linjc16/ctgov huggingface dataset:
Adherence to Dolutegravir and Outcome

Study Overview
=================
Brief Summary
-----------------
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance). While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.

Official Title
-----------------
Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 Age over 18 years Information letter signed ART (antiretroviral therapy) with at least 3 active molecules Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure) Exclusion Criteria: pregnant woman HIV-2 Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization) Patient receiving aid incompatible with compliance with the use of electronic pillbox

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to dolutegravir measured by the electronic pill boxes | Calculating the total compliance | From baseline up to week 24 | 
| Virologic Efficacy | Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples. | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Genotype resistance if failure |  | Week 16 and 24 |
Cardiotoxicity of Radiation Therapy (CTRT)

Study Overview
=================
Brief Summary
-----------------
The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.

Official Title
-----------------
Cardiotoxicity of Radiation Therapy (CTRT)

Conditions
-----------------
Breast Cancer, Lung Cancer, Mediastinal Lymphomas

Intervention / Treatment
-----------------
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older. Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy. Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose. Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed. Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Ability to read and comprehend English. Exclusion Criteria: Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Patients receiving stereotactic body radiotherapy Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study. Life expectancy less than 12 months Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners) Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study. Non-diagnostic echocardiography windows

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 |
| --- |
|Radiation: Radiation Therapy|less than 1 Gy with protons to 4-8 Gy with photons|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CV injury |  | 8 months |
Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes in Infective Endocaridtis

Study Overview
=================
Brief Summary
-----------------
The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.

Detailed Description
-----------------
Mortality and major complications among infective endocarditis remain high. In addition developing nations are crippled with a high incidence of culture-negative endocarditis and lack of wide availability of transesophageal echocardiography. We intended to identify predictors among admission clinical features, laboratory paramters and culture reports that can help risk stratify patients early in the course of treatment.

Official Title
-----------------
Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes Among Infective Endocaridtis Patients in a Tertiary-care Centre in Kerala

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfillment of modified Duke criteria Exclusion Criteria: No consent inadequate baseline data
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 |
| --- | --- | --- |
| In-hospital mortality |  | 30 days | 
| Major complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who had embolic events |  | 30 days | 
| Number of patients who needed urgent cardiac surgery |  | 30 days | 
| Short term Mortality |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiology, c reactive protein, urgent cardiac surgery
Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.

Official Title
-----------------
Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: TLK286
* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Histologically confirmed non-small cell lung cancer (NSCLC) Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation) Measurable disease by RECIST ECOG status of 0-1 Adequate liver and renal function Adequate bone marrow reserves Exclusion Criteria: Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC Up to one prior adjuvant or neoadjuvant chemotherapy is allowed History of bone marrow transplantation or stem cell support Pregnant or lactating women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triplet Combination of TLK286 Carboplatin & Paclitaxel<br>Experimental | Drug: TLK286<br>* Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²<br>Drug: carboplatin<br>* AUC 6 mg/mL/min Once every 3 weeks<br>Drug: paclitaxel<br>* 200 mg/m² Once every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Objectives | To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin | Every 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer
Safety and Efficacy of CDCA in CTX Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX)

Study Overview
=================
Brief Summary
-----------------
Retrospective study of CTX patients to investigate the safety and clinical efficacy of Chenodeoxycholic Acid

Official Title
-----------------
Retrospective Cohort Study to Investigate the Safety and Efficacy of Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX)

Conditions
-----------------
Cerebrotendinous Xanthomatoses

Intervention / Treatment
-----------------
* Drug: Chenodeoxycholic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CTX Received treatment with CDCA Age between 2 and 75 years Having at least one cholestanol level and/or urinary bile alcohol level no more than 3 months prior to treatment with CDCA and one cholestanol level and/or urinary bile alcohol level post-treatment within 2 years from the beginning of therapy with CDCA Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chenodeoxycholic Acid|Bile acid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Cholestanol Levels |  | 34 years |
Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?

Study Overview
=================
Brief Summary
-----------------
Total hip replacement is a very cost effective procedure to enhance life quality in a group of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions (1). Historically, many different principles have been used from the first resurfacings to cemented and uncemented total hip replacements as we know them today. In 2000, 28 different femoral stems and 26 different acetabular components were in regular use in Norway. There are several well-documented cemented acetabular components, but no such uncemented cup. On the femoral side there are several well-documented stems both cemented and uncemented. (2). From the late 1990's a reverse hybrid (uncemented stem and cemented cup) is being more frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is increasing. (1). This technique is solely based on experience and the fact that one combines the better of two principles (cemented and uncemented). There is no scientific evidence that this technique is as good or better than a cemented THR. One of the potential problems with hydroxyapatite coated components is that it is suspected that it may increase wear due to the particle theory. (3,4). There are no prospective randomised controlled RSA and DXA studies that conclude on this matter. This is such a study and our hypothesis is that there is no difference in wear or osteolysis between the methods.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: Total hip replacement, Spectron and Taperloc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis Indication for THR Exclusion Criteria: Significant anatomical abnormalities Rheumatoid artheritis, dysplasia, fracture sequela

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Total hip replacement, Spectron and Taperloc|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
-----------------
THR, reversed hybrid, wear
Circulating Tumor Cells in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify circulating tumor cells in patients with solid tumors. Quantify and characterize these cells, collect patient information in regards to the patient's cancer. Develop a database and a sample repository where future analysis could be done.

