linjc16/ctgov huggingface dataset:
Azoospermia Patients

Study Overview
=================
Brief Summary
-----------------
The Prospective Cohort Study for Azoospermia Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Detailed Description
-----------------
Infertility is an important problem with a multifactorial etiology that affects approximately 15% of couples who attempt pregnancy. Its cause in approximately 50% of infertile couples is male factors. Spermatogenesis is an extremely complex cell differentiation process involving 2,300 genes that regulate germ cell development and maturation. Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit azoospermia participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for azoospermia prognosis.

Official Title
-----------------
Prospective Cohort Study for Azoospermia Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Conditions
-----------------
Healthy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least three semen evaluations performed on separate occasions, when the seminal specimen after centrifugation showed no sperm under the microscope and was then diagnosed according to several clinical parameters； Exclusion Criteria: -

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of serum FSH (Follicle stimulation hormone) | mIU/mL | From date of inclusion, assessed by each 12 month, up to 40 years | 
| Level of serum LH (luteinizing hormone) | mIU/mL | From date of inclusion, assessed by each 12 month, up to 40 years | 
| Level of serum T (Testosterone) | ng/ml | From date of inclusion, assessed by each 12 month, up to 40 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of testicles | Record the Length (mm)*Width (mm) of each testicle | From date of inclusion, assessed by each 12 month, up to 40 years |
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess Efficacy and Safety of Tadalafil (LY450190) in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury

Conditions
-----------------
Erectile Dysfunction, Spinal Cord Injuries

Intervention / Treatment
-----------------
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males who developed erectile dysfunction as a result of spinal cord injury. Injury must have occurred 6 months before the start of the study. at least 4 sexual intercourse attempts during the first 4 weeks of the study without medication assistance no use of other erectile dysfunction treatment for at least 4 weeks before receiving the first dose of study drug. Also cannot use any other erectile dysfunction treatment during the study. Exclusion Criteria: Impotence caused by other primary sexual disorders including premature ejaculation or untreated endocrine diseases such as diabetes, hypopituitarism, hypothyroidism, or hypogonadism History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection and history of penile implant. History of cardiac conditions including angina requiring certain treatment with nitrates; heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. Significant renal problems within 6 months before starting the study. Also, active liver disease including jaundice at beginning of study. History of other central nervous system injuries, other than spinal cord injury, 6 months before starting the study.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe and effective as shown by improvement on erectile function IIEF scores and SEP scores. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional efficacy variables including GAQ, SEP, and IIEF subdomains. Quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction as a result of traumatic spinal cord injury
An Observational Study of Pain Assessment and Treatment Adequacy of Emergency Cancer Pain

Study Overview
=================
Brief Summary
-----------------
EMERGENCY CANCER PAIN DRAWS CANCER PATIENT TO EMERGENCY DEPARTMENT FOR TREATMENT. HOWEVER, THERE HAS BEEN INCONSISTENCY AND INADEQUACY OF PAIN MANAGEMENT IN EMERGENCY DEPARTMENT. THIS STUDY OBSERVES THE STATUS OF PAIN ASSESSMENT AND ITS ADEQUACY IN EMERGENCY DEPARTMENT IN A TERTIARY CARE CANCER HOSPITAL.

Official Title
-----------------
A Prospective Observational Study of Assessment of Pain and Its Treatment Adequacy in Emergency Department at Tertiary Care Cancer Hospital.

Conditions
-----------------
OBSERVE PAIN MANAGEMENT PRACTICES IN EMERGENCY DEPARTMENT

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADULT CANCER PATIENTS REPORTING TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF PAIN Exclusion Criteria: 1.PATIENTS BELOW 18 YEARS OF AGE, 2. PATIENTS WITH INCOHERENT BEHAVIOUR.

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
-----------------
EMERGENCY CANCER PAIN, ASSESSMENT, TREATMENT ADEQUACY.
A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus

Conditions
-----------------
Obesity, Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: CT-868


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or Females with T2DM BMI of ≥27 kg/m2, inclusive 18-75 years old, inclusive Stable body weight for 3 months Exclusion Criteria: Significant medical history Uncontrolled diabetes History of malignancy

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: CT-868 Low Dose<br>CT-868 | Drug: CT-868<br>* CT-868<br>|
| Experimental: CT-868 Maximum Tolerated Dose<br>CT-868 | Drug: CT-868<br>* CT-868<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c (HbA1c) |  | Baseline up to 12 and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean body weight |  | Baseline up to 12 and 26 weeks | 
| Fasting plasma glucose |  | Baseline up to 12 and 26 weeks |
The Effect of a Posture Shirt on Muscle Activity During Functional Tasks

Study Overview
=================
Brief Summary
-----------------
This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and standing repetitive upper limb task

Detailed Description
-----------------
Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort. This study sets out to investigate the effect of a posture shirt on muscle activity during a sitting and a standing repetitive upper limb task.

