TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Brief Summary: The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;


Options:
A: Number of Participants With Weight<10th Percentile for Age (36 weeks post-conceptual age); Number of Participants With Length <10th Percentile for Age (36 weeks post-conceptual age); Number of Participants With Head Circumference <10th Percentile for Age (36 weeks post-conceptual age); Cognitive Development Score (18-22 months corrected gestational age)
B: N/A
C: Number of withdrawal for intolerance (1 month)
D: Total RBC glutathione (0 days, 7 days, 60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial
Brief Summary: Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.


Options:
A: Hepatic steatosis (6 months)
B: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) (18 months)
C: Biomarkers related to oxidative stress (Twelve weeks)
D: Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18. (4 months); Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levels (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures: A Prospective, Double-Blind, Randomized Controlled Trial
Brief Summary: The goal of this study is to determine if the use of tranexamic acid, a safe and effective antifibrinolytic, in patients with intertrochanteric hip fractures will result in a reduction in blood transfusion rates. Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, cost of inpatient care, and rate of adverse events, including DVT, PE, infection, MI, cerebrovascular event, need for re-hospitalization or re-operation and 30 day mortality.


Options:
A: Change in hemoglobin (1 day and 3 days post-surgery)
B: Proportion of patients who received a blood transfusion during their hospital stay following surgery (From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).)
C: Intraoperative blood loss (End of surgery (last suture))
D: Blood transfusion rate (Hospital stay (3-7 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TOPICAL AND INTRAVENOUS ADMINISTRATION OF TRANEXAMIC ACID ARE EQUALLY EFFECTIVE IN DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Brief Summary: Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.

* RCT, prospective study
* Academic-monocentric study
* Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are

  1. The rate of perioperative and postoperative blood transfusion
  2. The number of blood units transfused
  3. The length of hospital stay
  4. Perioperative given intravenous isotonic fluid

The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.


Options:
A: Proportion of patients who received a blood transfusion during their hospital stay following surgery (From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).)
B: Postoperative Bloodloss (Day 1 after surgery)
C: Change in hemoglobin (1 day and 3 days post-surgery)
D: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TOPICAL AND INTRAVENOUS ADMINISTRATION OF TRANEXAMIC ACID ARE EQUALLY EFFECTIVE IN DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY - A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Brief Summary: Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.

* RCT, prospective study
* Academic-monocentric study
* Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are

  1. The rate of perioperative and postoperative blood transfusion
  2. The number of blood units transfused
  3. The length of hospital stay
  4. Perioperative given intravenous isotonic fluid

The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.


Options:
A: Postoperative Bloodloss (Day 1 after surgery)
B: Blood loss as calculated from change in haematocrit
C: The volume of postoperative blood loss in the drain (48 hours after the operation); Changes from baseline hemoglobin concentrations (48 hours after the operation); unit of blood transfusion (48 hours after the operation)
D: Perioperative Blood Loss (5 days after surgery); Total Hemoglobin Loss (5 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.


Options:
A: Incidence of Participants With Diarrhea by Parental Report (14 days)
B: Number of Participants Experiencing Diarrhea (14 days); Adverse Events (Days 0-180)
C: Reduction of the incidence of loose/watery stools following antibiotic treatment in children. (19-24 days)
D: To determine whether patients given oral Lactobacillus GG will have a smaller increase in the density of pathogenic bacterial in cultures from oral swabs, nasogastric aspirates, and minimally invasive bronchoalveolar lavage samples. (daily while intubated)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care: The mPeer2Peer Study
Brief Summary: The purpose of the mPeer2Peer Study (mP2P) is to see if we can use a smartphone and a Peer Navigator (PN) to improve medical care for HIV-positive people who have been out of HIV care for over one year.


Options:
A: antiretroviral treatment (primary) (6 months)
B: Change in IPV assessments (Screening and at 2 months post-birth.)
C: Acceptability and utility of the ProAsk intervention (12 months)
D: delayed bathing of baby (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Brief Summary: There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.


Options:
A: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
B: Alcohol consumption (12 weeks); Time to lapse (12 weeks); amount of alcohol consumption (12 weeks)
C: Percent Medication Adherence at 3-month Follow-up Assessment (3-month assessment); Percent Medication Adherence at 12-month Follow-up Assessment (12-month follow-up assessment)
D: 7-day Point Prevalence Smoking Abstinence at 8 Weeks (8 weeks); 7-day Point Prevalence Smoking Abstinence at 16 Weeks (16 Weeks); 7-day Point Prevalence Smoking Abstinence at 26 Weeks (26 Weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CIDRZ 1229- Better Health Outcomes Through Mentoring and Assessment (BHOMA)
Brief Summary: BHOMA Interventions

The purpose of this study is to assess the impact of the BHOMA intervention on health in 3 rural districts of Zambia.


Options:
A: Age standardized mortality rates in those aged <60 years. (4 years)
B: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
C: MEMS Adherence (12 months follow up)
D: Median "Laboratory turn-around-time" (TAT) (Days from the date a culture or drug susceptibility test (DST) result is obtained to the date when the result is obtained at health center); Percent laboratory errors, by type of error for health establishments in the intervention versus the control group. (2.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Etude de l'Effet du dropéridol et de l'Ondansetron Sur l'Incidence de l'Akathisie Post opératoire en Chirurgie Ambulatoire
Brief Summary: The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score \> 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.


Options:
A: Painscore during mobilization (2-24 hours after extubation time.)
B: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (up to 20-24 hours after surgery)
C: Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration (0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours)
D: Incidence of akathisia (1 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations
Brief Summary: In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.


