linjc16/ctgov huggingface dataset:
Contrast Induced Acute Kidney in Patients With Acute Stroke

Study Overview
=================
Brief Summary
-----------------
Computed tomographic angiography (CTA) is recommended for identifying eligible patient with acute ischemic stroke (AIS) to receieve endovascular treatment. We are going to conduct this prospective corhot study to observe if sequential use contrast in CTA examination and in endovascular treatment will cause acute kidney injury.

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Drug: Radiopaque Media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are suspected with AIS. Non-contrast head CT excludes intracranial hemorrhage. Exclusion Criteria: Lacking of pre-CTA Creatinine Lacking of post-angiography Creatinine with 24-48 hours
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTA<br>Patients with AIS only receieved cerebral CTA exam. | Drug: Radiopaque Media<br> <br> |
| CTA+DSA<br>Patients with AIS receieved cerebral CTA, followed by endovascular treatment with the guidence of digital substration angiography (DSA). | Drug: Radiopaque Media<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine | Contrast-induced acute kidney injury was defined as a relative increase of 25% or an absolute increase of 0.3 mg/dL (28.2mol/L) in the serum creatinine level at 48 hours following angiography | within 24h to 48h |
Named Patient Program for Olverembatinib (HQP1351)

Study Overview
=================
Brief Summary
-----------------
This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.

Detailed Description
-----------------
Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.

Official Title
-----------------
Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available

Intervention / Treatment
-----------------
* Drug: Olverembatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician. Exclusion Criteria: Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease Existing conditions of severe liver malfunction Existing conditions of severe myelosuppression Existing conditions of severe hemorrhage Pregnant or baby feeding

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olverembatinib|Oral Olverembatinib|

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
-----------------
Named Patient Program
Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Study Overview
=================
Brief Summary
-----------------
Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17

Official Title
-----------------
A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection

Conditions
-----------------
Bacterial Infection

Intervention / Treatment
-----------------
* Drug: solithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active. Exclusion Criteria: Serum creatinine >2 mg/dL Positive pregnancy test in females of childbearing potential History of intolerance or hypersensitivity to macrolide antibiotics

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: solithromycin<br>oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day | Drug: solithromycin<br> <br> * Other names: CEM-101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents |  | 5 to 7 days |
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age

Study Overview
=================
Brief Summary
-----------------
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.

Official Title
-----------------
A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age

Conditions
-----------------
Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae B

Intervention / Treatment
-----------------
* Biological: DTwP-HepB-Hib Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects ≥ 42 days to ≤ 64 days of age. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements Exclusion Criteria: Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine. History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component. Administration of parenteral immunoglobulin preparation and/or blood products since birth.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 64 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Biological: DTwP-HepB-Hib Vaccine<br>* Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate one month after the last dose of vaccine administration |  | One month after last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate and GMCs one month after the last vaccine administration |  | One month after last vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infants,, Immunogenicity,, Safety
Study on the Biological Prediction Models of Radiation Pneumonitis

Study Overview
=================
Brief Summary
-----------------
Radiation pneumonitis is the most common complication and the major dose-limiting toxicity associated with radiotherapy, which can cause poor quality of life or life-threatening symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently, establishing reliable predictors for the occurrence of RP is of great significance such that the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim of this study is to figure out the biological prediction models of radiation pneumonitis.

Detailed Description
-----------------
Establish a clinical data base for the lung cancer patients treated with radiotherapy in Tongji Hospital. Data including age, gender, smoking state, KPS, pulmonary function, disease history, histology, stage, surgery, chemotherapy, dosimetric parameters of radiotherapy were collected. Peripheral blood was collected from all patients enrolled. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest X-ray or CT and clinical information, including symptoms, is collected. RP is graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0. Select candidate genes and pathways which may be associated with radiation pneumonitis and identify their tagSNPs by Haploview. Use Kaplan-Meier and Cox model to analyze the association of all the factors collected with radiation pneumonitis. Establish a biological prediction models for radiation pneumonitis based on the statistics analysis

Official Title
-----------------
Study on the Biological Prediction Models of Radiation Pneumonitis

Conditions
-----------------
Radiation Pneumonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lung cancer by histology Radiation dose at least 45 Gy KPS>60 Life expectancy of at least 6 months Voluntarily signed the informed consent Exclusion Criteria: Previous thoracic irradiation Severe cardiopulmonary diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Group 1<br>Lung cancer patients treated with thoracic radiation therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation pneumonitis grade >=2 or 3 |  | 12 months after radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation pneumonitis, lung cancer, prediction models, genetic variants
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)

