linjc16/ctgov huggingface dataset:
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass

Study Overview
=================
Brief Summary
-----------------
This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.

Detailed Description
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The purpose of this project is to examine the relationships among low energy availability, H-P-A axis, menstrual function and bone density and bone turnover in high school female cross country runners. Our objectives are to: 1)determine energy intake, exercise energy expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners, using double labelled water, estimate total energy expenditure and indirect calorimetry to estimate resting metabolic rate; 3)assess the relationship between energy availability, hormones that regulate bone turnover, markers of bone formation and resorption and bone mineral content and density; 4)identify the relationship between energy availability, hormones that regulate menstrual function and current menstrual status; and 5)determine the energy intake and energy expenditure variables exhibiting the strongest associations with energy availability.

Official Title
-----------------
The Role of Low Energy Availability and the H-P-A Axis, Menstrual Irregularity, and Low Bone Mass

Conditions
-----------------
Bone Density, Energy Availability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high school female cross country runners ages 15-17 years 1-5 years experience as cross country runner 25 miles or more/week training Exclusion Criteria: medications known to affect bone metabolism pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adolescent female endurance athletes<br>High school female cross country runners in San Diego. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy availability |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone density, energy availability, menstrual status, female, adolescent
Assessing Patient Care Through Routine Use of Patient-Reported Outcomes

Study Overview
=================
Brief Summary
-----------------
Patient reported outcome measures (PROMs) are assessments of health status or health-related quality of life. The EuroQol-5D (EQ5D) is an example of a generic instrument to assess health-related quality of life. The investigators will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6 months and 12 months to track patient care in a cohort of 300 older adults who are at high-risk of falls.

Detailed Description
-----------------
Purpose: We will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6-months and 12-months to track patient care in a cohort of 300 older adults who are at high-risk of falls. Objectives: O1: Our primary objective is to use a routinely administered patient reported outcomes measure, the EuroQol-5D (EQ-5D), in older adults at high risk of falls to determine patients self-reported health status over a 12-month followup period. O2: Our secondary objective is to develop an explanatory model and a predictive model of covariates that explain significant gains or losses in health related quality of life.

Official Title
-----------------
Routine Use of Patient Reported Outcomes Among Older Adults at High Risk of Falls: A 12-Month Cohort Study

Conditions
-----------------
Falls

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred to falls clinic for assessment by general practitioner or emergency department physician. Index fall presentation not due to overwhelming force resulting in presentation to Emergency Department or general practitioner (including syncopal presentation, see below). At least 70 years of age. No progressive neurological disorder (e.g. Dementia, Parkinson's, Alzheimer's). Community dwelling (within Vancouver and Burnaby only). Mini Mental State Examination Score of at least 24. Walk at least 3 meters. Has at least one of the following 'high-risk' criteria: At least one other non-syncopal fall in the past 12 months PPA of at least 1.0 (using dominant score for strength test) TUG of at least 15 seconds Life expectancy of greater than 12 months as determined by the geriatrician. Exclusion Criteria: Any patients who do not meet the inclusion criteria specified above will be excluded from assessment at the Falls Prevention Clinic.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Patient Reported Outcome Measures, falls, older adults
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 200 subjects that completed diagnostic testing for GER in the 1970's and 1980's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.

Official Title
-----------------
The Natural History of Children With Gastroesophageal Reflux Disease (Ages 15 Months to 11 Years)

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Subjects: Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital Positive for GERD per biopsies or pH probe results Inclusion Criteria for Controls: No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease Date of birth is within 1 year of a subject's date of birth

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Subject with History of GERD<br>Children and adolescents ages 12-17 years, inclusive, seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 for symptoms of GERD and also had biopsies and / or a pH probe that was positive for GERD. | |
| Controls with out GERD<br>Individuals that do not have a history of GERD or other GI problems prior to age 21 and whose date of birth are with in a year of a subjects | |

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
-----------------
Gastroesophageal Reflux
The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients

Study Overview
=================
Brief Summary
-----------------
The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.

