linjc16/ctgov huggingface dataset:
Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)

Study Overview
=================
Brief Summary
-----------------
Single patient treatment with everolimus.

Official Title
-----------------
Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)

Conditions
-----------------
Gastrointestinal Stromal Tumor

Intervention / Treatment
-----------------
* Drug: Everolimus


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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Everolimus|mTOR inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine to define the point of insertion and the depth of the epidural space compared to the blind technique. The study hypothesis is the use of Ultrasound will improve the success rate of epidural placement and may also decrease the rate of complications.

Official Title
-----------------
Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique

Conditions
-----------------
Post Operative Trauma, Acute Pain

Intervention / Treatment
-----------------
* Device: Ultrasound scanning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years and older having a thoracic epidural catheter Both male and female patients. Exclusion Criteria: Pediatric population < 18 years of age Pregnancy Prisoners Absolute Contraindication to thoracic epidural placement severe scoliosis or deformity, Patients with previous spine surgery or hardware implanted at level of epidural placement, Anticipated ventilation postoperatively for a period more that 24 hrs Lack of patient consent to enroll in the study

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 |
| --- | --- |
| Ultrasound scanning<br> | Device: Ultrasound scanning<br>* Ultrasound scanning is used to define needle insertion point and depth of epidural space.<br>* Other names: LogicE GE portable ultrasound machine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of epidural catheter to control pain |  | post operative day # 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complication rate from epidural catheter placement. |  | Immediate complications 24 hrs after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post operative pain, thoracic epidural, acute pain, Ultrasound scanning of the thoracic spine
Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Delayed graft function (DGF) is defined as requirement for dialysis in the first week following kidney transplantation. DGF is a common complication occurring in 39% of the deceased donor renal transplants at the investigators' institution with significant cost and outcome implications. The 3 major risk factors for DGF are donor graft characteristics, recipient factors and perioperative management. The most easily modifiable of these factors is perioperative management, in particular intraoperative fluid therapy. The investigators propose to compare the amount of fluid administered using the current standard of care with the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta, optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration fails to produce an increase in CO.

Official Title
-----------------
Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Device: Esophageal Doppler Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age greater than 18 years signed informed consent listed for deceased donor transplantation. Exclusion Criteria: esophageal surgery or cancer esophageal stricture, varices or diverticulum upper airway surgery coarctation of the aorta significant valvular heart disease clinically significant cardiac arrhythmias patient randomized to other trials with an outcome variable of delayed graft function or early graft function will also be excluded

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goal directed fluid therapy using esophageal doppler monitor<br>The esophageal doppler monitor directs the fluid therapy. | Device: Esophageal Doppler Monitor<br>* Esophageal doppler monitoring (EDM) is a minimally invasive means of continuously measuring the cardiac output from the pattern of blood flow in the descending thoracic aorta.<br>|
| No Intervention: Fluid therapy using standard management<br>The esophageal doppler monitor is in place however blinded to the healthcare providers, fluid management is as per standard clinical practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of crystalloid solutions administered intraoperatively. |  | Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours |
Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.

Official Title
-----------------
ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Lithium
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression) The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent Exclusion Criteria: Schizophrenia or schizoaffective disorder Mental retardation Unstable clinical diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium<br>Potentiation of previous treatment (Quetiapine monotherapy) with Lithium (0.5 - 0.8 mEq/L) | Drug: Lithium<br>* Starting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability.<br>|
| Experimental: Aripiprazole<br>Potentiation of previous treatment (Quetiapine monotherapy) with Aripiprazole (10 - 15 mg) | Drug: Aripiprazole<br>* Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lithium Carbonate, Lithium, Central Nervous System Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Physiological Effects of Drugs, Antimanic Agents, Tranquilizing Agents, Central Nervous System Depressants, Psychotropic Drugs, Sensory System Agents, Antipsychotic Agents, Antidepressive Agents
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD). This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of CirculaseTM for the Treatment of Critical Leg Ischemia

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Drug: Ecraprost in lipid emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2 The subject has exhausted all standard revascularization treatment options at this time. Exclusion Criteria: Subjects with a previous major amputation (at or above ankle) Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of < 20 cc/min, or receiving chronic hemodialysis therapy.

