TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Serratus Anterior Plane (SAP) Block Versus Erector Spinae Plane (ESP) Block for Quality of Recovery After Video Assisted Thoracic Surgery : A Randomised Control Trial
Brief Summary: During VATS (Video assisted thoracic surgery) small incisions are made in the patient's chest through which a camera and instruments are inserted to allow a lung operation to be performed. Often patients experience a substantial amount of pain and difficult recovery after this type of operation. Anaesthesiologists sometimes use "Regional Anaesthesia" to minimise the pain and help patient recovery after the operation. This involves injecting local anaesthesia into the nerves around the chest wall to effectively numb that part of the chest. There is a variety of different locations on the chest wall where the local anaesthetic can be deposited and no study has measured whether one technique is better than the other in terms of improving patients' recovery experience. Our study compares two new techniques for Regional Anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either a SAP (Serratus Anterior Plane) or ESP (Erector Spinae Plane) Block. Both techniques are described within last five years, but have never been compared for chest surgery


Options:
A: the patient centred QoR-15 score among ESB and SAP block patients; (1 year)
B: Visual analogue score (24 hours); Total morphine consumption (24 hours); First time to receive morphine (24 hours)
C: Morphine consumption (postoperative first 24 hour)
D: Numeric Rating Scale Pain Scores (1 day (PACU pain scores)); OR and PACU Opioid Consumption (up to 1 day, in the OR and PACU)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Serratus Anterior Plane (SAP) Block Versus Erector Spinae Plane (ESP) Block for Quality of Recovery After Video Assisted Thoracic Surgery : A Randomised Control Trial
Brief Summary: During VATS (Video assisted thoracic surgery) small incisions are made in the patient's chest through which a camera and instruments are inserted to allow a lung operation to be performed. Often patients experience a substantial amount of pain and difficult recovery after this type of operation. Anaesthesiologists sometimes use "Regional Anaesthesia" to minimise the pain and help patient recovery after the operation. This involves injecting local anaesthesia into the nerves around the chest wall to effectively numb that part of the chest. There is a variety of different locations on the chest wall where the local anaesthetic can be deposited and no study has measured whether one technique is better than the other in terms of improving patients' recovery experience. Our study compares two new techniques for Regional Anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either a SAP (Serratus Anterior Plane) or ESP (Erector Spinae Plane) Block. Both techniques are described within last five years, but have never been compared for chest surgery


Options:
A: Morphine consumption (24 hour postoperatively)
B: the patient centred QoR-15 score among ESB and SAP block patients; (1 year)
C: The incidence of chronic post surgical pain (CPSP)12 months after surgery (12 months)
D: QoR 15 score (24 hours post operatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Midwifery Model in Palestine
Brief Summary: This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period.


Options:
A: Parenting self-efficacy (Up to 24 months of age, from 6 weeks after birth until 24 months of age); Parenting self-efficacy (Up to 24 months of age, from 6 weeks after birth until 24 months of age)
B: Mean sum-score satisfaction with care during the continuum of pregnancy,intrapartum and postnatal period (One to six months after birth)
C: Hospitalization, length of stay (LOS) (2 weeks post-partum)
D: Antenatal visits (0-9 months before delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Hypertensive Injury to the Brain by Intensive Treatment of Blood Pressure After Intracerebral Haemorrhage
Brief Summary: PROHIBIT-ICH will randomise participants (target=112) to compare a strategy of intensive blood pressure (BP) treatment (target \<120/80 mm Hg) guided by remote telemetric home BP monitoring, versus standard primary care, in adult survivors of small vessel disease-related ICH. The investigators will establish the feasibility and safety of the intervention, the efficacy of BP reduction, and explore whether it reduces the progression of SVD-related injury on brain MRI.


Options:
A: BP Study: Efficacy (3 months from randomisation); BP Study: Feasibility (3 months from randomisation); BP Study: Safety (3 months from randomisation); Imaging Study: Efficacy (12 months from randomisation); Imaging Study: Safety (12 months from randomisation)
B: Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events (within 24 months after randomization.)
C: The number of participants recruited per site per month (in the pilot phase of the trial) (1 year after trial initiation); Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial) (1 year after randomisation)
D: Symptomatic intracranial haemorrhage (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus - Randomized, Double Blind, Placebo Controlled Trial, Phase 4
Brief Summary: Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections.

Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated.

Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM.

Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects.

Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are:

1. The rate of women requiring medications for glycemic control
2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.


Options:
A: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
B: Prevalence of gestational diabetes mellitus, GDM (Assessed at gestational weeks 24-28); Fasting glucose levels (assessed at the third trimester of pregnancy); Prevalence of allergy in child (assessed at 12 and 24 months of age)
C: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
D: The rate of women who will require pharmacotherapy for glycemic control. (During the length of pregnancy (up to 9 months)); Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products. (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mixed-methods, Feasibility Randomized Control Trial of Mindfulness-Based Stress Reduction (MBSR) With Older Adults Living With Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI): a Primary Care Context
Brief Summary: People living with subjective cognitive decline (SCD) or mild cognitive impairment (MCI) experience less efficiency in performing complex everyday tasks, which may result in a general sense of discontentment and decreased satisfaction with their overall functional performance. Additionally, SCD and MCI have been associated with concomitant anxiety, depressive mood, perceived stress, a decrease in emotional well-being and quality-of-life (QoL) among community-dwelling older adults. These concomitant psychosocial issues may result in emotional distress which further exacerbates cognitive decline.

At the present time, there is a lack of evidence that supports pharmacologic interventions to ameliorate concomitant psychosocial issues with this particular population due to medication side-effects, drug-drug interaction and polypharmacy. Consequently, exploring alternative non-pharmacological interventions to assist in ameliorating psychosocial issues is an important consideration. Secondly, evaluating perceived satisfaction on functional performance with those living with SCD and MCI, and assessing interventions that may support this is also worthwhile to pursue. Primary care providers are often the first point of contact when older adults and their families become concerned about memory problems. Health care professionals, on an interdisciplinary Family Health Team (FHT), such as occupational therapists, are well-positioned to holistically address both the psychosocial and functional needs in a client/family centred way with this growing population in primary care. The study proposes to offer a Mindfulness-Based Stress Reduction (MBSR) program, which is an 8-week program that has been shown to be beneficial in alleviating emotional distress among adults living with physical and psychological issues in the general population.


Options:
A: Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2) (Measurement 1: 1 week prior to the intervention. Measurement 2: Change in AAQ2 from pre-intervention at 1 week post-intervention. Measurement 3: Change in AAQ2 from 1 week post-intervention at 6-month post intervention.)
B: Montgomery Asberg Depression Scale (MADRS) (12 week outcome); WHO Disability Assessment Schedule (WHODAS)-II (12-week outcome)
C: Improvement in patient quality of life (baseline to 18 months)
D: Canadian Occupational Performance Measure (COPM) (30 mins)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Brief Summary: The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.


Options:
A: Need for other uterotonics (2 minutes after giving the drug)
B: quantification of blood loss (15 minutes after treatment administration)
C: Blood loss greater than or equal to 500 mls after enrolment (Blood loss measured for minimum of 1 hour or until active bleeding ceased)
D: The amount of blood loss (6 hours post delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
Brief Summary: Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.

The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.


Options:
A: superficial site infection via southampton scoring system (higher score - worse outcome) (5 days); Wound Dehisence (5 days)
B: Surgical Site Infection (30 days)
C: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
D: questionnaire (1 YEAR)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Brief Summary: Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.


Options:
A: Alleviation of depressive symptoms
B: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))
C: Hamilton Rating Scale for Depression (HAMD) Changes (From Week 0 to Week 12)
D: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia (P-OpTTICCA): a Pilot Trial for a Large Pragmatic International Parallel Open-label Non-inferiority Randomised Controlled Trial.
Brief Summary: The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.


Options:
A: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)
B: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
C: Mortality at the 45th day (45 days)
D: Timed Up and Go-test (TUG)in seconds. (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia (P-OpTTICCA): a Pilot Trial for a Large Pragmatic International Parallel Open-label Non-inferiority Randomised Controlled Trial.
Brief Summary: The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.


Options:
A: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
D: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia (P-OpTTICCA): a Pilot Trial for a Large Pragmatic International Parallel Open-label Non-inferiority Randomised Controlled Trial.
Brief Summary: The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.


Options:
A: Cost-effectiveness ratio at 30 days (30 days)
B: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
C: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
D: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Virtual Reality on Transtibial Amputation Ouality of Life,Performance, Balance,Prothesis Adaptation and Gait Outcomes
Brief Summary: The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.


Options:
A: Quality of Life measured of individuals: SF-36 Scale (10 minute); Balance Test (5 minute); Performance Test (6 minute); Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale (5 minute); Gait Parameters (6 minute)
B: Physical Activity (Day 0 (start of conventional prosthetic rehabilitation), prosthetic rehabilitation end (3 months), intervention end (6 months), and 6 months after intervention end (12 months))
C: Timed Up-and-Go Test (Baseline, 12-weeks, and 24 weeks)
D: Prosthetic Limb Users Survey of Mobility (PLUS-M) (5-10 minutes); Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (5-10 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema
Brief Summary: This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE who live in Japan.


Options:
A: Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period (First injection up to 6 months)
B: Normalized Number of Angioedema Attacks Per Month in a Treatment Period (From start of treatment up to 12 weeks during each treatment period)
C: The mean acute angioedema attack rate (12 weeks)
D: Part 1: The Rate of Expert-confirmed HAE Attacks During Dosing in the Entire 24-week Treatment Period (Day 1 to Day 168) (24 weeks); Part 2: To Evaluate the Long-term Safety and Tolerability of Berotralstat 110 and 150 mg in Subjects With HAE (Part 1: 24 weeks (Week 0 to 24 to 52), Part 2: 28 weeks (Week 24 to 52)); Part 3: To Evaluate the Long-term Safety and Tolerability of Berotralstat Administered QD Over a 52- to up to 104-week Administration Period in Subjects With HAE. (Part 3: Week 52 to up to Week 104.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by recurrent airway infections, affecting many systems including lung, pancreas and sweat glands. Cough is an important defense mechanism for clearing the secretions that increase in respiratory diseases. There have been studies investigating the effect of expiratory muscle training on disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's disease, and the elderly and healthy individuals. Studies that evaluating effects of expiratory muscle training in cystic fibrosis are limited in the literature. The aim of this study was to evaluate the effect of cough strength in children and adolescents with CF and the effect of expiratory muscle training program on cough strength, exercise capacity, respiratory muscle strength and quality of life.


Options:
A: Physical activity (Measured at baseline, 6, and 12 months)
B: Cough capacity (6 weeks)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Change from baseline Posture at 4 weeks (Baseline and after 4 weeks of training); Change from baseline Health-related quality of life at 4 weeks (Baseline and after 4 weeks of training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messaging-Based Smoking Cessation Program for Homeless Youth
Brief Summary: Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking. This study will develop and pilot test a text messaging intervention (also known as a TMI) to help homeless youth quit smoking. Text messaging can provide ongoing support for homeless youth during a quit attempt, which is important given that these youth tend to be highly mobile and lack regular access to health services. Participants in this study will be homeless youth who currently smoke and are motivated to quit smoking. All participants will receive a 30-minute group-based smoking cessation counseling session and a nicotine replacement product. Half of these smokers will also receive the TMI, for 6 weeks following the group counseling session, which will provide ongoing support for quitting. The main goal of this study is to investigate whether receiving the TMI results in greater reductions in cigarette smoking over a 3-month period compared to receiving the group counseling session alone.


Options:
A: 7-day point prevalence abstinence from smoking (6 months after enrollment)
B: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)
C: CO-verified Smoking Status at 26 Weeks (7-day smoking abstinence at week 26 follow-up)
D: 90 day continuous abstinence (90 days); 7 day abstinence (7 days)

Answer: D