linjc16/ctgov huggingface dataset:
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast

Study Overview
=================
Brief Summary
-----------------
By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins. Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.

Official Title
-----------------
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast.

Conditions
-----------------
Carcinoma Breast

Intervention / Treatment
-----------------
* Procedure: Breast conservative surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years; female candidate to breast conservative surgery Exclusion Criteria: female with previous omolateral or controlateral breast cancer; female with previous radiotherapy (RT).

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

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

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 |
| --- |
|Procedure: Breast conservative surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ipsilateral Breast Tumor Recurrence (IBTR) |  | six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contralateral breast cancer (CBC) | the side effects of radiotherapy may outweigh the reduction in the risk of IBTR | six years |
Physical Activity Effects on Health Care Utilization

Study Overview
=================
Brief Summary
-----------------
To determine the magnitude of the relationship between physical activity level and subsequent health care utilization over a seven to ten week period in a general population.

Detailed Description
-----------------
BACKGROUND: In recent years, the benefits of a physically active lifestyle have been well established with respect to chronic health problems such as coronary heart disease, hypertension, obesity and osteoporosis. However, the extent to which physical activity influences health care utilization is less clear. If physical activity levels are inversely associated with utilization patterns, then policies encouraging exercise may produce short-term reduction in health care costs. DESIGN NARRATIVE: A multivariate regression analysis was conducted for a representative sample of more than 600 adults who participated in a longitudinal field trial of health risk appraisal instruments. Using the Harvard Alumni Activity Survey as the physical activity measure, the analysis controlled for a variety of predisposing, enabling, and need characteristics that also influenced utilization behavior. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study investigating the utility of 7 Tesla MRI to quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease and in at-risk cohorts at a premotor state of Parkinson's disease.

Official Title
-----------------
Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease

Conditions
-----------------
Parkinson Disease, REM Sleep Behavior Disorder

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep behavior disorder without signs/symptoms of Parkinson's disease. Age-matched controls. Exclusion Criteria: Atypical Parkinsonism Contraindications for MRI

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early onset Parkinson's disease<br>Idiopathic Parkinson's disease within 1 year of symptom onset | Other: MRI<br> <br> |
| Idiopathic REM Sleep Behavior Disorder<br>Idiopathic REM Sleep Behavior Disorder | Other: MRI<br> <br> |
| Age-matched healthy controls<br>Age-matched healthy controls | Other: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative signal analysis of nigrosome 1 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quantitative signal analysis of nigrosome 1 |  | 3 years |
Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome

Study Overview
=================
Brief Summary
-----------------
There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.

Detailed Description
-----------------
Evaluation of the serum carbon dioxide gradient (GapCO2), central venous saturation (ScvO2) and the clearance of serum lactate (Clac) in predicting hospital mortality after cardiac arrest syndrome (post-PCR). Prospective study, unicenter - Intensive Care Unit - HNSC. Period: May/2010 to June/2011. Serial assessment of GapCO2 of ScvO2 Clac and the first 72 hours post-PCR. Excluded under 18, survival of less than 6HS, pregnant women, traumatized, post-operative hypothermia and liver disease. T-student test, 95% (p <0.05).

Official Title
-----------------
Relationship Between Lactate and Venous Oxygen Saturation Gradient of Carbon Dioxide in Patients With Post Cardio Respiratory Syndrome

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace Exclusion Criteria: pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease. patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest less 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all patients after cardiac arrest<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of clearance markers of perfusion with the use of vasopressor and positive fluid balance |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest
Evaluation of Tetrix Cream in the Healing of Injured Skin in Subjects With Contact Dermatitis

Study Overview
=================
Brief Summary
-----------------
To determine if Tetrix Cream,, when applied to the skin lesions on patients with contact dermatitis, slows or interferes with the healing of the lesions.

Official Title
-----------------
A Study to Determine if Tetrix Cream Impedes the Resolution of Experimentally Induced Allergic Contact Dermatitis

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

Intervention / Treatment
-----------------
* Device: Tetrix
* Device: Tetrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects with sensitivity to nickel. Exclusion Criteria: Under 18 years of age.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Twice daily topical application | Device: Tetrix<br>* Twice daily topical application<br>|
| Placebo Comparator: 2<br>Twice daily topical application | Device: Tetrix<br>* Twice daily topical application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearing of signs and symptoms of contact dermatitis |  | 10 days after induction of lesion and start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tetrix Cream, Antigen reaction, effect on healing, To determine if application of Tetrix Cream to lesions of contact dermatitis interferes with their rate of healing
Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

Study Overview
=================
Brief Summary
-----------------
This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Detailed Description
-----------------
This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Official Title
-----------------
STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.

