linjc16/ctgov huggingface dataset:
Human Epididymis Protein 4 in Normal Menstruating Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle.

Official Title
-----------------
Human Epididymis Protein 4 in Normal Menstruating Women

Conditions
-----------------
Healthy Premenopausal Women

Intervention / Treatment
-----------------
* Other: blood draws


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women age 18-45 years old regular menstrual cycles (every 25-35 days) normal BMI (19-25) no hormonal contraception in the two menstrual cycles prior to enrollment Exclusion Criteria: pregnancy pelvic mass

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HE-4 levels, healthy premenopausal women<br> | Other: blood draws<br>* 5 blood draws during ovulatory menstrual cycles in premenopausal women<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HE-4 level |  | 5 times during menstrual cycle |
Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Detailed Description
-----------------
Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Official Title
-----------------
A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy

Conditions
-----------------
Advanced Non Small Cell Lung Cancer, Failed Prior Chemotherapy

Intervention / Treatment
-----------------
* Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological). Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer. Measurable disease per RECIST criteria. Adequate bone marrow, hepatic and renal function. Exclusion Criteria: Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years. Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days. Known hypersensitivity to minocycline. History of serious cardiac disease that is not controlled. Serious eye conditions. Prior treatment with inhibitors of EGFR of any kind.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 erlotinib<br> | Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)<br>* Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of correlating objective response rate and duration of response to grade of rash |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tarceva, erlotinib, NSCLC, Non-Small Cell Lung Cancer, EGFR, OSI-774
What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with significant morbidity and mortality. People at highest risk from progressive CKD are defined by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of this group will enable improved risk stratification and direct the development of better targeted management for people with CKD. To address these requirements we have established the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent follow-up.

Official Title
-----------------
What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decline of eGFR of ≥5mls/min/year or ≥10mls/min/5years and/or urinary albumin-creatinine ration (ACR) ≥70 mg/mmol on three occasions and/or CKD 4 or 5 (pre-dialysis) Exclusion Criteria: renal replacement therapy immunosuppression

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 |
| --- | --- |
| Chronic kidney disease<br>Stages 3-5 chronic kidney disease (pre-dialysis) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants not alive |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who reach End Stage Kidney Disease | End Stage Kidney Disease describes a requirement for chronic dialysis treatment or a kidney transplant | up to 10 years |
Paricalcitol Injection Phase II Trial

Study Overview
=================
Brief Summary
-----------------
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.

Detailed Description
-----------------
The purpose of this study is pharmacokinetic & tolerability.

Official Title
-----------------
A Phase 2, Open-Label, Multicenter, Multi-Dose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Injection in Chronic Kidney Disease Stage 5 Subjects With Secondary Hyperparathyroidism Undergoing Hemodialysis

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: paricalcitol
* Drug: paricalcitol
* Drug: paricalcitol
* Drug: paricalcitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure Exclusion Criteria: Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: paricalcitol<br>* paricalcitol 0.04 mcg/kg three times a week<br>* Other names: Zemplar;|
| Experimental: 2<br> | Drug: paricalcitol<br>* paricalcitol 0.08 mcg/kg three times a week<br>* Other names: Zemplar;|
| Experimental: 3<br> | Drug: paricalcitol<br>* paricalcitol 0.16 mcg/kg three times a week<br>* Other names: Zemplar;|
| Experimental: 4<br> | Drug: paricalcitol<br>* paricalcitol 0.24 mcg/kg three times a week<br>* Other names: Zemplar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 2 weeks |
Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)

Study Overview
=================
Brief Summary
-----------------
The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.

Official Title
-----------------
Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with a personal history of prostate cancer Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males) Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7 Men with a known familial mutation Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR - Exclusion Criteria: Age < 18 years Mental or cognitive impairment that interferes with ability to provide informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EMPOWeR Study<br>This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics. | Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics. | 6 months |
Korea University Anam Hospital Optical Coherence Tomography Registry

Study Overview
=================
Brief Summary
-----------------
All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention.

Detailed Description
-----------------
Optical coherence tomography registry is composed with before coronary stenting, immediate after coronary stenting and follow-up study.

