TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Short-term Diaphragmatic Breathing Training Program in COPD Patients: a Randomized Controlled Trial
Brief Summary: Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.

Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.


Options:
A: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
B: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
C: Re-hospitalization (90 days)
D: thoracoabdominal motion (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Short-term Diaphragmatic Breathing Training Program in COPD Patients: a Randomized Controlled Trial
Brief Summary: Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.

Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.


Options:
A: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)
B: N/A
C: Inspiratory muscle strengh (Baseline, 2 months follow up); ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC) (Baseline, 2 months follow up); Berg Balance Scale (BBS) (Baseline, 2 months follow up); Single Leg Stance (SLS) (Baseline, 2 months follow up); Timed Up and Go (TUG) (Baseline, 2 months follow up)
D: thoracoabdominal motion (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Short-term Diaphragmatic Breathing Training Program in COPD Patients: a Randomized Controlled Trial
Brief Summary: Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients with chronic obstructive pulmonary disease (COPD). Several studies have described an impairment in diaphragmatic mobility of COPD patients compared to age matched control subjects and it has been associated with increase in dyspnea, exercise intolerance and mortality. COPD patients also experiment a higher activity of the accessory breathing muscles, which greatly increases the work of breathing and dyspnea sensation.

Breathing strategies have been considered an important component of pulmonary rehabilitation and refer to a range of techniques, including/which includes the diaphragmatic breathing (DB). The principal aim of DB is to improve the participation of the abdominal motion while reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality in the rehabilitation of COPD patients remains controversial. Despite the conflicting results, improvement of the abdominal motion and a reduction of thoracic excursion, during voluntarily DB, has been described as a common finding of several studies. The investigators hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL. Therefore, in this randomized controlled trial the investigators aimed to test the effects of a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility, dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.


Options:
A: Inspiratory Capacity (at 0th, 5th, ~20th minutes of exercises); Borg scale (at 0th and 20th minutes of exercises)
B: thoracoabdominal motion (2 years)
C: Visual Analogue Scale (VAS) - distress due to breathlessness (End of intervention (8 weeks after baseline))
D: Exercise endurance (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy
Brief Summary: This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.


Options:
A: Progressive kidney failure (1-6 years); primary outcome for low dose cohort (1 year)
B: Serum creatinine; 24 hour urinary protein excretion
C: Patients reaching full clinical remission of their disease (at the end of the 3 year study period.); GFR loss of 15 ml/min or higher from baseline GFR (at the end of the 3 year study period)
D: Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio) (Week 0, week 12 and week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Brief Summary: This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.


Options:
A: The primary outcome measure was the proportion of patients with a clinical response, defined as a reduction from baseline in the CDAI score of at least 70 points at Day 57 (Days 1-57)
B: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
C: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation (Week 6)
D: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Brief Summary: This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.


Options:
A: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
B: Number of Participants With Adverse Events (From the first date of study drug administration through Day 253); Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85 (Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.); Cmin: Minimum Observed Plasma Concentration of Vedolizumab (Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.); Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab (Days 0-14, Days 85-99, Days 85-141); Terminal Phase Elimination Half-life (t½) of Vedolizumab (Pre-dose through Day 253); Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253); Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253); Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253); Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253)
C: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
D: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation (Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate
Brief Summary: Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic agents result in prolongation of the duration of the sensory and motor blockade induced by hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on the low-dose spinal anesthesia for the transurethral surgery.


Options:
A: Incidence of Postoperative Delirium (During the first five days after surgery)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion (At baseline and 15 minutes after starting study drug (prior to topicalization), and every 3 minutes thereafter throughout study drug infusion, at the end of topicalization, and prior to administration of any rescue medication.)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Brief Summary: Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.

Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.

Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.

Study design:

The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.

Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.

Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.

Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration \<12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of \>8.3mg/L. Infection will be assessed by raised CRP (\>10mg/L) as an indicator of acute inflammation and presence of malaria.


Options:
A: Hemoglobin (Start of study (T=0), End of study (T=4months))
B: Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2 (1 year)
C: "negative nutritional outcome" of a child (6 months follow-up)
D: Hemoglobin concentration (End of the 30-day fortification period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Brief Summary: Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.

Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.

Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.

Study design:

The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.

Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.

Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.

Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration \<12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of \>8.3mg/L. Infection will be assessed by raised CRP (\>10mg/L) as an indicator of acute inflammation and presence of malaria.


Options:
A: Hemoglobin (Start of study (T=0), End of study (T=4months))
B: Mean birth weight (9 months)
C: Linear growth velocity (6 to 18 months of age)
D: Haemoglobin; Plasma Ferritin; Plasma Transferrin receptor

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Brief Summary: Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification.

Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya.

Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study.

Study design:

The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks.

Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups.

Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories.

Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration \<12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of \>8.3mg/L. Infection will be assessed by raised CRP (\>10mg/L) as an indicator of acute inflammation and presence of malaria.


Options:
A: gut microbiota composition (Fecal sample after 2 months)
B: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
C: Product sales and use (coverage) (Every 2 weeks)
D: Hemoglobin (Start of study (T=0), End of study (T=4months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
Brief Summary: The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.


Options:
A: Objective response rate (ORR) (about 10 month (until progression))
B: Time to Progression (every 8 weeks up to a maximum of 36 months)
C: progression-free survival (every 8 weeks)
D: objective tumor response

Answer: C