linjc16/ctgov huggingface dataset:
Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS)

Study Overview
=================
Brief Summary
-----------------
Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis. The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT. In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis. The results of the CBCT will be compared to those of the CT scan.

Official Title
-----------------
Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis

Conditions
-----------------
Otosclerosis

Intervention / Treatment
-----------------
* Device: Cone-beam computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis Exclusion Criteria: Pregnancy Breast feeding Patient under a legal protection procedure Patient denying to participate to the study Lack of affiliation to a social security system

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: Eligible patients for cone-beam<br>A cone-beam computed tomography will be offered to the patients undergoing a CT scan for the diagnosis and/or the pre-operative assessment of an otosclerosis, fulfilling the inclusion criterias and without any exclusion criteria. | Device: Cone-beam computed tomography<br>* Cone-beam computed tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis |  | 1 minute |
ThermaChoice III Under Local Sedation in the Office Setting

Study Overview
=================
Brief Summary
-----------------
Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.

Detailed Description
-----------------
A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.

Official Title
-----------------
Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation

Conditions
-----------------
Heavy Uterine Bleeding

Intervention / Treatment
-----------------
* Device: Uterine Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heavy uterine bleeding Exclusion Criteria: Uterine or cervical cancer Unable to tolerate office hysteroscopy Uterine fibroid tumors that distort endometrial cavity Uterine cavity greater than 12 cm Patients with hyperplasia or premalignant changes of the endometrium Active genital or urinary tract infections Intrauterine device Pregnant or want to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

| Intervention/Treatment |
| --- |
|Device: Uterine Ablation|Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Uterine Ablation in the office setting |  | 30 days |
Pediatric Hypothalamic Obesity

Study Overview
=================
Brief Summary
-----------------
This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo. To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Sandostatin LAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female patients ages 6 to less than 18 Patients who have experienced any form of cranial insult related to cranial trauma, or to a tumor or it's treatment (i.e. surgery, radiation, and/or chemotherapy) Patients who are at least one year out following therapy for their tumor Patients who have severe cardiovascular dysfunction (for example cardiomyopathy, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation) will be excluded Patients with severe neurologic handicaps which preclude normal physical activity will be excluded. Patients confined to bed and those patients who are wheelchair bound which prevents them from activities of daily living or normal physical activity, i.e. walking, will be excluded from the trial Your child must be greater than 120% of their ideal body weight for their height or have a body mass index that is greater than or equal to 27.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sandostatin LAR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BMI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat |  |  |
Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery

Study Overview
=================
Brief Summary
-----------------
Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery

Official Title
-----------------
Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery

Conditions
-----------------
Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scoliosis patients Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of surgical guile | To evaluate the accuracy of surgical guide, we use the image during surgery to determine whether it's accurate. | 1 year |
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Study Overview
=================
Brief Summary
-----------------
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.

Detailed Description
-----------------
A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.

Official Title
-----------------
Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age

Conditions
-----------------
Hypothyroxinemia

Intervention / Treatment
-----------------
* Drug: thyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight: less than 1500g Gestation: 22 weeks 0 day ≤ Serum free thyroxine level lower than 0.8 ng/dl Serum thyrotropin lower than 10 μU/ml Age of between 2 and 4 weeks after birth Informed consent Exclusion Criteria: any known thyroid disease in mother

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 4 Weeks

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 |
| --- | --- |
| No Intervention: 2<br>No replacement therapy | Drug: thyroxine<br>* thyroxine at the dose of 5 μg/kg-wt /day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor development at 1.5 years of age |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor development at 3 years of age |  | 6 years | 
| Somatic growth at 3 years of age |  | 6 years | 
| Duration of hospital stay |  | 6 years | 
| Frequency of morbidities during the stay in NICu |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
very low birth weight infant, hypothyroxinemia, outcomes
In-vivo Efficacy of Patient Preoperative Prep

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Detailed Description
-----------------
The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.