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ecraprost in lipid emulsion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in proportion of subjects who experience a major amputation. |  |  | 
| Reduction in proportion of subjects who die within 6 months from treatment initiation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in major amputation rate only. |  |  | 
| Reduction in critical cardiovascular events. |  |  | 
| Improvement in complete ulcer healing. |  |  | 
| Improvement in pain at rest. |  |  | 
| Improvement in quality of life. |  |  | 
| Improvement in hemodynamic measurements. |  |  | 
| Improvement in neuropathy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ecraprost in lipid emulsion, CLI, peripheral, vascular, amputation, Critical Limb Ischemia due to peripheral arterial disease
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Study Overview
=================
Brief Summary
-----------------
This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Official Title
-----------------
A Phase III 2 Arms, Multicenter, Randomised, Double-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo

Conditions
-----------------
Impetigo

Intervention / Treatment
-----------------
* Drug: Ozenoxacin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area. Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1 Exclusion Criteria: Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozenoxacin<br>ozenoxacin cream 1% | Drug: Ozenoxacin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo cream | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain. | Visit 3 (Day 6-7) |
Addiction Among Mental Health Professionals

Study Overview
=================
Brief Summary
-----------------
Our goal is to determine the representations of addiction among caregivers working in the field of mental health. We hypothesize that caregivers, despite their investment in care, have a negative social representation of patients suffering from addictive disorders, which could be related to a lack of training on the pathology and its social repercussions.

Official Title
-----------------
Work on the Social Representation of Addiction Among Mental Health Professionals

Conditions
-----------------
Addiction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Health professional with more than 5 years of professional experience in the field of management of mental illnesses Health professional having accepted to participate in the study Exclusion Criteria: - Refusal to participate in the stud

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 |
| --- | --- | --- |
| Number of addictions |  | Period from 5 years of professional experience will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
addiction, mental health
Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.

Detailed Description
-----------------
OBJECTIVES: To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer. OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.

Official Title
-----------------
Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: microarray analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed endometrioid endometrial cancer Stage IA, IB, IC, or IIIC disease Any grade Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer Consented to allow their specimens and clinical data to be collected and stored for future research Underwent complete surgical staging, including the following: Hysterectomy Bilateral oophorectomy Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes) Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node) Sufficient high-quality frozen primary tumor for testing with ≥ 75% tumor cellularity and ≤ 10% necrosis PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: microarray analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between microRNA expression and lymph node metastasis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I endometrial carcinoma, stage III endometrial carcinoma
Fractionated Stereotactic Radiotherapy in Patients With Acromegaly

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Fractionated stereotactic radiotherapy is a safe therapy for treatment of patients with acromegaly in terms of both tumour control and biochemical remission

Detailed Description
-----------------
An audit was done on 34 patients with acromegaly (consecutive cohorte) treated with fractionated stereotactic radiotherapy in Rigshospitalet/National University Hospital, Copenhagen, Denmark. All patients had MR control regularly to monitor tunour control, and biochemical control assessed by growth hormone measurements during an oral glucose tolerance test. Furthermore all other pituitary axes were tested for sufficiency and concomitant medication likewise registered. The 7 year interim analysis demonstrated an acceptable tumour control and biochemical remission profile, and most patient had subsequent withdrawal of somatostatin analogue- and growth hormone receptor antagonis therapy. The observational study will continue with a new update in approx 2 years

Official Title
-----------------
Fractionated Stereotactic Radiotherapy in Patients With Acromegaly. Single Centre Experience

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Radiation: fractionated stereotactic radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults active acromegaly pituitary tumour on MRI biochemical activity - Exclusion Criteria: pregnancy no visible tumour on MRI -

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 |
| --- | --- |
| Fractionated stereotactic radiotherapy<br>patients with active acromegaly | Radiation: fractionated stereotactic radiotherapy<br>* Audit of outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour control by pituitary MRI |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical remission |  | 10 years | 
| Affection of other pituitary axes |  | 10 years | 
| withdrawal of somatostatin analogue and growth hormone receptor antagomist |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acromegaly, irradiation, remission, pituitary function