Official Title
-----------------
Optical Coherence Tomography Registry of Korea University Anam Hospital

Conditions
-----------------
Coronary Artery Disease, Optical Coherence Tomography

Intervention / Treatment
-----------------
* Device: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had undergone coronary intervention and optical coherence tomography Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optical Coherence Tomography registry group<br>Patients who had undergone optical coherence tomography within coronary intervention | Device: Optical coherence tomography<br>* Intracoronary imaging device which can precisely observe intracoronary structures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of participants with Major Adverse Cardiovascular Events (MACE) | Composite of non-fatal myocardial infarction, all cause death, target vessel revascularization | Up to 10 years |
Rates of Positive Basal Cell Carcinomas (BCCs) in Re-excisions

Study Overview
=================
Brief Summary
-----------------
Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is primarily surgical with the goal of excising the growth in its entirety. When pathology results show that this has not been achieved, a re-excision is routinely performed. This study examines retrospectively the percentage of re-excisions of BCC that actually proved to be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare Campus and Zvulun Community Medical Center during the years 2008-10.

Official Title
-----------------
Rates of Positive BCCs in Re-excisions

Conditions
-----------------
Basal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that underwent an incomplete BCC excision during the years 2008-2010. Exclusion Criteria: Patients that underwent an incomplete BCC excision and were subsequently referred to undergo a MOHS procedure.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Basal Cell Carcinoma
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.

Official Title
-----------------
Multicenter, Non-comparative, Open-label Study to Evaluate the Safety and Efficacy of Enoxaparin Sodium (RP54563) 20 mg Bid for 14 Days in Patients With Hip Fracture Surgery

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Drug: enoxaparin (XRP4563)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: femoral neck inside or outside fracture Exclusion Criteria: any major surgery on lower limbs within 3 months clinical signs of deep vein thrombosis use of non-steroidal anti-inflammatory drugs severe hepatic disease or renal insufficiency

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

| Intervention/Treatment |
| --- |
|Drug: enoxaparin (XRP4563)|14 days of treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding events |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of venous thromboembolism |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood thinner, enoxaparin, hip fracture surgery, bleeding, thromboembolism
Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions

Study Overview
=================
Brief Summary
-----------------
To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.

Detailed Description
-----------------
The flow cytometric protocol used for this study, was based on basophil selection by an anti- CCR3 and the analysis of basophil activation by the respective up and down regulation of the CD63 and IgE markers as described previously. Basophil activation was expressed in percentage CD63 expression on activated basophils and in activation index involving IgE and CD63 markers and calculated by a specific algorithm developed by our group.. Our aim is to test a sufficient number of patients in order to be able to establish the ROC curves related to the allergen type tested and validate the use of an allergen mixture (NMB mix containing the 7 usual NMB at the optimal activation concentrations). Patients will be included during the post-anaesthetic consultation on the basis of the diagnosis of an IgE dependant per-anaesthetic reaction. The allegro-anaesthetist diagnostical habits won't be changed.

Official Title
-----------------
Diagnostic Accuracy of Flow Cytometry Applied to the Diagnosis of Peri-anaesthesic Reactions Induced by Neuromuscular Blockers

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

Intervention / Treatment
-----------------
* Other: Blood simple


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged at least 18 years, patients having experienced an IgE dependant per-anaesthetic reaction affiliated to a social security Exclusion criteria: patients having taken anti-histamine drugs and corticoids during the last 8 days patients submitted to a juridical protection

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

| Intervention/Treatment |
| --- |
|Other: Blood simple|Single Blood simple at Day 1|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergy diagnosis assessed by cytometry flow data |  | At Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1Allergy, 2 Neuromuscular blockers
Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Official Title
-----------------
A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: fluocinolone acetonide
* Procedure: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and nonpregnant females at least 18 years of age, with DME in the study eye Edema must involve fixation and be at least 1 disc area in size Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye The study eye must have received at least one macular laser treatment > 12 weeks prior to entry into the study Ability and willingness to comply with treatment and follow-up Ability to understand and sign the Informed Consent form Exclusion Criteria: Pregnant, lactating females Allergy to fluocinolone acetonide or any component of the delivery system Any disease or condition that would preclude study treatment or follow up Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s). History of uncontrolled IOP within the last 12 months

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: Fluocinolone acetonide<br>Fluocinolone acetonide intravitreal implant | Drug: fluocinolone acetonide<br>* fluocinolone acetonide 0.59 mg intravitreal implant<br>|
| Active Comparator: Standard of Care<br>Standard of care | Procedure: Standard of Care<br>* Repeat macular grid laser or observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage |  | at 26 weeks and yearly through completion of the study |