linjc16/ctgov huggingface dataset:
Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.

Official Title
-----------------
A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma

Conditions
-----------------
Advanced Solid Tumors, Lymphoma

Intervention / Treatment
-----------------
* Drug: VTX-2337


Participation Criteria
=================
Eligibility Criteria
-----------------
Other specific eligibility criteria may apply. Examination by the investigator is necessary to fully determine eligibility. Inclusion Criteria: Ability and willingness to provide written informed consent Histologically or cytologically confirmed solid tumors or lymphoma Locally advanced or metastatic disease Life expectancy of at least 16 weeks ECOG performance status of 0 or 1 Acceptable physical exam and laboratory tests at study entry Willingness to use medically acceptable contraception A negative serum pregnancy test for women with reproductive potential Exclusion Criteria: Anticancer therapy within 2 weeks Treatment with an investigational agent within 4 weeks Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy Known brain metastases unless stable for at least 28 days Active autoimmune disease Insulin-dependent diabetes mellitus Clinically significant cardiac disease within 6 months Significant infection or fever within 1 week Pregnant or breast-feeding females Other conditions or circumstances that could interfere with 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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VTX-2337|Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and identification of dose-limiting toxicities |  | Study duration | 
| Pharmacokinetics |  | First dose of investigational drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics |  | Study duration | 
| Identification of the MTD |  | First cycle of investigational drug |
Expanded Access Program With Nivolumab to Treat Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to provide treatment with nivolumab to subjects with Stage III or Stage IV advanced melanoma.

Official Title
-----------------
Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti CTLA-4 Monoclonal Antibody (Checkmate 168: CHECKpoint Pathway for nivoluMAb Clinical Trial Evaluation 168)

Conditions
-----------------
Stage III (Unresectable) or Stage IV Advanced Melanoma

Intervention / Treatment
-----------------
* Drug: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: ECOG Performance Status of 0-1 Histologically confirmed malignant melanoma Progressed on or after treatment with an anti-CTLA4 Exclusion Criteria: Active brain metastases Life Expectancy <6 weeks Subjects who received prior therapy targeting T-cell costimulation or checkpoint pathways except for Anti CTLA-4 therapy Subjects with autoimmune disease

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: Nivolumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment. PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.

Detailed Description
-----------------
OBJECTIVES: Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer. Collect detailed clinical, pathological, and chemotherapy data from these patients. Identify genetic factors that relate to treatment response and outcome in these patients. OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes. Clinical and family history data is also collected by questionnaire. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Official Title
-----------------
The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Genetic: microarray analysis
* Genetic: mutation analysis
* Genetic: polymerase chain reaction
* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis
* Other: questionnaire administration


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of metastatic colorectal cancer Currently receiving chemotherapy at Weston Park Hospital PATIENT CHARACTERISTICS: Not Specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: microarray analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: polymorphism analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Other: questionnaire administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Progressive disease-free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV colon cancer, stage IV rectal cancer
Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

Study Overview
=================
Brief Summary
-----------------
ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.

Conditions
-----------------
Anterior Cruciate Ligament Tear

Intervention / Treatment
-----------------
* Procedure: acl reconstruction - double bundle technique
* Procedure: acle reconstruction - single bundle technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee instability with a history of ACL tear diagnosed ACL tear according to MRI age range 16-40. Exclusion Criteria: previous surgery in the knees multiple ligament raptures partial ACL tear severe cartilage degeneration genovaruse/genovalgus thin hamstrings tendons oper epiphysis in the knee joint patient with muscle/neurological problem that increases the tendency to fall

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single bundle<br>acl reconstruction - single bundle technique | Procedure: acle reconstruction - single bundle technique<br> <br> |
| Experimental: double bundle<br>acl reconstruction - double bundle technique | Procedure: acl reconstruction - double bundle technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test |  | pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthroscopic surgical procedure
Risperdal Consta and Health Care Utilization in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.

Official Title
-----------------
The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Risperdal Consta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of schizophrenia or schizoaffective disorder 4 or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year Medicaid recipient Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics) Exclusion Criteria: Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder Drug or alcohol dependence Serious, unstable medical illness or any acute medical condition Pregnant or lactating females Prior Risperdal Consta treatment Non-English speaking

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperdal Consta|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.

