linjc16/ctgov huggingface dataset:
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure. The principal research questions are: Does the use of a low residue diet increase patient concordance to the bowel preparation instructions? Does the use of a low residue diet decrease the adequacy of assessment of the mucosa? Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up? Does body weight affect perceived tolerability of either group?

Official Title
-----------------
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: low residue diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending for Colonoscopy. Patients referred for colonoscopy via General Practitioner. Exclusion Criteria: Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required) Previous episodes of total or partial small bowel obstruction Previous colonic surgery Known swallowing disorder Pregnancy Extremes of age (Less than 16 or greater than 80) Small Intestine disorders Renal Insufficiency (Serum Creatinine> 110) Congestive Heart failure Presence of ascites Severe Colitis

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fleet plus low residue diet sheet. | Other: low residue diet<br>* Fleet (usual preparation) plus diet sheet for low residue diet<br>* Other names: Sodium Phosphate;|
| No Intervention: 2<br>No intervention, usual care, Fleet plus liquid only diet | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clarity of the mucosa evaluated by the Ottawa Scale. |  | At endoscopy screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance with the bowel preparation. |  | Prior to the endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Colorectal screening, Colon preparation
Costs of Postoperative Nausea and Vomiting in Ambulatory Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This is an observational study with the goal of determining the costs of nausea and vomiting in ambulatory patients after surgery from the US societal perspective.

Detailed Description
-----------------
The direct cost between the end of outpatient surgery and discharge from the hospital will include costs of labors and supplies for any outpatient care, physician visits, laboratory tests, and prescribed medications, which may be used to treat operation side effects. Based on the time and motion study design, the timing of these healthcare activities will be collected. The study coordinator will observe the actual time taken for each activity for each patient. The observation period will begin after completion of the outpatient surgery. The start and end times for each activity performed will be recorded. Therefore, each activity and its duration will be concurrently recorded. We will also query patients daily to determine additional costs associated with PONV until the third postoperative morning.

Official Title
-----------------
Time-Motion Study of PONV Costs in Ambulatory Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older American Society of Anesthesiologists (ASA) physical status 1 to 3 Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids Patients must provide written informed consent and have at least two of the following PONV risk factors: (1) female gender, (2) history of PONV and/or currently prone to motion sickness, (3) non smoking status. Exclusion Criteria: Any drug with potential antiemetic efficacy within 24 hours prior to the anesthetic procedure Vomiting, retching, or nausea in the 24 hours preceding anesthesia Body mass index >40.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post surgery monitored group<br>Outpatients undergoing elective surgery with anesthesia that is expected to last one hour and to require significant postoperative opioids | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the costs of PONV in ambulatory patients from the US societal perspective |  | 72 hours post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outpatient surgery, Postoperative nausea and vomiting, Costs, Observational
Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Study Overview
=================
Brief Summary
-----------------
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.

Official Title
-----------------
Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Conditions
-----------------
Myeloma Multiple

Intervention / Treatment
-----------------
* Biological: Descartes 11


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years of age or older at the time of enrollment High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs). Exclusion Criteria: Patients who are pregnant or lactating. Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Descartes 11<br> | Biological: Descartes 11<br>* Car T-cells<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of stringent complete response |  | 2 years |
The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms

Study Overview
=================
Brief Summary
-----------------
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. A few studies point towards potential clinical benefits of better oxygenation and less hypoxic events by positioning very low birth weight infants prone, though a recent meta-analysis didn't find a clear benefit of prone position. The aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when positioned prone versus supine, as documented by SpO2 histograms.

Official Title
-----------------
The Effects of Prone Versus Supine Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms

Conditions
-----------------
Premature Infant, Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Procedure: Position change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants with a weight < 1500 g who are receiving respiratory support Exclusion Criteria: Congenital anomalies, acute lung pathology for example x-ray confirmed pneumonia, air leak, active culture proven sepsis or on inotropic support for low blood pressure.

Ages Eligible for Study
-----------------
Minimum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supine<br> | Procedure: Position change<br>* Each subject will serve as his or her own control. Half of the infants will be placed supine for 3 hours, followed by 3 hours of prone positioning and back to supine for 3 hours and the other half will be start in prone position with consecutive periods of supine and then prone<br>|
| Experimental: Prone<br> | Procedure: Position change<br>* Each subject will serve as his or her own control. Half of the infants will be placed supine for 3 hours, followed by 3 hours of prone positioning and back to supine for 3 hours and the other half will be start in prone position with consecutive periods of supine and then prone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation instability | SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it | 3 hours in each position |
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
Safety assessment of SANGUINATE™ in Healthy Volunteers.

Detailed Description
-----------------
Safety and Pharmacokinetic assessment in ascending doses of SANGUINATE™ in Healthy Volunteers.

Official Title
-----------------
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Biological: SANGUINATE™
* Drug: Normal Saline Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Volunteers; Age ≥18 years and ≤45 years; BMI ≥20- ≤30 kg/m² No clinically significant screening observations Exclusion Criteria: Female volunteers; Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the results; History of allergy or major allergic reactions considered to be clinically significant by the Investigator; Any screening assessment determined to be clinically significant by the Investigator; Donate blood within 60 days of screening or otherwise experienced blood loss >250 mL within the same period;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SANGUINATE™<br>PEG-bHb-CO | Biological: SANGUINATE™<br>* PEG-bHb-CO<br>* Other names: PEG-bHb-CO;|
| Placebo Comparator: Normal Saline Solution<br>Saline Solution | Drug: Normal Saline Solution<br>* Placebo<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability. | Adverse events of SANGUINATE™ | 7 days |
An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

Study Overview
=================
Brief Summary
-----------------
A feasibility study of treatment with a occlusive medical device or patch in pediatric patients with type 1 diabetes suffering from irritative contact dermatitis due to diabetes devices.

