linjc16/ctgov huggingface dataset:
Continuos Subcutaneous Insulin Infusion in Italy

Study Overview
=================
Brief Summary
-----------------
This is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with CSII in Italy.

Detailed Description
-----------------
The aim of the study is to collect clinical and metabolic characteristics of patient treated with CSII in Italy. Data will be collected through a questionnaire sent by e-mail to CSII experienced Diabetes Centers ( both adult and pediatric patients) . The questionnaire assessed: (1) number of CSII-treated patients; (2) patients and pump characteristics; (3) structure and organization of Diabetes Centers providing CSII therapy; (4) metabolic control.

Official Title
-----------------
Survey on Continuos Subcutaneous Insulin Infusion in Italy

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients treated with CSIIin Italy Exclusion Criteria: none
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 |
| --- | --- | --- |
| Efficacy Assessed by Median of HbA1c, | median of HbA1c measured in the last year | 1 year | 
| Patients With Severe Hypoglycemia | Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year | 1year | 
| Number of Patients With Glycated Hemoglobin on Target | number of patients who achieved HbA1c target (< 7,5% in patients < 18 years old; <7% in adult patients); | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting | number of patients adults with HbA1c <7,0% using advanced pump's functions, CGM and CHO counting number of paediatrics patients with HbA1c < 7.5% using advanced pump's functions, CGM and CHO counting | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, CSII
Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide Sildenafil therapy for subjects who completed A1481156 study and are judged by the investigator to derive clinical benefit from continued treatment with Sildenafil, prior to reimbursement and availability for subjects in the Russian Federation.

Official Title
-----------------
A LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATION

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Who Completed study A1481156 and Are Judged by the Investigator to Derive Clinical Benefit from Continued Treatment with Sildenafil, Prior to Reimbursement and Availability for Subjects in Russian Federation. Child bearing age women should have appropriate contraception. Signed informed consent. Patients who have a wish and possibility to follow treatment regimens in terms of the study. Exclusion Criteria: Pregnant and lactating women. Participation in other studies in the current moment or during study period except of A1481156. Patients with severe acute or chronic diseases psychiatric disorders or laboratory abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sildenafil|tablets of sildenafil 20 mg 3 times a day for subjects with body weight > 20 kg and 10 mg TID for subjects with body weight ≤ 20 kg. If subject is 18 years of age or older, the recommended dose is 20 mg TID, regardless of body weight.|

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
-----------------
sildenafil, pulmonary arterial hypertension, PAH
Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control.

Detailed Description
-----------------
40 renal colic patients have been divided into 2 groups randomly, one group has been received 30mg intravenous Ketorolac and 4 puffs nasal Normal Saline while other has been received 40 micrograms nasal Desmopressin and 1cc intravenous Normal Saline. Pain Score before drug administration,also 10, 30 and 60 minutes after drug administration has been measured bye Visual Analogue Scale ( VAS ).

Official Title
-----------------
Comparison of Intranasal Desmopressin vs IV Ketorolac in Renal Colic Patients

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Drug: Desmopressin
* Drug: Ketorolac
* Drug: Normal Saline
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal colic patients Exclusion Criteria: history of hypertension and cardiac disease pregnant patients use of analgesic within 4 hours before intervention

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline. | Drug: Ketorolac<br>* 30mg intravenous Ketorolac.<br>* Other names: Toradol;Drug: Normal Saline<br>* 4 puffs nasal Normal Saline.<br>* Other names: NaCl;|
| Active Comparator: Desmopressin<br>40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous | Drug: Desmopressin<br>* 40 micrograms Nasal Desmopressin.<br>* Other names: Ddavp;Drug: Normal Saline<br>* 1cc intravenous Normal Saline.<br>* Other names: NaCl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention |
Evaluation of pupillometrY for External Ventricular Drains Stop

Study Overview
=================
Brief Summary
-----------------
Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed. So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.

