linjc16/ctgov huggingface dataset:
Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK

Study Overview
=================
Brief Summary
-----------------
In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. The relationship between surgery type and nilotinib pharmakokinetic properties will be investigated in this study.

Official Title
-----------------
Pharmacokinetic Study of Nilotinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Showing Failure to Both Imatinib and Sunitinib

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic or unresectable gastrointestinal stromal tumor Patients receiving nilotinib after failure to imatinib and sunitinib

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Nilotinib<br>Patients who receive nilotinib with failure to both imatinib and sunitinib | Drug: Nilotinib<br>* Nilotinib 400mg bid daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nilotinib pharmacokinetics |  | Up to 3years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal stromal tumor, pharmacokinetics, nilotinib
CytOSorb TreatMent Of Critically Ill PatientS Registry

Study Overview
=================
Brief Summary
-----------------
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

Official Title
-----------------
CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting

Conditions
-----------------
Critical Illness, Septic Shock, Vasogenic Shock, Acute Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome, Liver Failure, Trauma, Rhabdomyolysis, Corona Virus Infection, Vasoplegic Syndrome, Cardiogenic Shock, Pancreatitis

Intervention / Treatment
-----------------
* Device: CytoSorb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CytoSorb® 300 mL device utilization Informed consent for prospective registry participation Exclusion Criteria: Use of the CytoSorb® 300 mL device for antithrombotic removal only Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CytoSorb|Sorbent hemoperfusion system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality |  | Through ICU discharge or date of death, whichever comes first [on average 7 days] | 
| In-hospital mortality |  | Through hospital discharge or date of death, whichever comes first [on average 14 days] |
Effect of Panretinal Photocoagulation on Optic Nerve Head Topography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the optic nerve head changes consequent to panretinal photocoagulation done for diabetic retinopathy.

Detailed Description
-----------------
Panretinal photocoagulation thermally ablates the retina to effect the regression of the neovascular process seen with diabetic retinopathy.2-6 Photocoagulative damage also damages the nerve fiber layer in the process. Since this should theoretically be associated with loss of nerve fibers it is expected to manifest as changes in optic nerve head cupping. There is no available literature to support this hypothesis. In fact the only available study done of the subject refuted the hypothesis.7 The study had a retrospective design and was done before any of the current technology to evaluate optic nerve head morphology was available. Patients with concurrent glaucoma and diabetes often undergo panretinal photocoagulation as a part of their diabetes treatment. Optic disc cupping is a standard outcome measure for glaucoma diagnosis and progression. If PRP were to cause increased cupping, this can be a significant confounder in determining glaucoma progression based on optic nerve cupping. The findings of the study will help us determine as to how much cupping can be attributed to the PRP, if any at all.

Official Title
-----------------
Effect of Panretinal Photocoagulation on Optic Nerve Head Topography and Nerve Fiber Layer Parameters

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy otherwise undergoing panretinal photocoagulation for treatment. Exclusion Criteria: Any patient with uncontrolled glaucoma (IOP above target on any occasion in the preceding 6 months) or other optic neuropathy that may confound the analysis of optic nerve head morphology. Patients with media opacities (significant cataract, corneal opacity, vitreous hemorrhage) precluding imaging of the optic nerve. No PRP done in the previous 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Changes in optic nerve head topography before and after panretinal photocoagulation | Compare changes in optic nerve head topography before and after panretinal photocoagulation (PRP) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
panretinal photocoagulation, diabetic retinopathy, optic nerve head changes
Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The measurement of the facial deformation according to the body posture will be conducted by 3D scanning for each posture after marking the landmarks on the face. A 3D scan of the face will be conducted for 1 minute in a static state for the sitting posture to be used as a reference, the supine posture to gaze at the ceiling while lying down correctly, and the lateral posture to the side with the upper body facing left. Healthy volunteer and ALS with bulbar palsy participants will be asked to keep their mouths closed gently while the 3D scan was being processed. A post-processing of the 3D face scan data will be conducted to analyze facial deformation by the body postures. A facial deformation will be analyzed by measuring the amount of change in position for each reference point after aligning and rotating the facial data on the same basis. The relative ratio of the amount of position change to the size of the face will be analyzed. The present study will analyze the effect of the body posture on the position changes of the landmarks.

Official Title
-----------------
Geometrical Facial Deformation According to Posture and Non-invasive Ventilation Mask Virtual Fit in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: 3-dimensional scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient a patient with Amyotrophic Lateral Sclerosis over 16 years a patient with respiratory difficulty a patient who requires or anticipates mechanical ventilation a patient who visit out- or inpatient clinic at rehabilitation hospital Healthy volunteer a volunteer without history of facial surgery or neuromuscular disease a volunteer without respiratory difficulty Exclusion Criteria: Patient a patient who cannot scan due to respiratory instability a patient who cannot bear posture for 3D scanning Healthy volunteer a volunteer with neuromuscular disease a volunteer with history of facial surgery or palsy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- |
| Healthy participants<br> | Diagnostic Test: 3-dimensional scan<br>* Facial 3-dimensional scan according to posture<br>|
| Amyotrophic Lateral Sclerosis with bulbar involvement patients<br> | Diagnostic Test: 3-dimensional scan<br>* Facial 3-dimensional scan according to posture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial deformation according to posture |  | 1 minute |
A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients. The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

Official Title
-----------------
A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: aflibercept (AVE0005)
* Drug: S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed cancer patients without standard of care ECOG performance status 0, 1, or 2 Adequate organ and bone marrow function Exclusion Criteria: Need for a major surgery or radiation therapy during the study History of hypersensitivity to S-1 Known dihydropyrimidine dehydrogenase deficiency Uncontrolled hypertension History of brain metastases Ascites requiring drainage Pregnancy or breastfeeding Patients who have previously been treated with AVE0005 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aflibercept (AVE0005)|intravenous infusion|
|Drug: S-1|oral administration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities |  | during the first cycle of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety: physical examination, laboratory safety tests, adverse events |  | treatment period | 
| pharmacokinetic values |  | treatment period | 
| objective response rate |  | treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antineoplastic agents, VEGF Trap
Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical

Study Overview
=================
Brief Summary
-----------------
The present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia Multiresistant Acinetobacter Baumannii . The main objective was to evaluate the efficacy of empirical treatment with colistin and combined targeted therapy. The different therapeutical interventions were administered following the routine clinical practice in the medical centre and the investigator did not assign specific interventions to the subjects of the study.

