linjc16/ctgov huggingface dataset:
Sun Protection Factor Assay (SPF Assay 205/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

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

Intervention / Treatment
-----------------
* Drug: BAY987521


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987521<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code:Z09-054)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

Study Overview
=================
Brief Summary
-----------------
To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI therapies in forthcoming randomised controlled multi-centre clinical trials following international standards and guidelines.

Detailed Description
-----------------
This is a multicentre, observational, registry study of outcome data on SCI patients in Mainland China and Hong Kong. The target population consists of patients who have a SCI, where acute SCI is defined as <7 days post-injury and chronic SCI is defined as >12 months post-initial SCI surgery. A total of 600 patients (300 acute and 300 chronic) will be enrolled from 6 cities in Mainland China (namely: Beijing, Shanghai, Guangzhou, NingBo, Xi'an and Kunming) and Hong Kong. The duration of the study will be one year, with a total of 4 visits.

Official Title
-----------------
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

Conditions
-----------------
Spinal Cord Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General Male or female adult subjects, 18 to 65 years of age Have a clinical diagnosis of SCI, defined by MRI Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures Acute SCI Study Group: Has an acute SCI (defined as < 7 days post-injury) Chronic SCI Study Group: 4. Has a chronic SCI (defined as > 12 months post-initial SCI surgery) Exclusion Criteria: General Severe head injury Is medically or mentally unstable according to the judgement of the Investigator History of Multiple Sclerosis or peripheral demyelinating disease Likely to have experimental therapy Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Impact on Linkage to HIV Care With Point of Care CD4 Testing and Home-based HIV Testing in Kenya

Study Overview
=================
Brief Summary
-----------------
Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western Kenya.

Official Title
-----------------
Randomized Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and Time to Antiretroviral Therapy Initiation Among HIV Infected Patients in Rural Western Kenya

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Device: Point of care CD4 device (Alere PIMA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults living in the study catchment area (Gem Village, Nyanza province Western Kenya) served by one of 23 HIV clinics and 3 referral labs Not having received HIV care in prior 6 months if known HIV+ Exclusion Criteria: current HIV care or HIV care within last six months
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Referral laboratory based CD4 measurement after home-based HIV testing | |
| Experimental: Point of care<br>POC CD4 testing after home-based HIV testing | Device: Point of care CD4 device (Alere PIMA)<br>* for persons testing + with home-based HIV testing using Kenya's two rapid test algorithm, intervention arm participants received point of care CD4 testing followed by counseling on results which included their treatment eligibility<br>* Other names: Alere Pima;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage to HIV care | As ascertained from clinic charts | Within six months from date of study enrollment | 
| ART initiation | As ascertained from clinic charts | Within six months from date of study enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
linkage to care, point of care diagnostics, point of care CD4, HIV care cascade, Kenya
microRNAs Tool for Stratifying Stage II Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators discover the investigators' miRNA tool can be a useful tool to predict the patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to make an observation study that may validation this tool.

Detailed Description
-----------------
This is an observation study. The investigators recruit patients who agree to use their postoperative specimen for miRNA tool examination and receive the investigators' follow up.Their receiving chemotherapy or not will decided by their doctors. The investigators just see whether the stratifying tool could predict prognosis.

Official Title
-----------------
microRNAs Tool for Stratifying Stage II Colon Cancer:a Perspective Study of Adjuvant Chemotherapy

Conditions
-----------------
Colonic Neoplasms, Effects of Chemotherapy

Intervention / Treatment
-----------------
* Device: miRNA tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The informed consent has been obtained from the patient. With confirmed diagnosis of stage II colon cancer. With moderate/good ECOG health rating (PS): 0-1 score. The patient receive no anti-cancer treatment before primary surgery. The patient receive radical operation for colon cancer with negative margin. Exclusion Criteria: With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. With bad compliance or contraindication to enrollment. Pregnant woman or lactating woman. With contraindication to receive adjuvant chemotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| high risk group<br>the miRNA tool predict this group of patients as high risk | Device: miRNA tool<br>* patients to be assessed by the miRNA tool. MicroRNA tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215. Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miR-21-5p)+(0.086×status of miR-20a-5p)+(0.240×status of miR-103a-3p)+(0.095×status of miR-106b-5p)- (0.238×status of miR-143-5p)-(0.237×status of miR-215),low expression status equals 0 and high expression status equals 1.Then we determine the patients who with a score higher than 1 as exposed patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS |  | 5 years |
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole Therapy

Study Overview
=================
Brief Summary
-----------------
To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline.