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

Intervention / Treatment
-----------------
* Device: Receives SCOUT at biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman >18 years and < 80 years of age; Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5; Lesion depth is < 6 cm from skin surface; Non-palpable lesions; Informed consent obtained. Exclusion Criteria: Multicentric breast cancer; Pregnant or lactating; Known or suspected nickel-titanium allergy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: Device<br>Receives SCOUT at biopsy | Device: Receives SCOUT at biopsy<br>* SCOUT Reflector<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of invasive visits | Number of visits to the breast centre for an invasive procedure between biopsy and surgery | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate | Device-related adverse event rate | through study completion; an average of 6 months | 
| Performance | Rate of successful procedure | through study completion; an average of 6 months |
The Efficacy of Surgical Site Treatment With Ropivacaine in Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

Detailed Description
-----------------
At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs

Official Title
-----------------
Local Analgesia in Laparoscopic Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Topical use
* Other: laparoscopic repair of inguinal hernia
* Other: laparoscopic bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic bariatric surgery Laparoscopic inguinal hernia surgery Exclusion Criteria: Cardiac arrythmias Active ischemic heart disease pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ropivacaine<br>Topical use of Ropivacaine | Drug: Topical use<br>* Topical use of Ropivacaine in laparoscopic surgery<br>* Other names: Placebo;Other: laparoscopic repair of inguinal hernia<br>* intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia<br>Other: laparoscopic bariatric surgery<br>* intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery<br>|
| Placebo Comparator: Placebo<br>Topical use of placebo | Drug: Topical use<br>* Topical use of Ropivacaine in laparoscopic surgery<br>* Other names: Placebo;Other: laparoscopic repair of inguinal hernia<br>* intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia<br>Other: laparoscopic bariatric surgery<br>* intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale as measured by pain scale questionnaire | post operative pain intensity will be assisted by VAS(visual analog pain scale) scale at fixed times after surgery | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing use of narcotics according to nurse records | patients will be treated by standard analgetic protocol, the records of analgetic drugs will be collected during patients hospitalization | 1 Week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery
Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.

Official Title
-----------------
Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.

Conditions
-----------------
Lymphoma, Osteoporosis

Intervention / Treatment
-----------------
* Radiation: Bone densitometry.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 18 to 80 with lymphoma, Histological diagnosis of Hodgkin's lymphoma (HL) or non-Hodgkin lymphoma (NHL) of follicular or aggressive (large cell or other), Patients who have not yet started their chemotherapy or who have started for less than a month Patient has signed informed consent. Exclusion Criteria: Pathological fractures at the time of initial diagnosis of lymphoma, Compression of neurological epidural, Patients receiving treatment for osteoporosis (including bisphosphonates, selective modulators of estrogen receptor, calcitonin and parathyroid hormone Teriparatide). Discovery of osteoporosis or osteopenia fracture during the initial evaluation requiring the establishment of an osteoporosis treatment, Radiotherapy to the lumbar spine or hip studied, Location of bone lymphoma in the lumbar spine or hip studied, History of disorders affecting bone metabolism (prostate cancer with androgen, stomach cancer, hyperparathyroidism, hyperthyroidism, uncontrolled ...) A person incapable of giving consent personally, Pregnant or breastfeeding women, Protected Person (under guardianship) Patient not affiliated with a social security system.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lymphoma<br> | Radiation: Bone densitometry.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of bone mineral density (BMD). | Patients will have a review of bone densitometry. | Change from Baseline of bone mineral density at 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Osteoporosis, Chemotherapy, Patient with
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

Official Title
-----------------
Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency

Conditions
-----------------
Hepatic Insufficiency, Healthy

Intervention / Treatment
-----------------
* Drug: FYU-981


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy subjects or adult cirrhosis patients Body mass index: >=18.5 and <30.0 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal group<br>Healthy control subjects | Drug: FYU-981<br>* Oral single dosing<br>|
| Experimental: Mild hepatic-insufficient group<br>Patients with mild hepatic impaired function (Child-Pugh A) | Drug: FYU-981<br>* Oral single dosing<br>|
| Experimental: Moderate hepatic-insufficient group<br>Patients with moderate hepatic impaired function (Child-Pugh B) | Drug: FYU-981<br>* Oral single dosing<br>|
| Experimental: Severe hepatic-insufficient group<br>Patients with severe hepatic impaired function (Child-Pugh C) | Drug: FYU-981<br>* Oral single dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 48 hours | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 48 hours | 
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) |  | 48 hours | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 48 hours | 
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 48 hours | 
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (MRT: Mean residence time) |  | 48 hours | 
| Pharmacodynamics (Serum concentration of uric acid) |  | 48 hours | 
| Pharmacodynamics (Amount of uric acid excreted in urine) |  | 48 hours | 
| Safety (Incidence of treatment-emergent adverse events) |  | 192 hours |