linjc16/ctgov huggingface dataset:
Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Official Title
-----------------
An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: human soluble insulin
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin aspart<br> | Drug: insulin aspart<br>* Injected subcutaneously (s.c, under the skin) as meal time insulin<br>Drug: insulin NPH<br>* Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin<br>|
| Active Comparator: human insulin<br> | Drug: human soluble insulin<br>* Injected subcutaneously (s.c, under the skin) as meal time insulin<br>Drug: insulin NPH<br>* Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycaemic events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Standard safety parameters: Haematology and biochemistry |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  |
REduction of Contrast Via DyeVert Used in CTO Procedures

Study Overview
=================
Brief Summary
-----------------
The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

Detailed Description
-----------------
The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity. No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted

Official Title
-----------------
REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)

Conditions
-----------------
Chronic Total Occlusion of Coronary Artery

Intervention / Treatment
-----------------
* Device: DyeVert System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing CTO PCI at each of the participating centers. Contrast volume recorded during CTO PCI Subjects included in the Multicenter Registry of Chronic Total Occlusion Interventions study (Allina IRB approval # 948134-1) Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing CTO PCI<br>Evaluates the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated CTO PCI. The system allows monitoring and display of contrast volumes that are manually injected during the procedure which will be compared to physician entered contrast usage thresholds during angiographic procedures. | Device: DyeVert System<br>* The DyeVert System (Osprey Medical, Inc) consists of a Contrast Monitoring Wireless Display (CMW) and the DyeVert Plus Disposable Kit which is inclusive of a disposable single-use sterile Smart Syringe and DyeVert Plus Module.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast volume administration during CTO PCI | The hypothesis of the study is that use of the DyeVert System will result in lower contrast volume, determined through real-time monitoring with the DyeVert System. | During the CTO PCI procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CTO, Chronic Total Occlusion, Coronary Artery Disease, Percutaneous Coronary Intervention, PCI
Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy

Study Overview
=================
Brief Summary
-----------------
In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up to 30 weeks pregnancy .

Detailed Description
-----------------
The digoxin will be injected intra-amniotic with U.S guided, trying to avoid any placental passage or intravascular injection / Any patient will have prior to the procedure a full examination including E.C.G and cardiac clearance.

Official Title
-----------------
The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion

Conditions
-----------------
ECG Changes, Arrhythmia, Hypotension

Intervention / Treatment
-----------------
* Drug: Intra-amniotic injection of DIGOXIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women with no medical, cardiac, hypertension, liver or renal problems - pregnant in their 20-30 week gestation, that need to have abortion due to fetal anomalies or any other reason need to have feticide prior to the procedure Exclusion Criteria: any patient with medical problem that may be a contra-indication to Digoxin cardiac problems, prior cardiac surgery, liver or kidney disease, hyper tension etc.

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

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

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: second trimester abortion , feticide<br>all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide . | Drug: Intra-amniotic injection of DIGOXIN<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of intra-amniotic Digoxin injection for second trimester feticide | To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion | a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digoxin, Intra-amniotic injection, feticide, second trimester abortion
Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6

Study Overview
=================
Brief Summary
-----------------
comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter

Official Title
-----------------
Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old

Conditions
-----------------
Alternating Exotropia

Intervention / Treatment
-----------------
* Procedure: Standard Recession
* Procedure: Reduced Recession


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9) Basic, pseudo- divergence excess and divergence excess types are included. If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector). Exclusion Criteria: Intermittent exotropia of the convergence insufficiency type. Intermittent exotropia with angle of deviation greater than 50 prism diopters. Patients with previous squint surgery. Patients with secondary deviation due to a sensory lesion or neurological condition.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Recession<br>Bilateral lateral rectus muscle recession using standard tables stated by Parks. | Procedure: Standard Recession<br>* Bilateral lateral rectus muscle recession will be performed through fornix approach using standard tables<br>|
| Experimental: Reduced Recession<br>Bilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables. | Procedure: Reduced Recession<br>* Bilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor success rate | Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern strabismus | Number of patients who develop pattern strabismus | 6 months |
Evaluating Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Fertile Males

Study Overview
=================
Brief Summary
-----------------
In this prospective open armed study we aim to see if bilateral hernia repair using a mesh alters the spermatogram (sperm count) or testicular volume.

