linjc16/ctgov huggingface dataset:
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed Description
-----------------
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA

Official Title
-----------------
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

Conditions
-----------------
Cerebral Arterial Diseases

Intervention / Treatment
-----------------
* Drug: Dotarem
* Other: TOF MRA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged more than 18 years Strongly suspected of having carotid or vertebral arterial disease Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination Exclusion Criteria: Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²) Contraindication to MRI Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotarem and TOF MRA<br>Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. | Drug: Dotarem<br>* Each subject will receive one injection of Dotarem 0.2ml/kg<br>* Other names: Gadoterate meglumine;Other: TOF MRA<br>* Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Failure Rate | Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061). | 2 - 28 days | 
| Sensitivity | Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061). | 2-42 days | 
| Specificity | Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061). | 2 - 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carotid or vertebral artery disease, Contrast agent, MRA
EXtension of Tablo TrEatmeNt Duration Registry

Study Overview
=================
Brief Summary
-----------------
Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours.

Official Title
-----------------
EXtension of Tablo TrEatmeNt Duration Registry (XTEND)

Conditions
-----------------
End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis, Acute Kidney Injury

Intervention / Treatment
-----------------
* Device: Tablo Hemodialysis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant weighs ≥ 34kg. Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy > 12 hours. Exclusion Criteria: Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tablo Hemodialysis System<br>Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours on the Tablo Hemodialysis System | Device: Tablo Hemodialysis System<br>* Renal Replacement Therapy between 12< to ≤ 24 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success | Percentage of treatments achieving prescribed dialysis treatment time ≤ 10% | Up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tablo Cartridge Life | Measure the average number of cartridge changes required to complete a Tablo XT Treatment | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tablo, Outset Medical, Hemodialysis, AKI, ESKD
Effect of Quercetin in Prevention and Treatment of Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.

Official Title
-----------------
Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias

Conditions
-----------------
Chemotherapy Induced Oral Mucositis

Intervention / Treatment
-----------------
* Drug: oral quercetin capsules
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient under chemotherapy for a hematologic malignancy the hematologist permits the trial on the patient agreement of patient for participating in the trial Exclusion Criteria: presence pf ANY oral lesion at the beginning of the trial loss of follow up use of digoxin and cyclosporine patient death

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral quercetin capsules<br>Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks | Drug: oral quercetin capsules<br>* 10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.<br>|
| Placebo Comparator: oral placebo capsules<br>Patients in the placebo group received two placebo capsules containing lactose . | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower grade of mucositis | grade of mucositis due to WHO criteria | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mucositis | duration of mucositis due to Who criteria | 3 weeks of study tiem span and after trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quercetin, Chemotherapy, Mucositis, Hematologic Malignancies
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.

Detailed Description
-----------------
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.

Official Title
-----------------
A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate
* Drug: Levocarnitine
* Drug: Adefovir dipivoxil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Your child may be eligible for this study if he/she: Is 3 months to 16 years old. Is HIV-positive. Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry. Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry. Agrees to use effective barrier methods of birth control, such as condoms, during the study. Has consent of parent or guardian. Exclusion Criteria Your child will not be eligible for this study if he/she: Has ever taken NFV. Has a history of opportunistic (AIDS-related) infection. Has any disease or illness that would prevent him/her from completing the study, including cancer. Has taken certain medications, including protease inhibitors at study entry. Is receiving an HIV vaccine at study entry. Is pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|nan|
|Drug: Levocarnitine|nan|
|Drug: Adefovir dipivoxil|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
-----------------
Dose-Response Relationship, Drug, Antiviral Agents, HIV Protease Inhibitors, Disease Progression, RNA, Viral, Adenine, Viral Load, Age Factors, Nelfinavir
Evaluation of Crestor® (Rosuvastatin) in Daily Practice

Study Overview
=================
Brief Summary
-----------------
This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.

Official Title
-----------------
Open-Label Non-Interventional Evaluation of Efficacy of Crestor® (Rosuvastatin) in Reduction of LDL-Cholesterol and Cardiovascular Risk Parameters in Patients With Hypercholesterolaemia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study. no treatment with any statin in the last 3 months Exclusion Criteria: hypersensitivity to rosuvastatin or any other ingredient of Crestor active liver disease, severe renal insufficiency myopathy or predisposing risk factors for myopathy/ rhabdomyolysis woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation

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 |
| --- | --- | --- |
| LDL-cholesterol reduction |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| achievement of target levels of total cholesterol and LDL-cholesterol |  | 12 weeks | 
| patient compliance |  | 12 weeks | 
| change in coronary risk |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, cholesterol, LDL-cholesterol, rosuvastatin, Crestor
Effectiveness of Physical Exercise in Women With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment. The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain. The practical of the RME reduces the pain of participants with FMS.