Official Title
-----------------
The Effect of a Posture Shirt on Muscle Activity During Functional Tasks

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Posture shirt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain free healthy participants Able to speak, read and understand Danish Exclusion Criteria: Pain from the back, neck or shoulder area during the past 6 months Experience of delayed onset muscle soreness (DOMS) on the day of testing Current or previous chronic or recurrent pain condition Regular use of analgesics Previous neurologic, musculoskeletal or mental illnesses that may influence the results Lack of ability to cooperate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy participants<br>Participants will be ask to perform a repetitive upper limb task while posture and muscle activity is being monitored.This will be done while wearing a posture shirt or without a shirt | Device: Posture shirt<br>* Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle actitity, reduce musculoskeletal pain and discomfort.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography (EMG) | EMG acitivty of axioscapular and trunk muscles will be recorded during upper limb tasks | During the test session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity: scale | Participants are to rate any perceived pain on a scale from 0-10 (0=no pain, 10= worst imaginable pain) | During the test session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electromyography, Musculoskeletal
Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify risk factors associated with indwelling urinary catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The study will also include a very extensive literature search in an attempt to create a national standard or guideline.

Official Title
-----------------
Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit

Conditions
-----------------
Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical records of 67 patients 0 to 17 years of age diagnosed with a catheter associated urinary tract infection (defined by CDC) acquired during a PICU hospitalization. Medical records of 67 patients 0 to 17 years of age who had an indwelling urinary catheter during a PICU hospitalization without a catheter associated urinary tract infection. Nurses employed at Children's Mercy Hospital in the PICU. Patient's who acquired a CA-UTI during 2009 and was adjudicated by infection control. Exclusion Criteria: Patients Patients with community acquired urinary tract infections Patients 18 years and older cared for in the PICU. Patients with catheter associated urinary tract infections hospitalized outside the PICU at Children's Mercy Hospital. Patients with UTI not related to catheterization Nurses Nurses floated to the PICU who are not permanent staff members (ICN nurse, float pool staff, travelers) Nurses on the research team

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 17 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 |
| --- | --- |
| 1<br>Patients who acquired a CA-UTI in the PICU between 2004-2007. | |
| 2<br>Patients who did not acquire a CA-UTI while hospitalized in the PICU but had an indwelling urinary catheter between 2004-2007. | |
| A<br>Nurses currently employed in the PICU at Children's Mercy Hospital. | |
| a<br>Root Cause Analysis on all patients who acquired a CA-UTI during 2009. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of risk factors associated with indwelling urinary catheters. |  | 2004-2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of nurses' knowledge of insertion, irrigation, care and maintenance of indwelling urinary catheters. |  | 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indwelling urinary catheters, urinary tract infections, foley-catheter related infections, hospital acquired CA-UTI
A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico

Study Overview
=================
Brief Summary
-----------------
Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever. In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.

Official Title
-----------------
The Perception of Celestamine Treatment in Mexico: a Retrospective Assessment of Consumer Perception of Prior Celestamine Use

Conditions
-----------------
Rhinitis, Allergic

Intervention / Treatment
-----------------
* Other: Online survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis Participants allowing to use the data for research and marketing purposes as well as talking to authorities Participants allowing us to use the pseudo-randomized individual data for further data analysis Able to read and understand the language of the online questionnaire Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| Participants<br>Participants who used betamethasone plus loratadine to treat allergic rhinitis within the previous two months. | Other: Online survey<br>* Participants will be invited to complete an online questionnaire about their experience of product use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience with betamethasone plus loratadine via an online questionnaire | Participants' experiences with betamethasone plus loratadine used under real life conditions. | 2 months |
Continue Entecavir Rollover From China

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.

Official Title
-----------------
A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China

Conditions
-----------------
Chronic Hepatitis B Virus

Intervention / Treatment
-----------------
* Drug: Entecavir
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection ALT ≤ 15 x upper limit of normal Compensated liver disease Exclusion Criteria: Coinfection with HIV, HCV, or HDV

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Entecavir 0.5<br> | Drug: Entecavir<br>* Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started<br>* Other names: BMS-200475;|
| Active Comparator: Entecavir 1.0<br> | Drug: Entecavir<br>* Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started<br>* Other names: BMS-200475;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events |  | Through 3 years of dosing and up to 48 weeks of off treatment follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort |  | Through 3 years of dosing |
Genetic Characteristics of Metastatic Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Genomic analysis for metastatic breast cancer(MBC) patients Participant (Inclusion criteria) Patients who diagnosed metastatic/stage IV breast cancer Patients who were not received treatment for metastatic breast cancer on palliative setting Process (1) Tissue/ Blood sample At diagnosis, MBC tissue / blood sample (20cc) will be obtained. At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional) (2) WES, RNASeq, ctDNA, Exosome We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

Official Title
-----------------
Genetic Characteristics of Metastatic Breast Cancer Patients

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

Intervention / Treatment
-----------------
* Diagnostic Test: Genomic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who diagnosed ad metastatic breast cancer Patients who were not received treatment on palliative setting Exclusion Criteria: Patients who did not agree this study Patients who did not have any pathologic specimen at MBC diagnosis.

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metastatic breast cancer cohort<br>Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome | Diagnostic Test: Genomic analysis<br>* WES, RNASeq, ctDNA, Exosome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomic profiling of MBC patients | Gemetic alteration frequency, the association between genetic alteration and survival | 60 months |