linjc16/ctgov huggingface dataset:
Infants With Protein Sensitive Colitis

Study Overview
=================
Brief Summary
-----------------
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.

Official Title
-----------------
Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis

Conditions
-----------------
Protein Sensitive Colitis

Intervention / Treatment
-----------------
* Other: Experimental Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 6 months of age 36-42 weeks gestational age at birth Singleton or Twin birth Diagnosed with protein sensitive colitis Negative stool culture at time of study entry No previous history of consuming free amino acid-based medical food Not receiving cisapride or steroids No vitamin mineral supplement administration during the study period with the exception of iron or fluoride No milk or soy products for the duration of the study

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Infant Formula<br>Experimental formula to be fed ad libitum. | Other: Experimental Infant Formula<br>* Nutritionally complete free amino acid-based medical food.<br>* Other names: EleCare;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Rated Symptom Score | Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43. | Study Day (SD) 1 and 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Rank Stool Consistency | Parent reported stool records | Study Day (SD) 2-4 and 40-42 | 
| Weight | Weight gain during the feeding period | Study Day (SD) 1 and 43 Visits | 
| Formula Intake | Parent reported records of formula intake | Study Day (SD) 2-4 and 40-42 | 
| Daily Stool Number | Parent reported stool records | Study Day (SD) 2-4 and 40-42 | 
| Stool Occult Blood | Parent collected sample of infant stool | Study Day (SD) 2-4 and 40-42 |
Validation of a Novel Frailty Index in Surgical Cohorts

Study Overview
=================
Brief Summary
-----------------
This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older

Official Title
-----------------
Testing and Validation of a Novel Frailty Index in a Surgical Cohort

Conditions
-----------------
Surgery--Complications, Anesthesia Morbidity, Perioperative Complication

Intervention / Treatment
-----------------
* Other: Frailty risk groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved Exclusion Criteria: No American Society of Anesthesiology classification provided

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Low frailty<br>Frailty risk score less than 5 | Other: Frailty risk groups<br>* Patients older than 65 will be separated into groups of varying frailty risk<br>|
| Intermediate Frailty<br>Frailty risk score 5-15 | Other: Frailty risk groups<br>* Patients older than 65 will be separated into groups of varying frailty risk<br>|
| High frailty<br>Frailty risk score 15 and above | Other: Frailty risk groups<br>* Patients older than 65 will be separated into groups of varying frailty risk<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Mortality within 30 days of surgery in each of the three frailty risk groups | 30-days | 
| Time to hospital readmission | For patients surviving index hospitalization, the proportional hazard ratio of readmission between the three frailty group | Up to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term mortality | Long-term mortality of the three different frailty risk groups, compared with proportional hazard modeling | Up to 14 years | 
| Prolonged hospital length-of stay | Incidence of patients staying more than 10-days after surgery in the three frailty risk cohorts | 3 months |
Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is: to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan. to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy. to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost. to propose new guidelines for tumour bed definition and delineation based on the study findings.

Detailed Description
-----------------
Start of the study: february 2012

Official Title
-----------------
Optimizing the Delineation of the Tumour Bed in Breast Irradiation

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: extra treatment planning CT-scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy. Exclusion Criteria: Metastases at time of diagnosis
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: extra treatment planning CT-scan<br>Extra pre-operative CT-scan for treatment planning in RT | Device: extra treatment planning CT-scan<br>* Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan. |  | 2 years | 
| the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV |  | 2 Years | 
| the volume changes over time (in case of adjuvant chemotherapy) |  | 2 years | 
| the usefulness of the surgical clips assessed by the 6 observers. |  | 2 years |
Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel. An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Detailed Description
-----------------
Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel. An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Official Title
-----------------
Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy

Conditions
-----------------
Pervasive Developmental Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with PDD Children aged from 2 years to 6 years Exclusion Criteria: Children with severe retardation

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Preschool children with PDD | |
| 2<br>Preschool children without PDD | |

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
-----------------
children with PDD
Intraoperative Hygiene Measures and Surgical Site Infections

Study Overview
=================
Brief Summary
-----------------
Surgical site infections are associated with high morbidity and cost Hypothesis: Extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures.

Detailed Description
-----------------
Intraoperatively two types of hygiene measures were performed randomly: standard and extensive. Standard hygiene measures included empiric accepted measures (e.g. gloves, masks, disinfection). Extensive hygiene measures included among others: double gloving, astro caps, extensive disinfection, extensive intraoperative rinsing. In addition, intraoperative adherence to the rules of asepsis were registered by an independent observer. Patients were followed for 30 days.

