linjc16/ctgov huggingface dataset:
Serum Cholinesterase Level in Aluminum Phosphide Poisoning, the Possible Proposing Role of Atropin & Pralidoxime

Study Overview
=================
Brief Summary
-----------------
Metal phosphides are widely used as a rodenticide and insecticide and poisoning with these substances has a very high mortality. The aim of this study was to evaluate the butyrylcholinesterase (BuCh) level in poisoning with metal phosphides.

Detailed Description
-----------------
Today, the use of pesticides in the world is considered as a recognized health It is estimated that around 30% of global suicides are due to pesticide self-poisoning . Metal phosphides pesticides are highly toxic, low cost, and are easily accessible as rodenticide agents and used for self-poisoning . aluminum phosphide (ALP) are among the most important metal phosphides. Poisoning with these agents is frequently seen in India, Srilanka and Iran. In a recent study, the incidence of fatal aluminum phosphide poisoning cases referred for phosphine analysis was 5.22 and 37.02 per million of population of Tehran, Iran in 2006 and 2013, respectively (9).The mechanism of toxicity is not clearly defined. ALP toxicity is related to the production of phosphine gas. Phosphine inhibits cytochrome c oxidase and causes mitochondrial destruction and inhibits oxidative respiration which leads to anaerobic metabolism, severe metabolic acidosis, multi-organ dysfunction and death. Phosphine can lead to severe cardiac suppression and cardiogenic shock. One of the proposed mechanisms of toxicity is the reduction of the true cholinesterase and serum cholinesterase (butyrylcholinesterase) enzyme, but usually do not show obvious clinical manifestations .

Official Title
-----------------
Assessment of Serum Cholinesrtrase Level in Aluminum Phosphide Poisoning Cases, the Possible Proposing Role of Atropine and Pralidoxime in Saving the Cases: Clinical and

Conditions
-----------------
Toxicity;Chemical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases of aluminum phosphide poisoning - Exclusion Criteria: concomitant ingestion -
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 |
| --- | --- | --- |
| persistent cholineastrase inhibition is one of the pathological pathway of the ALP poisoning | definite assessment of the pathogenesis of ALP helps in applying adaquqte treatment regmin | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum cholinestrase, atropin, aluminum phosphide
An Observational Study of Kadcyla Safety in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.

Official Title
-----------------
Post-Marketing Surveillance of Kadcyla in Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea. Exclusion Criteria: Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling. A pediatric patient (age ≤18 years) Hypersensitivity for Kadcyla or any ingredient in this product

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 |
| --- | --- |
| Cohort<br>Method of continuous surveillance per standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs |  | Up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) |  | Up to 8 years |
Oral Vitamin D Supplementation in Elderly Women

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments

Official Title
-----------------
Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial

Conditions
-----------------
Optimal Vitamin D Administration

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D twice daily
* Dietary Supplement: Vitamin D3 oil three times in a year


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females 70-80 years Living in the community Exclusion Criteria: Renal disease Diseases that contraindicate vitamin D supplementation Medications affecting bone Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Dietary Supplement: vitamin D twice daily<br>* Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year<br>|
| Experimental: 2<br> | Dietary Supplement: Vitamin D3 oil three times in a year<br>* Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood 25 OH D vitamin concentrations |  | 8 times during the year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum calcium, 24-hour calcium excretion in urine, creatinine clearance |  | 8 times during the year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, seasonal variation, PTH, bone markers
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

Study Overview
=================
Brief Summary
-----------------
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

Official Title
-----------------
A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: PRT-201
* Drug: PRT-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of at least 18 years. Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence. Planned creation of a new AVF. Exclusion Criteria: Patients for whom this is the only potential site for an AVF. By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch. Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent. Pregnancy, lactation or plans to become pregnant during the course of the study.

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 |
| --- | --- |
| Active Comparator: PRT-201<br> | Drug: PRT-201<br>* Applied topically to AVF during surgery<br>Drug: PRT-201<br>* Dose escalation study. Drug/placebo administered at the time of fistula creation<br>|
| Placebo Comparator: 2<br> | Drug: PRT-201<br>* Dose escalation study. Drug/placebo administered at the time of fistula creation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. |  | 2 & 6 weeks after AVF creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. |  | 3, 6, 9, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arteriovenous fistula, hemodialysis, vascular access, PRT 201, dose escalation, dialysis, fistula, access, vonapanitase, kidney, renal, AVF
Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the blood supply to patients that are suffering from fracture in the tibia by UltraSound Doppler.