Official Title
-----------------
Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP

Conditions
-----------------
Surgical Skin Preparation

Intervention / Treatment
-----------------
* Drug: ZuraPrep
* Drug: ChloraPrep
* Drug: ZP Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of any race Subjects in good health Minimum skin flora baseline requirements on abdomen and groin Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area. Exclusion Criteria: Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics. Subjects with a history of skin sensitivity, skin allergies, or skin cancer. Subjects who are pregnant, attempting pregnancy or nursing.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZP (70% IPA)<br>Isopropyl alcohol (IPA) 70% | Drug: ZuraPrep<br>* Apply topically.<br>* Other names: ZP;|
| Active Comparator: ChloraPrep<br>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | Drug: ChloraPrep<br>* Apply topically.<br>* Other names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%;|
| Placebo Comparator: ZP Vehicle<br>ZP without IPA | Drug: ZP Vehicle<br>* Apply topically.<br>* Other names: ZP without IPA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Reduction | A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success. | 10 minutes post product application | 
| Bacterial Reduction - Abdomen | A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success. | 10 minutes post product application |
The AVERT Sepsis Investigation

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to utilize heart rate variability and respiratory rate variability in patients with sepsis to predict clinical deterioration and death. Our specific objectives are: To study the ability of a change in composite variability (∆CVI) assessment to act as a prognostic aid in predicting disease progression in sepsis. To study the effect that standard resuscitation interventions will have on the direction and magnitude of ∆CVI in patients with sepsis. B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter composite variability index (CVI) over 4 hours will predict a significant increase in the combined outcome of overt shock, organ dysfunction, and mortality. H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over 4 hours will be associated with a low or declining CVI.

Official Title
-----------------
The AVERT Sepsis Investigation: Assessment of Variability in Early Resuscitation and Treatment of Sepsis

Conditions
-----------------
Sepsis, Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Antibiotics ordered or administered (as surrogate for suspected or confirmed infection as primary reason for hospital admission as determined by the primary team) 2. Serum lactate ≥ 2.0 mmol/L or transient hypotension (any systolic blood pressure < 100 mmHg). 3. Identification within 12 hours of a qualifying lactate measurement or hypotension episode 4. Hospital admission planned for suspected infection as primary reasons for admission (per emergency medicine team). Exclusion Criteria: 1. Age < 18 years 2. Pregnancy 3. Non-sinus cardiac rhythm (atrial fibrillation, active pacemaker, SVT) 4. Evidence of Overt Shock upon enrollment: Hypotension: SBP < 90 mmHg for ≥ 60 minutes Any vasopressor or inotrope use (e.g. norepinephrine, dopamine, vasopressin, dobutamine) 5. Acute respiratory support (BiPAP or mechanical ventilation) before enrollment 6. Inability to obtain written informed consent from patient or legally authorized representative 7. Inability to wear Zephyr Bioharness device

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 |
| --- | --- |
| ED patients with suspected infection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive organ failure | A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital) | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Shock
Hydronephrosis ARFI Study

Study Overview
=================
Brief Summary
-----------------
Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as the reference standard.

Official Title
-----------------
Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis

Conditions
-----------------
Hydronephrosis

Intervention / Treatment
-----------------
* Procedure: AFRI-SVI Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or younger You are scheduled for diuretic scintigraphy (DRS)testing - Exclusion Criteria: None -

Ages Eligible for Study
-----------------
Maximum 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: ARFI-SVI Ultrasound<br>Ultrasound scan using acoustic radiation force impulse-shear wave velocity imaging in the characterization of pediatric hydronephrosis. This is a non-invasive scan that uses sound waves to create the images. | Procedure: AFRI-SVI Ultrasound<br>* This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI)a new ultrasound technology in which unique sound waves create the images/pictures of the kidney beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARFI-SVI | fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology. | 6 months |
A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.

Official Title
-----------------
Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection

Conditions
-----------------
HIV Infections, Histoplasmosis

Intervention / Treatment
-----------------
* Drug: Itraconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. Residence in an area endemic for H. capsulatum. Absolute CD4 count < 150 cells/mm3. No current or past active histoplasmosis. No other active fungal infection. Life expectancy of at least 1 year. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma. Inability to take oral medication. Concurrent Medication: Excluded: Systemically-active antifungals. Investigational drugs (expanded access drugs are acceptable). Rifampin. Rifabutin. Terfenadine. Astemizole. Phenobarbital. Phenytoin. Carbamazepine. H2 blockers. Omeprazole. Continual antacids. Patients with the following prior conditions are excluded: History of intolerance to imidazole or azole compounds. Prior Medication: Excluded within 1 month prior to study entry: Investigational drugs (expanded access drugs are acceptable). Excluded within 15 days prior to study entry: Rifampin. Rifabutin. Terfenadine. Astemizole. Phenobarbital. Phenytoin. Carbamazepine.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itraconazole|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
-----------------
Itraconazole, Histoplasmosis, Acquired Immunodeficiency Syndrome