linjc16/ctgov huggingface dataset:
Impact of Nebivolol on Central Aortic Pressure

Study Overview
=================
Brief Summary
-----------------
A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease.

Official Title
-----------------
Impact of Nebivolol on Central Aortic Pressure

Conditions
-----------------
Central Aortic Pressure

Intervention / Treatment
-----------------
* Drug: Nebivolol
* Drug: Metoprolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with history of hypertension Subjects who have received metoprolol for a minimum of 3 months Exclusion Criteria: Patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebivolol<br>Nebivolol therapy for 2-6 weeks depending on blood pressure readings | Drug: Nebivolol<br>* 10 mg by mouth daily for 2 weeks 20 mg by mouth daily for 2 weeks 40 mg by mouth daily for 2 weeks<br>|
| Experimental: Metoprolol<br>Metoprolol therapy for 2-6 weeks depending on blood pressure readings | Drug: Metoprolol<br>* dosage prescribed prior to starting on study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stable blood pressure | Subjects will be randomized to nebivolol or metoprolol. Their medication will be titrated so that their blood pressure is within 10% of their initial reading. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Metoprolol, central aortic pressure, hypertension
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

Study Overview
=================
Brief Summary
-----------------
Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.

Official Title
-----------------
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: ProbeFix
* Other: Manual hold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing clinically indicated pharmacological stress-echocardiography Willingness to participate Exclusion Criteria: Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis) poor image quality Early termination of the stress-echocardiography examination for clinical reasons

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProbeFix arm<br>The echocardiography probe is fixated on the patient's thorax using the ProbeFix | Other: ProbeFix<br>* ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations<br>|
| Active Comparator: Controll arm<br>The sonographer manually holds the probe on the patient's thorax | Other: Manual hold<br>* ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of stress-echocardiography examination | Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion | During the examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography axis deviation in 4 chamber view | In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed | During the examination |
CT Scalar Localization

Study Overview
=================
Brief Summary
-----------------
Comparing the location of cochlear implants to level of retained hearing.

Detailed Description
-----------------
Subjects who have undergone cochlear implant surgery will have a CT scan to determine the exact anatomical location of the implant. This location will then be compared with audio testing levels and operative reports to determine any advances in implantation technique that would result in more preserved hearing

Official Title
-----------------
CT Scalar Localization of the Electrode Array Following Cochlear Implantation

Conditions
-----------------
Cochlear Implant

Intervention / Treatment
-----------------
* Device: CT Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently scheduled for a cochlear implant or currently have a cochlear implant 18 years of age and over Male and female Capacity to consent for patients will be determined by review of the medical history of subject at screening and in concert with the referring physician. Consent will be signed after all questions have been answered and the participant indicates they understand Exclusion Criteria: Younger than 18 years of age Current criteria for cochlear implantation Currently pregnant, all females will be asked to take a urine pregnancy test if of child bearing age, unless you cannot become pregnant

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 |
| --- | --- |
| 1<br>CT Scan Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6 | Device: CT Scan<br>* CT Scan Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Location | Determining location of implant using CT scan and correlating retained hearing levels | 3 Years |
Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction

Study Overview
=================
Brief Summary
-----------------
the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface

Official Title
-----------------
Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction

Conditions
-----------------
Best Tissue Constituent for Plantar Surface

Intervention / Treatment
-----------------
* Procedure: plantar surface reconstruction by free flaps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Posttraumatic large soft tissue defects of plantar surface requiring free tissue transfer for coverage At any age Exclusion Criteria: 1-defects that can be managed by local flaps 2-Non traumatic soft tissue defects -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| free skin flaps<br> | Procedure: plantar surface reconstruction by free flaps<br>* use of free skin or free muscle flaps for reconstruction of plantar surface<br>|
| free muscle flaps<br> | Procedure: plantar surface reconstruction by free flaps<br>* use of free skin or free muscle flaps for reconstruction of plantar surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to mobilize |  | 2 years | 
| Requirement of specialized Footwear |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flap ulceration |  | 2 years | 
| Shear forces across the flap |  | 2 years |
TRJ Post Market Clinical Follow Up

Study Overview
=================
Brief Summary
-----------------
Clinical and radiological 2 years results of TRJ® Hip Stem.

Official Title
-----------------
TRJ PMCF Köln: 2-years Results

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Device: TRJ® Total Hip Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: TRJ® implantation performed patient consent available for participation in the study Exclusion: permanent cortisone therapy alcohol or drug abuse
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TRJ®<br> | Device: TRJ® Total Hip Arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | Harris Hip Score | 24 months | 
| Osteolysis | Radiological Outcome | 24 months | 
| Ossification | Radiological Outcome | 24 months | 
| Migration | Radiological Outcome | 24 months | 
| TRJ® Implant Position | Radiological Outcome | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total hip arthroplasty, TRJ, PMCF, Hip stem
Carotenoid Rich Diet in Treating Cervical Dysplasia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: A diet rich in carotenoids may be an effective treatment for cervical dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia.

