linjc16/ctgov huggingface dataset:
Long-Term Follow-up Safety of Clonidine Micropellets

Study Overview
=================
Brief Summary
-----------------
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.

Official Title
-----------------
A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Conditions
-----------------
Lumbosacral Radiculopathy

Intervention / Treatment
-----------------
* Drug: Long-Term Safety Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate. Exclusion Criteria: Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures. Subjects who were unblinded to their treatment in STX-015-18-01 study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Safety Group<br>STX-015-18-01 Clonidine Micropellet long-term safety follow-up | Drug: Long-Term Safety Follow-up<br>* STX-015-18-01 long-term safety follow-up<br>|
| Sham Control<br>STX-015-18-01 Sham control long-term safety follow-up | Drug: Long-Term Safety Follow-up<br>* STX-015-18-01 long-term safety follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average and Worst NRS from Day 60 post injection to 12 months post injection | Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection | 10 months from completing Day 60 of the STX-015-18-01 study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgeries | Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01. | 12 months from day of injection | 
| Incidence of Invasive treatment received | Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01 | 12 months from day of injection | 
| Number of Prescription medications taken | Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01 | 12 months from day of injection |
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Study Overview
=================
Brief Summary
-----------------
The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood. We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

Official Title
-----------------
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: glucagon like peptide-1
* Dietary Supplement: glucose control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Non diabetic Exclusion Criteria: Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF) Anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetic Group<br>Participants with Type 2 diabetes | Drug: glucagon like peptide-1<br>* GLP-1 1 pmole/kg/min<br>Dietary Supplement: glucose control<br>* glucose without GLP-1<br>|
| Active Comparator: Non-diabetic Group<br>Participants who are non-diabetic will serve as control. treatment is matched to experimental group | Drug: glucagon like peptide-1<br>* GLP-1 1 pmole/kg/min<br>Dietary Supplement: glucose control<br>* glucose without GLP-1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin biosynthesis rate |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin, Type 2 diabetes, biosynthesis, Non diabetic control
Energy Expenditure Methodology

Study Overview
=================
Brief Summary
-----------------
This study is simply to test the repeatability of the indirect calorimetry instrument the investigators use for our clinical studies.

Detailed Description
-----------------
Participants will be required to attend two study visits at the Arkansas Children's Nutrition Center. During the first visit, informed consent will be obtained, participant will be measured and an indirect calorimetry assessment to measure resting energy expenditure will be performed. During the second visit, we will repeat the indirect calorimetry assessment to measure resting energy expenditure.

Official Title
-----------------
Energy Expenditure Methodology

Conditions
-----------------
Healthy Adults

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Exclusion Criteria: pulmonary or respiratory disorders

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repeatability of test results | test the repeatability of the indirect calorimetry instrument used in other clinical studies at our center | 2-3 hours up to 2-3 days |
A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

Study Overview
=================
Brief Summary
-----------------
This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.

Official Title
-----------------
Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Cervical Dystonia and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (POSTURe)

Conditions
-----------------
Torticollis

Intervention / Treatment
-----------------
* Biological: OnabotulinumtoxinA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician Exclusion Criteria: Participation in a clinical trial for any botulinum toxin indication Planning elective surgery during the observational study period Treatment with any botulinum toxin product for cervical dystonia (dystonie) Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| OnabotulinumtoxinA<br>OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice. | Biological: OnabotulinumtoxinA<br>* OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score |  | Baseline, 96 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change (PGIC) Using a 7-Point Scale |  | Baseline, 96 Weeks | 
| Work Productivity Assessment Using a 10-Item Questionnaire |  | 96 Weeks | 
| Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score |  | Baseline, 96 Weeks | 
| Reasons for Withdrawal of Treatment |  | 96 Weeks |
Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath

Study Overview
=================
Brief Summary
-----------------
Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient. Such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result of damaging processes that occur in the lung. Determining the VOC profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. In other words, searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath. The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the current study.

Official Title
-----------------
Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed sarcoidosis Exclusion Criteria: (ex-) smokers for healthy controls: controls with pulmonary disease excluded
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 |
| --- | --- |
| Sarcoidosis patients<br>Clinically relevant sarcoidosis patients with different stages and treatments. | |
| Healthy controls<br>Healthy people without any pulmonary conditions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis by exhaled breath |  | upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study |
A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration

Study Overview
=================
Brief Summary
-----------------
This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for Alzheimer's disease.

Conditions
-----------------
Frontotemporal Lobar Degeneration

Intervention / Treatment
-----------------
* Drug: Memantine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neary et al. Criteria for Frontotemporal Lobar Degeneration Age 40 -80 CDR < 3 or MMSE > 15 English Speaking Study Partner Exclusion Criteria: Concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
First Episode Psychosis and Pathway to Care in Nordland

Study Overview
=================
Brief Summary
-----------------
First episode psychosis patients often experiences treatment delay. This reduces their prospects for recovery and makes unnecessary burdens for them and their carers. A better understanding of help seeking intentions is required, and has not been explored in a county like Nordland, Norway, with long distances and challenging access to health services. The purpose of this study is to explore the process of help seeking, including how patients and their careers discover and understand the psychotic symptoms. Research exploring the impact on families mainly focuses on parents' experiences, and there are less studies focusing on experiences and needs of siblings. This study will therefore explore siblings' experiences separate from their parents. Methods will be qualitative interviews with patients, their carers and siblings. Analysis will be influenced by Grounded theory.

Official Title
-----------------
Patients and Carers Experiences With First Episode Psychosis and Pathway to Care in Nordland: A Qualitative Study

Conditions
-----------------
First Episode Psychosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 16-35, understand and speak Norwegian able to give consent no learning disabilities Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| Patient experience |  | up to 100 weeks | 
| Carers experiences |  | up to 100 weeks | 
| Siblings experiences |  | up to 100 weeks | 
| Pathway to care |  | up to 100 weeks |
Oxygenation and Perfusion in Patients With Acute Migraine Attacks

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to retrospectively evaluate brain perfusion and oxygenation in acute migraine attacks. Magnetic resonance perfusion and susceptibility weighted imaging are the technics to measure perfusion and oxygenation respectively.

Detailed Description
-----------------
The aim of the study is to demonstrate a possible correlation between areas of hypoperfusion and prominent cortical veins during migraine attacks. These focal ares of altered vascular supply of the brain will be evaluated for correlation with topograhy of symptoms.

Official Title
-----------------
Oxygenation and Perfusion in Patients With Acute Migraine Attacks

Conditions
-----------------
Migraine, Migraine With Aura, Migraine; Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: final clinical diagnosis of migraine Exclusion Criteria: brain tumors, seizures/epilepsy, confirmed cerebral infarct from cerebral atery occlusion, sinus vein thrombosis;

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack | Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack, measured with visual scores on imaging, using a consensus between two readers | Patients, who are admitted to hospital, undergo magnetic resonance imaging within 5 days of migraine attack; time frame: symptoms to imaging : 5 days; |
A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Official Title
-----------------
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder

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

Intervention / Treatment
-----------------
* Drug: GW597599B
* Drug: paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients meet the diagnosis of Major Depressive Disorder (MDD). Exclusion Criteria: Patients with a primary diagnosis other than MDD. Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder. Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit. Patient is actively suicidal. Patients who have a history of migraine headaches.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW597599B|nan|
|Drug: paroxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale |  | 8 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Psychiatry, Major Depressive Disorder
Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program

Study Overview
=================
Brief Summary
-----------------
Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.

Official Title
-----------------
Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program

Conditions
-----------------
Metastatic Castration Resistant Prostate Cancer Patients

Intervention / Treatment
-----------------
* Other: metastasis biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate Cancer patients Castration Resistant Prostatic tissue available Metastasis which may be biopsied Exclusion Criteria:

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>metastasis biopsy | Other: metastasis biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | success to evaluate at least one molecular analysis in tumor tissues (prostate and/or metastatic site) AND in CTC | assessed at the end of recruitment, up to 2 years |
Accuracy of Digital Implant Impression

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure.

Detailed Description
-----------------
Fully edentulous patients with 2-6 dental implants are included in this study. For each patient, the follow three impressions are made: conventional splinted open-tray impression, digital impression using scan bodies without extensional structure, and digital impression using scan bodies with extensional structure. The accuracy of the three impressions is compared in an inspection software.

Official Title
-----------------
Accuracy of Complete-arch Digital Implant Impression With Newly Designed Scan Bodies

Conditions
-----------------
Edentulous Jaw

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old and able to understand an informed consent Fully edentulous jaw 2-6 dental implants have been placed in the edentulous jaw The implants have been osseointegrated Mouth opening larger than 4.5 cm Exclusion Criteria: Poor oral hygiene Presence of peri-implantitis or peri-implant mucositis Presence of temporamandibular joint disease Unwilling to paticipate in the research

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy | the accuracy is evaluated by comparing the test scans with the reference scan | 0 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant, digital impression, scan body, accuracy