linjc16/ctgov huggingface dataset:
The Breast Program - Translational Cancer Resource

Study Overview
=================
Brief Summary
-----------------
TRACR will provide a data/biospecimen repository for translational research to better diagnose, prognose, treat and cure breast cancer (and related diseases/treatment conditions). Patients at the Rowan Breast Center will be consented for donation of blood and if available tumor/healthy/archived tissue. Patients will be consented to give permission to use said specimens for future research and to be contacted in the future about other research participation and additional information.

Official Title
-----------------
The Breast Program - Translational Cancer Resource

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

Intervention / Treatment
-----------------
* Other: Biospecimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RBC patients with known invasive cancer pre-surgery (greater or equal to 1.5cm) are given priority in recruitment. RBC patients with known invasive cancer pre-surgery (less then 1.5cm). 3. RBC patients who are postsurgery for invasive breast cancer (performed at UPHS or non-UPHS entities). Patients that are of high risk for breast cancer (family history, known deleterious genetic mutation(s)) seeking a prophylactic mastectomy at the breast clinic. Only persons who can understand and give informed consent will be eligible to participate in this study. Furthermore, no persons belonging to vulnerable populations with as children (below 18 years of age), fetuses, neonates or prisoners will be recruited in this study. Pregnant women, who are pre-surgery and having surgery for clinical reasons, can still be recruited for tissue and blood collection. Exclusion Criteria: Individual who cannot understand and give informed consent (cognitively impaired persons) Children (below 18 years of age), fetuses and neonates Prisoners

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

| Intervention/Treatment |
| --- |
|Other: Biospecimen Collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of biospecimen collected |  | 15 years |
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Official Title
-----------------
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: BLI4700


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. Have previously had a colonoscopy performed At least 18 years of age Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM) If female, and of child-bearing potential, is using an acceptable form of birth control. Negative urine pregnancy test at screening, if applicable In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study Key Exclusion Criteria: Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. Subjects who had previous significant gastrointestinal surgeries. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. Subjects with a prior history of renal, liver or cardiac insufficiency Subjects with impaired consciousness that predisposes them to pulmonary aspiration. Subjects undergoing colonoscopy for foreign body removal and/or decompression. Subjects who are pregnant or lactating, or intending to become pregnant during the study. Subjects of childbearing potential who refuse a pregnancy test. Subjects allergic to any preparation components. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI4700<br>BLI4700 Bowel Preparation | Drug: BLI4700<br>* BLI4700 bowel preparation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Subjects With Successful Bowel Cleansing | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent) | Day of colonoscopy |
Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men

Study Overview
=================
Brief Summary
-----------------
This study is being done to learn how the male hormone , testosterone, affects pituitary hormones in younger and older men. The pituitary is a gland in the brain that secretes hormones, some of which normally control growth and fertility.

Detailed Description
-----------------
Concentrations of bioavailable testosterone decline by 1.0-1.5% annually as men age. Reduced systemic testosterone availability is associated with decreased muscle mass, strength and aerobic capacity, decreased bone-mineral density and increased risk of hip fracture, waning sexual interest, inpaired spatial cognition and increased risk of visceral obesity, impaired glucose tolerance and coronary artery disease. Luteinizing hormone (LH) secretion often fails in healthy older individuals. In addition, aging is marked by an acceleration of LH pulse frequency, loss of high-amplitude LH pulses and disorderly release of LH and testosterone, as measured by the approximate entropy statistic. The mechanisms that underlie such complex adaptations are not known, but appear to involve multiple loci of regulatory failure.

Official Title
-----------------
Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Ketoconazole, Dexamethesone, Androgel,GnRH


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy Men Ages 18-80 All ethnicities eligible Men with indeterminate erectile dysfunction eligible with normal serum gonadotropin, total testosterone, prolactin and TSH concentrations and documented integrity of the neurovascular, cardiovascular, hepatorenal systems

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketoconazole, Dexamethesone, Androgel,GnRH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LH and Testosterone levels will be evaluated after 4 study visits |  |  |
Exercise Changes to Peripheral Blood Mononuclear Cells in Children

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health.

Detailed Description
-----------------
SPECIFIC AIMS: To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on: Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs). PBMC gene regulation of stress, inflammatory, and growth/repair mediators [including: interleukin-4 (IL-4), IL-6, IL-10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma), growth hormone (GH), insulin-like growth factor-I (IGF-I), heat shock proteins (Hsp)]. Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques. Circulating endogenous triggers of PBMC mediator responses-soluble Hsp, IL-6, and F2-isoprostanes. To determine how the acute PBMC responses are altered by gender, pubertal status, body composition (measured by whole-body and regional DEXA), and fitness (measured by progressive cycle ergometry and gas exchange). To determine the relationship in healthy children and adolescents among acute PBMC responses to exercise, biochemical precursors of the metabolic syndrome (insulin, glucose, lipids), and the balance of the TH1/TH2 immune response.

