TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Brief Summary: The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.


Options:
A: Intervention Type: DRUG; Name: Inhaled mannitol; Assigned to Arm(s): N/A
B: Arm Label: 1; Type: OTHER; Interventions: Drug: rhDNAse, Other: Placebo | Arm Label: 2; Type: OTHER; Interventions: Drug: rhDNAse, Other: Placebo | Intervention Type: DRUG; Name: rhDNAse; Assigned to Arm(s): 1, 2 | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): 1, 2
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Mannitol | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: mannitol | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dornase alpha | Arm Label: 3; Type: OTHER; Interventions: Drug: mannitol + pulmozyme | Intervention Type: DRUG; Name: mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: mannitol + pulmozyme; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Dornase alpha; Assigned to Arm(s): 2

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Brief Summary: The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Mannitol | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
B: Intervention Type: DRUG; Name: Inhaled mannitol; Assigned to Arm(s): N/A
C: Arm Label: eRapid Nebulizer; Type: EXPERIMENTAL; Interventions: Drug: dornase alfa [Pulmozyme®] | Arm Label: Jet Nebulizer; Type: ACTIVE_COMPARATOR; Interventions: Drug: dornase alfa [Pulmozyme®] | Intervention Type: DRUG; Name: dornase alfa [Pulmozyme®]; Assigned to Arm(s): eRapid Nebulizer | Intervention Type: DRUG; Name: dornase alfa [Pulmozyme®]; Assigned to Arm(s): Jet Nebulizer
D: Arm Label: Master Study Run-in; Type: N/A; Interventions: N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Brief Summary: The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: mannitol | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dornase alpha | Arm Label: 3; Type: OTHER; Interventions: Drug: mannitol + pulmozyme | Intervention Type: DRUG; Name: mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: mannitol + pulmozyme; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Dornase alpha; Assigned to Arm(s): 2
B: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Mannitol | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: Inhaled mannitol; Assigned to Arm(s): N/A

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Brief Summary: The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: inhaled mannitol | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo comparator | Intervention Type: DRUG; Name: inhaled mannitol; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Placebo comparator; Assigned to Arm(s): B
B: Intervention Type: DRUG; Name: Inhaled mannitol; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Mannitol | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: mannitol | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dornase alpha | Arm Label: 3; Type: OTHER; Interventions: Drug: mannitol + pulmozyme | Intervention Type: DRUG; Name: mannitol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: mannitol + pulmozyme; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Dornase alpha; Assigned to Arm(s): 2

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial
Brief Summary: The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.


Options:
A: Arm Label: N-3 PUFA; Type: EXPERIMENTAL; Interventions: Drug: N-3 Polyunsaturated Fatty Acids | Arm Label: Olive oil; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo: Olive oil | Intervention Type: DRUG; Name: N-3 Polyunsaturated Fatty Acids; Assigned to Arm(s): N-3 PUFA | Intervention Type: DRUG; Name: Placebo: Olive oil; Assigned to Arm(s): Olive oil
B: Arm Label: fish oil , corn oil; Type: EXPERIMENTAL; Interventions: Drug: Omega Three Polyunsaturated fatty acids | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Omega Three Polyunsaturated fatty acids | Intervention Type: DRUG; Name: Omega Three Polyunsaturated fatty acids; Assigned to Arm(s): fish oil , corn oil, placebo
C: Intervention Type: BEHAVIORAL; Name: Dietary intake; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle factors; Assigned to Arm(s): N/A | Intervention Type: BIOLOGICAL; Name: Blood biomarkers; Assigned to Arm(s): N/A | Intervention Type: BIOLOGICAL; Name: Health; Assigned to Arm(s): N/A | Intervention Type: GENETIC; Name: DNA; Assigned to Arm(s): N/A | Intervention Type: BIOLOGICAL; Name: Mental well-being; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Omega 3 (n-3 PUFA) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Omega 3 (n-3 PUFA); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial
Brief Summary: The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.


Options:
A: Intervention Type: DRUG; Name: rt-PA 0.9 mg/kg verum or placebo Intravenous; Assigned to Arm(s): N/A
B: Intervention Type: DRUG; Name: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM); Assigned to Arm(s): N/A
C: Arm Label: fish oil , corn oil; Type: EXPERIMENTAL; Interventions: Drug: Omega Three Polyunsaturated fatty acids | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Omega Three Polyunsaturated fatty acids | Intervention Type: DRUG; Name: Omega Three Polyunsaturated fatty acids; Assigned to Arm(s): fish oil , corn oil, placebo
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: AMR101 (ethyl icosapentate) - 2 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 2 g/day | Arm Label: AMR101 (ethyl icosapentate) - 4 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 4 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 2 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 2 g/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II, Placebo Controlled, Double-Blind, Randomized, Discontinuation Study of Lapatinib Administered Orally to Subjects With ErbB2 Positive Ovarian, Gastric/Esophageal Adenocarcinoma, Uterine Serous Papillary, or Bladder Cancer
Brief Summary: This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.


