linjc16/ctgov huggingface dataset:
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

Official Title
-----------------
A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Conditions
-----------------
Primary Open Angle Glaucoma (POAG)

Intervention / Treatment
-----------------
* Device: iStent
* Device: iStent
* Device: iStent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma (POAG) Subject on two topical hypotensive medications Exclusion Criteria: Traumatic, uveitic, neovascular, or angle closure glaucoma Fellow eye already enrolled

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

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

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

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: First Arm: One iStent<br>Device: One iStent | Device: iStent<br>* Implantation of One iStent through a small temporal clear corneal incision.<br>|
| Experimental: Second Arm: Two iStents<br>Device: Two iStent devices | Device: iStent<br>* Implantation of Two iStents through a small temporal clear corneal incision<br>|
| Experimental: Third Arm: Three iStents<br>Device: Three iStent devices | Device: iStent<br>* Implantation of Three iStents through a small temporal clear corneal incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP <18 mmHg at month 12 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle, Glaucoma, surgery, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.

Official Title
-----------------
Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil

Conditions
-----------------
Normal Pregnancy

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Levobupivacaine
* Drug: Sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of ASA class I or II Variable parity Aged of 18 years or more With a normal pregnancy Cervical dilation between 3 and 8 cm) Wishing an epidural analgesia Normal childbirth Giving their written assent Affiliated with a social security system Must have had an anaesthesia consultation more than 48 hours before inclusion. Exclusion Criteria: Request of the patient Failure of epidural analgesia Childbirth in the 90 minutes following the induction of analgesia Realization of a Caesarean section

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: Clonidine|nan|
|Drug: Levobupivacaine|nan|
|Drug: Sufentanil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor blockade quantification by a score of modified Bromage specific way. |  |  | 
| Labor analgesia. |  |  | 
| Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor analgesia - clonidine - epidural
A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).

Official Title
-----------------
A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers

Conditions
-----------------
ICDs, Quality of Life, Implantable Cardiac Defibrillators

Intervention / Treatment
-----------------
* Behavioral: Quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: Patient has an ICD Age > 18 Fluent in English Consistent and reliable access to a phone. Caregivers of Patients: Age > 18 Fluent in English Consistent and reliable access to a phone Exclusion Criteria: Not having an ICD

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with ICDs<br> | Behavioral: Quality of life<br>* Improving Quality of Life<br>|
| Other: Caregivers of Patients with ICDs<br> | Behavioral: Quality of life<br>* Improving Quality of Life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Symptoms | physical symptoms of pain, shortness of breath, depression, anxiety | every 3 months plus after hospitalizations for an average of 1 year | 
| Psychological Symptoms | Psychological symptoms of anxiety and depression | every 3 months plus after hospitalizations for an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | every 3 months plus after hospitalizations for an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Implantable Cardiac Defibrillators, ICDs
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Study Overview
=================
Brief Summary
-----------------
A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.

Detailed Description
-----------------
Providers will be surveyed twice at 4 and 8 months using open ended methods.

Official Title
-----------------
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Device: CAPP use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient receiving CAPP during study period. Exclusion Criteria: None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAPP application<br>Patients in whom device is used | Device: CAPP use<br>* Any abdominal pelvic pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage | Number of patients on whom CAPP is used | Eight months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects | Any recorded complications | Eight months |
A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves

Study Overview
=================
Brief Summary
-----------------
This is a national retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.

Official Title
-----------------
The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Device: AtriCure Cryo Nerve Block (cryoNB) Device Family


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled to undergo or have undergone cryo nerve block procedure as post operative pain management Patient >= 18 years of age Patient willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements Exclusion Criteria: Patient is enrolled in a concurrent study that may interfere with the outcome of the registry Patient with exclusion criteria required by FDA or local governance

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

| Intervention/Treatment |
| --- |
|Device: AtriCure Cryo Nerve Block (cryoNB) Device Family|Use of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management | Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 1 year. | 12 months | 
| Safety of cryo nerve block to generate cryoanalgesia as post operative pain management | Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure. | 12 months |
A Single High-dose Oral Supplement of Vitamin D in Young Chinese

