linjc16/ctgov huggingface dataset:
S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Immobilization devices such as thermoplastic masks are used routinely in the radiation treatment of head and neck cancer patients. It is important to assess how well they function at preventing patient motion while the radiation treatment is being delivered. (i.e. isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks such as MedTec S-frame allow less movement, then smaller margins are needed during radiation therapy which, in turn, would decrease side effects from the treatment.

Official Title
-----------------
Evaluation of Setup Accuracy in Med Tec S-Frame Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Device: MedTec S-frame Immobilization Masks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmation of mucosal malignancy in the head and neck (H&N) region Undergoing radiotherapy (RT) with curative intent using a lateral parallel pair treatment with an anterior or anterior/posterior low neck filed technique using a MedTec S-frame mask

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

| Intervention/Treatment |
| --- |
|Device: MedTec S-frame Immobilization Masks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the accuracy of MedTec S-frame head and neck immobilization system (isocentre set-up accuracy, patient movement margins and movement of the normal tissue critical structures and planning target volumes) |  |  |
The High Cup/Disc Ratio in Children

Study Overview
=================
Brief Summary
-----------------
To investigate of high cup/disc ratio in children.

Detailed Description
-----------------
ophthalmologic examination cycloplegic refraction axial length and anterior chamber depth intraocular pressure B. optic nerve head and retinal nerve fiber layer disc photography Heidelberg Retina Tomograph

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high cup/disc ratio more than 0.5 age : five to twelve Exclusion Criteria: previous surgery (except strabismus surgery) previous glaucomatous medication history poor cooperated children.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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
-----------------
high cup disc ratio, glaucoma suspect
Correlation Between the Severity of Coronary Artery Disease and Peripheral Arterial Stiffness in Patients With Premature Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
Premature coronary heart disease (CHD) refers to the onset of myocardial infarction in men < 55 years old, women < 65 years old. At present, researches on early-onset coronary heart disease mostly focus on its risk factors and clinical characteristics, but there is no relevant research on the relationship between early-onset myocardial infarction and atherosclerosis.

Detailed Description
-----------------
Premature coronary heart disease is defined as the first onset of male < 55 years old, female < 65 years old, confirmed by clinical examination. A number of studies have found that smokers have a significantly increased risk of acute myocardial infarction, and suggest that continued smoking is still an independent predictor of mace. These findings suggest that smoking is significantly associated with early-onset coronary heart disease. A number of studies have found that smoking can increase peripheral arterial stiffness. At present, there is no study on peripheral arterial stiffness in patients with early-onset myocardial infarction, so we suspect that peripheral arterial stiffness in patients with early-onset myocardial infarction is significantly increased

Official Title
-----------------
Correlation Between the Severity of Coronary Artery Disease and Peripheral Arterial Stiffness in Patients With Premature Coronary Heart Disease

Conditions
-----------------
Premature Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The onset of coronary heart disease (including acute coronary syndrome and stable angina pectoris) was less than 55 years old in men and 65 years in women Exclusion Criteria: Non coronary heart disease leading to chest pain (myocarditis, pericarditis, pulmonary embolism, aortic dissection, unstable angina pectoris) definite infection tumor liver and kidney insufficiency autoimmune disease acromegaly hyperthyroidism and subclinical hyperthyroidism secondary hypertension, etc.
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 |
| --- | --- | --- |
| Arterial stiffness | The arterial stiffness of HFpEF patients, for exampleambulatory arterial stiffness indexbrachial ankle pulse wave velocity, ardioankle vascular index and so on. | On admission | 
| Degree of coronary stenosis | Degree of coronary stenosis indicated by coronary angiography | On admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature coronary heart disease, Degree of coronary stenosis, arterial stiffness
Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.

Official Title
-----------------
Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved). The ability to understand and willingness to sign a written informed consent are necessary. Exclusion Criteria: Patients with tumor parameters that fall outside of the inclusion criteria. Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease. Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP). A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration. The use of other concurrent investigational agents. There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease. No life expectancy restrictions will apply. Performance status will not be considered.

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

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

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 |
| --- | --- | --- |
| To quantify patient quality of life after prostate SBRT using validated questionnaire tools |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T1c, T2a, T2b
Lung Injury Prediction Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to externally validate the acute lung injury/acute respiratory distress syndrome (ALI/ARDS) prediction model (Lung Injury Prediction Score - LIPS) in a multicenter sample of patients at risk presented to the acute care hospitals: United States Critical Illness and Injury Trials Group (USCIITG).

Official Title
-----------------
Identifying Patients at Risk of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) at the Time of Hospital Admission: External Validation of a Lung Injury Prediction Score (LIPS)

Conditions
-----------------
Respiratory Distress, Acute Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission Exclusion Criteria: ALI/ARDS already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital

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 |
| --- | --- | --- |
| Acute Lung Injury or Acute Respiratory Distress Syndrome |  | during hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | in hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory distress, adult, risk, emergency room, high risk surgery, sepsis, trauma, aspiration, pneumonia
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

Study Overview
=================
Brief Summary
-----------------
The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.