Detailed Description
-----------------
OBJECTIVES: I. Determine whether a carotenoid rich diet will cause a significant increase in the regression of disease in patients with grade I or II cervical intraepithelial dysplasia. II. Determine whether the regression of disease in this patient population is reflected in the modulation of intermediate biological markers (viral genome copy number of human papilloma virus (HPV) and HPV E6/E7 expression). OUTLINE: This is a randomized, controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive dietary counseling and eat 5-10 servings of carotenoid rich fruit and vegetables each day for a year. Arm II: Patients receive no counseling and maintain their normal diet. Carotenoid levels, HPV status, progression of cervical dysplasia, and diet (by food frequency checklist and food diary) are monitored in both groups. PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 5 years.

Official Title
-----------------
Carotenoid-Rich Diet Trial to Reverse CIN II

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Other: preventative dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically proven cervical intraepithelial dysplasia, grade CIN II, or CIN I by repeat cytology No invasive carcinoma by Pap smear No positive endocervical curettage PATIENT CHARACTERISTICS: Age: 18 to 55 (premenopausal) Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent beta carotene supplements Not pregnant or nursing No prior malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 6 months since prior cauterization, cryosurgery, laser, or conization of the cervix

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

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: preventative dietary intervention|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
-----------------
cervical cancer
Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to retrospectively investigate the effect of combined modality treatment of pediatric hepatoblastoma and the factors affecting the prognosis in accordance with the experience at the pediatric oncology department at South Egypt Cancer Institute.

Detailed Description
-----------------
Background: Hepatoblastoma (HB) is the most common malignant liver tumor in children, with an incidence of 0.7 to 1 per million children <15 years of age. Till 1970s, surgery was the primary modality of treatment of HB. Unfortunately, up to 60% of the patients present in an unresectable stage. Later, the chemo- responsiveness of the tumor was demonstrated which led to the incorporation of adjuvant chemotherapy with cisplatinum and doxorubicin in the treatment of HB. International Society of Pediatric Oncology (SIOP) pioneered the concept of neoadjuvant chemotherapy in the management of HB. Patients & Methods: In the period from 2002 January till 2016 January, retrieval & analysis of the medical records of pediatric patients with hepatoblastoma will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. After pathologic confirmation of the diagnosis, these data will be categorized according to patients' demographics, presenting features, laboratory studies, including tumor markers & histologic subtype, radiographic evaluation, disease staging, treatment course given, and subsequent treatment outcomes.

Official Title
-----------------
Combined Modality Therapy in Hepatoblastoma: South Egypt Cancer Institute Experience

Conditions
-----------------
Hepatoblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose age less than 19 years. Patients diagnosed with hepatoblastoma. Exclusion Criteria: Patients whose age more than 18 years.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Overall survival (OS) | Time from the date of initiation of treatment until death from any cause | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 
| Event Free Survival (EFS) | Time from the date of initiation of treatment until disease progression, or death for any reason. | Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood Cancer, Pediatric Oncology
Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

Study Overview
=================
Brief Summary
-----------------
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.

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

Intervention / Treatment
-----------------
* Device: Rainbow DCI and R1-25 sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must understand and consent to be in the study. American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all). Exclusion Criteria: Subjects who have any systemic disease at all. Subjects who do not understand the study and the risks. Smokers. Subjects who are pregnant. Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor. | Device: Rainbow DCI and R1-25 sensor<br>* Noninvasive Measurement of SpHb<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation | Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 1-5 hours per subject |
Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.

Official Title
-----------------
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer

Conditions
-----------------
Gastrointestinal Neoplasms

Intervention / Treatment
-----------------
* Drug: BMS-582664


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good performance status Advanced colorectal, pancreatic, esophageal or gastric cancer Tissue for analyses Adequate bone marrow, hepatic, renal function 4-6 weeks since prior therapy Adequate protection for women of child bearing potential (WOCBP) Exclusion Criteria: Brain metastasis Thromboembolic disease Cardiovascular disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BMS-582664|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw) |  |  | 
| Echocardiogram every 2 cycles (q 2 cycles) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response (q 2 cycles) |  |  | 
| PK parameters (during 1st cycle) |  |  | 
| PD markers (weekly) |  |  | 
| Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Gastrointestinal Malignancies