Official Title
-----------------
Prospective Trial to Evaluate Changes in Spermatogram Following Bilateral Laparoscopic Inguinal Hernia Repair in Males in the Fertility Age

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Procedure: laparoscopic bilateral hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males ages 18-40 years, undergoing bilateral laparoscopic hernia repair, who agree to have a sperm test both prior to and following surgery. Exclusion Criteria: History of prostatic surgery, testicular surgery, azospermia on first spermatogram, single testis, patients after chemotherapy, patients receiving hormonal therapy, patients receiving alpha blockers for any indication, patients who are receiving or received oral antifungal therapy six months prior to surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic bilateral hernia repair|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Constraint Induced Movement Therapy (CIMT) in Babies Home Program

Study Overview
=================
Brief Summary
-----------------
The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.

Conditions
-----------------
Hemiplegia, Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Constraint induced movement therapy (CIMT)
* Behavioral: play


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy Exclusion Criteria: Epilepsy not treated

Ages Eligible for Study
-----------------
Minimum Age: 7 Months
Maximum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental CIMT<br>Two month home program that includes restricting the non hemiplegic hand an hour a day during play | Device: Constraint induced movement therapy (CIMT)<br>* soft mitten worn on the non hemiplegic hand<br>* Other names: Modifide constraint induced movoment therapy;|
| Active Comparator: Active Play<br>Two month home program that includes active use of hemiplegic hand during play one hour a day | Behavioral: play<br>* play which encourages the use of the hemiplegic hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assistive Hand Assessment | Evaluation of the use of the hemiplegic hand as an assiting hand in bilateral activities | after two months of treatment |
The Incretin Effect in Patients With Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.

Official Title
-----------------
Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.

Conditions
-----------------
Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 years old GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group) Exclusion Criteria: Previous diagnosis of DM Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA) Affected biochemical liver parameters (ALAT > 2 times normal upper range) Affected biochemical kidney parameters (se-creatinine > 130 µM) Treatment with medicine interacting with insulin secretion (e.g. steroids) Treatment with medicine that can not be paused for 16 hours

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

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 |
| --- | --- |
| GDM<br>Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT | |
| NGT<br>Pregnant patients with normal glucose tolerance as observed in 75g OGTT | |

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
-----------------
GDM, incretin effect, gestation, reversibility
Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fed State

Study Overview
=================
Brief Summary
-----------------
Phamacokinetics and safety profiles of DA-5210 10/500mg in Healthy subjects at Fed State

Official Title
-----------------
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/500mg in Healthy Subjects at Fed State

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

Intervention / Treatment
-----------------
* Drug: DA-5210 10/500mg
* Drug: DA-5210-R 10/500mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18 and 30 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5210 10/500mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/500mg<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5210 10/500mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/500mg<br>* single dose administration (one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 48 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 48 hours post-dose |
Upper Extremity paın and Ultrasound Use

Study Overview
=================
Brief Summary
-----------------
The relationship between perinatologists' ultrasound use and upper limb joint pain will be evaluated.

Official Title
-----------------
Investigation of the Relationship Between Upper Extremity Pain and Ultrasound Use in Perinatologist

Conditions
-----------------
Pain, Chronic, Upper Extremity Problem

Intervention / Treatment
-----------------
* Other: upper extremity pain
* Procedure: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who have received specialization training in the branch of perinatology and have completed their specialty in the branch and worked as a perinatologist Those who want to participate in the study Exclusion Criteria: Patients with discomfort and operation in the upper limb prior to perinatology training Physicians in other branches
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: perinatologists<br>perinatologists working actively and performing ultrasonography every day | Other: upper extremity pain<br>* upper extremity pain in perinatologists due to working actively and performing ultrasonography every day<br>Procedure: ultrasonography<br>* ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper extremity pain in perinatologists | The relationship between perinatologists' ultrasound use and upper extremity pain. Perinatologists use ultrasound for a long time during the day. This can cause some pain in the upper extremities. In our study, the investigators will have a survey of perinatologists and ask some questions: How long have they been doing this profession, which hands they use, how many patients they examine per day, do they have any complaints of upper extremity. The investigators will try to relate upper extremity pain with their answers. | 2 month |
Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome

Study Overview
=================
Brief Summary
-----------------
The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome

Conditions
-----------------
Lamotrigine, Topiramate, Memnatine, Diazepam, Placebo

Intervention / Treatment
-----------------
* Drug: Anticonvulsants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcohol dependence Alcohol withdrawal syndrome Exclusion Criteria: Drug dependence Major psychiatric diagnoses Severe somatic illness

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |