linjc16/ctgov huggingface dataset:
A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, non-interventional cohort study . Its primary objectives are: assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice; learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Detailed Description
-----------------
The main purpose of this study is to understand patients with DILI clinical outcome and influencing factors in China's second and tertiary general hospitals (including Western medicine hospital, Chinese medicine hospital andIntegrated traditional Chinese and Western Medicine Hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, Pulmonary, etc.) in mainland. The main purpose assess the DILI patients' clinical outcomes and influencing factors in the real world; learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc. Secondary objectives assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.; evaluate the histological features of DILI patients; assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)

Official Title
-----------------
A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China

Conditions
-----------------
Drug-induced Liver Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury patient can provide informed consent form Exclusion Criteria: non-drug-induced liver injury
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 1<br>Compound glycyrrhizin tablets / injection | |
| cohort 2<br>Isoglycyrrhizinate magnesium injection / diammonium glycyrrhizinate enteric-coated capsules | |
| cohort 3<br>Bicyclol | |
| cohort 4<br>Silibinin capsules | |
| cohort 5<br>Ursodeoxycholic acid capsules | |
| cohort 6<br>N- acetylcysteine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover |  | 6 months |
PET Imaging of Cancer Patients Using 68Ga-DOTA-Siglec-9

Study Overview
=================
Brief Summary
-----------------
This is a scientific study to determine expression of vascular adhesion protein 1 (VAP-1) in cancer patients by 68Ga-DOTA-Siglec-9 positron emission tomography/computed tomography (PET/CT) before and after cancer treatment.

Detailed Description
-----------------
The purpose of this study is to evaluate expression of vascular adhesion protein 1 (VAP-1) in bone marrow and cancerous lesions before and after therapy using 68Ga-DOTA-Siglec-9 positron emission tomography/computed tomography (PET/CT). Patients with acute myeloid leukemia (AML) that undergo bone marrow transplantation and patients with melanoma and lung cancer that undergo chemotherapy will be studied. In addition, imaging results will be compared with clinical data and research data from blood samples. The study is of great clinical importance as other methods do not provide such comprehensive information on the presence of the VAP-1 molecule in the body, especially in the bone marrow and cancer tissue before and after cancer treatment. Research is also important for drug development targeting VAP-1.

Official Title
-----------------
PET Imaging of Cancer Patients Using 68Ga-DOTA-Siglec-9

Conditions
-----------------
Acute Myeloid Leukemia, Melanoma, Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute myeloid leukemia (AML) and fit for allogeneic hematopoietic stem cell transplantation (alloHSCT), as assessed in the standard operating procedures. Diagnosis of metastatic melanoma and fit for immune checkpoint inhibitors or BRAF- and MEK inhibitors. Diagnosis of metastatic non-small cell lung cancer (NSCLC) (stage IV) and fit for immune checkpoint inhibitors and/or chemotherapy. Able and willing to give written informed consent and to comply with the study protocol. Exclusion Criteria: Unsuitable for alloHSCT (AML), checkpoint inhibitors or BRAF- and MEK inhibitors (melanoma or checkpoint inhibitors and/or chemotherapy (NSCLC) according to the standard operating procedures. Unable or unwilling to comply with the study protocol for any reason. Evidence of significant uncontrolled concomitant diseases such as neurological, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the Investigator, would preclude patient participation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-DOTA-Siglec-9 uptake in bone marrow and cancerous lesions | Standardized uptake value of PET tracer 68Ga-DOTA-Siglec-9 in the bone marrow and cancerous lesions | within a 1 day |
Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

Study Overview
=================
Brief Summary
-----------------
This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.

Official Title
-----------------
A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects

Conditions
-----------------
Healthy Subjects

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy male and female subjects, ages 18-50.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>40-mg tablet | Drug: neratinib<br>* HKI-272<br>|
| Experimental: 2<br>240-mg tablet | Drug: neratinib<br>* HKI-272<br>|
| Experimental: 3<br>80-mg capsule | Drug: neratinib<br>* HKI-272<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272 |  | 6 weeks |
Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT

Study Overview
=================
Brief Summary
-----------------
To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT). Trial with medical device

Conditions
-----------------
Glaucoma Patients and Healthy Controls

Intervention / Treatment
-----------------
* Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: control group: age 18yo or older, healthy glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG) Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies. or severe optic media opacities.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproducibility of retinal nerve fiber layer thickness measurement |  |  |
Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction

Study Overview
=================
Brief Summary
-----------------
Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access

Official Title
-----------------
Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction

Conditions
-----------------
Dialysis Access Malfunction, Kidney Failure

Intervention / Treatment
-----------------
* Drug: Paclitaxel Drug Coated Balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included Exclusion Criteria: All patients below 21

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel Drug Coated Balloon|Failing AVF/AVGs treated with Paclitaxel Drug Coated balloons are captured in this database|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circuit Access Patency | Circuit Access Patency is lost when AVF/AVG is intervened on | 12 Months | 
| Primary Assisted Patency | Primary Assisted Patency is lost when circuit undergoes thrombectromy/thrombolysis | 12 months | 
| Secondary Patency | Secondary Patency is lost when entire dialysis access circuit is abandoned. | 12 months |
Bassini Inguinal Hernia Repair: Obsolete Or Still A Viable Surgical Option?

Study Overview
=================
Brief Summary
-----------------
Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.