Official Title
-----------------
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study

Conditions
-----------------
Acromioclavicular Joint Dislocation

Intervention / Treatment
-----------------
* Procedure: hook plate
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood men and women 18-65 years and able to work understand spoken and/or written Swedish or English language be able to start treatment within 3 weeks from trauma consent form signed Exclusion Criteria: earlier injury to, or surgery of either of the shoulders simultaneous fracture of the clavicle or acromion associates neurovascular injury severe osteoporosis open dislocation open growth plate of the acromion local skin damage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative treatment<br>Operative treatment with hook plate. | Procedure: hook plate<br>* Surgery with hook plate followed by physiotherapy<br>* Other names: hook plate by Synthes;|
| Active Comparator: Conservative treatment<br>Physiotherapy | Other: Physiotherapy<br>* Patients will be following a program specific for AC joint dislocations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score |  | change from Baseline in Constant Score at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of Arm, Shoulder and Hand function (QuickDASH) |  | change from Baseline in QuickDASH at 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acromioclavicular joint dislocation, ac joint dislocation, acromioclavicular joint separation, hook plate, Rockwood
Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.

Official Title
-----------------
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients

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

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: Cyclophosphamide
* Drug: Vincristine
* Drug: Prednisone
* Drug: Doxorubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL; Age >= 18 years; Presence of at least 1 factor that defines the cardiopathy; Life expectancy > 3 months; In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; Written informed consent. Exclusion Criteria: Histology different from NHL diffuse large cell CD20 + or follicular IIIb Age < 18 years Inability to sign informed consent; HIV positivity; Patients HBsAg positive; AST/ALT > 2 times the standard; Bilirubin > 2 times the standard; Creatinine > 2.5 mg / dl; Location of CNS disease; Pregnancy ongoing; Damage to that organ or medical problems that could interfere with the therapy; Current uncontrolled infection; Senile dementia

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

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>R-COMP | Drug: Rituximab<br>* 375 mg/m2 day 1<br>Drug: Cyclophosphamide<br>* 750 mg/m2 day 2<br>Drug: Vincristine<br>* 1,4 mg/m2 (max 2 mg) day 2<br>Drug: Prednisone<br>* 40 mg/m2 day 2-6<br>Drug: Doxorubicin<br>* 50 mg/m2 day 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of R-COMP in cardiopathic patients |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates |  | 1 year | 
| Progression free survival |  | 2 years | 
| Overall Survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diffuse Large B-Cell Lymphoma
Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study

Study Overview
=================
Brief Summary
-----------------
A prospective multicenter study including all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision). Patients will be screened for glycemic control using HbA1c levels, fructosamine levels, and blood glucose levels. Blood samples will be obtained at the preadmission testing (PAT) within 30 days of surgery. On postoperative day 1 (POD-1), morning glucose levels will be obtained for all patients as well. Patients will be followed up for 90 days postop. Study aims To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes. To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes. To determine the best threshold of fructosamine to determine adverse outcomes.

Official Title
-----------------
Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision) 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic<br> | |
| Non-diabetic<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic Joint Infection |  | within 90 days of surgery |
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

Detailed Description
-----------------
General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality. The following are our specific goals in this endeavor; To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a >10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.

Official Title
-----------------
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the Claus Model). May have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations.

Detailed Description
-----------------
Patients are randomized to two study arms for at least 48 weeks of treatment. Arm A receives SQV SGC plus RTV plus two NRTIs of choice. Arm B receives EFV plus two NRTIs of choice. NRTIs approved for study use are stavudine (d4T), didanosine (ddI), zidovudine (AZT), lamivudine (3TC), Combivir, and zalcitabine (ddC). Abacavir is excluded. The following immunology variables and HIV-1 viral characteristics will be evaluated during study visits: CD4 and CD8 cell counts; naive and memory T-cells; T-cell activation markers (HLA-DR and CD38); T-cells expressing T helper 1- (TH1-) and T helper 2- (TH2-) associated intracytoplasmic cytokines; anti-CD3 T-cell activation responses; T-cell receptor V Beta repertoire; cytotoxic T-lymphocyte (CTL) activity levels; lymph node histology (optional); HIV-1 qualitative microcultures and viral phenotyping for non-syncytium-inducing (NSI) and syncytium-inducing (SI) viral isolates. Laboratory determinations, adverse effects, neurological exams (including mental status evaluations), and lipodystrophy parameters (including fasting lipid profile and physical parameters) also are evaluated.

Official Title
-----------------
Evaluation of Immune Reconstitution in HIV Infected Patients Treated With Fortovase (Saquinavir) SGC QD Plus Ritonavir QD Plus 2 NRTIs Vs Efavirenz QD Plus 2 NRTIs

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Ritonavir
* Drug: Efavirenz
* Drug: Saquinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load of at least 5,000 copies/ml and a CD4 cell count greater than 75 cells/mm3. Are at least 16 (need consent of parent or guardian if under 18). Are able to complete the study. Exclusion Criteria Patients will not be eligible for this study if they: Have ever taken anti-HIV medications. Are pregnant or breast-feeding.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritonavir|nan|
|Drug: Efavirenz|nan|
|Drug: Saquinavir|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
-----------------
Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz