linjc16/ctgov huggingface dataset:
Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

Detailed Description
-----------------
When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

Official Title
-----------------
Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma

Conditions
-----------------
Colorectal Adenocarcinoma, Liver Metastases

Intervention / Treatment
-----------------
* Drug: perioperative chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage IV colorectal cancer isolated to the liver one measurable lesion metastases are completely resectable or amenable to ablation Karnofsky >70 Adequate bone marrow function adequate hepatic function adequate renal function informed consent Exclusion Criteria: primary tumor not controlled by locoregional treatments bilateral portal vein and/or hepatic artery involvement previous chemotherapy directed at treatment of metastatic colorectal cancer underlying acute or chronic liver disease Gilbert's disease patients receiving phenytoin or phenobarbital prophylaxis presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy pregnancy malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years use of another investigational medication concurrently or within 4 months of enrollment

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perioperative chemotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resectable liver metastases, colorectal adenocarcinoma, survival, neoadjuvant chemotherapy
Time-to-Detection in Culture of Mycobacterium Tuberculosis

Study Overview
=================
Brief Summary
-----------------
determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission

Official Title
-----------------
Time-to-Detection in Culture of Mycobacterium Tuberculosis : Performance for Assessing Index Cases Infectivity

Conditions
-----------------
Pulmonary Tuberculoses

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have at least 1 contact case explored for tuberculosis latent tuberculosis infection Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 94 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 |
| --- | --- |
| Index cases<br> | Other: No intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tuberculosis transmission | duration of Tuberculosis transmission between an infected person and a contact case | 2 months | 
| contact case tracking | screening time for contact cases | 2 months |
uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

Study Overview
=================
Brief Summary
-----------------
This is an observational, non-interventional study to assess the equivalence of wearable monitors with formal CPET testing for the prediction of physiological reserve before major surgery.

Detailed Description
-----------------
This project will exploit the rapid development of wearable technology to allow perioperative risk prediction to become logistically easier, cost effective and used more broadly. It will use low cost wearable technology to complement or act as a surrogate to complex CPET testing performed for perioperative risk stratification. The data gained from a Garmin Vivosmart HR+ wearable device, will be used in the community by patients awaiting surgery, and will be correlated with key CPET indices including anaerobic threshold and peak VO2. Ultimately, this study aims to assess whether wearable technology can provide the data needed for the formation of prediction models to risk assess perioperative outcomes in patients undergoing high-risk elective surgery. In addition, an International Physical Activity Questionnaire (IPAQ) will be completed to compare the activity captured with self-reported activity. This will be combined with frailty scores and handgrip strength as is routinely collected during CPET. Finally, a saliva based genetic analysis will be conducted on genetic variations known to be of significance in critical illness and response to physical stress. This will be delivered by a laboratory (Fitness Genes) that has developed a bespoke panel of genetic markers ideally suited to this patient cohort.

Official Title
-----------------
uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

Conditions
-----------------
Perioperative Care

Intervention / Treatment
-----------------
* Device: Garmin wearable device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older with capacity to consent Clinical indications for planned CPET testing before planned major elective surgery Exclusion Criteria: Atrial fibrillation Nickel allergy Unable to wear a watch Unable to conduct CPET Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Garmin wearable device|Physiological data capture only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful recoding of accelerometer data | Successful recoding of accelerometer data | 7 days |
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure. III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, placebo controlled, dose escalation study. Initially, patients are randomized to receive either 1 of 3 different dosages of liothyronine or placebo after undergoing the Fontan procedure. If no unacceptable toxicity is observed in this group, a third dose level of liothyronine is added to the randomization. A total of 7 patients are enrolled at each dose level. All randomized study drugs are administered by continuous infusion over 1 hour after surgery. Cardiac function is assessed 5 days after surgery.

Conditions
-----------------
Tricuspid Atresia, Heart Defects, Congenital

Intervention / Treatment
-----------------
* Drug: liothyronine I 131


Participation Criteria
=================
Eligibility Criteria
-----------------
Single ventricle congenital cardiac malformation Must undergo modified Fontan procedure No concurrent medications known to interfere with thyroid metabolism including propranolol and amiodarone No hepatic dysfunction No renal dysfunction No pre-existing thyroid dysfunction

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liothyronine I 131|nan|

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
-----------------
cardiovascular and respiratory diseases, heart defects, rare disease
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

Study Overview
=================
Brief Summary
-----------------
Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.

