linjc16/ctgov huggingface dataset:
Observational Study of How Patients Take Eye Drops

Study Overview
=================
Brief Summary
-----------------
This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease.

Official Title
-----------------
The Relationship Between Glaucoma Medication Self-Efficacy, Outcome Expectations, Eye Drop Tech., Adherence and IOP.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: MEMS cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 year old currently taking 1 or more hypotensive topical eye drops takes drops in the right eye for more than 6 months expect to continue drop use for the next 3 months subjects instill their own eye drops subject is able to take HVF tests subject will expect to complete the 3 months enrollment period Exclusion Criteria: unable/unwilling to instill own medications eye drops are discontinued unable to take HVF test unable to complete follow-up investigators discontinue subject for safety reasons not using drops in left eye

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Subject's adherence to prescribed therapy will be monitored with an electronic compliance device. | Device: MEMS cap<br>* The Medication Event Monitoring System will be used to assess the level of subject adherence to recommended topical eye drop therapy.<br>* Other names: MEMS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence measured by MEMS caps |  | 3 months | 
| Eye drop technique measured by video evaluation |  | 1 time observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence measured by self-report |  | 3 months | 
| Severity of VF damage |  | 1 test date | 
| Intraocular pressure readings |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
compliance, eye drop administration, MEMS, adherence
Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of interferon alfacon-1 and ribavirin in hepatitis C patients.

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Interferon alfacon-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis C patients (high titer, genotype1) Exclusion Criteria: Patients with autoimmune disorder Patients with negative HBs antigen Patients with hepatic cirrhosis, hepatic failure and hepatic cancer Patients with depression or psychoneurotic disorder

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: Interferon alfacon-1|nan|

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
-----------------
Interferon alfacon-1, Virus disease, Hepatitis C
Safety Evaluation of Panitumumab and Sirolimus in Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with Stage IIIB/IV NSCLC

Official Title
-----------------
An Open-Label Clinical Trial Evaluating the Safety and Pharmacodynamics of Sirolimus and Panitumumab in Subjects With Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Oncology, Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: AMG 954/Panitumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically- or cytologically-confirmed diagnosis of stage IIIB or IV Non-Small Cell Lung Cancer Received only one prior treatment (not including radiation) Measurable disease per Response Evaluation Criteria in Solid Tumors Group (RECIST) guidelines Life expectancy of ≥ 4 months Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate hematologic, renal and hepatic function Serum-fasting cholesterol ≤ 300 mg/dL Serum-fasting triglycerides ≤ 2.5 X ULN Exclusion Criteria: Brain metastases requiring treatment History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline Systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment Prior epidermal growth factor receptor targeting agents with the exception of the small molecule EGFr tyrosine kinase inhibitors Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment Prior therapy with sirolimus, sirolimus analogs Immunosuppressive agents within 28 days before enrollment

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AMG 954/Panitumumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety within the first 3 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamic analysis of mTOR |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, Lung cancer, Panitumumab, Sirolimus, mTOR, Monoclonal antibody
Clevidipine in Neurocritical Patients

Study Overview
=================
Brief Summary
-----------------
Acute blood pressure elevation is a frequent problem in neurocritical patients. Its effective management is challenging and must avoid significant decreases of blood pressure leading to lower cerebral perfusion pressure worsening ischemia and elevations probably associated with bleeding, rebleeding or hematoma expansion associated with poor prognosis

Detailed Description
-----------------
Retrospective, observational and single-group study for observe effectiveness and safety of clevidipine for perioperative control of hypertension in patients admitted to Post-Operative Intensive Care Unit after thrombectomy for stroke, intracerebral hemorrhage requiring surgical treatment, embolization of aneurysm after subarachnoid hemorrhage, scheduled neurosurgical and neuroradiology procedures.

Official Title
-----------------
Clevidipine for Acute High Blood Pressure Control in Neurocritical Patients

Conditions
-----------------
High Blood Pressure

Intervention / Treatment
-----------------
* Drug: Clevidipine 0.5 MG/ML Intravenous Emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: -Adult patients older than 18 years old admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment. -Acute High Blood Pressure requiring urgent treatment (SBP ≥160 mmHg or ≥ 20% increase in preoperative values that persists for more than 15 minutes) -Clevidipine used as a first line or after failure of different antihypertensive drugs. Exclusion criteria: -Adults older than 90 years admitted to Post-Operative Intensive Care Unit with neurocritical condition requiring surgical or interventional treatment. -Patients admitted to Post-Operative Intensive Care Unit with neurocritical condition not requiring surgical or interventional treatment.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clevidipine 0.5 MG/ML Intravenous Emulsion|Effectiveness and safety of clevidipine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of clevidipine | Percentage of patients achieving target systolic blood pressure (SBP) | 1 to 6 hour of clevidipine infusion beginning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events related to clevidipine treatment | Tachycardia, atrial fibrillation, hypotension, fever, acute kidney failure, nausea, headache and facial redness. | 1 hour after beginning to 24 hours after clevidipine infusion stop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clevidipine, neurocritical
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

