linjc16/ctgov huggingface dataset:
Breast Cancer Tumor Heterogeneity

Study Overview
=================
Brief Summary
-----------------
Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.

Official Title
-----------------
Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?

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

Intervention / Treatment
-----------------
* Other: Post Surgical Her2 testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women > age 18 with capacity to consent Invasive breast cancer identified on CNB at AAMC within 45 days of study consent IHC biomarkers performed on original CNB (including HER2) Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or Multifocal or multicentric tumors Exclusion Criteria: Men Women with HER2 positive tumors detected on CNB specimens Women receiving neoadjuvant chemotherapy Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment Women whose IHC marker results were inconclusive on CNB or not performed -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>Post Surgical Her2 testing | Other: Post Surgical Her2 testing<br>* Eligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of additional Her2 testing | To identify a subset of women with invasive breast cancer who may benefit from additional Her2 testing (by immunochemistry and FISH) on their surgical specimen to ensure that areas of Her2 amplification are not missed due to sampling error of the core needle biopsy. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer Heterogeneity Her2
Dexmedetomidine on Pediatric Heart Operation

Study Overview
=================
Brief Summary
-----------------
we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Detailed Description
-----------------
dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic stability for operative procedure. It had been already reported that dexmedetomidine reduce the impairment of renal functon after cardiac operation in adult. we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Official Title
-----------------
Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study

Conditions
-----------------
Acute Renal Injury

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: no dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-6yr pediatric cardiac patients Exclusion Criteria: previous renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 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: no dexmedetomidine<br>no administration of dexmedetomidine | Drug: no dexmedetomidine<br>* no administration of dexmedetomidine on control group<br>* Other names: no administration of dexmedetomidine;|
| Active Comparator: dexmedetomidine<br>administration of 0.5ug/kg dexmedetomidine for 10 min and infusion of 0.5ug/kg/h of dexmedetomidine until weaning of cardiopulmonary bypass | Drug: Dexmedetomidine<br>* administration of dexmedetomidine on dexemedetomidine group<br>* Other names: administration of dexmedetomidine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function | at immediate after anesthetic induction (baseline), after weaning of cardiopulmonary bypass, 2h after end of operationCPB, sodium and creatinine in the urine and serum, N-acetyl-b-glucosaminidase (NAG)and albumin in only urine could be studied | from anesthetic induction up to postoperative 2h |
Effects of Heating Massaging Vibrating Vicinity of the Insulin Delivery Site

Study Overview
=================
Brief Summary
-----------------
The aim of this experiment is to test the pharmacodynamics and pharmacokinetics of insulin analogs and their dependence on external and physiological alterations. The investigators plan compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming, movement and topical application of Capsaicin cream. The investigators will also test the effect of local heating and topical application of Capsaicin cream on the post prandial glucose levels following a bolus.

Official Title
-----------------
Protocol for Evaluation of the Effects of Heating Massaging Vibrating or Application of Topical Agent on the Vicinity of the Insulin Delivery Site

Conditions
-----------------
DIABETES

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant age between 18- 65 years old Type I or Type II diabetes HbA1c 6-12% Does not suffer from sever hypertension, kidney, liver or heart disease Does not suffer from active Ischemic heart disease Is willing to sign the consent form Exclusion Criteria: Participants age < 18 or > 65 Pregnancy Breast feeding women Un-controlled diabetes, HbA1c values > 12% range Suffers from active Ischemic heart disease Alcohol addiction Is not prepared to signed the informed consent

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DIABETES, PHARMACOKINETICS, PHARMACODYNAMICS, INSULIN
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in addition to standard treatment (arm I) or standard treatment only (arm II). Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. Patients may receive up to 3 courses. Standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels. If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment arm originally assigned. Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter.

Conditions
-----------------
Lead Poisoning

Intervention / Treatment
-----------------
* Drug: succimer


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Asymptomatic children with confirmed venous blood lead of at least 20 mcg/dL and less than 45 mcg/dL Children with blood lead of 45 mcg/dL or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --Patient Characteristics-- Other: No contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: succimer|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
-----------------
environmental/toxic disorders, lead poisoning, rare disease
Institut Paoli Calmettes Acute Leukemia Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia

Official Title
-----------------
Institut Paoli Calmettes Acute Leukemia Database

Conditions
-----------------
Acute Leukemia Diagnosis

Intervention / Treatment
-----------------
* Other: Clinical data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of acute leukemia Exclusion Criteria: Non applicable

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 |
| --- | --- |
| Patient with new diagnosis of Acute Leukemia<br> | Other: Clinical data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with acute leukemia | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments

Study Overview
=================
Brief Summary
-----------------
The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.