Official Title
-----------------
Incidence of POUR in the Veteran Population After Elective Inguinal Hernia Repair: A Retrospective Study

Conditions
-----------------
Inguinal Hernia, Surgery--Complications, Surgical Complication

Intervention / Treatment
-----------------
* Procedure: Bassini hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inguinal hernia repair without mesh - Exclusion Criteria: Mesh repair -

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

| Intervention/Treatment |
| --- |
|Procedure: Bassini hernia repair|Non-mesh tissue inguinal hernia repairs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inguinal hernia recurrence | chart review | 5-13 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection | chart review | 5-13 years | 
| urinary retention | chart review | 5-13 years | 
| groin pain | chart review | 5-13 years | 
| durability of repair | chart review | 5-13 years postop | 
| testicular ischemia | chart review | 5-13 years |
Remote Ischemic Conditioning to Reduce Burn Wound Progression

Study Overview
=================
Brief Summary
-----------------
Burned skin areas, which were initially vital, can be irreversibly damaged by wound progression. The aim of the present study is to evaluate the feasibility of ischemic conditioning to reduce secondary wound progression.

Official Title
-----------------
Remote Ischemic Conditioning to Reduce Burn Wound Progression

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Procedure: Remote ischemic conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand the study information and the consent to sign Thermal injury (burn / scalding) with a clinical evaluated depth of at least 2a (superficial partial) At least one of the following sites must not have skin lesions : Upper arm right and left hospital admission within 6 hours after trauma has taken place Exclusion Criteria: Participation in another experimental study Pregnancy (women are subjected to a pregnancy test (urine) Contraindication for the use of the tourniquet, for example Lymph drainage disorders after axillary lymphadenectomy or Irradiation of the axilla Non-compliant patients who are, e.g. Intubated Pure 3rd degree burns (full thickness) or charring Thermal injuries older than 6 hours

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic conditioning<br>Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet. | Procedure: Remote ischemic conditioning<br> <br> |
| No Intervention: Control group<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of burn depth | Clinical assessment of burn depth | day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin's relative amount of hemoglobin | relative amount of hemoglobin (Arbitrary Units) | day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180 | 
| Change in skin's blood flow | blood flow (Arbitrary Units) | day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180 | 
| Change in skin's oxygen saturation | oxygen saturation (%) | day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180 | 
| Change in skin elasticity | objective measurement of the skin elasticity | day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360 | 
| Differences in scare development between the study groups | Assessment with the Vancouver scare scale | day 90, 180, 360 |
Diagnostic Accuracy of Direct MR Arthrography Of The Wrist At 1.5, 3.0 And 7.0T

Study Overview
=================
Brief Summary
-----------------
The purpose of our study is to evaluate the diagnostic accuracy of MR arthrography of the wrist at 1.5, 3.0, and 7.0T with wrist arthroscopy as reference standard.

Conditions
-----------------
Wrist Injuries

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age >18; clinical evidence for wrist joint abnormalities; request for MR arthrography prior to wrist arthroscopy; willingness to take part in our study with written informed consent; Exclusion criteria: age<18; history of prior wrist surgery; systemic diseases e.g. rheumatoid arthritis; infection; history of adverse contrast reactions; contraindication for MR imaging (e.g. pacemaker, metallic implants, etc.); history or possible signs of renal failure (see section nephrogenic systemic fibrosis)

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

| Intervention/Treatment |
| --- |
|Other: MRI|MR arthrography is used to evaluate wrist abnormalities|

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
-----------------
Wrist abnormalities
Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication

Study Overview
=================
Brief Summary
-----------------
Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. Previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. In addition to shock therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to first shock in primary prevention patients.

Official Title
-----------------
Programming Implantable Cardioverter Defibrillators (ICDs) in Patients With Primary Prevention Indication to Prolong Time to First Shock

Conditions
-----------------
Shock

Intervention / Treatment
-----------------
* Device: ICD/ CRT-D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Prevention indication for ICD/ CRT-D Exclusion Criteria: No prior documented history of spontaneous VT/VF

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 |
| --- | --- |
| Control<br>PROVE Trial settings | Device: ICD/ CRT-D<br>* Cardiac device<br>|
| Experimental<br>Pre-selected settings | Device: ICD/ CRT-D<br>* Cardiac device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study is the rate of first shock |  | Average follow-up period is 530 days | 
| The primary safety endpoint of this study is the rate of arrhythmic syncope |  | Average follow-up period is 530 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reducing shocks
Survey of Tourniquet Use in a Combat Support Hospital

Study Overview
=================
Brief Summary
-----------------
Data will be collected on the type of tourniquet and circumstances of its use. Patients with penetrating extremity injury will have clinical and pre-clinical hospital data collected.

Detailed Description
-----------------
This is a performance improvement project that is a prospective observational cohort design with subgroup analyses. This project meets the criteria of research with its intent to publish. No data is generated and only existing data are used. No interventions are made and the comparisons will be with within subgroups in the cohort. Aim 1. Describe the number of tourniquets which were appropriately used (wound required a tourniquet and tourniquet was placed properly) as assessed by treating physician Aim 2 &3. Describe if limbs wounds with tourniquets were bleeding upon admission, resuscitation, and following tourniquet removal Aim 4. Describe if mortality for the cohort of patients with tourniquets is different than the mortality predicted by various injury scoring systems Aim 5. Compare patient outcomes between those in which a tourniquet was indicated but not used and those for whom a tourniquet was indicated and used Aim 6. Determine if patients that received tourniquets for an extended time period exhibit any known tourniquet complications

Official Title
-----------------
Survey of Tourniquet Use in a Combat Support Hospital

Conditions
-----------------
Vascular Injury

Intervention / Treatment
-----------------
* Device: CAT (Combat Arms Tourniquet)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: penetrating extremity injury with tourniquet use Exclusion Criteria: non penetrating extremity injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| A<br>Individuals on whom tourniquet was used. | Device: CAT (Combat Arms Tourniquet)<br>* device<br>|

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
-----------------
tourniquet, extremity injury, hemostatic device