linjc16/ctgov huggingface dataset:
Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia. The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.

Detailed Description
-----------------
Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration. We also analyze post-operative complications.

Official Title
-----------------
Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?

Conditions
-----------------
Hypoparathyroidism

Intervention / Treatment
-----------------
* Other: analysis of hypocalcemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Total thyroidectomy Exclusion Criteria: concomitant parathyroidectomy for primary hyperparathyroidism lobectomy only completion thyroidectomy central and lateral neck dissection patients with calcium and/or vitamin D supplementation prior surgery patients with known and significant osteoporosis and renal failure
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 |
| --- | --- |
| 477 patients<br>the biological tests of 477 patients undergoing total thyroidectomy were analyzed | Other: analysis of hypocalcemia<br>* analysis of postoperative calcium and PTH levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calcium and PTH thresholds | For all 477 patients postoperative calcium and PTH levels and treatment with calcium and vitamin D will be analyzed. Objective is to identify the calcium and PTH thresholds at which the patient after total thyroidectomy can be discharged without risk of hypocalcemia. | one years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
discharge, thyroidectomy, hypocalcemia, hypoparathyroidism, PTH
Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Detailed Description
-----------------
Model 4196 LV lead complication-free survivability will be summarized.

Official Title
-----------------
Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive an Attain Ability Model 4196 LV lead Patient within 30 day post implant enrollment window Exclusion Criteria Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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 |
| --- | --- | --- |
| Lead-related complication rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of lead-related events |  | 5 years | 
| Percent of subjects with changes in electrode programming |  | 5 Years | 
| Percent of fractures with loss of function |  | 5 years | 
| Mean bipolar pacing threshold |  | 1 year | 
| Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations |  | 1 year |
Observational Study Comparing Home to Office Spirometry

Study Overview
=================
Brief Summary
-----------------
This is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. The aim of the study is to estimate the accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home measurements.

Detailed Description
-----------------
After successful completion of the run-in period, participants will have 3 in-person visits, at which office spirometry will be performed and weight and height measured. Participants will perform home spirometry weekly during the study period. They will also electronically complete a weekly electronic patient reported outcome (ePRO) Within one week of each in-person visit, they will measure height and weight at home and perform home spirometry with virtual coaching by site research staff. They will complete a brief ePRO every 4 weeks regarding acceptability and feasibility of home spirometry in research. Within two weeks after study completion, a purposive subsample will complete an exit interview.

Official Title
-----------------
Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documentation of a CF diagnosis Clinically stable ≥6 years of age at Screening Visit During the run-in period, performed acceptable home spirometry at least twice without virtually coaching and once with virtually coaching Exclusion Criteria: History of lung transplantation Initiation of a highly effective modulator therapy within 2 months before Screening Visit

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- | --- |
| Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change | Difference between home and office spirometry estimates of FEV1 (% predicted) change from Week 0 to Week 12 (home estimate - office estimate) | Week 0 to Week 12 | 
| Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change | Factor by which trial sample size must increase/decrease to maintain a given power going from office to home spirometry | Week 0 to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telehealth, Spirometry, Cystic Fibrosis, CF, Telemedicine, ZEPHYRx
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES

Study Overview
=================
Brief Summary
-----------------
Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department. European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.

Official Title
-----------------
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)

Conditions
-----------------
Acurate Heart Failure

Intervention / Treatment
-----------------
* Other: MEESSI score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Patient admitted to emergencies with suspicion of ICA according to the clinical intuition of the emergency doctor after interrogation, clinical examination, biology and imaging Patient with health insurance Subject who accept to participate in the research Exclusion Criteria: Patient who refuse to participate in the study Patient with coronary syndrome with ST segment elevation Other diagnosis of dyspnea Persons deprived of their freedom or under the protection of justice Persons under guardianship or curatorship Impossibility of giving the patient informed information Pregnant woman

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 |
| --- | --- |
| patients with acurate heart failure<br> | Other: MEESSI score<br>* MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEESSI score | Tscore to predict the patient's future in the month following management for ED ICA. That is to say the number of days alive outside the hospital in the month following an ICA episode. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-admission rate | 30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score | 30 days | 
| Mortality rate | Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score | 30 days | 
| Sensitivity | Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caring, emergency
A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade

Study Overview
=================
Brief Summary
-----------------
To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin effect on QT and QTc will also be assessed in atrially paced patients at two different pacing rates with and without autonomic blockade

Official Title
-----------------
A Methodological Open-Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarisation and QT Interval At Fixed Heart Rate Under Autonomic Blockade

Conditions
-----------------
Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Intervention / Treatment
-----------------
* Drug: GTN
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pace-makers but otherwise normal ventricular function Exclusion Criteria: Nitrates, beta blockers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GTN|nan|
|Drug: Moxifloxacin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT and QTc changes at two different pacing rates in atrially paced patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QT and QTcF before and after Moxifloxacin with and without autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade at each pacing rate |  |  |
Surgery Versus Non-surgical Treatment for Esophageal Squamous Cell Carcinoma in Patients Older Than 70 Years

Study Overview
=================
Brief Summary
-----------------
To determine whether older patients who underwent esophagectomy had better outcome survival than those who were non-surgically treated.

