TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency: Noninferiority Randomised Controlled Trial Pragmatic and Multi-center in the Primary Healthcare Setting (OB12 Project)
Brief Summary: Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with Cobalamin Deficiency.

Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (Madrid Region).

Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent. Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).

Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume.

Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate.

All data (excluding patient identification data) will be record in an electronic database.

Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.

Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.


Options:
A: Arm Label: i.m. injection of Vitamin B12; Type: ACTIVE_COMPARATOR; Interventions: Drug: i.m. injection of vitamin B12 | Arm Label: Oral administration of vitamin B12; Type: EXPERIMENTAL; Interventions: Drug: Oral administration of vitamin B12 | Intervention Type: DRUG; Name: Oral administration of vitamin B12; Assigned to Arm(s): Oral administration of vitamin B12 | Intervention Type: DRUG; Name: i.m. injection of vitamin B12; Assigned to Arm(s): i.m. injection of Vitamin B12
B: Intervention Type: DRUG; Name: Metformin on top of intensive insulin therapy; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: mecobalamin | Intervention Type: DRUG; Name: mecobalamin; Assigned to Arm(s): 1
D: Arm Label: oral Cobalamin (vitamin B12); Type: EXPERIMENTAL; Interventions: Drug: oral Cobalamin (vitamin B12) | Arm Label: intramuscular Cobalamin (vitamin B12); Type: EXPERIMENTAL; Interventions: Drug: intramuscular Cobalamin (vitamin B12) | Intervention Type: DRUG; Name: oral Cobalamin (vitamin B12); Assigned to Arm(s): oral Cobalamin (vitamin B12) | Intervention Type: DRUG; Name: intramuscular Cobalamin (vitamin B12); Assigned to Arm(s): intramuscular Cobalamin (vitamin B12)

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Controlled Trial in Human Neonates to Determine the Effect of Vitamin A Supplementation on Immune Responses
Brief Summary: Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6 months of age, but has a null or detrimental effect when given between 1-5 months. Studies of neonatal VAS (NNVAS) have produced conflicting findings. These age-pattern variations might result from immunological interactions between VAS and vaccines. The potential efficacy of NNVAS is being retested in 3 large new intervention trials with mortality as endpoint. Complementary mechanistic studies in animals and in human infants in The Gambia (this proposal) and Bangladesh have been commissioned to run in parallel.

The investigators will use a 2-arm double blind RCT to test whether NNVAS modulates the early ontogeny of human immune development. Neonates, recruited through a peri-urban clinic in The Gambia, will receive either 50,000 International Units (IU) VAS orally within 48 hours of birth (intervention group, n=100) or a placebo (control group, n=100). Male and female neonates will be randomized separately at enrolment for later analyses by sex. All infants will be followed up from birth to age 1 year. A broad panel of immunological outcomes will examine whether NNVAS: a). normalises thymic development (thymic index by ultrasound); b). skews mycobacterial and recall antigen responses towards a Th2 profile; c). diminishes Th1 and Th17 reactivity to mycobacterial and recall antigens; d). diminishes the tuberculin skin test (TST) response; e). causes increased innate immune reactivity; f). increases the frequency of circulating regulatory T cells (Tregs) expressing gut homing receptors; g). enhances B cell immune responses after routine vaccination (increase of B cell numbers and activation status); h). increases circulating IgA in mucosal immune compartment, especially oral polio vaccine (OPV) specific IgA post-vaccination; i). decreases bacterial translocation, by improving mucosal barrier function; and j). decreases markers of infection or inflammation. Growth and morbidity will also be assessed.


Options:
A: Arm Label: Vitamin A; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin A (retinyl palmitate). | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Vitamin A (retinyl palmitate). | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin A (retinyl palmitate).; Assigned to Arm(s): Placebo, Vitamin A
B: Arm Label: Vitamin A; Type: EXPERIMENTAL; Interventions: Dietary Supplement: retinyl palmitate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: retinyl palmitate; Assigned to Arm(s): Vitamin A | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
C: Intervention Type: DRUG; Name: Vitamin A; Assigned to Arm(s): N/A
D: Arm Label: Low birth-weight cohort; Type: N/A; Interventions: N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia
Brief Summary: The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.