Official Title
-----------------
Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity

Conditions
-----------------
Tibial Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 16 years old Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Study of ATH434 in Participants With Multiple System Atrophy

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of ATH434 in participants with Multiple System Atrophy

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy

Conditions
-----------------
Multiple System Atrophy

Intervention / Treatment
-----------------
* Drug: ATH434 dose level 1
* Drug: ATH434 dose level 2
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has clinical features of parkinsonism. Participant has evidence of orthostatic hypotension and/or bladder dysfunction. Participant has ataxia and/or pyramidal signs on neurological examination. Participant is ambulatory. Participant has biomarker evidence of MSA in biologic fluid and on MRI. Exclusion Criteria: Participant has motor symptoms for > 4 years. Participant has advanced disease, as indicated by frequent falls or choking. Participant has structural brain abnormality on MRI. Participant has any significant neurological disorder other than MSA. Participant has an unstable medical or psychiatric illness. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATH434 Arm 1<br> | Drug: ATH434 dose level 1<br>* ATH434 taken BID<br>* Other names: PBT434;|
| Experimental: ATH434 Arm 2<br> | Drug: ATH434 dose level 2<br>* ATH434 taken BID<br>* Other names: PBT434;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo taken BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iron content as measured by brain MRI |  | Change from Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aggregating alpha-Synuclein Levels |  | Change from Baseline to Week 52 | 
| Change in Neurofilament Light Chain Levels |  | Change from Baseline to Week 52 | 
| Change in Unified MSA Rating Scale (UMSARS) Score |  | Change from Baseline to Week 52 | 
| Change in SF-36 Score |  | Change from Baseline to Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Synucleinopathies, Atypical parkinsonism, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Multiple System Atrophy
French Post-Marketing Surveillance Survey

Study Overview
=================
Brief Summary
-----------------
To assess the safety and effecacy of the Cypher stent ™ & Cypher Select ™ in the normal use of medical practices, within the labeled indications.

Detailed Description
-----------------
Multi-center, retrospective and prospective French register. This register does not impose any constraint on the evaluated population, the procedure, or the required examinations. The local practice routines should be applied.

Official Title
-----------------
French Post-Marketing Surveillance Survey

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Cypher stent ™ or Cypher Select ™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic ischemic heart disease due to de novo lesions (lesions <30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries. Exclusion Criteria: Patients suffering from coronary heart disease. Patients for whom treatment antiplatelet and / or anticoagulant is against the state; Patients with injuries incompatible with the full inflation of a balloon angioplasty; Transplant patients ; Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cypher drug-eluting stent | Device: Cypher stent ™ or Cypher Select ™<br>* Cypher drug-eluting stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There is no pre-specified endpoint. |  | 12 Months |
T-DOC® NXT Clinical Investigation

Study Overview
=================
Brief Summary
-----------------
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Official Title
-----------------
Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Conditions
-----------------
Incontinence, Urge

Intervention / Treatment
-----------------
* Device: TDOC NXT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female (Adult age 21+) Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician. Exclusion Criteria: Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria) Patients who are pregnant Patients with recent (less than 2 weeks) pelvic floor surgery Patients who require the use of a suprapubic catheter Patients with significant cognitive deficiency that prevent the patient from giving informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urodynamics Arm<br> | Device: TDOC NXT<br>* Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. | A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 20 patient questionnaires is required to answer YES the device is safe for a positive outcome and a maximum of 40. | 2 months | 
| The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults. | A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 20 patient questionnaires is required to answer YES the device is effective for a positive outcome and a maximum of 40. | 2 months |
Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.

Official Title
-----------------
An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled HKI-272 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects, aged 18 to 50 years. Exclusion Criteria: Female subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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>240 mg | Drug: neratinib<br>* HKI-272, Single-dose capsule and solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance, metabolic distribution, PK |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19

Study Overview
=================
Brief Summary
-----------------
Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays. The performance of the immunoassays is then assessed by comparing the 2 groups of samples.

Detailed Description
-----------------
Achieved serum samples of the different testing groups are retrieved and tested with the immunoassays according to manufacturer's instruction. The test results are then compared and analyzed with statistical tests to assess the immunoassays'performance

Official Title
-----------------
Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 antibody immunoassays


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for COVID-19 infected sera: any patient with PCR confirmed COVID-19 infection Inclusion criteria for COVID-19 negative sera: sera collected after a negative SARS-CoV-2 PCR Exclusion Criteria: -
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 |
| --- | --- |
| With COVID-19 infection<br>Subjects with a positive SARS-CoV-2 PCR | Diagnostic Test: SARS-CoV-2 antibody immunoassays<br>* Different commercial SARS-CoV-2 antibody immunoassays<br>|
| Without COVID-19 infection<br>Subjects with COVID-19 negative serum | Diagnostic Test: SARS-CoV-2 antibody immunoassays<br>* Different commercial SARS-CoV-2 antibody immunoassays<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of the different commercial SARS-CoV-2 antibody immunoassays | To investigate the accuracy (including sensitivity, specificity, positive and negative predictive value) of the commercial SARS-CoV-2 antibody immunoassays | 1 month |