TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Pessary vs. Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial
Brief Summary: The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations.

All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial.

Women who meet eligible criteria will be invited to participate in the clinical trial.

Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary).

Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.


Options:
A: Spontaneous Delivery Before 34 Completed Weeks (Between 24 and 34 weeks)
B: Recruitment feasibility (Up to 24 weeks (18 to 42 weeks of gestation))
C: preterm birth before 34 weeks of gestation rate in singleton pregnancies (up to 20 weeks from recruitment); preterm birth before 32 weeks of gestation rate in twin pregnancies (up to 20 weeks from recruitment)
D: Children's survival without neurodevelopmental disability at the age of 3 years (assessment of the newborn at age of 3 years (corrected age for prematurity))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interactive Exoskeleton Robot for Walking - Ankle Joint
Brief Summary: A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.


Options:
A: Change in 10 meter walk test from baseline in gait speed (session 0 (initial visit); session 11 (at approximately 4 weeks))
B: Change From Baseline in Berg Balance Scale at 4 Weeks (Baseline and 4 weeks from baseline)
C: Walking ability - Functional Ambulation Category (Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks))
D: 6-minute Walk Test (3-month follow-up); Functional Ambulation Category (3-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
Brief Summary: This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.


Options:
A: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
B: Number of Patients With Drug Related Adverse Events (After the first drug intake until 7 days after the last treatment administration, up to 383 days)
C: Change From Baseline in A1C at Week 26 (Excluding Rescue Approach) (Baseline and Week 26); Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (Up to Week 106); Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (Up to Week 104)
D: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 (Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF) - Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).


Options:
A: Compare number of oocytes using GnRH antagonist versus PMA. (36 hours: from triggering until Oocyte retrieval)
B: live birth rate (10 months for group A, 12 months for group B)
C: donor ovarian response (1 month)
D: Ongoing pregnancy (12 weeks of gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF) - Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).


Options:
A: Ongoing pregnancy rates (Two years)
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: Ongoing pregnancy (12 weeks of gestation)
D: Implantation rate (8 weeks after replacement)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Freeze All Protocol Versus Fresh Embryo Transfer in Women Undergoing In-vitro Fertilization (IVF) - Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).


Options:
A: Clinical pregnancy rates (7 weeks)
B: Ongoing pregnancy (12 weeks of gestation)
C: implantation rate (4 weeks)
D: Implantation rate (8 weeks after replacement)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms.
Brief Summary: Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by identifying underlying causes and tailoring a treatment plan (pharmacological or non-pharmacologic treatments including provision of staff education and support, training in problem solving, and targeted therapy directed at the underlying causes for specific behaviors).


Options:
A: Change of hospital admissions (21 months)
B: Caregiver Perceptions of Pain Medicine Questionaire (Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure)
C: Acceptability of the TM among the LTCF staff (6 months)
D: Hospital admission, length of stay

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lymphocytic Enteritis and Suspected Coeliac Disease: Double-blind Gluten vs Placebo Rechallenge
Brief Summary: Patients with lymphocytic enteritis (LE), HLA-DQ2/8+, negative celiac serology and clinical and histological response to a gluten-free diet (GFD) do not fulfil the diagnostic criteria of coeliac disease (CoD). At present it remains unclear whether they suffer from coeliac gluten sensitivity (CGS) or non-coeliac gluten sensitivity (NCGS). There are specific tissue markers of CoD such as anti-transglutaminase deposits (tTG) and intraepithelial lymphocytes expressing T-cell receptor (TCR) gamma/delta+.

Aim: To demonstrate the existence of CGS in these patients despite having negative celiac serology.

Methods: Double-blind randomized clinical trial of gluten vs placebo rechallenge for 6 months in patients with LE on a GFD. Inclusion criteria: \>18 years, initial presentation with GI symptoms, HLA-DQ2/8+, negative celiac serology, good clinical and histological response to GFD. Patients were randomised to gluten (20 g/day) and placebo (maltrodextrin) (identical powder sachets mixed with meals). Clinical symptoms were analysed using visual analogue scales. Quality of life (GIQLI), adherence to diet, serology, and histological changes including gamma/delta+ IEL and tTG deposits were evaluated.


