linjc16/ctgov huggingface dataset:
Muscle Mass and Body Composition

Study Overview
=================
Brief Summary
-----------------
ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

Detailed Description
-----------------
The weakness and disability that result from these neuromuscular disorders can dominate the lont-term course and impede recovery. In this observational study we try to measure muscle mass and body composition by echocardiography and BIVA at admission and on day 2, 5

Official Title
-----------------
Time Course of Changes in Muscle Mass and Body Composition During ICU Admission

Conditions
-----------------
Muscle Loss

Intervention / Treatment
-----------------
* Other: muscle mass measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all acute admitted patients in ICU Exclusion Criteria: age < 18 stay on ICU < 48 hours use of corticosteroids neurological diseases acute kidney injure / nead of CVVH

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

| Intervention/Treatment |
| --- |
|Other: muscle mass measurement|measurement of muscle mass by echocardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle mass measurements during ICU stay | measurement by echography | baseline, day 2 and day 5 |
Determination of Drugs and Their Metabolites in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
The current state of knowledge on the concentration of drugs and their metabolites in the individual human body is not satisfying concerning the question about behavior of drugs in the human body, taking into account individual patient factors such as age, weight and organ dysfunctions. This projects deals with the question of drug levels in the blood of hospitalized patients. The aim of this study is to extend the knowledge about the behavior of drugs in the human body significantly, for the safety and benefit of future patients. This also includes to establish a relationship between drug levels in patients and the desired and undesired effects of a drug. As a result, the future perspective is to find the optimal dose for the individual patient by measuring the blood concentration of a drug.

Detailed Description
-----------------
The primary goal of the study is to gain an overview of the plasma concentrations of relevant drugs which occur in different patient populations and to what extent they are consistent with those concentrations described in the literature. If the expectation is confirmed, that a significant heterogeneity in the plasma concentrations of these patients exists, the investigators will try to find influencing factors for this circumstance on the basis of routine clinical parameters (height, weight, renal function, concomitant medications, etc.). Ultimately, this project will identify substances with a high interindividual variability in plasma levels, where drug monitoring might be suggested.

Official Title
-----------------
Determination of Drugs and Their Metabolites in Hospitalized Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: legal capacity Exclusion Criteria: severe anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Plasma concentrations [ng/mL] of various drugs at different timepoints |  | up to five years |
Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.

Official Title
-----------------
A Pilot Study to Access the Feasibility and Safety of Intrathecal Rituximab Added to Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20 Positive Non Hodgkin Lymphoma

Conditions
-----------------
Non Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy. Exclusion Criteria: Primary central nervous system lymphoma or established secondary central nervous system disease. History of spinal surgery and/or ineligible for intrathecal injections.

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
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential dose cohorts
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal rituximab<br>Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5 | Drug: Rituximab<br>* Intrathecal administration over 3-5 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to deliver greater than 80% of planned doses | Percentage of planned doses administered for planned accrual | 28 months | 
| Related Grade 3 or higher non-hematological toxicity | Number of related grade 3 or higher non-hematological toxicities | 28 months |
Do Antibiotics Prevent Anal Fistulae Formation?

Study Overview
=================
Brief Summary
-----------------
Purpose: This randomized study assesses the effects of antibiotics on the formation of fistulae after drainage of anorectal abscesses. Methods: Patients who underwent abscess drainage in 3 major colorectal units between September 2005 and January 2008 were included. Previous anorectal surgery history, immunecompromised states, pregnancy, inflammatory bowel disease, antibiotic usage prior to surgery and the presence of an anal fistulae at the time of surgery were the exclusion criteria. Patients were randomized and given either placebo or amoxicillin-clavulanic acid combination treatment for 10 days. Patients were followed one year for perianal fistulae formation.

Official Title
-----------------
Does Adjuvant Antibiotic Treatment After Drainage of Anorectal Abscess Prevent the Development of Anal Fistulae? A Prospective Randomized, Placebo Controlled, Double Blind, Multi-Center Clinical Study

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Drug: Amoxicillin-Clavulanate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of anorectal abscess Exclusion Criteria: Allergy to penicillin derivatives Treatment with any antimicrobial agent in the week before enrolment Recognized other infection at the time of surgery Previous anorectal surgery Presence of inflammatory bowel disease Suspicion of Fournier's gangrene Secondary and recurrent anorectal abscesses Presence of an internal opening Any additional surgical procedure performed in the same session or during follow-up Antibiotic prophylaxis indicated for another reason Immunosuppressive and/or anticoagulant drug treatment being taken at the time of surgery Diabetes mellitus Known chronic disabling disease Pregnancy Lactation.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic<br>Patients who received antibiotic treatment after abscess drainage | Drug: Amoxicillin-Clavulanate<br>* oral 875/125 mg tablets of Amoxicillin/Clavulanate 2 times a day for 10 days<br>* Other names: Bioment 1 gr BID tablets;|
| Placebo Comparator: Placebo<br>Patients who received placebo after abscess drainage | Drug: Placebo<br>* oral Placebo tablets two times a day for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula formation |  | 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perianal, Abscess, Fistulae in ano, Antibiotic, Anorectal
Arizona Alzheimer's Disease Research Center (ADRC)

Study Overview
=================
Brief Summary
-----------------
The Arizona Alzheimer's Disease Research Center (ADRC) is the National Institute on Aging's (NIA's) first statewide AD Center (ADC), the only ADC in the Southwestern United States, and a leading example of statewide collaboration in biomedical research. It capitalizes on Arizona's strengths in brain imaging, genomics, computer science and biomathematics, the basic, cognitive and behavioral neurosciences, clinical, and neuropathological studies of AD, the discovery and evaluation of investigational treatments, and the study of normal cognitive aging.

Official Title
-----------------
Arizona Alzheimer's Disease Research Center (ADRC)

Conditions
-----------------
Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitively normal persons, individuals with mild cognitive impairment or dementia who are at least 40 years of age. Willing to undergo health and cognitive assessments, and collection and banking of blood with venipuncture for genetic research, biomarker research, and DNA banking. Exclusion Criteria: 1. Participants whose diagnosis is unclear and confounded by multiple possible factors are excluded. Participants with diagnoses of non-AD dementias are not excluded. 2. Participants whose primary diagnosis is cognitive impairment due to a penetrating or single severe closed head injury, multiple sclerosis, brain tumor, metabolic or toxic encephalopathy, post-infectious (e.g., viral encephalitis, bacterial meningitis), paraneoplastic, primary psychiatric illness, or otherwise not deemed relevant to the intent of the Alzheimer Disease Center program are excluded. 3. Procedure specific exclusion criteria also apply but this does not impact the participants ability to be included in the study.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Status | The ADRC uses a prospective, standardized, and longitudinal clinical evaluation of participants to determine their cognitive status. This includes tests that assess short and long term memory, ability to complete daily tasks, and processing of information. | 12 months |
Nefazodone in the Treatment of Social Phobia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).

Detailed Description
-----------------
The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes in cerebral blood flow were correlated with self-rated anxiety measures.

Official Title
-----------------
Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates

Conditions
-----------------
Social Anxiety Disorder (SAD)

Intervention / Treatment
-----------------
* Drug: Nefazodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65 Exclusion Criteria: A history of bipolar disorder, psychotic illness, or any other anxiety disorders, organic brain disease or active drug or alcohol abuse within one year as assessed by the SCID-P and interview, or a concurrent medical condition that would not be compatible with the study in the opinion of the principal investigator. Patients required to be free of psychotropic or beta-blocker medication for 2 weeks prior to study. Pts taking fluoxetine required to be drug-free for 6 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nefazodone|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
-----------------
Social anxiety disorder, social phobia, positron emission tomography (PET, regional cerebral blood flow (rCBF), nefazodone, amygdala
Automated System for Gathering and Reporting Clinical Outcomes to Providers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to design and test the feasibility of a system to survey patients regarding the outcome of acute care visits and to report back to the healthcare providers.

Official Title
-----------------
Automated System for Gathering and Reporting Clinical Outcomes to Providers

Conditions
-----------------
Ambulatory Care

Intervention / Treatment
-----------------
* Other: Online survey - Follow up for Better Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 and older visiting participating primary care clinics who agree to be contacted by email to complete a survey on clinical outcomes. Exclusion Criteria: None

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

| Intervention/Treatment |
| --- |
|Other: Online survey - Follow up for Better Care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey response rate |  | Assessed at the end of the 12 week study period |
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation

Study Overview
=================
Brief Summary
-----------------
The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.

Official Title
-----------------
Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation

Conditions
-----------------
Malignant Neoplasm, Advanced Cancer, Metastatic Cancer

Intervention / Treatment
-----------------
* Drug: adagrasib (MRTX849)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor Confirmed presence of a KRASG12C mutation Ineligible for an ongoing clinical trial of MRTX849 No available or not eligible for standard of care treatment Adequate organ function CNS Metastases (within set parameters) are allowed ECOG performance status of ≤ 2 Exclusion Criteria: History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow Prior therapy targeting a KRAS G12C mutation Other active cancer

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adagrasib (MRTX849)|adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen|

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
-----------------
adagrasib, expanded access
Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.

Official Title
-----------------
An Open-label, Single-dose Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: MLDL1278A
* Drug: MLDL1278A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males/females aged 18 to 55 years inclusive at screening; Subjects who are between 18.0 and 30.0 kg/m2 body mass index (BMI) inclusive and weigh between 55.0 and 100.0 kg inclusive; Exclusion Criteria: Any clinically relevant disease or disorder (past or present), which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study; Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, coagulation, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study;

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br> | Drug: MLDL1278A<br>* Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.<br>|
| Experimental: Cohort B<br> | Drug: MLDL1278A<br>* Single subcutaneous dose of 360 mg MLDL1278A.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of MLDL1278A. |  | Up to 70 days post administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of MLDL1278A. |  | Up to 70 days post administration. | 
| Plasma clearance (CL) of MLDL1278A. |  | Up to 70 days post administration. | 
| Number of participants with an anti therapeutic antibody (ATA) response. |  | Up to 140 days post administration. | 
| Number of participants with adverse events. |  | Up to 140 days post administration. |
Forxiga CKD Japan Post-Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
To capture safety when Forxige is administrated to CKD patients in the real world setting

Detailed Description
-----------------
The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch for treatment of CKD. ADRs which are unexpected from the precautions for use in our JPI Understanding of incidence of ADRs during use of Forxiga in the real world setting Factors (ie demography, treatment) possibly having an impact on the safety

Official Title
-----------------
Forxiga Tablets 5mg, 10mgGeneral Drug Use-Results Study n in Chronic Kidney Disease (CKD) Patients

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CKD except for dialysis and/or renal failure chronic Exclusion Criteria: None
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 ADRs during use of Forxiga in the real world setting | To be calculated incidence of ADRs related to Forxiga during the observation period | from baseline of 1year | 
| Incidence of ADRs which are unexpected from the precautions for use in our JPI | To be calculated incidence of ADRs related to Forxiga during the observation period not expected from the precautions for use of Forxiga JPI | from baseline to 1 year | 
| Factors (ie demography, treatment) possibly having an impact on the safety | Factors which may impact incidence of ADRs analysed by patient demographic characteristic (past medical history and concomitant disease etc) | from baseline to 1 year |