linjc16/ctgov huggingface dataset:
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

Official Title
-----------------
A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: cefepime-taniborbactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 18-55 years Males or non-pregnant, non-lactating females Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight >50.0 kg. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study Exclusion Criteria: History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug Recent history of known or suspected Clostridioides difficile infection Abnormal ECG or history of clinically significant abnormal rhythm disorder Abnormal lab tests

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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: cefepime-taniborbactam<br> | Drug: cefepime-taniborbactam<br>* IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ELF Cmax | Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF) | 0-8 hours after 6th dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | Day 1 - Day 8 |
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.

Detailed Description
-----------------
To collect and characterise the incidence of adverse events related to the safety specifications*1 of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA. This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. *1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity

Official Title
-----------------
LYNPARZA Tablets 100 mg, 150mg General Drug Use-results Study in Patients on Maintenance Treatment After Platinum-based Chemotherapy for BRCA Mutated Curatively Unresectable Pancreas Cancer.

Conditions
-----------------
Pancreatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who receive LYNPARZA for the first time for the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated curatively unresectable pancreas cancer after the approval date of partial change application for the additional indication (25/Dec./2020). Exclusion Criteria: Patients who have no treatment history with LYNPARZA
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 |
| --- | --- | --- |
| Incidence of adverse events related to the safety specifications | Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity | from baseline to 1year |
Traumatic Characteristics of the Forensic Cases Admitted to Emergency Department and Errors in the Forensic Reports

Study Overview
=================
Brief Summary
-----------------
Objectives: to detect the mistakes and deficiencies of the forensic reports which was written and to detect the injury characteristics of the forensic cases applied to emergency service of a tertiary hospital.

Detailed Description
-----------------
All patients who applied for reasons such as crushing, traffic accidents, firearms and explosive injuries, assault, all kinds of injuries, burns, electric shock, asphyxia, torture, child abuse, falls and other injuries, poisoning and suicide attempt are a forensic case.Traumatic forensic cases are often confronted in emergency departments, Aim to this study is to detect the mistakes and deficiencies of the forensic reports which was written and also aimed to detect the injury characteristics of the forensic cases applied to emergency department which is the most important center in region at a tertiary hospital.

Official Title
-----------------
Characteristics of the Traumatic Forensic Cases Admitted to Emergency Department and Errors in the Forensic Reports

Conditions
-----------------
Emergencies, Trauma

Intervention / Treatment
-----------------
* Other: Forensic cases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic forensic cases which written a forensic report were included in study. Exclusion Criteria: The forensic cases which can not be reached the forensic report and patients' emergency department chart

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Forensic cases|Forensic cases which were admitted to the Emergency Department|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forensic cases admitted to Emergency department | Forensic cases by data obtained from medical records | one year |
Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR 168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be evaluated.

Detailed Description
-----------------
Chronic leg cramps are prevalent among the aging population affecting sleep patterns and quality of life. Magnesium deficiency may cause muscle weakness and cramps. Magnesium supplementation will be evaluated for the relief and/or improvement of symptoms. The primary objective is to evaluate the efficacy of magnesium supplementation, MagTabSR, 168mg's twice a day, for the relief and/or improvement in the frequency, duration, intensity of leg cramps. Secondary objectives are to evaluate the improvement in sleep disturbances and quality of life.

Official Title
-----------------
Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Conditions
-----------------
Muscle Cramp

Intervention / Treatment
-----------------
* Dietary Supplement: MagTabSR
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40-85 Years Old No Kidney Impairment 2 or more leg cramps per week for last 30 days Exclusion Criteria: < 40 or > 85 Years Old Kidney Impairment < 2 leg cramps per week for last 30 days Enrolled in another research study History of seizure disorder Current treatment with Lithium Malabsorption or major intestinal disorders Significantly elevated magnesium level History of allergy to magnesium compound Use of Quinine for leg cramps History of significant diarrhea History of drug or alcohol abuse in the last 2 years Currently diagnosed with a terminal illness

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MagTabSR<br> | Dietary Supplement: MagTabSR<br>* MagTabSR/placebo 168 mgs BID for 6 six weeks<br>|
| Placebo Comparator: Sugar Pill<br> | Dietary Supplement: Placebo<br>* MagTabSR/placebo 168 mgs BID for 6 six weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frequency of Leg Cramps | Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline). | 30 days | 
| Frequency/Duration of Muscle Cramps |  | 30 days |
Binding of Lu AG06466 in the Brain in Healthy Men

Study Overview
=================
Brief Summary
-----------------
A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

Detailed Description
-----------------
The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group PET scans will be used to quantify MAGL occupancy

Official Title
-----------------
Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lu AG06466


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body weight ≥60 kg. body mass index ≥18.5 and ≤27 kg/m2. waist circumference ≤94 cm. The subject has a normal sMRI performed during the screening period. The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test. Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination. The subject must make use of contraception. Exclusion Criteria: The subject is left handed. Other in- and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A Single doses<br>Lu AG06466 in fast and fed state | Drug: Lu AG06466<br>* capsules, orally<br>* Other names: ABX-1431;|
| Experimental: Part B Repeated doses<br>Lu AG06466 after light meal | Drug: Lu AG06466<br>* capsules, orally<br>* Other names: ABX-1431;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central monoacylglycerol lipase (MAGL) occupancy |  | From dosing to 8 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C(PET) | Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging | From zero to Day 10 | 
| AUC (0-24) | Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours | From zero to 24 hours post-dose | 
| Cmax | Maximum observed plasma concentration for Lu AG06466 and Lu AG06988 | From zero to 24 hours post-dose |
Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.

Official Title
-----------------
Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure> 50 mmHg, normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month. Exclusion Criteria: Patients with other cardiac and noncardiac diseases will be excluded.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sildenafil 20mg oral<br> | Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous<br>* 2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg<br>* Other names: REVATIO oral vs REVATIO intravenous;|
| Other: Sildenafil 10mg intravenous<br> | Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous<br>* 2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg<br>* Other names: REVATIO oral vs REVATIO intravenous;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance. | one day per patient |
Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM

Study Overview
=================
Brief Summary
-----------------
Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).

Detailed Description
-----------------
Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) to be defined in 3 categories: elderly FIT (ADL 6; IADL 8; 0 score= 3-4, < 5 score=2) elderly UNIFIT (ADL 5; IADL 6-7; 0 score= 3-4, 5-8 score=2; ≥ 80 fit) elderly FRAIL (ADL ≤ 4; IADL ≤ 5; 1 score= 3-4, > 8 score=2; ≥ 80 unfit)

Official Title
-----------------
Prospective Data Collection of Elderly Patients (≥ 65 Years) With Diffuse Large B-cell Lymphoma (DLBCL) Receiving at the Time of Diagnosis Multidimensional Geriatric Assessment (VGM)

Conditions
-----------------
Lymphoma, Large B-Cell, Diffuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Large B-cell Lymphoma Age ≥ 65 years informed Consent Exclusion Criteria: Violation of inclusion criteria Abscence of data considered essential for the study Withdrawal of Consent

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly patients with DLBCL<br>Elderly patients (Age ≥ 65 years) with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 5 years | 
| FFS | Failure Free Survival | 5 years | 
| Response to initial therapy |  | 5 years | 
| Early mortality rate |  | 5 years | 
| % of patients who performed pre-phase therapy | Come to the prefect Therapy is a steroid-based therapy (administered at dosage of at least 25 mg / day) and / or vincristine, which precedes the beginning of the program of chemoimmunotherapy. | 5 years |
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.

Official Title
-----------------
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery

Conditions
-----------------
Elective Cardiac Surgery

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective, cardiac surgery requiring cardiopulmonary bypass with anticipated duration of >180 minutes Exclusion Criteria: Platelet count < 20,000/ uL Body mass index <18 Pregnant women Life expectancy of <14 days End stage organ disease Active infection Undergoing cardiac transplant or ventricular assist device explant, isolated primary coronary artery bypass grafting (CABG) or single valve procedure Contraindication to anticoagulation with heparin Declined informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CytoSorb Device<br>Standard of care plus treatment with CytSorb device installed on the CPB machine | Device: CytoSorb<br>* Cytosorb device use during cardiopulmonary bypass<br>|
| No Intervention: Control<br>Standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Serious Device Related Adverse Events | The primary safety endpoint of this trial was to determine the product safety profile through the assessment of serious device related AEs through discharge from the ICU. | From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in the ICU | Days in ICU, Post Surgery | From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) | 
| 30 Day All Cause Mortality | Mortality within 30 Days of Surgery | From time of enrollment through 30 days post procedure | 
| Adverse Event Rates | Total number of Serious Adverse Events | through 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CytoSorb device, Plasma free hemoglobin, inflammation, extracorporeal bypass
Circulating Tumor Material in Colorectal Cancer and Melanoma

Study Overview
=================
Brief Summary
-----------------
Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma

Official Title
-----------------
Protocol to Permit the Acquisition of Circulating Tumor Material in Colorectal Cancer and Melanoma

Conditions
-----------------
Colorectal Cancer and Melanoma

Intervention / Treatment
-----------------
* Other: blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be a patient at the Hospital of the University of Pennsylvania Patients with presumed stage II, III, or IV colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the Hospital of the University of Pennsylvania Patients with histologically confirmed melanoma stage IIb, IIc, IIIa, IIIb, or IIIc/IV scheduled for surgical resection being evaluated at the Hospital of the University of Pennsylvania. The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf. The subject must be 18 years of age or older. Exclusion Criteria: The subject is not able to provide informed consent.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colorectal cancer<br> | Other: blood collection<br>* Patients will receive a research draw for circulating tumor material analysis with standard clinical labs<br>|
| melanoma<br> | Other: blood collection<br>* Patients will receive a research draw for circulating tumor material analysis with standard clinical labs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood samples collected |  | 24 months |