TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
Brief Summary: There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.


Options:
A: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
B: Hemoglobin difference (14 days)
C: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
Brief Summary: There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.


Options:
A: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
B: Physical Fatigue (on day 3 postpartum)
C: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
D: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
Brief Summary: There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.


Options:
A: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
B: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
C: 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))
D: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage: a Multicenter Randomized Trial
Brief Summary: The aim of our study is to assess three anticoagulation strategies for intermittent hemodialysis(IHD) in patients at risk of hemorrhage. A registry of consecutive hemodialysis patients with high risk of hemorrhage was conducted at the Guangdong General Hospital, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, the Second Affiliated Hospital of Guangzhou Medicine University or Guangzhou Hospital of Chinese Medicine, between Sep 10, 2017 and June 30th,2018. In this multi-center prospective and randomized study, participants were randomly divided into three groups during IHD according to different anticoagulation, including with regular saline flushes, one stage regional citrate anticoagulation (RCA) and two-stage RCA.


Options:
A: Prothrombin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Activated partial thromboplastin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Anti-Xa level (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH); Dialyser urea and creatinine clearances (At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis); Dialyser thrombus score (At the end of hemodialysis (8th hour))
B: thromboprophylaxis of catheter induced thrombosis (6 months)
C: therapy interruption event (through study completion, from start to four hours)
D: Clotting of the dialysis session (During first dialysis session_Dialysis duration: 4 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques: a Clinical, Volumetric and Radiological Randomized Controlled Clinical Trial.
Brief Summary: It is well known that following the loss of a single tooth, severe hard- and soft-tissue alterations may take place within the affected site, resulting in a subsequent reduction of both vertical and horizontal ridge dimensions, often not allowing neither appropiate pontic fabrication nor correct placement of endosseous implants.

Over the past 20 years, various surgical procedures, grouped under the term of "alveolar ridge preservation" (ARP), have been introduced, aiming to maintain the existing soft and hard tissue envelope as well as a stable ridge volume, simplifying subsequent treatment procedures and optimizing functional and esthetic outcomes. They have been widely tested in controlled and not controlled clinical studies with various materials and approaches, and a number of recently published systematic reviews on this topic have confirmed the efficacy of ARP in preventing post-extraction dimensional changes of alveolar ridges.

After these procedures a minimum of four to six months must be awaited before implant insertion can be performed, bringing the patient compromised comfort, function and aesthetics and needing of a second surgical procedure for the implant placement.

Dental implant insertion at the time of tooth extraction (type I or immediate placement) reduced the number of dental appointments, of surgeries required and the overall treatment time. Nevertheless this surgical protocol does not provide predictable outcomes, since it may contribute towards a more pronounced bone resorption during healing. Different anatomical factors, as the thickness of the buccal bone wall and the dimension of the horizontal gap, may influence the dimensional changes of the alveolar crest following immediate implant placement. Such morphological changes could lead to negative esthetic complications, such as marginal soft tissues recessions, especially when affecting the buccal side of maxillary sites in patients with a high smile line.

It is unknown if immediate implant placement plus grafting materials and/or barrier membranes could influence post-extraction dimensional changes of alveolar ridges. No consensus exists on the need for bone augmentation simultaneously with immediate implant placement. Furthermore, no human study has yet compared dimensional changes of both hard and soft tissues after two different treatments: an alveolar ridge preservation technique for a subsequent implant placement, and an alveolar ridge preservation technique with an immediate implant placement.


Options:
A: % Vital Bone Formation (Histological) (3 months after ridge preservation)
B: Histologic Percentage of Vital Bone Formation (18-20 weeks after grafting)
C: Percent New Vital Bone Formation (18-20 weeks)
D: Hard tissue volumetric changes (4 months); Soft tissue volumetric changes (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
Brief Summary: The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants.

Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and \< 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. (2 months)
C: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (at D14 and D21.)
D: Stool Microbiome (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label Extension Phase.


Options:
A: Visual Analogue Scale (VAS) Score for Pruritus (VAS score at baseline and after 6 -week phototherapy)
B: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)
C: Investigator Global Assessment (Disease severity assessed at baseline and 4 weeks, week 4 reported)
D: Change from Baseline in Detailed score proposed by Duo for pruritus (Change from Baseline in Detailed score at 1months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems
Brief Summary: This study evaluates a health theory based mobile health behavioral intervention to reduce blood pressure (BP) among hypertensive patients evaluated in a community Emergency Department (ED) setting.