Official Title
-----------------
A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, in Pre-haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: Hepatitis B adjuvanted vaccine
* Biological: Engerix-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects were to have completed primary vaccination course. A male or female > = 15 years of age at the time of the first vaccination. Written informed consent obtained from the subject/ from the parents or guardians of the subject. If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination. Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. Pregnant or lactating female.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis B adjuvanted vaccine|nan|
|Biological: Engerix-B|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs seroprotection |  |  | 
| Response to booster |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited, unsolicited symptoms and serious adverse events |  |  |
IL-26 and Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could be a marker of the disease activity and then a potential therapeutic target. In the present study, serum IL 26 level in lupus patients and control will be measured.

Official Title
-----------------
Intérêt de l'IL-26 Comme Nouveau Marqueur Biologique du Lupus érythémateux systémique

Conditions
-----------------
Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnostic of Lupus according to ACR criteria ( four criteria are necessary) age > 18 years old Exclusion Criteria: treatment by cyclophosphamide, rituximab, belimumab in the year before inclusion study

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with lupus<br>Patients with lupus (four levels of activity disease) | |
| healthy volunteers<br>Subjects controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess serum IL-26 as a biological marker of SLE compared with sera from control subjects |  | 2 years |
Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

Detailed Description
-----------------
Blood samples will be collected from HIV infected adolescents and adult men and women presenting to a physician's office or outpatient clinic. Capillary whole blood samples will be obtained by fingerstick in duplicate from all Subjects in the study for immediate measurement of CD4+ T-cell count on the Pima CD4 Test by a trained healthcare professional. Venous whole blood samples from all Subjects in the study will also be collected and transported to the clinical laboratory of each study site for concurrent testing on the reference method by a trained laboratory professional. Venous samples from all Subjects in the study will also be measured on the Pima CD4 Test at the study site. Hematocrit will also be measured for all Subjects.

Official Title
-----------------
Clinical Evaluation of the Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Conditions
-----------------
HIV Infection, AIDS, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 years of age or older Confirmed HIV infection, HIV-1 or HIV-2 according to medical history (this inclusion will be waived for healthy non-HIV infected individuals who may need to be enrolled in order to fill the high end of the CD4+ T-cell measurement range of the Pima CD4 Test. Subject agrees to complete all aspects of the study Exclusion Criteria: Subject has already participated in this study at a previous date Subject is enrolled in a study to evaluate a new drug Patient unable or unwilling to provide informed consent Vulnerable populations as deemed inappropriate for study by site principal investigator.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Adults<br>Adult men and women over age of 18 | |
| Pediatrics<br>Pediatric boys and girls ages 12-18 | |

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
-----------------
HIV, AIDS, CD4
Serum Sclerostin Level & Treatment of Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D. Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.

Detailed Description
-----------------
This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board. This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment. Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C. Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.

Official Title
-----------------
Serum Sclerostin Level in Patients With Vitamin D Deficiency

Conditions
-----------------
Endocrine System Diseases, Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal Serum 25(OH)D < 10 ng/mL Exclusion Criteria: Anemia Tumor-induced osteomalacia (hypophosphatemia) Hypothyroidism Hepatic / renal disease Primary hyperparathyroidism Fibromyalgia Polymyalgia rheumatica Serum 25(OH)D > 10 ng/mL Vitamin D and calcium treatment commenced prior to study participation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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 |
| --- | --- | --- |
| Serum sclerostin level | Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sclerostin, osteomalacia, vitamin D deficiency
An Observational Study of Post-cesarean Delivery Respiratory Patterns Using a Non-invasive Minute Ventilation Monitor (Exspiron ™ System)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the breathing patterns of women who undergo cesarean delivery with spinal or epidural morphine for post-operative pain control in the first day after surgery. Some women who undergo cesarean delivery may be at risk for respiratory complications related to opiate administration for post-operative pain. The primary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring, and to see if there are predictive risk factors that may predispose women to post-operative hypoventilation.

Official Title
-----------------
An Observational Study of Post-cesarean Delivery Respiratory Patterns Using a Non-invasive Minute Ventilation Monitor (Exspiron ™ System)

Conditions
-----------------
Pregnancy, Analgesia, Respiratory Depression, Obstructive Sleep Apnea, Postpartum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older planned cesarean delivery with neuraxial morphine for post-operative analgesia Exclusion Criteria: Non-English speaking subjects patients who undergo urgent or emergent cesarean deliveries patients who receive general anesthesia or do not receive neuraxial morphine

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Women who undergo cesarean delivery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in minute ventilation |  | baseline and 24 hours post cesarian delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berlin Questionnaire |  | Baseline | 
| STOP-BANG Questionnaire |  | Baseline | 
| Epworth Sleepiness Scale |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory depression, postpartum, neuraxial morphine, cesarean delivery