linjc16/ctgov huggingface dataset:
Ultrasound for Guidewire Detection

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to check if there is a possibility for a nephrologist to visualise the guidewire by means of available ultrasound scanners. To evaluate that, the procedure of catheter insertion will be expanded by ultrasound examination of right atrium and inferior vena cava border using substernal view. Such imaging seems to ameliorate the safety of catheter implementation and could be a good alternative for fluoroscopy, eliminating its adverse effects.

Official Title
-----------------
Dialysis Catheter Insertion With Substernal Ultrasound Guidance

Conditions
-----------------
Kidney Failure, Acute, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound guidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal failure requiring hemodialysis through a dialysis catheter Capable of giving informed consent Placement of internal jugular vein catheter Exclusion Criteria: Inability to provide informed consent Poor visualisation of inferior vena cava

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasound guidance|Jugular vein is punctured with ultrasound guidance and guidewire is advanced. Right atrium and inferior vena cava junction is visualized by ultrasound using substernal view. Presence of guidewire in inferior vena cava or right atrium is confirmed. The procedure of catheter insertion is continued.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful guidewire insertion | Visualization of guidewire in right atrium-inferior vena cava junction | 5 minutes | 
| Successful catheter placement | Catheter tip in lower part of superior vena cava or right atrium on chest x-ray. Good catheter function. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Presence of pneumothorax, hematoma, catheter dysfunction | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, vascular access, dialysis catheter
Review of Multimodality Management of Anaplastic Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
To describe the outcome of patients with anaplastic thyroid cancer treated with hyperfractionated radiotherapy and concomitant chemotherapy

Official Title
-----------------
A Retrospective Review of Multimodality Management of Anaplastic Thyroid Cancer

Conditions
-----------------
Anaplastic Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anaplastic thyroid cancer treated with multimodality treatment Exclusion Criteria: differentiated thyroid cancer
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
-----------------
anaplastic thyroid cancer, chemotherapy, radiotherapy
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

Detailed Description
-----------------
Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

Official Title
-----------------
A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy

Conditions
-----------------
Hand and Foot Syndrome

Intervention / Treatment
-----------------
* Drug: Vitamin B 6
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient starting capecitabine-containing chemotherapy Has never had capecitabine before Performance status 0-2 using the ECOG classification Life expectancy more than 6 months Agreed to stop any vitamin supplements, apart from vitamin D. Liver function studies including AST/ALT within 3x upper limit of normal Signed informed consent must be obtained from participating individuals
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin B6<br>patient receiving xeloda and vitamin B6 | Drug: Vitamin B 6<br>* vitamin b6 100 mg po daily<br>* Other names: pyridoxine;|
| Placebo Comparator: 2 placebo<br>patient receiving xeloda and placebo | Drug: placebo<br>* placebo is given in the placebo arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hand-Foot Syndrome (HFS) | Incidence of HFS based on CTCTAE adverse event table | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of Hand-Foot Syndrome (HFS) | Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3 | 1 year |
Artificial Oocyte Activation Comparing Tow Different Agents

Study Overview
=================
Brief Summary
-----------------
Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.

Detailed Description
-----------------
The IVF outcome had been varied widely with a good portion of total fertilization failure even after the most advanced procedure for this group of patient Intracytoplasmic Sperm Injection, many factors that had been tested for assisting the failed group of patient to be fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to compare the clinically proven factors for the efficacy and safety in a well randomized clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.

Conditions
-----------------
Oocyte Fertilization

Intervention / Treatment
-----------------
* Other: Artificial Oocyte activation
* Drug: Ca Ionophore
* Drug: Strontium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous fertilization failure poor quality Oocytes poor sperms Exclusion Criteria: normal patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ca Ionophore group<br>Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection | Other: Artificial Oocyte activation<br> <br> Drug: Ca Ionophore<br> <br> |
| Experimental: Strontium Chloride group<br>Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection | Other: Artificial Oocyte activation<br> <br> Drug: Strontium Chloride<br> <br> |
| No Intervention: Only Intracytoplasmic Sperm Injection<br>after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate ( % ) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst rate ( % ) |  | 9 months |
Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: interferon-alfa-2b and ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses Exclusion Criteria: Hemoglobin levels<8.5g/dL, Platelet counts<50,000/mm3, Total polymorphonuclear counts<1000/mm3 Pregnancy, Renal dysfunction,

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interferon-alfa-2b and ribavirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of sustained viral response |  | 6 months |
A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.

Official Title
-----------------
A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea

Conditions
-----------------
Somatostatin Receptor-positive GEP-NET

Intervention / Treatment
-----------------
* Other: Lutathera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who start Lutathera treatment per clinical judgment, according to the locally approved labeling. - somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. Patients who are willing to provide written informed consent. Exclusion Criteria: 1. Patients with contraindication according to prescribing information for Lutathera in Korea.

