TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients
Brief Summary: Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask \[with or without a bag and with or without the Venturi system\] to achieve SpO2≥95%.

Oxygen therapy may be combined with non-invasive ventilation \[NIV\] providing both end-expiratory positive pressure and pressure support. However, in a recent trial by our group, non-invasive ventialtion \[NIV\] was not superior over oxygen without NIV.

High-flow nasal oxygen \[HFNO\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with Fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnoea and discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimising day-28 mortality


Options:
A: Reintubation at Day 7 (up to 7 days)
B: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
C: All-cause day-28 mortality (28 days)
D: percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) (1 hour after tracheal extubation (day 1))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients
Brief Summary: Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask \[with or without a bag and with or without the Venturi system\] to achieve SpO2≥95%.

Oxygen therapy may be combined with non-invasive ventilation \[NIV\] providing both end-expiratory positive pressure and pressure support. However, in a recent trial by our group, non-invasive ventialtion \[NIV\] was not superior over oxygen without NIV.

High-flow nasal oxygen \[HFNO\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with Fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnoea and discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimising day-28 mortality


Options:
A: The decrease of diaphragmatic workload (thickening fraction of the diaphragm) (30 minutes)
B: Tidal variation (Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy))
C: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)
D: All-cause day-28 mortality (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy.

Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.


Options:
A: The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains
B: Best Corrected Visual Acuity, Stereopsis (30 days)
C: Visual acuity improvement
D: Change from baseline in visual acuity (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
Brief Summary: Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.


Options:
A: Incident Type 2 Diabetes (baseline to 12 years postpartum)
B: Weight gain (4 weeks)
C: Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks)
D: Peak Change in Milk Output (baseline and 4 weeks post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Follow-up Study on the Sustained Impact of Alive & Thrive Behavior Change Communication Interventions on Infant and Young Child Feeding Practices in Bangladesh
Brief Summary: Alive \& Thrive (A\&T) is a multi-year initiative to improve infant and young child feeding (IYCF) practices. During Phase 1 (A\&T-1, 2009-2014), funded by the Bill \& Melinda Gates Foundation, A\&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices in three countries - Bangladesh, Ethiopia, and Viet Nam.

In 2014, IFPRI in collaboration with DATA conducted the endline survey in Bangladesh. The overall findings of the evaluation indicate that A\&T's work in Bangladesh is a remarkable success story of scaling up what has been challenging to date in the field of nutrition: complex, high intensity and at-scale behavior change communications interventions.

In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF practices, expansion of operations and promoted practices into new areas, and diffusion of IYCF information, two years after the termination of external project support.


Options:
A: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment. (2 weeks - 24 months postpartum); Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire. (2 months-12 months postpartum); Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ). (24 months postpartum); Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time. (6 and 24 months postpartum); Group differences in children's physical activity levels as assessed by accelerometry. (18 months-24 months postpartum); Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment. (2 weeks-24 months postpartum); Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time. (2 weeks-24 months postpartum)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Exclusive breastfeeding (EBF) among children 0-6 months of age (2 years after endline); Early initiation of breastfeeding (2 years after endline); Complementary feeding among children 6-23.9 months of age (2 years after endline)
D: Excessive weight gain (0-6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Observer Blinded Controlled Non Inferiority Trial to Evaluate the Safety and Immunogenicity of Locally Manufactured Inactivated Bivalent Whole Cell-oral Cholera Vaccine (WC-OCV) 'Cholvax' in Bangladeshi Healthy Adults and Children
Brief Summary: To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks.

Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).


Options:
A: Number of participants with vaccine related reactogenicity as assessed by study personnel (Within 30 minutes after administration of vaccine); Number of participants with solicited adverse events as assessed by study personnel (Within 7 days after administration of vaccine); Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician (Within 6 months after administration of vaccine); Number of participants showing seroconversion against sero group V. cholerae O1 (7 days after administration of vaccine)
B: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)
C: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
D: Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection (7 days to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.
Brief Summary: Objective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject.

Study design: Randomized Controlled trial, non-inferiority study.

Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy.

Intervention:

* Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH.
* Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).