Options:
A: Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score) (These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9))
B: Intestinal mucosal gluten-dependent immune response before and after a gluten-free diet (12 months)
C: Clinical relapse (6 months)
D: Small-bowel mucosal morphology and inflammation (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Training and Cancer- Effects and Understanding of Mechanisms for Prevent and Minimizing Cancer Related Fatigue, Improve Quality of Life and Disease Outcome
Brief Summary: Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality of life negatively. There is limited knowledge about the physical mechanisms that cause fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience, but the investigators need to learn more about the type and intensity of exercise that works the best as well as how to motivate patients to exercise. The overall aim, is to evaluate the efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM) intensity physical training, with or without behavioural medicine (BM) support strategies, during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life (QoL), mood disturbance, adherence to the cancer treatment, adverse effects, disease outcome, return to a daily life after completed treatment and return to work. The investigators will also describe changes in inflammatory markers and cytokines related to physical training and gene expressions following training to investigate whether these serve as mediators for the effects of physical training on CRF and QoL. This will be evaluated in newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design will be used, 600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train two times per week during 6 months. This project will give; new knowledge about aspects for individuals to gain improved well-being and quality of life, facilitated return to work, and possibly reduced risk of cancer recurrence. This in turn would result in lower burden on the health care system, reduced societal costs and have a positive impact on public health. Implementation of the results into clinical practice will be facilitated by the close collaboration between researchers and clinicians, and the fact that the study is performed in clinical settings.


Options:
A: Health-related quality of life (Week 10)
B: Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients. (2 years)
C: Change in Fatigue (post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years)
D: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access
Brief Summary: This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.


Options:
A: Major amputation
B: Ankle brachial index (6 months)
C: N/A
D: AE and symptomatic relief (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access
Brief Summary: This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.


Options:
A: Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale. (Primary follow up in a 6 month period)
B: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
C: N/A
D: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
Brief Summary: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:

WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis


Options:
A: Isometric Quadriceps Strength (2 weeks)
B: Length of hospital stay (participants will be followed for the duration of hospital stay, an expected average of 3 days").)
C: isometric quadriceps-force measured (pre operatively and 48 hrs post op)
D: Biochemical Data (During operation 60 min Ischemia/Shame-Ischemia Time)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
Brief Summary: This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.

2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)


Options:
A: Progression-Free Survival (Up to 17 months)
B: Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B (IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.)
C: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 (Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]).); Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 (Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]).)
D: Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment (IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
Brief Summary: This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.

2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)


Options:
A: Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B (IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.)
B: Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria (Baseline until disease progression or death up to approximately 3.75 years)
C: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
D: PFS (Progression Free Survival) (Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
Brief Summary: The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy in community dwelling older adults at risk of falls recruited from 86 primary care practices around the U.S.


Options:
A: Change in PTSD Checklist (PCL-5) (Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment)
B: Fear of falling (Prospective change from baseline to end of intervention (8 weeks)); Functional mobility (Prospective change from baseline to end of intervention (8 weeks))
C: Fear of falling (2 months (primary)); Activity avoidance (2 months (primary))
D: First Adjudicated Serious Fall-Related Injury (Enrollment through last completed follow-up or death interview (max 44 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment
Brief Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.


Options:
A: Overall Survival (OS) (Up to 4.3 years)
B: overall survival (ten years)
C: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)
D: Progression-free Survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment
Brief Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.


Options:
A: Progression-free Survival(PFS) (up to 2 years)
B: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)
C: Overall Objective Response (1 year after end inclusion)
D: Overall survival (After follow-up is complete (year 3-4 of the trial))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment
Brief Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.


Options:
A: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)
B: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
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