linjc16/ctgov huggingface dataset:
Retinal Care Data Repository

Study Overview
=================
Brief Summary
-----------------
The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.

Detailed Description
-----------------
The initial focus is to develop algorithms that prevent, delay the progression, or improve treatment of diabetic retinopathy (DR) and age-related macular degeneration (AMD). Examples include but are not limited to: describing the incidence, prevalence, and severity distribution of DR and AMD in the overall population and subgroups; diagnosing specified severity thresholds for DR and AMD; predicting the development and progression of DR and AMD for the overall population, subgroups, and individuals; and recommending tests and treatments to prevent or delay the progression of DR and AMD for the overall population, subgroups, and individuals. Data will be collected retrospectively and prospectively.

Official Title
-----------------
Retinal Care Data Repository

Conditions
-----------------
Diabetic Retinopathy, Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes or age 65 years and older Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DR<br>Patients with diabetes | Other: Observation<br>* Patient data will be collected from eye exams, surveys and medical record review.<br>|
| AMD<br>Patients age 55 and older | Other: Observation<br>* Patient data will be collected from eye exams, surveys and medical record review.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Stratification | Predict the participant's risk of developing specific severity levels of DR and AMD | Decade |
Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias

Official Title
-----------------
Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

Conditions
-----------------
Internal Hernias

Intervention / Treatment
-----------------
* Procedure: Closing the mesenteric defects with clips during opration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who meet the requirements for a Gastric Bypass at Køge Hospital. Exclusion Criteria: Patients who do not meet the inclusion criteria Patients who converted to open surgeon

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inertervention group_Clips to avoid internal herniation<br>LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation. | Procedure: Closing the mesenteric defects with clips during opration<br>* The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).<br>* Other names: Clips, Herniestapler, Internal hernia, Gastric bypass;|
| No Intervention: Control group<br>conventional LRYGB without closure of the mesenteric defects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To avoid the risk of Internal Hernias in patient with a Gastric bypass |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score (VAS) |  | 5 years | 
| Operative time consumption, the amount of clips, trocar and sutures used |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internal Hernias, Clips, Gastric Bypass, Avoid
Home Based Environmental Adherence Trial

Study Overview
=================
Brief Summary
-----------------
To conduct a randomized trial in asthmatic children to compare the effectiveness of a home-based allergen control program with a customary educational program delivered in offices

Detailed Description
-----------------
DESIGN NARRATIVE: Two-hundred-forty children, 6 to 17 years of age, were recruited to participate in the study. Following the collection of baseline data, all families in the study received standard environmental control education prior to randomization to the control or experimental group. This education provided parents and children with information about such topics as the child's sensitivity profile, the relationship between exposure to allergens and asthma, and the risks of passive smoking. All families were given information on how to receive environmental control aids and services available by mail at no or reduced costs. Once families were randomized, those in the control group received no additional intervention. Those in the experimental group received a home-based allergen control intervention delivered by trained environmental counselors. Primary outcomes were changes in asthma-related quality of life and changes in targeted allergen levels in the home. Secondary outcome measures included self-efficacy for environmental allergy control, FEV1, and parent-reported health care utilization. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |
Local Wound Infiltration in Renal Surgery

Study Overview
=================
Brief Summary
-----------------
Multimodal analgesia is a rational approach to treat various components of postoperative pain.

Detailed Description
-----------------
Local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.

Official Title
-----------------
Effect of Local Wound Infiltration Plus Usual Care Versus Usual Care Alone on Pain Relief After Open Renal Surgery.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: local wound infiltration plus usual care
* Drug: usual care only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery Exclusion Criteria: history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local wound infiltration<br>local wound infiltration plus usual care | Drug: local wound infiltration plus usual care<br>* local wound infiltration plus usual care<br>|
| Placebo Comparator: Control<br>usual care only | Drug: usual care only<br>* usual care only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Visual analogue scale ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain. | The first 48 hours after surgery |
A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.

Official Title
-----------------
An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653A (ezetimibe [+] simvastatin)
* Drug: Comparator: atorvastatin
* Drug: Comparator: fluvastatin
* Drug: Comparator: lovastatin
* Drug: Comparator: pravastatin
* Drug: Comparator: rosuvastatin
* Drug: Comparator: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol Exclusion Criteria: Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.

