linjc16/ctgov huggingface dataset:
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.

Official Title
-----------------
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial

Conditions
-----------------
Urinary Retention Postoperative

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18-80 undergoing outpatient minimally invasive hysterectomy Exclusion Criteria: Inability to provide informed consent Bladder malignancy Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization Plan for sling or anterior repair

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin- intervention group<br> | Drug: Tamsulosin<br>* Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to spontaneous void |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge from the hospital |  | 8 weeks |
Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

Study Overview
=================
Brief Summary
-----------------
Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.

Official Title
-----------------
Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis

Conditions
-----------------
Radiotherapy, Nasopharyngeal Carcinoma, Cerebral Radiation Necrosis, MRI

Intervention / Treatment
-----------------
* Drug: GM1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months. Exclusion Criteria: CRN combined with local or regional relapse, or with distant metastasis. ② CRN combined with other cerebrovascular disease. ③CRN combined with the second primary malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes. ⑥CRN patients that were supposed to live less than 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| group one will receive non-GM1 conservative therapy<br>Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or wait and see policy | Drug: GM1<br>* This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.<br>* Other names: monosialotetrahexosylganglioside;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The necrotic volume showed on MRI |  | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relief of the symptoms related to CRN |  | 6-8 months |
The Correlation Between Oxidative Stress and Indinated Contrast-Media Nephrotoxicity

Study Overview
=================
Brief Summary
-----------------
Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM. Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists, cardiologists, and radiologists. The present study is aimed to determine the norepinephrine concentration, oxidative markers, and tubular damage markers in the urine samples of patients undergoing intravenous pyelography (IVP). The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress and greater tubular damage than iso-osmolarity contrast media (IOCM).

Official Title
-----------------
The Correlation Between Oxidative Stress and Indinated Contrast-Media Nephrotoxicity

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years old) Undergoing IVP with an appropriate medical indication Signing informed consent Exclusion Criteria: 1. Without signing informed consent

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
-----------------
oxidative stress markers in urine, urine norepinephrine, renal tubular enzyme markers
Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The development of regular sleep-wake cycle is an important factor of the newborn maturation and it has influence on behavior .Factor that may influence the process of the maturation of the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected and measured with actigraphy, using a wrist-watch like device that continuously measures and records the subject's movements.The present study aims to compare vacuum delivery with regular, elective and not elective caesarean sections. We hypothesize that the sleep of vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.

Official Title
-----------------
Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborn, born either by regular delivery, vacuum extraction or cesarean section Exclusion Criteria: Preterms, newborns that need special medical treatment and/or repeated blood sampling as glucose.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Days

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

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
-----------------
delivery mode, Sleep pattern, newborn, actigraphy, Parents' approval
Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

Study Overview
=================
Brief Summary
-----------------
TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.

Official Title
-----------------
Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block for Patient Undergoing Lower Abdominal Surgery

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

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 24 ASA I-II patients (age 18-60 years weight 50-89 kg Exclusion Criteria: a known allergy to the study drugs significant cardiac respiratory, renal or hepatic diseases bleeding diathesis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Dexmedetomidine group<br>patients were given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine + dexmedetomidine 1 μg•kg-1 diluted in 20 ml saline | Drug: Dexmedetomidine<br>* 20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 μg•kg-1<br>* Other names: active group;|
| Placebo Comparator: bupivacaine group<br>patients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine | Drug: bupivacaine<br>* 20 ml of 0.5 % bupivacaine<br>* Other names: control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure dexmedetomidine level into systemic circulation after local administration | assessment of systemic dexmedetomidine level after local administration in TAP block after 15 minutes after giving the block, 30 min, 45 min, 1hrs, 2hrs, 4hrs and 6 | up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dose of IV PCA morphine consumption in the first 24 h postoperative | postoperative morphine consumption | 24 hours |
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole

Study Overview
=================
Brief Summary
-----------------
To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.

