linjc16/ctgov huggingface dataset:
A Clinical Study of Tranilast in the Treatment of Mucinoses

Study Overview
=================
Brief Summary
-----------------
56 participants with Mucinoses will be selected to receive treatment of tranilast. After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.

Detailed Description
-----------------
56 participants with Mucinoses will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos,the thickness and area of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast (0.1g each time, three times a day,12 months) treatment, participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness and area. With 3 month as a time point, participants were observed for four points. After the experiment, the experimental data will be arranged and the data of the thickness and area change of skin lesions will be statistically processed to determine whether it is meaningful.

Official Title
-----------------
A Clinical Study of Tranilast in the Treatment of Mucinoses

Conditions
-----------------
Mucinoses

Intervention / Treatment
-----------------
* Drug: Tranilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and histopathological examination has been proved to be Mucinoses; Ultrasound and magnetic resonance detection found that the skin was thickened. Exclusion Criteria: With a liver or kidney disease, or accompanied by a severe infection; Poor control of primary disease; With mental disease.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranilast<br>Subjects who were treated with tranilast | Drug: Tranilast<br>* Subjects will be treated with tranilast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the volume change of skin lesions by ultrasound | During tranilast (0.1g each time, three times a day, 12 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective | This experiment will last for 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucinoses, Tranilast
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.

Official Title
-----------------
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

Conditions
-----------------
Acute Migraine Headache

Intervention / Treatment
-----------------
* Drug: prochlorperazine and benadryl IV
* Drug: Imitrex SubQ, saline IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute migraine headache Exclusion Criteria: Pregnant Hypertension Chest pain < 18 Allergy to any of the meds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: 1<br>prochlorperazine and benadryl IV, saline subQ | Drug: prochlorperazine and benadryl IV<br>* prochlorperazine and benadryl IV, saline subQ<br>|
| Active Comparator: 2<br>imitrex SubQ, saline IV | Drug: Imitrex SubQ, saline IV<br>* Imitrex SubQ, saline IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain measured by VAS |  | 80 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of sedation, nausea, akathisia |  | 80 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Emergency, imitrex, prochlorperazine, Acute Migraine Headache in the Emergency Department
Renal Denervation in Patients With Refractory Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Official Title
-----------------
Renal Denervation in Patients With Refractory Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Renal Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure of 160 mmHg or greater On 3 or more antihypertensive medications eGFR >= 45 mL/min Exclusion Criteria: Renal artery abnormalities Known secondary hypertension attributable to a cause other than sleep apnea MI, angina, CVA within 6 months Type 1 diabetes Others

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br> | Device: Renal Denervation<br> <br> * Other names: Symplicity Renal Denervation System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. |  | Through 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic response to renal denervation (e.g., blood pressure reduction) |  | Through 3 years |
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.

Official Title
-----------------
A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: 17ß-Estradiol/Dydrogesterone
* Drug: Tibolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Natural or surgical postmenopausal amenorrhea since ≥ 12 months, non hysterectomized women, complaining of at least 14 hot flushes per week Exclusion Criteria: Known, suspected or history of breast cancer or hormone-dependent neoplasia, undiagnosed genital bleeding, venous or arterial history or presence of thromboembolism, cerebrovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 17ß-Estradiol/Dydrogesterone<br>* 1/5 mg/day for 12 cycles of 28 days<br>|
| Active Comparator: 2<br> | Drug: Tibolone<br>* 2,5 mg/day for 12 cycles of 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF1 values after 12 cycles of 28 days |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause, IGF-1, HRT
Hypertension and Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.

Official Title
-----------------
Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors

Conditions
-----------------
HYPERTENSION

Intervention / Treatment
-----------------
* Drug: VALSARTAN+HYDROCHLOROTHIAZIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who give consent Men and women 18 to 80 years of age Patients with hypertension (systolic >159 mm, diastolic >100 mm) Patients meeting laboratory criteria Exclusion Criteria: - Pregnant women Women not using approved contraception methods Secondary hypertension Other protocol-defined exclusion criteria may apply.