Official Title
-----------------
Cartilage Repair Registry

Conditions
-----------------
Articular Cartilage, Cartilage Diseases

Intervention / Treatment
-----------------
* Biological: Carticel (autologous cultured chondrocyte) implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort Exclusion Criteria: All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Carticel (autologous cultured chondrocyte) implantation|Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation | 6 month post implantation | 
| Physician assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation | 12 month post implantation | 
| Physician assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the physician based on knee examination and progress of rehabilitation | 24 month post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient assessment of effectiveness of autologous chondrocyte implantation | Overall assessment of the patient by the patient based on pain, swelling, giving-way, grinding, stiffness, catching and locking and quantity of exercise | 6 month post implantation |
Vitamin D Estimation With Giardia Lamblia Infections

Study Overview
=================
Brief Summary
-----------------
investigators will take stool and blood samples from two groups of humans :- 1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

Detailed Description
-----------------
In this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :- 1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

Official Title
-----------------
Estimation of Vitamin D in Humans Infected With Giardia Lamblia

Conditions
-----------------
Giardia Lamblia Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient infected with Giardia lamblia. Exclusion Criteria: patient takes vitamin D supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.
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 |
| --- | --- |
| Group A<br>1-Group A(Healty group with negative Giardia lamblia or control group) 96 samples | |
| Group B<br>2- Group B(Cases group with positive Giardia lamblia )96 sample | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluctuation level of vitamin D level | Estimation of vitamin D level in humans infected with Giardia lamblia | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
estimaion of vitamin D in humans infected with Giardia lamblia
25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center

Study Overview
=================
Brief Summary
-----------------
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 1992 to December 2019. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.

Official Title
-----------------
25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center.: Polytrauma Between 1995 and 2019: What Has Changed

Conditions
-----------------
Polytrauma

Intervention / Treatment
-----------------
* Other: retrospective analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ISS >16 points AIS >3 in one body region at least 2 body regions affected Exclusion Criteria: patients younger than 18 years of age isolated traumatic brain injury minor injuries (AIS <3 or ISS <16 points)

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 |
| --- |
|Other: retrospective analysis|The investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality in polytrauma patients. |  | January 1st 1992 to December 31st 2019 | 
| Possible prognostic factors influencing the outcome of polytrauma patients. | Evaluation of concomitant traumatic brain injury, resuscitation, injury severity and trauma mechanisms in polytrauma patients. | January 1st 1992 to December 31st 2019 |
Complications in Inguinal Hernia Surgery

Study Overview
=================
Brief Summary
-----------------
Inguinal hernia repair is the most common procedure in general surgery. Even with acceptable complication rates, thousands of patients worldwide suffer from inguinal hernia surgery complications every year. In Finland, the Finnish Patient Insurance Centre (FPIC) receives reports from surgical complications. In this study, the database of FPIC is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.

Official Title
-----------------
Complications in Inguinal Hernia Surgery - a Nationwide Registry Study

Conditions
-----------------
Inguinal Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery between 2002 and 2010 complicated inguinal hernia surgery reported to FPIC Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 110 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complication |  | 2 years |
MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

Study Overview
=================
Brief Summary
-----------------
determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

Detailed Description
-----------------
Compare anxiety discomfort and side effects

Official Title
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MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

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

Intervention / Treatment
-----------------
* Drug: Oxygen/nitrous oxide equimolar mix
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant 18 and over monofetal pregnancy chorionic villus sampling medical indication without contra indication informed consent signature Exclusion Criteria: pregnant under 18 multiple pregnancies pregnancy inferior 11 aw no informed consent signature

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxygen/nitrous oxide equimolar mix<br>96 participants undergoing chorionic villi sampling. self administered inhalation of equimolar mixture of oxygen and nitrous oxide (MEOPA) | Drug: Oxygen/nitrous oxide equimolar mix<br>* an experimental strategy inhalation by means of a breathing mask diffusing MEOPA<br>* Other names: MEOPA;|
| Active Comparator: Lidocaine<br>96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine | Drug: Lidocaine<br>* standard strategy by local injection anesthesia of lidocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia efficiency | assessment of pain with visual analog scale | 5 min after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of anxiety | assessment of anxiety with visual analog scale | 5 min after biopsy |
Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.

Detailed Description
-----------------
Current strategies for AKI detection rely primarily on elevations in serum creatinine in conjunction with diminished urine output. Unfortunately, deviations in these crude parameters of renal function are largely insensitive and late manifestations of AKI, where acute tubular necrosis has likely already transpired and therefore well beyond the phase where preventive measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) are critical mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular injury, providing a potential therapeutic window to prevent permanent damage. To date, no study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in advanced heart failure patients undergoing cardiac replacement therapies. Therefore, the aim of this prospective observational study will be to evaluate the effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD implant, or TAH implant.

Official Title
-----------------
Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

Conditions
-----------------
Acute Kidney Injury, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will receive LVAD or heart transplantation Exclusion Criteria: Patients who are unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation |  | 1 year | 
| Occurrence of AKI following LVAD or TAH implantation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left Ventricular Assist Device, Heart Transplantation, Perioperative, Acute Kidney Injury, Renal, Kidney, Total Artificial Heart