Conditions
-----------------
Group A- 23 Implant Using Switch Platform -SPK Abutment., Group B- 22 Implant Using the Traditional -CPK Abutment.

Intervention / Treatment
-----------------
* Procedure: spk
* Procedure: CPK Abutments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient aged 18 - 80 yrs. Implants treatment planned for single crown rehabilitation. Submerged implant placement. Patients willing to participate in a twelve month study. Up to 2 implants per patient will be allowed. Exclusion Criteria: Active periodontal disease. Systemic condition and medication that may affect soft and hard tissue healing. Pregnancy or intention to become pregnant in the next twelve months. Parafunctional occlusal scheme and habits.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>23 implants using SPK Abutments | Procedure: spk<br>* implants using SPK Abutments<br>|
| Active Comparator: Group B<br>implants using CPK Abutments | Procedure: CPK Abutments<br>* implants using CPK Abutments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue evaluation: | Three month following abutment connection (approximately 2 months following cementation of the final crowns) baseline measurement will be taken. This will include probing pockets depth (PPD) and bleeding on probing (BOP) dichotomized in to 0 and 1 This measurement will be repeated at 12 month post surgery. | 12 month | 
| Radiographic evaluation: | Bite wing radiographs will be used to assess changes in radiographic bone height. Baseline radiographs will be taking immediately following abutment connection and final radiographic evaluation will be taken 12 months post surgery. | 12 month post surgery |
Spinal Stabilization Exercise Effects in Hypermobility

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome

Official Title
-----------------
Assistant Professor

Conditions
-----------------
Hypermobility Syndrome

Intervention / Treatment
-----------------
* Behavioral: spinal stabilizaton exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers in an age range of 18 to 30, being women, having benign joint hypermobility syndrome diagnosed according to the Brighton criteria, having no contraindication to join an exercise program. Exclusion Criteria: having rheumatologic or neurologic diseases, any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains, associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta, severe psychological disorders, being pregnant, intervention including exercise or physical therapy in the last 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>spinal stabilization exercise program was applied | Behavioral: spinal stabilizaton exercise<br>* In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in musculoskeletal pain intensity as measured by Visual Analog Scale |  | Change from baseline musculoskeletal pain intensity at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests |  | Change from baseline trunk muscle endurance at 8 weeks | 
| Change in postural stability as measured with Biodex Balance System SD |  | Change from baseline postural stability at 8 weeks |
Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..

Official Title
-----------------
Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Subjects with a diagnosis of GERD and with predominant typical GERD symptoms: heartburn/regurgitation Subjects who fail to obtain satisfactory symptomatic response after their first full course (4-8 weeks) of standard dose PPI (once a day) Exclusion Criteria: Inability to read and/or understand Patient Reported Outcomes questionnaires Subjects where the only reason for the visit is renewing the prescription A history of an incomplete response to PPI treatment prior to current course of treatment

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 |
| --- | --- | --- |
| To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms |  | Once, at first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the frequency and severity of extra-oesophageal and/or atypical GERD symptoms and to assess the concordance between patient-reported and physician-reported symptom load |  | Once, at first visit | 
| To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit |  | Once, at first visit | 
| To describe the impact of persistent GERD symptoms on work productivity |  | Once, at first visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, PPI
Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels for no apparent reason. The pulmonary artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the heart's pumping chambers) to the lungs. In the lungs, the blood picks up oxygen, then flows to the heart's left side, where the left ventricle pumps it to the rest of the body through the aorta. In the United States, an estimated 500 to 1,000 new cases of primary pulmonary hypertension are diagnosed each year. The greatest number is reported in women between ages 20 and 40. However, men and women in all age ranges as well as very young children can develop PPH. Researchers have identified more than 40 BMPR2 mutations that can cause primary pulmonary hypertension. Many of these mutations introduce a stop signal that halts protein production prematurely, decreasing the amount of functional BMPR2 protein. Other mutations prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot form a complex with other proteins. It remains unclear how BMPR2 mutations cause primary pulmonary hypertension. Researchers suggest that a mutation in this gene prevents cell death or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of the lungs. Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and resulting in elevated blood pressure. However, it has not yet been reported regarding the genetic variants in Taiwan. Further details have been described in this project proposal.

Official Title
-----------------
Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Procedure: for BMPR II study
* Genetic: BMPRII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as idiopathic pulmonary artery hypertension and associated family Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: other<br> | Procedure: for BMPR II study<br> <br> Genetic: BMPRII<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause follow up | all cause follow up | eight years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic pulmonary artery hypertension