Official Title
-----------------
Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of Informed Consent Resectable breast cancer patients, with histological confirmation Patients eligible to receive hormonal adjuvant treatment with Anastrozole They are allowed patients treated with adjuvant chemo or radiotherapy concurrently Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH level >40UI/L / women under 50 years with FSH levels>40UI/L). Women showing progesterone and/or estrogen receptors positive. Exclusion Criteria: Patients with evidence of metastatic disease Patients unsuitable to receive the medication according the Anastrozole label Patients not giving their Informed Consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global incidence of endometrial changes during the adjuvant treatment with Anastrozole |  | From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the endometrial changes both clinically(vaginal bleeding) and through the scan. |  | During the study, at least annually | 
| Histological assessment when indicated(type of hyperplasia) |  | When applicable | 
| To assess global incidence of endometrial changes in this patient population before taking Anastrozole |  | During the study | 
| To evaluate type of surgery required for endometrial changes control(hysterectomy rate) |  | During the study | 
| To assess treatment tolerability |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adjuvant postmenopausal breast cancer women
Lofexidine for Opiate Withdrawal - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate lofexidine for opiate withdrawal.

Detailed Description
-----------------
An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Official Title
-----------------
A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lofexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female as least 18 yrs of age & above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method. Exclusion Criteria: Additional criteria available during screening at the site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate withdrawal symptoms |  |  | 
| Potential Abuse Liability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opiate dependence
Partial Meal Replacement and Inulin in Obese Women

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to test the efficacy of a partial meal replacement added with vitamins, minerals and inulin on weight reduction, blood lipids and micronutrients intake in obese Mexican women

Official Title
-----------------
Evaluation of the Effectiveness of a Partial Meal Replacement With Inulin on Obesity and Dyslipidemias in Women.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Partial meal replacement
* Dietary Supplement: Partial meal replacement with inulin
* Dietary Supplement: Inulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 25 kg/m 2 Exclusion Criteria: Pregnant Lactating Diagnosed with diabetes Diagnosed with hypertension Fasting glucose ≥126 mg/dL Blood triglycerides ≥400mg/dL

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partial meal replacement<br> | Dietary Supplement: Partial meal replacement<br>* The PMR was designed to contain sufficient amounts of all vitamins and minerals. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.<br>|
| Experimental: Partial meal replacement with inulin<br> | Dietary Supplement: Partial meal replacement with inulin<br>* The PMR was designed to contain sufficient amounts of all vitamins and minerals plus inulin. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.<br>|
| Active Comparator: Inulin<br> | Dietary Supplement: Inulin<br>* Women were asked to consume one 5g serving of inulin mixed with any drink at breakfast and same amount at dinner (10 g of inulin/d).<br>|
| No Intervention: No intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  |  | 
| Blood lipids |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Micronutrients intake |  |  |
Development of Cardio-Vascular Emergency Patients Database Using Voice and Image Technology

Study Overview
=================
Brief Summary
-----------------
Video and audio data of cardio-vascular patients who visit the emergency department (ED) will be collected to build a database. Clinical information retrieved from the database using voice and image technology will be compared to that retrieved by physicians. The degree of agreement will be evaluated.

Detailed Description
-----------------
Study Objectives: To develop a platform to record video and audio data of cardio-vascular patients who visited the ED. To retrieve clinical information using voice and image technology. To develop a tool to retrieve clinical information using voice and image technology. To build a clinical database using video and audio data using voice and image technology. Study design: Single-center observational study (tertiary hospital emergency department in Korea). A platform to record video and audio data of physicians examining patients will be developed. The camera and microphone will be installed at an optimal location to retrieve video and audio data of cardio-vascular patients. Voice and image technology will be used to retrieve clinical information including chief complaint, type and onset of symptoms, past medical history, and physical examination results to build a database. Clinical information including examination notes, diagnosis, patient vital signs, test results, and ED results will be retrieved from the hospital database.

Official Title
-----------------
Automatic Clinical Information Extraction Technology Development and Database Construction for Cardio-Vascular Emergency Patients Based on Voice and Image Recognition Technology

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 years or older Visited the emergency department of the study hospital Chief complaint of chest pain, dyspnea, syncope, altered mentality, side weakness, dizziness, and dysarthria Exclusion Criteria: Patients who do not agree to enroll to this study Pregnant patient Without a family Foreign patients

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of agreement between clinical information retrieved using voice/image technology and information recorded by physicians. | Clinical information include chief complaint, type and onset of symptoms, and physical examination results. | At the time of study completion (March 2023 anticipated). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Image recognition, Voice recognition, Emergency department