Options:
A: 60 day Medication Adherence (60 days); 120 day medication adherence (120 days)
B: Blood Pressure (one year)
C: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) (At 1 year from the time of initiation of the intervention); Mean HbA1c (At 1 year from the time of initiation of the intervention)
D: Change in Mean Systolic Blood Pressure (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Gluconate Cloth and Chlorhexidine Gluconate Vaginal Scrub Reduces Infectious Morbidity in Patients Undergoing Cesarean Section After Labor
Brief Summary: Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor.

Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.

Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.


Options:
A: Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. (1 month)
B: Postpartum Endometritis (30 day postoperative)
C: Number of Participants With Surgical Site Infection (up to 6 weeks postpartum)
D: Post-intervention Aerobic Bacterial Colony Counts (From intervention to 7 days post); Post-intervention Anaerobic Bacterial Colony Counts (From intervention to 7 days post)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Using Sterile Single-use and Reused Polyvinylchloride Catheter For Intermittent Catheterization With Clean Technique In Neurogenic Bladder Due to Spina Bifida
Brief Summary: The objective of the study is to determine whether single-use polyvinylchloride (PVC) catheters reduce urinary tract infections (UTI) compared to reused PVC catheters for patients with neurogenic bladder due to spina bifida that require intermittent catheterization for bladder emptying. The investigators conducted a clinical trial with an 8-week follow-up comparing single-use and reused (washed with soap and water, and stored in a container with benzalkonium chloride or washed with soap and water alone) PVC intermittent catheterization. Evaluations were established on days 0, 7, 14, 28, 42, and 56. Participants reported symptoms and urine culture results, collecting urine samples from a fresh midstream catheter specimen using a sterile technique.


Options:
A: Percentage of Participants (1 week)
B: Quality of Life (0-100 Point) (6 weeks)
C: Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. (14 days)
D: UTIs (Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Libera Efficacy 2 Cycles at Home Study
Brief Summary: Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.


Options:
A: Change in sexual functioning over the course of one year (T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later])
B: Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention. (2 months)
C: Time to Pregnancy (Up to one year.)
D: Cortisol Measurement (Twice monthly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Strategies to Improve General Practitioner-nurse Collaboration and Communication in Regard to Hospital Admissions of Nursing Home Residents.
Brief Summary: Previously,six measures were developed for a better collaboration of general practitioners and nurses in nursing homes in a qualitative multistep bottom-up process. These measures, summarised as the interprof ACT intervention, shall improve the flow of information and the communication between the involved parties and lead to more transparency and effectiveness regarding treatment decisions of nursing home residents.The major aim of this trial is to examine the clinical effectiveness of interprof ACT. The main hypothesis is that implementation of interprof ACT reduces the cumulative incidence of hospitalisations of nursing home residents within 12 months from 50% to 35% (15% absolute reduction).


Options:
A: Rate of reduction in wound surface area (cm2/days) (6 mths)
B: Software/user problems (6 months); functionality problems (6 months); workload (6 months); medication chart review (6 months); practical problems (6 months); GPs that refuse (6 months); non-consenting eligible residents (n) (6 months); Non-consenting proxies for eligible residents (n) (6 months); Optimeds completion (6 months)
C: Acceptability of the TM among the LTCF staff (6 months)
D: cumulative number of hospitalisation (within 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™
Brief Summary: Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies to improve survival rates and limit morbidity is a major goal. Over the past decades, blood purification has been proposed as an adjuvant therapy for sepsis. The goal of blood purification is to restore the immune homeostasis and efficiency through the removal of bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising. This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits enhanced blood purification capacities. Previous studies on animals have already proven that this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This ability to remove endotoxins is particularly interesting since endotoxins are believed to be the trigger of the immune cascade at the initiation of sepsis.

The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore, the aim of the present clinical trial is to characterize the blood purification properties of the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not only cytokines but also endotoxins due to the positive charges of PEI at the surface of the membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and cytokine removal compared to a standard polysulfone ("PrismafleX HF1400") filter in patients with septic shock.


Options:
A: Interleukin 6 (IL-6) plasmatic concentration (24 hours after the initiation of CVVH); Endotoxin plasmatic mass concentration (24 hours after the initiation of CVVH)
B: Mortality (Day 28 after ICU admission)
C: Middle molecular weight molecules clearances (18 months)
D: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: mDOT: A Pilot Study of Video Directly Observed Therapy for Immunosuppressant Adherence in Adult Kidney Transplant Recipients
Brief Summary: The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppression medication adherence among adult kidney transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult kidney transplant recipients at the Johns Hopkins Hospital.


Options:
A: Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? (2013)
B: 12-week immunosuppression medication adherence (12 weeks)
C: 90- day readmission (90 days)
D: The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
Brief Summary: In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.


Options:
A: Suicide Attempts (Assessed bimonthly)
B: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
C: Existence of a suicide (6 months); Existence of a suicide (13 months)
D: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)

Answer: C