Official Title
-----------------
Sichuan Cancer Hospital & Institute

Conditions
-----------------
Esophageal Squamous Cell Carcinoma, Esophagectomy, Radiotherapy, Chemotherapy

Intervention / Treatment
-----------------
* Diagnostic Test: Since the data were collected retrospectively, there were no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathology confirmed ESCC, Patients with esophagectomy or radiotherapy (RT)/chemotherapy (CT), Age ≥ 70. Exclusion Criteria: Having other malignant tumours, Missing of required data.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 100 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 |
| --- | --- |
| S group<br>underwent surgical treatment. | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|
| NS group<br>underwent non-surgical treatment with RT and/or chemoradiotherapy. | Diagnostic Test: Since the data were collected retrospectively, there were no interventions<br>* Since the data were collected retrospectively, there were no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selection of treatment modalities for elderly patients with oesophageal cancer | Surgical data were retrospectively collected | 2009.01.01-2017.12.30 |
Analysis of the Kinematics of the Shoulder Complex in Sports Overhead Gestures Such as Kayaking Polo Throwing (Overhead)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to analyze the throwing gesture specific to the kayak polo. A throw in a seated position with fixation of the pelvis (by the seat) and antepulsion of the hip ipsilateral to the throwing shoulder.

Official Title
-----------------
Analysis of the Kinematics of the Shoulder Complex in Sports Overhead Gestures Such as Kayaking Polo Throwing (Overhead)

Conditions
-----------------
Kayak Polo, Overhead

Intervention / Treatment
-----------------
* Other: Arm throws with his dominant arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: free and informed consent signed Benefiting from a social protection insurance Over 18 years-old Male Having a level of expertise greater than or equal to the national level 4 Exclusion Criteria: Present during the study or have presented within the year any musculoskeletal pathology in the right and left shoulder. Have a body mass index greater than 30kg / m2 (to ensure sufficient accuracy to measure the movements of the scapula)

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

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

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

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 |
| --- | --- |
| Experimental: kayak polo players<br>Having a level of expertise greater than or equal to the national level 4 | Other: Arm throws with his dominant arm<br>* Seated patient with different sensors on his naked torso. Patients will throw a ball with their dominant arm. The trajectories will be recorded by Vicon MX-40<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glenohumeral and scapulothoracic angles | Glenohumeral and scapulothoracic angles during throwing gestures with fixed pelvis associated with an initially antepulsed hip and free pelvis with the hip initially posteriorized | 1 hour |
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review. If subject meets the eligibility criteria during the study period, data from the medical chart were extracted retrospectively from the date of vaccination and the infant (s) health status were followed until 8 weeks after the delivery.The unexposed cohort included pregnant women who did not receive any influenza vaccine during pregnancy. Within each participated study center, women who were gestation after April 2009 were randomly selected according to maternal age matching. The pregnancy outcome, including the status of delivery, abortion and gestational age, were extracted retrospectively by chart review.

Conditions
-----------------
Adverse Drug Reactions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exposed Cohort: The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02.l The woman was pregnant at the time of vaccination. Unexposed Cohort: The woman was gestation after April 2009. Exclusion Criteria: Exposed Cohort: Received any other H1N1 vaccination, e.g., Focetria. Unexposed Cohort: The woman received any influenza vaccine during gestation period.
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 |
| --- | --- |
| Exposed cohort<br>The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02. The woman was pregnant at the time of vaccination. | |
| Unexposed cohort<br>The woman was gestation after April 2009. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this study was to evaluate the incidence, nature and seriousness of adverse drug reactions (ADRs) occurring after vaccination. | If subject meets the eligibility criteria during the study period, data from the medical chart were extracted retrospectively from the date of vaccination and the infant (s) health status were followed until 8 weeks after the delivery. | 8 weeks after the delivery or abortion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incidence, nature, seriousness, ADRs, vaccination
Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients

Study Overview
=================
Brief Summary
-----------------
This research study is designed to work in cooperation with another study being conducted by the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of a drug called raloxifene on premenopausal women believed to have a high risk of developing breast cancer (98-C-0123). In this study, researchers are interested in learning about the effects of raloxifene on the uterus and ovaries of the women participating in the NCI study. To do this researchers plan to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if found to be necessary. The purpose of this study is to determine the reproductive effects of raloxifene on women who have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus (endometrium).

Detailed Description
-----------------
Raloxifene is a selective estrogen receptor-modulating agent that has been recently approved by the FDA for the treatment of osteoporosis in postmenopausal patients. A phase II trial evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for developing breast cancer has been recently approved by the IRB (98-C-0123). In this protocol, for assessment of the effects of raloxifene on the endometrium and ovaries, patients are scheduled to be studied with transvaginal sonography and hysterosonography, once during their menstrual cycle at periodic intervals. They are also scheduled to have endometrial biopsies as indicated. It is known that all SERMs (clomiphene, tamoxifen and in one small study raloxifene) raise the area under the curve of estradiol levels throughout the cycle in premenopausal women. Our study is designed to study the reproductive effects of raloxifene in these young women with competent ovaries using sonography of the ovaries and endometrium, and correlating it with steroid hormone levels which would be obtained under protocol 98-C-0123.

Official Title
-----------------
Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer

Conditions
-----------------
Breast Cancer, Breast Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Women must be enrolled in NCI Study 98-C-0123.
Sexes Eligible for Study
-----------------
Female

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
-----------------
Sonohysterography, Color Doppler Sonography, Endometrium, Gynecologic, Menstrual Cycle, Premenopause