Official Title
-----------------
Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery

Conditions
-----------------
Surgery, Surgical Site Infection, Hygiene, Discipline, Colorectal Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied Exclusion Criteria: Previous inclusion into study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Extended hygiene measures | |
| 2<br>Standard hygiene measures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection 30 days postoperative |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to rules of asepsis by members of the surgical team |  | intraoperative |
Mean Systemic Pressure Measurement During Prone Position Surgery

Study Overview
=================
Brief Summary
-----------------
Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Indeed, the mean systemic pressure is the one that would be measured anywhere within the vascular system after cardiac arrest. Recent advances in hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac output measurements during respiratory pauses under mechanical ventilation. In this way, it is possible to calculate MSP, the pressure gradient and the venous return resistances. The investigators aim is to explain the hemodynamic variations and the decrease in cardiac output observed during prone position. The investigators hypothesis is that venous return resistances are increased during prone position probably following an increased intra-abdominal pressure.

Official Title
-----------------
Study of Hemodynamic Variations During Prone Position Surgery: Measurement of Mean Systemic Pressure and Venous Return Resistance

Conditions
-----------------
Hemodynamic Variation During Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prone position neurosurgery High-risk neurosurgery Exclusion Criteria: Emergency surgery Pregnancy

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 |
| --- | --- |
| prone position<br>Patient scheduled for surgery in the prone position | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean systemic pressure variation | change of mean systemic pressure from supine position to prone position during surgery | during surgery after the patient is put in prone position | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intrathoracic pressure variation | Change of intrathoracic pressure from supine position to prone position during surgery | during surgery during surgery after the patient is put in prone position | 
| intravesical pressure variation | Change of intravesical pressure from supine position to prone position during surgery | during surgery during surgery after the patient is put in prone position | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prone position, hemodynamic variation, mean systemic pressure
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Official Title
-----------------
A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Conditions
-----------------
Secondary Hyperparathyroidism, Chronic Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: cinacalcet (AMG 073)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have chronic renal insufficiency (pre-dialysis) Have below normal creatinine clearance Have elevated parathyroid hormone levels Exclusion Criteria: Pregnant or nursing Heart attack in the last 3 months.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cinacalcet (AMG 073)<br> | Drug: cinacalcet (AMG 073)<br>* Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: cinacalcet (AMG 073)<br>* Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase | Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase | Efficacy assessment phase (weeks 12-18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase | Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase | Baseline, efficacy assessment phase (weeks 12-18) |
Reflectance Confocal Microscopy to Diagnose BCC

Study Overview
=================
Brief Summary
-----------------
It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.

Detailed Description
-----------------
Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC. Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%. The secondary hypothesis is that the intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement). Patients will be recruited from the outpatient clinic of Skin Care Network London.

Official Title
-----------------
Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: In-vivo imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment. Patient willing and able to give informed consent Exclusion Criteria: Recurrent or other higher-risk BCC Patient with basal cell naevus syndrome Patient treated with hedgehog inhibitor medication (vismodegib) Patient not suitable for diagnostic biopsy Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator Patient with co-morbidities such as other skin disease

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: In-vivo imaging|Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | Specificity & Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology | During exam (biopsy results typically available within one week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra- & inter-observer agreement for interpreting the RCM images | A measure of how consistently readers can diagnose from confocal images. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCM, Confocal, Imaging, Skin cancer
The Use of Computer-Assisted Learning Pediatrics Program (CLIPP) in the Pediatric Clerkship

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if utilizing CLIPP (Computer-Assisted Learning Pediatrics Program) cases in the pediatric clerkship will standardize students' exposure to essential pediatric conditions and enhance their learning experience.

Detailed Description
-----------------
The Computer-Assisted Learning Pediatrics Program was developed by members of the Council on Medical Student Medical Education (COMSEP) and has been very well received by both medical students and faculty. The program is a comprehensive Internet-based learning method designed for use by third year medical students during their pediatric rotation. More than 80 medical schools in the US and Canada have been successfully using the CLIPP cases with an estimated 3000 to 4000 cases being reviewed by students weekly. All third year medical students will be required to complete specific cases, based on gaps identified through review of prior student contact logs. Using the students' own patient contact logs, they will also be strongly encouraged to complete any cases for which they have not met the clerkship requirement. Students will be allowed to complete any other cases they choose. The study proposes that by utilizing CLIPP cases in the pediatric rotation, student exposure to essential pediatric conditions will increase, thereby increasing retention of knowledge and increasing their performance on end of clerkship OSCEs (Observed Structured Clinical Exam) and on NBME Pediatric Subject Exam (shelf exam).

Official Title
-----------------
The Use of Computer-Assisted Learning Pediatrics Program (CLIPP) in the Pediatric Clerkship

Conditions
-----------------
Learning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all third year medical students will be required to complete a specific number of CLIPP cases as part of their pediatric rotation. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>all third year medical students entering their pediatric clerkship at the Medical College of Wisconsin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| student exposure to essential pediatric conditions will increase, thereby increasing knowledge retention and increasing their performance on end of clerkship exams |  | 2007-2008 academic year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLIPP cases, Pediatric clerkship, Standardizing, Students' exposure, Essential, Enhancing, Experience