linjc16/ctgov huggingface dataset:
Improving Genetic Counseling for BRCA+ Mothers

Study Overview
=================
Brief Summary
-----------------
Genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. This includes biological children, both male and female. We do not yet know the best ways to educate mothers who have a risk gene (are BRCA+) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. The purpose of this study is to help mothers make more informed choices about talking with children about hereditary breast cancer, provide them with age-and gender-appropriate information and emotional support, and improve their psychological well-being.

Official Title
-----------------
Parent Communication Study IV: Improving Genetic Counseling for BRCA+ Mothers

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

Intervention / Treatment
-----------------
* Behavioral: Education and counseling
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers/primary caregivers to adolescents/young adults ages 13-24 years-old. Participating in genetic testing for hereditary breast cancer. Adequately speak/read English. Exclusion Criteria: - Does not meet inclusion criteria.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br> | Behavioral: Education<br>* Education includes a workbook.<br>|
| Experimental: Enhanced Care<br> | Behavioral: Education and counseling<br>* Education includes a workbook, counseling includes peer support.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication | Parent-child and family communication of hereditary cancer risk. | 1- and 6-months post-treatment |
An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.

Official Title
-----------------
An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Conditions
-----------------
Renal Cell Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Advanced and/or metastatic renal cell carcinoma Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label At least one measurable and non-measurable lesion according to RECIST criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate bone marrow, renal and liver function Exclusion Criteria: Contraindications to Avastin and/or interferon alpha-2a as per local label

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival: time from first drug administration to documented disease progression or death of any cause |  | approximately 4 years | 
| Overall response rate: complete response or partial response according to RECIST criteria |  | approximately 4 years | 
| Overall survival |  | approximately 4 years |
Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study aims to learn more about avoidance of hyperglycaemia in adults with type 1 diabetes. People who attend a type 1 diabetes clinic will be invited to complete a number of self-report questionnaires and a survey. A subsection of people who experience avoidance of hyperglycaemia will be invited to take part in an interview in order to gain a more in-depth understanding of this issue.

Official Title
-----------------
Avoidance of Hyperglycaemia in People With Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes of at least 6 months duration Exclusion Criteria: Inability to understand or write in the English language Pregnant women Unable to participate in the study due to other factors, as assessed by the Chief Investigators

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 |
| --- | --- |
| Questionnaire group<br>Individuals who attend the type 1 diabetes clinic will complete a number of self-report questionnaires and a survey. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycaemia Avoidance Scale | Questionnaire. Scored 0-96, with higher scores suggesting greater hyperglycaemia avoidance | Baseline | 
| General Anxiety Disorder-7 (GAD-7) | Questionnaire. Scored 0-21, with higher scores suggesting greater anxiety | Baseline | 
| Patient Health Questionnaire 9 (PHQ-9) | Questionnaire. Scored 0-27, with higher scores suggesting greater depression | Baseline | 
| State Trait Anxiety Inventory - Trait Subscale | Questionnaire. Scored 20-80, with higher scores suggesting higher levels of trait anxiety | Baseline | 
| Hypoglycaemia Fear Survey 2 - Behaviour Subscale | Questionnaire. Behaviour subscale scored 0-60; Worry subscale scored 0-72, in both cases with higher scores suggesting greater fear of hypoglycaemia. Please see outcome measure 7 for worry subscale results. | Baseline | 
| Problem Areas in Diabetes 5 | Questionnaire. Scored 0-20, with higher scores suggesting greater diabetes stress. | Baseline | 
| Hypoglycaemia Fear Survey 2 - Worry Subscale | Questionnaire. Behaviour subscale scored 0-60; Worry subscale scored 0-72, in both cases with higher scores suggesting greater fear of hypoglycaemia Please see outcome measure 5 for behaviour subscale results. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Hyperglycaemia, Psychology
Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes

Study Overview
=================
Brief Summary
-----------------
The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.

Conditions
-----------------
Shoulder Instability

Intervention / Treatment
-----------------
* Procedure: Open Latarjet technique
* Procedure: Arthroscopic Latarjet techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 15 years Traumatic anterior shoulder instability Recurrent instability Glenoid defects larger than 25% Clinical and radiographic data at pre-operation and follow-up Exclusion Criteria: Younger than 18 years Non-traumatic shoulder instability Primary episode of instability Glenoid defects less than 25% Previous surgical procedure Incomplete clinical or radiographic data Combination with rotator cuff tear

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroscopic Latarjet technique<br>Arthroscopic Latarjet technique | Procedure: Arthroscopic Latarjet techniques<br> <br> |
| Active Comparator: Open Latarjet technique<br>Open Latarjet technique | Procedure: Open Latarjet technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The functional and clinical outcomes are evaluated with the range of motion(ROM),VAS scores, UCLA scores, Constant scores, ASES scores and SST scores. The radiographic outcome is also assessed with X-ray plain film . |  | up to 3 years |
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.

