TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Brief Summary: Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.

This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.


Options:
A: Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom (One year)
B: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)
C: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)
D: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Brief Summary: Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.

This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.


Options:
A: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery (2 years)
B: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)
C: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (2 years)
D: Anatomic cure defined by standardized POPQ measures (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Brief Summary: Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.

This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.


Options:
A: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)
B: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery (4 years)
C: Combined primary outcome measure: anatomical assessment according to the pelvic organ prolapse quantification system and prolapse specific symptom (One year)
D: Number of Participants With Anatomic Cure at 3 Years (3 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C
Brief Summary: Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels


Options:
A: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
B: HCV RNA (At each clinic visit, throughout study); Adverse events, laboratory parameters, vital signs (At each clinic visit, throughout study)
C: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
D: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C
Brief Summary: Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels


Options:
A: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
B: Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B) (At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B))
C: Sustained Virologic Response (SVR) Rate (Assessed at the end of a 24-week post-treatment follow-up)
D: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C
Brief Summary: Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels


Options:
A: Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients) (Baseline and up to 4 weeks); Occurrence of Adverse Events (AEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time (Baseline and up to 4 weeks)
B: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
C: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)
D: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants (Posttreatment Week 12); Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Brief Summary: This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.


Options:
A: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))
B: Wolf Motor Function Test (8 Weeks)
C: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
D: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Brief Summary: This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.


Options:
A: Change in peak walking speed (At baseline, following 8 weeks of training and a 2 month follow-up)
B: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)
C: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
D: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Brief Summary: This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.


Options:
A: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
B: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
C: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
D: Wolf Motor Function Test (8 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease
Brief Summary: This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.


Options:
A: Surgical cure by transsphenoidal surgery (Primarily 3 months postoperatively, but up to 10 years postoperatively)
B: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 (12 months)
C: Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24) (Screening to end of study (Week 24)); Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24) (Screening to end of study (Week 24))
D: Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5) (Week 1 and Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
Brief Summary: We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.


Options:
A: Resolution or improvement in screened chronic condition; Improved communication with primary care doctor; Improved patient satisfaction; Improved physician satisfaction
B: Change in catastrophizing cognitions (T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1)
C: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
Brief Summary: We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.


Options:
A: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
B: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
C: 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)
D: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
Brief Summary: We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.


Options:
A: Pain VAS
B: Pain (6 weeks); Functional Disability (6 weeks)
C: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
D: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Low Back Pain in the Military. A Randomized Clinical Trial
Brief Summary: We are studying whether specific back exercise and education programs effectively limit the development of chronic low back pain in Soldiers in the United States Army. These programs represent the current best evidence for prevention of low back pain from an exercise and education perspective. This innovative study will investigate whether a combination of evidence-based exercise and education programs effectively decreases the impact of chronic low back pain, when compared to individual evidence-based exercise and education programs, or a traditionally implemented exercise program.


Options:
A: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
B: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
C: N/A
D: Pain VAS

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes
Brief Summary: The aim of the present study is to investigate the influence of several anti-diabetic regimens (metformin,glitazone,sulfonylurea,glinidine) and diet on metabolic parameters in patients with recently diagnosed type 2 diabetes.


Options:
A: Novel cardiovascular risk factors modification (2 years)
B: Glycosylated Hemoglobin (HbA1c) Change From Baseline (Baseline, 52 weeks)
C: Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Baseline, Week 24)
D: Changes in Insulin secretion rate (Baseline and 96 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Study of the Safety and Efficacy of Two Dosing Regimens of QRX-101 (Becocalcidiol) Ointment in the Treatment of Plaque-Type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when applied topically twice daily for 8 weeks


Options:
A: Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001. (84 days)
B: - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
C: Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8; Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
D: Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms (12 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3a: Efficacy, Safety, and Tolerability of Dihydroartemisinin/Piperaquine (Artekin®) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Peruvian Amazon Region
Brief Summary: In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P. falciparum malaria in the Amazonian Region, and has proved its efficacy against multi-resistant P. falciparum parasites, but several side effects have been reported. Dihydroartemisinin-piperaquine (DHA-PPQ) is a new co-formulated and well tolerated ACT, increasingly used in Southeast Asia where it has proved to be highly effective against Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PPQ in patients with uncomplicated P. falciparum malaria. A RCT to evaluate DHA-PPQ was carried out, between 2003 and 2005. Patients with uncomplicated P. falciparum malaria were randomly allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period. Five hundred twenty two patients were included in the analysis, 262 were allocated to receive DHA-PPQ, and 260 to receive MAS3. The two groups were comparable at baseline in demographic and clinical characteristics. The mean time for parasite clearance into the DHA-PPQ group was 32.0 hours and 35.5 hours in the MAS3 group. Twenty-four hours after the first dose, the proportions of patients whose cleared parasitaemia were 67.2% in the DHA-PPQ group, and 58.1% in the MAS3 group (RR 1.25, \[95% CI 1.03-1.52\], p = 0.017). All patients were able to clear parasites within 72 hours after the first dose. The mean time for fever clearance was 28.0 and 29.5 hours in DHA-PPQ and MAS3 group respectively. (P= 0.69). Twenty-four hours after the first dose, 85.5% and 83.1% of patients cleared fever in the DHA-PPQ and MAS3 group respectively (p\>0.05). The Adequate Clinical and Parasitological Response (ACPR), PCR adjusted, were 97.7% and 99,2% for the DHA-PPQ and MAS3 group respectively, (RR 0.99, 95% CI \[0.86-1.13\], P = 0.88). No Early Treatments Failures were reported in any group. In the DHA-PPQ group, according to the PCR adjusted results, 6 subjects had Late treatment Failures. In the MAS3 group, two Late Treatment Failures was reported. The frequency of adverse events was significantly lower in patients treated with DHA-PPQ than in those treated with MAS3.

DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P. falciparum malaria and suitable for use in the Peruvian Amazon region. It also has the advantage of being better tolerated. In terms of cost, DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú.


Options:
A: Overall Cure Rate at Day 42
B: adequate clinical and Parasitological response (ACPR)by day 28.
C: Adequate Clinical and parasitological response (Day 63)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder
Brief Summary: This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.


Options:
A: Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (Baseline and 4 weeks (or last observation after Baseline))
B: cognition (six weeks)
C: Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests. (8 weeks)
D: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint (Baseline and Endpoint (Week 24 or last observation after baseline))

Answer: B