linjc16/ctgov huggingface dataset:
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

Study Overview
=================
Brief Summary
-----------------
Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Detailed Description
-----------------
Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]

Official Title
-----------------
A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001

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

Intervention / Treatment
-----------------
* Drug: Cu(II)ATSM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent prior to initiation of any study-specific procedures and treatment documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002 Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM Exclusion Criteria: not dependent on mechanical ventilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Cu(II)ATSM<br>copper-containing synthetic small molecule | Drug: Cu(II)ATSM<br>* cooper-containing synthetic small molecule<br>* Other names: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related changes in disease severity | Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related changes in cognitive function | Treatment-related changes in cognitive function by Edinburgh Cognitive and Behavioral Assessment (ECAS) score | 24 weeks | 
| Treatment-related changed in respiratory function | Treatment-related changes in respiratory function by seated slow vital capacity (SVC) | SVC | 
| Treatment tolerance | Treatment tolerance based on dose reductions and dose terminations due to adverse events | 24 weeks |
AM-101 in the Treatment of Post-Acute Tinnitus 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.

Detailed Description
-----------------
This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.

Official Title
-----------------
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study

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

Intervention / Treatment
-----------------
* Drug: AM-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of TACTT3 study; Negative pregnancy test (woman of childbearing potential); Willing and able to attend the study visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Adverse event leading to treatment discontinuation in TACTT3; Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane; Ongoing drug-based therapy for otitis media or otitis externa; Drug-based therapy known as potentially tinnitus-inducing; Other treatment of tinnitus; Drug abuse or alcoholism; Subjects with psychiatric diseases requiring drug treatment; Use of antidepressant or anti-anxiety medication; Any clinically relevant disorder or abnormality in physical examination; Women who are breast-feeding, pregnant or who are planning to become pregnant during the study; Women of childbearing potential who are unwilling or unable to practice contraception. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 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: AM-101 injection<br>AM-101 gel for intratympanic injection | Drug: AM-101<br>* AM-101 gel for intratympanic injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing threshold | Occurrence of deterioration in hearing threshold in the treated ear(s) | Up to Day 203 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing threshold | Difference and occurence of deterioration of hearing threshold in the treated ear(s) | Up to Day 252 | 
| Adverse events and serious adverse events | Occurrence and severity of adverse events and serious adverse events | Up to Day 252 |
PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

Detailed Description
-----------------
This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

Official Title
-----------------
Pegylated-liposome Doxorubicin Combined With Ifosfamide As First-line Treatment for Patients With Advanced or Metastatic Soft Tissue Sarcoma

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Drug: PLD and IFO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-70 years with histologically confirmed advanced or metastatic STS Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months have not received chemotherapy before at least one measurable lesion LVEF≥50% have adequate bone marrow, hepatic, and renal function Exclusion Criteria: osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans patients with symptomatic brain metastases active clinical severe infection

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: PLD-IFO<br>pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) | Drug: PLD and IFO<br>* PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 2 months | 
| overall survival |  | 12 months | 
| Adverse Events |  | 2 months | 
| biomarker analysis |  | 6 months |
Patient-reported Outcomes in the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004 protocols

Official Title
-----------------
Patient-reported Outcomes With Bifeprunox or Olanzapine in the Treatment of Schizophrenia. A Pharmacoeconomic Study Carried Out in Connection With the S1543003 And S1543004 Clinical Trials

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participate in S1543003 and S1543004 in the U.S. sites Exclusion Criteria: Participate in S1543003 and S1543004 other than U.S. sites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bifeprunox|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this placebo-controlled clinical trial are to evaluate the analgesic efficacy and safety of bicifadine 200 mg BID compared with placebo in patients with moderate to severe chronic low back pain. The secondary objectives are to evaluate the effect of bicifadine on function and general quality of life, to evaluate safety following discontinuation of bicifadine treatment and to investigate the population pharmacokinetics of bicifadine.

Official Title
-----------------
A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID in the Treatment of Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Drug: Bicifadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients with low back pain assessed as Class 1, Class 2 or Class 3 according to the Quebec Task Force Classification for Spinal Disorders and without detectable leg weakness on neurological examination. Patients with pain categorized as Class 1 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of >17 at baseline to qualify. Patients with pain categorized as Class 2 or Class 3 according to the Quebec Task Force Classification must have a Roland-Morris Disability Rating of at least 10 at baseline to qualify. Patients must have required daily analgesics for the treatment of low back pain for at least 3 months prior dosing. Main Exclusion Criteria: Patients may not have persistent moderate or severe pain in a location other than the lower back (with the exception of radiation to the lower extremity). Patients must not have had lower back surgery within 6 months prior to baseline, nor epidural corticosteroid injections within 3 months prior to baseline. Patients may not have an unstable medical condition.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicifadine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity Rating (100 mm visual analog scale) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form McGill Pain Questionnaire (SF-MPQ) |  |  | 
| Roland-Morris Disability Questionnaire (RDQ) |  |  | 
| Short-Form 36 (SF-36) Health Survey |  |  | 
| Patient's Global Impression of Change (7-point categorical scale) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bicifadine, chronic low back pain
Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Study Overview
=================
Brief Summary
-----------------
Prospective study at Duke University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to blood culture results in admitted patients with bacteremia/septicemia.