Official Title
-----------------
Evaluation of pupillometrY for External Ventricular Drains Stop

Conditions
-----------------
All Indication for External Ventricular Drain Clamping

Intervention / Treatment
-----------------
* Other: Electronic pupillometer analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients for whom the doctor orders an external ventricular bypass clamp test Neuro-injured patients and non-neuro-injured patients whose state of health requires sedation and mechanical ventilation Exclusion Criteria: Ophthalmological pathology making impossible to carry out measurements by the pupillometer (chemosis, eyelid edema, enucleation, etc.). Pregnant woman.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intensive care patients<br> | Other: Electronic pupillometer analysis<br>* Electronic pupillometer analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in pupillary contraction speed during the photomotor reflex measured by electronic pupillometer as a function of the outcome of the External ventricular lead clamping test |  | 48 HOURS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the pupillometry parameters between neuro wronged's patients and not neuro wronged's patients (parameters measured by pupillometer) |  | 48 HOURS |
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)

Study Overview
=================
Brief Summary
-----------------
A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.

Official Title
-----------------
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Atomoxetine Hydrochloride
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female patients with ADHD ages 18-54. Patient must have ADHD symptoms that cause problem(s) in the home setting. Exclusion Criteria: Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication. Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 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: Atomoxetine Hydrochloride|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults. |  |  |
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors

Official Title
-----------------
Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Advanced or Metastatic Solid Tumors

Intervention / Treatment
-----------------
* Drug: ONO-7475
* Drug: ONO-7475 + ONO-4538


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically confirmed advanced or metastatic solid tumors ECOG Performance Status 0～1 Patients with life expectancy of at least 3 months Exclusion Criteria: Patients with history of severe allergy Patients with multiple cancers

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-7475 monotherapy<br> | Drug: ONO-7475<br>* ONO-7475 specified dose on specified days<br>|
| Experimental: ONO-7475 in combination with ONO-4538<br> | Drug: ONO-7475 + ONO-4538<br>* ONO-7475+ONO-4538 specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of paticipants with dose-limiting toxicities during the DLT evaluation period |  | 28 days | 
| Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax) | Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538 | Through study completion | 
| Pharmacokinetics (Tmax) | Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538 | Through study completion | 
| Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538 | Through study completion |
Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy

Official Title
-----------------
A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Irbesartan/Amlodipine low
* Drug: Irbesartan/Amlodipine high
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 19 years or older on screening Signed informed consent Patients with Essential Hypertension Other inclusion applied Exclusion Criteria: Orthostatic hypotension Other exclusion applied

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irbesartan/Amlodipine low<br> | Drug: Irbesartan/Amlodipine low<br>* Irbesartan/Amlodipine low once daily for 8 weeks<br>|
| Experimental: Irbesartan/Amlodipine high<br> | Drug: Irbesartan/Amlodipine high<br>* Irbesartan/Amlodipine high once daily for 8 weeks<br>|
| Active Comparator: Irbesartan<br> | Drug: Irbesartan<br>* Irbesartan once daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic blood pressure(mmHg) |  | Week8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic blood pressure(mmHg) |  | Week 4 | 
| 2.Change from baseline in mean sitting diastolic blood pressure(mmHg) |  | Week 4,8 | 
| Responder rate |  | Week 4,8 | 
| Target blood pressure reach rate |  | Week 4,8 |
Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

Detailed Description
-----------------
In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics. The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis. Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.

Official Title
-----------------
Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine

Conditions
-----------------
Pain, Osteoporosis, Fracture

Intervention / Treatment
-----------------
* Genetic: Poly methylmetacrylate, PMMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new pain in spine (within 6 months) x-ray verified low energy spinal fracture(s) Exclusion Criteria: less than 20% or more than 90% reduction of the vertebral height lack of pain at fracture level no need for continuous analgesic treatment patient no able to communicate general anaesthesia contraindicated MRI not possible coagulopathy (not adjustable) spondylitis discitis spinal metastasis
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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Poly methylmetacrylate, PMMA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain |  | before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needs for analgetics, number of days at hospital, level of ADL |  | before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, vertebra, fracture, pain, percutaneous, vertebroplasty, polymethylmetacrylate
Low Cost OCT for Point of Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.

Official Title
-----------------
Low Cost Optical Coherence Tomography for Point of Care

Conditions
-----------------
Optical Coherence Tomography (OCT) of the Retina

Intervention / Treatment
-----------------
* Device: OCT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled to receive standard OCT testing as part of their clinical visit Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT imaging<br>OCT device images retina | Device: OCT imaging<br>* imaging of retina using OCT device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acceptable OCT Image Quality | measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Macular Thickness | compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system | day 1 | 
| Total Macular Volume | compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system | day 1 |