Conditions
-----------------
Acinetobacter Infections

Intervention / Treatment
-----------------
* Drug: Colistin
* Drug: Tigecycline
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critics included patients ≥ 16 years with monomicrobial bloodstream infections by multiresistant acinetobacter baumannii to carbapenems and sensitive to colistin accompanied by systemic inflammatory response syndrome, provided they have received targeted treatment with colistin.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Colistin|nan|
|Drug: Tigecycline|nan|
|Drug: Vancomycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause 30-day mortality (crude). |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause 14 day mortality (crude). |  | 14 days |
Cephalic Version by Acupuncture for Breech Presentation

Study Overview
=================
Brief Summary
-----------------
We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy. Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham. Protocol : Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy. Randomization. First group : acupuncture by stimulation of 67 Bladder point.Second group : stimulation of 45 Stomach point (sham). Ultrasonographic control of presentation at 35 weeks.

Official Title
-----------------
Study of Cephalic Version by Acupuncture for Breech Presentation.

Conditions
-----------------
Breech Presentation

Intervention / Treatment
-----------------
* Other: Acupuncture stimulation
* Other: Acupuncture stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Single pregnancy at 32-34 weeks of pregnancy. Fetus in breech presentation. Exclusion criteria: Twins. Story of preterm birth or any preterm birth risk Fetal malformations, abnormal karyotype

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stimulation of 67 Bladder point | Other: Acupuncture stimulation<br>* Acupuncture by stimulation of 67 Bladder point<br>|
| Sham Comparator: 2<br>Stimulation of 45 Stomach point (sham) | Other: Acupuncture stimulation<br>* Acupuncture stimulation of 45 Stomach point (sham)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cephalic or breech presentation (ultrasonographic control at 35 weeks of pregnancy) |  | 35 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general outcomes about external cephalic version, delivery and neonates |  | 35 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, moxybustion,, Cephalic version,, Breech presentation
Transperineal, MRI-guided, Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
Primary purpose: Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies. Secondary purposes: Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies. Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies Study of correlation between radiologic images and anatomopathologic result Description of needle track during the procedure Description of real time template saturation prostate biopsy Comparison of transperineal prostate biopsy relevance according to EBM Comparison of 1.5T MRI and 3T MRI for prostate cancer detection

Official Title
-----------------
Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Transperineal, MRI-guided, prostate biopsy
* Procedure: Transrectal prostate biopsy (TRB):


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men 40 to 80 years' old Affiliation to French social health system Signed consent Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA < 10) Exclusion criteria: Gleason > 6 prostate cancer Metastatic prostate cancer Contraindication to MRI Contraindication to general anesthesia Non-reversible hemostasis trouble Inability to give consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transperineal prostate biopsy (TPB)<br>Transperineal prostate biopsy MRI-guided | Procedure: Transrectal prostate biopsy (TRB):<br> <br> |
| Active Comparator: Transrectal prostate biopsy (TRB)<br>Transrectal prostate biopsy echo-guided | Procedure: Transperineal, MRI-guided, prostate biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of complications and rehospitalizations by using questionnaire |  | 12 months |
Optimizing the Tobacco Cessation Clinical Decision Support Tool.

Study Overview
=================
Brief Summary
-----------------
The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. The BPA was designed to help facilitate tobacco cessation interventions; it is part of the The Centers for Medicare & Medicaid Services (CMS) Quality Payment Program (QPP). The purpose of the project is to optimize this BPA utilization and improve patient outcomes by comparing multiple versions of the tobacco cessation BPA.

Official Title
-----------------
Using Rapid Cycle Randomized Controlled Trials to Study a Tobacco Cessation Best Practice Advisory.

Conditions
-----------------
Tobacco Use Cessation

Intervention / Treatment
-----------------
* Other: Patient Outcomes
* Other: Billing documentation
* Other: Regulatory


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation. Exclusion Criteria: non smokers

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Improved outcomes<br> | Other: Patient Outcomes<br>* The intervention includes different versions of the BPA design and message.<br>|
| Regulatory reminder<br> | Other: Regulatory<br>* The intervention includes different versions of the BPA design and message.<br>|
| Billing and documentation<br> | Other: Billing documentation<br>* The intervention includes different versions of the BPA design and message.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alert acceptance rate |  | 1 year |
Detection of Emotions in a Spoken Language Among Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
Tinnitus may affect the ability of patients to detect emotions in spoken language. This study will compare this ability between tinnitus patients and non-tinnitus patients.

Official Title
-----------------
Detection of Emotions in a Spoken Language Among Tinnitus Patients

Conditions
-----------------
Tinnitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tinnitus lasting 3 months and longer Hebrew speakers Exclusion Criteria: Tinnitus which began less than 3 months ago Learned Hebrew after the age of 5

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Tinnitus patients<br>Patients with tinnitus lasting over 3 months | |
| Non-tinnitus patients<br>Patients without tinnitus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion scores |  | 1 Year |