Options:
A: Arm Label: Pre-intubation CHX; Type: EXPERIMENTAL; Interventions: Procedure: Pre-intubation CHX | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Control | Intervention Type: PROCEDURE; Name: Pre-intubation CHX; Assigned to Arm(s): Pre-intubation CHX | Intervention Type: PROCEDURE; Name: Control; Assigned to Arm(s): Control
B: Arm Label: Toothbrushing with a manual brush; Type: EXPERIMENTAL; Interventions: Device: Toothbrushing with a manual brush | Arm Label: No toothbrushing; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Toothbrushing with a manual brush; Assigned to Arm(s): Toothbrushing with a manual brush
C: Arm Label: Placebo (Vehicle Control); Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: 0.12% chlorhexidine gluconate oral rinse; Type: EXPERIMENTAL; Interventions: Drug: chlorhexidine gluconate oral rinse (0.12%) | Arm Label: 0.12% chlorhexidine oral rinse; Type: EXPERIMENTAL; Interventions: Drug: chlorhexidine gluconate oral rinse (0.12%), Drug: placebo | Intervention Type: DRUG; Name: chlorhexidine gluconate oral rinse (0.12%); Assigned to Arm(s): 0.12% chlorhexidine gluconate oral rinse, 0.12% chlorhexidine oral rinse | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 0.12% chlorhexidine oral rinse, Placebo (Vehicle Control)
D: Arm Label: Standard care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chlorhexidine oral care (CHX-Oro), Drug: Selective oropharyngeal decontamination (SOD), Drug: Selective Digestive Decontamination (SDD) | Arm Label: Chlorhexidine oral care (CHX-Oro); Type: EXPERIMENTAL; Interventions: Drug: Chlorhexidine oral care (CHX-Oro) | Arm Label: Selective oropharyngeal decontamination; Type: EXPERIMENTAL; Interventions: Drug: Selective oropharyngeal decontamination (SOD) | Arm Label: Selective digestive decontamination; Type: EXPERIMENTAL; Interventions: Drug: Selective Digestive Decontamination (SDD) | Intervention Type: DRUG; Name: Chlorhexidine oral care (CHX-Oro); Assigned to Arm(s): Chlorhexidine oral care (CHX-Oro), Standard care | Intervention Type: DRUG; Name: Selective oropharyngeal decontamination (SOD); Assigned to Arm(s): Selective oropharyngeal decontamination, Standard care | Intervention Type: DRUG; Name: Selective Digestive Decontamination (SDD); Assigned to Arm(s): Selective digestive decontamination, Standard care

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Toothbrushing for the Prevention of Ventilator-associated Pneumonia
Brief Summary: The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.


Options:
A: Arm Label: Toothbrushing with a manual brush; Type: EXPERIMENTAL; Interventions: Device: Toothbrushing with a manual brush | Arm Label: No toothbrushing; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Toothbrushing with a manual brush; Assigned to Arm(s): Toothbrushing with a manual brush
B: Arm Label: povidone iodine; Type: EXPERIMENTAL; Interventions: Drug: povidone iodine | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: povidone iodine; Assigned to Arm(s): povidone iodine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: Placebo (Vehicle Control); Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: 0.12% chlorhexidine gluconate oral rinse; Type: EXPERIMENTAL; Interventions: Drug: chlorhexidine gluconate oral rinse (0.12%) | Arm Label: 0.12% chlorhexidine oral rinse; Type: EXPERIMENTAL; Interventions: Drug: chlorhexidine gluconate oral rinse (0.12%), Drug: placebo | Intervention Type: DRUG; Name: chlorhexidine gluconate oral rinse (0.12%); Assigned to Arm(s): 0.12% chlorhexidine gluconate oral rinse, 0.12% chlorhexidine oral rinse | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 0.12% chlorhexidine oral rinse, Placebo (Vehicle Control)
D: Intervention Type: DRUG; Name: Chlorhexidine gluconate (drug) vs placebo; Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Brief Summary: Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency Training Program is an innovative training strategy based on simulations designed to train hospital personnel to respond to obstetric emergencies. The objective of this study is to implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in influencing key behaviors in hospital practices, as well as measuring maternal and neonatal outcomes in intervention versus control hospitals.


