linjc16/ctgov huggingface dataset:
Assessment of Clinical Effects of Coenzyme Q10 Levels in COVID-19 Patients in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The study will be done in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. The investigators will accept COVID-19 diagnosed or suspected patients to the ICU. In the first day of hospitalization and after that once a week, the investigators will take blood samples from the patients to evaluate Coenzyme q10 levels. Our hypothesis is that there is a relationship between low coenzyme q10 levels and poor clinical outcome.

Official Title
-----------------
Our Study Will be Carried Out in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. COVID-19 Positive or Suspected Patients Will be Admitted to the Unit. Coenzyme Q10 Levels Will be Checked in the First Day of Hospitalization and Once a Week. The Relationship Between Results and Clinical Course Will be Evaluated.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: being under the age of 18 being pregnant patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| COVID-19 positive patients<br> | Diagnostic Test: blood sample<br>* weekly blood sample - coenzym q10 levels<br>|
| COVID-19 negative patients<br> | Diagnostic Test: blood sample<br>* weekly blood sample - coenzym q10 levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | yes or no | from the first day of hospitalization until the date of death from any cause | 
| duration of mechanical ventilation | days | from the first day of hospitalization and during ICU stay period | 
| duration of vasopressor agent requirement | days | from the first day of hospitalization and during ICU stay period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any organ failure | yes or no | from the first day of hospitalization until the date of death from any cause or discharge from ICU | 
| new thromboembolic event | yes or no | from the first day of hospitalization until the date of death from any cause or discharge from ICU | 
| ICU stay period | days | from the first day of hospitalization until the date of death from any cause or discharge from ICU | 
| hospital stay period | days | from the first day of discharge from ICU to ward until the date of death or discharge from the hospital |
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis

Official Title
-----------------
A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents

Conditions
-----------------
Mild to Moderate Atopic Dermatitis

Intervention / Treatment
-----------------
* Device: Zarzenda
* Drug: Elidel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female children and adolescents (aged 2 - 17) mild to moderate atopic dermatitis patients in whom a treatment with topical corticosteroids in not recommended or possible wash out periods to be observed Exclusion Criteria: known allergy to one of the two treatments known immunodeficiency known hepatic or renal insufficiency acute skin infections

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| Active Comparator: 1<br>Zarzenda applied topically twice daily for three weeks | Device: Zarzenda<br>* Topical cream, applied twice daily for three weeks<br>|
| Active Comparator: 2<br>Elidel 1% cream, applied topically twice daily for three weeks | Drug: Elidel<br>* 1% cream, applied topically twice daily for three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment |  | End of study compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI |  | End of study compared to baseline | 
| Affected body surface area |  | End of study compared to baseline | 
| Patient's assessment of itch, quality of sleep, and global assessment |  | End of study compared to baseline | 
| Children's Dermatological Life Quality Index |  | End of study compared to baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopic dermatitis
Study of the Neurobiology of Tourette Syndrome and Related Disorders

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics. II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive compulsive disorder by systematic assessment of all first-degree family members of patients selected for cerebrospinal fluid studies. III. Establish the neurochemical and neuropeptide profile associated with the range of expression of the putative Tourette gene expression in adult and adolescent patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: All patients are screened with a complete physical and neurologic exam, and a semi-structured interview. Patients then receive a comprehensive assessment of systemic disease. Patients and first-degree family members also participate in a genetic study. Any patient who experiences an unusual exacerbation of symptoms or significant side effects is removed from the study.

Conditions
-----------------
Tourette Syndrome, Obsessive Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnostic and Statistical Manual of Mental Disorders IV lifetime diagnosis of 1 or more of the following: Tourette syndrome (TS) Obsessive compulsive disorder Chronic tics Severely affected adolescents with a score of 3 or greater on the TS-Clinical Global Impression Scale eligible --Prior/Concurrent Therapy-- At least 1 month since any medication --Patient Characteristics-- Other: In good physical health No alcohol or substance abuse No Intelligence Quotient below 80 Negative pregnancy test required of fertile women

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 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
-----------------
Tourette syndrome, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, obsessive compulsive disorder, oncologic disorders, rare disease
Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation

Study Overview
=================
Brief Summary
-----------------
This study aims to gather additional information to support the theory that bipolar disorder is due to cellular (mitochondrial) dysfunction. To test this theory adults with bipolar disorder who are not currently symptomatic will receive a one-time brain scan (magnetic resonance spectroscopy [MRS] scan) with light stimulation. To test whether any MRS findings are specific to bipolar disorder, healthy controls and adults with schizophrenia will also be included in this study.

Detailed Description
-----------------
This study will include males and females between the ages of 18 and 55 years. Participants will include adults with stable bipolar disorder or schizophrenia as well as healthy controls. The study involves a one-time visit that includes a clinical evaluation, laboratory tests, and a magnetic resonance scan that will last approximately 90 minutes. The procedures can also be separated into two study visits, if necessary.