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

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

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

| Intervention/Treatment |
| --- |
|Drug: VALSARTAN+HYDROCHLOROTHIAZIDE|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure at 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure less than 140/90 mmHg at 8 weeks |  |  | 
| Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg |  |  | 
| Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HYPERTENSION, VALSARTAN, VALSARTAN AND HYDROCHLOROTHIAZIDE, RISK FACTORS
The Role of Pro-angiogenic Immune Cells in Human Pregnancies

Study Overview
=================
Brief Summary
-----------------
Identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders.

Conditions
-----------------
Fetal Growth Retardation, Preeclampsia

Intervention / Treatment
-----------------
* Other: Biological specimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Placentas that have been delivered in the Medical Center Exclusion Criteria: None
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 |
| --- | --- |
| Placentas after delivery or abortion<br> | Other: Biological specimen<br>* Biological specimen taken from placenta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find the angiogenic potential of proangiogenic immune cells derived from human placentas. |  | Two years |
Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.

Official Title
-----------------
Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori Using Biopsies Taken During Gastroscopy in Patients in Which the Bacterium is Suspected

Conditions
-----------------
Helicobacter Pylori

Intervention / Treatment
-----------------
* Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing gastroendoscopy with suspected Helicobacter Pylori Exclusion Criteria: Patients with active bleeding Patients treated with anti-coagulation medication

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori<br>During gastroscopy additional biopsies are taken in cases where infection with helicobacter pylori is suspected. It will then undergo laboratory analysis with fluorescent-labeled urease inhibitor marker. Results will be compared to standard analysis to determine efficacy. | Diagnostic Test: Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori<br>* Diagnostic laboratory test for detection of helicobacter pylori<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection | Comparison of results of biopsies analyzed with a fluorescent-labeled urease inhibitor marker to detect Helicobacter Pylori infection and results will be compared to standard tests to detect Helicobacter Pylori | Two years |
Evaluation of Residual Urine After Intermittent Catheterisation

Study Overview
=================
Brief Summary
-----------------
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Official Title
-----------------
Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters

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

Intervention / Treatment
-----------------
* Device: Intermittent catheter
* Device: Compact intermittent catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18 years and above A negative urine dip-stick Have signed informed written consent to participate Exclusion Criteria: The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SC<br>Speedicath (SC) catheter is a catheter for intermittent catherisation | Device: Intermittent catheter<br>* SpeediCath catherter (SC) for intermittent catherisation<br>|
| Experimental: SCCM<br>SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males | Device: Compact intermittent catheter<br>* SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Urine Measured by Ultra Sound |  | 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjectively Measured Handling |  |  | 
| Subjectively Measured Insertion of the Catheter |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Residual urine, Hematuria, Ultra sound
A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.

Official Title
-----------------
A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)

Conditions
-----------------
Upper Limb Spasticity After Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject able to comply with the protocol Provision of written informed consent prior to collecting the data Male or female patients of 18 years or older Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated Exclusion Criteria: The subject has already been included in this survey Patients who already received BoNT-A treatment for upper limb spasticity Patients with known intolerance for BoNT-A Subjects unable to comply with the protocol

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 |
| --- | --- | --- |
| Documentation of the injection intervals |  | 3 years | 
| Documentation of treatment modalities |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the main reason(s) for change in injection intervals |  | 3 years | 
| Documentation of the main reason(s) for dose change(s) |  | 3 years | 
| Documentation of the patient satisfaction with the treatment |  | 3 years | 
| Documentation of the physician satisfaction with the treatment |  | 3 years |
OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Official Title
-----------------
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Conditions
-----------------
Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteria: Any intraocular inflammation in the study eye present during the screening slit lamp examination Score greater than 0 on the Ocular Pain Assessment in the study eye at Screening Any intraocular inflammation in the study eye present during the screening slit lamp examination

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Anterior Chamber Inflammation | Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14 | Day 14 | 
| Absence of Ocular Pain | Absence of pain (i.e., score of '0') in the study eye at Day 8 | Day 8 |