saphenous vein is the most commonly used material in coronary vascular bridging operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the incision open groin to ankle. This operation may damage the lymphatic, cause lymph circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around hematoma and other a series of symptoms.Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following Stripping saphenous vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC application on postoperative complications and wound healing after Stripping saphenous vein in Coronary bypass in comparison to conventional suction drain.


Options:
A: Post-operative wound infection (6 weeks post-operative)
B: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
C: Number of participants with seroma (3 months)
D: Early Complications of Vascular Zone (2 weeks)

Answer: D