TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Brief Summary: Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.

Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.


Options:
A: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
B: Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase (Weeks 1, 2, 3, 4, 6, and 8); Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) (Weeks 1, 2, 3, 4, 6 and 8)
C: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
D: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Brief Summary: Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.

Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.


Options:
A: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
B: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)
C: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
D: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Brief Summary: Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.

Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.


Options:
A: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
B: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
C: Clinical Global Improvement (Week 12)
D: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Empowering Daughters and Mother-in-laws to Mitigate Gender-based Violence and Promote Women's Health in India
Brief Summary: A growing body of research indicates that gender-based violence (GBV) is a major global public health challenge. Yet, there is a dearth of evidence to guide program planning and policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and potential effectiveness of an innovative women's empowerment intervention to reduce GBV and related adverse health outcomes. It is expected that the study findings will provide evidence to determine if a phase 3 effectiveness trial is merited and advance the science underlying GBV prevention.


Options:
A: condom use (4.5 months)
B: depression (On completion of intervention and six months post-intervention)
C: Intimate partner violence (One year)
D: Incident Gender-Based Violence (GBV) (3 months postpartum); Incident GBV (6 months postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Empowering Daughters and Mother-in-laws to Mitigate Gender-based Violence and Promote Women's Health in India
Brief Summary: A growing body of research indicates that gender-based violence (GBV) is a major global public health challenge. Yet, there is a dearth of evidence to guide program planning and policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and potential effectiveness of an innovative women's empowerment intervention to reduce GBV and related adverse health outcomes. It is expected that the study findings will provide evidence to determine if a phase 3 effectiveness trial is merited and advance the science underlying GBV prevention.


Options:
A: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
B: Incident Gender-Based Violence (GBV) (3 months postpartum); Incident GBV (6 months postpartum)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ankle Robotics Training After Stroke: Effects on Gait and Balance
Brief Summary: Veterans and other Americans who survive stroke often face disabling motor impairments that impede performance of activities of daily living and limit free-living activity. Prominent among these are diminished walking and balance functions, which not only foster a sedentary lifestyle and physical deconditioning, but also increase the risk of injuries due to falls. Recent research has demonstrated how motor learning based interventions can modify brain activity and improve motor functions in persons with stroke. Now there is a major research opportunity to advance the effectiveness of these interventions by applying new robotics technologies to improve control of essential functions such as gait and balance. One critical area for performance of walking and standing balance is the control of the ankles, as they are a major conduit of mechanical power in gait and also modulate torques affecting the motion of the whole body center of mass when balancing. Thus the current proposal is designed to investigate two approaches for using an impedance controlled ankle robot to improve gait and balance among stroke survivors with chronic lower extremity weakness. One approach uses the ankle robot in a seated visuomotor training program that focuses has subjects play video games with the weaker ankle to improve paretic ankle motor control that may carry over to gait and balance functions. The other approach uses task-specific gait training by integrating use of the ankle robot during treadmill exercise training to assess effects on the same functions. The effectiveness of both robotics approaches will be compared to that of a treadmill exercise program without robotics.


Options:
A: N/A
B: Motor Control (3 weeks)
C: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)
D: Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention (Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset
Brief Summary: Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.


Options:
A: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration (within the first 60 minutes after administration)
B: Airway responsiveness as a measure of salbutamol bronchoprotection (ten minutes post 200mcg salbutamol on day 1); Airway responsiveness as a measure of salbutamol bronchoprotection (ten minutes post 200mcg salbutamol on day 3); Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance. (ten minutes post 200mcg salbutamol on day 5); Airway responsiveness as a measure of salbutamol bronchoprotection (ten minutes post 200mcg salbutamol on day 7)
C: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)
D: Length of stay in hospital

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study
Brief Summary: Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. The intensive education has the capacity to deliver effective interventions to a large number of people. The investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.


Options:
A: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
B: HbA1c (Screen,16weeks)
C: N/A
D: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and was the most common cause of maternal death in the Turkey \[1,2\]. Most of these deaths occur within 4 h of delivery and are a result of problems during third and fourth stages of labor. It also contributes significantly to serious maternal morbidity. Obstetric, surgical and radiological interventions play central role in the management of obstetric hemorrhage; however, pharmacologic management and in particular prohemostatic therapies also play an important role in the final maternal outcome. Administration of tranexamic acid (TA), intravenously in the third stage of labor may be one of these methods.

TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding. TA may enhance the effectiveness of the patient's own hemostatic mechanism \[3,4\]. In nonobstetric surgery, a systematic review of randomized controlled trails showed that tranexamic acid reduced the risk of blood transfusion \[ relative risk (RR) 0.61; 95% CI 0.54-0.69\] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95% CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events \[5\].

In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and is an effective and well-tolerated treatment when administered orally \[5,6,7\]. Bleeding associated with pregnancy (placental abruption, placenta previa) has also been treated with TA \[6\]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum hemorrhage (PPH) following cesarean delivery \[7-11\]. Only one randomized trail is available evaluating the effect of TA use to prevent bleeding in the postpartum period following spontaneous vaginal delivery \[12\].

The purpose of our study was to estimate the effect of the addition of intravenous TA to a standard active management of the third stage of labor (which includes prophylactic injection of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and controlled cord traction).


Options:
A: Estimated Blood loss (24 hours)
B: Incidence of PPH (24 hours after birth)
C: 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))
D: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and was the most common cause of maternal death in the Turkey \[1,2\]. Most of these deaths occur within 4 h of delivery and are a result of problems during third and fourth stages of labor. It also contributes significantly to serious maternal morbidity. Obstetric, surgical and radiological interventions play central role in the management of obstetric hemorrhage; however, pharmacologic management and in particular prohemostatic therapies also play an important role in the final maternal outcome. Administration of tranexamic acid (TA), intravenously in the third stage of labor may be one of these methods.

TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding. TA may enhance the effectiveness of the patient's own hemostatic mechanism \[3,4\]. In nonobstetric surgery, a systematic review of randomized controlled trails showed that tranexamic acid reduced the risk of blood transfusion \[ relative risk (RR) 0.61; 95% CI 0.54-0.69\] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95% CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events \[5\].

In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and is an effective and well-tolerated treatment when administered orally \[5,6,7\]. Bleeding associated with pregnancy (placental abruption, placenta previa) has also been treated with TA \[6\]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum hemorrhage (PPH) following cesarean delivery \[7-11\]. Only one randomized trail is available evaluating the effect of TA use to prevent bleeding in the postpartum period following spontaneous vaginal delivery \[12\].

The purpose of our study was to estimate the effect of the addition of intravenous TA to a standard active management of the third stage of labor (which includes prophylactic injection of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and controlled cord traction).


Options:
A: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
B: Pharmacokinetic (24 hours after randomisation)
C: postpartum hemorrhage (day 2)
D: o compare the estimated blood loss (EBL) during cesarean delivery among the three groups (Intraoperative and within the first 24 hours postoperative.)

Answer: A