linjc16/ctgov huggingface dataset:
The Evolution of Relationship Between Results of Peripheral Blood Test and Outcomes of in Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the relationship between infertility blood test results and outcomes of pregnancy and alive birth of women who underwent with or without intravenous immunoglobulin (IVIG) before in vitro fertilization.

Detailed Description
-----------------
Study Design (Brief Description) Inclusion criteria Patients had underwent infertility blood test or treatment in Lee's women hospital Exclusion criteria No Endpoint 1. Values of blood test (PTT, IDM, ANA, Lupus, protein-s) 2. Embryo quality 3. Results of intravenous immunoglobulin (IVIG) treatment (pregnancy or not) 4. Alive birth rate 4. Withdraw criteria and rescue medication No 5. Sample Size and Study Duration Sample Size: total 500 women who underwent IVF treatments and tests from Jan. 2007 to Dec. 2010. Study Duration: from date of IRB agreement to Dec. 2012 6. Please specify objectives of study when collecting extra specimen from participants No more need to collect extra specimen from participants in this study 7. Expected Endpoints of Treatment No 8. Others No

Official Title
-----------------
Division of Infertility, Lee Women's Hospital, Taichung, Taiwan

Conditions
-----------------
Infertility, Female, Immune Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had underwent both infertility blood test and IVF treatment in Lee's women hospital Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| implantation rate | sac and heart bit can be detected after embryo transfer | 6-8 weaks after last menstrual | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | live birth after IVF treatment | live birth after pregnant |
Database and Calibration of a Non-invasive Glucose Monitoring Device

Study Overview
=================
Brief Summary
-----------------
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Detailed Description
-----------------
Subjects will collect 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

Official Title
-----------------
Database and Calibration of a Non-invasive Glucose Monitoring Device

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: WM3.4NR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 18 years of age or older Diabetic (all types) patients Exclusion Criteria: Pregnant women Subjects not able to understand and read Danish In investigator's opinion, subject is not able to follow instructions as specified in the protocol Subjects not able to hold hand/arm steadily Extensive skin changes, tattoos or diseases on probe application site Rejection by prescreening optical measurements Known allergy to medical grade alcohol used to disinfect skin

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short term collection of IMD data<br>Subjects will collect spectral raman data on WM3.4NR four times a day for 30 days distributed over a time period of 60 days. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements. | Device: WM3.4NR<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|
| Experimental: Long term collection of IMD data<br>Subjects will collect spectral raman data on WM3.4NR four times a day for the initial 30 days, distributed over a time period of 60 days. Subjects will for the remaining 60 days of measurements, distributed over 120 days collect spectral data twice a day. Each timepoints are conducted in duplicate. Spectral data will be compared to standard BG measurements. | Device: WM3.4NR<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation and validation of predictive algorithms for determining blood glucose levels | Collected spectral raman data will found the development of predictive algorithms for glucose determination. Performance of predictive models will be evaluated using the consensus error grid | 7 months |
Compliance With Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.

Detailed Description
-----------------
The investigatror's objective will be to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients who continue using CPAP one year after initiation of treatment) and objective compliance with treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405 patients was recruited, recruited consecutively at a rate of 33 patients per month among those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a possible abandonment rate of 5%. For the statistical analysis of the data related to compliance with the therapy and compliance with the follow-up process, descriptive analysis of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical analysis of the factors influencing compliance: multivariate logistic regression.

Official Title
-----------------
Evaluation of Compliance With CPAP Therapy in Patients Diagnosed With Obstructive Sleep Apnea Syndrome at the Hospital de Sabadell

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Device: Continuous Positive Airway Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS (clinical picture and AHI> 10). Exclusion Criteria: Diagnosis of a psychiatric illness or dementia. Communication problems or inability to read and speak Spanish.

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 |
| --- | --- |
| Patients SAHS with CPAP<br>Continuous Positive Airway Pressure treatment | Device: Continuous Positive Airway Pressure<br>* CPAP indication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate to CPAP treatment | % of patients who still use CPAP | 1 year after starting treatment | 
| Ratio of patients with compliance with the treatment | % of patients use CPAP ≥4h / night | 1 year after starting treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment adherence and compliance, attitudes, Continuous Positive Airway Pressure, cross-cultural validation
Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

Study Overview
=================
Brief Summary
-----------------
Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers. The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.

Official Title
-----------------
Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

Conditions
-----------------
Arthralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with ovarian, colorectal or lung cancer receiving bevacizumab therapy Male or female (aged ≥18 years old) Performance Status (PS) between 0 and 2 Expected life> 3 months Ability to answer a self-questionnaire Obtaining the non-opposition of patient participation Exclusion Criteria: Pregnant or lactating woman Rapid evolution of neoplastic pathology Major cognitive disorders that do not allow filling of the self-questionnaire Impossibility to submit to medical monitoring for social, psychological or geographical reasons Patients under guardianship or curatorship

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 |
| --- | --- |
| Patients<br>patients with ovarian, colorectal or bronchopulmonary cancer receiving Bevacizumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of arthralgia | Frequency of joint manifestations of any grade according to the CTCAE (Common Terminology Criteria for Adverse Events) scale version 4.0 observed between the start of bevacizumab treatment and 6 months of treatment. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between global cancer response and occurrence of arthralgia |  | baseline, at 3 months, at 6 months | 
| auto questionnaire specific to the study | 16 questions concerning the location, intensity, management of joint pain | Baseline at 3 months, at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bevacizumab
Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity.

