linjc16/ctgov huggingface dataset:
Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences

Study Overview
=================
Brief Summary
-----------------
There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.

Detailed Description
-----------------
Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.

Official Title
-----------------
Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treated with prostate brachytherapy low risk or intermediate risk prostate cancer ambulatory stable medical condition 18 years of age or older capable of informed consent Exclusion Criteria: no use of any hormonal therapy unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seed movement, implants, prostate brachytherapy, localized
Immunohistochemical & Immunoblot Analysis of NIS (Na+/I-Symporter) in Archival & Frozen Tissue Sample

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to study NIS expression in benign and malignant breast and thyroid samples using archival formalin-fixed paraffin-embedded tissue sections.

Detailed Description
-----------------
The objective of the study is to further understanding of proteins that occur in both normal cells and tumor cells and to learn more about certain diseases and potential alternative treatments for these diseases.

Official Title
-----------------
Immunohistochemical & Immunoblot Analysis of NIS (Na+/I-Symporter) in Archival and Frozen Human Tissue Samples

Conditions
-----------------
Breast Cancer, Stomach Neoplasms, Salivary Gland Neoplasms, Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be over the age of 18. Patients must have benign and malignant breast and thyroid cancer. Patient mus sign consent form. Exclusion Criteria: 1. No children will be allowed.

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

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

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 |
| --- | --- | --- |
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.

Detailed Description
-----------------
Inclusion criteria T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic complication

Official Title
-----------------
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: Insulin
* Drug: Sitagliptin
* Drug: Exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM <3 months GAD Antibody+ or Stimulated C peptide<0.5 ng/ml Ketosis at onset Age < 30 yr Exclusion Criteria: Age > 30 yr Pancreas disease Significant systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 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 |
| --- | --- |
| Active Comparator: Insulin alone<br>Type 1 DM only on Insulin | Drug: Insulin<br>* Exenatide Sitagliptin<br>* Other names: Premixed Insulin;|
| Active Comparator: Insulin and Exenatide<br>Newly detected Type 1 DM on Insulin and exenatide | Drug: Exenatide<br>* Exenatide 10 micrograms daily twice<br>* Other names: GLP 1 analogues;|
| Active Comparator: Insulin and Sitagliptin<br>Newly detected Type 1 DM using Insulin and Sitagliptin | Drug: Sitagliptin<br>* Sitagliptin 100 mg per day oral<br>* Other names: DPP 4 inhibitors;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in insulin requirement | To assess the change in insulin requirement with use of GLP 1 analogues or DPP 4 inhibitors along with insulin in type 1 diabetes | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C peptide response | To assess the endogenous insulin secretion after one year of use of GLp 1 analogue and DPP 4 inhibitors | at the end of one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, exenatide, sitagliptin
Evaluation of Sestrin Levels in Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
Serum sestrin levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

Detailed Description
-----------------
Serum sestrin levels are compared with 45 endometriosis patients and 45 healthy volunteers of the same age. The energy metabolism of the endometriosis group and its possible relationship with the endometriosis stage will be compared since sestrin gives information about the energy metabolism of the people.

Official Title
-----------------
The Sestrin Levels in Patients With Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: sestrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with endometriosis (Surgery or ultrasound) Women without endometriosis Exclusion Criteria: Women without endometriosis women who are only suspected endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| women with endometriosis<br>It consists of women between the ages of 18-45 who have been diagnosed with endometriosis by surgery or ultrasonography. | Other: sestrin<br>* Serum sestrin levels involved in inflammation and energy metabolism are compared between endometriosis and healthy control group.<br>|
| control<br>It consists of healty women between the ages of 18-45 | Other: sestrin<br>* Serum sestrin levels involved in inflammation and energy metabolism are compared between endometriosis and healthy control group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum sestrin levels in women with endometriosis | Serum sestrin levels involved in inflammation and energy metabolism are compared between endometriosis and healthy control group. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the relationship between serum sestrin level and endometriosis stage | By comparing the relation of serum sestrin level with the stage of endometriosis, its relation with serum level in patients with advanced and early stage endometriosis will be examined. The possible effect of sestrin on disease pathogenesis will be examined. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sestrin
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and North America. The aim of the trial is to assess disease activity and safety in subjects with moderately to severely active Crohn's disease (CD) when treated with NNC 0142-0000-0002.