Detailed Description
-----------------
Our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery

Official Title
-----------------
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Device: hypothermic CPB
* Device: normothermic CPB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: requirement of surgical correction of two or more valves

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normothermic CPB<br>cardiopulmonary bypass with maintenance of normal body temperature | Device: normothermic CPB<br>* maintenance of normal body temperature during cardiopulmonary bypass<br>|
| Active Comparator: hypothermic CPB<br>cardiopulmonary bypass using mild hypothermia | Device: hypothermic CPB<br>* maintenance of mild hypothermia during cardiopulmonary bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygen saturation | measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively | perioperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time until fit for ICU discharge fulfillment | measurement of time to fulfillment of the fit for discharge criteria | 5 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perfusion, cardiopulmonary bypass, hypothermia, cerebral oxygenation
TRK-100STP Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Study Overview
=================
Brief Summary
-----------------
In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease: To confirm the superiority of TRK-100STP over placebo To determine the recommended therapeutic dose in the 2 doses of TRK-100STP To assess the safety of TRK-100STP

Official Title
-----------------
TRK-100STP PhaseIIb/III Clinical Study - Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Conditions
-----------------
Chronic Renal Failure, Glomerular Disease, Nephrosclerosis

Intervention / Treatment
-----------------
* Drug: TRK-100STP high dose
* Drug: TRK-100STP low dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease The patient with progressive CRF Exclusion Criteria: The patient with secondary glomerular disease The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRK-100STP<br> | Drug: TRK-100STP high dose<br> <br> Drug: TRK-100STP low dose<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal composite endpoints [Time to first occurrence of one of the following events:] | (i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value (ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher | 2-4 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESRD, Chronic Renal Failure, Prostaglandin, Prostacyclin, Asian Multinational Study
Evaluation of Allergy to Potato in a Large Cohort

Study Overview
=================
Brief Summary
-----------------
Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever suspicion of allergy were asked to participate in the study. Besides a standard battery of respiratory allergens, native raw and cooked potato were tested by means of the prick to prick method, using a metal lancet.

Official Title
-----------------
Study of Sensitization to Potato in Patients Consulting at the Allergy Unit in Montpellier

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Other: Prick to prick test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients aged 2 years or older consent obtained from patients or their parents/legal representative Exclusion criteria: refusal to participate in the study antihistamine drugs taken before testing pregnant women vulnerable patients according to French regulation

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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 |
| --- | --- |
| Other: Prick to prick<br> | Other: Prick to prick test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sensitization and allergy to potato |  | 35 months after the first inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of risk factors of sensitization to raw potato |  | 35 months after the first inclusion | 
| Rate of risk factors of sensitization to cooked potato |  | 35 months after the first inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, cross-reactivity, oral allergy syndrome, potato, sensitization
Septic Encephalopathy and Late Cognitive Dysfunction

Study Overview
=================
Brief Summary
-----------------
Delirium and long-term cognitive dysfunction are important problems in intensive care patients. Patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction. Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to therapeutically influence the inflammatory response and its effects on the brain.

Official Title
-----------------
Septic Encephalopathy and Late Cognitive Dysfunction in Patients With Sepsis - the Role of Inflammation

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

Intervention / Treatment
-----------------
* Drug: n-3 fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock Age 18 or older Exclusion Criteria: Primary infection of the CNS History of cerebrovascular disease History of any neoplasia involving the CNS History of long-term psychiatric medication History of allergy to fish- or egg-protein Severe coagulation abnormalities Clinical signs of altered coagulation, active bleeding Pregnancy

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br> | Drug: n-3 fatty acids<br> <br> |
| No Intervention: No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Absorbable Sutures in Perineal Laceration Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.

Conditions
-----------------
Perineal Laceration Repair

Intervention / Treatment
-----------------
* Device: Absorbable Sutures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Able to sign informed consent Vaginal laceration that requires sutures but does not involve the anal sphincter (third-degree tear) or rectal mucosa (fourth-degree tear) Exclusion Criteria: Inability to speak and understand English or Spanish Previous diagnosis of vulvodynia, dyspareunia, or other chronic vulvar pain syndrome Extensive perineal warts or vulvar varicosities

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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Absorbable Sutures|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
-----------------
perineal trauma, perineal laceration, persistent perineal pain
Monitoring by Microdialysis of Postoperative Complications After Proctectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.

Official Title
-----------------
Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Device: cma microdialysis catheter placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal disease requiring proctectomy with anastomosis and stomy proctectomy by laparoscopy or laparotomy written consent Exclusion Criteria: history of colorectal surgery rectal surgery without anastomosis breastfeeding or pregnancy ASA score IV

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cma microdialysis catheter placement<br>At the end of the surgery the cma microdialysis catheter is placed near the anastomosis | Device: cma microdialysis catheter placement<br>* the microdialysis catheters are sold by CMA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic leaks rate | the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan or at the clinical examination | postoperative day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| superficial surgical site infection rate | the surgical site infection rate is defined as the number of infection near the incision | postoperative day 30 | 
| functional success of microdialysis | the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter | postoperative day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectum, microdialysis, anastomotic leaks