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 |
| --- | --- |
| Lutathera<br>Patients administered Lutathera by prescription | Other: Lutathera<br>* Prospective observational study. There is no treatment allocation. Patients administered Lutathera by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Incidence of Adverse Events (AEs), Serious AE and unexpected AEs. | Up to 36 weeks | 
| Incidence of Adverse Drug Reactions | Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs. | Up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in terms of Overall Response Rate (ORR) | ORR is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1. Partial Response (PR): At least a 30% decrease from baseline, confirmed at 4 weeks. Complete Response (CR): Disappearance of all known disease, confirmed at 4 weeks, lymph nodes must be less than 10 mm short axis | Up to 32 weeks (4 cycles of 8 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
somatostatin receptor-positive GEP-NET, Lutathera, Observational, prospective
Mechanisms of Fronto-Subcortical Dysfunction: Comparing PD and OCD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize and compare irregularities in dopaminergic function in fronto-subcortical circuits, between Parkinson's Disease patients (ON and OFF medication) and patients with obsessive-compulsive disorder, by examining performance on cognitive tasks involving cognitive flexibility, decision-making, and attentional bias.

Official Title
-----------------
Characterizing Mechanisms of Fronto-Subcortical Dysfunction: A Comparison Between Parkinson's Disease and Obsessive-Compulsive Disorder

Conditions
-----------------
Parkinson's Disease, Obsessive-Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic PD or OCD for control group - age-matched to study groups Exclusion Criteria: psychotic symptoms (past or present) head injury with loss of consciousness other neurological conditions (excepting PD in PD group) for OCD group - use of dopaminergic medications

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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 |
| --- | --- |
| Parkinson's Disease<br>Patients with idiopathic Parkinson's disease | |
| Obsessive-compulsive disorder<br>Individuals with a diagnosis of obsessive-compulsive disorder | |
| OCD controls<br>Healthy controls, matched in age and number to obsessive-compulsive group | |
| PD controls<br>Healthy controls, matched in age and number to Parkinson's disease group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Vitamin D Supplementation on Antimycobacterial Immunity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.

Official Title
-----------------
Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Drug: Ergocalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Tuberculosis (TB) contact or TB patient Exclusion Criteria: Pregnancy Breastfeeding Hyperparathyroidism Sarcoidosis Renal failure HIV infection

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ergocalciferol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacillus Calmette-Guerin (BCG) lux whole blood assay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigen-stimulated whole blood interferon gamma production |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Latent tuberculosis infection, Active tuberculosis infection
Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic Approach

Study Overview
=================
Brief Summary
-----------------
Multicentric prospective study with collection of biological samples as part of type II research

Official Title
-----------------
Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Stool
* Other: Blood sample
* Other: Saliva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with cancer who will start treatment anticancer (see cohorts). Patient information and signature of the consent form before any specific procedure for the study. The patient must be able and must be inclined to cooperate in the study procedures. Patient affiliated to a social security scheme or beneficiary of a similar scheme. Exclusion Criteria: Pregnant or lactating woman Patient under guardianship or curatorship or deprived of liberty by a decision judicial or administrative or patient unable to give his consent.
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 who will start cancer treatment<br>Collection of biological samples (stool, blood, saliva) and data from patients included in the study will be performed: By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). Collection of biological resources (all samples will be collected in fresh): Stool: collected at diagnosis, before initiating anticancer treatment, during treatment Blood: 40 mL collection before, 3 and 6 months of treatment cancer Saliva: 5 mL collection before initiation of treatment cancer Collection of clinical data corresponding to each patient included in the study by a clinical research assistant | Other: Stool<br>* collection at diagnosis, before initiating anticancer treatment, during treatment<br>Other: Blood sample<br>* 40 mL collection before, 3 and 6 months of treatment cancer<br>Other: Saliva<br>* 5 mL collection before initiation of treatment cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define metagenomic signatures associated with cancer | overall survival | Up to 2 years | 
| To Define metagenomic signatures associated with the effectiveness of anticancer therapies | objective response rate, progression free survival | Up to 2 years |
Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how the human body processes and eliminates the drug (BMS-690514.

Official Title
-----------------
Pharmacokinetics and Metabolism of [14C] BMS-690514 in Healthy Male Subjects

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: EVRI (BMS-690514)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects Body mass index (BMS) of 18 - 30 kg/m², inclusive Exclusion Criteria: Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: EVRI (BMS-690514)<br>* Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose pharmacokinetics of BMS-690514 and radioactivity in plasma and urine |  | measured for 10 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of biotransformation profiles and recorded adverse events |  | for 10 days post-dose |