linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.

Official Title
-----------------
A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: LY3000328


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Single dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose. | Drug: Placebo<br>* Administered orally<br>|
| Experimental: LY3000328<br>Single escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose. | Drug: LY3000328<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with one or more drug related adverse events (AEs) or any serious AEs |  | Baseline to study completion (estimate 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328 |  | Pre-dose up to Day 6 post-dose | 
| Pharmacokinetics: Maximum concentration (Cmax) of LY3000328 |  | Pre-dose up to Day 6 post-dose | 
| Change in Cathepsin S (CatS) activity |  | Pre-dose, up to 48 hours post-dose |
A Study to Evaluate PT-523 in Patients With Refractory Leukemia

Study Overview
=================
Brief Summary
-----------------
This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with refractory leukemia.

Official Title
-----------------
A Phase I/II Study of PT-523 in Patients With Refractory Leukemia

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: PT-523 for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy. Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II. ECOG performance status 0 - 2. Adequate organ function and bone marrow reserve. At least 4 weeks must have elapsed from the time of major surgery. Use of appropriate contraceptive method. Signed patient informed consent. Exclusion Criteria: Known human immunodeficiency virus (HIV). Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine. Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PT-523 for Injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Detailed Description
-----------------
This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers tested include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Official Title
-----------------
Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients

Conditions
-----------------
Hepatorenal Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation Willing to give informed consent Exclusion Criteria: Patients with co-existing renal diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Hepatorenal syndrome group<br>Patients with advanced cirrhosis who develope hepatorenal syndrome | |
| Non-hepatorenal syndrome group<br>Patients with advanced cirrhosis who do not hepatorenal syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatorenal syndrome |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 months | 
| Chronic renal impairment |  | 6 months |
Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

Detailed Description
-----------------
Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.

Official Title
-----------------
Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography

Conditions
-----------------
Mild Nonproliferative Diabetic Retinopathy, Moderate Nonproliferative Diabetic Retinopathy, Severe Nonproliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy, Diabetic Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year Exclusion Criteria: Patients with diabetes already under the care of an Ophthalmologist. Patient not willing to give Consent for participation in the study

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 |
| --- | --- |
| No treatment Study<br>Population of subjects will have been diagnosed with mild NPDR, Moderate NPDR, Severe NPDR, PDR and DME | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HgA1C from Primary Care Physician referral to post retinal specialist visit |  | six months |
PegIntron Injection Surveillance Plan (Study P04123)

Study Overview
=================
Brief Summary
-----------------
Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated. The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of PegIntron Injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.

Detailed Description
-----------------
The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Pegintron approval.

Official Title
-----------------
PegIntron Injection Surveillance Plan

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Biological: Peginterferon alfa-2b (SCH 54031)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with chronic hepatitis C treated with peginterferon alfa-2b. Signed written contract. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Chronic Hepatitis C<br>Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with Chronic Hepatitis C are generally treated. | Biological: Peginterferon alfa-2b (SCH 54031)<br>* Surveillance will be conducted after administration of peginterferon alfa-2b (administered according to the directions on the products' labeling). PegIntron Injection for surveillance is a weight-based dosing product administered at a dose of 0.5/1.0 ug/kg or 1.5 ug/kg. Administration of treatment is not part of this study.<br>* Other names: PegIntron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Reported a Serious Adverse Event | Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported. | 24 weeks after administration of PegIntron Injection | 
| Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold | Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported. | 24 weeks after administration of PegIntron Injection. |
Anterior Tibiotalar Arthrodesis With Blade Plate Fixation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.

Official Title
-----------------
Anterior Tibiotalar Arthrodesis With Blade Plate Fixation in Treatment of Post-traumatic Arthritis Secondary to Pilon Fracture

Conditions
-----------------
Pilon Fracture, Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients whom have undergone anterior ankle arthrodesis with a blade plate construct, performed by a single surgeon, between January 2003 and July 2011 at the University of Utah or Primary Childrens Medical Center (PCMC) will be eligible for inclusion. Exclusion Criteria: Any patient who is not 18 years of age or older will not be eligible for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Outcome Questionnaires relating to the patients current condition | These questionnaires will include the FAOS, FADI, SF-36, PromisCAT, SMFA, and the DRAM. | 1 Year after Surgery |
Study HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent. The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study. The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.

Official Title
-----------------
Study HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease

Conditions
-----------------
Hemorrhoids, Chronic Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient whose age is ≥ 18 years Patient with IBD (Crohn's or UC) with a diagnosis prior to hemorrhoidal surgery Patient operated on for hemorrhoidal surgery performed between November 1, 2013 and July 7, 2020 in our center French-speaking patient Exclusion Criteria: Patient with severe inflammatory disease Patient with ano-perineal involvement of Crohn's disease Patient under guardianship or curatorship Patient deprived of liberty Patient under legal protection Patient objecting to the use of their data for this research

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Morbidity from hemorrhoidal surgery | This outcome corresponds to the prevalence of postoperative complications. | Year 1 |
Initiating Early Control of Migraine Pain and Associated Symptoms

Study Overview
=================
Brief Summary
-----------------
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo. This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.

Official Title
-----------------
A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: • Has an established diagnosis of migraine with or without aura. Key Exclusion Criteria: Has previously received any investigational drug or device or investigational therapy within 30 days before Screening. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-07<br>Taken once upon migraine | Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)<br>* AXS-07 tablet taken once upon the earliest onset of migraine pain.<br>|
| Placebo Comparator: Placebo<br>Taken once upon migraine | Drug: Placebo<br>* Placebo tablet taken once upon the earliest onset of migraine pain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reporting headache pain freedom | Absence of headache pain | Hour 2 | 
| Percentage of subjects with absence of Most Bothersome Symptom | Absence of Most Bothersome Symptom, defined at the onset of migraine | Hour 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, AXS-07, Meloxicam, Rizatriptan
Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

Study Overview
=================
Brief Summary
-----------------
Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.

Detailed Description
-----------------
Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.

Official Title
-----------------
Phase II Study of Tumor Cell-derived Microparticles Used as Vectors of Chemotherapeutic Drugs to Treat Malignant Ascites and Pleural Effusion

Conditions
-----------------
Malignant Pleural Effusion,, Malignant Ascites

Intervention / Treatment
-----------------
* Other: Drug-packaging microparticles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of malignant ascites or malignant pleural effusion Exclusion Criteria: Non-malignant ascites or pleural effusion

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-packaging Microparticles<br>Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week. | Other: Drug-packaging microparticles<br>* Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Ascites or Pleural Effusion |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pleural Effusion, ascites, Malignant