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

| Intervention/Treatment |
| --- |
|Drug: MK0653A (ezetimibe [+] simvastatin)|nan|
|Drug: Comparator: atorvastatin|nan|
|Drug: Comparator: fluvastatin|nan|
|Drug: Comparator: lovastatin|nan|
|Drug: Comparator: pravastatin|nan|
|Drug: Comparator: rosuvastatin|nan|
|Drug: Comparator: simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks |  | After 12 weeks of treatment |
Amisulpride in Schizophrenic Acute Phase Patients

Study Overview
=================
Brief Summary
-----------------
To collect the safety and response of using Amisulpride in acute schizophrenic patients

Official Title
-----------------
The Use of Amisulpride in Schizophrenic Acute Phase Patients.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Amisulpride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode Exclusion Criteria: Patients previously treated with amisulpride Patients have comorbidity which may interfere with the treatment or follow-up Patients currently taking depot antipsychotics (at least 30 days washout period is needed) Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse Pregnant or lactation The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: 1<br>Amisulpride 400-800mg per day on a twice-a-day regimen | Drug: Amisulpride<br>* Oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | all across the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions |  | All accross the study | 
| Patient compliance |  | all across the study | 
| Percentage of patient completing treatment |  | all across the study | 
| Changes in body weight |  | At baseline and day 84 |
Experiences and Perceived Needs Among Parents of Children Exposed to Potentially Traumatic Events: a Qualitative Inquiry

Study Overview
=================
Brief Summary
-----------------
This study aims at exploring qualitatively experiences and perceived needs among parents of children exposed to potentially traumatic events, including their attitudes and understanding of trauma and resilience, their perceptions of their parental role in the peri-traumatic period, and their expectations of a family intervention for post-traumatic stress. This will ultimately guide future research to develop and design and intervention that would be tailored to their needs and expectations

Official Title
-----------------
Experiences and Perceived Needs Among Parents of Children Exposed to Potentially Traumatic Events: a Qualitative Inquiry

Conditions
-----------------
Post Traumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Being a parent of a child aged 7-17 exposed or who recently revealed a potentially traumatic event in the past six months Exclusion criteria: Abusive parent Child and/or parent with intellectual deficiency

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Experiences and attitudes around trauma | Qualitative inquiry into parents' experiences in the post-traumatic period of their child | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions of parental role and ways to cope | Qualitative inquiry into parental's Perceptions of parental role and ways to cope | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Traumatic Stress, Child and Adolescent Psychiatry, Parental perceived needs
Evaluation of Blood Brain Barrier Integrity and Structural Abnormalities in MPS IIIB Patients Using Multimodal Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize structural abnormalities in the brain and the integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS IIIB).

Official Title
-----------------
Evaluation of Blood Brain Barrier Integrity and Relationship to Structural Brain Abnormalities in MPS IIIB Patients Using Cerebrospinal Fluid/Serum Albumin Index (CSF-AI) and Multimodal Magnetic Resonance Imaging

Conditions
-----------------
MPS IIIB (Sanfilippo B Syndrome)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject and/or subject's parent or legal guardian provides informed consent Subject is ≥5 years of age. Subject has a definitive diagnosis of MPS IIIB, as determined by either a documented deficiency in alpha-N-acetylglucosaminidase (NAGLU) enzyme activity or documented functionally-relevant mutations in both alleles of the NAGLU gene. Exclusion Criteria: The subject has any internal or non-removable external metal items that may present a safety risk (for MRI), or any other medical condition or circumstance in which an MRI is contraindicated. The subject has a known or suspected hypersensitivity to anaesthesia, a bleeding disorder, or any other medical condition or circumstance in which a lumbar puncture (for collection of CSF) is contraindicated. Previous allergic reaction to gadolinium-based MRI contrast media.

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| MPS IIIB<br>Those with a definitive diagnosis of MPS IIIB (Sanfilippo B Syndrome). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Brain Barrier integrity in MPS IIIB subjects | Blood Brain Barrier integrity in MPS IIIB subjects by estimating the CSF-AI. | Day 0 | 
| Blood Brain Barrier transfer coefficient | The Blood Brain Barrier transfer coefficient will be measured by DCE-MRI in MPS IIIB subjects. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural brain abnormalities in MPS IIIB | Structural brain abnormalities in MPS IIIB using imaging and biomarkers related to underlying disease biology of MPS IIIB subjects | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MPS IIIB, Mucopolysaccharidosis, Mucopolysaccharidosis type IIIB, Sanfilippo Syndrome, Metabolism, Inborn Errors, Metabolic Diseases, Genetic Diseases, Inborn
Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.

Official Title
-----------------
Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study

Conditions
-----------------
Liver Tumor, Hepatic Fibrosis

Intervention / Treatment
-----------------
* Other: two-dimensional shear-wave elastography (SWE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (i) patients with a solid focal liver lesion that was pathologically proven or diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients scheduled to undergo a hepatectomy; (iii) patients with a lesion ≥1.0 cm in diameter. Exclusion Criteria: (i) patients with a history of chemotherapy; (ii) patients unable to properly hold their breath.

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 |
| --- | --- |
| study group<br>patients with liver tumor intend to perform hepatectomy | Other: two-dimensional shear-wave elastography (SWE)<br>* performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of hepatic fibrosis | compare the stage of hepatic fibrosis between SWE test with specimens after surgery | within the first 7 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shear-wave elastography, hepatic fibrosis, liver tumor
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease. Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year. Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: -aminosalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Mildly to moderately severe ulcerative colitis Patient age: 18 to 80

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: -aminosalicylic acid|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
-----------------
gastrointestinal disorders, rare disease, ulcerative colitis