TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion
Brief Summary: Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.

A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).


Options:
A: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))
B: Maximal uterine tone (within the first 5 minutes after cord clamping)
C: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
D: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion
Brief Summary: Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.

A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).


Options:
A: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
B: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
C: Maximal uterine tone (within the first 5 minutes after cord clamping)
D: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (baseline to discharge (2 - 3 days)); Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage (Initial hospital discharge (2-3 days)); Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors (baseline to discharge (2-3 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
Brief Summary: The objective of this study is to investigate the efficacy of a treatment based on Movement System Impairment based classification (MSI) model in patients with chronic non-specific low back pain.


Options:
A: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
B: Five Times Sit-to-stand (5XSTS) (Change from Baseline sit-to-stand at 3 and 6 months)
C: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
Brief Summary: The objective of this study is to investigate the efficacy of a treatment based on Movement System Impairment based classification (MSI) model in patients with chronic non-specific low back pain.


Options:
A: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
B: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)
C: Muscle activity onset in transversus abdominal muscle (1 year)
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial
Brief Summary: The objective of this study is to investigate the efficacy of a treatment based on Movement System Impairment based classification (MSI) model in patients with chronic non-specific low back pain.


Options:
A: Pain VAS
B: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
C: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
D: Pain (6 weeks); Functional Disability (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
Brief Summary: The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.


Options:
A: Health related quality of life (Change from Baseline HRQoL at 6 months)
B: Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs) (6 months)
C: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (baseline, 3month, 6month, and 12month)
D: Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (Baseline); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (Four weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (10 weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (18 weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Brief Summary: Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors. Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast cancer. Through strong community-academic partnerships, the investigators seek to improve the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this project, the investigators plan to further develop and refine the intervention and then test it through a randomized controlled trial. First, the investigators will conduct in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention fits for survivors and caregivers in different parts of the country. Then, the investigators will revise the intervention. Finally, the investigators will test the intervention in a randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be a part of our study. Half will be asked to complete the intervention and half will be offered the usual services, such as support groups. The information learned from this study could help improve the quality of life in Latina breast cancer survivors and their caregivers. Physicians, survivors, and community groups can also benefit from this study because they will have more information about the needs of Latina breast cancer survivors. The investigators hope to use the information to help other types of survivors and caregivers in the future.


Options:
A: impact on patient outcomes of targeted physician communication skills training (3 years)
B: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)
C: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
D: PROMIS Physical Functioning (6 months); PROMIS Satisfaction With Social Roles (6 months); PROMIS Anxiety (6 months); PROMIS Depression (6 months); PROMIS Fatigue (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Brief Summary: Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors. Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast cancer. Through strong community-academic partnerships, the investigators seek to improve the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this project, the investigators plan to further develop and refine the intervention and then test it through a randomized controlled trial. First, the investigators will conduct in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention fits for survivors and caregivers in different parts of the country. Then, the investigators will revise the intervention. Finally, the investigators will test the intervention in a randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be a part of our study. Half will be asked to complete the intervention and half will be offered the usual services, such as support groups. The information learned from this study could help improve the quality of life in Latina breast cancer survivors and their caregivers. Physicians, survivors, and community groups can also benefit from this study because they will have more information about the needs of Latina breast cancer survivors. The investigators hope to use the information to help other types of survivors and caregivers in the future.


Options:
A: Change in Quality of Life (Baseline, 3 and 6 months)
B: Caregiver Quality of Life Index - Cancer (4 weeks); Perceived Stress Scale (4 weeks); Hospital Anxiety and Depression Scale (4 weeks); Basic Psychological Needs Scale (4 weeks); Healthcare Climate Questionnaire (4 weeks); Perceived Competence Scale (4 weeks); Interpersonal Support Evaluation List (4 weeks); Benefit Finding (4 weeks); Satisfaction and Feedback Questionnaire (4 weeks)
C: PROMIS Physical Functioning (6 months); PROMIS Satisfaction With Social Roles (6 months); PROMIS Anxiety (6 months); PROMIS Depression (6 months); PROMIS Fatigue (6 months)
D: Change in the mean score of distress (Hospital Anxiety Depression Scale) (Baseline, after 3, 6 and 9 months); Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey) (Baseline, after, 3, 6 and 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Uncontrolled, Three-Stage, Dose-Escalation Cohort Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Clinical Activity of OMS721 in Adults With Thrombotic Microangiopathies
Brief Summary: The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).


