linjc16/ctgov huggingface dataset:
Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)

Study Overview
=================
Brief Summary
-----------------
This study is performed to confirm the optimal dose for THR (total hip replacement).

Official Title
-----------------
Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium（RP54563）20mg qd and 20mg Bid for 14 Days in Patients With Total Hip Replacement

Conditions
-----------------
Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Drug: Enoxaparin sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective primary THR (total hip replacement) surgery Exclusion Criteria: Patient with risk of clinical significant bleeding

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enoxaparin sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of VTE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Replacement, Enoxaparin
Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.

Official Title
-----------------
A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: interferon gamma-1b


Participation Criteria
=================
Eligibility Criteria
-----------------
At least 6 years of age Diagnosis of cystic fibrosis (against certain criteria) Able to perform pulmonary (lung) function tests and participate in induced sputum procedures Pulmonary function values must meet certain minimal requirements Must have acceptable laboratory test results Cannot be on certain medications during and immediately prior to study Cannot have a history of unstable or deteriorating cardiac or neurologic disease

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interferon gamma-1b|100 or 200 mcg, SQ, 3x per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in sputum neutrophil count |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8 |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, pulmonary impairment
Breast Cancer and Quality of Life

Study Overview
=================
Brief Summary
-----------------
The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.

Official Title
-----------------
Impact of Breast Cancer on Quality of Life of the Young Women, Her Life Partner and Her Couple

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

Intervention / Treatment
-----------------
* Behavioral: interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 45 non metastatic breast cancer at least 6 months of relationship Exclusion Criteria: no life partner inclusion criteria failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Within chemotherapy<br>30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis) | Behavioral: interview<br>* psychological, emotional, family and social parameters<br>|
| within Herceptin<br>30 couples, within herceptin treatment (the first year after diagnosis) | Behavioral: interview<br>* psychological, emotional, family and social parameters<br>|
| within hormonotherapy<br>30 couples, within hormonotherapy (between 2 and 7 years after diagnosis) | Behavioral: interview<br>* psychological, emotional, family and social parameters<br>|
| without hormonotherapy<br>30 couples, did not received hormonotherapy (1 year after diagnosis) | Behavioral: interview<br>* psychological, emotional, family and social parameters<br>|
| end of treatment<br>30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis) | Behavioral: interview<br>* psychological, emotional, family and social parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life at different time of medical follow up | interviews with couples at different time frame depending on which group they are in | 6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, everyday issues, couple
Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study

Study Overview
=================
Brief Summary
-----------------
5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Other: 5D ultrasound
* Other: 2D ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 28 to 34 weeks preterm termination of pregnancy singleton pregnancy any obstetric or medical cause for termination of pregnancy Exclusion Criteria: IUFD multiple pregnancy congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women with preterm delivery<br>5D LB and 2D ultrasounds will be done to pregnant women between 28 and 34 weeks planned for termination of pregnancy for obstetric or medical causes. | Other: 5D ultrasound<br> <br> Other: 2D ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses | Sensitivity specificity positive predictive value and negative predictive values will be determined | 72hours |
Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.

Official Title
-----------------
Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration

Conditions
-----------------
Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: choroidal neovascularization caused by age-related macula degeneration no previous treatment a follow-up at least 12 months a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart Exclusion Criteria: choroidal neovascularization caused by other eye diseases ocular surgery within the past 3 mouths history of uveitis intraocular pressure higher than 25 mmHg, or glaucoma history of systemic or ocular thromboembolic events.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Bevacizumab<br> | Drug: Bevacizumab<br>* A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | The comparison between baseline and 12-month |
Twin Pregnancy Cohort

Study Overview
=================
Brief Summary
-----------------
The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure. The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.

Official Title
-----------------
Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM

Conditions
-----------------
Pregnant With Complication, Twin Pregnancy With Antenatal Problem

Intervention / Treatment
-----------------
* Other: Impact of environment upon obstetrical
* Other: neonatal and maternal adverse outcome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Pregnant women Delivery of a twin pregnancy Gestational age >25 weeks Age >18 years Exclusion criteria: Singleton pregnancy Miscarriage

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All pregnant women delivering a twin pregnancy<br>All pregnant women delivering a twin pregnancy | Other: Impact of environment upon obstetrical<br>* Impact of environment upon obstetrical<br>Other: neonatal and maternal adverse outcome<br>* neonatal and maternal adverse outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal adverse outcome | Pomaternal adverse outcome | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal adverse outcome | Neonatal adverse outcome | day 1 | 
| Obstetrical adverse outcome | Obstetrical adverse outcome | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnant women, Environment, Adverse outcome, Age >18 years, Gestational age >25 weeks, Delivery of a twin pregnancy
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure. The aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.