Study Overview
=================
Brief Summary
-----------------
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years; haven't taken vitamin D supplement for the past 6 months; with a normal BMI (18-25 kg/m2); with baseline serum 25(OH)D < 30 ng/ml; be willing to follow the instruction and complete the study. Exclusion Criteria: clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness; self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment; Severe anemia (hemoglobin concentration < 70 g/L); Serum 25(OH)D ≥ 30 ng/mL at enrollment; participating in other research studies within the 3 months before enrollment; history of drug dependence or drug abuse; History of heavy drinking (drinking 14 cups or more per week, equivalent to 360 mL beer or 150 mL white wine or 45 mL liquor per cup) and smokers (more than 10 cigarette per day); clinical abnormal of blood biochemistry, hematology or urine laboratory values; current pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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: vitamin D3<br> | Dietary Supplement: vitamin D3<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D3 supplementation on serum 25(OH)D changes |  | within 140 day after supplementation | 
| Effect of vitamin D3 supplementation on serum PTH |  | within 140 day after supplementation | 
| Effect of vitamin D3 supplementation on serum calcium |  | within 140 day after supplementation | 
| Effect of vitamin D3 supplementation on serum creatinine |  | within 140 day of supplementation | 
| Effect of vitamin D3 supplementation on urinary calcium / creatinine |  | within 140 day after supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D3 supplementation on fasting blood glucose |  | within 140 day after supplementation | 
| Effect of vitamin D3 supplementation on serum lipids |  | within 140 day after supplementation |
Diagnostic Performance of Two Tools

Study Overview
=================
Brief Summary
-----------------
Developing new tools for early detection of AKI in open-heart surgeries.

Official Title
-----------------
Diagnostic Performance of Two Tools for Early Prediction of Acute Kidney Injury After Open-heart Surgery

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: urinary oxygen partial pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes Exclusion Criteria: Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: urinary oxygen partial pressure|measuring urinary oxygen partial pressure and measuring US Doppler renal resistive index|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury | Incidence of AKI according to AKIN criteria | up to 48 hours | 
| Urinary oxygen partial pressure | Urinary oxygen partial pressure measured in mmHg at induction, before rewarming and in the ICU | up to 48 hours | 
| Renal resistive index | Renal resistive index measured at induction and in the ICU | up to 48 hours |
The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS

Study Overview
=================
Brief Summary
-----------------
Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS). Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.

Detailed Description
-----------------
We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS). PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. Furthermore there are changes similar to those seen in diabetes. Cipralex is known to decrease stress hormones. But no investigations are on the effect of cipralex on PCOS, or how the increased stress hormones affect the PCOS condition. We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo. Treatment duration is 12 weeks.

Official Title
-----------------
The Effect of Cipralex in Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >25 and <50 Age < 50 PCOS Exclusion Criteria: Epilepsia use of metformin or oral anticonceptives pregnancy/breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active comparator<br>Drug: Cipralex | Drug: Cipralex<br>* the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.<br>* Other names: Escitalopram;|
| Placebo Comparator: placebo comparator<br>Drug: Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Measured by questionaires | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of cortisone in 24 hour urine sample | Cortisone and cortisone metabolites, measured by 24 hour urine sample. | June 2013 to October 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Adrenal hyper activity, Glucose metabolism
Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.

Official Title
-----------------
Intravesikal Instillation af Botulinum Toxin Type A Til Patienter Med Urge Urininkontinens

Conditions
-----------------
Urge Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: refractory urge urinary incontinence Exclusion Criteria: neurological disease pregnant or lactating bladder neoplasias

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: botulinum toxin type A|100 or 200 units intravesically|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence episode frequency |  | 1 year |
Deutsches Device Qualitätsregister

Study Overview
=================
Brief Summary
-----------------
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.

Detailed Description
-----------------
The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.

Official Title
-----------------
Deutsches Device Qualitätsregister

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Device register will include all consecutive patients with an intended implantation of an ICD / CRT. Exclusion Criteria: Missing signed informed consent
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 |
| --- | --- | --- |
| Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany |  | 01/03/2007-12/31/2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specification of the device and the realization of the implantation as well as the success of the operation |  | 01/03/2007-12/31/2011 | 
| Documentation of further interventions needed after the Index Event during hospital stay |  | 01/03/2007-12/31/2011 | 
| Documentation of hospital mortality and non-fatal complications |  | 01/03/2007-12/31/2011 | 
| Documentation of the 1-year mortality and non-fatal complications |  | 01/03/2007-12/31/2011 | 
| Documentation of the dispensary of shocks within one year |  | 01/03/2007-12/31/2011 | 
| Documentation of symptomatology and number of hospitalizations |  | 01/03/2007-12/31/2011 | 
| Documentation of medication therapy after 12 months |  | 01/03/2007-12/31/2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT, Heart failure, Cardiac insufficiency, Implantable Cardioverter/Defibrillator, Cardiac Resynchronization therapy, ICD, Register