Options:
A: Proportion of time with SpO2 spent within set target range (Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.)
B: proportion of time spent in extreme saturation ( less than or equal to 80%) (Through study completion, an average of 8 weeks)
C: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg (the first 15 minutes of resuscitation)
D: Cerebral tissue oxygen saturation (48 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Investigation of the Safety and Efficacy of Clenbuterol on Motor Function in Individuals With Late-onset Pompe Disease and Receiving Enzyme Replacement Therapy
Brief Summary: Funding Source- FDA OOPD

The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme replacement therapy (ERT).


Options:
A: Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0 to 2.5 years); Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104); Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104)
B: Summary of Patients Reporting Treatment-Emergent Adverse Events (weeks 0-78); Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline (weeks 0, 78); Percent of Predicted Forced Vital Capacity (FVC) (weeks 0, 78); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC) (weeks 0, 12 and 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax) (weeks 0, 12, 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax) (weeks 0, 12, 52)
C: Number of Participants With a Change in Creatine Kinase (CK) Reflecting Worsening of Muscle Involvement (Any point up to week 52); Number of Participants With a Change in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Bilirubin Representing Liver Toxicity (Any point up to week 52)
D: PAP: Change From Baseline in Percent Predicted FVC in Upright Position at Week 49 (Baseline, Week 49)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus
Brief Summary: This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.


Options:
A: Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day (baseline to week 12); Mean Change the Severity of Moderate to Severe Vasomotor Symptoms (baseline to week 12 (12 weeks))
B: Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Primary Safety Endpoint: Endometrial Protection - Hyperplasia (Baseline and Month 12)
C: Mean change from baseline in number of daily moderate to severe hot flushes.; Mean change from baseline in daily hot flush severity.; Mean change from baseline in vulvovaginal atrophy symptoms.
D: To measure estrone, estradiol and estriol levels at baseline and after achieving a steady state with 15-days of administration of three commonly used doses of bioidentical compounded estrogen cream and a standard dose conventional estrogen patch. (Day 1 and Day 15); To measure the progesterone levels at baseline and after achieving a steady state with 15-days of administration of 100 mg/day of two different oral progesterone formulations. (Day 1 and Day 15)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus
Brief Summary: This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.


Options:
A: Most Bothersome Symptom (MBS) Severity (Baseline, Week 4, Week 12)
B: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes (Baseline to End of Treatment (Week 12))
C: Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Primary Safety Endpoint: Endometrial Protection - Hyperplasia (Baseline and Month 12)
D: To show non-inferiority in breast cancer recurrence of tibolone 2.5 mg versus placebo in women with climacteric symptoms who have been surgically treated for primary breast cancer within the last 5 years (At clinical completion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the WiiFit to Enhance Walking in Older Adults With Lower Limb Amputation
Brief Summary: WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to improve walking capacity in individuals with either a unilateral below-knee or above-knee amputation. This is a randomized control trial to evaluate the effectiveness of the WiiNWALK program in older (50+ years) community living adults with lower limb amputations (LLA).

Hypothesis: We expect the WiiNWALK intervention will have a treatment effect with improvement in functional walking capacity, compared to the control group who will only be playing cognitive games. Secondarily, a functional walking capacity will also include an improvement in lower extremity strength and balance, inter-limb gait symmetry, balance confidence along with participation in daily and social activities, locomotor capabilities and an increase in physical activities.


Options:
A: 2 Minute Walk to assess walking speed and endurance improvement (Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up); Change in Two Minute Walk Test from baseline (Post-Intervention (1 month from Baseline)); Change in two minute walk test from 1 month assessment (Follow-Up (3 weeks from post-intervention))
B: Retention Rate (3 months); Dose Goal Attainment (3 months); Acceptability (3 months); Study-Related Adverse Events (3 months)
C: Step Length Symmetry (Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.)
D: Quality of Life measured of individuals: SF-36 Scale (10 minute); Balance Test (5 minute); Performance Test (6 minute); Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale (5 minute); Gait Parameters (6 minute)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
Brief Summary: Attending day care centres with programs specifically designed for patients with dementia is believed to postpone admittance to nursing home as well as increase quality of life and well-being for both patients and their family caregivers. We aim to investigate to what degree attendance in day care centres with programs for people with dementia is effective for patient and their caregivers whilst also cost efficient for society. The study consists of a quasi-experimental trial with comparison group. 400 patients with dementia, along with a family caregiver, will be included in the trial. Effects will be measured at baseline, after one and two years. Data collection will be made at three levels; at patient level with measures of cognition, depression, quality of life, functioning in activities in daily living, neuropsychiatric symptoms and death; at caregiver level with measures of depression, level of burden and quality of life; and at societal level with measures of nursing home admittance, hospital stays and use of other health resources. Additionally,a qualitative interview study will include 20 dyads from the main trial. The main focus will be on how attending day care centre programs for patients with dementia affect the lives of both patients and caregivers. Five of these dyads will be followed closely throughout the participation period to be used as case examples.


Options:
A: Admittance to nursing home care (24 months)
B: The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. (Baseline, 4 month (short-term follow-up), 8 month (long-term))
C: Neuropsychiatric inventory (NPI) score (NPI score will be measured at 7 months)
D: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
Brief Summary: The purpose of this research study is to learn about the effects of supplemental intranasal oxytocin as a treatment for improving social difficulties in children and adolescents with autism. This study will also provide additional information about the safety and tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social motivation, improving daily living skills and quality of life.


Options:
A: Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2) (Baseline, Week 12); Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) (Baseline up to Week 12); Percentage of Participants With Adverse Events (From Baseline up to Week 18)
B: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)
C: Change From Baseline in Vineland™-II Adaptive Behavior Scale Two Domain Composite (2DC) Score at Week 24 for Balovaptan (R05285119) 10 mg Equivalent Compared to Placebo (Baseline, Week 24)
D: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)

Answer: B