linjc16/ctgov huggingface dataset:
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy

Official Title
-----------------
A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as lung or gynecological cancer patients receiving platinum containing chemotherapy written informed consent hemoglobin concentration less than 11 d/dL at enrollment life expectancy of more than 4 months Exclusion Criteria: hemolysis, gastrointestinal bleeding, postoperative bleeding iron deficiency megaloblastic anemia any primary hematological disorder that could cause anemia received > 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization prior treatment with KRN321 received erythropoetin therapy within 8 weeks before treatment

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the proportion of subjects who reach red blood cell transfusion trigger |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response |  |  | 
| To compare the proportion of subjects who receive red blood cell transfusions |  |  | 
| To compare the effectiveness of KRN321 based on quality of life scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
darbepoetin alfa, anemia, cancer patients, platinum containing chemotherapy
Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Study Overview
=================
Brief Summary
-----------------
Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK). Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has numerous serious complications, especially glaucoma. Loteprednol, a new generation of corticosteroid has less potency than dexamethasone and was proposed to has less side effect regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after PRK and risk of glaucoma.

Conditions
-----------------
Epithelial Defect After Phototherapeutic Keratectomy

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Loteprednol etabonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patient with epithelial defect after phototherapeutic keratectomy Exclusion Criteria: the patient with systemic disease such as diabetes and connective tissue disease the patient with ocular surface disease such as dry eye and recurrent corneal erosion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loteprednol etabonate<br>Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks | Drug: Dexamethasone<br> <br> |
| Active Comparator: Dexamethasone<br>Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks | Drug: Loteprednol etabonate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal epithelial healing |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | 6 month |
Chinese Herb Nephropathy Epidemiology and Association With CYP2D6, CYP2C19, PXR, or MDR1 Polymorphism

Study Overview
=================
Brief Summary
-----------------
Chinese herb nephropathy (CHN), a kind of kidney failure caused by Chinese herbs, may be related to the a component called aristolochic acid (AA). AA may form AA-DNA adducts and accumulate in the kidney and ureter and cause kidney failure and/or cancer Different enzymes have been reported to detoxify plant alkaloids or other components. Genes that regulate the production of these metabolic enzymes may affect the chance of CHN. By comparing the differences in the polymorphisms of these genes between patient with CHN and control, we may find the changes that play a significant genetic factors for CHN.

Official Title
-----------------
Epidemiology of Chinese Herb Nephropathy and Its Association With CYP2D6, CYP2C19, PXR, or MDR1 Polymorphism

Conditions
-----------------
Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with suspected Chinese herb nephropathy, and their family Control group match for sex age and geographic area (with or without herabla use)
Sexes Eligible for Study
-----------------
All

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

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
-----------------
kidney diseases, drugs, Chinese herbal, aristolochic acid, polymorphism, genetic
Phacoemulsification Under Topical Anesthesia and Its Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if topical anesthesia is safe for phacoemulsification in eyes with comorbidities.

Conditions
-----------------
Phacoemulsification

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with cataract with a visual acuity less than 0.8 Exclusion Criteria: none
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 |
| --- | --- |
| Other: Topical anesthesia<br> | Procedure: Phacoemulsification<br>* Phacoemulsification under topical anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Postoperative events | To describe any postoperatives events in a phacoemulsification surgery under topical anesthesia | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical anaesthesia, Phacoemulsification
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Study Overview
=================
Brief Summary
-----------------
Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

Detailed Description
-----------------
The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).