Official Title
-----------------
A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease

Conditions
-----------------
Inflammation, Crohn's Disease

Intervention / Treatment
-----------------
* Drug: NNC 0142-0000-0002
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with CD for at least 3 months Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound Exclusion Criteria: Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess History of dysplasia or malignancy in the colon Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation Body mass index (BMI) higher or equal to 38.0 kg/m^2

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 0142-0000-0002<br> | Drug: NNC 0142-0000-0002<br>* A single dose administered subcutaneously (s.c., under the skin)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* A single dose administered subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity assessed by CDAI (Crohn's disease activity index) |  | From baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) |  | From baseline to weeks 12 and 24 | 
| Immunogenicity of NNC 142-0002 |  | At week 24 |
Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in Parkinson's Disease (PD) Without Dementia

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.

Detailed Description
-----------------
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.

Official Title
-----------------
Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in PD Without Dementia

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria PD participants: WUSM Movement Disorders Clinic patients males or females between 40 and 70 meet criteria for idiopathic typical PD classified at Hoehn & Yahr12 stage I, II, or III are currently treated with levodopa/carbidopa Inclusion Criteria Control: The groups will be matched for age, education and gender No Parkinson Disease Exclusion Criteria PD participants and Control: suspected dementia treatment with certain dopaminergic, anticholinergic or benzodiazepine medications other neurological problems brain surgery history or current psychotic disorder any condition which would interfere with testing control only: a biological family history of PD and being a caregiver or spouse of someone who has PD

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| Parkinson's Disease<br>Parkinson Disease participants without dementia | |
| Control<br>Non-PD participants, matched for age, education and gender. | |

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
-----------------
Parkinson's Disease
Effect of Exercise Before Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals. The aims of this study is to investigate if High-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.

Official Title
-----------------
Effect of Exercise Before Gastric bypass-a Pilot Study

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Behavioral: High intensity exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: > 20 years BMI: > 40 or > 35 with comorbidity Resident: Sør Trøndelag Exclusion Criteria: Unstable Angina Resent cardiac infarction (within last year) heart failure Uncontrolled hypertension cardiomyopathy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity exercise<br> | Behavioral: High intensity exercise<br>* High intensity exercise 3xweek for minimum 6 weeks<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization days after gastric bypass |  | Baseline, pre-operation and 6 months post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications after gastric bypass |  | 6 months post operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High intensity exercise, morbid obesity, gastric bypass
Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder

Detailed Description
-----------------
Case-control study Repeated measures design

Official Title
-----------------
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV-TR major depressive disorder aged between 20 and 80 durg-naive or drug-free Exclusion Criteria: DSM-IV-TR substance-related disorders (except nicotine) significant medical or neurological conditions mental retardation or organic brain damage

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>depressed patients receiving escitalopram treatment | Drug: escitalopram<br>* SSRI antidepressant<br>* Other names: lexapro;|
| No Intervention: Control<br>healthy controls matched for age, gender, and BMI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz) | the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state | 0, 3, 7, 14, and 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiorespiratory coupling during 6 weeks | change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration | 0, 3, 7, 14, and 42 days | 
| Change in HF during 6 weeks | change in high frequency component of heart rate variability | 0, 3, 7, 14, and 42 days | 
| Change in persistent homology during 6 weeks | change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks | 0, 3, 7, 14, and 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, treatment, electrophysiology, biomarker
Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).

Official Title
-----------------
A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: ALK HDM tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of house dust mite induced asthma Use of inhaled corticosteroids (ICS) Positive skin prick test to house dust mites Positive specific IgE to house dust mites Exclusion Criteria: FEV1 lower than 70%

Ages Eligible for Study
-----------------
Minimum Age: 14 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: ALK HDM tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of inhaled corticosteroid (ICS). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue medication and symptoms. |  |  | 
| Quality of Life. |  |  |
Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to try to correlate vitamin D dosing and dosing adjustment with Vitamin D levels, measure affects of seizure medications on levels as well as pathologic fractures and bone density in severely cognitively impaired, non-mobile children and adolescents with CP.

Official Title
-----------------
Vitamin D Serum Concentrations and Vitamin D Supplementation in Children and Young Adults With Cerebral Palsy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recorded vitamin D supplementation dose (i.e. prescribed diet and any additional sources of vitamin D) with at least two serum vitamin D concentrations recorded in the medical chart from January 1, 2008 to June 30, 2013. Resident of HLCCD since 2008 Exclusion Criteria: No vitamin D levels recorded. History of hyperthyroidism or parathyroid pathology. Short gut syndrome that requires TPN. Poor medical documentation. Heritable disorders that affect vitamin D levels such as Pseudovitamin D deficiency rickets, Vitamin D resistant rickets, autosomal dominant hypophosphatemic rickets and X-linked hypophosphatemic rickets

Ages Eligible for Study
-----------------
Maximum Age: 50 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 |
| --- | --- |
| Vitamin D supplementation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum vitamin D concentrations |  | 5 years |