Detailed Description
-----------------
This study will evaluate and compare the effectiveness of a supervised resistance muscular exercise (RME) , walking program (WP)and control group (just observation) in women with FMS during 16 weeks, on decrease of pain. Participants will undergo an assessment including medical some questionnaires to assess their FMS symptoms at baseline, after 8 weeks, 16 weeks and 28 weeks.

Official Title
-----------------
Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: walking program, resistance muscular exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria diagnosis according ACR 1990 Wash-out of medication specific for fibromyalgia for 1 month Only paracetamol 750mg will be allowed during the period of study. Exclusion Criteria: Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

| Intervention/Treatment |
| --- |
|Behavioral: walking program, resistance muscular exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of pain and use of specific medicine for fibromyalgia |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life) |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Rehabilitation, Strength exercise, Aerobic exercise, Pain
Quality of Life After Thyroidectomy (ThyrQol)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the evolution of quality of life and voice function with different questionnaires (VIH, SF36) before and after total thyroidectomy.

Official Title
-----------------
A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.

Conditions
-----------------
Total Thyroidectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult over 18 years Notice to total thyroidectomy Thyroidectomy under cervicotomy or videoscopy Existence of a written informed consent of the patient Affiliation to a social security Possible follow-up for 6 months Exclusion Criteria: Impossibility for the patient to complete the forms Impossibility to follow the patient patient with serious disease which impact the quality of life Medullary thyroid cancers Preoperative examination of vocal cords (if performed) finding a violation of the vocal cords Lack of monitoring possible during the 6 months after surgery Pregnant women or during lactation Minors and adults under guardianship

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 |
| --- | --- | --- |
| Evaluate the differences in terms of impact on quality of life among patients without sequelae 6 months after thyroidectomy (laryngeal paralysis or hypoparathyroidism) and patients with hypoparathyroidism. (SF36 v1,3, self-administered questionnaire) |  | Evaluation at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the impact of post thyroidectomy laryngeal paralysis on the quality of life (SF36 v1,3, self-administered questionnaire) |  | Evaluation at 2 and 6 months | 
| Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire) |  | Evaluation at 2 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life-Thyroidectomy-Morbidity
Effects of Mineralocorticoid Receptor Stimulation on Cognition

Study Overview
=================
Brief Summary
-----------------
In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals.

Detailed Description
-----------------
80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition, Task Switch, visual spacial memory and decision making will be conducted.

Official Title
-----------------
Effekte Von Fludrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten

Conditions
-----------------
Individuality

Intervention / Treatment
-----------------
* Other: Fludrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: free of medication age 18 - 30 Exclusion Criteria: any medication severe illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fludrocortisone<br>effects of fludrocortisone on cognition compared to placebo | Other: Fludrocortisone<br>* effects of fludrocortisone on cognition compared to placebo<br>* Other names: Florinef (Squibb & Sons Limited);|
| Placebo Comparator: Placebo<br>effects of fludrocortisone on cognition compared to placebo | Other: Fludrocortisone<br>* effects of fludrocortisone on cognition compared to placebo<br>* Other names: Florinef (Squibb & Sons Limited);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| social cognition | computer based tests: emotion recognition | 25 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| memory | computer based test on visuospacial memory | 20 min | 
| decision making | computer based tests: BART | 25 min |
A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.

Detailed Description
-----------------
Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020. The two groups will be HydroPICCs and the standard of care for the facility. A comparison of multiple endpoints will be evaluated between the two groups.

Official Title
-----------------
A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line

Conditions
-----------------
Peripheral ICC, PICC

Intervention / Treatment
-----------------
* Device: HydroPICC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have been inserted with the HydroPICC during a specific time range. During the same time period, any competitor 4 Fr single lumen placed. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HydroPICC<br>Cohort who received the HydroPICC | Device: HydroPICC<br>* PICC lines<br>* Other names: Standard of Care;|
| Standard of Care<br>Cohort who received something different than HydroPICC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intended dwell time based on a comparison of the actual dwell time to the intended time | Comparison of actual vs intended dwell times of each arm | August 2020 through October 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of failure rates | Compare the failure rates between the two arms | August 2020 through October 2020 |