Options:
A: Percent Change In Lactate Dehydrogenase Levels From Baseline To Day 183 (Baseline, Day 183)
B: Adverse events and serious adverse events and their severity and relationship to the drug (12 weeks)
C: Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA (Day 1 to 37 days after end of treatment, approximately up to 31 weeks.); Number of Participants With HSCT-TMA Who Respond to OMS721 (Day 1 to up to 2 years following the first dose of OMS721)
D: Percentage Of Complement Inhibitor Treatment-naïve Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment in Late Pre-term and Term Infants; a Facility-based Randomized-controlled Trial in Nepal
Brief Summary: The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development is evaluated by questionnaire (Ages \& Stages Questionnaire ) at 12 months of age, and by testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a high proportion of anemia at one year of age (about 75%), we can reduce the number of children in the study and still achieve significant results.

Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in children. Anemia is estimated by WHO to occur among 25% of all children before school age, and the corresponding figure in Europe is 3-9 %.

By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume remaining in the placenta is transfused over to the child's body. Research shows that the neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months' supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could reduce iron deficiency in children at four months of age by 90%. Globally, most countries practice early cord clamping and the child is deprived of the placental blood transfusion. The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at 8 and 12 months will be reduced an this in turn will be beneficial for the childrens development.

The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It hosts approximately 23,000 births annually.


Options:
A: Hemoglobin (8 months plus/minus one month)
B: Superior Vena Cava Flow (<12 hours of life)
C: Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth. (at 4-6 hours of age)
D: Hematologic status at 6 months of age; Iron status at 6 months of age

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reverse Innovation and Patient Engagement to Improve Quality of Care and Patient Outcomes
Brief Summary: Project CONNECT ("Community-based Organizations Neighborhood Network: Enhancing Capacity Together") is a randomized controlled trial that involves 22 community-based organizations (CBOs) located in Baltimore, MD. Half of these organizations were randomly assigned to the intervention group using a constrained cluster randomization process. The remaining 11 are a part of the control intervention group. The intervention is a co-developed set of IT tools hypothesized to improve the connections among intervention CBOs, Johns Hopkins health care facilities and CBO clients.


Options:
A: Change in Emergency Department Visits + Hospital Days (Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015)
B: WH-PACT Achievement (Baseline to 24-month)
C: Change in Child Body Mass Index (BMI) Z-score (Post intervention (9 months after baseline))
D: 7-Day Point Prevalence Abstinence From Smoking for 6 Months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Multi-center, Cluster-randomized, Pragmatic, Mixed-method Pilot Study Evaluating a Consultation Training Program for Physicians Within the Framework of KOKON (Competence Network Complementary Medicine in Oncology)
Brief Summary: The aim of the study is to investigate the effect of a consultation training program for physicians on the quality of their consultations of breast cancer patients regarding complementary medicine. We assume that the training program might enhance the communication of relevant information, empathy of the physicians or satisfaction with the consultation.


Options:
A: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
B: Effectiveness of the training program (day 1-7)
C: Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires (4 months)
D: Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC) (4/1/2007-3/31/2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Preimplantation Genetic Screening for Aneuploidies in Infertile Female Patients With Recurrent Spontaneous Abortion History
Brief Summary: Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all couples and challenges both patients and clinicians technically and emotionally. IVF clinics see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction treatment with or without other infertile factors. Guidelines for evaluation and treatment of RPL patients include screening for uterine abnormalities, parental chromosomes, autoimmune antibodies and cure gynecological infections, but there are still half of RPL patients remain unexplained.

The documented high incidence of chromosomal errors in first-trimester miscarriages and an increased rate of aneuploidy in patients with RPL has led to the theory that screening embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and serve as a possible treatment. The technology, indications of use, and even terminology for genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal screening or comprehensive chromosome screening, PCS or CCS, or the investigators generally termed PGS) based on array-comprehensive genome hybridization(aCGH), single nucleotide polymorphism array(SNP-array) or next generation sequencing(NGS), to be the most powerful technology. However, for whom this PGS technique is most suitable to achieve improved clinical outcome have not yet been identified by well defined, ITT based research with carefully selected control and adequate sample size.

The investigators research is to determine whether in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile female patients with recurrent spontaneous abortion history.


Options:
A: Ongoing pregnancy (12 weeks after embryo transfer for the patient)
B: Clinical pregnancy (At 7 - 8 gestational weeks)
C: Impact of next generation sequencing on the embryos produced from IVF on implantation rates (2 years)
D: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)

Answer: A