TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Thinking Healthy Program - Peer Delivered in Pakistan - Child-Focused
Brief Summary: Background

The negative effects of perinatal depression on mother and child start early and persist throughout the life-course. Given that 10-35% of children worldwide are exposed to perinatal depression in their first year of life, 16 mitigating this intergenerational risk is a global public health priority. However, there is a dearth of studies on whether a maternal depression intervention can have long-term benefits for either the mother or her child. This is a study of the effectiveness of an extended 36-month peer-delivered depression intervention, the Thinking Healthy Programme PLUS (THPP+) for women and their children in rural Pakistan.

Study Design

The THPP+ study aims to evaluate the effects of an extended 36-month perinatal depression intervention on mother and child outcomes using a cluster randomized controlled trial (c-RCT) design. The trial will recruit 560 pregnant women who screened positive for perinatal depression (PHQ-9 \>=10) from 40 village clusters, of which 20 clusters will receive the THPP+ intervention delivered by trained peers. These women will have already been participating in the trial of the shorter, 6 month long, version of the intervention. Women in the THPP+ intervention arm will receive bimonthly group-based sessions. Primary outcomes are 3-year maternal depression and 3-year child socio-emotional and cognitive development. All primary analyses will be intention-to-treat and will account for the clustered study design.

Discussion

This trial has the potential to further significantly our understanding of whether intervening on women's perinatal depression can mitigate the negative effects of maternal depression on 36-month child development.


Options:
A: Depression (PHQ-9 Instrument) (36 months post-partum); Child Strength and Difficulties Questionnaire (SDQ) Total Difficulties (TD) Score (36 months)
B: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
C: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors (24-months post-intervention)
D: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.

The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.


Options:
A: Investigator-assessed Objective Progression-free Survival (PFS) (Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months))
B: Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 (From first dose to database lock (Up to 18 months)); Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 (9 weeks after first dose); Number of Participants With Adverse Events (AEs) - Part 2 (Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 (From first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 (From first dose to 30 days post last dose)
C: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))
D: Number of subjects reporting adverse events (Screening through 90 days after the last dose of study medication); Objective response (At least 24 weeks as compared to baseline); Number of subjects experiencing dose-limiting toxicities (DLTs) (Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
Brief Summary: The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.

The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.


Options:
A: Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 (From first dose to database lock (Up to 18 months)); Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 (9 weeks after first dose); Number of Participants With Adverse Events (AEs) - Part 2 (Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 (From first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 (From first dose to 30 days post last dose)
B: Progression Free Survival (PFS) Rate at Month 6 (Month 6)
C: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 413 deaths, up to March 2015 (approximately 29 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma
Brief Summary: This is a randomized phase II study, aimed at evaluating the efficacy (through progression free survival at 6 months) and safety of 5 different treatments involving atezolizumab, bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian cancer patients in order to select the optimal treatments for further development in Phase III.


Options:
A: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
B: ORR (Up to 2 years); PFS (Up to 2 years)
C: Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (6 months)
D: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma
Brief Summary: This is a randomized phase II study, aimed at evaluating the efficacy (through progression free survival at 6 months) and safety of 5 different treatments involving atezolizumab, bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian cancer patients in order to select the optimal treatments for further development in Phase III.


Options:
A: Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (6 months)
B: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
C: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator (Up to ~38 months)
D: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
Brief Summary: Background:

The immune system fights infection and can affect cancer cells. T cells are white blood cells that are a major part of the immune system. T cells can destroy tumors. Researchers want to try to manipulate the immune system to better recognize and kill tumor cells.

Objective:

To test the safety of giving T cells expressing a novel fully-human anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) to people with advanced B-cell cancer.

Eligibility:

People ages 18-73 with a B-cell cancer that has not been controlled by other therapies.

Design:

Participants will be screened with:

Physical exam

Blood and urine tests

Heart tests

Bone marrow sample taken

Scans in machines that take pictures

Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory.

Participants will get 2 chemotherapy drugs over 3 days.

Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will have visits 6 visits for 1 year after the infusion. Some may have more follow-up visits.

Participants may samples taken of spinal fluid, bone marrow, and tumors.

...


Options:
A: Overall Response Rate (ORR) (From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
B: Percentage of Enrolled Participants Who Actually Get Treated (4-5 weeks after the first dose)
C: Overall response rate (12 weeks); Overall Survival (6 months,1 year, 2 years); Progression-free Survival (12 weeks,6 months,1 year, 2 years); Event-free Survival (12 weeks,6 months,1 year, 2 years)
D: Overall Response Rate (ORR) (From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.
Brief Summary: Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.

Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).

Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is \>=1 follicle \>=18 mm. and \>=3 follicles \>=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.

Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.


Options:
A: Rate of clinical pregnancy (Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.)
B: Positive Pregnancy Test (12 to 14 days after embryo transfer); Clinical Pregnancy (5 weeks of pregnancy)
C: implantation rate (14 days after embryo transfer); clinical pregnancy rate (4 weeks after embryo transfer)
D: Rate of clinical pregnancy (5 weeks after the embryo implantation in an IVF procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 5-day, Multicentre, Randomized, Open-label, Parallel Group, Active Control Pilot Study to Evaluate the Efficacy and Safety of OxyNorm® (Oxycodone Hydrochloride Injection) in Comparison With Morphine Sulfate Through the IV Continuous Infusion Regimen in Patients With Cancer Pain
Brief Summary: The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.


Options:
A: Change in pain score and treatment success
B: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale (Baseline, Last 3 Days of Study Drug Administration (4 weeks))
C: Proportion of Non-Responder (NR) Participants (28 days)
D: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study
Brief Summary: The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH\> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone


Options:
A: the incidence of postpartum hemorrhage (24 hour)
B: Safety of Tampostat as measured by number of serious adverse events in primary PPH management (2 months); Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH (12 months); Comparison of the efficacy of Tampostat as measured by number of successful cases in arresting primary PPH and the time takes to arrest the bleeding with that of the condom catheter tamponade (12 months)
C: intraoperative blood loss (during the operation)
D: Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes (during hospital stay)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
Brief Summary: The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Options:
A: MV Coverage at 12 months of age (12 months of age)
B: Measles - 2 Completion (When the participants reach 2 years of age)
C: The Proportion who tested for HIV over 2 months follow-up (2 months following the first text message)
D: Differences in the Screen IVF questionaire between the intervention groups (through study completion, an average of 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
Brief Summary: The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Options:
A: Patient retention in care (12 months)
B: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
C: MV Coverage at 12 months of age (12 months of age)
D: Excessive weight gain (0-6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
Brief Summary: The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Options:
A: Immunization Rate (12 months)
B: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
C: The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. (~ 6 months); Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR (~ 6 months)
D: MV Coverage at 12 months of age (12 months of age)

Answer: D