linjc16/ctgov huggingface dataset:
Study of ORL-1G (D-galactose) in Patients With Glycogen Storage Disease Type 14

Study Overview
=================
Brief Summary
-----------------
Study of ORL-1G in Patients With Glycogen Storage Disease Type 14

Official Title
-----------------
Study of ORL-1G (D-galactose) in Patients With Glycogen Storage Disease Type 14

Conditions
-----------------
Glycogen Storage Disease, Type 14

Intervention / Treatment
-----------------
* Drug: ORL-1G - D-galactose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Glycogen Storage Disease Type 14. Less than 18 years old. Exclusion Criteria: Diagnosis of any other disease that is not a manifestation of Glycogen Storage Disease Type 14.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Other: Treatment with ORL-1G - D-galactose<br> | Drug: ORL-1G - D-galactose<br>* Oral ORL-1G - D-galactose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in liver function. | Statistically significant decrease in plasma liver enzyme levels | 3 months after treatment starts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in serum transferrin glycosylation pattern. | Decreased serum level of hypoglycosylated transferrin. | 30 days after treatment starts | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDG It; CDGIt PHOSPHOGLUCOMUTASE 1 DEFICIENCY PGM1 DEFICIENCY GLYCOGEN STORAGE DISEASE XIV; GSD14 GSD XIV
Xience/Promus for Long Coronary Lesion Registry

Study Overview
=================
Brief Summary
-----------------
The utilization of everolimus-eluting coronary stents in a coronary artery diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of multiple everolimus-eluting coronary stent implantation in long (>30mm) coronary lesions.

Official Title
-----------------
A Multi Center Registry to Evaluate Multiple Stenting Using by Everolimus-eluting Stents for Treatment of Long Coronary Artery Disease

Conditions
-----------------
Long Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Intracoronary stent implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥20 years and are able to undergo CABG Females who are not pregnant Patients who present with angina symptoms or myocardial ischemia Patients available for post-procedural observation and coronary angiography at 24 months Patients who have signed patient informed consent Lesion length is more than 30mm De novo lesion or non-stented restenosed lesion Exclusion Criteria: Patients contraindicated for antiplatelet therapy or anticoagulant therapy Patients with significant allergic reaction to contrast medium Chronic total occlusion Lesion with TIMI0 Patients with chronic renal failure (SCr>3.0mg/dl) -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single arm study<br> | Device: Intracoronary stent implantation<br>* Everolimus-eluting stent implantation in patients with long coronary artery disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | Initial | 
| Angiographic restenosis |  | 9 months | 
| Target vessel revascularization |  | 1 year | 
| Target lesion revascularization |  | 2 year | 
| Target vessel revascularization |  | 2 year | 
| Incidences of acute, sub acute, and late stent thrombosis |  | 2 year | 
| Incidence of MACCE | defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events | 2 year |
Synthetic Human Secretin in Children With Autism

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.

Official Title
-----------------
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Drug: RG1068 (Synthetic Human Secretin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Autism

Ages Eligible for Study
-----------------
Minimum Age: 32 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RG1068 (Synthetic Human Secretin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.

Official Title
-----------------
An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.

Conditions
-----------------
Hypertension, Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO5093151


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, at least 21 years of age, inclusive Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye Able to participate and willing to give informed consent Exclusion Criteria: Presence of extreme narrow angle with complete or partial closure Progressive retinal or optic nerve disease from any cause other than glaucoma History or signs of penetrating ocular trauma Uncontrolled hypertension Clinically significant abnormalities in laboratory test results Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2 Kidney disease or dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to RO5093151<br>|
| Experimental: RO5093151<br> | Drug: RO5093151<br>* oral doses twice daily for up to 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean daily intraocular pressure (IOP) |  | Up to 28 days | 
| Change in mean intraocular pressure (IOP) at each assessment time-points |  | Up to 28 days | 
| Change in intraocular pressure (IOP) during a placebo lead-in phase |  | 7 days | 
| Pharmacokinetics (area under the concentration time curve) |  | Day 7 | 
| Urinary ratio of tetrahydrocortisol to tetrahydrocortisone |  | 7 days | 
| Safety (incidence of adverse events) |  | Up to 28 days |
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)

Study Overview
=================
Brief Summary
-----------------
The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.