Options:
A: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PRONTO training; Type: EXPERIMENTAL; Interventions: Other: PRONTO training | Intervention Type: OTHER; Name: PRONTO training; Assigned to Arm(s): PRONTO training
B: Arm Label: In situ simulation; Type: EXPERIMENTAL; Interventions: Other: In situ simulation | Arm Label: Off site simulation; Type: ACTIVE_COMPARATOR; Interventions: Other: Off site simulation | Intervention Type: OTHER; Name: In situ simulation; Assigned to Arm(s): In situ simulation | Intervention Type: OTHER; Name: Off site simulation; Assigned to Arm(s): Off site simulation
C: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Low dose high frequency health worker training approach | Arm Label: Comparison; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active Comparison | Intervention Type: BEHAVIORAL; Name: Low dose high frequency health worker training approach; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Active Comparison; Assigned to Arm(s): Comparison
D: Intervention Type: BEHAVIORAL; Name: Labor and Delivery Team Coordination Course; Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Brief Summary: Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency Training Program is an innovative training strategy based on simulations designed to train hospital personnel to respond to obstetric emergencies. The objective of this study is to implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in influencing key behaviors in hospital practices, as well as measuring maternal and neonatal outcomes in intervention versus control hospitals.


Options:
A: Arm Label: package; Type: EXPERIMENTAL; Interventions: Other: package of 3 interventions | Intervention Type: OTHER; Name: package of 3 interventions; Assigned to Arm(s): package
B: Arm Label: EMONC: Community mobilization, HBLSS and Facility Improvement; Type: EXPERIMENTAL; Interventions: Behavioral: Community Mobilization, HBLSS and facility improvement | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Community Mobilization, HBLSS and facility improvement; Assigned to Arm(s): EMONC: Community mobilization, HBLSS and Facility Improvement
C: Arm Label: NRP Training (Intervention); Type: EXPERIMENTAL; Interventions: Procedure: Neonatal Resuscitation | Arm Label: Control; Type: OTHER; Interventions: Procedure: Neonatal Resuscitation | Intervention Type: PROCEDURE; Name: Neonatal Resuscitation; Assigned to Arm(s): Control, NRP Training (Intervention)
D: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PRONTO training; Type: EXPERIMENTAL; Interventions: Other: PRONTO training | Intervention Type: OTHER; Name: PRONTO training; Assigned to Arm(s): PRONTO training

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact
Brief Summary: Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency Training Program is an innovative training strategy based on simulations designed to train hospital personnel to respond to obstetric emergencies. The objective of this study is to implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in influencing key behaviors in hospital practices, as well as measuring maternal and neonatal outcomes in intervention versus control hospitals.


Options:
A: Arm Label: Facilities; Type: OTHER; Interventions: Other: HBB/ENC supplies | Arm Label: Master Trainers; Type: OTHER; Interventions: Behavioral: HBB/ENC Training and Equipment | Arm Label: Facilitators; Type: OTHER; Interventions: Behavioral: HBB/ENC Training and Equipment | Arm Label: Learners; Type: OTHER; Interventions: Behavioral: HBB/ENC Training and Equipment | Intervention Type: BEHAVIORAL; Name: HBB/ENC Training and Equipment; Assigned to Arm(s): Facilitators, Learners, Master Trainers | Intervention Type: OTHER; Name: HBB/ENC supplies; Assigned to Arm(s): Facilities
B: Arm Label: intervention; Type: EXPERIMENTAL; Interventions: Other: Neonatal resuscitation protocol | Arm Label: control; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard of care | Intervention Type: OTHER; Name: Neonatal resuscitation protocol; Assigned to Arm(s): intervention | Intervention Type: OTHER; Name: Standard of care; Assigned to Arm(s): control
C: Arm Label: NRP Training (Intervention); Type: EXPERIMENTAL; Interventions: Procedure: Neonatal Resuscitation | Arm Label: Control; Type: OTHER; Interventions: Procedure: Neonatal Resuscitation | Intervention Type: PROCEDURE; Name: Neonatal Resuscitation; Assigned to Arm(s): Control, NRP Training (Intervention)
D: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PRONTO training; Type: EXPERIMENTAL; Interventions: Other: PRONTO training | Intervention Type: OTHER; Name: PRONTO training; Assigned to Arm(s): PRONTO training