Detailed Description
-----------------
All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Official Title
-----------------
An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Saquinavir
* Drug: Lamivudine
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Plasma HIV-1 RNA titers > 10,000 copies/ml. CD4 cell count > 100 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions will be excluded: Any prior anti-retroviral drug therapy. Prior Medication: Excluded: Previous anti-retroviral drug therapy.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saquinavir|nan|
|Drug: Lamivudine|nan|
|Drug: Zidovudine|nan|

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
-----------------
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
A Phase I Study of a Novel Tracer for Positron Emission Tomography PET Myocardial Perfusion Imaging MPI

Study Overview
=================
Brief Summary
-----------------
[11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open-label, Safety and Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel 11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging

Official Title
-----------------
A Phase I Study of a Novel Tracer for Positron Emission Tomography PET Myocardial Perfusion Imaging MPI

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

Intervention / Treatment
-----------------
* Other: [11C]-DMDPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index (BMI) between 18.0 and 30.0 kg/m2 good health written informed consent Exclusion Criteria: smokers subject receiving medication a blood transfusion in the 4 weeks prior to screening positive alcohol blood test Subjects who suffer from claustrophobia Subjects who have had a clinically significant illness Subjects exposed to radiation within 12 months prior to screening

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A single Intravenous bolus injection<br>A single Intravenous bolus injection of 11C[DMDPA] | Other: [11C]-DMDPA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of absorbed radiation dose for all target organs in megabecquerel (the activity of a quantity of radioactive material in which one nucleus decays per second). |  | within 80 minutes |
Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction

Study Overview
=================
Brief Summary
-----------------
Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Detailed Description
-----------------
The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Official Title
-----------------
Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction Immobilised on a Biodegradable Carrier

Conditions
-----------------
Periodontitis, Chronic

Intervention / Treatment
-----------------
* Biological: mesenchymal stem cells
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - chronic medium-severe periodontitis Exclusion Criteria: pregnancy breast-feeding acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>standard treatment according to clinical protocols plus mesenchymal stem cells | Biological: mesenchymal stem cells<br>* autologous mesenchymal stem cells<br>Other: standard treatment<br>* standard treatment according to clinical protocols<br>|
| Active Comparator: standard treatment<br>standard treatment according to clinical protocols | Other: standard treatment<br>* standard treatment according to clinical protocols<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients cured | number of patients cured | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontitis, Mesenchymal stem cells
Immunological Profile for Patients Treated With CAR-T Cells

Study Overview
=================
Brief Summary
-----------------
In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection. A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed

Official Title
-----------------
Immunological Profile for Patients Treated With CAR-T Cells

Conditions
-----------------
Hematologic Neoplasms

Intervention / Treatment
-----------------
* Other: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Planned injection of CAR-T cells within the scope of marketing authorization Signed informed consent French social security affiliation Exclusion Criteria: Pregnant women, or women of childbearing potential (without medically acceptable contraception) or breastfeeding women. Patient in emergency situation, adult under legal protection (patient placed under tutorship, curatorship, or judicial protection) or unable to give his consent Impossibility to comply with trial medical follow-up for geographic, social or psychological reasons

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient treated with CAR-T cells<br> | Other: Blood sample collection<br>* Blood samples collection: at Day (D)-6 and D0 before CAR-T cells injection, post injection at Day (D)3, D5,D7, D9, D11, D14, D18, D 21, Month 2 and Month 12 post injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion | Serum concentration of cytokines in relation to adverse events | 1 year after T cells infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAR-T cells rate from infusion to one year after CAR-T cells infusion | Flow cytometry | From CAR-T cells infusion to one year | 
| Number of participants with a relapse | Relapse rate from CAR-T cells infusion to one year | From CAR-T cells infusion to one year | 
| Number of participants with a cytokine release syndrome | Cytokine release syndrome from CAR-T cells infusion to one year | From CAR-T cells infusion to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAR-T cells, Immunological Profile
Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.

Study Overview
=================
Brief Summary
-----------------
The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content. 100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice. Patients will be part of one of the following groups: Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.

Conditions
-----------------
Female Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women age from < 38 years normal body mass index (BMI ) from 18 to 26 parameters for ovarian reserve in the normal range (day 3 FSH levels < 10 mUI/ml ; day 3 E2 levels < 80 pg/ml; anti-mullerian hormone (AMH) levels > 1.5 ng/ml ; AFC (antral follicular count) > 6 ) Exclusion Criteria: polycystic ovary syndrome (PCOS) ovarian surgery pelvic endometriosis POR according to ESHRE criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Single embryo transfer on day 5, according to standard embryo morphological criteria | |
| Group 2<br>Single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Rate |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
r-hLH, Cytokines, Follicular Fluid