Study Overview
=================
Brief Summary
-----------------
The study will assess the number of patients who become asymptomatic from clinical signs of COVID19 and will assess the efficacy of Hydroxychloroquine (HCQ) and Azithromycine effects on paucisymptomatic patients with ou without co-morbidities

Official Title
-----------------
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia

Conditions
-----------------
Patients With COVID19

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed COVID19 (+) Qt<500ms no severity criteria pauci-symptomatique patients signed consent form Exclusion Criteria: no confirmed patient COVID19 severity criteria known allegies to macrolides and HCQ Treated with HCQ within 1 month prior to inclusion hepatitis insufficiency Renal insufficiency treatment no indicated with azithro and HCQ hypovolemia complete brach block retinopathia psoriasis pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open, interventional, multicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCQ Arm<br> | Drug: Hydroxychloroquine<br>* 400mg per day during 10 days<br>Drug: Azithromycin<br>* 500 mg per day during 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvment or healing of clinical signs | no respiratory infectious signs | at the end of the study treatment - 1 month after inclusion | 
| Evolution of clinical signs | Low respiratory signs with severity criteria | at the end of the study treatment - 1 month after inclusion |
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar

Study Overview
=================
Brief Summary
-----------------
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.

Detailed Description
-----------------
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.

Official Title
-----------------
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar

Conditions
-----------------
Long-term and Permanent Contraceptive Methods

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be a participant of the MSM service evaluation and continue using Zarin at 3 months agree at the time of Zarin insertion to be contacted regarding an opportunity to participate in more research related to the implant Exclusion Criteria: -
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 |
| --- | --- |
| 1<br>healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative probability of pregnancy through one year |  | 1 year | 
| Prevalence and incidence rate of adverse events |  | 1 year | 
| Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal |  | 1 year | 
| The cumulative probability of early discontinuation through one year |  | 1 year | 
| Reasons for discontinuation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRF: Case Report Form, DM: Data Management, FHI: FHI (formerly known as Family Health International), IRB: Institutional Review Board, IUD: Intra-uterine Device, LTPM: Long-term and Permanent Contraceptive Methods, MSI: Marie Stopes International, MSM: Marie Stopes Madagascar, PHSC: Protection of Human Subjects Committee, PI: Principal Investigator, SAE: Serious Adverse Event, Sino-Implant (II), SOP: Standard Operating Procedure, Zarin
6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.

Official Title
-----------------
A 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid Arthritis

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requirement of regular NSAID therapy With primary osteoarthritis of the target knee (by ACR Criteria) or with a diagnosis of rheumatoid arthritis (by ACR Criteria) Exclusion Criteria: Evidence of active ulceration of the UGI tract within 6 months prior to the screening visit or history of active bleeding of the UGI tract within the previous 5 years. As well as with pyloric or duodenal obstruction or with history of gastrointestinal parasites. History of cardiac and cerebral thrombotic/ischemic diseases and/or events Patients taking additional NSAIDs (including COX-2 inhibitors) during the course of the study. Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: Lumiracoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability profile of lumiracoxib in comparison to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that lumiracoxib 200mg o.d. is effective in treating OA and pain due to RA with respect to overall OA/ RA pain intensity on a 0-100 mm Visual Analog Scale (VAS) after 6 weeks of treatment in comparison to baseline |  |  | 
| Assess efficacy of lumiracoxib compared to baseline with respect to a) overall OA/ RA pain intensity b) patient's and physician's global assessment of disease activity c) patient functional status |  |  | 
| Use of rescue medication |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Rheumatoid Arthritis, Cox-2, lumiracoxib
Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.

Official Title
-----------------
Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases

Conditions
-----------------
Liver Metastases

Intervention / Treatment
-----------------
* Other: Magnetic Resonance Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Diagnosis of solid cancers with the presence of one or more liver metastases Minimum metastasis diameter ≥ 2 cm Planning to receive radiation therapy with immunotherapy Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester Exclusion Criteria: Contraindications for MRI including claustrophobia, pace maker, metal implants, aneurism clips Patients who are not able to consent

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Magnetic Resonance Elastography|rapidly developing technology for quantitatively assessing the mechanical properties of tissue, using externally applied mechanical waves|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify tissue mechanical properties of the liver and liver tumor using MRE in patients receiving radiation therapy + immunotherapy at baseline, mid-treatment and time of followup imaging determined by standard of care to assess response to therapy |  | 1 year |