Official Title
-----------------
A Magnetic Resonance Spectroscopy Study of Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation

Conditions
-----------------
Bipolar Disorder, Schizophrenia, Healthy Controls

Intervention / Treatment
-----------------
* Device: Magnetic resonance spectroscopy (MRS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of female 18-55 years Bipolar, currently euthymic OR schizophrenia, stable, OR healthy control with no history of psychiatric illness On stable medication with no changes in the two weeks prior to enrollment Exclusion Criteria: History of substance abuse or dependence within 3 months of enrollment Positive urine drug screen Significant medical or neurological illness Pregnancy Any contraindication to magnetic resonance scanning, including claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All subjects will receive the intervention (MRS scan). | Device: Magnetic resonance spectroscopy (MRS)<br>* 90-minute magnetic resonance scan.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain levels of phosphocreatine (PCr), beta-nucleoside triphosphate (B-NTP), and intracellular pH (pHi). |  | 42 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, Schizophrenia, Healthy volunteer, Brain imaging, Photic stimulation
Low-dose Hydrocortisone in Acutely Burned Patients

Study Overview
=================
Brief Summary
-----------------
Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.

Official Title
-----------------
Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: hydrocortisone 200 mg/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females, between 18 and 75 year old who present a burned surface more than 30% of the body surface who need catecholamine infusion between J0 and J3 after the injury. Exclusion Criteria: pregnancy, trauma, sepsis, cardiac insufficiency, AIDS, etomidate administration

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hydrocortisone 200 mg/day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of catecholamine administration |  |  | 
| Doses of administered catecholamine |  |  | 
| Adrenal insufficiency incidence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, adrenal insufficiency, hydrocortisone, short corticotropin test
Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Gestational Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25), rich in omega-6 fatty acids, will be selected as a controlled oil. The intervention will start from the third trimester of these pregnant women and finish at the 4wk after the birth of their children. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in these patients.

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Fish oil
* Dietary Supplement: Flaxseed oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1)gestational diabetes 2) female, <40 years old 3)willing to participant in the trial Exclusion Criteria: 1）type 1 diabetes or type 2 diabetes before pregnancy 2）Deny to sign the informed consent 3）Family history of hypertriglyceridemia or fasting triglyceride>4.56 mmol/L 4）Have severe liver disease, kidney disease or cancer 5)Participating in the other clinical trial within 30 days 6)Other diseases or conditions, for which the doctor of the patients do not agree his or her participating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fish oil<br>Patients will receive fish oil capsules, at a dose of 2g/day. Each 1g capsule will contain 220mg of EPA and 170mg of DHA | Dietary Supplement: Fish oil<br> <br> |
| Experimental: Flaxseed Oil<br>Patients will receive flaxseed oil capsule, at a dose of 2g/day. Each 1g capsule will contain 550mg of ALA | Dietary Supplement: Flaxseed oil<br> <br> |
| Placebo Comparator: Placebo Supplementation<br>Patients will receive corn oil in the capsules at the same dose as fish oil. The corn oil will appear identical in size and color to the fish oil | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glucose |  | 14 weeks | 
| Fasting insulin |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight, length of children |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
omega-3 fatty acid, gestational diabetes, insulin sensitivity
Phase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF

Study Overview
=================
Brief Summary
-----------------
This study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic contrast agent, AI-700, in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF).

Detailed Description
-----------------
In ongoing clinical trials, AI-700 is currently being evaluated for its value to provide enhanced echocardiography to detect CAD. The patient population is comprised of those patients who have chest pain and are being evaluated for inducible ischemia. This population may include patients with compromised pulmonary function due to COPD or CHF. This study was to evaluate the safety of AI-700 in these patients.

Official Title
-----------------
A Phase 1, Double Blind, Crossover, Placebo-Controlled, Dual-Injection, Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)

Conditions
-----------------
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: AI-700


Participation Criteria
=================

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AI-700|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF |  |  | 
| To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound contrast agent, pharmacokinetics, congestive heart failure, chronic obstructive pulmonary disease, safety
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy

Study Overview
=================
Brief Summary
-----------------
This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure

Official Title
-----------------
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy: A Prospective Randomized Trial

Conditions
-----------------
Ureter Stone

Intervention / Treatment
-----------------
* Other: no stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older unilateral ureteric stones managed by ureteroscopy Exclusion Criteria: Stone size < 2 cm bilateral ureteral stones incomplete stone removal due to impacted stones failed ureteroscopic access to the stone stone migration to the kidney pregnancy active urinary tract infection solitary kidney ureteral stent placed preoperatively severe mucosal injury or perforation suspected additional ureteral pathology such as ureteral stricture urothelial carcinoma or polyp.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: uncomplicated ureteroscopic lithotripsy with DJ-US<br>Following uncomplicated uretroscopic lithotripsy, a double J uretric stent will be placed (usually the standard of care) | |
| Active Comparator: uncomplicated ureteroscopic lithotripsy without US<br>Following uncomplicated uretroscopic lithotripsy no uretric stent will be placed | Other: no stent<br>* following uretroscopy, no stent will be placed<br>|
| No Intervention: uncomplicated ureteroscopic lithotripsy with DJ-US-string<br>Following uncomplicated uretroscopic lithotripsy, a double J uretric stent with an extraxtion string will be placed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score (VAS) | Visual Analog Score (VAS) for flank pain and dysuria score, urgency, frequency, suprapubic pain, hematuria, analgesia requirement, operative time, re-hospitalization, and return to normal physical activity. This is a widely-used scale. It a unidimensional measure of pain intensity. It is administered as a straight horizontal line orientated from the left (worst) to the right (best) , where the patient indicates their situation. | 1 week |