Official Title
-----------------
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial

Conditions
-----------------
Uterine Bleeding

Intervention / Treatment
-----------------
* Drug: Lidocaine spray
* Other: Normal saline spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital Exclusion Criteria: Lidocaine allergy Pregnancy Previous uterine or cervical surgical procedures Neurological abnormalities Coagulopathy Infection of cervix, vagina, or pelvic cavity Taking any analgesic drugs within 4 hours before the procedure

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine spray<br> | Drug: Lidocaine spray<br>* Patients are locally anesthetized with 8 puffs (80 mg, 10mg/puff, 0.8 ml) of 10% lidocaine spray applied thoroughly to the cervix, 3 minutes before starting the procedure.<br>|
| Sham Comparator: Normal saline spray<br> | Other: Normal saline spray<br>* 0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure<br>|
| No Intervention: No spray<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration pain | A visual analog scale pain score associated with endometrial aspiration biopsy | Immediately following endometrial aspiration biopsy | 
| Postprocedure pain | A visual analog scale pain score after the procedure | 10 minute after procedure completion |
The Impact of Melanoma and Drug Treatment in the Real World

Study Overview
=================
Brief Summary
-----------------
An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the knowledge of melanoma and improve patient care.

Detailed Description
-----------------
The registry uses Vitaccess' digital real-world evidence platform, and has been developed in collaboration with the patient advocacy group Melanoma UK. Eligible participants install a study app on their smartphone or tablet. Researchers access aggregated, anonymised data via a cloud-based research portal. The platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to upload electronic documents such as scans, and access an online melanoma community. The aggregated data are available in close to real time via dashboards and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location). State-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. Participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.

Official Title
-----------------
The Impact of Melanoma and Drug Treatment in the Real World

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with melanoma of any stage, resident in the UK with National Health Service (NHS) or Community Health Index (CHI) number, aged 18 and over, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet. Exclusion Criteria: no specific exclusion criteria

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 |
| --- | --- | --- |
| Health-Related Quality of Life (HRQL), general | EQ-5D-5L | Monthly throughout 4 year study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life (HRQL), oncology | QLQ-C30 | Monthly throughout 4 year study duration | 
| Health-Related Quality of Life (HRQL), symptoms | PRO-CTCAE | Monthly throughout 4 year study duration |
Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year.

Official Title
-----------------
Pilot Project to Determine Rates and Reasons for Non-Adherence in Patients Receiving Chronic Oral Antiarrhythmic Therapy for Atrial Fibrillation in the State of Nebraska

Conditions
-----------------
Atrial Fibrillation, Medication Adherence

Intervention / Treatment
-----------------
* Other: Education and telephone follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prescribed a new anti-arrhythmic medication for atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone follow-up<br>All study participants will be receiving education and monthly telephone follow-up. | Other: Education and telephone follow-up<br>* Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to anti-arrhythmic medication | Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Anti-arrhythmic medication, Medication adherence
Resistance Versus Balance Training in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Comparison of resistance training versus balance training to improve postural control in patients with Parkinson's Disease

Official Title
-----------------
Resistance Training Versus Balance Training to Improve Postural Control in Patients With Parkinson's Disease - a Randomized Controlled Rater Blinded Trial

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: Resistance Training
* Behavioral: Balance Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic Parkinson's Disease, postural instable Exclusion Criteria: cardiopulmonary/metabolic diseases that could interfere with the safe conduct of the study protocol, unstable medication, severe cognitive impairments that do not allow the patients to follow exercise instructions, participation in a resistance or balance training program (beside usual physical therapy), Deep Brain Stimulation.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Training<br>Group performing resistance training. | Behavioral: Resistance Training<br> <br> |
| Experimental: Balance Training<br>Group performing balance training. | Behavioral: Balance Training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fullerton Advanced Balance scale |  | up to 2 years |