Official Title
-----------------
PBMC, Exercise and Children: Initial Mechanisms

Conditions
-----------------
Physical Fitness, Obesity, Child Development, Growth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: appropriate Tanner Stage No evidence of disease or disability Exclusion Criteria: no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators elite children participating in extensive exercise or dance programs pregnant

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- |
| Children<br>Early and late pubertal girls and boys | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS

Study Overview
=================
Brief Summary
-----------------
This study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department. This is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software. All performances will be evaluated and compared.

Official Title
-----------------
PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS

Conditions
-----------------
Radiography, Emergencies, Diagnostic

Intervention / Treatment
-----------------
* Diagnostic Test: Emergency radiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Working in an emergency radiography department Volunteer to participate in the study Exclusion Criteria: Planned departure from the establishment within 12 months.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Emergency radiography|The intervention is to determine how the radiographer classify emergency radiography.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the radiographers' diagnostic performance to issue an advisory opinion to X-ray reading of the appendicular skeleton in emergency department | The primary outcome measure evaluation radiographers' diagnostic will use accurancy, sensibility and specificity. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the proportion of radiographers reaching the goal of 90% accurancy | This is a proportion in % of performance radiographers' diagnosctic treshold | 4 months | 
| Quantify and qualify Radiographers diagnostic changes before and after the in house training. | This a proportion in % about the progression of performance radiographers'diagnostic in the formation. | 4 months | 
| Evaluate the performance of the association of AI and radiographer after training | Thiis output is the difference between accurancy, sensibility and sensitivity with or without IA. | 4 months |
Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.

Official Title
-----------------
An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy

Conditions
-----------------
Cancer, Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: recombinant interleukin-21
* Drug: caelyx (pegylated liposomal doxorubicin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced epithelial Ovarian Cancer (stage IIB-IV) Persistent or progressive disease after or relapse within one year of completion of first line therapy Measurable or assessable disease Eastern Cooperative Oncology Group status less than or equal to 2 Exclusion Criteria: History of any other active malignancy Signs of CNS metastasis More than one prior chemotherapy regimen Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks First line chemotherapy completed at least 1 month prior to start of treatment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: recombinant interleukin-21<br>* Administered i.v. in treatment cycles of 28 days.<br>* Other names: NN028;Drug: caelyx (pegylated liposomal doxorubicin)<br>* Administered i.v. in treatment cycles of 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination. |  | after max. 6 treatment cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Initially | 
| IL-21 antibody formation |  | For the duration of the trial | 
| Progression free survival |  | For the duration of the trial | 
| Patient reported outcomes |  | For the duration of the trial | 
| Biomarker assessments CA-125 |  | For the duration of the trial |
Inflammatory Parameters as Predictive Factors for Complicated Appendicitis

Study Overview
=================
Brief Summary
-----------------
Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. Some series have studied some clinical and analytical parameters as possible predictors of complicated acute appendicitis. A retrospective analysis of patients admitted for acute appendicitis and undergoing appendectomy between January 2014 and December 2017 was performed in order to assess the possible existence of preoperative analytical predictive factors for complicated acute appendicitis (such as leukocytosis, C-reactive protein and ratio between neutrophils and lymphocytes).

Official Title
-----------------
Inflammatory Parameters as Predictive Factors for Complicated Appendicitis

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Other: dosing of inflammatory parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted for acute appendicitis Exclusion Criteria: excluded if no existence of dosing of all the inflammatory parameters cited above

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Group 1 - uncomplicated appendicitis<br> | Other: dosing of inflammatory parameters<br>* View and register the dosing of inflammatory parameters<br>|
| Group 2 - complicated appendicitis<br> | Other: dosing of inflammatory parameters<br>* View and register the dosing of inflammatory parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein dosage |  | 4 years | 
| Leukocytosis dosage |  | 4 years | 
| Ratio between neutrophils and lymphocytes dosage |  | 4 years |
Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the changes in the carotid artery when subjects receive high or low doses of rosuvastatin.

Official Title
-----------------
Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing.

Conditions
-----------------
Carotid Artery Stenosis, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting blood low density lipoprotein cholesterol level as defined by the protocol Diagnosed carotid arterial stenosis Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Heavy or total occlusion of the carotid artery or recent stroke Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in carotid wall volume as measured by MRI scan |  | At 40 weeks and 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events & abnormal laboratory markers |  | 2 weekly for first 4 weeks then 4 weekly | 
| Other changes in the structure and composition of the carotid arterial wall as defined in the protocol. |  | At 40 weeks and 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, Carotid Artery Stenosis, Hypercholesterolemia, Rosuvastatin, Crestor
The Predictive Role of HPV Integration in HSIL and Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.

Official Title
-----------------
The Predictive Role of HPV Integration in HSIL and Cervical Cancer

Conditions
-----------------
HPV Integration

Intervention / Treatment
-----------------
* Diagnostic Test: HPV integration test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent. Exclusion Criteria: Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HPV integration test|The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue pathological diagnosis | Tissue pathological diagnosis in 1 year since HPV integrated test | 1year since HPV integrated test |