Official Title
-----------------
Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France

Conditions
-----------------
Tissue and Organ Procurement

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paramedical or medical care personnel from a participating center participates in organ donor activities works in a department with organ donor activity Exclusion Criteria: personnel with no contact with organ donor activities personnel from non-participating centers refuses to participate
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 |
| --- | --- |
| all 5000 subjects<br>this is a purely descriptive study with one group | Other: Questionnaires<br>* The subjects are asked to fill out a questionnaire on the personal and professional situations, organ donation legislation, what happens in everyday practice, their own experience with donating their own organs, and what position they take.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Negative/positive feeling | Visual Analog Scale from 0 to 100 where 0 is negative and 100 is positive. | 1 day |
Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.

Detailed Description
-----------------
Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.

Official Title
-----------------
Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries, Male Sexual Dysfunction

Intervention / Treatment
-----------------
* Other: using questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of traumatic spinal cord injury injury time less than six months sexually active Exclusion Criteria: patients who had erectile dysfunction attributed to endocrine or metabolic disease order those who underwent surgery in the genital area, such as radical prostatectomy or penile implant cognitive impairment

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: using questionnaires|using questionnaires International Index Erectile Function and Beck Depression Inventory.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depressive symptoms | Depressive symptoms assessed by Beck Depression Inventory (BDI) | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of neurological lesion | Level of neurological lesion assessed by ASIA Impairment Scale (AIS) according to the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury | one day | 
| Degree of neurological lesion | Degree of neurological lesion assessed by ASIA Impairment Scale (AIS) according to the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury | one day | 
| Male Sexual Dysfunction | Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF) | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexuality, Spinal cord injuries, Erectile dysfunction, depression
LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma

Official Title
-----------------
A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

Conditions
-----------------
Tumors, Cutaneous T-Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: LBH589


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy. World Health Organization (WHO) Performance Status of ≤ 2 Patients must have the adequate laboratory values Exclusion Criteria: Patients with a history of primary CNS tumors Patients with any history of brain metastases Patients with any peripheral neuropathy ≥ CTCAE grade 2 Patients with unresolved diarrhea ≥ CTCAE grade 2 Impairment of cardiac function Impairment of gastrointestinal (GI) function or GI disease Liver or renal disease Other protocol-defined inclusion/exclusion criteria may apply

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBH589<br> | Drug: LBH589<br> <br> * Other names: panobinostat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum-tolerated dose of LBH589 |  | 1st cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessed by AEs, SAEs and laboratory values. |  | Every 2 weeks | 
| To characterize the pharmacokinetic (PK) profile of LBH589 |  | every 3 cycles | 
| To assess antitumor activity of LBH589 |  | every 2 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced solid tumor, Cutaneous T-cell lymphoma, Phase I, HDAC inhibitor, Adult patients
Topical Finasteride in the Treatment of Idiopathic Hirsutism

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment of idiopathic hirsutism

Official Title
-----------------
The Efficacy of Topical Finasteride in the Treatment of Idiopathic Hirsutism

Conditions
-----------------
Idiopathic Hirsutism

Intervention / Treatment
-----------------
* Drug: topical finasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic hirsutism which is defined as normal levels of androgens and normal ovulation Normal serum prolactin Exclusion Criteria: Pregnancy Simultaneous use of other drugs for the treatment of hirsutism
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topical finasteride|0.2%topical(cream)finasteride twice a day for six months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of topical finasteride was determined by comparison of Ferriman-Gallwey score before and after medication |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of topical finasteride was determined by comparison of mean hair thickness before and after medication |  | 6 months |
Use of Lidocaine in Endoscopic Submucosal Dissection

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection. The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.

Official Title
-----------------
Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm

Conditions
-----------------
Gastric Neoplasm

Intervention / Treatment
-----------------
* Drug: Lidocaine 1%
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm Exclusion Criteria: Allergy to lidocaine Chronic pain Chronic abuse of opioid or NSAID Atrioventricular conductance block Liver dysfunction Renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>Administration of lidocaine 1% | Drug: Lidocaine 1%<br>* Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation. Sedation with fentanyl and propofol<br>|
| Placebo Comparator: Control group<br>Administration of normal saline | Drug: Normal saline<br>* Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation. Sedation with fentanyl and propofol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption during sedation |  | During sedation, an expected average of 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured by numerical rating scale | 0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale) | 30 min, 6 hr, and 24 hr after procedure | 
| Incidence of nausea and vomiting | Nausea requiring antiemetics and retching and/or vomiting | Up to 24 hours |