TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Brief Summary: Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.


Options:
A: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
B: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
C: Change from baseline compassion fatigue at 1 and 6 months assessed by compassion fatigue subscale of Professional quality of life scale (Data collected before the program starts and one months after the end of the program and six months); Change from baseline burnout at 1 and 6 months assessed by burnout subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months); Change from baseline compassion satisfaction at 1 and 6 months assessed by compassion satisfaction subscale of Professional quality of life scale (Data collected before the program starts (pretest) and one months after the end of the program and six months)
D: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Brief Summary: Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.


Options:
A: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
B: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
C: State-Trait Anxiety Inventory (week 0 (baseline)); Hamilton Anxiety Rating Scale (week 0 (baseline)); Clinical Global Impression - Severity scale (week 0 (baseline)); Clinical Global Impression - Improvement scale (week 0 (baseline)); Mini-International Neuropsychiatric Interview 5 (week 0 (screening)); Becks Depression Inventory II (week 0 (screening)); State-Trait Anxiety Inventory (week 12 (end of treatment)); Hamilton Anxiety Rating Scale (week 12 (end of treatment)); Clinical Global Impression - Severity scale (week 12 (end of treatment)); Clinical Global Impression - Improvement scale (week 12 (end of treatment)); Mini-International Neuropsychiatric Interview 5 (week 12 (end of treatment)); Becks Depression Inventory II (week 12 (end of treatment)); State-Trait Anxiety Inventory (week 24 (follow-up)); Hamilton Anxiety Rating Scale (week 24 (follow-up)); Clinical Global Impression - Severity scale (week 24 (follow-up)); Clinical Global Impression - Improvement scale (week 24 (follow-up)); Mini-International Neuropsychiatric Interview 5 (week 24 (follow-up)); Becks Depression Inventory II (week 24 (follow-up))
D: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
Brief Summary: There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.


Options:
A: Serum 25-hydroxyvitamin D concentration (Maternal: during 3rd trimester; Neonatal (cord blood))
B: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)
C: The number of days of detectable milk vitamin D concentrations (28 days)
D: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
Brief Summary: There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.


Options:
A: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
B: Change in Vitamin D status, infections and inflammation across pregnancy after Vitamin D supplementation (Entry into study, mid-gestation and delivery)
C: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
D: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh
Brief Summary: There is a growing body of data suggesting that vitamin D modulates the host's immune response to acute respiratory infection (ARI). The primary aim of this study is to determine whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh. Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B) incidence of clinical ARI (without the need for positive microbiology), and C) quantitative density of pneumococcal carriage. Infants will be followed from birth until 6 months of life. Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed Description' section), nasal swab specimens will be collected. Respiratory samples will be analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza types 1, 2, and 3) plus quantitative density of S. pneumonia.


Options:
A: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)
B: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
C: Microbiologically confirmed viral acute respiratory infection (URTI and/or LRTI) (0 to 6 months)
D: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)
Brief Summary: The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
C: Recurrence-free Survival (RFS) (up to 36 months)
D: Adverse Events (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)
Brief Summary: The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


Options:
A: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
B: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)
C: Recurrence-free Survival (RFS) (up to 36 months)
D: Distant metastases free survival (3 Years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria
Brief Summary: This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.

All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.

Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).


Options:
A: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
B: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
C: PCR-Corrected ACPR at Day 28 (Day 28)
D: result of PCR (42 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria
Brief Summary: This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.

All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.

Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).


Options:
A: Evaluation and identification of hepatic safety events, including raised liver function tests (Assessment up to Day 28.)
B: Crude Cure Rate on Day 14 (Day 14)
C: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
D: result of PCR (42 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke - Randomized, Double Blind
Brief Summary: Background: Transcranial direct current stimulation (tDCS) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects of a session of tDCS over the primary motor cortex combined with functional electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. Methods/design: A randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve an identification and screening chart, the classification of motor impairment using the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified Ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. After the initial evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be administered over the primary motor cortex and FES will be administered over the tibialis anterior muscle. The order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.


Options:
A: Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke (assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)
B: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
C: maximum voluntary isometric strength of knee extensors (2 hours)
D: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke - Randomized, Double Blind
Brief Summary: Background: Transcranial direct current stimulation (tDCS) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects of a session of tDCS over the primary motor cortex combined with functional electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. Methods/design: A randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve an identification and screening chart, the classification of motor impairment using the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified Ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. After the initial evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be administered over the primary motor cortex and FES will be administered over the tibialis anterior muscle. The order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.


Options:
A: Jebsen Taylor test (5-15-30 days)
B: JTT (crossover design, four different sessions with four different interventions)
C: Behavioural Inattention Test (BIT) (Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)); Neglect Test Battery (Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.)
D: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroprotection In Patients Undergoing Aortic Valve Replacement
Brief Summary: To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).


Options:
A: Composite endpoint of postoperative SIRS and at least one major organ dysfunction (day-7)
B: 90-day mortality (90 day)
C: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (up to 10 days post procedure)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Immediate Effects of Mulligan Mobilization With Movement Technique in Pain, Range of Motion and Physical Function in Patients With Osteoarthritis of the Hip
Brief Summary: The concept of mobilization with movement, also referred to as a Mulligan mobilization, has not been studied in patients with hip osteoarthritis, subsisting questions about the possible effects in this population. The aim of this randomized controlled study is to compare the immediate effects of Mulligan mobilization with movement technique of pain, range of motion and physical function in patients with osteoarthritis of the hip.


Options:
A: Self-report measure of exercise adherence over the last 3-months on a numeric rating scale (24 month)
B: Change in the intensity of daily pain. (The treatment will be 5 daily sessions.The pain level will be assessed before treatment, after each session and at the end of treatment.Totaling six days.); Change in the pressure pain threshold. (The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.)
C: Changes in the intensity of hip pain before and after the treatment (participants will be assessed before and after intervention (interval: 15-20 minutes))
D: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Change from baseline at 9 weeks, 1 year and 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
Brief Summary: To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.


Options:
A: Surgical Site Infection (30 days)
B: Postoperative Surgical Site Infection (SSI) (30 days following operation)
C: Post-operative wound infection (6 weeks post-operative)
D: Number of Participants With Wound Complications (Four weeks after cesarean section)

Answer: C