Detailed Description
-----------------
The primary purpose of this correlative study is to create a prospective database documenting the quantity and characterization of circulating tumor cells (CTCs) in solid tumor patients as identified by a various laboratory techniques and analyses. The investigators are developing this resource to provide data to achieve the following objectives: 1) correlate CTCs with known prognostic factors, 2) correlate CTCs with burden of disease, 3) evaluate the ability of CTCs to be used in the surveillance of disease recurrence, and 4) evaluate CTCs ability to be used as a biomarker for treatment response.

Official Title
-----------------
Quantification and Characterization of Circulating Tumor Cells in Solid Tumors

Conditions
-----------------
Solid Tumor, Adult

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years of age Biopsy proven solid tumor malignancy Seen at UNC Chapel Hill Hospital and Health Care System Consents to abstraction of their medical records Signed an institutional review board (IRB)-approved informed consent document for this protocol Exclusion Criteria: < 18 years of age Dementia, altered mental status, incarceration or any psychiatric condition that would prohibit the understanding or rendering of 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

| Intervention/Treatment |
| --- |
|Other: Observational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the Quality of CTCs from Patients with Solid Tumors | Enumeration of participants' circulating solid tumor cells | Through study completion, an average of 5 years | 
| Documentation of the Characterization of CTCs from Patients with Solid Tumors | Characterization of participants' circulating solid tumor cells | Through study completion, an average of 5 years |
A Comparison of Protein Intake Between ERAS and Conventional Care After Elective Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this prospective cohort study is to compare protein intake and adequacy between patients receiving Enhanced Recovery After Surgery (ERAS) protocols with patients receiving conventional care. The study will also compare energy intakes, gut function, and clinical outcomes between groups. The ability of nutritional parameters, including preoperative malnutrition risk and postoperative protein intake, to predict length of hospital stay will be evaluated.

Official Title
-----------------
Higher Protein Intakes Are Associated With Reduced Length of Stay: A Comparison Between ERAS and Conventional Care After Elective Colorectal Surgery

Conditions
-----------------
Colorectal Disorders, Surgery

Intervention / Treatment
-----------------
* Other: ERAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients ≥18 years of age elective colorectal resection Exclusion Criteria: co-morbidities that could have interfered with oral intake (e.g., dysphagia) concurrent enteral or parenteral nutrition prior to surgery were excluded since food intakes could be influenced by these conditions.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enhanced Recovery After Surgery (ERAS)<br>ERAS group followed the ERAS protocol. The protocol was implemented 13 months prior to the start of data collection. | Other: ERAS<br>* Patients in the ERAS group received the ERAS protocol<br>|
| Conventional<br>Conventional group received conventional care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total protein intake (grams) as assessed by food records. | Protein intake from food records on postoperative days 1, 2 and 3 will be recorded. Patients will record the amount of food, fluid, and oral nutrition supplements consumed using quartiles (none, ¼, ½, ¾, all) on a food record. Research staff will verify the self-reported food records with the patients after each meal. Total protein intake in grams will be determined by comparing actual food intake (obtained from the food records) to the food composition records of our institution. | Average in first three postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay (number of days) | Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge. | Number of days spent in hospital during admission for surgery up to 6 months |
Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Official Title
-----------------
A Multinational Multicenter, Randomized , Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients With Stable Angina

Conditions
-----------------
Stable Angina

Intervention / Treatment
-----------------
* Genetic: AdF5FGF-4 vs. Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill Exclusion Criteria: Unstable angina, CCS class 1 angina optimal candidates for revascularization

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ad5FGF-4 | Genetic: AdF5FGF-4 vs. Placebo<br>* Intracoronary infusion<br>|
| Experimental: 2<br>Ad5FGF-4 | Genetic: AdF5FGF-4 vs. Placebo<br>* Intracoronary infusion<br>|
| Placebo Comparator: 3<br>Placebo | Genetic: AdF5FGF-4 vs. Placebo<br>* Intracoronary infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treadmill exercise duration |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to coronary events |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angina, FGF-4, angiogenesis, adenovector, growth factor, myocardial ischemia, revascularization