Options:
A: how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy (6-8 hours after removal of catheter)
B: Re-insertion rate of urinary catheter after removal (after removal of urinary catheter)
C: Urinary retention (inability to void) (6 hours after removal of urinary catheter)
D: the subjective pain assessment provided by the patient post-operatively (post operatively day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm
Brief Summary: To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm


Options:
A: Suicide Attempt Self Injury Interview SASII (up to 12th months)
B: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
C: Changes in score of Affective Lability Scale (Baseline and then weekly for 12 weeks); Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder (Baseline and then weekly for 12 weeks)
D: Beck Depression Inventory (V2) (Baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm
Brief Summary: To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm


Options:
A: Suicide Attempt Self Injury Interview SASII (up to 12th months)
B: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
C: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
D: suicidal act frequency (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm
Brief Summary: To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm


Options:
A: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))
B: Suicide Attempt Self Injury Interview SASII (up to 12th months)
C: Number of suicide reattempts in every group (6 months)
D: Suicide ideation (12 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Brief Summary: Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection


Options:
A: Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment (8 weeks)
B: A Randomized Controlled Trial of Oral Vancomycin Followed by Fecal Transplantation versus Tapering Oral Vancomycin Treatment for Recurrent Clostridium difficile Infection. (3 years)
C: Safety (up to 6 mo post FMT)
D: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Investigating the Use of a Therapeutic Wand in Addition to Physiotherapy for Bladder Pain Syndrome
Brief Summary: Bladder pain syndrome is a condition where pain is experienced when the bladder fills with urine and eases briefly when the bladder empties. There can also be a constant need to urgently empty the bladder.

The internal pelvic floor muscles in people with bladder pain syndrome can be tense and painful, and relaxing and stretching them may improve symptoms; reducing bladder pain, urgency and how often people have to empty their bladder.

This pelvic floor release is done by specialist physiotherapists.Therapeutic wands, such as the TheraWand®, are used routinely throughout the United Kingdom to allow people to relax and stretch their pelvic floor themselves. Using a therapeutic wand has been shown to be safe and to reduce pelvic pain, improve bladder and bowel symptoms and relax the pelvic floor muscles. However, this research was conducted mostly in men with pelvic pain.

The aim of this study is to find out if using a therapeutic wand at home as well as having a specialist physiotherapist massage the pelvic floor gives any added benefit than just having the physiotherapy treatment. The investigators hope to find out if the therapeutic wand gives women a way of managing their symptoms independently in their own homes.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: IC/BPS Symptoms Change With Overall Global Response Assessment (GRA) (Week 2)
C: Change From Baseline in Average Daily Pain Score at Week 6 (Baseline, Week 6)
D: Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score (Baseline to 6 weeks and 6 to 12 weeks); Change in O'Leary-Sant Interstitial Cystitis Problem Index Score (Baseline to 6 weeks and 6 to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Warning Labels Decrease Soda Purchasing?
Brief Summary: Investigators will run a field study evaluating the impact different labels have on the purchasing of sugar sweetened beverages. This field study will take place in a hospital cafeteria.


Options:
A: Sweetened beverages purchased (2 week condition blocks)
B: Employee purchases of healthy (green-labeled) items (6 months)
C: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
D: Purchase of sugar-sweetened beverages (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Carefully seLected and Easily Accessible at No Charge Medications
Brief Summary: This trial evaluates the effect of providing primary care patients with free and convenient access to a set of essential medicines. Half of the participants will receive free and convenient access to these essential medicines, while the other half will have usual access to medicines.


Options:
A: Appropriate medicine adherence (During entire study period (24 months))
B: Geriatric Depression Scale (12 months); Physical Performance Test (PPT) (12 months); SF-36 Health Survey (12 months); Mental Mental Status Exam (MMSE) (12 months); Hospitalization (12 month enrollment period); Hospital Days (12 Month Enrollment Period); Emergency Department Visits (12 month Enrollment Period); Medicare Costs (12 Month Enrollment Period)
C: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (6 months)
D: Medication Adherence (12 months); Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Non Surgical Treatment of Periodontitis on Glycaemic Control in a Type 2 Diabetic Populations of Cameroon
Brief Summary: The aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. The treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three months following enrolment.


Options:
A: Metabolic (3 months)
B: Change in Glycosylated Hemoglobin (HbA1c) (6 months after randomization)
C: HbA1c percentage (At baseline and 120 days after treatment)
D: Effect of periodontal intervention on plaque score levels in diabetics with periodontal disease (Changes from baseline to 3 months); Effect of periodontal intervention on gingival bleeding index of diabetics with periodontal disease (Changes from baseline to 3 months); Effect of periodontal intervention on probing pocket depths of diabetics with periodontal disease (Changes from baseline to 3 months); Effect of periodontal intervention on probing attachment levels of diabetics with periodontal disease (Changes from baseline to 3 months)

Answer: A