Conditions
-----------------
Infantile Spasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008. Clinical and electroencephalography findings are compatible with infantile spasms Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering). Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion. Exclusion Criteria: Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects. Patients who have a history of nephrolithiasis.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| a short-term trial of the ketogenic diet<br> | |
| long-term trial of the ketogenic diet.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet. |  | Finally, 35 patients could be followed up for more than 12 months after successful discontinuation of the diet and then primary outcome will be measured. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory infantile spasms
An Open Label Study of Severe Sepsis in Adults

Study Overview
=================
Brief Summary
-----------------
This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).

Detailed Description
-----------------
To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.

Official Title
-----------------
An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Drug: drotrecogin alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria: Must be 18 years. Suspected or proven infection Have or have had two or more sepsis-induced organ failures sepsis Exclusion Criteria: Patients will be excluded from entry in this study for any of the following reasons: Documented first organ dysfunction greater than 48-hours prior to start of study drug. Patients greater than 135 kg in weight. Patients with a platelet count less than 30,000/mm3 Active internal bleeding or at increased risk for bleeding

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>24 microgram/kg/hr for 96 hours (+ or - 1 hour) | Drug: drotrecogin alfa (activated)<br> <br> * Other names: Xigris;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Data |  | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality data. |  | 9 Months | 
| To determine the final disposition of sepsis patients treated with drotrecogin alfa (activated)(that is, patient location at discharge from study hospital or 90 days). |  | 9 Months |
What Are the Main Themes Concerned by the Second-line SMUR 67, Known as Reinforcements, in the Bas-Rhin Sector

Study Overview
=================
Brief Summary
-----------------
In this study the investigators wish to evaluate the possibility of anticipating the requests for SMUR reinforcement within the SAMU67. The studied population concerns each patient having benefited from an SMUR at the time of his pre-hospital care. The investigators expect from this study an improvement of the assumption of responsibility of the patients in the future with optimization of the delay of sending of an SMUR when this one is necessary.

Official Title
-----------------
State of Play at the SAMU 67: What Are the Themes Mainly Concerned by the Second Intention SMUR, Called Reinforcements, on the Sector of the Bas-Rhin? Are There Modifiable Factors That Could Allow us to Anticipate Them Better

Conditions
-----------------
Reasons for Emergency Calls

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients having benefited from a pre-hospital SMUR over the period from 01/01/2020 to 14/07/2020. No opposition from the patient or his parental authority to the re-use of his medical data for scientific research. Exclusion criteria: - Presence of opposition from the patient or his parental authority to the re-use of his medical data for scientific research purposes.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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 |
| --- | --- | --- |
| Retrospective description of the main reasons and themes of patient calls leading to the Emergency Medical Service being sent for reinforcement |  | Through study completion, an average of 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency calls, SAMU67, SMUR
Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the changes of functional status, symptoms distress and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.

Detailed Description
-----------------
This is an observational cohort study. The participants will be inpatients undergoing elective CABG surgery at one tertiary medical center. Functional status (including activity of daily living, cognitive and nutritional status), symptom distress, and quality of life will be measured at multiple points: pre-surgery, day 1 to 7 post-surgery, before discharge, and 2-4 weeks after discharge. Structured questionnaire will be used to collect demographic and medical characteristics. The Barthel Index, hand-held dynamometer, 6-minute walking test, Mini-Nutritional Assessment (MNA), Mini-Mental State Examination (MMSE), Confusion Assessment Method (CAM), Symptoms Distress Scale, and Short-Form-36 Health Survey (SF-36) will be used to collect functional data and compared for changes. The trajectory of functional status, symptoms distress, and quality of life will be further analyzed. The findings will add to the literature by raising the awareness on changes of functional status, symptoms distress, and quality of life for patients undergoing elective CABG so targeted and timely intervention could be developed and planned.

Official Title
-----------------
Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing CABG Surgery

Conditions
-----------------
Coronary Artery Bypass Graft Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: receive elective coronary artery bypass surgery able to communicate in Chinese and Taiwanese walk independently or use walker length of stay is over 7 days Exclusion Criteria: unable to walk mechanical ventilation neural or muscle disease to influence ambulation(ex: Parkinson Disease) asthma severe psychotic disorder that prevents patient from participating in test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, functional status, symptoms distress, quality of life, the trajectory of functional status, the changes of symptoms distress, the changes of quality of life