Official Title
-----------------
Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Conditions
-----------------
Bacteremia, Septicemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older A positive blood culture A suitable residual blood sample collected within 24 hours of the positive blood culture OR A blood sample obtained for the study obtain within 48 hours of the positive blood culture For Endocarditis Cohort: 1. All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria Exclusion Criteria: Inability to understand instructions and comply with study-related procedures Any condition that in the opinion of the treating physician will prevent the subject from completing the study

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 |
| --- | --- |
| Staphylococcus aureus Infection<br>Patients with blood culture confirmed S. aureus bloodstream infections. | |
| Gram Negative Infection<br>Patients with blood culture confirmed Gram Negative bloodstream infecrions | |
| Endocarditis<br>Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NGS, Sepsis, Infection, Culture, Sequencing, Non-invasive
Comparison of Telemedical and Conventional Treatment of Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements. Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.

Official Title
-----------------
Treatment of Hypertension Using Telemedical Home Blood Pressure Measurements

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Telemedical home blood pressure measurements
* Behavioral: Conventional blood pressure monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 to 64 years Registered address in the Municipality of Holstebro Enrolment at a practice of one of the general practitioners who had agreed to participate in the study Telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3. Elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80) Hypertension confirmed by daytime ambulatory blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80) ECG verified sinus rhythm Exclusion Criteria: Unwillingness to participate Normotension Withdrawal of consent to participate

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 64 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedical blood pressure monitoring<br>Telemedical home blood pressure measurements for three days every second week. The average of all measures excluding day one is electronically transmitted to the General Practitioners. Following communication primarily by email or telephone. | Behavioral: Telemedical home blood pressure measurements<br> <br> |
| Active Comparator: Conventional blood pressure monitoring<br>Conventional blood pressure monitoring | Behavioral: Conventional blood pressure monitoring<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure reduction | Difference in daytime ambulatory blood pressure from baseline to followup between intervention and control group | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients reaching target blood pressure |  | 3 month |
Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality . Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections, including bacterial infections, viral infections, and infections of other etiologies. Early initiation of adequate antibiotic therapy is the cornerstone in the treatment. However, overuse of antibiotics and prolonged duration of antibiotic therapy in patients with bacterial ARIs in the hospital and intensive care setting is associated with increased resistance for common bacteria, high costs, and adverse drug reactions.

Official Title
-----------------
Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: Lung Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or greater Ventilator associated pneumonia (VAP) with positive sputum culture. Exclusion Criteria: pregnancy, use of immunosuppressive agents except for steroids, neutropenia (white blood cell count ≤1000/mL) patients whose primary diagnosis was community acquired pneumonia and other source of infection.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lung Ultrasound|We will evaluate the role of lung ultrasound on the duration of antibiotics, we hypothesize that ultrasound imaging may have a role, will be correlated with, procalcitonin (PCT). The created database will help in establishing conclusion and recommendations that will help to improve the antibiotics duration and decrease the resistance.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between lung ultrasound and procalcitonin. |  | 7 days |
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.

Official Title
-----------------
Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure:Effects On Endothelial Function, Left Ventricular Remodelling, Natriuretic Peptide Levels, And Exercise Capacity

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: Omacor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic heart failure of non-ischemic origin Age ≥18 years NYHA functional class III-IV LVEF < 35 % Optimized heart failure therapy plasma NT-BNP >2000pg/ml Exclusion Criteria: Current treatment with Omacor or other fish oil products Known hypersensitivity to the study drug Ischemic cardiomyopathy Uncorrected significant valvular heart disease Heart failure due to congenital heart disease Restrictive cardiomyopathy Alcoholic heart disease Acute myocarditis Continuous i.v. therapy for heart failure Mechanical assist device Life expectancy <1 year due to non-cardiac causes Inability to perform bicycle testing Women of childbearing potential not practicing a save contraception method Current participation in another intervention study Participation in another study with an intervention within the last 3 months.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>4 gelatine capsules/d | Dietary Supplement: Omacor<br> <br> |
| Active Comparator: 1g/d Omacor<br> | Dietary Supplement: Omacor<br> <br> |
| Active Comparator: 4g/d Omacor<br> | Dietary Supplement: Omacor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |