linjc16/ctgov huggingface dataset:
Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the clinical feasibility of low amplitude electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low amplitude ECT could potentially reduce the risks associated with ECT while preserving its unparalleled efficacy. This novel development would remove key obstacles to allow for the wider adoption of ECT as a safe and effective therapy.

Official Title
-----------------
Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: MECTA Spectrum 5000Q


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects, age 18-70 DSM-IV-TR diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the MINI-PLUS MMSE total score > 26 Referred for ECT Competent to provide informed consent Able to read or comprehend English Exclusion Criteria: Lifetime history of schizophrenia, schizoaffective disorder, mental retardation Current neurostimulation treatment (e.g., ECT, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation) Current alcohol abuse or dependence within past 6 months Current substance abuse or dependence within past 6 months History of central nervous system (CNS) disease Current diagnosis of dementia or delirium MoCA total score < 26 Current visual, auditory, or motor impairment that compromises ability to complete evaluations Patients with intracranial implants MRI contraindications: pregnancy, implanted metal, and claustrophobia

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 500 mA ECT<br>Right unilateral, ultra brief pulse ECT, with 500 mA current amplitude | Device: MECTA Spectrum 5000Q<br> <br> |
| Active Comparator: 800 mA ECT<br>Right unilateral, ultra brief pulse ECT, with 800 mA current amplitude | Device: MECTA Spectrum 5000Q<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in California Verbal Learning Test-II |  | Baseline and within 24 to 48 hours of each ECT session |
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.

Official Title
-----------------
A Multi-Center, 52-Week, Open-Label Extension Study (From Studies WEL-301, WEL-302, and WEL-303) to Evaluate the Long-Term Safety and Tolerability of WelChol® in Type 2 Diabetic Patients

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

Intervention / Treatment
-----------------
* Drug: Colesevelam hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion/Rollover Criteria: Patients who have completed studies WEL-301, WEL-302, or WEL-303 with treatment compliance at least 80% Patients who have completed studies WEL-301, WEL-302, or WEL-303 who have not met withdrawal criteria

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Colesevelam hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long-term effect on hemoglobin A1c |  |  | 
| To assess the long-term effect on fasting plasma glucose |  |  | 
| To assess effects on lipids and lipoproteins |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open label, Diabetes Mellitus, Long term safety study, extension study
Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.

Study Overview
=================
Brief Summary
-----------------
Oral Hydoxychloroquine is a very popular medication widely used by patients with rheumatoid arthritis, Systemic Lupus Erythematosus and other diseases. Ocular side effects of this medication are very serious and causes loss of central vision. In most patients these side effects are dose related, cumulative. This means that the risk of side effects would increase in all patients with continued use of the medication. In few people use of the medication would not be recommended if they have some bilateral macular problems. This is because the side effects of this medication does cause serious degredation of the macula in both eyes.

Detailed Description
-----------------
The ocular side effects of Hydroxychloroquine has been known for long time. Due to the seriousness of these side effects all possible efforts were done to prevent them. Preventing these side effects would ideally need prior screening of all patients who are to use oral Hydroxychloroquine. If patients are not screened prior to oral Hydroxychloroquine use they should be examined as soon as possible after starting this medication. Advances in technology, specifically the advent of optical coherence tomography, made screening and monitoring for Hydroxychloroquine toxicity much more easier and reliable meantime.

Official Title
-----------------
Update on Monitoring and Preventing Hydroxychloroquine Toxicity.

Conditions
-----------------
Hydroxychloroquine Toxicity

Intervention / Treatment
-----------------
* Diagnostic Test: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who need treatment with oral Hydroxychloroquine. - Exclusion Criteria: patients who are not using oral Hydroxychloroquine. -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: optical coherence tomography|screening and monitoring all patients who are to use or have been using oral Hydroxychloroquine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optical coherence tomography (OCT) is a very reliable, accessible and documented way for monitoring all people who are to use or have been using oral Hydroxychloroquine | OCT would very much help in selecting patients who may safely use oral Hydroxychloroquine. It is also the most preferred way so far for monitoring all patients who use oral Hydroxychloroquine to prevent serious and bilateral ocular side effects | Ten years |
A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.

Detailed Description
-----------------
The pathological classification of the prostate following radical prostatectomy provides important prognostic information; an accurate pathology report is the cornerstone to cancer treatment and follow-up. In addition to the preoperative serum PSA, Gleason score on pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical margin with extraprostatic extension (EPE) are significant predictors of clinical and biochemical recurrence. However, the prognostic implication of a capsular incision, a tumor extending to the inked margins without a histologically documented EPE, remains to be defined.

Official Title
-----------------
Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy

Conditions
-----------------
Radical Perineal Prostatectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically proven prostate cancer follow-up for at least 6 months Exclusion Criteria: insufficient biopsy data seminal vesicle invasion or lymph node involvement on pathology neoadjuvant or adjuvant therapy

Ages Eligible for Study
-----------------
Minimum Age: 43 Years
Maximum Age: 78 Years

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

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 |
| --- | --- | --- |
| biochemical recurrence of prostate cancer |  | upto the final date of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors for capsular incisions |  | at surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsular incision, biochemical recurrence, radical perineal prostatectomy
Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)

Study Overview
=================
Brief Summary
-----------------
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order : i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)

Official Title
-----------------
Biological Material Bank for Studies Related to Organ Transplantation

Conditions
-----------------
Organ Transplantation

Intervention / Treatment
-----------------
* Other: Biobank


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patient ≥18 years old Recipient of an organ transplant Written informed consent Exclusion Criteria: Non-affiliation to a social security system. Subjects deprived of liberties Pregnant or breastfeeding woman

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Biobank|For each patient included in the study the following samples will be collected at the indicated time points after transplantation: Serum samples and plasma sample: Day1, Month 1, Month 3, Month 6, Month 12, month 60, month 120 and at the time of each allograft biopsy. Urines samples: Month 3 and Month 12 and at the time of each allograft biopsy. Peripheral Blood Mononuclear Cell (PBMC): for each organ allograft biopsy. Allograft biopsies: systematically at Month 3, and Month 12, and for cause in case of allograft dysfunction.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the biological samples | The goal of this study is to provide biological materials from transplanted patients | At inclusion | 
| Change Biological Samples | The goal of this study is to provide biological materials from transplanted patients | Month 1 | 
| Change Biological Samples | The goal of this study is to provide biological materials from transplanted patients | Month 3 | 
| Change Biological Samples | The goal of this study is to provide biological materials from transplanted patients | Month 6 | 
| Change Biological Samples | The goal of this study is to provide biological materials from transplanted patients | Month 12 | 
| Change Biological Samples | The goal of this study is to provide biological materials from transplanted patients | Month 60 | 
| Change Biological Samples | The goal of this study is to provide biological materials from transplanted patients | Month 120 |
ADenoVirus Initiative Study in Epidemiology in France

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Detailed Description
-----------------
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in France. The planned duration of the study is one year from the first patient visit to the last patient visit.

Official Title
-----------------
Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

Conditions
-----------------
Viral Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components). Exclusion Criteria: Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. Previous enrolment in the present study. Any direct involvement with the study conduct at site or any family link with study site staff.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Frequency of patients with adenovirus conjunctivitis | The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis. | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate: cold water immersion modulates the reinforcing effects of nitrous oxide in healthy volunteers.

Official Title
-----------------
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 0% N2O
* Drug: 40% N2O


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 32 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lukewarm water<br>Subjects will immerse forearm in lukewarm water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial | Drug: 0% N2O<br>* Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water<br>Drug: 40% N2O<br>* Subjects will inhale 40% N2O then immerse forearm in warm water and cold water<br>|
| Active Comparator: Ice cold water<br>Subjects will immerse forearm in ice cold water while inhaling 0% and 40% N2O in 2 sampling trials, then choose between intervntions for one choice trial | Drug: 0% N2O<br>* Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water<br>Drug: 40% N2O<br>* Subjects will inhale 40% N2O then immerse forearm in warm water and cold water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's choice of intervention |  | After sampling trials | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, choice, subjective effects, pain, analgesia, reinforcer, healthy volunteer
Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors

Study Overview
=================
Brief Summary
-----------------
Phase-II, prospective, open label, no control group to assess the safety of 68Ga-DOTA-TATE injection in patients with suspected or diagnosed with tumors expressing somatostatin receptors. Each included patient will receive an administered dose of 50 mcg or less of the peptide (DOTA-TATE) and a range of activity between 100 - 200 MBq of 68Ga-DOTA-TATE. The efficacy of 68Ga-DOTA-TATE in assessing this kind of tumors has been proved by numerous studies.

Official Title
-----------------
Phase II Study to Measure the Safety of 68Ga-DOTA-TATE PET/CT in the Diagnosis of Tumors Expressing Somatostatin Receptors

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Other: Gallium-68 DOTA TATE PET scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected or proven tumors expressing Somatostatin receptors Informed consent by patient (or parents if patient is less than 18 years of age) Exclusion Criteria: Pregnancy (confirmed). In the case of a diagnostic procedure in a patient who is or may be pregnant, a clinical decision is necessary considering the benefits against the possible harm of carrying out any procedure. Patient refusal to participate. Impossibility to tolerate a decubitus position for 25 minutes Prior allergic reaction to DOTA-TATE or somatostatin analogs
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Gallium-68 DOTA TATE PET scan|One PET/CT scan using Gallium-68 DOTA TATE|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record all adverse events |  | June 2016-June 2018 |
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT

Study Overview
=================
Brief Summary
-----------------
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT

Official Title
-----------------
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT

Conditions
-----------------
Abdominal CT

Intervention / Treatment
-----------------
* Drug: NEOVIST 370 INJ.(Iopromide 768.86mg)
* Drug: Ultravist 370 INJ.(Iopromide 768.86mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 20 to 75 years old. Subjects who need CT scan Subjects who are willing to participate in the study and to write the informed consent form. Exclusion Criteria: Subjects with severe hepatopathy whose AST or ALT ≥ 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT ≥ UNL(upper normal limit) X 3 Severe disorder of thyroid gland homocystinuria pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods Participation in another clinical trial within 30days of enrollment into this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NEOVIST 370 INJ.(Iopromide 768.86mg)|nan|
|Drug: Ultravist 370 INJ.(Iopromide 768.86mg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| imaging quality | Two readers evaluate image quality of the abdomen CT by four-points scale | end of study enrollment | 
| Adverse reaction |  | immediate after CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNR (signal to noise ratio) / CNR (contrast to noise ratio) | ROI measurement at abdominal aorta and liver | at the end or enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)