Official Title
-----------------
A Single Center Explorative Study of the Treamtent ofDiabetes Patients With Contact Dermatitits Caused byInsulin Infusion Pump or Glucose Monitor

Conditions
-----------------
Contact Dermatitis Irritant, Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: DPLX-PT1
* Other: Control arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, and for patients under the legal age consent by a legal guardian Clinically confirmed, active and evaluable irritant contact dermatitis (ICD) Age 6-20 at the time of signing the informed consent form (ICF) Ability to answer study questionnaires Exclusion Criteria: Any type of skin irritation other than ICD Use of occlusive therapy for the treatment of their ICD, or unwilling to refrain from this treatment for duration of study For any other reason considered unsuitable by the investigator Pregnant or of child-bearing potential unwilling to use acceptable effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Medical Device, an occlusive patch for 3 days. | Device: DPLX-PT1<br>* A polymer skin patch for occlusional therapy<br>|
| Active Comparator: Control<br>Standard of Care | Other: Control arm<br>* Standard of care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of active treatment versus standard of care |  | 8 days after active treatment compared to 8 days after standard of care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of Irritative contact dermatitis |  | After 8 days |
Use of Theater to Invoke Empathy and Reduce Bias in Medical Students

Study Overview
=================
Brief Summary
-----------------
The effect of medical humanities on medical student bias and clinical management is unclear. This study characterized medical student attitudes toward obese individuals and whether reading a play employing empathic characters can modulate negative reactions.

Conditions
-----------------
Medical Student Bias

Intervention / Treatment
-----------------
* Behavioral: Medical Lecture
* Behavioral: Dramatic Reading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical student at UC Davis, UC Irvine, or Mayo Medical School Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theater<br>1-hour dramatic reading of The Most Massive Woman Wins | Behavioral: Dramatic Reading<br> <br> |
| Active Comparator: Lecture<br>1-hour lecture on the medical management of obese patients | Behavioral: Medical Lecture<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explicit fat bias | Assessment of conscious bias against fat people (unit of measure from 11 to 99). | four months | 
| implicit fat bias | Measurement using the implicit association test (IAT) with scores from -2.0 to +2.0. | four months | 
| empathy scale | Score of Jefferson Scale of Physician Empathy (JSPE) from 20 to 180. | four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Centered Care | Open-ended question on the clinical management of an asymptomatic, obese, elderly woman who is otherwise healthy, with coding for a response that is either patient-centered (ie: asking patient preferences and goals) or prescriptive (ie: telling the patient to diet and/or exercise). | four months | 
| Appraisal of obesity | An open-ended question asking participants whether they felt obesity was primarily an issue of discrimination (ie: civil rights) or a public health concern (ie: medical). | four months |
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.

Official Title
-----------------
An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: AZD1386


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index of 18 - 30 and weight of 50 to 100 kilos. Healthy volunteer must have regular bowel movements (at least once daily) Exclusion Criteria: History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator. A family history of short QT syndrome or sudden cardiac death amongst first degree relatives. Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1386<br>* 1 dose of oral solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386 |  | Until >90% of predicted total radioactivity has been recovered | 
| Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta |  | Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AZD1386 metabolites in plasma+excreta if feasable |  | Predose, 1h, 4h, 8h 24h | 
| Safety + tolerability of AZD1386 |  | Predose, 2h, 6h, 12h, 24h, 48h, 168h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain
Ultrasound in Acute Dyspnea in the Field

Study Overview
=================
Brief Summary
-----------------
Acute heart failure is one of the main causes of acute respiratory distres in prehospital emergency setting. The early and correct diagnosis is important because the misdiagnosis can result in deleterious consequeance to patients. Rapid bedside tests (like NT-proBNP) and point-of-care lung ultrasound could be useful methods in field. This study confirmed that the combination of ultrasound sign in combination with rapid NT-proBNP test has a hibh diagnostic accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea in the field and the tretament possibilities in clinical obscure cases are mainly improved.

Official Title
-----------------
Combination of Lung Ultrasound(a Comet-tail Sign) and N-terminal Pro-brain Natriuretic Paptide in Differentiating Acute Dyspnea in Prehospital Emergency Setting

Conditions
-----------------
Heart Failure, COPD, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criterion for the study was shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea). Exclusion Criteria: Exclusion criteria were age <18 years, history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: pneumonia, pulmonary embolism, carcinoma, pneumothorax, pleural effusion, intoxications (drugs), anaphylactic reactions, upper airway obstruction, bronchial stenosis, and gastroesophageal reflux disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute dyspnea, field, diagnostic<br>All patients with shortness of breath as the primary complaint (defined as eitherthe sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea and were age >18 years. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute dyspnea, prehospital emergency setting, differential diagnosis, ultrasound, NT-proBNP