Options:
A: Arm Label: open label; Type: EXPERIMENTAL; Interventions: Drug: bevacizumab, Drug: erlotinib | Intervention Type: DRUG; Name: bevacizumab; Assigned to Arm(s): open label | Intervention Type: DRUG; Name: erlotinib; Assigned to Arm(s): open label
B: Intervention Type: DRUG; Name: carboplatin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: cisplatin; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: neoadjuvant therapy; Assigned to Arm(s): N/A
C: Arm Label: Lapatinib Oral Tablets; Type: EXPERIMENTAL; Interventions: Drug: Oral lapatinib tablets or placebo tablets | Arm Label: Placebo Control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Oral lapatinib tablets or placebo tablets | Intervention Type: DRUG; Name: Oral lapatinib tablets or placebo tablets; Assigned to Arm(s): Lapatinib Oral Tablets, Placebo Control
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Vandetanib | Intervention Type: DRUG; Name: Vandetanib; Assigned to Arm(s): 1

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Dietary Adherence Enhancement in Peritoneal Dialysis
Brief Summary: This randomized study will pilot test an intervention, based on self-efficacy theory and involving personal digital assistant (PDA)-based dietary self-monitoring, to improve adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis, will be recruited to the study. Participants will be randomized to one of 2 groups. Group A will receive a 4-month active intervention of decreasing intensity over time delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. Group B will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education. With this study the investigators will:

1. Explore the impact of the intervention on dietary sodium intake,
2. Explore the intervention on blood pressure,
3. Explore the impact of the intervention on morning post dialysis weight (i.e. weight after conclusion of continuous cycling peritoneal dialysis (CCPD) or after long dwell for continuous ambulatory peritoneal dialysis (CAPD) patients, AND
4. Explore the feasibility and acceptability of the intervention


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Behavioral: BalanceWise-PD | Arm Label: B; Type: OTHER; Interventions: Behavioral: Attention control | Intervention Type: BEHAVIORAL; Name: BalanceWise-PD; Assigned to Arm(s): A | Intervention Type: BEHAVIORAL; Name: Attention control; Assigned to Arm(s): B
B: Arm Label: Diuretic treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Amiloride, Drug: Hydrochlorothiazide | Arm Label: Low-sodium diet; Type: ACTIVE_COMPARATOR; Interventions: Other: Low-sodium diet | Intervention Type: DRUG; Name: Amiloride; Assigned to Arm(s): Diuretic treatment | Intervention Type: DRUG; Name: Hydrochlorothiazide; Assigned to Arm(s): Diuretic treatment | Intervention Type: OTHER; Name: Low-sodium diet; Assigned to Arm(s): Low-sodium diet
C: Arm Label: Low Sodium Diet; Type: EXPERIMENTAL; Interventions: Behavioral: Low Sodium Diet | Arm Label: Usual Diet; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Low Sodium Diet; Assigned to Arm(s): Low Sodium Diet
D: Arm Label: Study group; Type: EXPERIMENTAL; Interventions: Behavioral: Low-salt educational programme, Behavioral: Low-salt Bangladeshi educational programme | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Low-salt educational programme; Assigned to Arm(s): Study group | Intervention Type: BEHAVIORAL; Name: Low-salt Bangladeshi educational programme; Assigned to Arm(s): Study group | Intervention Type: BEHAVIORAL; Name: Low-salt Bangladeshi educational programme; Assigned to Arm(s): Study group

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Brief Summary: With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:

1. adherence to dietary sodium targets as assessed from 3-day food recalls,
2. average monthly interdialytic weight gain, and
3. average pulse pressure. Secondary dependent variables are:
4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.


Options:
A: Arm Label: Lifestyle intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Controls; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): Lifestyle intervention
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes Care for Korean Americans | Intervention Type: BEHAVIORAL; Name: Diabetes Care for Korean Americans; Assigned to Arm(s): 1
C: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard hemodialysis dietary instruction | Arm Label: B; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet | Intervention Type: BEHAVIORAL; Name: Standard hemodialysis dietary instruction; Assigned to Arm(s): A | Intervention Type: BEHAVIORAL; Name: Behavioral counseling plus PDA-based self-monitoring of diet; Assigned to Arm(s): B
D: Arm Label: Community Health Worker Model; Type: EXPERIMENTAL; Interventions: Behavioral: CARIÑO Project | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced Usual Care | Intervention Type: BEHAVIORAL; Name: CARIÑO Project; Assigned to Arm(s): Community Health Worker Model | Intervention Type: BEHAVIORAL; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care

Answer: C