Detailed Description
-----------------
TOI is the sum of the scores from the physical and functional well-being and the breast cancer subscales. To assess incidence of adverse events (including cardiovascular, cerebrovascular, and endocrine, musculoskeletal) in Korean postmenopausal breast cancer patients in early adjuvant setting. To assess the effect of letrozole (Femara) on BMD in early adjuvant setting. To assess the effect of letrozole (Femara) on total cholesterol in early adjuvant setting.

Official Title
-----------------
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have undergone surgery of the breast cancer and proven histologically to be breast cancer with postmenopausal women older than 45 years. Postmenopausal state was defined the following conditions, at least one of a, b, c. serum FSH ≥ 30 mIU/mL amenorrhea ≥ 1 year oophorectomy patients with estrogen receptor(+) and/or progesterone receptor(+) WHO(ECOG) performance status 0-2 Adequate haematological function, renal function, hepatologic function. No evidence of metastasis. Exclusion Criteria: patient with hormone receptor negative. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin. Other hormone therapy given within the previous 4 weeks. Patients with other aromatase inhibitor and chemotherapy Uncontrolled infection, medically uncontrollable heart disease Other serious medical illness or prior malignancies Patients with BMD T-score ≤-2.5 Patients who were treated with bisphosphonate Patients with postmenopausal state induced chemotherapy Estimated life expectancy of <12 months

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| letrozole (Femara)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormonal therapy(letrozole), postmenopausal breast cancer, quality of life
OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)

Conditions
-----------------
Chronic Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Other: Placebo Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation Exclusion Criteria: History of ocular surgical intervention within the past 3 months Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit Use any of the following disallowed medications during the period indicated

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

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

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

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: OTX-DP<br>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: PV<br>PV (placebo drug delivery vehicle) | Other: Placebo Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching) | 14 days post insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Redness | Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness) | 14 days post insertion |
Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Recent studies on the impact of perioperative duloxetine for treatment of acute postoperative pain have yielded positive outcomes with respect to reduction opioid consumption. The aim of the present study is to investigate the role of perioperative duloxetine on the management of postoperative pain in patients undergoing LC.

Official Title
-----------------
Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients who are scheduled to undergo elective LC Exclusion Criteria: 1- Patients with acute pancreatitis 2. Patients undergoing chronic pain treatment 3. Patients who received analgesics or sedatives 24 h before scheduled surgery 3. Patients had alcohol or drug addiction 4. Severe hepatic and renal dysfunction 5. Previous allergic response to duloxetine 6. Pregnancy and lactation 7. Patients with communication problems, cognitive dysfunction, or psychological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>patients scheduled for elective LC will receive 60 mg duloxetine before surgery | Drug: Duloxetine<br>* 60 mg duloxetine<br>|
| Placebo Comparator: Control<br>patients scheduled for elective LC will receive placebo before surgery | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative pain between the two groups using visual analogue score (VAS) | pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain) | 24 Hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (PONV) | will be assessed using PONV scale a 4-point scale: none (0): no nausea, vomiting, and retching; mild (1): happened once; moderate (2): happened 2-3 times; and severe (3): continuous or more than three times. | 24 Hours postoperative |
Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]

Study Overview
=================
Brief Summary
-----------------
This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS patients.

Official Title
-----------------
Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]

Conditions
-----------------
Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
-----------------
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically probable-laboratory supported, clinically probable, or clinically definite amyotrophic lateral sclerosis Exclusion Criteria: Allergic or idiosyncratic response to tamoxifen. Other active neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms. Psychiatric, psychological, or behavioral symptoms that would interfere with the subject's ability to participate in the trial. Clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or endocrine (poorly controlled insulin-dependent diabetes mellitus or hyperthyroidism) disease that may confound interpretation of the study results. Previous kidney or pancreas transplants. Significant hepatic or renal disease (AST > 5 times normal, serum creatinine > 2.0 mg/dL for males or > 1.8 mg/dL for females).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals. |  |  | 
| Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals. |  |  | 
| Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals. |  |  | 
| Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals. |  |  |