Official Title
-----------------
A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant Major Depressive Disorder (MDD)

Conditions
-----------------
Major Depressive Disorder, MDD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent form Male and Female age: 18-65 years Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent) Treatment resistance defined as non-response to at least 2 antidepressants given in an ade Exclusion Criteria: Patients already participating in clinical trial or any other interventional study Patients unable to understand HCL-32 item meaning

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| MDD<br>Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the potential bipolarity status in treatment resistant MDD patient population | assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening | 3 months | 
| Hypomanic condition will be defined if the patient will give positive answer to at least 12 items of HCL32. HCL-32-positive patients is expected to be ranged between 4.3% and 21.3%. The difference between the means in the two groups will be estimated. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect patient characteristics by evaluation of demographic information |  | 3 months | 
| To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode |  | 3 months | 
| To collect information on the ongoing treatment |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Major Depressive Disorder
Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD

Study Overview
=================
Brief Summary
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Drug: NYX-783
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD (DSM-5 criteria) Stable allowed medications with no planned changes from 30 days prior to screening through study participation Willing to use highly effective birth control Willing to comply with protocol visits and procedures Exclusion Criteria: Moderate to severe traumatic brain injury Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders Substance use disorder or alcohol use disorder within 6 months prior to screening Psychotherapy or cognitive based therapy within 30 days prior to screening Use of investigational drug within 30 days prior to screening Prior participation in study of NYX-783, NYX-2925 or NYX-458.

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: 50 mg NYX-783 QD<br>50 mg NYX-783 QD | Drug: NYX-783<br>* NYX-783<br>|
| Placebo Comparator: Placebo<br>Placebo QD | Drug: Placebo<br>* Placebo for 50 mg NYX-783<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition) | Change from Baseline in CAPS-5 | study endpoint, up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S (Clinician Global Impression - Severity) | Change from Baseline in CGI-S | study endpoint, up to 10 weeks | 
| PGI-S (Patient Global Impression - Severity) | Change from Baseline in PGI-S | study endpoint, up to 10 weeks | 
| SDS (Sheehan Disability Scale) | Change from Baseline in SDS | study endpoint, up to 10 weeks |
Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine three different ways to control pain after hip replacement: One time injection of ropivacaine before wound closure One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours Standard practice of patient controlled pump

Official Title
-----------------
The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Ropivacaine infiltration and saline infusion.
* Procedure: Ropivacaine infiltration and infusion.
* Procedure: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total knee replacement Exclusion Criteria: History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine infiltration and infusion.<br>Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours. | Procedure: Ropivacaine infiltration and infusion.<br>* 50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.<br>|
| Experimental: Ropivacaine and Saline<br>Ropivicaine infiltration followed by normal saline infusion. | Procedure: Ropivacaine infiltration and saline infusion.<br>* 50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour<br>|
| Placebo Comparator: Saline infiltration and infusion.<br>Normal saline infiltration followed by saline infusion. | Procedure: Normal Saline<br>* 50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain medication requirement for 48 hours after surgery in three groups. |  | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores, incidence of nausea and vomiting and patient satisfaction in each group. |  | 48 hours after surgery |
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.

Detailed Description
-----------------
All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.

Official Title
-----------------
A Multicenter, Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation (Saquinavir SGC) in Combination With Other Antiretroviral Drugs

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Saquinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral treatments other than PIs. Patients must have: HIV infection. No prior experience with PIs. (Note: At least 75 percent of patients must be naive to PIs.) Exclusion Criteria Concurrent Medication: Excluded: PIs other than SQV. Prior Medication: Excluded: Any PIs (see note in General Criteria--Inclusion).

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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
-----------------
Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Dosage Forms, Anti-HIV Agents
Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality MRI study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. This study will include 100 patients treated in a single institution between 2011 and 2016

Official Title
-----------------
Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer, With Focus on Background Parenchymal Enhancement

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Patients with breast cancer treated with neoadjuvant chemotherapy Patients with pre- and post-chemotherapy MRI Patients who have given their agreement to use their data for research purposes. Exclusion Criteria: - Refusal to participate in the study

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 |
| --- | --- | --- |
| Presence or absence of of pathologic enhancement of breast by MRI | This work concerns 110 patients treated with neoadjuvant chemotherapy for breast cancer and having received a breast MRI in pre and post-chemiotherapy at the Hautepierre Hospital. | 1 hour after the realization of the MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Neoadjuvant chemotherapy