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties
Brief Summary: The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?


Options:
A: Arm Label: Quality improvement program; Type: OTHER; Interventions: Other: multifaceted strategy | Arm Label: Hospital standard treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: multifaceted strategy; Assigned to Arm(s): Quality improvement program
B: Arm Label: physician chart reminder; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physician chart reminder | Arm Label: chart reminder, educational mat'ls, FIT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physician chart reminder, Behavioral: chart reminder, educational mat'ls, FIT | Arm Label: CR, ed mat'ls, FIT, phone call; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physician chart reminder, Behavioral: CR,ed mat'ls, FIT, phone call | Intervention Type: BEHAVIORAL; Name: Physician chart reminder; Assigned to Arm(s): CR, ed mat'ls, FIT, phone call, chart reminder, educational mat'ls, FIT, physician chart reminder | Intervention Type: BEHAVIORAL; Name: chart reminder, educational mat'ls, FIT; Assigned to Arm(s): chart reminder, educational mat'ls, FIT | Intervention Type: BEHAVIORAL; Name: CR,ed mat'ls, FIT, phone call; Assigned to Arm(s): CR, ed mat'ls, FIT, phone call
C: Intervention Type: BEHAVIORAL; Name: Opinion Leaders, Academic Detailing, Reminders, and Feedback; Assigned to Arm(s): N/A
D: Arm Label: Arm 1; Type: OTHER; Interventions: Behavioral: Use of Xrays for diagnosis | Intervention Type: BEHAVIORAL; Name: Use of Xrays for diagnosis; Assigned to Arm(s): Arm 1

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties
Brief Summary: The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?


Options:
A: Arm Label: Targeted Feedback Reports; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Targeted Feedback Reports | Arm Label: Targeted Feedback Report; Type: EXPERIMENTAL; Interventions: Behavioral: Targeted Feedback Report | Intervention Type: BEHAVIORAL; Name: Targeted Feedback Reports; Assigned to Arm(s): Targeted Feedback Reports | Intervention Type: BEHAVIORAL; Name: Targeted Feedback Report; Assigned to Arm(s): Targeted Feedback Report
B: Intervention Type: BEHAVIORAL; Name: E-mail coaching to improve patient communication with doctor; Assigned to Arm(s): N/A
C: Intervention Type: BEHAVIORAL; Name: Customized Physician Intervention; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Customized Patient Intervention; Assigned to Arm(s): N/A
D: Arm Label: physician chart reminder; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physician chart reminder | Arm Label: chart reminder, educational mat'ls, FIT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physician chart reminder, Behavioral: chart reminder, educational mat'ls, FIT | Arm Label: CR, ed mat'ls, FIT, phone call; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physician chart reminder, Behavioral: CR,ed mat'ls, FIT, phone call | Intervention Type: BEHAVIORAL; Name: Physician chart reminder; Assigned to Arm(s): CR, ed mat'ls, FIT, phone call, chart reminder, educational mat'ls, FIT, physician chart reminder | Intervention Type: BEHAVIORAL; Name: chart reminder, educational mat'ls, FIT; Assigned to Arm(s): chart reminder, educational mat'ls, FIT | Intervention Type: BEHAVIORAL; Name: CR,ed mat'ls, FIT, phone call; Assigned to Arm(s): CR, ed mat'ls, FIT, phone call

Answer: D