Official Title
-----------------
Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: ARX201
* Drug: ARX201
* Drug: ARX201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-30 years old GHD of childhood onset completed growth IGF-1 <=2SDS rhGH treatment naive hGH levels below cut-off Exclusion Criteria: History of malignancy or intracranial tumors ECG abnormality ICH hepatic dysfunction renal impairment major medical conditions inadequate T4 positive for HBV, HCV, or HIV alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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: 1<br>low dose | Drug: ARX201<br>* Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.<br>|
| Active Comparator: 2<br>Medium dose | Drug: ARX201<br>* Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.<br>|
| Active Comparator: 3<br>High Dose | Drug: ARX201<br>* Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporal profiling of circulating IGF-1 levels. |  | 3 period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition measurements at start of study and end of study |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone, growth hormone deficiency, GHD, PEG, pegylated, IGF-1
TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial

Study Overview
=================
Brief Summary
-----------------
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Detailed Description
-----------------
The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Official Title
-----------------
TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial

Conditions
-----------------
Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Device: Topaz TTVR System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject of age >18 years. Subject with severe symptomatic tricuspid regurgitation presenting following conditions: TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or symptoms requiring use of diuretics. Subject presenting with New York Heart Association Class NYHA ≥II. Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision. Exclusion Criteria: Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months. Subject undergoing cardiac interventions within 30 days prior to index procedure. Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis. Subject who had previous tricuspid valve replacement or repair and a device is still in situ.

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
Interventional Model Description: Topaz TTVR System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Cohort<br>Device: Topaz TTVR system | Device: Topaz TTVR System<br>* Transcatheter tricuspid heart valve replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hierarchical composite endpoint | including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days | 30 days |
A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.

Official Title
-----------------
A Randomized, Single-blind, Placebo Controlled, Cross-over Study to Evaluate the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to complete a 1-week wash-out of current anti-diabetic medications Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose Blood glucose criteria must be met BMI <40 Exclusion Criteria: History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes Need for insulin within 3 months or patients on thiazolidinediones Significant concommitant disease or complications of diabetes Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons Abnormal liver function tests as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of acute effects of vildagliptin on gastric emptying |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on steady state levels of active GLP-1 and GIP |  |  | 
| Change in fasting and postprandial glucose levels. |  |  | 
| Change in glucagon secretion |  |  | 
| Change in postprandial glucose kinetics |  |  | 
| Effect on gastric peristalsis |  |  | 
| Effect on satiety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildagliptin, type 2 diabetes, gastric emptying
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

Study Overview
=================
Brief Summary
-----------------
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

Official Title
-----------------
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2, or IFN Based Therapy

Conditions
-----------------
Melanoma, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: CC-5013


Participation Criteria
=================
Eligibility Criteria
-----------------
Understand and voluntarily sign an informed consent form Able to adhere to the study visit schedule and other protocol requirements Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC-5013|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
-----------------
Revimid, Metastatic Melanoma, Melanoma, CC5013
Human Photoallergy Test

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential of a test material to produce a photo allergic response.

Official Title
-----------------
Human Photoallergy Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: Sun screening Sport Lotion, (BAY987516)
* Other: Untreated skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator; Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products; subjects who are employees of the CRO and/or Bayer or is a household member of an employee;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>All subjects are patched. | Drug: Sun screening Sport Lotion, (BAY987516)<br>* 50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ cm*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation Number - RB# Y65-110)<br>Other: Untreated skin<br>* This site is patched without treatment as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point grading scale |  | Up to 72 hours |
Computer-assisted Detection of Colonic Polyps

Study Overview
=================
Brief Summary
-----------------
Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect lesions. Recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. The program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. The program was now refined so that the respective structures can be highlighted during real time colonoscopy. The aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.

Conditions
-----------------
Colon Adenoma

Intervention / Treatment
-----------------
* Device: Automatic polyp detection software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for colonoscopy age ≥ 40 years Exclusion Criteria: American Society of Anesthesiologists class IV or higher pregnant women indication for colonoscopy: inflammatory bowel disease indication for colonoscopy: polyposis syndrome indication for colonoscopy: emergency colonoscopy e.g. acute bleeding

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Routine colonoscopy Cohort<br>Patients receiving routine colonoscopy at the study site | Device: Automatic polyp detection software<br>* A computer program for the detection of colonic polyps will be used during colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection | After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks) it can be determined whether the resected specimen contained polyp histology or not. | up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoma, computer, automatic, polyp, detection